JP2008538937A - Apparatus and method for endovascular annuloplasty - Google Patents

Abstract

 Methods, apparatus and systems are provided for performing endovascular repair of atrioventricular valves and other heart valves in the heart. Atrioventricular valves, particularly mitral valve regurgitation, can be repaired by modifying a tissue structure selected from the leaflets, annulus, valve chordae and papillary muscles. These structures can be repaired using an interventional tool introduced into the chamber of the heart by suturing, stapling, applying a snare or shortening. The tissue structure can be temporarily repaired before permanent modification. For example, the opposing leaflets can be temporarily grasped and held in place before permanent attachment. In one embodiment, the structure is placed in the groove region of the annulus and the shape of the valve is modified.

Description

(Reference to priority document)
This application claims the priority of co-pending US Provisional Patent Application No. 60/674931, filed April 25, 2005 and having the name “DEVICE AND METHODS FOR ENDOSCOPIC ANNULOPLASTY.” Priority is claimed herein and the entire contents of the provisional US application are incorporated herein by reference.

  This application is a continuation-in-part of US Provisional Patent Application No. 10/820581 filed April 7, 2004 and having the name “METHODS AND APPARATUS FOR CARDIAC VALUE REPAIR”. Which is a continuation of US patent application Ser. No. 10 / 635,766 filed on May 5, which is now US Pat. No. 6,629,534, under 37 CFR 1.78 (a). US patent application Ser. No. 09 / 544,930 filed Apr. 7, 2000 claiming the benefit of US Provisional Patent Application No. 60 / 128,690 filed Apr. 9, 1999 under section 119 (e). This is a continuation application of the issue. The entire contents of that application are incorporated herein by reference.

  The present invention relates generally to medical methods, apparatus and systems. In particular, the present invention relates to a method, apparatus and system for a less invasive intravascular surgical repair to a cardiac atrioventricular valve, particularly a mitral valve.

  Mitral regurgitation is characterized by a retrograde flow from the left ventricle of the heart through the less capable mitral valve to the left atrium. During the normal cycle of heart contraction, the mitral valve acts as a check valve that prevents oxidized blood from flowing back into the left atrium. Thereby, the oxidized blood is sent into the aorta through the aortic valve. Reflux in the valve can significantly reduce the efficiency of the heart to pump blood and risk serious and progressive heart failure for the patient.

  Mitral regurgitation can result from many different structural defects in the mitral valve. The leaflet of the valve, the tendon of the valve that connects the leaflet to the papillary muscle, or the papillary muscle itself can be damaged or dysfunctional. In general, damage to the annulus, hypertrophy, or loss of function may limit the ability of the mitral valve to fully close against increased blood pressure in the left ventricle.

  The most common treatment for mitral regurgitation is by valve replacement surgery or by enhancing the annulus function by implanting a mechanical support ring or other structure. The latter is commonly referred to as “valve annuloplasty”. Recent techniques related to mitral valve repair based on suturing the adjacent sites of the opposing leaflets of the valve include what are referred to as “bow-tie” or “edge-edge” techniques.

  All of these techniques are very effective, but they are usually by open heart surgery, which typically opens the patient's chest by a sternotomy and the patient is bypassed with a heart-lung machine. The requirement of both opening the chest and providing the patient with a bypass poses a psychological trauma to the patient, resulting in the morbidity associated therewith.

  For these reasons, alternative and alternative methods, devices and systems are desired for repairing heart valves, including mitral valves and other tricuspid valves, which are separate atrioventricular valves. Such methods, devices and systems preferably do not require open chest access and are performed intravascularly, i.e., inserted from a location within the patient's vasculature remote from the heart toward the heart. Should be used. More preferably, the methods, devices and systems should not require cardiac bypassing, but the methods, devices and systems may be bypassed by the patient and / or the heart by drugs or other techniques. It should also be useful for patients who can be temporarily stopped.

  It is an object of the present invention to provide a method, apparatus and system for less invasive endovascular surgical repair of the heart atrioventricular valve, particularly the mitral valve.

  The present invention provides for intravascular repair of a heart valve, particularly an atrioventricular valve that prevents backflow of blood from the ventricle during systole, and more particularly a mitral valve between the left ventricle and the left atrium. Methods, apparatus and systems are provided. As used herein, “endovascular” refers to the use of interventional tools, guides, and support catheters and other devices that are introduced into the heart chamber from the arterial or venous vasculature of a patient at a distance from the heart. Means the procedure to be performed. Interventional tools and other devices can be introduced percutaneously, i.e., through an access sheath (sheath) or via a surgical phlebotomy, and then through the vascular system from a distal access point. Until it reaches the heart. That is, this procedure generally does not require a penetration directly through the muscles outside the heart, i.e. the myocardium, but a penetration is made inside the heart, i.e., through the atrial septum, to ensure the desired access path. May be. Although these procedures are usually performed percutaneously and intravascularly, many of these tools are very minimally invasive and open surgical procedures, and include resection surgery or port access through the heart wall. Applicable. In particular, a tool that captures the leaflets prior to attachment is applicable in almost any type of procedure for modifying the function of the heart valve.

  Atrioventricular valves are located at the junction of the atria and their corresponding ventricles. The atrioventricular valve between the right atrium and the right ventricle has three leaflets (anterior leaflets) and is called the tricuspid valve or right atrial valve. The atrioventricular valve between the left atrium and the left ventricle is a bicuspid valve having only two leaflets (anterior leaflets) and is generally called a mitral valve. In either case, the leaflets are coupled to a base in a region called the atrial annulus, and the leaflets generally extend downwardly from the annulus into the associated ventricle. In this way, the leaflets open during diastole when the atria are full of blood, allowing blood to flow into the ventricle. However, during systole, the leaflets are pushed together and close, preventing the backflow of blood into the atria. The lower ends of the leaflets are connected to each other via a tendon-like tissue structure called a chordae, and the chords themselves are connected to the papillary muscles at the lower ends. The interventional operations described herein can be performed on any of the leaflets, chords, annulus, papillary muscles, or combinations thereof. The general purpose of such interventional manipulation is to modify the way the leaflets coalesce or close during systole to minimize or prevent backflow. Although this procedure is most useful for atrioventricular valves, at least some of the tools described herein can also be used to repair other heart valves, including aortic valves.

  The methods described herein typically access a vascular system remote from the patient's heart, through which the interventional tool is delivered to the ventricle and / or the atrium to form or support an atrioventricular valve. And engaging this tool. Engaging the tool with the tissue structure modifies the tissue structure in such a way as to reduce valve leakage or backflow that occurs during ventricular contraction. The tissue structure referred to here is any one or more of a group consisting of a leaflet, a chord, an annulus, a papillary muscle, an atrial wall, a ventricular wall, or an adjacent structure. Prior to engaging the tool with the tissue structure, the orientation of the interventional tool can also be determined in relation to the atrioventricular valve and / or tissue structure, if desired. The interventional tool may be oriented by itself (eg, pre-shaped) or may include an active mechanism that determines, adjusts, and otherwise positions the tool in the direction of travel. Alternatively, the orientation of the intervention tool may be determined completely or partially using another guide catheter, in which case the guide catheter is pre-shaped and / or determines the direction or position of the tool. Active means for determining may be included, such as US patent application Ser. No. 10 / 441,753 filed May 19, 2003, No. 10/441508 filed May 19, 2003, and May 19, 2003. Illustrated in the apparatus described in US application Ser. No. 10 / 441,687, the contents of all of these patents are incorporated herein by reference. In all cases, it is desirable to verify the position of the tool prior to engaging the leaflet or other tissue structure. This orientation step includes determining the position of the tool relative to the fusion direction within the atrioventricular valve, eg, engaging the positioning element within the commissure of the valve, MRI, intracardiac ultrasonography ( ICE), transesophageal echo diagnosis (TEE), fluoroscopic imaging diagnostic apparatus, endoscope, intravascular ultrasound diagnostic apparatus (VUS), and the like, and the target position is confirmed.

  In a first embodiment, the tissue structure consists of leaflets and the engaging step consists of attaching one or more opposing points on or along the leaflets to each other. In the case of a bicuspid mitral valve, the attachment point may be located at or near the center of each leaflet and generally has a symmetrical structure between the two openings or attachment points and each of the two commissures. To produce. Alternatively, the attachment point may be proximate to each of the commissures. Both effectively reduce the area in which the valve can be opened. In the case of a tricuspid valve, any two of the three leaflets may be completely or partially closed together, or all three may be partially closed.

  In either case, the leaflets can be attached by various methods such as stitching, clipping, needle closure, rivet locking, adhesion, fusion, and so on. Each of these methods vary greatly in the procedure and the equipment used to perform them, but the end result is the same, i.e., the atrioventricular valve closes against the increased pressure in the ventricle during systole It is to increase ability. In order to improve the juxtaposition of the leaflets, it may be preferable to attach the leaflets to a point located inside the free end of the leaflets. Usually, the attachment point in the leaflet is a position of 1 mm to 4 mm inward from the free end.

  In many cases, it is desirable to stabilize the interventional tool against the leaflets and other cardiac tissue structures at least at some point during the interventional procedure. In a broad sense, the main purpose of such stabilization is to link the movement of the interventional tool with the movement of the heart so that the difference in movement when the tool engages a leaflet or other target tissue structure is minimized. Is to do. This stabilization can be done via an interventional tool or via a guide catheter or other platform used to deliver the interventional tool. In either case, stabilization is usually achieved by engaging the atrial septum, atrial wall, annulus, chordae, papillary muscles and other cardiac tissue structures. As an antegrade approach, it is particularly effective to fix the guide catheter, interventional tool or both against movement relative to the annulus or valve commissure. As a retrograde approach, it is particularly effective to fix against the papillary muscles, chords or the leaflets themselves. Stabilization should be distinguished from valve capture, which usually occurs after interventional tools and / or guide catheters have been stabilized in the heart. Thus, the method may consist of up to four independent steps prior to valve fixation. Initially, the interventional tool and / or guide catheter is placed either actively or passively. Second, the interventional tool and / or guide catheter is stabilized in the heart. The interventional tool is then used to capture the leaflets. The leaflets are then placed prior to fixation, and repositioning is performed to determine if specific fusion or fixation can prevent valve backflow if necessary. Finally, if it is confirmed that the backflow can be sufficiently prevented, the leaflets can be fixed by any of the methods described below.

  In a specific method, the interventional tool can be mechanically stabilized by fixing the shape of the tool after it has been advanced to a position close to the atrioventricular valve. For example, the interventional tool can be composed of a plurality of interconnected elements that can be locked in place, such as a “bend-shaped” device. Such mechanically lockable devices can be used alone or in combination with any of the other stabilizing devices described herein.

  When attaching leaflets together, it is often desirable to temporarily capture the leaflets before performing the final attachment step. For example, the leaflets can be captured using forceps or other grippers introduced as part of the intervention tool or separately. After capturing the leaflets, transesophageal echo diagnosis (TEE), intracardiac ultrasonography (ICE), other ultrasound imaging techniques, angioscopy, magnetic resonance imaging techniques using catheters (MRI) ), Normal heart imaging techniques such as computer tomography (CT) can be used to observe the flow through the valve. By observing the flow through the valve in this way, and more importantly, by determining whether the backflow continues or is sufficiently prevented, the desired attachment shape for the leaflets can be determined. it can. If continuation of backflow is observed, the leaflets are repositioned and it is again determined if there is backflow. This rearrangement is repeated until a position where backflow is sufficiently prevented is found. Before determining the final attachment location, the location of attachment within the leaflets, the stress acting on the leaflets, and other factors can be visually checked. In a preferred embodiment, the same is achieved if the leaflets are fused by a gripping device that also has a locking mechanism such as staple closure, stitching, clipping or rivets, so that the desired attachment shape is achieved temporarily. Final gripping can be done using tools, leaflet gripping is a joint-type gripping tool, a gripping tool using vacuum, a gripping pin, and other temporary attachment modes described in more detail below. Can be achieved using. After the leaflets are in the desired shape, they can be permanently secured together by any of the techniques described above.

  In a second embodiment, the tissue structure consists of chordae and the engagement step consists of joining opposing chordae, ie chords attached to different leaflets. Typically, chords are partially collected using sutures or other loop structures or joined together. It may be desirable to tie each chord in close proximity to one another at one or more locations.

  In a third embodiment, the tissue structure consists of chordae and the engaging step consists of supplying energy to shorten the chordae. It has been found that certain forms of thermal energy, more specifically high frequency energy, modify and contract collagen, thereby tightening chordal support. Applying energy to shorten one or more chordae that attach one or both of the leaflets (all three in the case of a tricuspid valve) modifies the flow through the atrioventricular valve and It can be minimized. In one embodiment, the chords are first grasped or captured and processed to temporarily apply tension to the leaflets. The effects of such temporary shortening can then be visually assessed, and if the performance of the valve is observed to be improved, energy can be supplied to shorten the chordae. In many cases, however, clips, rings, suture loops or other mechanical elements are used to twist the chords, fold, or otherwise, as described elsewhere herein It would be preferable to shorten the chords permanently.

  In a fourth aspect, the tissue structure consists of an annulus and the engaging step consists of tightening or shortening the annulus from the outer periphery. In a preferred technique, the annulus is reinforced by placing and attaching a support structure on the annulus in a manner that is broadly similar to the patency surgical placement of the annuloplasty ring. Alternatively, the annulus can be contracted by plication, or, in some cases, by contracting tissue within the annulus by supplying high frequency energy as mentioned above for shortening chords. it can.

  In a fifth embodiment, the tissue structure consists of papillary muscles and the engaging step consists of capturing and pulling opposing points or portions of the papillary muscles together. This method is similar in many respects to the acquisition of chords, and generally consists of suturing opposing portions of the papillary muscle or otherwise forming a bond between them. As with chordae, it is generally undesirable to close both papillary muscles together, but in some cases such methods may also be useful.

  In all aspects of the method described above, the heart continues to beat normally while the interventional tool engages the tissue structure. However, if the heart is beating, temporarily stop valve activity at least at some point during the procedure to facilitate grasping of the leaflets, especially when such techniques are employed. May be desired. The heart rate can be lowered temporarily by intravenous injection of a beta blocker such as esmolol, or it can be completely stopped for a short time, eg 5-10 seconds, by injection of a drug such as adenosine. Alternatively, valve activity can be stopped by temporarily raising the corresponding intraventricular pressure higher than the pressure in the diastole. In this case, the heart continues to beat, but the opening and closing operation of the leaflets stops, so that a gripping operation is possible. As yet another method, as described in more detail below, leaflet movement can be mechanically suppressed directly or by capturing chordae. Although such a method may be effective for some purposes, the difficulty of initially capturing the leaflets still exists.

  Although each of the methods described herein is particularly desirable because it allows the procedure to be performed without stopping the heart, they can also be applied to patients undergoing cardiopulmonary bypass surgery. Such cardiopulmonary bypass includes both conventional systems and recently developed intravascular bypass systems such as those obtained from Heartport Inc., Redwood City, California, and can be accomplished by currently available techniques.

  During procedures performed while the heart is beating, it is often desirable to stabilize the interventional tool against one or more heart tissues before grasping the leaflets with the interventional tool. Such stabilization reduces the relative movement between the tool and the structure. The mechanism for stabilization may be independent of or integral with any part of the system or device, including but not limited to guidewires, guide catheters and interventional tools. Similarly, the stabilization mechanism may provide one or more additional functions during the tissue modification procedure, such as determining the direction of travel, assessing orientation, grasping, healing, adjusting, and fixing. it can. Thus, many components of the system can have a dual purpose.

  The fusion can be performed by many methods such as capturing each leaflet or releasably capturing the chord attached to each leaflet. An example of a capture device consists of one or a pair of snares that advance through the chordae to capture or entangle individual chordae. The snare can then be contracted to pull the chords together and at least partially constrain the valve movement. After such a fusion has taken place, the leaflets, chords, papillary muscles or annulus can be engaged and modified, for example using other interventional tools as described above or elsewhere. Can be attached. Alternatively, if it is deemed that the function of the valve is sufficiently repairable with temporary fusion, it can form a permanent connection, bridge or capture of the chordae. In some cases it may be sufficient to simply disconnect the snare or other capture mechanism and leave it permanently in place. In other cases, a more permanent attachment structure, such as a suture loop or metal coil, can be substituted for the snare. For example, after placing the snare in place, if the valve function is restored to an acceptable level, the snare may be pulled from the chord through the placement catheter, in which case the snare removes the tissue. Pull over the length of the suture in a needle-like manner. The suture is then tied or otherwise formed with a permanent capture loop for the chordae. Alternatively, another attachment structure such as a metal coil, a key-shaped catheter, or a Marco Co catheter can be sent around the chords of the snare, and the structure can be separated and permanently captured to be left in place. it can.

  The above method can be performed by antegrade or retrograde access within the blood vessel through the vasculature. Hereinafter, antegrade and retrograde access methods for accessing the mitral valve will be described. Access to the mitral valve is generally more difficult than access to the tricuspid valve. In the retrograde method, an intervention tool, optional guide catheter or other support device is introduced through the distal arterial vasculature, over the aortic arch and through the aortic valve into the left ventricle. Typically, a normal femoral artery access route is taken through the aortic arch or through the brachial artery, but it is also possible to reach the desired location through the brachial artery, axillary artery or carotid artery. Upon entering the left ventricle, the interventional tool is generally directed downward and away from the mitral valve structure. The interventional tool is then bent and approaches the mitral valve from below, usually through the chords and toward the annulus. For example, the intervention tool enters the left ventricle through the aortic valve and then bends or otherwise turns 90 degrees to directly access the mitral valve and chordae. Control of the direction of travel of the tool can be achieved by means such as bending the support catheter using a pull wire or using a pre-formed curved catheter. Since the papillary muscle is generally located below the aortic valve and aligned in the same orientation as the tool as it enters the left ventricle, access to the papillary muscle may be more direct.

  It is often desirable to deploy an interventional tool toward a target tissue structure using a pre-formed and / or guide catheter with controllable direction of travel. In a retrograde approach, a guide catheter is inserted from an access point, eg, a femoral artery in the patient's buttocks, over the aortic arch, through the aortic valve, and introduced into the left ventricle, where the target tissue structure is reached. Form an access path. If the tissue structure in question is a chord or leaflet, the guide catheter must usually be bent, flipped, or inverted to allow it to go around the interventional tool. In addition, it may be desirable to stabilize the distal end of the guide catheter. Stabilization can be achieved by extendable elements, wires, cages, balloons and other structures that engage annulus, chordae or ventricular wall portions. Alternatively, two or more stabilizing extensions may be provided that project forward from the guide catheter and seat in valve commissure to place and hold the guide catheter in place. Such extendable elements can also be used to stabilize guidewires, interventional tools, and other types of catheter systems. A specific stabilization structure will be described in more detail below.

  Access to perform an antegrade endovascular approach is made into the right atrium through the inferior or superior aorta. Such antegrade access is itself sufficient to perform treatment for the tricuspid valve from the top of the valve. However, such treatment is not described in detail here. Access to the mitral valve typically requires passing a tool through the atrial septum from the right atrium into the left atrium. The atrial septum can be penetrated intravascularly by conventional techniques, but is typically done using a Brockembler needle as described in the literature on valvuloplasty. Once penetration into the atrial septum has taken place, the treatment tool is passed into the left atrium to access the mitral valve from the apex. Such an approach requires the access path to bend downwards, but the angle is typically in the range of 0-120 degrees.

  The superior vena cava can be accessed through various normal peripheral access sites such as the internal jugular vein, while the inferior vena cava can be accessed through the femoral vein. Such access can be made percutaneously or by phlebotomy.

  Guide catheter placement can be used for the antegrade vein approach as well as the retrograde artery approach. A guide wire is used to route the guide catheter from the initial access position through the superior or inferior vena cava into the right atrium. The guide catheter is then adapted to pass through the path through the atrial septum and into the left atrium, where the guide catheter is pre-shaped or deflected to access the mitral valve from the top. The interventional catheter delivering the guidewire, guide catheter and / or interventional tool can be controlled in direction of travel and can have a stabilizing element. For example, in this particular embodiment, the guide catheter has two or more laterally extensible wires that can control the direction of travel and / or projects forward and sits around the annulus or commissure to place the guide catheter in place. Can have multiple stabilizing arms. The interventional tool is then placed through the guide catheter and the desired valve repair procedure is performed.

  The system described herein includes a guide catheter configured to pass from a patient's distal vasculature to a location within the heart adjacent to a target atrioventricular valve or other heart valve. The system further includes an interventional catheter configured to pass through the guide catheter and engage the target atrioventricular valve or other heart valve and / or associated cardiac structure, and the target atrioventricular valve or And other interventional tools for interventional catheters adapted to modify the heart valve, annulus, valve chords or papillary muscles to reduce reflux. In particular, the guide catheter can be configured to provide an antegrade or retrograde approach to the mitral valve, as described above. The guide catheter can further include a stabilizing element for engaging tissue within the heart to reduce relative movement between the guide catheter and tissue while the heart is beating. This structure may be any of the cages, wires, etc. already described with respect to the method description. In addition, the interventional catheter can have a stabilizing element for engaging tissue structures within the heart so as to reduce relative movement between the interventional catheter and the tissue. The stabilizing element may also be an expandable cage, a wire with controllable direction of travel, etc., and may include a vacuum mechanism and / or surface finish to enhance the bond. Specifically, the intervention tool includes a suturing device, a staple device, a clip application device, a high-frequency electrode, a surgical adhesive application device, an annuloplasty ring, and the like.

  Both the interventional tool and the guide catheter are stabilized to engage tissue structures within the heart so as to reduce relative movement between the interventional tool and / or guide catheter and the heart, particularly the atrioventricular valve. A mechanism can be used. The stabilization mechanism is the same in both cases. Typically, the stabilization mechanism is adapted to engage at least one tissue structure selected from the group consisting of the atrial septum, atrial wall, annulus, valve commissure, valve chords and papillary muscles. . For example, the stabilization mechanism can be deployed radially outward and can have one or more extendable wires that can engage tissue structures such as valve commissures. Alternatively, the stabilization mechanism can have an expandable cage that can be placed to occupy all or at least a majority of the atria above the atrioventricular valve. In yet another configuration, the stabilization mechanism is a pair of inflated balloons spaced apart from each other and adapted to engage the atrial septum as the intervention tool and / or guide catheter passes through it. Yes.

  In a more specific embodiment, the interventional tool can comprise a leaflet capture device intended to temporarily hold the leaflets before correction, eg, fixation. For example, the leaflet capture device comprises a pair of extendable elements that can be advanced from the tip of the intervention tool tool to engage and capture two leaflets of the mitral valve or three leaflets of the aortic valve. be able to. Certain capture tools can grasp the leaflets by pinching the leaflets and partially or completely penetrating or puncturing and / or aspirating. The tool can consist of a claw device, a loop device, a coil-type device, a fork (prong) type device or a vacuum device for gripping and holding the leaflets.

  The present invention further provides a method for grasping an atrioventricular valve or other heart valve, particularly a mitral valve, to serve a subsequent procedure or other purpose. The grasping method consists of capturing a chord attached to at least one leaflet of the valve while the heart is beating. Capturing the chord from below the valve can modify the leaflet movement, improve the valve function, and close the opposing leaflet parts toward each other as needed. Normally, the chords attached to the leaflets (or three leaflets in the case of a tricuspid valve) are simultaneously captured. For example, one or more snares, such as a helical coil, can be advanced into the chord to capture that portion and prevent it from moving. Alternatively, the loop element is advanced through the valve chords and contracted to modify the function of the valve. In some cases, capture of the chords can be permanent and sufficient to treat potential reflux. Otherwise, the chordal capture is primarily due to the healing of the leaflets and the leaflets are fixed by subsequent treatment steps. Preferably, the subsequent intervention step is performed while the chord is being captured. The chords can then be released after the leaflets or other tissue structures have been modified.

  The present invention further provides a chordae capturing catheter comprising a catheter body having a proximal end and a distal end. Means for capturing the chords are provided at or near the distal end of the catheter body. The first exemplary means consists of one or more coils that can extend from the tip of the catheter and engage the chordae when advanced into the chordae. A second exemplary means can be extended from the tip of the catheter and is a loop-shaped element that is pre-shaped to pass through the chordae on one or both, preferably both leaflets It consists of and pulls each chord together to modify the function of the valve.

  Another method according to the invention for grasping atrioventricular or other heart valve leaflets consists of capturing the two leaflets separately, preferably sequentially. Such capture is performed by a leaflet capture catheter having at least three claws or fork-like protrusions for grasping. The first leaflet is captured between the first pair of forked protrusions and the second leaflet is captured between the second pair of forked protrusions. The two pairs of fork-like projections can have a common projection in the center as needed. Typically, the center projection is fixed (non-movable), and the two outer projections are axially supported and adjacent to each other. A gripping device such as a pair of nails is formed. By capturing the two leaflets separately and sequentially, each leaflet is held in a suitable juxtaposition and an improvement in valve function is observed. Alternatively, two leaflets may be captured simultaneously. If sufficient improvement is obtained, the valve can be permanently attached in separate steps. The leaflet capture catheter can optionally include a device for securing the valve, for example, a clip attached to the valve when the leaflet capture catheter is withdrawn.

  The present invention also provides a leaflet capture catheter suitable for performing the above method. These catheters consist of a catheter body having a proximal end and a distal end. A leaflet gripping device is provided at or near the distal end of the catheter body. The leaflet gripping device has at least three fork-like protrusions, and at least two of the three protrusions are pivotally supported. It can be activated separately to capture individual leaflets separately, or it can be activated simultaneously to capture each leaflet together. The catheter optionally further comprises means for attaching the leaflets after they have been captured, preferably a clip attachment device.

  The present invention further includes a leaflet capture catheter and tool that utilizes a vacuum to grip the leaflet and manipulate the leaflet to place it in the desired location, the catheter typically having at least two vacuum channels at the tip. The channels are preferably positionable separately at the tip and can be activated independently of each other. This allows at least two leaflets to be captured and positioned separately while the basic catheter is stationary. The catheter can be placed in an antegrade or retrograde manner with the tool between the leaflets and optionally between the chordae. The tool and / or catheter may further include a modification device as needed, which may include a suturing device, a staple driving device, a clip mounting device, a rivet driving device, an adhesive applicator, heating to shorten the chordae Devices, and for specific intervention tools described below. Similarly, the present invention further includes catheters and tools having a lumen for monitoring pressure in the chamber of the heart and / or injecting a radiopaque contrast agent.

  The invention further includes a method of modifying a patient's heart valve. This method consists of feeding a catheter through the vascular system and into the heart from a vascular access point at a location remote from the patient's heart. The catheter has at least one structure releasably coupled thereto. The method further comprises inserting the structure from the catheter into a groove on the ventricular side of the annulus of the heart valve, the structure modifying the annulus to reduce backflow in the heart valve. Also, in combination with the arrangement of the structure, the valve leaflets of the heart valve are held together to reduce backflow in the heart valve.

  The invention further includes a method of modifying a patient's heart valve. This method consists of feeding a catheter through the vascular system and into the heart from a vascular access point at a location remote from the patient's heart. The catheter has an annuloplasty device releasably coupled thereto. The method further modifies the annulus to treat the groove on the ventricular side of the annulus of the heart valve to reduce backflow in the heart valve, and in combination with performing the procedure, Including reducing back flow in the heart valve by modifying the spatial relationship between the first and second leaflets of the heart valve.

The details of the embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims.
I. Cardiac physiology

  The left ventricle LV during the systole of a normal heart H is shown in FIG. The left ventricle LV is contracted, and blood flows outward and flows in the direction of the arrow through the tricuspid valve (aorta) AV. The reverse flow of blood through the mitral valve MV, i.e., regurgitation, means that the mitral valve is configured as a check valve and flows in the opposite direction when the pressure in the left ventricle is higher than the pressure in the left atrium LA. Prevented by preventing. The mitral valve MV has a pair of leaflets with a free end FE that must be uniformly closed, as shown in FIG. The opposite end of the leaflet LF is attached to the surrounding heart structure along an annular region called the annulus AN. The free end FE of the leaflet LF is fixed to the lower part of the left ventricle LV via a chord CT (hereinafter referred to as a chordae) including a plurality of branching tendons fixed to the lower surface of each leaflet LF. . On the other hand, the chord CT is attached to the papillary muscles PM extending upward from the lower portions of the left ventricle and the atrial septum IVS.

  Referring now to FIGS. 2-4, various structural defects in the heart can cause mitral valve regurgitation. In the broken chordae RCT as shown in FIG. 2, insufficient tension is transmitted to the leaflets via the chordae, which may cause a step-out of the leaflets LF2. The other leaflets LF1 maintain a normal shape, but these two leaflets cannot properly associate and leak from the left ventricle LV to the left atrium LA as indicated by the arrows.

  Reflux also occurs in patients with cardiomyopathy, where the heart is enlarged and the leaflets LF cannot associate properly as shown in FIG. 3 due to its size. Cardiac hypertrophy enlarges the mitral valve annulus, making it impossible for the free end FE to associate during systole. The free ends of the anterior and posterior leaflets normally meet along the fusion line C as shown in FIG. 3A, but a large gap G remains as shown in FIG. 3B for patients with cardiomyopathy there is a possibility.

Mitral regurgitation can also occur in patients with ischemic heart disease, in which case papillary muscle PM function is inhibited as shown in FIG. Even if the left ventricle LV contracts during systole, the papillary muscle PM does not contract sufficiently to close the valve properly. Then, as shown in the figure, the leaflets LF1 and LF2 cause a step-out. In this case as well, leakage from the left ventricle LV to the left atrium LA occurs as indicated by the arrow.
II. Interventional approach

  The methods and apparatus described herein treat heart valve regurgitation, particularly mitral regurgitation, through interventional procedures at various sites. First, as shown in FIG. 5, the leaflets LF are directly attached or coupled to each other by the structure S or other means. Typical structures include sutures, staples, clips, pins, and other types of locking devices commonly used to attach opposing tissue surfaces. Alternatively, the surface of the tissue facing the leaflets can be attached using an adhesive, fusion energy such as high-frequency current, laser energy, microwave, or ultrasonic energy. Hereinafter, various specific methods for attaching the leaflets will be described.

  A second and often preferentially used intervention point is in the chord as shown in FIG. Here, the attachment structure S connects individual chords attached to each of the two leaflets LF. Various structures such as snares, sutures, staples, coils, clips, snaps, rivets, adhesives, etc. can be used. Opposing chords are also attached, usually directly and optionally using any of the above structures. Alternatively, the opposing chords can be linked or coupled indirectly by a structure that links or couples their movement but does not physically attach the chords that exit each of the leaflets directly directly to each other. . In addition to attaching chordae, interventions on chords include shortening chords. For example, the chordae can be physically shortened by applying energy to contract the collagen in the chords or using a mechanical pleating device such as a clip.

The third intervention point is the annulus AN (see FIG. 1) of the mitral valve MV. An annuloplasty device, such as a ring or partial ring, can be mounted on the annulus to strengthen or reshape the annulus. The atrial side of the annulus has a smooth and inclined surface around the mitral valve. However, it is difficult to attach the annuloplasty device to the smooth surface of the annulus. The ventricle side of the annulus has a concave annular groove along the periphery of the valve. This groove provides a place where the annuloplasty device can be placed and secured to the tissue. Thus, percutaneous annuloplasty can be achieved more easily by feeding the annuloplasty ring to the ventricle side rather than the atrial side of the annulus, which will be described in more detail below.
III. Access to the mitral valve

  Access to the mitral valve or other atrioventricular valve is preferably achieved by a percutaneous approach through the patient's vasculature. The term percutaneous means that access to parts of the vasculature away from the heart is made through the skin, typically using phlebotomy or less invasive procedures such as Seldinger technique Used to mean access with a needle. The possibility of percutaneous access to the distal vasculature is described in the patent and medical literature and is well known. Depending on the access point to the vasculature, the approach to the mitral valve may be “antegrade” and may require entering the left atrium across the atrial septum. On the other hand, the approach to the mitral valve is “retrograde” and may require entry into the left ventricle through the aortic valve. Once percutaneous access has been made, the interventional tool and support catheter are advanced into the blood vessel to the heart and then placed in a position adjacent to the target heart valve in various ways as described elsewhere herein. Can be placed. While these methods are preferably percutaneous and endovascular, many of the tools described herein perform open surgery that stops the heart and accesses the heart valve through myocardial tissue. It can also be used in some cases. Many of these tools can also be used in minimally invasive procedures that are accessed using a thoracoscope and stop the heart, but in some cases the beat may continue.

  A typical antegrade approach to the mitral valve is shown in FIGS. Access to the mitral valve MV is from the inferior vena cava IVC or the superior vena cava SVC, through the right atrium RA, across the atrial septum IAS, and approaching the left atrium LA above the mitral valve MV You can do it. As shown in FIG. 7, the catheter 10 with the needle 12 can be advanced from the inferior vena cava IVC to the right atrium RA. When the catheter 10 reaches the anterior side of the atrial septum IAS, the needle 12 can be advanced through the septum at the fossa FO or foramen ovale and inserted into the left atrium LA. At this point, the needle 12 can be replaced with a guide wire and the catheter 10 can be withdrawn.

  As shown in FIG. 8, access through the atrial septum IAS usually holds the placement of the guide catheter 14 typically above the guidewire 16 positioned as described above. Maintained by Guide catheter 14 allows subsequent access and allows for the introduction of interventional tools used to make valve or tissue modifications, as will be described in more detail below.

  The antegrade approach to mitral valve described above has many advantages. For example, by employing an antegrade approach, centering and stabilization of the guide catheter and / or interventional tool can usually be more accurately and effectively performed. As well as being placed in the correct position, it corrects the tissue modification, especially the fixation of the leaflets or chords. The antegrade approach can also reduce the risk of damaging the structure under the valve while introducing and operating the catheter and interventional tool. In addition, the antegrade approach eliminates the risks associated with crossing the aortic valve. This is especially important in patients with artificial aortic valves that must not be traversed. When using chordal fixation, the tool can be placed very close to the free end of the leaflets. This is because the tool is removed in a direction away from the chord on which fixation is performed. In addition, the antegrade approach allows more direct access to the leaflets that are not hindered by the presence of chordae.

  A typical retrograde approach to the mitral valve is shown in FIG. In this case, access to the mitral valve MV is performed by approaching the aortic valve AV from the aortic arch AA and approaching the left ventricle below the mitral valve MV. Access to the aortic arch AA may be through a normal femoral artery access path and also by a more direct approach through the brachial artery, axillary artery or radial artery or carotid artery. Such access can be achieved by using a guide wire 42. Once placed in place, the guide catheter 40 can be manipulated over the guide wire 42. Guide catheter 40 allows for subsequent access and allows for the introduction of interventional tools used to make valve or tissue modifications, as described in more detail below.

  In some cases, a retrograde arterial approach to the mitral valve has advantages and is preferred. The retrograde approach eliminates the need for a puncture through the septum. The retrograde approach also has the advantage that it is more commonly done by cardiac specialists and is therefore accustomed. In addition, the retrograde approach allows more direct access to the chordae.

Intervention tools used to perform valve or tissue modifications may be specifically designed for the approach or may be interchangeable. For example, a tool can be designed specifically for an antegrade or retrograde approach, or it can be designed to be used in both approaches. In either case, the tool can be used in any suitable way to achieve the desired result. However, to eliminate ambiguity, a nomenclature has been devised that shows the general usage of such tools. Tools that are primarily located within the atrium to perform corrective actions are called “atrial” tools. These use an antegrade approach. Tools that are primarily located in the ventricle for performing corrective actions are called “ventricular” tools and employ a retrograde approach. Tools for performing corrective actions across the valve, whether located in the atrium or in the ventricle, are called "atrial-ventricular" tools and employ either an antegrade or retrograde approach You can also
IV. Control of direction of travel

  In order to approach a given valve or tissue for effective treatment, it is necessary to position the catheter, tool and device in the proper orientation as described above throughout the treatment procedure. Placing in such an orientation necessitates general control of the progress of the device to a predetermined position, and then finely controlling the movement of each part of the device to achieve the desired result.

  Schematic control of device progress can be achieved in a number of ways. First, a guide catheter, interventional tool, and / or treatment device can be introduced into the appropriate location using a wire whose direction of travel is controllable. A guide catheter can be introduced by accessing the femoral artery at the patient's buttocks, for example by phlebotomy or Seldinger technique. After placing the guide wire, the guide catheter can be introduced to the desired location along the guide wire. Alternatively, it is possible to introduce a shorter and differently shaped guide catheter through the other paths described above.

  Second, the guide catheter may be pre-formed in a shape that provides the desired orientation with respect to the mitral valve. For example, as shown in FIGS. 9 and 10, the distal end of the guide catheter 40 is formed in a J shape in advance, and after being placed through the aortic valve AV above the aortic arch AA, the distal end is the mitral valve MV. You can be headed towards. As shown in FIG. 9, the guide catheter 40 is configured to extend downward into the left ventricle LV and turn over so that the intervention tool or catheter is positioned closer to the axial direction of the mitral valve MV. be able to. 10 guides an interventional catheter (not shown) transverse to the direction of access to the mitral valve MV. Each of the guide catheters shown in FIGS. 9 and 10 has applications for different situations. For example, the guide catheter 40 of FIG. 10 is particularly suitable for introducing a tool for correcting chord CT, but the guide catheter 40 of FIG. 9 may be more useful for engaging the tool with the leaflets. As shown in FIG. 9, the guide wire 42 can be placed directly from the tip of the guide catheter 40 through the opening of the mitral valve MV. The interventional tool is then guided along the guidewire 42 and placed to perform the specific procedure described below. Similarly, the intervention tool itself can be pre-formed to achieve the desired orientation.

  Third, the guide wire, guide catheter or interventional tool can be actively bent. For example, it has a push / pull wire that can be bent by selecting the direction of the tip in 1, 2, 3 or 4 directions depending on the number of pull wires, a shape memory nitinol, or a balloon With a wire, wire cage, or similar mesh structure, the device can be moved away from the heart structure, i.e., to the desired location, but these are only examples.

  Any of the guide catheters 40 shown in FIGS. 9 and 10 can have the ability to control the direction of travel. For example, as shown in FIG. 11, two or more adjustment wires 46 may be provided at the distal end of the guide catheter 40. These adjustment wires can be active or passive and can be placed within the commissure of the valve to improve the positional relationship between the mitral valve MV and the guide catheter. As shown in FIGS. 12A and 12B, the adjustment wires 46 can be placed in the inner commissure MVC and the outer commissure LVC so that the guide catheter 40 can be moved further inward in FIG. 12B from the central position as shown in FIG. 12A. Can move to a position. The catheter can be moved laterally (not shown) as well. The ability to deploy a guide catheter has significant advantages in performing the specific interventions and valve modifications described below. It will be appreciated that an interventional catheter introduced via a guide catheter can be provided with a similar direction control mechanism. And in some cases, it is most desirable to have the ability to control and position the guidewire, guide catheter and interventional catheter in the direction of travel.

  A direction control wire 50 may be provided on the guide catheter 40 to engage the opposing surface in the left ventricle LV as shown in FIG. By providing such a control capability in the traveling direction, it is possible to move the distal end of the guide catheter 40 further downward from the mitral valve. The guide catheter 40 of FIG. 13 has its own controllability in the direction of travel and is particularly useful when combined with an interventional catheter that engages a portion of the mitral valve, such as the valve commissures described above. It is.

  As shown in FIG. 14, the guidewire 52 can have a direction of travel control element 54 that can be bent in a lateral direction that can be placed, for example, within the commissure of the valve as previously described. In this way, the guidewire 52 can be placed inside or outside the mitral valve MV, and the interventional catheter 56 can be placed along or along the guidewire to the desired target structure in or around the mitral valve MV. To be introduced. Providing a guide wire that can be controlled and positioned in this manner is particularly advantageous when it is desired to place the tip of the interventional catheter 56 in a region sufficiently below the mitral valve opening. is there. That is, neither the guide catheter nor the interventional catheter need to be fully advanced to the mitral valve opening, so they can be freely placed in different locations.

  In some cases, it may be desirable to introduce each interventional tool sequentially or simultaneously from both antegrade and retrograde directions. The guide catheter and guidewire can be introduced separately by the approach described above, but at least in some cases, a single guidewire is passed between the vena cava and the right atrium, as previously described It may be preferred to cross the atrial septum. The guidewire can then be passed through the aortic valve in an antegrade direction, through the ascending and descending aorta, and percutaneously out of the vasculature at a location remote from the heart, such as the femoral artery.

  By deploying a single guidewire in this way, a continuous “rail” through the heart is achieved, allowing separate devices to be deployed in both antegrade and retrograde directions. In addition, any interaction between the devices since each device advances toward each other in a controlled and guaranteed positional relationship with the guide wire, eg, any two devices meet each other when fully advanced Alternatively, cooperative operation is possible. In this way, one device extends inwardly from the venous side of the heart in a antegrade direction to the mitral valve and a second device enters from the retrograde direction through the arterial side of the heart. . These two devices will be in precise positional relationship during the subsequent approach and will meet at or near the mitral valve as needed. A specific example is the introduction of a stabilizing catheter in a retrograde direction to approach the chordae below the mitral valve leaflets, and temporary stabilization as generally described above And / or leaflet fusion can be achieved. The catheter carrying the anchoring device is then advanced in a antegrade manner so that the leaflets are approached from above. Thereafter, if adequate temporary stability is obtained by the first device, the second device can be driven independently to fix the leaflets.

  Fourth, a guide wire, guide catheter or interventional tool can be positioned using a floating balloon. This seems most useful in the antegrade approach. The balloon at the tip of a balloon guide wire or balloon floppy catheter can be inflated and antegradely lifted within the mitral valve. When the heart is beating slowly, blood flows from the left atrium through the mitral valve to the left ventricle. The floating balloon can move along this flow trajectory, pulling on the guide wire or catheter. The balloon is then deflated and a newly placed guidewire or catheter can be used as needed.

  Fifth, a rigid and pre-formed mandrel or insertable member can be used to place a hollow guidewire, guide catheter, interventional tool or other tool. As shown in FIGS. 15A-D, the mandrel 600 can be composed of wire, metal, plastic, or any suitable material that can be formed to hold a desired shaped portion 601 such as a bend or protrusion. The mandrel 600 can then be inserted into the lumen within the flexible structure 602 to be positioned. Such a structure may be a hollow guidewire, guide catheter, interventional tool or any other tool or structural component. As the shape portion 601 is advanced, the flexible structure 602 conforms to its shape and deforms as the shape portion 601 passes through it. This can be used to place the structure or components of the structure at the desired location for subsequent steps in the treatment procedure.

It will be appreciated that any of the devices, systems and methods used for general control of the direction of travel can be applied to fine control over the direction of travel of the device or device components to achieve the desired result. Let's go. In particular, it is desirable to operate the components of the intervention tool independently or interdependently throughout the procedure. Such control of the direction of travel allows the component to be energized and moved relative to the leaflets, annulus, atrial wall or other specific heart structure. This can be achieved using any of the devices or methods described above.
V. Orientation evaluation

  Performing valve or tissue modifications requires that the systems and devices be properly oriented. Both the device and the components of the device need to take into account the relative orientation with respect to the heart structure and where they are placed. Heart structures whose orientation is a problem include the atrial wall, atrial septum, annulus, leaflets, valve commissures, valve chords, papillary muscles and ventricular walls, but many others . Evaluation of component and device orientation can be accomplished by a number of mechanisms and methods.

  First, the orientation can be evaluated with feedback on the user's haptics. Introduction and manipulation of the device and components allows contact with the heart structure or other devices. Such contact allows the device to be guided to an appropriate position and in an appropriate orientation. For example, the force on the tip of a guide wire, catheter or interventional tool against the leaflets, valve commissures, annulus, valve chords, papillary muscles and ventricular and / or atrial wall and others can be sensed tactilely. This force is transmitted over the entire length to the proximal end, providing feedback to the physician or operator. Similar results can be obtained using sensors. In addition, the catheter or tool can have a lumen for monitoring pressure. This provides feedback throughout the treatment procedure, which indicates the presence and extent of mitral regurgitation.

  Second, orientation can be assessed by visualization of the device and the component itself. Components of the entire system can be modified to improve the visibility of echo images and / or fluoroscopic images. The visibility of the substance contained in the blood medium in the echo image depends on the acoustic impedance between the substance and the blood (the product of the density of the medium through which the sound wave propagates and the speed of sound). Thus, a thin polymer coating on the component or the entire system results in modulation of acoustic impedance at the interface between the component and blood, improving the visibility of the echo image. Similarly, small air bubbles trapped in the surface or embedded in the coating can also improve the visibility of the echo image. Similarly, the visibility of a fluoroscopic image can be improved by using a coating or a marker band that does not transmit radiation. Furthermore, by providing a lumen inside the catheter or tool and injecting a radiopaque contrast medium, it is possible to improve the visibility of the surrounding tissue in a fluoroscopic image. In any case, such coatings, markings and fluids allow the device or component itself, as well as the structure or element to be visible throughout the treatment procedure. Similarly, orientation can be checked using a blood vessel microscope throughout the procedure.

  Third, one or more orientation elements can be used to assess the relative orientation of the heart structure, particularly the target valve and component and / or system. An orientation element may be any structure or function that provides information regarding the orientation of the components, devices or systems described herein. These elements may be separate from the device or system and may be integral with any part thereof. They are removably or fixedly attached to guidewires, guide catheters, interventional tools and / or other devices. Similarly, an element may be a component of a device, or part of a component, that provides one or more additional functions in a tissue modification procedure, such as stabilization, grasping, fusion, adjustment or fixation. Furthermore, the element is an atrium, ventricle or atrial-ventricular device, which may or may not traverse the valve in the orientation assessment process. In addition, such elements can be used to control and / or determine the direction of component and system travel prior to or simultaneously with the evaluation.

  The orientation element can take the form of a propeller, wing, petal, arm, loop, and the like. One or more of these elements are present, but typically extend radially from the central shaft. If there are two elements, they are generally spaced 120 to 180 degrees around the central shaft. More than two elements are arranged in a radial pattern around the central shaft. In a preferred embodiment, the orientation elements are arranged perpendicular to or along the fusion line. This provides the most useful criteria, but other orientations can be used.

  Examples of orientation elements arranged perpendicular to the fusion line are shown in FIGS. FIG. 16 is a view of the mitral valve MV viewed in the short axis direction, and shows an orientation element 612 having a pair of orientation structures 613 arranged around the central shaft 614 at intervals of 180 degrees. The orientation element 612 is shown perpendicular to the fusion line C. Such a position of the orientation element 612 is such that the device is positioned in the desired orientation, the component is positioned in the desired orientation, or the device or component is easier to see than the rest of the device. Indicates that the element is oriented.

  FIG. 17 is a view of the mitral valve MV as viewed in the long axis direction. Here, the guide wire 615 having a pair of orientation propellers 616 is shown inserted through the mitral valve MV in a retrograde approach. Visualization of the propeller 616 allows the guidewire 615 to be repositioned until the propeller is perpendicular to the fusion line C. At this point, the guide catheter, intervention tool or other tool can be guided along the catheter in the desired orientation. Such a guidance operation can be performed using a keyway, a notch, an ellipse or other shaped lumen as a guide. Similarly, such an orientation propeller 616 can be mounted on a guide catheter and a keyed lumen can be used to guide the insertion of the intervention tool.

  Examples of orientation elements arranged along the fusion line are shown in FIGS. FIG. 18 is a view of the orientation element 620 inserted in the opening of the valve along the fusion line C as viewed in the long axis direction. The end view of FIG. 19 shows the orientation element 620 passing through the valve opening and the leaflet LF sealing against the element 620. Some portions of the orientation element 620 can contact the commissure CM at each end of the valve opening for support and / or reference. By using the position of the orientation element 620 as a reference, the position of various heart structures, particularly the leaflets LF, can be known. In addition, if the position of specific elements of the device can be known in relation to the orientation element 620, such positional relation can be used to define the positional relation of those elements with the heart structure. For example, if it is known that the orientation element is perpendicular to the grasping device, the orientation device is disposed in the manner described above so that the grasping device is disposed perpendicular to the fusion line C, or It is guaranteed that it is in the desired position for gripping the leaflet LF.

  In this example, the orientation element 620 is a bag that can be inflated and is coaxially attached to the central shaft 621 at the tip. Such bags are composed of compliant or non-compliant materials such as PET, PUR, silicone, chronoprene. The bag material itself can appear in an echo or fluoroscopic image, or it can be filled with a fluid or suitable medium, such as carbon dioxide or stirred saline, that appears in the echo or fluoroscopic image. In the inflated state, as shown in FIG. 19, when the mitral valve is viewed in the short axis direction, the bag is wide or thick so that the end face of the bag can be seen. It is desirable for the bag to have a length or height sufficient to seal against it.

  In addition, as shown in FIG. 20, the bag 625 can be supported by a frame 626. The frame 626 is made of a suitable material such as nitinol, stainless steel, plastic or combinations thereof, and its flexibility is constant or variable or variable, such as round wire, hollow tube or flat ribbon shape It can have a cross-sectional shape. This material may be a material that appears in an echo or fluoroscopic image or may be processed to have such an effect. Furthermore, the shape of the frame 626 can be any suitable symmetric or asymmetric shape including, but not limited to, a triangle, a square, a circle, an ellipse, a one or two humps, and the like. FIG. 20 shows a rectangular case. Frame 626 may also be inflatable as shown in FIGS. 21A-C. In the collapsed state shown in FIG. 21A, the bag 625 and contained frame 626 can be inserted through a lumen in the guide catheter or interventional tool. Once in place, the frame 626 is slowly expanded as shown in FIG. 21B to the desired shape shown in FIG. 21C. It will be appreciated that the orientation element functions without inflating the bag 625 or with only the frame 625 without the bag.

Fourth, the orientation of the device can also be assessed by visualizing the flow pattern caused by the relative position of the system or component relative to the heart structure. As mentioned above, the heart may be beating slowly during the tissue modification procedure. As the heart beats, blood flows from the left atrium through the mitral valve to the left ventricle. By visualizing this flow pattern using color Doppler echocardiography, one can infer how the system or components are arranged. For example, as shown in FIG. 22A, if a thin planar structure 650 is inserted into the opening of the valve so that its long axis is perpendicular to the fusion line C, it will be high for blood passing through the unsealed portion 651. Level backflow may occur. As shown in FIG. 22B, if this structure 650 is inserted so that the long axis is along the fusion line C, a lower level of backflow may occur due to a better seal of the leaflets LF to the structure 650. . In this way, such a structure 650 or similarly designed device can be used as an orientation element.
VI. Stabilization

  It may normally be desirable to temporarily stabilize the condition of the interventional tool relative to the heart structure prior to performing valve or tissue modification or interventional procedures. The term “stabilization” means that the interventional tool is somehow coupled to the heart structure so as to reduce any relative movement between the tool and the heart structure. Heart structures available for this connection include the atrial wall, atrial septum, annulus, leaflets, valve commissure, valve chords, papillary muscles and ventricular walls, but many others. Such stabilization is performed to facilitate subsequent interventional procedures. For example, an access catheter can be mechanically coupled to a valve or tissue surrounding a valve such as an annulus or chordae, an interventional tool can be placed from the catheter, sutured, stapled, snared, annuloplasty, high frequency The desired interventional procedure such as modifying the tissue can be performed. Stabilization is usually released after a particular valve correction procedure is completed, but in some cases, stabilization may be re-executed many times throughout the duration of the treatment procedure.

  The stabilization mechanism may be separate from the system or device or may be integrated with that part. They are removably or fixedly attached to guidewires, guide catheters, interventional tools and / or other devices. Similarly, an element is a component or part of a device that provides one or more additional functions in a tissue modification procedure, such as control of direction of travel, orientation assessment, grasping, fusion, adjustment or fixation. It may be. Furthermore, this mechanism is an atrium, ventricle or atrial-ventricular device that may or may not traverse the valve in the stabilization process. In particular, such a mechanism can be used to control and / or orient the components and the system's direction of travel before or simultaneously with stabilization.

  In the preferred embodiment, the stabilization mechanism can be classified into three general categories for purposes of illustration: 1) stabilization for the atrial septum, atrial wall or ventricular wall, 2) stabilization for the valve, and 3) chordae Or stabilization for papillary muscles. Stabilization to the atrial septum is useful when approaching antegradely with an atrial or atrial-ventricular device. As described above, the antegrade approach involves traversing from the right atrium RA through the atrial septum IAS to the left atrium LA. This can be done with a needle bearing catheter, which is then replaced with an introducer, guide catheter or similar catheter. An interventional tool is introduced through this catheter to perform a tissue modification procedure. To prevent the catheter from moving axially, a stabilization mechanism can be used to engage and lock the catheter to the atrial septum. In the preferred embodiment shown in FIG. 23, a catheter shaft 660 having a distal balloon 661 and an inflated proximal balloon 662 is shown on the opposite side of the atrial septum IAS. By inflating the balloons 661, 662 toward the septum, the shaft 660 is engaged with the septum and the system is stabilized. It will be appreciated that similar results can be obtained using many components having a disk, cage, ball, mesh, or other structure in place of one or more balloons.

  Stabilization to the atrial septum can also be achieved by forming a rigid introducer or guide catheter that passes through the atrial septum and the left atrium. Such introducer or guide catheter is typically flexible over its entire length so that it can be introduced through a tortuous path of the vasculature. As described above, in the antegrade approach, the catheter is inserted through the atrial septum and its distal end hangs down in the left atrium. In the case of a flexible catheter, the movement in the septum is not transmitted linearly to the catheter tip. Therefore, relative movement may occur between the tip and the portion passing through the partition wall. As a result, the bond between the tip and the portion that passes through the septum may be weakened. In a preferred embodiment, the catheter shaft between and including the tip and the portion passing through the septum is configured to be rigid. Referring to FIG. 24, the catheter shaft 670 can be composed of stacked elements 671. The element 671 is a disk having a dome portion or a coller portion having a dome-shaped end portion, and this is mechanically coupled by a structure 672. The structure 672 connects the respective central portions of the elements 671 in a flexible manner as shown so that the shaft 670 can be formed into a desired shape suitable for use in a tissue modification procedure. Once the desired shape is formed, the structure 672 is stiffened to maintain that shape. By providing such rigidity, any movement of the atrial septum is transmitted to the tip of the catheter shaft, thereby coupling the catheter to the heart movement. This improves the stability of the devices and systems used in tissue correction procedures. It will be appreciated that shafts of varying stiffness as described above can be used for coupling to any cardiac function and can be used with or as part of any device component used in the procedure. . This function can thus be used to lock any component of the device, catheter or tool in place once it has been manipulated to the desired shape. This is useful in various situations in addition to those described above.

  Stabilization to the valve is most useful when performing an antegrade approach with an atrial device or an atrial-ventricular device, but is also useful when performing a retrograde approach with a ventricular device or an atrial-ventricular device. When taking an antegrade approach, stabilization is most easily achieved by coupling one or more components of the device to the atrial wall, annulus, leaflets and / or commissures of the valve.

  Coupling to the atrial wall can be achieved by a number of stabilization mechanisms. In each embodiment, a structure such as a wire, ribbon, mesh, cage or balloon is extended outward from the device to contact the atrial wall and apply a radial force. Such contact couples the atrial movement to a stabilization device. A preferred embodiment is shown in FIG. In this case, the flexible wire 680 bends radially from the catheter shaft 681, and the bent portion contacts the atrial wall AW. It will be appreciated that any number of wire patterns or means extending from the shaft can be utilized as described above.

  Coupling to the annulus can be accomplished by a number of stabilization mechanisms, many of which involve simultaneous coupling to other functions of the valve such as leaflets and / or commissures. In a preferred embodiment, such stabilization mechanism consists of a ring, wing, petal, arm, and the like. Bonding can be strengthened by changing the surface friction and / or combining the structures in a vacuum. One or more of these mechanisms exist, but typically extend radially from the central shaft. If there are two elements, they are generally arranged around the central shaft at an interval of 90 to 180 degrees, preferably at an interval of 120 to 180 degrees. More than two elements are arranged in a radial pattern around the central shaft. The structure, dimensions, angles and arrangement can be adjusted to the individual patient's physical characteristics.

  An example of such an embodiment is shown in FIGS. In FIG. 26, the guide catheter 14 can have a placeable adjustment wire 20 that functions as a stabilization mechanism. The wire 20 is typically attached at one end to the distal end of the guide catheter 14 and advanced at the other end for selective placement from the guide catheter to engage the mitral valve MV. The adjustment wire 20 can act to stabilize or secure the guide catheter relative to the mitral valve MV by coupling to the annulus, leaflet or commissure.

  Similarly, the guide catheter 14 can have any number of stabilizing elements as shown in FIGS. 27-29. As shown in FIG. 27, the stabilization element consists of a number of petals 22 arranged around the tip of the guide catheter 14. Similarly, the stabilizing element may be a single large loop 25 as shown in FIG. Alternatively, the interventional catheter 30 can have a plurality of stabilizing arms 34 (FIG. 29) that position and secure the distal end of the interventional catheter 30 relative to the annulus. Usually at least three stabilizing arms are used, but the figure shows four cases and any number can be used. The stabilizing arm is a pre-formed elastic metal rod (eg, composed of Nitinol or other shape memory alloy or superelastic alloy), ribbon, tube, polymer or composite thereof, It can be selectively extended from the tip to engage the annulus. The interventional catheter 30 of FIG. 29 is shown with an independently extendable intervention tool 36 that performs the desired valve or tissue modification as described in detail below. Such a stabilizing element preferably engages an annulus located around the mitral valve MV to apply forward pressure to the annulus and achieve axial stabilization while maintaining contact.

  Stabilization can also be achieved by applying radial pressure to the commissures. As shown in FIG. 30, a pair of stabilizing elements 32 extend radially from the guide catheter 14 or intervention tool 30 and are brought into commissural contact. The distance between the elements 32 is equal to or slightly larger than the distance between commissures to which a radial force is to be applied. Stabilizing element 32 is composed of any suitable material such as nitinol, stainless steel, plastic, or combinations thereof, the flexibility of which is constant or unchanged or variable, round wire, flat ribbon, hollow It can have any cross-sectional shape such as a tube. As shown in FIGS. 31A-31D, the shape of the stabilizing element includes a triangle (FIG. 31A), a quadrangle (FIG. 31B), a circle, an ellipse, a double hump (FIG. 31C) or a single hump (FIG. 31D). Can be any suitable symmetric or asymmetric shape, but not limited thereto. It will be understood that such a stabilization mechanism can also function as an aforementioned frame 626 (FIG. 20), particularly in orientation assessment. Therefore, these are materials that appear in echoes or fluoroscopic images, or may be processed to have such effects. In addition, such stabilizing elements are passive, i.e. pre-sized and shaped to the patient's physical characteristics and are intended to engage the annulus without adjustment, or active It will be appreciated that it may be used to control the direction of travel of the guide catheter as described above.

  Many stabilization mechanisms apply radial and axial pressure to the valve for stabilization. For example, the two-hump element shown in FIG. 31C includes an upper hump 700 protruding into the left atrium and contacting the upper annulus and possibly the left atrial wall, and a lower surface of the annulus protruding into the left ventricle And optionally has a lower hump 701 that contacts the left ventricular wall or chordae. The upper hump 700 can apply a downward axial force to the annulus, and the lower hump 701 can apply an upward axial force. The constriction 702 between the humps is configured or adjustable to fit between each commissure and apply a radial force to the commissure. Similarly, the single hump element shown in FIG. 31D can provide similar stabilization without additional support from the protruding lower hump. In addition, this design is easier to place within the mitral valve.

The last descriptive category of stabilization mechanism is stabilization against chordae. Stabilization against chords is most useful when approaching retrogradely with ventricular or atrial-ventricular devices. Coupling to the chords is useful for stabilization in making tissue modifications to the valves, chords, annulus, or combinations thereof. When modifying the valve, contact with the valve structure (typically gripping the leaflets) is still required. However, when modifying chordae, this step is included in the stabilization method, so no additional contact (eg grasping chordae) is required. Therefore, stabilization for chords is described in Section VIII “Grip”.
VII. Immobilization

  Immobilization refers to substantially delaying or reducing the movement of the heart structure or temporarily stopping the heartbeat cycle. This can be done in various ways. First, drugs are injected to temporarily slow or stop the heart cycle. Such drugs include, but are not limited to, esmolol, adenosine, isofluorane and transarrest (stop) mixtures, with or without electrical pacing. Similarly, the heart cycle can be stopped by inducing atrial fibrillation.

  The mechanical immobilization of the valve can be done in various ways. The simplest is to reduce or stop valve motion by making the corresponding intraventricular pressure higher than the pressure in the atrium during systole. For example, an appropriate fluid is injected into the ventricle to increase ventricular pressure, or the aortic valve is temporarily disabled to increase ventricular systolic pressure. Alternatively, interventional tools and / or catheters bearing such tools may simply be mechanically stabilized with respect to valves, valve commissures, annulus, ventricular wall, atrial wall, etc. as generally described above.

Mechanical valve immobilization usually involves more interaction with the valve than simple stabilization. Immobilization usually involves the capture and immobilization of either or both leaflets (or all three in the case of a tricuspid valve) or the acquisition and immobilization of chordae. For example, a balloon or mesh cage is placed under one or both leaflets to temporarily close them. By temporarily immobilizing or adjusting the valve motion, eg, changing the fusion point, it can be determined whether a particular corrective action is sufficient to treat the reflux sufficiently. For example, by temporarily grasping the leaflet at a specific point and holding both leaflets together, the backflow is sufficiently reduced by permanent stitching, stapling or other fixation at that point It can be determined whether it is possible. When the heart is beating, the valve regurgitation can be examined in real time by a normal imaging method such as TEE. If a temporary valve modification seems sufficient, any of a variety of intervention techniques can be used to make it permanent.
VII. Grip

Valve or tissue modification or intervention most commonly involves grasping a portion of the valve or tissue to be modified. Grasping in this way adjusts the tissue to make appropriate corrections (such as leaflet fusion), checks the position of the tissue to improve biological function, and also performs tissue correction for the correction procedure It is useful for stabilizing or immobilizing. As described above, grasping in this way stabilizes another tissue that is modified in the procedure, and also stabilizes the valve by grasping the chords to correct the valve, for example. Useful. Since the most common treatment procedures include, for example, valve modification or chordal modification, the following describes gripping these cardiac structures. However, it will be understood that the grasping devices, systems and methods described herein are applicable to other structures of the heart.
A. Grasping chords

  Grabbing the chords includes capturing and securing the chords, as shown in FIGS. 32-40. In particular, as shown in FIGS. 32A and 32B, the guide catheter 40 can deploy a first capture coil 60 and a second capture coil 62 through a pair of deployment catheters 64 and 66, respectively. By arranging each coil while visualizing, the first capture coil 60 captures the chords attached to the first leaflet LF, and the first coil 62 attaches to the second leaflet LF. Capture chords. The capture coil is typically an elastic wire, preferably made of a superelastic material such as Nitinol, and fed out of a linearly shaped indwelling catheter. The capture coil takes the form of a helix or other shape that can be unwound from entering the chordas as it is advanced out of the placement catheter.

  Next, the coils 60 and 62 are pulled together in the lateral direction, and the leaflet LF is fused by advancing the holding ring 68 fixed to the distal end of the placement wire 70 as shown in FIG. 32B. This draws the leaflets together and immobilizes them for subsequent interventional procedures. Alternatively, if only immobilization through the coils 60 and 62 is sufficient, this placement state can be made permanent. In particular, temporary immobilization is a great advantage in that the operation of the valve can be examined by a real-time image inspection technique when examining whether a sufficient response to backflow has been made. If the response to the backflow is not sufficient, the coil placement state may be redone, or the relative positions of the two coils 60 and 62 may be changed until a sufficient response is realized.

  It will be appreciated that if further interventional steps are then required, it can be done either in an antegrade or retrograde approach. In the following, various specific intervention techniques are described in detail.

  An antegrade approach to deploy a single chordal snare 74 and secure the suture loop around the captured chordas as needed is shown in FIGS. 33A and 33B. The guide catheter 14 placed on the leaflet LF of the mitral valve MV can be placed as described above. A pair of deployment catheters 76 and 78 are advanced from the tip of guide catheter 14 and can be viewed in real time using any of the aforementioned imaging techniques. As shown in FIG. 33A, a pre-formed snare 74 is unwound from the first deployment catheter 76 and advanced through both chords CT. The capture loop 80 is advanced out of the second deployment catheter 78 and is positioned so that it is in the path of the pre-formed snare 74 when advanced through the chord CT. After the capture tip 82 has passed through the capture loop 80, the loop is contracted and secured to the capture tip 82, and the tip is pulled into the second placement catheter 78. The capture tip 82 is attached to the end of the suture 84 (FIG. 33B) that passes back through the lumen in the snare 74. In this way, the suture is pulled into the second deployment catheter 78, while the snare 74 is pulled back into the first deployment catheter 76, and only the suture in place grips both chordae. Leave in state. The fusion of the leaflets LF can then be corrected in the desired manner by forming a permanent loop through the chordae by tying or otherwise securing the suture. As in the previous embodiment, the advantage of this approach is that the valve fusion is first observed using a real-time imaging function, sufficient for valve regurgitation prior to permanent chordal capture. It is to be able to confirm whether or not an appropriate measure has been taken.

  FIG. 34 shows another method for placing the suture and capturing the chord CT. A first deployment catheter 90 (placed through a guide catheter not shown) is placed through the opening between the leaflets LF. The balloon 93 attached to the tip of the chord snare 92 is extended through the chord as described above. Balloon 93 is inflated and floats through the mitral valve during backflow. The balloon passes through a pre-placed capture snare 95. Alternatively, the chordal snare 92 is formed so that the chordae snare 92 surrounds the chordae and then passes out through the valve opening and into the pre-placed capture snare 95.

  A chordal stabilization catheter 100 that is particularly suitable for a retrograde approach is shown in FIG. Catheter 100 includes a catheter body 102 having a pair of lumens 104 and 106 extending from a proximal end (not shown) to the tip shown in FIG. 35A. The main lumen 104 extends completely to the distal end of the catheter body 102, and the chordal snare 108 slides into the lumen. Snare 108 has a pre-formed loop at its tip and takes the shape shown in FIG. 35 when extended from catheter 100. The loop generally has a diameter in the range of 3 mm to 20 mm and is shaped to flip inside the second loop formed by the capture snare 112. The capture snare 112 is disposed within the second lumen 106 and exits from an opening 114 formed at a distance from the distal end of the catheter 100 to the proximal side. The distal end of the capture snare 112 is secured at an anchor point 116 within the distal end of the catheter body 102. This allows the capture loop to move between the two positions depicted by the solid and dashed lines by extending and pulling the capture snare 112 back.

  With reference to FIGS. 36A and 36B, the use of the catheter 100 to capture and stabilize chordae CT will be described. The catheter 100 is introduced in a retrograde direction (although an antegrade direction is possible) and typically passes through the guide catheter 40 as generally described above. While observing directly (for example, in a fluoroscopic image), the tip of the catheter 100 is generally guided to a position in the chord CT as shown in FIG. 36A. The chordal snare 108 is then extended from the tip so that it passes through and entangles the chordae CT attached to both leaflets LF. The tip of the chordal snare 108 passes through the loop defined by the capture snare 112, also as shown in FIG. 36A. The capture snare is then tightened to hold the tip of the chordal snare, and then the capture snare is tightened to tighten the snare loop that typically passes through the chordae as shown in FIG. 36B. In general, the catheter 100 is not intended to permanently fix the chordae CT. Instead, immobilization of the leaflet LF is intended to facilitate subsequent treatment steps as described below. Employing a retrograde approach to immobilization of chordae CT is particularly useful in the case of antegrade intervention.

However, the catheter of FIG. 35 can be modified to facilitate retrograde intervention while the chords are stabilized. As shown in FIG. 37, the catheter 120 includes a catheter body 122 that is generally the same as that shown for the catheter 100 of FIG. 35 (common components are given the same reference numerals). , Except that a third actuation lumen 124 is provided. By using the working lumen 124 to deliver and place various interventional tools, at least most of the specific interventional procedures described elsewhere in this application can be performed. Of course, the catheter 120 is particularly useful in performing interventions that rely on retrograde stabilization for the type of chord CT as enabled by the catheter. For example, the lumen 124 can be used to place a high frequency energy supply tool for heating the chord to cause contraction as described in more detail below. Alternatively, the working lumen 124 can be used to place a chordal stabilization coil 130, generally shown in FIGS. 39A and 39B. The coil is typically a helical filament having a secondary helical structure consisting of, for example, three main loops. The coil consists of an internal element composed of a shape memory material such as Nitinol and is inserted into an outer coil 132 made of a radiation opaque material such as a platinum alloy. The shape memory coil 134 is formed in a “laminated coil” shape (no gap between adjacent windings of the coil) and is then programmed to become a laminated coil shape at a temperature slightly above body temperature. Coil assembly 130 is formed by heat treating platinum 132 to a dimension of diameter D1 and length L1 as shown in FIG. 39A. The shape memory coil 134 is then stretched to a generally straight shape and inserted into the platinum coil 132 and the two are joined at the ends. Upon heating, the shape memory coil shrinks and returns to the shape of a tightly stacked coil, compressing the platinum coil 132 and causing the entire assembly 130 to assume the small diameter D2 and length L2 shown in FIG. 39B. The coil 130 is delivered through the working lumen 124 using an extrusion catheter and is placed in and entangled in the chord CT as shown in FIG. Extrusion catheters (not shown) are described in US Pat. Nos. 5226911, 5234437, 5250071, 5261916, 5312415, 5350397, and 5690671, all of them. The disclosure may be similar in shape to an embolic coil delivery catheter as incorporated herein by reference.
B. Grab the leaflets

  The leaflets can be grasped in many ways, three of which are the most common: 1) pinching (pinching), 2) partially or completely penetrating or puncturing, and 3) using suction or vacuum. It is. Pinching includes grasping the surface or edge of the leaflet without penetrating the tissue. This can be accomplished by employing an antegrade or retrograde approach using an atrium, ventricle or atrial-ventricular device. The following embodiments are examples described with respect to a particular approach (forward or retrograde), but it is understood that each device or component can be used in or can be adapted for use in all approaches. The

  In the preferred embodiment shown in FIGS. 41-43, pinching of the leaflet LF is accomplished, for example, by using a grasping catheter introduced in a retrograde direction to temporarily capture the free end of the leaflet LF. it can. It is possible to capture both opposing leaflets using a simple two-claw tool attached to the tip of the catheter. FIG. 41A shows a state where the two-nail tool 710 is in the open position. In this position, the opposing claw 711 is located on the opposite side of the free end of the leaflet LF. In the closed position shown in FIG. 41B, the leaflets are attracted and pinched together to immobilize the valve. While this is sufficient, it is preferable to use the three-nail capture tool shown in FIGS. 42-43. Catheter 140 can generally be delivered through the guide catheter described above. The catheter has a tool 142 at its tip. Tool 142 is best shown in FIG. 42B, and includes a fixed central pawl 144 and a pair of outer pawls 146 and 148 pivoted. The pawls 146 and 148 open independently into the “capture” position, shown in dashed lines in FIG. 42B. Activation of the claws 146 and 148 can be accomplished in a variety of conventional ways, such as a pull wire, push wire, inflatable balloon, thermal memory alloy motor, and the like. The leaflets LF can be captured independently by opening and closing the capture claws 146 and 148 independently toward the fixed claw 144.

  As shown in FIG. 42A, the first leaflet LF can be captured first. The catheter 140 is then manipulated and positioned while typically monitoring real-time images to capture the second leaflet LF as shown in FIG. It will be appreciated that capturing each leaflet independently greatly facilitates the procedure. When using a pair of capture claws, it is necessary to catch the leaflets at the moment each leaflet just faces. In the case of a step-out valve, such a moment never occurs. Once captured and immobilized as shown in FIG. 43, the leaflets can be modified by any of the various methods described elsewhere in this application.

  In another embodiment shown in FIGS. 44-46, a grasping catheter introduced in an antegrade direction is used to pinch the leaflet LF and temporarily capture the surface or free end of the leaflet LF. included. 44A-44D, the leaflet LF can be sandwiched between the upper loop 720 and the lower loop 721. In a preferred embodiment, the gripping device consists of a flat ribbon made of Nitinol that is thermally set in the shape of a double loop 720,721. The ribbon can be mounted on three coaxial shafts connected in series: a lower shaft 725, a central shaft 726, and an outer shaft 727. The ribbon tip can be attached to the lower shaft 725 tip 730, the center of the ribbon can be attached to the tip 731 of the center shaft 726, and the proximal end of the ribbon can be attached to the tip 732 of the outer shaft 727. One or more ribbons can be attached to the coaxial shaft, and in this example, two ribbons arranged 180 degrees apart are shown. When stretched as shown in FIG. 44A, the grasping device is pulled and flattened along the shafts 725, 726, 727 to facilitate passage through the guide catheter or tool and inserted into the desired position between the leaflets LF. It becomes easy to do. When the central shaft 726 is retracted or the outer shaft 727 is advanced as shown in FIG. 44B, the upper loop 720 extends radially from the shaft. Upper loop 720 rides on the upper surface of leaflet LF in the atrium, as shown in FIG. 44D. In this position, the upper loop 720 can be visualized with echo or fluoroscopy, and the relationship with the heart structure or other devices or components can be easily seen, thus helping to assess orientation. Once in the desired position, the lower shaft 725 is retracted to widen the lower loop 721 radially from the shaft as shown in FIG. 44C. The lower loop 721 contacts the lower surface of the leaflet LF in the ventricle. As a result, the leaflet LF can be sandwiched between the lower loop 721 and the upper loop 720. It will be understood that the lower loop 721 can be placed before the upper loop 720.

  45A-45B, the leaflet LF can be sandwiched between the lower roller 751 and the upper roller 750. As shown in FIG. 45A, rollers 750 and 751 are mounted on shaft 755 and connected by a pull actuation wire 756. The rollers 750 and 751 can be subjected to a surface treatment with knurling or other directions in order to facilitate gripping of the leaflets 1F. In order to grip the leaflet LF, the rollers 750 and 751 are disposed in contact with the surface or free end of the leaflet LF. When the operating wire 755 is pulled, the upper roller 750 and the lower roller 751 rotate toward each other. Thereby, as shown in FIG. 45B, the leaflet LF is drawn between the rollers 750 and 751. In this way, the leaflets LF can be individually gripped and treated.

  46A-46B, the leaflet LF can be sandwiched between a pair of flat coils 770. In a preferred embodiment, each coil 770 consists of a flat ribbon of Nitinol that is thermally set to the shape of the coil. As shown in FIG. 46A, the coils 770 are linked to each other by curved surfaces facing each other by a clip 772. As clip 772 moves along coil 770, coil 770 is stretched into a straight shape. As shown in FIG. 46B, this can also be achieved by a catheter shaft 773 disposed over the coil 770. In the straight extended position, the coil 770 can be inserted between the atrial-ventricular leaflet LF and the tip 775 of the coil 770 is located in the ventricle. When the shaft 773 or the clip 772 is pulled back, the coil 770 curls in the radial direction below the leaflet LF and moves upward, and the tip 775 of the coil 770 contacts the lower surface of the leaflet LF. Similarly, as coil 770 continues to curl, a portion of the flat ribbon near tip 775 contacts the leaflet. In this way, the leaflets can be grasped and treatment can be performed. Such a gripping device can also function as a locking device with the pair of coils 770 left in place, as will be described later in this application.

  Partial or complete penetration or puncture can also grip the valve or tissue structure with minimal damage to the tissue. It can be achieved by various gripping mechanisms. In a preferred embodiment, one or more prongs (pointed rods) extending from an interventional tool arranged to grasp a particular structure are included. Specifically, three prongs facing each other extend from the grasping sheath, and the tip of the prong is sandwiched and partially penetrated or punctured. Such ends may be pointed or soft as in the case of ends covered with round urethane or solder. Referring to FIG. 47A, when the prongs 800 facing each other are drawn into the grasping sheath 801, the prongs 800 are held closed. When the target tissue position is known, the prong 800 is extended to grasp the tissue structure as shown in FIG. 47B. This can be done by extending the prong 800 or pulling back the grasping sheath 801. The target tissue can be pinched, partially penetrated, or punctured with this configuration of prongs 800, or by closing or partially closing the prongs 800 as shown in FIG. 47A. Operation becomes easy. Alternatively, as shown in FIG. 47C, a prong 800 can be attached to or integrally formed with a tube 802 with a prong attached to the tip. Such a design is advantageous for inserting a tool or fixation device for subsequent treatment steps such as tissue modification. The tool or device can be inserted through a lumen in a tube 802 with a prong as indicated by arrow 804 for use at or near the gripping location. Similarly, a tool or device can be inserted through the lumen in the hollow prong 806 as shown in FIG. 47D. In that case, one or more prongs 806 can be hollow and the remaining prongs 808 can be composed of solid wire or other suitable material. The tool or device can be inserted through a lumen in a hollow prong 806 indicated by arrow 810 for use at or near the gripping location. The prongs, whether hollow or solid, can be composed of stainless steel, NiTi, plastic or other suitable material. They may also be coated or coiled for clarity. The shape of the prongs can be changed so that a tissue of a desired size can be grasped. The sharpness of the tip and the surface finish can also be changed depending on the size of the puncture.

In addition to directly engaging the leaflets for stabilization and / or immobilization with the gripping device described above, the devices and methods have vacuum or suction means for temporarily capturing the leaflets. A catheter or other tool may be employed. As shown in FIG. 48, the catheter 812 consists of a shaft with a pair of vacuum actuating rods 813 and 814. The vacuum actuating rods 813 and 814 typically comprise separate shafts that can move axially relative to the main shaft of the catheter. Furthermore, if necessary, the shaft may be articulated or otherwise maneuverable so that the relative position relative to the leaflets and other tissue structures is independent of each other after the catheter 812 is in place. It can also be decided. The vacuum actuating rod has one or more openings that allow it to contact and adhere to tissue when connected to an external vacuum source. Typically, the shaft is placed across the valve in an antegrade or retrograde direction, and the vacuum actuating rod is placed in a position to grip and manipulate the leaflets. The catheter 812 can optionally be provided with additional wires for controlling the direction of stabilization and / or travel as previously described. For example, with a wire 815 for controlling the direction of travel (and a second wire for controlling the second direction of travel on the opposite side if necessary) to engage the commissure of the valve and position the catheter relative to the leaflets Can do. The vacuum actuating rod is further independently positioned and engages the valve in the desired manner. This catheter can be used to grasp the leaflets and the method described above can be used to assess valve performance. The valve can then be adjusted using any of the intervention methods described herein. Furthermore, in each embodiment, the timing of grasping can be grasped by controlling the opening / closing operation by the patient's EKG, the pressure wave of the heartbeat cycle, the heart sound, the electronic pressure attached to the grasping device, or the contact sensor.
VIII. Fusion, adjustment and evaluation

If a leaflet, chord or tissue structure is grasped by an interventional tool, the tissue can be manipulated to achieve a desired result, such as improved valve function. Such a procedure can be performed during the gripping step, but may require a separate step following the gripping. In the case of a leaflet modification, the leaflets are fused or pulled toward each other and held in a preferred position. The valve function is then evaluated for signs of improvement in the valve function, such as reduced backflow. If further improvement is required, additional procedures or adjustments are made to the leaflets. Adjustments should be made primarily in upper / lower (up / down) movements to guide the leaflets to the final position where backflow is minimized. During adjustment, one or both leaflets may be released and recaptured at the new location. After the final evaluation, the leaflets are fixed in the desired position by an appropriate fixing device. Similar steps are taken when shortening chords or modifying other tissues.
IX. Modify organization

Atrioventricular valve or other heart valve repair modifies the structure of the valve or support tissue in some way, affecting the flow of blood through the valve during certain phases of the heart cycle, for example, filling the ventricle with blood This is done by allowing blood to flow through the valve during diastole, but preventing the backflow of blood through the valve during systole. A number of techniques for correcting valve closure have been described above by capturing or grasping chords attached to each leaflet. These techniques are often employed solely for valve grasping and / or fusion and corrections made prior to another valve correction step, but are permanent for final valve correction. It can also be a thing. Other techniques for more directly modifying leaflet and other atrioventricular valve support structures are described in this section. These techniques can be used with or without the valve grasping and / or fusion and valve modification techniques described above. However, for the sake of clarity, the following description of the method will focus on methods and devices involved in fixation, without specifically showing such grasping, fusion and revision approaches. Although the embodiments described below are examples described with respect to a particular approach (forward or retrograde), each device or component can be used in all approaches or can be adapted to use Is understood. Further, although devices and methods for fixing specific tissues such as leaflets or chordae are described, such devices and methods can be used with any cardiac tissue.
A. Valve leaf fixation

  A suture can be fed through the leaflets and tied in the same manner as in open surgery. In some embodiments, the suturing tool 200 shown in FIG. 49 is placed at the distal end of the interventional catheter. The interventional catheter is typically advanced in an antegrade direction (ie, from above the mitral valve), either directly through the guide catheter or through the working lumen in the stabilization catheter. The tool 200 entrains a length of suture 202 attached to a pair of needles 204 at its ends. The suture is made of normal suture material or wire, typically stainless steel, nitinol or other material. The needle is held on a reciprocating shaft 206 disposed within the lumen of the retrieval sheath 208. The tool 200 can be placed in a position to capture the opposing free ends of the mitral leaflet LF shown generally in FIG. The needle can then be advanced between the leaflets LF by pulling the shaft 206 toward the sheath 208, and the needle 204 passes through the leaflets and is captured in the needle receiver 210 formed in the sheath 208. Is done. The sheath can then be pulled back. A suture can be knotted, and the knot is advanced through the associated catheter to tighten the leaflets. The tool 200 can carry 2, 3, 4 or more sutures, which are introduced simultaneously or sequentially into the leaflets to allow the formation of multiple suture loops. The resulting tied suture loop is similar to the “bow tie” suture formed in open surgical procedures that have been addressed in the medical literature as described above.

  The need to place and pull long sutures that pass through the leaflets is inconvenient for delicate leaflet structures. As such, alternative needles and devices that use mechanical fasteners for relatively short sutures are preferred. In one embodiment, the hollow suture coil 1300 shown in FIG. 49A is placed at or near the distal end of the interventional catheter. The suture coil 1300 can be formed of any material that has sufficient rigidity to penetrate the leaflet LF, such as stainless steel, various shape memory or superelastic materials, alloys, and various polymers. Various materials and other materials can be used. The hollow suture coil 1300 includes a suture 1302 made of conventional suture material or wire, typically stainless steel, nitinol or other material. The suture 1302 is fixed to the tip 1304 of the coil 1300 having the toggle rod 1305. After the leaflet LF is gripped and fused, the suture coil 1300 is advanced in the manner of cork removal through the leaflet LF as shown in FIG. 49A. Although the forward movement is shown from above, the forward movement can be done from any direction, regardless of how many leaflets are combined in any shape. When moving forward, the pointed tip 1304 of the coil 1300 can penetrate the leaflet LF any number of times. Such corkscrew-type puncture is performed through the middle part of the leaflet, and is performed once every half rotation, or puncture is performed many times along the edge of the leaflet and 1 per rotation. It will be understood that it can be implemented in various ways, such as a puncture being performed.

  When the coil 1300 advances to a desired position, the toggle rod 1305 is fixed to the leaflet LF, and the suture thread 1302 is held at a predetermined position. At this point, the coil 1300 can be removed by retracting the coil 1300 in the reverse cork removal manner as shown in FIG. 49B, but the suture 1302 remains behind. Since the coil 1300 has a diameter much larger than the leaflet thickness (to facilitate placement), the suture 1302 is loosely hooked and the leaflet LF may not be properly corrected. Therefore, as shown in FIG. 49C, the suture thread 1302 is tightened so that the suture thread 1302 collectively holds the leaflets LF in a desired shape. This is facilitated by using a catheter 1306 with a soft tip, but this catheter is advanced to contact the surface of the leaflet LF when contracted to prevent the leaflet LF from stepping out. When the suture thread 1302 is tightly tensioned, the restriction collar 1308 is drawn out from the catheter 1306 or another device and placed, thereby fixing the suture thread 1302 and performing terminal processing. The regulation coller 1308 can be composed of a heat shrinkable tube, a shape memory nitinol, a superelastic coil, or the like. Therefore, the present embodiment eliminates the need for a needle feeding device and a needle receiver and provides a simple method for fixing the leaflets.

  Alternatively, referring to FIGS. 50 and 51, a short suture 220 can be placed using a curved needle 222 that can extend from the tip 224 of the interventional catheter 225. Needle 222 is formed of an elastic material such as a shape alloy and is generally regulated in a straight shape within catheter 224. When extended as shown in FIG. 50, the needle becomes curved and can be advanced through the valve leaf LF of the atrioventricular valve or other heart valve as shown in FIG. 51A. The distal anchor 226 is secured to the distal end of the suture 220, while the slidable locking anchor 228 is positioned over a portion of the suture located near the distal anchor 226 as shown in FIG. The catheter 225 can be advanced to the leaflet LF in a retrograde approach as shown in FIG. 51 using the guide catheter 40 as generally described above. The tip 225 of the catheter 225 is positioned adjacent to the underside of the leaflets, at which time the needle 222 is advanced outward from the distal tip and passes through both leaflets.

  In order to ensure that the leaflets are in the proper orientation prior to advancement of the needle, the leaflets are fused and observed using any of the techniques described above. Once the needle has advanced past the leaflet LF, the deployment sleeve 230 is advanced to release the slidable anchor catheter 228 from the needle and advance toward the underside of the leaflet LF. As anchor 228 approaches the leaflet, distal anchor 226 is pulled from the needle due to the tension on suture 220. The deployment sleeve 230 is advanced sufficiently to pull the two anchors 226 and 228 on the opposite side of the leaflets together as shown in FIG. The suture is then tied and released, or locked in place using a mechanical lock 232. When the suture is made of a malleable wire as described above, the wires may be twisted together. In either case, the suture is then cut and the catheter 225 is withdrawn.

  50 anchors 226 and 228 are generally oval and have a length dimension that is greater than the width of the needle used to introduce them. Therefore, when pulled sideways, both anchors seal against the opposing surfaces of the two leaflets. In some cases, however, it may be desirable to use an anchor that can expand to much larger dimensions so that it does not pull through the relatively fragile leaflet tissue. An example of an inflatable anchor is shown in FIG. 53 in a collapsed state in the needle 242, and shown in FIG. Anchor 240 is connected to a single suture 244 and can be used with a slidable and expandable anchor (not shown) similar to non-expandable anchor 228 of FIG.

  Additional inflatable anchors are shown in FIGS. 55A and 55B. In this embodiment, the anchor consists of an inflating wire coil formed in a random orientation. The coil is made of a shape memory Nitinol wire, and is cooled after being annealed (heat set) in a linear shape. As shown in FIG. 55A, the different portions 820, 821 of the coil can be treated to have different characteristics by having a diameter and tension that varies in the coil over its length. When the coil is heated with high frequency energy to a certain level (T1), a designated portion 821 of the coil becomes a clump of wires 824 having a random orientation and has a self-locking protrusion that prevents it from coming off. Heating the coil to another specific level (T2) results in a random orientation of another designated portion 825 of the coil. As each portion of the coils 824, 825 expands and changes shape, each coil can be completely entangled, effectively compressing and securing the two halves 824, 825 of each coil. The coil can be introduced through the leaflet LF by using a needle introducer 826 activated by shape memory, superelasticity or heat / current. When the leaflet LF is pierced, the anchor 824 is activated and placed in the distal position. Then, the introduction device 826 is pulled back to the proximal side of the second leaflet LF2, and a second anchor (not shown) is placed in the same manner. The strength of the tension between the anchors 824, 825 can be affected by the shape memory or superelastic properties of the expanding anchor. It will be appreciated that the thermally activated expanding coil may take other forms, such as a wire mesh. The additional inflatable anchor may be in the form of an inflatable chamber filled with a liquid that can be partially or fully solidified as required.

  Yet another form of a removable anchor attached to a suture is shown in FIGS. 56 is a front view, and FIG. 57 is a side view of the same structure. A self-penetrating anchor 260 attached to the suture is carried by a pair of rods 264. Each rod is mounted in the open lumen of the placement catheter 266. The anchor 260 is pivotally supported by a retaining structure 268 formed between the distal ends of the both placement rods 264. The anchor has a sharp tip 270 that allows the anchor to penetrate the leaflet tissue directly when the rod is extended from the catheter 266.

  Referring to FIG. 57, the catheter 266 can be placed over the leaflet LF of the mitral valve MV in the antegrade direction through the guide catheter 14 as generally described above. Catheter 266 can be used to sequentially deliver a pair of anchors 260. As shown in FIG. 58, the first anchor 260a was placed through the first leaflet and the second anchor 260b was placed through the second leaflet. Anchors 260a and 260b are deployed by pushing them through the leaflets, while the pointed tip 270 generally remains facing forward. After passing through the tissue, the anchors 260a / 260b can be turned by pulling back the placement rod 264 or pulling the suture 262 back. The two ends of the suture 262 can then be tied or secured using a mechanical fixture, and the opposing leaflets can be pulled into place.

  Referring to FIGS. 59 and 60, a suture catheter 290 having a needle 280 with a pointed tip 282 can be used to place a suture loop within an individual leaflet. Needle 280 is carried to a pair of activation rods 284 and a single suture 286 is attached to the needle. Needle 280 is first passed through the leaflets generally in an axial orientation relative to catheter 290. As shown in FIG. 60, after passing through the leaflets from the guide catheter 14, the needle is tilted at an angle of 20 to 30 degrees and then passes back through the leaflets at different positions. A locking groove 288 in the needle is caught in a bar 292 at the tip of the catheter 290. Needle 280 is thus removed from rod 284 and pulls suture 286 in the loop back through the leaflets. In this way, the suture loop is sequentially placed through both leaflets LF of the mitral valve MV as shown in FIG. The suture loops are then tied, connected with fasteners, fused together with high frequency, microwave or ultrasonic energy, or otherwise secured to close the valve in the desired position.

  In addition to sutures and suture-utilizing devices as described above, opposing points on the leaflets and / or chordae can be attached with various staples and tissue penetrating fasteners. Staples and other fasteners can be delivered through the guide catheter generally described above, and can also be placed during or after the above-described valve grasping, coalescence and adjustment.

  61A and 61B, a staple driving catheter 300 is schematically shown. Typically, the mitral valve or other atrioventricular valve leaflet LF is first accessed with any of the techniques described above. The catheter 300 is then introduced, for example, in the retrograde manner illustrated previously. The staple 302 is held in the open position at the distal end of the catheter 300 and has a generally W-shaped configuration with two recesses for receiving each of the leaflets LF as shown in FIG. 61A. After visually confirming that the position is appropriate, the staple 302 is closed on the leaflets and the leading cords 304 are pulled as shown in FIG. It penetrates the opposite point. The activation cord is then removed and the catheter 300 is withdrawn, leaving the staple 302 holding the leaflets together in place. Additional clips can be arranged in a similar manner as needed to further enhance leaflet fixation. As described above, the clip is a malleable clip that undergoes plastic deformation when installed. Alternatively, the clip is formed of an elastic material such as a shape memory alloy and held in its open position as shown in FIG. 61A. The clip is then released to return to the stored (closed) shape as shown in FIG. 61B. Other activation mechanisms can also be used, such as a method of thermally inducing a shape change in a staple made of a thermal memory alloy.

  In addition, two leaf snaps, rivets and staples can be used to secure the leaflets together and hold them in place. This can be achieved with devices of various designs. A preferred embodiment uses two discs 850, gauze, etc. disposed on opposite sides of the tissue or leaflets LF to be joined together as shown in FIG. 62A. Typically, a shaft 852, pin or needle pierces the leaflet LF to join the two disks 850. The disk 850 is coupled by interlocking one or both of the disks 850 to the shaft 852 and / or portions of the shaft 852 to each other. Such a fixation device can be introduced through the lumen of a specially constructed catheter 854, introducer device or intervention tool component as shown in FIG. 62B. The disc 850 is a hollow and / or rigid material that needs to be placed on each side of the tissue, or the disc 850 is flexible and can be crushed and / or swelled, It can be inserted through the tissue and placed on the opposite side of the tissue. The preferred embodiment also uses two discs 855, gauze, etc. that are placed between the tissue or leaflets LF to be joined together, as shown in FIG. 62C. Here, the disc 855 has prongs 856 that pierce each end and penetrates and grasps the tissue. When the disk 850 is coupled by interlocking (meshing) one or both of the disks 855 to the shaft 858 and / or parts of the shaft 852 shown in FIG. 62D, the leaflets LF are coupled to each other.

  Another embodiment of a two-part rivet-like staple driving mechanism is shown in FIG. The staple driving mechanism 322 at the distal end of the catheter 320 consists of a first claw 324 carrying a fixture 326 and a second claw 328 carrying a retaining ring 330. The fixture has a cone that can be crushed at its tip and can be pushed into the opening 334 of the retaining ring 330. The claws 324 and 328 are pivotally supported in the distal end 340 of the catheter, and can be opened and closed so as to hold the free end of the leaflet between them. However, even if the claws 324 and 328 are closed, the fixture 326 is not locked in the retaining ring 330. Therefore, the leaflets are temporarily gripped, and the improved state of the valve backflow can be visually evaluated. If sufficient improvement is obtained, the fastener 332 can be pushed into the tissue and locked with the retaining ring 330. If the improvement is not sufficient, place the nail on the leaflets one more time and repeat until sufficient or optimal repositioning of the leaflets is achieved. The fixture 332 can be pushed into the retaining ring in various ways. In the illustrated embodiment, a cam device 342 is slidably mounted behind an inclined surface 344 behind the fixture 326. By pulling the cam actuator 342 downward using the pull string 348, the rivet can be driven into the retaining ring 330 through the leaflet as shown in FIG.

  In addition to rivets, snaps, pins, coils, etc. can be used in a similar manner and the leaflets can be secured in the desired arrangement as shown in FIG. 65A. The coil 900 may be formed of a superelastic material and pre-formed into a coil shape to engage the leaflets. The coil 900 can be delivered from the introduction sheath 902, and the coil 900 can be placed in a direction approximating the leaflets in the compressed state. Alternatively, the coil 900 may be formed of a shape memory material that changes with heat or current. As shown in FIG. 65B, the coil 900 is straight in the initial state, and can easily pierce the leaflet LF and advance through it. When in place, the material is activated by heat or current to cause the coil shape corresponding to FIG. 65A to be taken. Also in this case, the coil 900 is oriented to approximate the leaflet in the compressed state. When delivering a coil 900 made of superelastic or shape memory material to achieve maximum compression of the leaflets at the fusion point, the coil is in an inverted orientation across the leaflets as shown in FIG. 65C. Do it in a way. This can be done using a special delivery system 904. When released from the delivery system 904, the coil tip 905 generates a compressive force as the coil tends to be in an uninverted orientation.

  As yet another form, as shown in FIG. 66, the equine bandage type fixing device 360 may be arranged in a loop passing through the leaflets LF facing each other. The fixture 360 can be advanced in both a retrograde direction and a forward direction, but the forward direction is shown in the figure for convenience. The positioning catheter 362 can be introduced through the pre-positioned guide catheter 14 by any of the techniques described above. For example, by pushing a preformed fixture 360 past the leaflets so that it returns to the distal end of the deployment catheter 360, the horse's bandage-type fixture 360 is advanced through the leaflets. After that, this time, the fixing coller 364 is advanced to tighten the fastener loop 360 until the leaflets are in the desired position. Alternatively, the fastener may be twisted to tighten the open loop. Typically, the fixture 360 has a surface shape that travels in only one direction, such as a chevron, so that it will stay in place without loosening over time after the locking column has advanced or twisted. When moving forward, the torsion does not disappear over time. The fixture 360 is then released and additional fixtures are placed in a similar manner if necessary. The securing coller 364 can also be used to secure a suture, as previously shown in FIG. The coller 364 can be locked in place by caulking the suture 202 or using a combination of the coller 364 and the suture 202 with a surface shape that advances in only one direction.

  Furthermore, various means of a piercing or non-piercing type, such as a clip, a key, a hook, etc., can be used to fix the leaflets in the desired shape. As described above, a pair of flat coils can be used as a fixing device as a means for gripping the leaflet in a manner that pinches the free end. As described above with reference to FIG. 46A, a plurality of coils 770 can be linked together by clips 772 on their opposing curved surfaces. When inserted as shown in FIG. 46B, each coil 770 is permanently coupled in this orientation and remains as a permanent implant. Alternatively, the coil 910 may be pierced into the leaflet LF to hold the leaflet in place as shown in FIGS. 66A and 66B. During placement, the coil 910 is inserted through the delivery catheter 911 in a straight shape, punctures the leaflet LF in this shape, and after piercing the leaflet LF as shown in FIG. 66A, The free end is made to curl. The proximal end curls after coming off the delivery catheter 911 and remains as an implant as shown in FIG. 66B.

  Similarly, various key-shaped structures can be used in a similar manner to secure the leaflets in the desired shape. Referring to FIG. 67, a shaft 920 having one or more curved key-shaped tips 922 can be arranged so that the tips penetrate partially or completely the leaflets LF to be fixed. The shaft 920 may be a wire made of shape memory material or superelastic material. If a shape memory material is used, the shape of the shaft 920 is changed by heat or current, and if a superelastic material is used, the shaft 920 can take on a pre-formed shape, and several keys 922 are obtained. Thus, the leaflets can be fused at a desired position. Alternatively, some discontinuous keys 922 can be tensioned, caulked, coupled using a coupling or trimming system. Similarly, as shown in FIG. 68, a shaft 924 having a key-shaped tip portion 926 that expands may be disposed so that the tip portion 926 passes through each of the leaflets LF to be fixed. In this case, however, the tip 926 may comprise one or more protrusions 927 that expand and prevent the shaft 924 from retracting. Such expansion can be achieved by changing the shape of the shaft 924 with heat or current, or by allowing the device to take a pre-formed shape. In addition to inflating the tip 926, several discontinuous shafts can be tensioned, caulked, coupling or trimming systems can be used to fuse the leaflets to the shaft 924.

  In addition to the fixation method, a leaflet may be used to retract the leaflet into a suitable healing shape. Clips can be placed to maintain the desired position or further manipulate the leaflets while temporarily holding two or more leaflets in the desired shape as in the case of a gripping tool . For example, clip 940 is mounted on a delivery catheter or grasping tool 942 as shown in FIG. 69A. Thereafter, as shown in FIG. 69B, the leaflets LF can be arranged at desired positions. In the state of being placed and activated as shown in FIG. 69C, the clip 940 pinches the leaflet inward as indicated by an arrow 944 and tries to pull it. This can be achieved by activating a superelastic or shape memory material. Alternatively, as shown in FIGS. 70A and 70B, the clip 945 may be pinched inward as indicated by arrow 948 by manually caulking the barb 946 or by interlocking the piercing leg 948. If properly positioned between the leaflets LF as shown in FIG. 70B, the leaflets can be retracted together by caulking the barb 946 of the clip 945 using a removable actuator 950. . When the actuator 950 passes over the barb 946, the barb 946 can be plastically deformed to a new shape. Alternatively, when the actuator 950 passes over the barb 946, the proximal end of the puncture leg 948 is interlocked. In either case, the inward movement of the clip 945 can be controlled by passing the actuator 950 only over each portion of the barb 946 where it is desired to be pinched.

  An inward force can also be applied by components of the intervention tool, such as a gripping device. As described above, the grasping device is a device that grasps and holds tissue (for example, fusion of leaflets) in order to perform appropriate correction such as fixation. Thus, in most cases, the gripping device will be in place when the securing device is placed and properly positioned. 71, a state in which the leaflets LF are held on opposite sides of the clip 962 placed in the embodiment of the gripping device 960 is shown. An inward force can be applied to the clip 962 by moving the gripping device 960 or applying an inward force to the gripping device 960 as indicated by the arrow. In yet another embodiment, the gripping device functions as a gripping device as well as an embedded fixation device. Referring to FIG. 72A, a state is shown in which the leaflets LF are fused and held together in an embodiment of the gripping device 960. Thereafter, as shown in FIG. 72B, the gripping device 960 can be coupled by the coupling device 964 and then separated and embedded.

  Because the tissue in the leaflets is fragile, it may be performed using methods or devices that do not completely puncture or penetrate the tissue. For example, by applying high frequency, laser, microwave or ultrasonic energy to a specific fusion point, the leaflets can be fused together at a predetermined fusion position. In addition, or alternatively, an external clip that penetrates partially or not at all may be used. Clips made of various deformable or elastic materials can be used, and the clips are usually placed in a retrograde state so that the openings in the clips rest on the underside of the adjacent leaflets.

A suitable clip application catheter 380 is shown in FIGS. 70A, 73B and 73C. The catheter 380 has a three-nail clip applying device 382 at its distal end. Because of the three-claw structure, the clip application device can be used as a three-claw gripping device before the clip is finally placed. Such a gripping operation has already been described with reference to FIGS. 42A, 42B and 43. The central pawl 384 of the device has a tubular structure that allows the catheter to be introduced over the guide wire 396, where the guide wire can be placed through the atrioventricular valve prior to positioning the catheter. The clip 386 has a V-shaped structure and is normally closed, and a force is required to open the tip of the clip. The claws 390 and 392 hold the clip, and the clip can be opened by selectively opening one of the claws. In FIG. 73A, the state where the claw 392 is opened is indicated by a broken line. Accordingly, the pawl 392 can be opened first to capture the free end of the first leaflet. With the catheter 380 attached to the first leaflet, the catheter can be repositioned to open another nail 390 and used to capture the second leaflet. After the leaflets are captured and held in the proper orientation, the improvement status of the valves can be confirmed by visual observation. If the improvement is sufficient, the clip can be detached from the catheter and left in place as shown in FIG.
B. Shortening chords

  In addition to physically attaching the leaflets and / or chordae of the leaflets and / or sutures, fixing, and closing the leaflets by contracting one or both of the chordae attached to the two leaflets Can be improved. An exemplary catheter 400 having an energy application coil 402 at its tip is shown in FIG. Such energy may be in the form of radio frequency (RF), laser, microwave, ultrasound, heat or current. Although the catheter 400 can be placed in an antegrade or retrograde direction, the retrograde direction is generally preferred to facilitate access to the chord. One or more chordae CT is captured in the coil and, for example, RF energy is applied using a normal power source. By applying RF energy over the length L to the chords composed of collagen and other normal tissue components, the tissue contracts to a length shorter than the initial length L. Similarly, applying such energy to the chordae can be done using an energized chordae snare or similar device. By shortening the chords as such, valve conditions such as step-out valves can be effectively treated.

In addition to shortening the chordae by applying energy, the chordae can be pleated using a mechanical plication device 420 as shown in FIG. Each of the devices 420 includes a cap member 422 and a receiving member 424. The receiving member has a channel 425 that receives the pin portion 428 of the cap member 422. There is a sufficient gap between the pin portion 428 and the channel 426. By setting the cap member in the receiving member, a portion of the chord CT is captured and folded therein. Each plication device 420 thus shortens a portion of the chord by a predetermined amount. Multiple devices are used to achieve a predetermined total amount of shortening for the chord. Each device is placed using a nail-type device, and the shortening situation can be visually observed using any of the techniques described above. Alternatively, the chord can be pleated using a suture loop. Referring to FIG. 77A, suture 980 penetrates chordae CT at a first position 982 and then again penetrates chordae CT at a second position 984 to form a loop. Pulling the closed loop as shown in FIG. 77B reduces the effective length of the chord CT. The suture loop can then be secured, trimmed and embedded. This may be repeated along the chords to form multiple individual loops or continuous loops and / or may be repeated along multiple chordae. Similarly, such pleats can be formed using a coil of shape memory material or superelastic material that penetrates the chordae at one or more points and pulls the tissue together when activated. .
C. Annuloplasty

  The endovascular approach described here is for placing an annuloplasty device including a support ring and other devices around an annulus of an atrioventricular valve that includes a mitral valve annulus AN (see FIG. 1). Can also be used. Such annuloplasty devices are similar to those provided by an annuloplasty ring that is implanted in open surgery.

  As described above, the annuloplasty device may be disposed on either the atrial side or the ventricular side of the annulus. An advantage of placing the annuloplasty device on the ventricular side of the annulus is that the device can be placed in the groove G of the annulus located directly adjacent to the ventricular side of the mitral valve MV. FIG. 91 is a cross-sectional view of the left ventricle LV and illustrates the groove G. FIG. As described above, the groove G has a concave shape, which provides geometric support so that the annuloplasty device can be securely combined during and after placement of the device. The rounded concave shape of the groove G increases the contact area between the annuloplasty device wall and the left ventricle located in the groove.

  The annuloplasty device can have various shapes. For example, referring to FIGS. 92A and 92B, the annuloplasty device 1090 can be formed as a ring (FIG. 92A) or a partial ring (FIG. 92B). The annuloplasty device 1090 can comprise any of a variety of fixation or retention structures for securing the device to the heart, such as hooks, keys, prongs, adhesive anchors, and foldable legs. In addition, secondary attachment devices or materials can be coupled to the annuloplasty device 1090, such as staples or adhesives, for example, to permanently or temporarily secure the device to the annulus.

  FIG. 78 shows an example of another ring forming device including the ring forming ring 500. The annuloplasty ring 500 can be deployed using a catheter 502 placed through the guide catheter 14, as will be described in detail below. Sutures, staples, tissue adhesives, and other conventional techniques can be used to secure the ring in place. The catheter 502 can then be removed along with the placement spokes 504, leaving the ring permanently in place. One or more spokes can be attached to one or more clips that coalesce the leaflets. The spokes may be difficult to bend or may be composed of sutures or other flexible materials that allow the clip to have free or limited movement. Alternatively, a rigid or flexible member having the form of a suture or pin / post is extended upward from the annuloplasty device and penetrates the annulus tissue to the left atrium where the member May be fixed to the atrial side of the clip to which tension is applied. This helps to keep the annulus forming device in place and can be partially or fully immobilized if the clip needs to be immobilized.

  Magnets can also be used to secure the annuloplasty device 1090 to the heart. This will be described in detail with reference to FIG. 93, which shows a state in which the ring forming device is disposed in the groove G. A pair of magnets 9310a and 9310b sandwich at least a portion of the annuloplasty device therebetween. The magnet 9310a is disposed on the ventricular side of the mitral valve, and the magnet 9310b is disposed on the atrial side of the mitral valve. Both magnets are of opposite polarity and exert an attractive force on each other to press the device against the wall of the groove G and hold the annuloplasty device in the groove G. Alternatively, a magnetic material integrally formed in the ring forming device may be used instead of the magnet 9310a. The atrial magnet 9310b may be left permanently in place, or once the annuloplasty device is permanently fixed, either by a fixation device or by tissue growth, the atrial magnet 9310b may be removed. May be.

  In an exemplary embodiment, the annuloplasty device is configured to be reshaped after being placed in the annulus. For example, an annuloplasty device is a malleable material that can be deformed to a desired shape after the device has been placed by an endovascular grasping / forming tool. In another embodiment, a pull wire is stretched around the device. The pull wire has a gripping means such as a loop, a handle, and a snare. After the annuloplasty device is deployed, the end of the puller wire is grasped and pulled by the catheter, and the wire tightens the device to reduce the diameter of the device or deform the device in a predetermined manner.

  The puller wire can also be extended from the annuloplasty device at a location outside the heart, in the thoracic cavity or peripheral tube for later access. The pull wire can be left under the skin like an electrode of a cardiac pacemaker for easy access. The pull wire and / or annuloplasty device may be coated with an agent to prevent the occurrence of internal tumors, tissue encapsulation and infection.

  In another approach, the annuloplasty device is at least partially formed of a thermal shape memory material that changes shape upon heating. A heat source, such as an electrode that conducts current, can be coupled to the annuloplasty device when needed, causing a change in shape of the device. Alternatively, the annuloplasty device may have a remotely operable mechanism (from outside the body) that can be displaced into the desired shape at any time during or after the treatment procedure without further intervention. For example, the apparatus can be provided with magnetic parts and its shape can be controlled by MRI technology. Other remote control mechanisms can also be used.

  In another approach to a reshapeable annuloplasty device, the device has one or more joints, with a mechanism that locks or ratchets in one direction for each joint, and can be transformed from a straight state into a curved or bent shape. (By pulling the wire attached to one end). The annuloplasty device can then be locked into a shape with any desired degree of curvature or angle.

  The annuloplasty device is elastic and flexible and can be compressed to a reduced size such that it fits through the lumen of the guide or delivery catheter. In the reduced size state, the annuloplasty device consists of a flattened flat ring. When released from the guide catheter, the annuloplasty device elastically returns to a predetermined shape, such as the ring or partial ring shown in FIGS. 92A and 92B. Thus, the elastic annuloplasty ring is crushed and fed through the guide catheter, placed over the annulus, then sutured into place using a suitable catheter, or stapled To do.

  Rather than being composed of a single ring or partial ring structure, the annuloplasty device is composed of multiple structures that collectively work together when placed in the annulus to shape the annulus. You may make it correct. A plurality of attachment members, such as staples or clips, can be disposed within the annulus formation region along the entire circumference of the annulus or along a portion of the annulus. Each attachment member is attached to the annulus in such a way as to modify the local shape of the tissue. The plurality of attachment members work collectively to modify the annulus extensively.

  An approach using multiple anchors is shown in FIG. 51, which is a multiple anchor composed of staples 540 around the mitral valve annulus, as in the previously described groove. The suture 542 and other filaments are then tied to maintain the desired tightness and reinforcement of the annulus.

  As yet another form, the annulus can be pleated by placing a plurality of staples around the annulus as shown in FIG. In this case, each staple 560 is pleated or shortened in a small peripheral portion of the annulus. The staple driving catheter 562 can have the same general structure as described above with reference to FIGS. 61A and 61B.

  In certain embodiments, a period of time elapses after the annuloplasty device is placed in the annulus. After the period has elapsed, the shape of the annuloplasty device is corrected. During this period, the tissue surrounding the annulus forms scar tissue to which the annuloplasty device was attached. As such, the annuloplasty device is covered with a suitable material such as Dacron that promotes tissue recovery and growth. Scar tissue enhances adhesion between the tissue and the annuloplasty device, reducing the possibility of injury to the tissue or loss of tissue during shape modification. The length of this time varies. In one embodiment, the annuloplasty device is placed in the annulus and the shape of the annuloplasty device is modified after a period of 4 to 24 weeks has elapsed.

  The annuloplasty device can be delivered to the annulus using a variety of methods and devices. An annuloplasty device can be delivered using an antegrade or retrograde approach. As described with reference to FIG. 9 for the retrograde approach, an annuloplasty device is placed by placing a delivery device through the distal arterial vasculature, over the aortic arch and through the aortic valve into the left ventricle. Is introduced. As noted above, guidewire 42 can be used to allow initial access to the left ventricle. Guide catheter 40 is then tracked over guidewire 42 to the left ventricle.

  The internal lumen of the guide catheter 40 allows subsequent access to the left ventricle by a delivery catheter that holds the annuloplasty device at the tip. When entering through the left ventricle, the delivery catheter may require a curved or bent shape to access the mitral valve annulus groove from below. In this regard, the delivery catheter can have a predetermined shape that facilitates such an approach. The delivery catheter may also have a flexible tip that can be bent (such as via a pull wire) so that the tip is angled outward and upward toward the groove region of the annulus. it can. The delivery catheter then places the annuloplasty device in the groove region and the annuloplasty device is secured in place. A second catheter is also placed in the groove and secures the annuloplasty device in place while the delivery catheter temporarily holds the annuloplasty device in place. It will be appreciated that the delivery device and method for accessing the mitral valve annulus described above can be used to deliver the annuloplasty device.

  In the antegrade approach, the device is introduced into the right atrium RA through the inferior vena cava IVC or superior vena cava SVC, as previously described with reference to FIGS. Next, the atrial septum IAS is penetrated, such as by using a catheter 10 having a needle 12 as shown in FIG. As shown in FIG. 8, access through the atrial septum IAS can be maintained by placement of the guide catheter 14, typically beyond the guidewire 16. The guide catheter 14 allows introduction of a delivery device having an annuloplasty device at the distal end into the left atrium LA. The delivery device passes down the mitral valve MV and approaches the groove region from below the mitral valve MV. As described above, the delivery catheter can be preformed to facilitate such an approach, or it can be provided with a mechanism that allows the tip of the delivery catheter to bend toward the groove region.

  Alternatively, the annuloplasty ring 520 can be delivered over a balloon catheter 522 as shown in FIGS. The ring 520 can be formed of a deformable material, and the balloon 520 is inflated within the annulus to place the ring as shown in FIG. The balloon catheter can be placed directly on the guidewire 524, but is typically positioned using a combination of guide catheter and guidewire. Once the ring 520 is deployed, it is sutured around the annulus, using staples, gluing, or otherwise secured.

  Another approach that can be used in place of or in combination with the annuloplasty device arrangement is to apply RF energy to the groove region of the annulus to cause the annulus to contract or otherwise change its shape, Annular remodeling is achieved. A catheter with one or more RF electrodes at the tip is inserted through the guide catheter into the groove region of the annulus. Remodeling is performed by supplying power to the RF electrode to supply energy to the annulus or surrounding tissue. The catheter, including a suction port, stabilizes the device by aspirating the heart tissue near the annulus. Also in this case, the traveling direction can be controlled by means such as a pull wire.

  The arrangement of the ring forming device can be combined with any of the other procedures described in this application. For example, grasping of chords and / or grasping of leaflets can be employed in combination with the placement of the annuloplasty device. The catheter that delivers the annuloplasty device includes a gripping arm at the tip so that the leaflets can be grasped while the annuloplasty device is delivered.

Annuloplasty device placement can also be combined with temporary or permanent tissue modification, such as leaflet fixation or chordal shortening, which has been described in detail above. In connection with leaflet fixation, the delivery catheter used to deliver the annuloplasty device can be combined with the suturing tool 200 (see FIG. 49), or variations of the suturing tool described herein. The staple driving catheter 300 (see FIGS. 61a and 61b) can also be used to deliver an annuloplasty device. The staple mechanism catheter 320 (see FIG. 63) can be provided with another lumen for delivering the annuloplasty device. Depending on the delivery method, one of the catheters described herein is used to attach a clip or staple to the leaflet or to suture the leaflet. Before or after the leaflets are fused, an annuloplasty device is placed in the groove G of the annulus AN of the mitral valve. It will be appreciated that any of the delivery devices or interventional devices described herein can be modified and used with an annuloplasty device.
D. Ring formation through the coronary sinus

FIG. 94 is a cross-sectional view of the heart showing the mitral valve MV, the leaflet LF, the annulus AN and the coronary sinus CS. The coronary sinus CS is located adjacent to the mitral valve MV. Since the coronary sinus substantially surrounds the mitral valve annulus AN, modifying the shape of the coronary sinus CS results in modifying the shape of the annulus AN. A device of a predetermined shape is implanted in the coronary sinus CS and awaits recovery at that location so that scar tissue is formed adjacent to the device. Thereafter, the shape of the device is substantially changed to reshape the coronary sinus CAS and the adjacent annulus AN in the desired manner. Scar tissue reinforces the tissue to provide a strong attachment to the device and reduce the risk of injury.
X. Apparatus embodiment

The three device embodiments described below illustrate a complete device design that utilizes the various specific components described above and / or new design components to achieve a similar purpose.
A. Atrial device

  Referring to FIG. 83, atrial apparatus 1000 includes a catheter shaft 1002 having a distal end 1004 and a proximal end 1006. The catheter shaft 1002 comprises a conduit 1008, a coaxial outer sheath 1010, a central guidewire lumen 1011 and many other components. A pair of stabilizers 1012 having a hump shape (see FIG. 31D) toward the tips 1004 are fixedly attached to the outer sheath 1010 at their proximal ends 1014 and are attached to the extension 1016 at their tips 1018. Mounted fixedly or pivotably mounted. Although the stabilizer 1012 is illustrated as bent outward, the stabilizer collapses inward by extending the extension 1016 or retracting the outer sheath 1010. It can be bent outward by the reverse process.

  Referring to FIG. 84, the atrial device 1000 can be used in a typical antegrade approach to the mitral valve MV. As previously described and shown in FIGS. 7 and 8, such an antegrade approach involves penetrating the atrial septum IAS and maintaining such access with the guide catheter 14. Guide catheter 14 allows introduction of atrial device 1000 into left atrium LA and mitral valve MV. In order to allow the device 1000 to pass through the guide catheter 14, the stabilizer 1012 must be collapsed as shown. In addition, the grasping device described below can be fully retracted to avoid damaging the heart tissue. They are therefore not visible in FIG.

  Referring to FIG. 85, the atrial device 1000 can be stabilized with respect to the mitral valve MV. The stabilizer 1012 can be inserted through the mitral valve MV and can be positioned along the fusion line C between the leaflets LF1, LF2. In order to minimize mitral valve regurgitation (MVR) upon insertion of the device 1000, the stabilizers 1012 are positioned approximately 120 degrees apart. This angle can be fixed or variable. Due to the single hump shape of the stabilizer 1012, the lower portion 1030 passes through the valve to apply radial pressure to the commissure CM, and the upper portion 1032 (or hump) rides on the commissure CM and axially It becomes possible to apply pressure.

  Referring again to FIG. 83, a pair of grasping devices comprised of three opposing prongs 1021 configured to partially or fully penetrate or puncture the grasping sheath 1020 bisects the corners of the stabilizer 1012. A state extending from the pipe line 1008 (that is, approaching the center of the leaflet) is shown in the plane to be moved. This corner may be fixed or variable. However, when not in use, the gripping device is fully retracted into the conduit 1008. Tension from the lateral direction control wire 1022 deflects each gripping device away from each other and approaches the most desirable angle for gripping. The amount of deflection can be controlled from the proximal end of the apparatus by the traveling direction control wire 1022. When each gripping device is arranged at a desired position as shown in FIG. 85, the prongs 1021 are placed and the gripping sheath 1020 is retracted, or the prongs 1021 are advanced beyond the gripping sheath 1020, so that the prongs be opened. Since the position of the gripping device is not greatly affected even when the sheath 1020 is retracted, the user can contact the leaflets LF1 and LF2 with the prongs 1021 within the sheath 1020, and then the gripping sheath. By reversing 1020, gripping of the leaflets can be started at the contact position. The opposing prongs 1021 can be closed by advancing the grasping sheath 1020 or retracting the prongs 1021 into the grasping sheath 1020 to grasp (pinch, partially penetrate or puncture) the leaflet tissue.

  After both leaflets are gripped, the tension in the direction of travel control wire 1022 is released and the conduit 1008 advances over the gripping sheath 1020. By this advancement, the sheath 1020 is pulled, and at the same time, the grasped leaflets are also pulled together and coalesce. After fusion, mitral valve regurgitation is evaluated to determine if the grasped position is appropriate for fixation. If the gripping point is not appropriate, the leaflets are released and gripped again individually or simultaneously in the manner described above. If the grasped point is appropriate, the preferred embodiment allows the guidewire disposed within the guidewire lumen 1011 to be replaced with a fixation device. For example, staples, sutures, coils, clips, rivets, fusion devices, zippers, snares, clamps, hooks, chordal fixation devices or chordae shortening devices can be used to fix mitral valve regurgitation. can do. Specifically, the fixation device may be the hollow suture coil 1300 shown in FIGS. 49A-C. As shown in FIG. 84A, a hollow suture coil 1300 including a suture 1302 (not shown) can be placed through the guidewire lumen 1011 in a coiled state. If the coil 1300 is made of a suitable shape memory material or superelastic material, the coil 1300 can expand or change shape upon exiting the lumen 1011. Similarly, as shown in FIG. 84B, the suture coil 1300 is placed in a straight shape through the guide wire lumen 1011 and is rounded and / or inflated or changed in shape as soon as it exits the lumen 1011. It can also be made to do.

The components described above can be manipulated and controlled by a handle 1026 connected to the proximal end 1006 of the catheter shaft 1002 as shown in FIG. The handle 1026 retracts and extends the extension device 1016, places the stabilizer 1012, adjusts and locks the outer sheath 1010, translates and flexes the gripping sheath 1020, stops and locks the gripping sheath, and slides the tube 1008 in the axial direction. Allows independent control of each component, including but not limited to movement. In addition, whether the heart is beating or stopped, to access the mitral valve across the atria for minimally invasive surgical (MIS) procedures, The device can be easily adapted.
B. Atrial-ventricular device

  Referring to FIG. 86, the atrial-ventricular device 1100 includes a catheter shaft 1102 having a distal end 1104 and a proximal end 1106. The catheter shaft 1102 is comprised of a conduit 1108, a coaxial outer sheath 1110, a central lumen 111 through which a two-nail gripper 1113 can be inserted, a central guidewire lumen 1105 and many other components. To the tip 1104, a pair of triangular stabilizers 1112 (see FIG. 31A) are fixedly attached to the outer sheath 1110 at their proximal ends 1114 and fixedly attached to the extension device 1116 at their tips 1118. It is done. Although the stabilizer 1112 is shown bent outward, it can be collapsed inward by extending the extension device 1116 or retracting the outer sheath 1110. It can be bent outward by the reverse process. The two-nail gripping device 1113 comprises two articulated nail arms 1120 that can be opened and closed with respect to the central shaft 1122 independently or in conjunction (movement is indicated by arrows). The gripping device 1113 is shown in the open position in FIG. The respective surfaces of the nail arm 1120 and the central shaft 1122 can be toothed as shown, or the surface feel can be varied to provide different friction.

  87A-C, the atrial-ventricular device 1100 can be stabilized relative to the mitral valve MV. The stabilizer 1112 can be disposed on the upper surface of the leaflets LF1, LF2 at an angle of 90 degrees with respect to the fusion line. With the gripping device 1113 closed, it can be advanced between the leaflets LF1, LF2 from the conduit 1108 until the claw arm 1120 is completely under the leaflets in the ventricle. At this point, the gripping device 1113 can be opened and retracted so that the claw arm 1120 can engage the lower surface of the leaflets LF1, LF2. In this way, the leaflets are fixed between the stabilizer 1112 and the claw arm 1120. This operation makes it possible to fix leaflets having various shapes and orientations. Cardiomyopathy valves are often enlarged and distorted, so they coalesce irregularly. Such irregularities make it difficult to mechanically coalesce these valves for tissue modification. Many of these difficulties are overcome by the operation of the gripping device 1113.

  Referring to FIG. 87B, the gripping device 1113 slowly closes and pulls the leaflets LF1, LF2 together, but keeps the leaflets firmly between the stabilizer 1112 and the claw arm 1120. This can be accomplished in many ways. For example, the stabilizer 1112 gradually collapses by extending the extension 1116 or by retracting the outer sheath 1110. When the stabilizer 1112 is crushed, the spring load gradually closes the gripping device 1113 so that the claw arm 1120 is crushed. Alternatively, the claw arm 1120 can be activated and closed with respect to the central shaft 1122, and the stabilizer 1112 can be crushed by applying a force. In either case, such an operation is performed simultaneously when the leaflets are sandwiched between the claw arm 1120 and the central shaft 1122 and the stabilizer 1112 is retracted in the vertical direction and returned away from the leaflets. Is possible. In this way, the leaflets are effectively transferred to the gripping device 1113. Referring to FIG. 87C, when the collapsed stabilizer 1112 is completely pulled back, the leaflets LF1 and LF2 are held by the gripping device 1113 in the vertical direction in a more natural fusion shape. At this point, the leaflets can be adjusted and fixed. Fixing can be achieved by an external element or the gripping device 1113 can be left in place as a fixing device.

The aforementioned components can be manipulated and controlled by a handle 1126 connected to the proximal end 1106 of the catheter shaft 1102 as shown in FIG. Each component described above can be controlled independently by the handle 1126.
C. Ventricular device

Referring to FIG. 88, a ventricular device 1200 comprises a catheter shaft 1202 having a distal end 1204 and a proximal end 1206. The tip 1204 comprises a coupling coil 1208, an upper claw 1210, a lower claw 1212, an actuator 1214 and a central lumen 1216 into which a guide wire 1218 or other wire can be inserted. The upper claw 1210 is opened and closed with respect to the lower claw 1212 by the operation of the actuator 1214 (indicated by an arrow). The upper claw 1210 is shown in an open state. These components can be manipulated and controlled by a handle 1226 connected to the proximal end 1206 of the catheter shaft 1202 as shown.
Referring to FIG. 89, the ventricular device 1200 can be used in a typical retrograde approach to the mitral valve MV, as described above and illustrated in FIG. Access to the mitral valve MV is achieved by an approach that traverses the aortic valve AV from the aortic arch AA and enters the left ventricle LV below the mitral valve MV. Such access is maintained with a guide catheter 40 through which the ventricular device 1200 can be introduced. With the upper nail 1210 in the closed position, the ventricular device 1200 can be inserted through the guide catheter 40. After exiting the guide catheter 40 just below the aortic valve AV, the device 1200 can be advanced toward the mitral valve MV. The catheter shaft 1202 can be pre-shaped to provide a suitable curve for placing the tip 1204 below the leaflets ALF, PLF. In addition, two mandrel having a suitable shape can be advanced into the lumen within the catheter shaft 1202. By changing the position of the two axes relative to each other and relative to the catheter shaft 1202, the overall curve of the shaft 1202 can be changed in situ.

  It is desirable to position the tip 1204 of the device 1200 below the mitral leaflets ALF and PLF with the upper claw 1210 in the open position. As shown in FIG. 89, the lower claw 1212 is in the vicinity of the front leaflet ALF, the upper claw 1210 is in the distal position of the rear leaflet PLF, and each leaflet is between the claws 1210 and 1212. Should be fixed. In order to achieve such an arrangement, the device 1200 would need to bend at an extreme angle within the region of the coupling coil 1208. As such, the coupling coil 1208 is designed to provide such flexibility.

  Balloon wire 1250 can be used to assist in positioning device 1200. The balloon wire 1250 is first inserted through the aortic valve AV, advanced downward to the apex of the ventricle, and then returns upward toward the mitral valve MV behind the posterior leaflet PLF. Once the position is determined, the balloon 1252 is inflated to help keep it in a steady state. Next, the cuff wire 1260 is inserted into the aortic valve AV. The cuff wire 1260 tracks along the balloon wire 1250 by a locking ring 1262. When the cuff wire 1260 is advanced to the desired position, the locking ring 1262 is activated to lock the cuff wire 1260 to the balloon wire 1250. A typical means for activation is to inflate the locking ring 1262. The ventricular device 1200 is then tracked along the cuff wire 1260 to the desired position as shown in FIG. A balloon or balloon wire 1250 can be used to facilitate gripping by biasing the rear leaflet toward the center of the valve.

  Once the position is determined, the upper claw 1210 is closed relative to the lower claw 1212 so that the leaflets are gripped between them. Once the leaflets are grasped, it is often desirable to adjust or manipulate them. Processing operations should only be performed in upper / lower (up / down) movements to bring the leaflets to the final position where backflow is minimized. The lower pawl 1212 can be provided with a moving mechanism for extending and retracting it. Thereby, one leaflet can be moved up and down with respect to the other leaflet. Once the leaflets are well adjusted, fixation can be performed by any of the methods described above. In a preferred embodiment, fixation can be achieved through the lower pawl 1212 as shown in FIGS. 90A and 90B. As shown in FIG. 90A, an incision can be made in the lower claw 1212 that accesses a lumen 1272 that extends through the catheter shaft 1202 and the lower claw 1212. Such a lumen can also function as a guidewire lumen 1216. When the upper claw 1210 closes with respect to the lower claw 1212, the leaflet LF is captured between the claws. As shown in the side view of FIG. 90B, the captured leaflet LF enters the lumen 1272 through the notch 1270. The fixation device 1274 can then be inserted through the lumen 1272 (in the direction of the arrow) to fix the leaflets LF together. It will be appreciated that such a fixation method can be used with many devices, including a nail-type shame device, such as the atrial / ventricular device 1100 shown in FIG.

  Although the device and method have been described in detail by way of illustration and example for clarity of understanding, it will be understood that various alternatives, modifications and equivalents may be used and that the above description will limit the scope. It should be clear that it should not.

It is a schematic diagram of the left ventricle of the heart, and blood flow in the systole is indicated by arrows. It is a schematic diagram of the left ventricle of the heart and shows a state in which lobular prolapse occurs in the mitral valve. It is a schematic diagram of the heart of a patient with cardiomyopathy, showing a state where the heart is dilated and the leaflets are not associated. FIG. 3A shows normal closure of the leaflets. FIG. 3B shows an abnormal closure in the dilated heart. FIG. 5 shows mitral valve regurgitation in the left ventricle of a heart with papillary muscles damaged. It is a schematic diagram which shows the direct adhesion | attachment of the opposing leaflet for reducing the backflow of a valve. It is a schematic diagram which shows the state which attached the chord of the valve in order to treat the backflow of the valve. FIG. 6 shows an example of an antegrade approach from the venous vasculature to the mitral valve. FIG. 6 shows an example of an antegrade approach from the venous vasculature to the mitral valve. FIG. 6 shows an example of a retrograde approach to a mitral valve through the aortic valve and the arterial vasculature. FIG. 6 shows an example of a retrograde approach to a mitral valve through the aortic valve and the arterial vasculature. FIG. 6 shows the use of an adjustment wire to control the direction of travel. FIG. 6 shows the use of an adjustment wire to control the direction of travel. FIG. 6 shows the use of an adjustment wire to control the direction of travel. FIG. 6 shows the use of an adjustment wire to control the direction of travel. 15A-15D illustrate the use of a preformed mandrel to control the direction of travel of a component or structure. It is a figure which shows various direction evaluation tools. It is a figure which shows various direction evaluation tools. It is a figure which shows various direction evaluation tools. It is a figure which shows various direction evaluation tools. It is a figure which shows various direction evaluation tools. It is a figure which shows various direction evaluation tools. It is a figure which shows various direction evaluation tools. It is a schematic diagram of the stabilization apparatus of the atrial septum. FIG. 3 is a schematic view of a catheter shaft designed to stabilize a structure such as the atrial septum, or to provide flexible adjustment capability and stability at various locations. It is a schematic diagram of an atrial stabilization device. It is a figure which shows the stabilization mechanism using the coupling | bonding to an annulus. It is a figure which shows the stabilization mechanism using the coupling | bonding to an annulus. It is a figure which shows the stabilization mechanism using the coupling | bonding to an annulus. It is a figure which shows the stabilization mechanism using the coupling | bonding to an annulus. FIG. 5 illustrates a stabilization mechanism that utilizes valve commissure and / or coupling to leaflets. FIG. 5 illustrates a stabilization mechanism that utilizes valve commissure and / or coupling to leaflets. FIG. 6 shows stabilization of the mitral valve by using a snare to capture the chords of the valve. FIG. 6 shows stabilization of the mitral valve by using a snare to capture the chords of the valve. FIG. 6 shows an antegrade approach for treating valve regurgitation by tightening a snare around the valve chords and stitching together the chords as needed. FIG. 6 shows an antegrade approach for treating valve regurgitation by tightening a snare around the valve chords and stitching together the chords as needed. FIG. 6 shows an antegrade approach to stabilize a mitral valve by tightening a snare on the chords of the valve. FIG. 5 shows a snare catheter specifically intended to capture the chords of the valve with a retrograde approach. FIG. 36 shows the use of the catheter of FIG. 35 to tighten the snare on the valve chord. FIG. 36 shows the use of the catheter of FIG. 35 to tighten the snare on the valve chord. A catheter similar to that shown in FIGS. 35 and 35A is shown, except that it includes an interventional catheter for treating a mitral valve or other atrioventricular valve and a working channel for introducing an interventional tool. A catheter similar to that shown in FIGS. 35 and 35A is shown, except that it includes an interventional catheter for treating a mitral valve or other atrioventricular valve and a working channel for introducing an interventional tool. 39A and 39B show a coil that can be implanted in the chordae of the valve to stabilize the mitral valve. It is a figure which shows the arrangement | positioning condition of the coil of FIG. 39A and 39B in a retrograde approach. It is a figure which shows the leaf-leaf holding apparatus using pinching (pinch). It is a figure which shows the leaf-leaf holding apparatus using pinching (pinch). It is a figure which shows the leaf-leaf holding apparatus using pinching (pinch). It is a figure which shows the leaf-leaf holding apparatus using pinching (pinch). It is a figure which shows the leaf-leaf holding apparatus using pinching (pinch). 44A to 44D are schematic views of an atrioventricular valve leaf gripping device that uses pinching. 45A-45B are schematic views of a gripping device that uses a roller for pinching. 46A-46B are schematic views of a gripping device that uses a pair of opposed coils for pinching. 47A-D are views showing a fork-shaped leaflet device utilizing a pinching, partially penetrating, or piercing method. FIG. 2 shows a stabilization catheter utilizing a vacuum used in the methods described herein. It is a figure which shows embodiment of the suturing device of a valve. 49A-49C illustrate another embodiment of a valve suturing device. FIG. 9 shows yet another embodiment of a valve suturing device. FIG. 6 shows the use of a catheter to capture and suture the opposing leaflets of the mitral valve. FIG. 52 shows the mitral valve leaflets fixed as shown in FIG. 51. 53 and 54 show another anchor that can be used with the suturing device. 53 and 54 show another anchor that can be used with the suturing device. 55A-55B illustrate the use of an expandable anchor in a fusion procedure. 55A-55B illustrate the use of an expandable anchor in a fusion procedure. It is a figure which shows another suturing device. It is a figure which shows another suturing device. FIG. 58 illustrates the use of the suturing device of FIGS. 56 and 57 to place a suture between the mitral leaflets. It is a figure which shows another embodiment of a suturing device. FIG. 60 illustrates the use of the device of FIG. 59 and the stitching of the opposing leaflets of the mitral valve. 61A-61B illustrate a staple driving device that can be used to connect opposing leaflets of an atrioventricular valve with a needle (staple). It is a schematic diagram of a fixing device. It is a schematic diagram of a fixing device. It is a schematic diagram of a fixing device. It is a schematic diagram of a fixing device. It is a figure which shows another embodiment of a suturing device. FIG. 64 is a diagram showing the use of the staple driving device shown in FIG. 63 for stapling the opposing leaflets of the mitral valve. 65A to 65C are schematic views of a coil-type fixing device. FIG. 5 shows the use of a self-fixing anchor to attach an opposing surface on the mitral leaflet. 66A-66B are schematic views of a fixing device that penetrates. It is a schematic diagram of the fixing device which the front-end | tip became the key shape and penetrates. It is a schematic diagram of the fixing device which the front-end | tip became the key shape and penetrates. It is a schematic diagram of the clip used as a fixing device. It is a schematic diagram of the clip used as a fixing device. It is a schematic diagram of the clip used as a fixing device. It is a schematic diagram of the clip used as a fixing device. It is a schematic diagram of the clip used as a fixing device. FIG. 6 is a schematic view of a clip including the use of a gripping device within a securing mechanism. 72A-72B are schematic views of a clip including the use of a gripping device within a locking mechanism. 73A-73C are views showing a three-nail clip mounting device. FIG. 73C is a diagram showing a clip mounted by the clip mounting apparatus of FIGS. 73A-73C. It is a figure which shows the apparatus which applies high frequency energy in order to shorten the chord of a valve. FIG. 5 shows a device used to pleat and shorten a valve chord. FIG. 5 shows a device used to pleat and shorten a valve chord. FIG. 5 shows a device used to pleat and shorten a valve chord. FIG. 3 shows a first exemplary approach for placing an annuloplasty ring. FIG. 6 shows a second exemplary approach for placing an annuloplasty ring. FIG. 6 shows a second exemplary approach for placing an annuloplasty ring. FIG. 6 shows a method for placing a fixed filament around a mitral valve annulus, which can be used to tighten the annulus. FIG. 6 is a view showing a method for placing a plurality of sutures around the annulus of the mitral valve, wherein individual sutures are plied to the annulus. FIG. 2 shows an embodiment of an atrial device for modifying valve tissue. FIG. 2 shows an embodiment of an atrial device for modifying valve tissue. FIG. 2 shows an embodiment of an atrial device for modifying valve tissue. FIG. 2 shows an embodiment of an atrial device for modifying valve tissue. FIG. 2 shows an embodiment of an atrial device for modifying valve tissue. FIG. 3 shows an embodiment of an atrioventricular device for modifying valve tissue. 87A-C illustrate an embodiment of an atrioventricular device for modifying valve tissue. FIG. 3 shows an embodiment of a ventricular device for modifying valve tissue. FIG. 3 shows an embodiment of a ventricular device for modifying valve tissue. 90A and B illustrate an embodiment of a ventricular device for correcting valve tissue. FIG. 91 is a cross-sectional view of the left ventricle LV. 92A-92B show an annuloplasty device for placement in the left ventricular groove. It is sectional drawing of the left ventricle where the ring formation apparatus was laid in the groove | channel. 1 is a cross-sectional view of a heart showing a mitral valve, a leaflet, an annulus, and a coronary sinus.

Claims (19)

A method for modifying a patient's heart valve,
Advancing a catheter having at least one structure releasably coupled through the patient's vasculature from an access point of the vasculature away from the heart into the heart;
The structure is adapted to modify the annulus of the heart valve to reduce backflow in the heart valve and place the structure from the catheter into a groove on the ventricular side of the annulus of the heart valve And, in combination with placing the structure, holding the leaflets of the heart valve together to reduce backflow in the heart valve;
Including methods. Advancing the catheter comprises advancing the catheter into the right atrium;
Passing through the atrial septum to form an opening in the atrial septum;
Advancing the catheter into the left atrium through an opening in the atrial septum;
Advancing the catheter downward through the mitral valve,
The method of claim 1 comprising:   3. The method of claim 2, further comprising bending the distal region of the catheter upward toward the groove so that the structure approaches the groove from below the mitral valve.   The method of claim 1, wherein holding the leaflets of the valve together comprises permanently attaching points opposite each other on or along the leaflet.   Holding the leaflets of the valve together involves stitching, clipping, stapling, rivet locking, bonding or fusing points on or along the leaflet facing each other The method according to claim 1.   The method of claim 1, wherein holding the leaflets of the valve together is accomplished by linking opposing chords of the leaflets.   9. A method according to claim 8, wherein linking comprises suturing, capturing, fusing, clipping or gluing opposing chords.   The method of claim 1, wherein modifying the annulus comprises shortening an outer periphery of the annulus.   The method of claim 1, wherein the structure comprises a ring that at least partially surrounds the annulus within the groove.   The method of claim 1, wherein the structure comprises a plurality of staples located in an annular configuration in the groove around the annulus.   The method of claim 1, wherein the structure includes at least one securing member that secures the structure within the groove.   The method of claim 1, wherein the heart valve comprises a mitral valve. Allowing scar tissue to grow around the structure in the groove, and reforming the structure to modify the shape of the annulus, wherein the scar tissue is between the structure and the groove Realizing a straight adhesion of
The method of claim 1 comprising:   14. The method of claim 13, wherein the structure is reshaped after a period of 4 to 24 weeks has elapsed. A method for modifying a patient's heart valve,
Advancing a catheter having a releasably coupled annuloplasty device through the patient's vasculature and into the heart from a vascular access point away from the heart;
Intervening in the ventricular groove of the heart valve to correct the annulus of the heart valve and reduce back flow in the heart valve;
Modifying the spatial relationship between the first and second leaflets of the heart valve in combination with performing an intervention to reduce regurgitation in the heart valve;
Including methods.   16. The method of claim 15, wherein performing an intervention comprises applying radio frequency (RF) energy to the groove to change the shape of the structure.   16. The method of claim 15, wherein performing an intervention comprises laying a structure from the catheter into the groove. Allowing scar tissue to grow around the structure in the groove, and reforming the structure to modify the shape of the annulus, wherein the scar tissue is between the structure and the groove Realizing a straight adhesion of
16. The method of claim 15, further comprising:   19. The method of claim 18, wherein the structure is reshaped after a period of 4 to 24 weeks has elapsed.

Images