WO1996039997A2 - Device and method for delivering and deploying intraluminal devices - Google Patents
Device and method for delivering and deploying intraluminal devices Download PDFInfo
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- WO1996039997A2 WO1996039997A2 PCT/US1996/010405 US9610405W WO9639997A2 WO 1996039997 A2 WO1996039997 A2 WO 1996039997A2 US 9610405 W US9610405 W US 9610405W WO 9639997 A2 WO9639997 A2 WO 9639997A2
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- catheter
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09008—Guide wires having a balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09175—Guide wires having specific characteristics at the distal tip
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
Definitions
- This invention relates to a device and method for delivering and deploying an intraluminal device.
- the invention has particular utility as a device and method for delivering and deploying stents and endovascular grafts within a blood vessel.
- An endovascular graft is placed within a blood vessel and serves as a conduit for blood flow to exclude a vascular occlusion, aneurysm or other vessel abnormity. It may be made of a variety of materials, but most commonly is made of dacron, expanded polytetrafluoroethylene (ePTFE) or human vein. It is necessary to anchor the graft within the lumen of the blood vessel and this can be accomplished by means of an intravascular stent which is also commonly used to hold open diseased or occluded arteries.
- ePTFE expanded polytetrafluoroethylene
- stents There are a number of known stents; some are of the self-expand ⁇ ing type and some are made of a material (for example metal) which can be expanded after the stent is in place to frictionally engage the blood vessel. Palmaz U.S. Patent No. 4,776,337 illustrates in Figs. 2A and 2B a stent of the latter type which is currently in use.
- graft stent complex is intended to include the combination of a graft and one or more stents.
- the delivery and deployment systems for a graft stent complex typically includes a guide sheath (catheter) which is properly positioned within the vasculature to guide the passage of a deployment mechanism (commonly a balloon catheter support- ing the graft stent complex) to the proper site.
- the guide sheath have a relatively large diameter resulting in difficulty passing the sheath through arteries which usually are not straight and may have many curves or twists in them.
- arteries may contain areas of disease (atherosclerotic plaque) which may obstruct the passage of the guide sheath through the vascular tree. Irregularly shaped plaque which could accidently engage an endoluminal catheter may create potential sites for arterial injury.
- the vasculature may contain segments which are weaker than others, putting them at risk for perforation should they engage the guide sheath as it is being moved along the arterial wall.
- the conventional technique for positioning a guide sheath within a blood vessel requires the use of a stylet (or mandrel or stiffening catheter as it is sometimes called), which includes a tapered distal end extending from the distal end of the guide sheath to enhance pushability of the guide sheath while providing a tapered distal face to ease passage of the guide sheath through the artery.
- the stylet does not completely cover the relatively sharp edges of the guide sheath. Patients, therefore, are subject to arterial injury, and dislodgement of intraluminal thrombus and accumu ⁇ lated plaque on the arterial wall. This can lead to severe injury. Moreover, there is a trade-off between stiffness and flexibility.
- the sheath is too stiff, movement through the artery is difficult. If it is too flexible, the sheath is difficult to push. Since the flexibility of the stylet is not adjustable, passage of the catheter through sharp turns in the vasculature can be very difficult, if not impossible.
- the iliac artery is commonly kinked in patients with aortic aneurysm disease because of the frequent elongation of the vasculature during formation of the aneurysm. Manipulation of a wide guide sheath through such an artery using conventional techniques can be exceedingly difficult. Also, conventional guide sheaths need to be large enough to permit ease of movement of an endovascular graft out of the sheath and into the vasculature.
- the sheath size has to be large enough to maintain a low coefficient of friction between the inner surface of the deployment catheter and the graft stent complex. Such large sheaths require large holes into the inserting blood vessel.
- the balloon catheter containing the graft stent complex must be introduced through a hemostatic valve at the proximal end of the guide sheath and pushed through the entire length of the guide sheath (for example about sixty cm) to the deployment position. This can prove to be time consuming and difficult.
- the stent can be dislodged from the balloon while being pushed through the long guide sheath.
- Figs. 1-9 show two devices for delivering and deploying intraluminal devices such as stents which overcome the above problems.
- Those devices comprise a guide sheath and a lead balloon which, when inflated, seals the guide sheath and provides a tapered leading edge for the guide sheath.
- a tortuous vasculature i.e. an arterial system in which the blood vessels have many twists and turns, as is often the case with elderly patients, it can be extremely difficult to push the guide sheath through the vasculature.
- a primary object of the invention is to provide an improved device for delivering and deploying an endovascular stent and/or graft stent complex. Another object is to provide a device for delivering and deploying a stent and/or graft stent complex which avoids or at least reduces the foregoing drawbacks of prior art stent delivery and deployment systems.
- a still further object is to provide a device for delivering and deploying a stent and/or graft stent complex in which the profile (diameter) of the device is reduced for a given size prosthesis.
- a device for delivering and deploying a stent comprises a guide sheath and a lead balloon within the guide sheath.
- a catheter containing the intraluminal device to be deployed is positioned within the guide sheath.
- the lead balloon extends partially from the distal end of the guide sheath and, when it is inflated, provides a tapered surface at the distal end of the guide sheath which merges smoothly with the outer surface of the guide sheath, thereby reducing the likelihood of accidental arterial injury or dislodgement of thrombus or plaque.
- fluid under pressure is applied to the sheath to control the flexibility of the sheath so that the tradeoff between pushability and flexibility can be optimized for the specific conditions of the vasculature.
- a handle is provided for retaining the proximal end of the guide sheath.
- the deployment catheter extends through the guide sheath and a locking valve in the end of the handle so that the handle and catheter can be locked together.
- the guide sheath is moveable a preselected distance within the handle so that the surgeon can retain the stent in position by holding the handle and moving the guide sheath the proper distance to expose the stent.
- the lead balloon is mounted on a separate lead balloon catheter which can be connected in end-to-end fashion to the deployment catheter within the guide sheath.
- the intraluminal device may be delivered by pushing on the deployment catheter and pulling on the lead balloon catheter. This is particularly beneficial in the case of a tortuous vasculature as may exist in the case of elderly patients.
- a transluminal device is deliv ⁇ ered into a blood vessel by first directing a guide wire through the vasculature with the guide wire extending from an entrance point and an exit point. A first catheter is then passed over the guide wire through the vasculature from one point to the other with the ends of the catheter protruding from the entrance and exit points. A second catheter containing the transluminal device is then connected to an end of the first catheter. The transluminal device is positioned within the vasculature by pushing on the second catheter and, simultaneously pulling the first catheter. By simultaneously pushing and pulling on the catheter containing the transluminal device, it is much easier to traverse a tortuous path which otherwise might be unpassable.
- a balloon catheter is used to deploy the stent, although mechanical deployment means or self expanding deployment means may be used as well.
- the stent is mounted on the deployment means which is movable with the stent to a position distal of the guide sheath when the stent is to be deployed.
- a single catheter shaft supporting both the deployment and lead balloons may be used, but it is also contemplated that a deployment catheter separate from the lead balloon catheter may be used. In the latter case, an opening is provided in the lead balloon catheter shaft and the distal end of the deployment catheter is inserted into the opening in such a way that a guide wire inserted into the distal end of the lead balloon catheter shaft will pass automatically into the guide wire lumen of the deploy ⁇ ment balloon catheter.
- the second catheter is positioned within a guide sheath and the first catheter contains a lead balloon which provides a tapered leading surface for the guide sheath and seals the distal end of the guide sheath so that it can be selectively pressurized to optimize its properties of steerability and pushability.
- the invention provides a number of significant advantages as compared to prior art devices for delivering and deploying a stent.
- a stylet or mandrel
- the ability to control the trade-off between stiffness and flexibility by pressurizing the guide sheath enables the operator to optimize the compromise between these two parameters depending on the patient's vasculature; moreover, since the pressurization of the sheath can be varied at will, the operator can change the trade-off as the sheath traverses the artery. That is, in tortuous sections, flexibility (steerability) can be favored at the expense of pushability. In straighter, more distal portions of the vasculature, the sheath can be stiffened to enhance pushability. This is particularly beneficial when encountering sharp turns as can occur in the iliac artery of patients suffering aortic aneurysm disease.
- the wall of the sheath can be extremely thin. This increases the potential internal diameter of the sheath relative to the outer diameter and thereby increases the space available to house the graft or graft stent complex; this means that for a given outer diameter, the invention is capable of delivering and deploying a larger stent (or graft stent complex) than is possible in the prior art.
- a valuable benefit of the invention is the fact that the sheath can be muzzle loaded with a graft stent complex prior to use. This provides two important advantages over conventional prior art techniques, wherein the graft stent complex is introduced through the proximal end of the sheath after the sheath is in position. In the first place, it avoids the need to traverse the entire length of the guide sheath to position the graft stent complex within the sheath. Secondly, since it is not necessary to introduce the complex through the hemostatic valve at the proximal end of the guide sheath, a smaller hemostatic valve can be used resulting in less blood loss during catheter manipulations.
- a further feature of the invention resides in the fact that the use of a lead balloon results in a completely smooth transition between the distal face of the guide sheath and the tapered surface formed by the balloon. This smooth transition avoids the sharp edges which may exist when a stylet system is used, and which may injure the artery and cause dislodgement of intraluminal thrombus and accumulated plaque.
- Figs. 1 A and IB comprise a plan view, partially in section, of a first embodiment of the invention assembled and ready for use prior to lead balloon inflation and sheath pressurization.
- Figs. 2 A and 2B are slightly enlarged views of the proximal and distal ends, respectively, of the device shown in Figs. 1A and IB with a guide wire in place and the lead balloon at the distal end of the guide sheath inflated;
- Fig. 3 is a cross sectional view along the line 3-3 of Fig. 2B;
- Fig. 4 is an enlarged side sectional view showing the manner in which the distal end of the deployment catheter is joined to the lead balloon catheter;
- Figs. 5A and 5B are slightly enlarged views showing the device with the deployment balloon positioned within the guide sheath and the lead balloon deflated and extended off and beyond the guide wire;
- Figs. 6 A and 6B are slightly enlarged views showing the balloons after the deployment balloon has been inflated to expand the distal stent with the deflated lead balloon previously retracted into the sheath.
- Figs. 7A and 7B comprise a plan view partially in section showing a second embodiment of the invention.
- Fig. 8 is a sectional view along the line 8-8 of Fig. 7A;
- Fig. 9 is a sectional view along the line 9-9 of Fig. 7B;
- Fig. 10 is a plan view partially in section of a handle according to the invention.
- Fig. 11 is a top view of the handle;
- Fig. 12 is a cross sectional view along the line 12-12 of Fig. 10;
- Fig. 13 is an enlarged view of a lead balloon and sheath
- Fig. 14 is a plan view of a third embodiment in which the lead balloon is introduced into the distal end of the sheath; and Fig. 14A is an enlarged side sectional view of the embodiment of Fig.
- Figs. 1-6 illustrate an embodiment of the invention in which separate deployment and lead balloon catheters are used to deploy a graft stent complex shown as comprising a graft 12 and stent 14.
- Stent 14 for example, may be a conventional Palmaz stent.
- the specific construction of the device to be deployed is not a feature of the invention.
- the delivery and deployment device comprises a guide sheath 20 which is adapted to be positioned within the patient's vasculature to facilitate delivery of the graft stent complex to the location where it is to be deployed.
- the guide sheath 20 terminates at its proximal end in a three way hemostatic valve 21.
- Hemostatic valve 21 may be a modified Tuoy Borst hemostatic valve having deployment catheter port 22, an end catheter port 24 and a sheath pressurization port 26 for purposes described below. Hemostatic valve 21 prevents the loss of blood through sheath 20 when its distal end is not sealed. Thumb screws 22A and 24A close ports 22 and 24, also locking in position the catheter which passes through the port.
- the sheath pressurization port 26 is connected through a syringe 28 which may be of the type which includes an integral infusion pressure manometer 29 to provide the operator with a continuous indication of the pressure applied by the syringe to the port 26.
- the syringe 28 may include a piston which is threadedly received within a bracket 31 fixed to the barrel.
- the guide sheath 20 contains a deployment catheter 30 and a lead balloon catheter 40.
- the deployment catheter 30 comprises an elongated flexible shaft 32 which includes a guide wire lumen 34 and an inflation lumen 36 (see Fig. 3).
- a deployment balloon 38 is mounted on the distal end of the deployment catheter 30 in such a way that it can be inflated and deflated through the inflation lumen 36.
- the deployment balloon catheter 30 terminates at its distal end in luer locks 38A and 38B which are connected by means of a standard bifurcated connector 39 to the proximal end of the catheter shaft 32.
- the luer lock 38A is in fluid commu ⁇ nication with the inflation lumen 36 and the luer lock 38B communicates with the guide wire lumen 34.
- Balloon catheters of this construction are conventional; there- fore, the deployment catheter 30 is not described in further detail.
- the lead balloon catheter 40 likewise is of conventional construction and includes an elongated flexible shaft 42 which includes a guide wire lumen 44 and an inflation lumen 46.
- a lead balloon 47 is mounted at the distal end of the catheter 40 and can be selectively inflated and deflated through the inflation lumen 46.
- a luer lock 49 is attached to the proximal end of the lead balloon catheter 40 so that the balloon 47 can be inflated by the introduction of fluid through the luer lock 49.
- the lead balloon shaft 42 includes an opening 50 which, as most clearly shown in Fig. 4, is adapted to receive the distal end of the deployment catheter 30. Opening 50, which may be formed by skiving shaft 42, does not affect the inflation lumen 46 but enables the guide wire lumens 34 and 44 to be aligned in a substantially collinear relationship so that a standard guide wire 52 can be passed from the lead balloon catheter 40 to the guide wire lumen 34 of the deployment catheter 30 during use.
- sheath 20 has a constant outer diameter, but the inner diameter of the proximal portion of the sheath (Fig. 1 A) is less than the inner diameter of the distal portion (Fig. IB), i.e.
- the distal section is more flexible (less stiff) and includes a wider lumen.
- the proximal portion of the sheath provides increased pushability and torquability of the catheter as it is inserted. Because the graft stent complex is muzzle loaded (as explained below), there is no need for a large internal diameter in the proximal segment of sheath 20 and a thicker wall is feasible.
- the wall is thin and indeed, may even be flimsy, for example, comparable to cellophane film. Reduction of wall thickness in the distal portion of the sheath provides increased space in which the graft stent complex can be housed, which means that for a given outer diameter, a larger complex is possible with the invention. Pushability of the catheter is enhanced in part by the presence of the stent graft complex within the sheath but, primarily, the stiffness required is achieved by pressurizing the sheath by the introduction of fluid under pressure through port 26 of valve 21.
- the surgeon can continuously vary the stiffness (and thus pushability and flexibility) of the sheath throughout the insertion procedure. This means that the surgeon has the capability of varying the stiffness of the catheter sheath during different phases of insertion depending on the degree of tortuosity of the vascular system.
- the sheath 20 may be made of PTFE (Teflon).
- the length and charac ⁇ teristics of the sheath will vary depending upon the particular application. Where an aortic aneurysm graft is to be deployed, the sheath 20 may be approximately 60 cm in length with the distalmost 15-20 cm comprising the flexible portion of the sheath.
- the sheath may be manufactured by standard extrusion techniques with the distal flexible portion thereafter cored from the extruded tube to form a thinner-walled flexible section.
- the device may be assembled and sold in the condition shown in Figs. 1A and IB, or it may be assembled at the time of use.
- the method of assembly is as follows.
- Deployment catheter 30 and lead balloon catheter 40 are passed through the deployment catheter port 22 and tip catheter port 24 of hemostatic valve 21 with the valve screws 22A and 22B open until the balloons 38 and 48 extend from the distal end of the sheath. If the device is to be used to deploy a graft stent complex 12, 14, the complex is then placed over the distal end of deployment catheter 30 with the balloon 38 beneath the stent 14. In conventional fashion, the stent 14 is crimped to balloon 38. The distal tip of deployment catheter 30 is then inserted into the opening 50 within the shaft 42 of lead balloon catheter 40 so that a continuous or collinear passageway is formed between the guide wire lumens 34 and 44.
- the graft stent complex and catheters 30 and 40 are then muzzle loaded into the sheath 20 (i.e., retracted proximally into the sheath) and positioned so that, for example, about half of the lead balloon 48 extends from the distal end of the sheath 20, as shown in Fig. 2B.
- the lead balloon 48 may be about four cm. in length which means that approximately two cm. of the balloon will extend distaUy from the sheath 20.
- the ability to muzzle load the catheters and graft-stent complex into the sheath is a valuable feature of the invention since it avoids the need to push the graft through the entire sheath which, in view of the length of the sheath, can be time consuming and may result in separation of the graft-stent complex (14,12) from the underlying balloon.
- a one-way valve 51 (Fig. 2A) is attached to the lead balloon inflation port luer lock 49 and the lead balloon 48 inflated with saline solution from a standard ten cc. syringe 53 attached to luer lock 49.
- the balloon 48 when the balloon 48 is inflated, it seals the distal end of the sheath 20 and provides a smooth taper which facilitates movement of the sheath through the patient's vasculature. Expansion of the balloon also results in a smooth transition between the sheath and balloon (see Fig. 2B) which means that the sheath is less likely to injury the artery or dislodge thrombus or plaque as it is pushed through the artery.
- the lead balloon also serves to aid in hemostasis, since blood cannot travel back through the sheath and out of the patient while the balloon is inflated.
- the syringe 28 attached to the sheath pressurization port 26 is then used to inject saline into sheath 20 to a desired sheath pressure as measured by the infusion pressure manometer. After all air has been evacuated, i.e. the system has been bled, the catheter infusion ports are closed.
- the device is now ready to be inserted into the patient.
- the device is inserted as follows. First, the guide wire 52 is passed through the patient's vasculature with its location being confirmed fluoroscopically. In Figs. 5A, 5B, 6A and 6B, a blood vessel is shown at 56 for purposes of explanation. The operator then inserts the proximal end of the guide wire into the distal end of the guide wire lumen 44 within lead balloon catheter 40.
- the operator next introduces sheath 20 into the patient over the guide wire. Because of the way in which the deployment catheter 30 is nested within the lead balloon catheter 40, the guide wire passes from the lead balloon guide wire lumen 44 into the collinear deployment guide wire lumen 34 as shown in Fig. 4. With the inflated lead balloon 48 providing a smooth taper for the pressurized sheath 22, the operator guides the sheath with the enclosed catheters to the location where the stent is to be deployed. As the sheath is being moved, the surgeon can vary its flexibility to accommodate the specific vascula ⁇ ture by adjusting the pressure within the sheath as indicated by manometer 54. The sheath position is determined fluoroscopically in a conventional fashion. For example, the sheath 20 may have regularly placed radiopaque markers so that the exact location of the sheath tip can be identified. When the proper location is reached, lead balloon 48 is deflated using the syringe.
- the thumbwheel 24A for the lead balloon catheter 40 is then released and the lead balloon catheter advanced distaUy (with the position of the deployment catheter 30 held in place) until the catheter 40 is disengaged from the guide wire 52 (Figs. 5 A and 5B). This occurs when the opening 50 moves distaUy beyond the distal end of the guide wire 52.
- the thumb screw 22A which secures the deployment catheter 30 is loosened and the sheath 20 retracted to expose the stent 14.
- the syringe with saline is attached to the luer lock 38B and the deployment balloon 38 is expanded to deploy the stent (Figs. 6A and 6B).
- the deployment balloon 38 is deflated. It may then be exchanged for a second deployment catheter containing a second stent to be properly positioned with respect to the graft 12 and deployed.
- graft 12 may be provided with both stents, in which case the deployment catheter 30 can be withdrawn until the deployment balloon 38 is beneath the second stent.
- the balloon can then be expanded to deploy the second stent.
- the sheath 20 and catheters 30 and 40 are then removed and a completion angiogram performed.
- the catheter comprises an elongated flexible shaft 60 having a central guide wire lumen 62 and peripheral inflation lumens 64 and 66.
- a lead balloon 68 is provided at the distal end of the catheter 60 for inflation through the lumen 64.
- a deployment balloon 70 is positioned on the shaft 60 proximally of the lead balloon 68 and adapted to be inflated or deflated by means of the lumen 66.
- the lead balloon 68 and deployment balloon 70 function the same way as the lead balloon 48 and deploy- ment balloon 38 of the embodiment shown in Figs. 1-6 but, of course, cannot be separated.
- the proximal end of the guide sheath 20 terminates in a hemostatic valve 72 through which the catheter shaft 60 extends.
- the hemostatic valve 72 includes a port 74 which may be connected to the syringe 28 shown in Fig. 1A.
- the port 74 provides access to the interior of the sheath 20.
- a standard hemostatic valve may be used as valve 72.
- the catheter shaft 60 terminates in a conventional trifurcated fitting 76 having three proximal ports which terminate in luer lock 78, 80, and 82.
- the luer locks 78 and 82 provide access to the inflation lumens 64 and 66, respectively, while the luer lock 80 provides access to the guide wire lumen 62.
- the guide wire 52 is inserted in conventional fashion through the guide wire lumen 62 of the catheter shaft 60.
- a one-way valve would be connected to luer lock 78 to maintain the inflation of the lead balloon during use.
- hemostatic valve 21 may be an ANGEDAPT Y-connector manufactured by Angeion Medical Products, Model No. AYC-020.
- Hemostatic valve 72 may be of the type sold by Universal Medical Instrument Corp. under the trademark CATH-SEAL (Model No. 1200-90-3003).
- the pressure syringe 28 may be a LeVeen disposable inflation syringe with pressure gauge manufactured by the MedTech Division of Boston Scientific (Model No. 15-101).
- the guide sheath comprises a relatively stiff flexible portion and a relatively flexible distal portion. It is conceivable that it may prove beneficial to have a continuously variable change in stiffness/flexibility, in which case the inner wall may taper gradually with the diameter increasing from the proximal end to the distal end. It is also possible that stiffness/flexibility may vary in a number of discrete steps, rather than in a single step as illustrated.
- the entire sheath can be made of a highly flexible plastic (e.g., PTFE), which can be folded so as to reduce its cross section prior to insertion.
- PTFE a highly flexible plastic
- the advantage of this construction is that a small introducer (and thus a smaller hole in the patient's artery) could be used to introduce the sheath into the patient's artery. Once in position, the sheath would be pressurized as described in the foregoing to increase its diameter as required for delivery and deployment of the stent.
- Figs. 10-12 illustrate a handle mechanism which, in use, reduces the likelihood of stent displacement when the physician retracts the sheath.
- Figs. 10-12 illustrate a handle construction for use with the two balloon embodiment shown in Figs. 7-9 although the handle would have equal utility with the two catheter embodiment of Figs. 1-6.
- Figs. 10-12 the same numerals are used to identify corresponding parts although some parts are illustrated as slightly different in appearance.
- the proximal end of the sheath 20 is slidably retained within a handle 100 which includes an elongated slot 102 through which port 74 of the hemostatic valve 72 extends.
- the catheter shaft 60 extends through a locking screw 104 attached to the proximal end of the handle 100 and through a locking screw 106 of the hemostatic valve 72 into the sheath 20.
- the hemostatic valve includes a distal stop 108 adapted to abut against the distal edge 109 of slot 102 and a proximal stop 110 adapted to abut against the proximal edge 111 of slot 102.
- hemostatic valve 72 In use, hemostatic valve 72 is pushed distaUy until the stop 108 abuts edge 109 of slot 102.
- the locking screw 106 is loosened to permit movement of the valve 72 relative to the catheter shaft 60.
- Locking screw 104 is tightened so that the handle 100 cannot move relative to the catheter shaft 60.
- the physician holds the handle in one hand and puUs back on the port 74 until stop 110 abuts against the edge 111 of slot 102. Because the locking screw 104 retains the catheter 60 with respect to the handle 100, the sheath 20 is moved relative the catheter 60 the distance determined by the length of slot 102 and the positions of the stops 108 and 110. This permits the physician to hold the catheter 60 (and thus the stent) in a fixed location and withdraw the sheath by a precise amount. Therefore, the likelihood of human error causing improper positioning of the stent when the sheath is retracted is reduced.
- the inner surface of the distal end of sheath 20 and the outer surface of the lead baUoon 47 may be provided with mating circumferential ribs and grooves. These grooves may extend over about 1/2 inch and wiU prevent accidental expulsion of the lead baUoon when sheath 20 is pressurized.
- Other comparable means may be used to retain the expanded lead baUoon within the pressurized sheath 20.
- Fig. 14 shows an embodiment of the invention in which the lead baUoon is mounted on a separate lead baUoon catheter adapted to be introduced into the distal end of the sheath.
- the construction of Fig. 14 is designed for use in a novel stent deployment procedure, described below, which is of special utiUty with patients having a tortuous vasculature through which it is difficult to move a stent deployment catheter.
- the catheter construction is described.
- parts corresponding to the parts shown in the embodiment of Figs. 7-9 bear the same numbers.
- the catheter 60 serves as a stent deployment catheter. It supports an inflatable baUoon 70 on which stent 14 is mounted for deployment as explained above. BaUoon 70 and stent 14 are retained within the sheath 20 which may be pressurized as described above.
- the lead baUoon 68 is on a separate lead baUoon catheter 120.
- the adjoining ends of the lead baUoon catheter 120 and the deployment catheter 60 can be connected together in any suitable fashion which enables the catheters to be selectively connected and disconnected.
- the end of lead baUoon catheter 120 may be tapered and include a circumferential 122 detent adapted to engage a mating rim 124 on the deployment catheter 60 so that the two catheters are held securely together, as shown in detaU in Fig. 14A.
- Numerous other connecting means such as bayonet type connecters, threaded connectors, etc. can be used. The object is to make sure that the two catheters are securely held together during use but, as explained below, in such a way that they can be separated when it is necessary to withdraw them from the patient's vasculature.
- the catheter 60 and 120 may be similar to the cross section shown in Fig. 8 with a central lumen through which a guidewire 52 passes. In each case, only a single inflation lumen 64 (or 66) is necessary.
- a smaU port 126 may be provided in the catheter 120 for the purpose of introducing an angiographic contrast material as described in further detaU below.
- a conventional one- way valve (not shown) should be provided in front of the port 126 (to the right of the port as illustrated in Fig. 14) so that the contrast material introduced into the central lumen wUl be blocked from flowing through the guide wire lumen and thus wiU exit through the port 126.
- Fig. 14 The catheter construction of Fig. 14 is designed to enable two physicians to simultaneously push and puU the deployed stent through the patient's vasculature. This is particularly beneficial in the case of patients with tortuous arteries as frequently encountered in the case of elderly patients. The way in which this is achieved is explained in the foUowing.
- a needle puncture technique Using a needle puncture technique a needle is inserted into the brachial artery in the patient's arm through a percutaneous approach. This needle is guided by palpating the pulse of the brachial artery and thereby advanced into the lumen of the artery. Through this needle, guidewire 52 is inserted and advanced into the lumen of the artery. Under fluoroscopic control, the guidewire is advanced retrograde (against the flow of blood) within the brachial artery to the axillary artery. From the axillary artery the wire moves directly into the left subclavian artery which connects directly with the thoracic portion of the aorta.
- the wire When the wire has entered the aorta in this retrograde fashion, it is advanced under fluoroscopic control down the thoracic aorta into the abdominal aorta. Once it has reached the distal end of the abdominal aorta it is selectively directed into either the right or left common iliac artery. The side into which the wire is directed depends upon which artery has been chosen for subsequently advancing the sheath 20 and the stent deployment catheter 60. GeneraUy, the larger of the two iliac arteries is chosen as the access vessel. The wire 52 is then advanced under fluoroscopic control down through the common iliac artery into the external iliac artery and finally into the common femoral artery.
- the lead baUoon catheter 120 is advanced through the percutaneous puncture in the left brachial artery over the wire through aU the vessels previously described down through the aorta and out the appropriate iliac artery, continuously foUowing the guidewire 52. Once the baUoon has emerged out of the common femoral artery, the stent deployment device is ready for use. The tip of lead baUoon catheter 120 is inserted into the distal end of deploy ⁇ ment catheter so that the detent 122 and ridge 124 are locked together to form a tight union.
- the lead baUoon catheter 120 is advanced into the distal end of the sheath 20 so that approximately half of the baUoon 168 is inside the sheath while the remaining half of the baUoon is outside the sheath.
- the lead baUoon 68 is then inflated to maximum pressure thereby providing a smooth taper at the distal end of sheath 20. With the lead baUoon 68 fuUy inflated and locked into position, the distal end of the sheath 20 and lead baUoon are carefuUy inserted into the previously created arteriotomy in the femoral artery.
- This process is done by slowly pulling back slack on the lead baUoon catheter 120 in the arm as the sheath 20 is advanced into the femoral artery and then retrograde into the external iliac artery.
- the sheath 20, at this juncture, is then pressurized to an appropriate pressure as previously described to produce an optimized balance of flexibUity and pushabUity.
- the entire system is advanced from the iliac arteries into the abdominal aorta and into a suitable position for deployment of the stent graft.
- the lead baUoon 60 is deflated.
- the sheath 20 covering the stent 14 is then withdrawn to expose the stent and graft.
- an arteriogram may be performed. This arteriogram is performed as foUows.
- the guide wire 52 which extends from the brachial artery to the common femoral artery is first removed.
- the one way valve in the tip of the lead baUoon catheter 120 permits only retrograde fluid flow in the catheter. Removing the guide wire 52 closes the valve mechanism permitting pressurization of the central lumen of the lead baUoon catheter 120.
- Angiographic contrast material is injected through the external port of lead baUoon catheter 120 into the guide wire lumen of the catheter and exits from port 126 in the catheter shaft. Contrast cannot continue down the baUoon catheter shaft because the closed valve occludes the passage way.
- This angiogram injection wiU permit final localization of the appropriate position for the stent graft.
- the guide wire 52 is then reinserted through the groin and out through the brachial artery.
- sheath 20 is retracted and the deployment baUoon 70 inflated to deploy the stent 14.
- tension is maintained on the lead baUoon catheter shaft 120 (with lead baUoon 68 deflated.
- the catheters 120 and 60 are disconnected either by applying gentle opposite tension to both baUoon catheter shafts or by advancing the tips of both catheters out of the common femoral artery where they can be disengaged manuaUy. Additional procedures including the placement of additional stents could then be performed using weU described standard techniques.
- the foregoing description relates to the deployment of an aortic stent graft or stent but the principals of the invention may be used for the passage of other transluminal devices into other vascular systems using this push-puU technique.
- the stent deployment means may comprise a mechanical device rather than a baUoon.
- One suitable device for mechanicaUy deploying a stent is shown in copending U.S. patent appUcation Serial No. 08/196,278, filed February 10, 1994, in the names of Michael and Ralph Marin, and entitled APPARATUS AND METHOD FOR DEPLOYMENT OF RADIALLY EXPAND- ABLE STENTS BY A MECHANICAL LINKAGE.
- a baUoon catheter may be introduced into the thoracic aorta and the baUoon expanded to permit the blood flow to push the catheter distaUy to a desired location such as the common femoral artery.
- the right or left artery can be selected by applying pressure to one artery causing the baUoon to move to the other.
- the catheter can then be puUed from the artery and used as explained above or in any desired way to simultaneously push and puU an intraluminal device through the patient's arteries.
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- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
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Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU61784/96A AU6178496A (en) | 1995-06-07 | 1996-06-07 | Device and method for delivering and deploying intraluminal devices |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/483,191 US5569296A (en) | 1994-05-13 | 1995-06-07 | Method for delivering and deploying intraluminal devices |
US08/483,190 US5697948A (en) | 1994-05-13 | 1995-06-07 | Device for delivering and deploying intraluminal devices |
US483,190 | 1995-06-07 | ||
US483,191 | 1995-06-07 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO1996039997A2 true WO1996039997A2 (en) | 1996-12-19 |
WO1996039997A3 WO1996039997A3 (en) | 1997-02-20 |
Family
ID=27047562
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1996/010405 WO1996039997A2 (en) | 1995-06-07 | 1996-06-07 | Device and method for delivering and deploying intraluminal devices |
Country Status (2)
Country | Link |
---|---|
AU (1) | AU6178496A (en) |
WO (1) | WO1996039997A2 (en) |
Cited By (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2000033906A1 (en) * | 1998-12-04 | 2000-06-15 | Advanced Cardiovascular Systems, Inc. | Contrast medium injection device and method of use |
US6306106B1 (en) | 2000-06-19 | 2001-10-23 | Advanced Cardiovascular Systems, Inc. | Diagnostic sheath for reduced embolic risk |
WO2007079135A1 (en) * | 2005-12-29 | 2007-07-12 | Nmt Medical, Inc. | Syringe activated-valve for flushing a catheter and methods thereof |
WO2016115099A1 (en) * | 2015-01-13 | 2016-07-21 | Pigott John P | Intravascular catheter balloon device having a tool for atherectomy or an incising portion for atheromatous plaque scoring |
EP2585157A4 (en) * | 2010-06-28 | 2017-02-08 | Colibri Heart Valve LLC | Method and apparatus for the endoluminal delivery of intravascular devices |
US10485570B2 (en) | 2011-09-13 | 2019-11-26 | John P. Pigott | Intravascular catheter having a cantilevered expandable incising portion |
US10610255B2 (en) | 2011-09-13 | 2020-04-07 | John P. Pigott | Intravascular catheter having an expandable incising portion and medication delivery system |
US10828471B2 (en) | 2013-07-15 | 2020-11-10 | John P. Pigott | Balloon catheter having a retractable sheath |
US10973632B2 (en) | 2010-12-14 | 2021-04-13 | Colibri Heart Valve Llc | Percutaneously deliverable heart valve including folded membrane cusps with integral leaflets |
US11033712B2 (en) | 2015-01-13 | 2021-06-15 | Venturemed Group, Inc. | Intravascular catheter having an expandable portion |
US11154693B2 (en) | 2013-07-15 | 2021-10-26 | John P. Pigott | Balloon catheter having a retractable sheath |
US11154694B2 (en) | 2013-07-15 | 2021-10-26 | John P. Pigott | Balloon catheter having a retractable sheath and locking mechanism with balloon recapture element |
US11202892B2 (en) | 2013-07-15 | 2021-12-21 | John P. Pigott | Balloon catheter having a retractable sheath |
US11357533B2 (en) | 2011-09-13 | 2022-06-14 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion and abrasive surfaces |
US11413062B2 (en) | 2011-09-13 | 2022-08-16 | Venturemed Group, Inc. | Methods for preparing a zone of attention within a vascular system for subsequent angioplasty with an intravascular catheter device having an expandable incising portion and an integrated embolic protection device |
US11559325B2 (en) | 2011-09-13 | 2023-01-24 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion and grating tool |
US11576698B2 (en) | 2011-09-13 | 2023-02-14 | Venturemed Group, Inc. | Intravascular catheter device for improved angioplasty |
US12096955B2 (en) | 2017-02-24 | 2024-09-24 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion and abrasive surfaces |
US12324603B2 (en) | 2011-09-13 | 2025-06-10 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion |
US12408932B2 (en) | 2022-03-23 | 2025-09-09 | Venturemed Group, Inc. | Intravascular device having feedback elements |
US12433633B2 (en) | 2022-07-01 | 2025-10-07 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5391172A (en) * | 1993-05-24 | 1995-02-21 | Advanced Cardiovascular Systems, Inc. | Stent delivery system with coaxial catheter handle |
US5456694A (en) * | 1994-05-13 | 1995-10-10 | Stentco, Inc. | Device for delivering and deploying intraluminal devices |
-
1996
- 1996-06-07 AU AU61784/96A patent/AU6178496A/en not_active Abandoned
- 1996-06-07 WO PCT/US1996/010405 patent/WO1996039997A2/en active Application Filing
Cited By (31)
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US6129700A (en) * | 1998-12-04 | 2000-10-10 | Advanced Cardiovascular Systems, Inc. | Contrast medium injection device and method of use |
WO2000033906A1 (en) * | 1998-12-04 | 2000-06-15 | Advanced Cardiovascular Systems, Inc. | Contrast medium injection device and method of use |
US6306106B1 (en) | 2000-06-19 | 2001-10-23 | Advanced Cardiovascular Systems, Inc. | Diagnostic sheath for reduced embolic risk |
WO2007079135A1 (en) * | 2005-12-29 | 2007-07-12 | Nmt Medical, Inc. | Syringe activated-valve for flushing a catheter and methods thereof |
US7842026B2 (en) | 2005-12-29 | 2010-11-30 | Nmt Medical, Inc. | Syringe activated-valve for flushing a catheter and methods thereof |
EP2585157A4 (en) * | 2010-06-28 | 2017-02-08 | Colibri Heart Valve LLC | Method and apparatus for the endoluminal delivery of intravascular devices |
US10973632B2 (en) | 2010-12-14 | 2021-04-13 | Colibri Heart Valve Llc | Percutaneously deliverable heart valve including folded membrane cusps with integral leaflets |
US11559325B2 (en) | 2011-09-13 | 2023-01-24 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion and grating tool |
US11576698B2 (en) | 2011-09-13 | 2023-02-14 | Venturemed Group, Inc. | Intravascular catheter device for improved angioplasty |
US12324603B2 (en) | 2011-09-13 | 2025-06-10 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion |
US10610255B2 (en) | 2011-09-13 | 2020-04-07 | John P. Pigott | Intravascular catheter having an expandable incising portion and medication delivery system |
US12185968B2 (en) | 2011-09-13 | 2025-01-07 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion |
US10939936B2 (en) | 2011-09-13 | 2021-03-09 | Venturemed Group, Inc. | Intravascular catheter with incising devices |
US10485570B2 (en) | 2011-09-13 | 2019-11-26 | John P. Pigott | Intravascular catheter having a cantilevered expandable incising portion |
US10485572B2 (en) | 2011-09-13 | 2019-11-26 | John P. Pigott | Intravascular catheter having an expandable incising portion |
US11123097B2 (en) | 2011-09-13 | 2021-09-21 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion |
US11571239B2 (en) | 2011-09-13 | 2023-02-07 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion and medication delivery system |
US11413062B2 (en) | 2011-09-13 | 2022-08-16 | Venturemed Group, Inc. | Methods for preparing a zone of attention within a vascular system for subsequent angioplasty with an intravascular catheter device having an expandable incising portion and an integrated embolic protection device |
US11357533B2 (en) | 2011-09-13 | 2022-06-14 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion and abrasive surfaces |
US11202892B2 (en) | 2013-07-15 | 2021-12-21 | John P. Pigott | Balloon catheter having a retractable sheath |
US11154694B2 (en) | 2013-07-15 | 2021-10-26 | John P. Pigott | Balloon catheter having a retractable sheath and locking mechanism with balloon recapture element |
US11154693B2 (en) | 2013-07-15 | 2021-10-26 | John P. Pigott | Balloon catheter having a retractable sheath |
US10828471B2 (en) | 2013-07-15 | 2020-11-10 | John P. Pigott | Balloon catheter having a retractable sheath |
WO2016115099A1 (en) * | 2015-01-13 | 2016-07-21 | Pigott John P | Intravascular catheter balloon device having a tool for atherectomy or an incising portion for atheromatous plaque scoring |
US11033712B2 (en) | 2015-01-13 | 2021-06-15 | Venturemed Group, Inc. | Intravascular catheter having an expandable portion |
US11850376B2 (en) | 2015-01-13 | 2023-12-26 | Venturemed Group, Inc. | Intravascular catheter having an expandable portion |
US10603069B2 (en) | 2015-01-13 | 2020-03-31 | John P. Pigott | Intravascular catheter balloon device having a tool for atherectomy or an incising portion for atheromatous plaque scoring |
US12408942B2 (en) | 2016-07-01 | 2025-09-09 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion and embolic protection device |
US12096955B2 (en) | 2017-02-24 | 2024-09-24 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion and abrasive surfaces |
US12408932B2 (en) | 2022-03-23 | 2025-09-09 | Venturemed Group, Inc. | Intravascular device having feedback elements |
US12433633B2 (en) | 2022-07-01 | 2025-10-07 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion |
Also Published As
Publication number | Publication date |
---|---|
AU6178496A (en) | 1996-12-30 |
WO1996039997A3 (en) | 1997-02-20 |
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