JPH03501212A - Atherotomy device and method - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Atherotomy device and method FIELD OF THE INVENTION The present invention generally relates to atherotomy devices. More specifically, the present invention Distal cutter for removing plaque buildup from the walls of severely occluded blood vessels or lymph vessels An improved atherotomy device is disclosed.

Coronary and peripheral arteriole sclerosis, also known as atherosclerosis, A disease in the human body that involves deposits of fat-like substances called atheroma or plaques in the walls of blood vessels. It is a common chronic disease that occurs. These plaques supply the extremities of the human body. It is most commonly found in peripheral blood vessels and the coronary arteries that supply the heart. Sometimes these Fatty deposits occur within highly localized areas of blood vessels, thus restricting blood flow. limits and poses a serious health risk.

In the past, several attempts were made to restore normal blood flow through the affected vessels. This method has been tried. Traditionally, extensive surgery removes atheroma It was the only practical method. Furthermore, in recent years, balloon angioplasty Increasing the size of the flow channels within plaque-filled arteries using a swelling process known as I succeeded in doing so. However, in cases where balloon angioplasty is used, In a significant proportion of cases, metastatic atheroma will recur. Become.

Co-pending application No. 732.691 discloses that removing at least a portion of the atheroma by using a cutting device inserted into the atheroma; Discloses an atherotomy device and method for atherectomy. At this time, the shape is cylindrical. A cutting blade exposed through the cutout on the side of the housing is actuated and removed from the vessel wall. Cut out part of the atheroma. However, in the embodiment described , which is especially useful for removing atheroma that is almost completely or completely blocking an artery. It is not fully suitable for

Therefore, the first object of the present invention is to treat atherosclerosis that almost completely or completely occludes blood vessels. To provide an atherotomy device particularly well adapted for the removal of carcinoma material. be.

Another object of the present invention is to provide an atherotomy device that is safe and has the intended effect. Our goal is to provide the following.

Another object of the invention is to retain most of the removed atheroma material. An object of the present invention is to provide an atherotomy device that can perform the following steps.

Another object of the present invention is to remove atheroma from various blood vessels including coronary arteries. The object of the present invention is to provide an atherotomy device that can be removed.

Another object of the invention is to use guide wires to position the device. An object of the present invention is to provide an atherotomy device adapted to do so.

Another object of the invention is to place the cutter of the atherotomy device near the atheroma being cut. An object of the present invention is to provide an atherotomy device having a mechanism for anchoring a portion. .

In order to achieve the foregoing and other objects and in accordance with the present invention, flexible guidance atherectomy from a blood vessel with a cutting assembly that can be introduced through a catheter for An atherotomy catheter for removal of tumor material is provided. this atheroma Dissection catheters include a catheter disposed within an outer flexible tubular member for rotational movement therein. It includes a flexible drive means mounted in such a manner. Proximal end of flexible drive means Proximal actuator means in communication with the cutter assembly through the drive means. Adapted to provide axial and rotational motion.

The cutting assembly includes a cutter with a forwardly extending annular cutting surface and a removed atherosclerosis. A collection chamber is included to hold the bulk material. This drive means is flexible Preferably, the guide wire is tubular with an internal passageway therethrough. Temptation The guide wire is adapted for axial movement within the tubular drive means and is extending forwardly beyond the distal end of the assembly. Preferably, the guiding wire has an expandable member near its distal tip. Furthermore, it makes the inside of the artery safer and more conducive. A flexible coil spring is provided at its distal tip to facilitate advancement. Preferably.

A housing supported on the distal end of the outer tubular member houses the cutter and cuts the blood vessel. shaped to facilitate insertion of the device therein.

Preferably, the housing is an extension of the tubular member itself.

In one preferred embodiment of the invention, the expandable member does not perform any cutting. It expands and engages either the atheroma itself or the vessel wall. follow This expandable member limits cutter slippage and accommodates removed atheroma material. Helpful. The cutter then rotates toward the expandable member until it stops. The removed portion of the atheroma is then advanced into the atherotomy device. It will be locked inside.

In an alternative embodiment, the expandable member is subjected to a cutting stroke. expand in between, limit the travel of the cutter and remove the atheroma from the removed part of the atheroma. to help retain it within the dissection device.

Another preferred embodiment of the invention is to reduce the size of the exposed cutting edge. It has a housing that covers a portion of the distal end of the cutter. This embodiment In some embodiments, the atherotomy device includes means for simultaneously advancing the tubular member and the drive means. It is rare.

Another preferred embodiment of the invention includes a guide wire instead of an expandable member. includes a rigid member supported by a distal portion of the. This rigid member is stronger than the cutter itself. The cutter also has a small diameter and passes through the occluded blood vessel before the cutter, thus allowing the cutter to to reduce the risk of cutting into a healthy part of the artery wall. removal of atheroma In order to retain the removed portion within the atherotomy device, the member is cut and placed in contact. A means is provided to bring it out in such a way that it becomes

In a preferred method embodiment of the invention, the guide wire has a distal end that is to be removed. inserted into the occluded artery, extending distally to the atheroma. It will be done. The cutter is used to remove occluded blood close to the atheroma material to be removed. introduced into the tube simultaneously or sequentially. The cutter is then rotated and the atheroma, thus removing a portion of the atheroma. removed a Teloma material is collected and the device is withdrawn.

The features of the invention that are believed to be novel are pointed out in the appended claims. It is also listed. The present invention has among other objects and advantages the following: It is best understood by reference to the following description in conjunction with the accompanying drawings.

FIG. 1 is a side view of an atherotomy device incorporating the present invention.

2 is a side cross-sectional view of the cutting assembly shown in FIG. 1; FIG.

FIG. 3 shows the cutter assembly shown in FIG. 2 taken along line 3--3. FIG.

Figure 4 shows the cutting assembly shown in Figure 2 with its basket expanded; It is a side sectional view of a solid.

FIG. 5 is a cross-section of the cutter assembly shown in FIG. 4 taken at line 5--5. It is a diagram.

6 is a side cross-sectional view of the proximity actuator assembly shown in FIG. 1; FIG. .

FIG. 7 shows the proximity actuator shown in FIG. 6 taken along line 7-7. FIG. 3 is a cross-sectional view of the eta assembly.

Figure 8 shows an expandable basket that is activated by hitting the cutter. FIG. 3 is a side cross-sectional view of an alternative embodiment of a cutter assembly according to the invention having a cutter assembly according to the present invention;

Figure 9 shows the cutter shown in Figure 8 cutting through an atheroma. FIG. 3 is a side cross-sectional view of the assembly.

FIG. 10 shows a cutter assembly according to the present invention including an inflatable balloon fixing device. FIG. 6 is a side cross-sectional view of yet another embodiment.

Figure 11 shows an elongated flexible collection channel with separately actuated baskets. FIG. 4 is a side cross-sectional view of another embodiment according to the invention having a bar;

FIG. 12 shows the cutout shown in FIG. 11 taken along line 12-12. FIG.

Figure 13 shows a device adapted to remove atheroma material from only one side of the blood vessel wall. FIG. 5 is a side cross-sectional view of yet another embodiment of a cutter assembly according to the present invention; It is.

Figure 14 shows the cutter shown in Figure 13 taken along line 14-14. FIG. 3 is a cross-sectional view of the assembly.

FIG. 15 shows another implementation of a cutter assembly according to the invention with an enlarged cutter. FIG. 3 is a side cross-sectional view of an embodiment.

Figure 16 shows the cutter shown in Figure 15 taken along line 16-16. FIG. 3 is a cross-sectional view of the assembly.

FIG. 17 shows another cutter assembly according to the invention with a leading bullet. FIG. 3 is a side sectional view of an embodiment of the invention.

Figure 18 shows the cutter shown in Figure 17 taken along line 18-18. FIG. 3 is a cross-sectional view of the assembly.

Figure 19 shows the cutter shown in Figure 17 taken along line 19-19. FIG. 3 is a cross-sectional view of the assembly.

Figure 20 is shown in Figure 18 placed in close proximity to the atheroma before the cut is made. FIG.

Figure 21 is shown in Figures 18 and 20 while the atheroma is being cut open. 18, 20, and 21 are side cross-sectional views of an embodiment of the cutter assembly. FIG.

FIG. 23 is a side cross-sectional view of another embodiment of a cutter assembly according to the present invention; be.

Figure 24 shows the cutter shown in Figure 23 taken along line 24-24. FIG. 3 is a cross-sectional view of the assembly.

As shown in the drawings, a severe occlusion atherotomy device according to the present invention is shown. The catheter 1 generally includes a cutting assembly 2, a proximal actuation assembly 3, and Includes flexible guiding means for connecting the two. This flexible guiding means 7 includes: Includes a guide wire 8 located within the hollow center of the drive tube 10 . The drive tube 10 itself is contained by a flexible tubular member 12.

Referring first to FIGS. 1 through 5, a preferred embodiment of the cutting assembly of the present invention will be described. One example will be explained. The cutting assembly 2 is supported by the distal end of the drive tube 10. It includes a cutter 4 having an annular cutting blade 5. This implementation The housing 6, which is an enlarged extension of the tubular member 12, has an exposed cutting edge 5. The cutter 4 is completely accommodated to prevent it from happening.

The cutter 4 is generally cup-shaped and has an internal collection chamber 14 . Fourth As best seen with reference to the figure, a portion of the atheroma 99 is attached to the wall of the artery 98. The forward motion of the cutter collects the removed atheroma material as it is excised from the into the chamber 14. The loose debris flows downstream through the artery and elsewhere. The removed atheroma material should be preserved to prevent it from causing blockage. It is important to maintain The secondary effects of keeping such materials intact An advantage is that large masses also provide excellent specimens for biopsy.

The cutter 4 is attached to the housing 6 when the atherotomy device 1 is not in use. Adapted to retreat inside. The cutting blade 5 is therefore a cutting assembly. 2 is being pumped into the blood vessels toward or from the atheroma. , not exposed to fragile blood vessel walls. Thus, the atherotomy device The risk of trauma to cleaned vessels that often accompanies use will be significantly reduced. Ru.

The cutter 4 can be used as long as its leading edge can be made into an effective cutting edge 5 and the material can enter the bloodstream. Any suitable material may be used, provided that it does not adversely affect health when placed there. or a combination thereof. Metals and plastics that can be used There are many types of metals and ceramics. An example of a suitable cutter material is an annular cutting surface. A thin stainless steel ring that has been ground at its leading edge to form a 5.

The flexible guide wire 8 has retention means 20 near its distal end. this In an embodiment, the retaining means 20 are individually actuatable and have multiple functions. It takes the form of an expandable member 20 with a First of all, it expands to the artery wall or It can engage with the telome itself and limit the slippage of the cutter.

Second, it limits translation of the cutter through the artery.

Thirdly, this is essentially a collection channel to hold the removed atheroma material. It acts as a cap for the bar 14.

The distal end of the guide wire 8 increases its rebound resilience and prevents the guide wire from damaging the blood vessel wall. Spring that allows immediate passage through tortuous blood vessels without causing injury It has a tip 22.

The spring tip 22 can also be attached to the guide wire in any conventional manner. It is believed that. For example, one suitable method is to wrap around the tip of the guide wire 8. Place a spring that fits tightly into the hole and solder the two parts together. cormorant.

Testing has shown that to advance the cutter through severe plaque deposits, this may be somewhat I found out that I had to push it. Each of the cutters according to the invention has an extended Located at the distal end of the drive tube, this pushing force is often applied by It's difficult. Therefore, we have several mechanisms to prevent such slippage. developed a structure. Overall, it has a much smaller distal tip than a cutter. A device supporting an expandable member near its distal end is pushed across the lesion. . The expandable member is advanced into or across the lesion and then penetrates the wall of the artery. or opened radially far enough to engage either the atheroma itself. In fact, the expandable member becomes anchored to the device and resists being pulled back. Therefore, the expandable part The material is shaped so that any relative movement between it and the cutter will move the cutter forward. It can be used as a fixing device to promote

In the embodiment shown in FIGS. 2 and 4, the retaining means It takes the form of an expandable member capable of exerting a force. In other words, the expandable bar This is Sket 20.

The expandable basket 20 comprises a plurality of braids attached together at opposite ends. It is made with a mesh structure woven from braided wire. Basquera) 20 and its braid 2 9 has a radial diameter slightly larger than the cutting surface 5 of the cutter 4 when compressed in the axial direction. dimensioned to have a width. The compressed diameter of the blade is preferably It is 0.5 mm. Its expanded radial diameter is preferably about 2 to 3 mm. It is between the rimmeters.

To facilitate radial expansion and compression of basket 200, guide wire 8 is , is a hypodermic injection tube with a pole (small coaxial lumen 21 running inside it. The diameter of the lumen is 0. ．． 0.005 inch to 0.010 inch (0.125 to 0.25 mm) It is fine as long as it is between. The dilator wire 25 is passed through the hypodermic tube 8 and the spring tip 22 form the core of. The proximal end R24 of the basket 20 is attached to the hypodermic injection tube 8. However, its distal end 23 is attached to an expansion wire 25. Ru. These attachments can be made using any conventional technique.

- For example, they can be attached by soldering or brazing. Ru.

In order to expand the basket 20, an expansion means 76 is provided at the proximal end of the guide wire 8. It is equipped. Expansion means 76 extend wire 2 in relation to hypodermic tube 8. Continue to pull 5 backwards. Thus Vasquera) 20 is compressed in the axial direction and the radius This will force a direction expansion. On the other hand, the wire 25 is inside the hypodermic injection tube 8. If pulled forward, the basket 20 will flatten. Guiding wire 8 A simple screw-in mechanism with a bulbous outer diameter on the proximal end of the This is an example of an expansion means that allows the basket to be easily activated.

The braided basket 20 may be constructed of a plurality of wires, with the optimal The number depends on the material used. Braided material, for example stainless steel is selected An effective basket can contain 10 to 50 stainless steel wires. The most preferred number is about 16 to 32 strands. (stranded wire).

The operation of the braided atherotomy device can be explained by referring to FIGS. 1 and 2. best understood. The guiding wire 8 is first inserted into the occluded blood vessel 98. , where the braided basket 20 is just beyond the atheroma 99 to be removed. It can be advanced until it extends all the way to the end. The rest of the atheroma device is then is introduced onto the ear 8 and the distal end of the cutter 4 essentially abuts the atheroma 99. be advanced until it reaches the end. Guide wire fixing hand on proximity actuator means 3 Stage 43 (as seen in FIGS. 1 and 6) is then activated, causing tubular member 12 to The guide wire 8 is then firmly fixed in relation to the housing 6. a The means for rotation disposed on the actuator assembly remains substantially fixed in position. The driving tube 10 is rotated within the tubular member 12. Similarly actuator assembly The translation means 54 arranged above rotate as it exits the housing 6. This allows the translational movement of the cutter 4 to be selectively controlled. The rotating cutter It is forced forward and thus cuts a passage through the obstruction. preferably In this case, the cutter 4 is rotated at a speed of 1500 to 2500 revolutions per minute.

Proximity actuator set adapted for use with the cutter assembly described above Solid 3 is shown in FIG. The actuator assembly 3 includes a housing 37, Cutter control device 40° includes guiding wire fixing means 43 and cutter fixing means 46 It is. Housing 37 is securely secured to the proximal end of tubular member 12. Ru.

The cutter control means 40 is initially located within the housing 37 and adjacent to the flexible drive tube 10. It is connected to the distal end. Cutter control means 40 provides rotational and axial movement to drive means 10. It is adapted to provide both motion independently. The illustrated embodiment includes a drive shaft A distal end of 50 includes an off-axis cylindrical gear 52 . The drive shaft is for an electric drive (not shown) capable of rotating the shaft at high angular velocity; It is offset (off-axis) in preparation for installation. One of the suitable electric drive devices Examples include Co-pending Application No. 834.743, filed February 28, 1986. It is disclosed in. However, in-line drive shafts can be used just as easily. Note that it is possible to Especially for giving rotational motion to drive pipes. Easy to use when combined with an electric drive with a hollow drive shaft or a manual knob. Can be used.

The cylindrical gear 52 is directly connected to a plunger 53 forming an extension of the drive tube 10. It meshes with the driven gear 55. Therefore, any rotation within the drive shaft 50 is used for driving. A corresponding rotation within the tube 10 is caused. Gear between cylindrical gear 52 and drive gear 550 Ratios can be varied to suit specific purposes. Similarly connected to the plunger 53 arm 54 extends through a slot 56 in housing 37 and thus in relation to the housing 37 and thus in relation to the fixed tubular member 12. The driving tube 10 can be translated in the axial direction. Cutter 4 (see FIG. 2) is retracted into the extension of the tubular member 12, so that the arm 54 is directly controls the entry and exit of the cutter 4 in relation to the housing 6 of the cutter 4. Ah The thumb 54 is moved manually by the physician, preferably using thumb pressure. drive The translational movement of the utility tube 10 is controlled by a manual mechanism in this embodiment, but the It is also conceivable that it is possible to mechanize the translational movement of the cutter 4.

For example, this can also be linked to rotational movement.

The plunger 53 has a lumen in the drive tube 10 and an aperture 5 in the housing 37. 8 is a hollow cylinder with a borehole aligned with both. Therefore, the temptation The guiding wire 8 can freely pass through it. However, the guide wire A basket expansion means 76 located at the proximal end of the ear 8 is located within the aperture 58. Too big to fit in. The guiding wire fixing means 43 is connected to the aperture 5 It is formed by a friction lever 44 located on the outside of the housing 37 adjacent to 8. Ru. This friction lever 44 is threaded against the housing 37 coaxially with the aperture 58. It is attached in a removable manner. The wedge 45 is rotated by 440 rotations of the friction lever. Tighten the guiding wire 8 to secure it in place. A pair of wedge-shaped clips are located between the housing and the friction lever 44 adjacent to the percher 58. A lamp 45 is placed.

The cutter assembly is properly positioned over the guide wire 8 and the cutter 4 is removed. When the target atheroma is in the predetermined position next to it, the friction lever 44 is activated. to securely secure the guiding wire 8 in relation to the housings 37 and 6. Set. As the cutter 4 moves forward, the guide wire 8 and its support The expansion member 20 will remain in place.

The cutter securing means 46 is in the form of a clamp arm 60 and is located near the proximal end of the drive tube 10. The housing 37 is disposed on the distal side of the housing 37.

The clamp arm 60 has two coaxial threaded fittings that are also coaxial with the drive tube 10. It is T-shaped with a frame. The distal threaded arm 68 includes the tubular member 1 of reduced diameter sized to accommodate the flared proximal end of 2. An extension 67 is included. The clamp arm 60 is in relation to the housing 37. When rotated, this compresses the O-ring 65 and the O-ring pushes against the plunger 53. Lower it. This operation prevents the plunger 53 and therefore the drive tube 10 from moving in the axial direction. prevent. By fixing the driving tube 10 in a predetermined position, the cutter 4 can be In relation to the guiding wire 8 which is fixed in a predetermined position by the ear fixing means 43. and held in place. The primary purpose of the clamp arm 60 is to the cutter 4 remains in contact with the expandable member 20 after being cut. to this This prevents the collected atheroma material from escaping. Normal operating clan The pull arm 60 remains open, so that the O-ring 65 is against the plunger 53. are not pressed airtight and are therefore driven under the influence of the cutter control means 40. The active pipe 10 can now move freely. However, if the disconnection takes place After the expandable member 20 is brought into contact with the cutter 4, the clamp arm 60 rotates. compress the OIJ song 5, tighten the drive shaft 10 in place, and remove the catheter from the human body. maintain this abutting relationship between the cutter and the expandable member until the cutter is withdrawn. hold

In addition to being pressed against the plunger 53 to hold the drive tube 10, , the O-ring 65 slightly seals around the plunger 53 when compressed and drives it. The backflow of blood is prevented through the gap between the utility tube 10 and the tubular member 12, and to allow the plunger to move forward or backward. Therefore, the atherotomy device Before being inserted into the patient's body, the clamp arm 60 has an O-ring 65 plunged into the clamp arm 60. The cap 53 is tightened to form a seal with the cap 53.

The distal threaded arm 68 of the crank arm 60 is threaded by an adapter 63. accepted in a way that is acceptable. The proximal end of the tubular member 12 is connected to a clamp arm 60. and the reduced diameter extension 6 of the distal threaded arm 68 between the adapter 63 and the adapter 63. It opens in the shape of a morning glory to accept the number 7. The tightening on the screw-in arm 68 is Adapter 63 securely secures tubular member 12 in place.

A second O-ring 69 is connected to the adapter 63 by a reduced diameter extension 67. It occupies the gap between the recessed arms 68. This 200th ring is also a tubular member. 12 and the drive tube 100 to prevent blood from flowing backwards.

In the illustrated embodiment, the clamp arm 60 also includes a fluid inlet tube. It also acts as a connection port 61. This fluid inflow pipe connection port 61 is particularly suitable for introduces saline into the atherotomy device and closes it before inserting the device into the body. equipment by allowing all trapped air and gases to be removed. Facilitates standard sterile cleaning of instruments. In addition, radioscope (radioscopic) die If desired, these can be implemented using conventional techniques well known to those skilled in the art. The fluid can be introduced through the fluid inflow pipe connection port.

To remove the atheroma, the sterile device is opened, inspected, and KOed. Next This device was introduced into the fluid inflow pipe connection port 61 through a stop valve (not shown). Cleaned with sterile solution. The device is then inserted into the guiding catheter using conventional techniques. (not shown) into the blood vessel. The guiding wire 8 is located far in front of the device. The tumor is advanced across the lesion in the opposite direction. The cutting assembly is then advanced to the lesion. I am made to do so. The distance from the distal end of the cutter 4 to the proximal end of the basket 20 is approximately Must be 0.200 inches (5 mm). Next, the friction lever 44 is tightened to secure the guiding wire 8 in place. Next, the expansion means 26 is activated. to expand the basket 20 and thus hold the distal tip in place. Ru. The drive shaft 50 is then rotated and the arm 54 is pushed forward, thus The cutter 4 is advanced across the lesion until it hits the cutter 20.

A clamp arm 60 is used to keep the cutter 4 in contact with the basket 20. It is tightened and the device is pulled out. If necessary, remove extensive blockages. You can repeat the steps.

Cutter control means 40, guiding wire fixing means 43, cutter fixing means 46, and fluid It can be used to perform the function performed by the inflow pipe connection port 61. It will be seen that there are a variety of alternative structures. For example, driving There are many mechanisms for imparting rotational motion to the dynamic pipe 10. The drive shaft 50 is a drive tube 10 direct proximal extensions. Alternatively, manual rotation of the cutter An enlarged manual knob is provided at the end of the drive tube 10 to facilitate Good too.

8 and 9 are similar to those described above in all respects except for the method of activating the braided basket 20. 1 shows a variant embodiment of the invention which is the same as the embodiment; can be started individually Instead of having a basket, the expandable member 20 is actuated by the stroke of the cutter itself. Ru.

Therefore, there is no need for the guidewire 108 to have a central lumen, but rather an expansion means. consists solely of the constituent elements near the distal tip of the device.

Similar to those described above, expandable member 20 is made from a plurality of reticulated braided wires 129. It takes the form of a braided basket 120. However, in this embodiment , the distal end 123 of the braided basket 120 is firmly attached to the guide wire 108. The proximal end 124 is fixed and flared around the guide wire 108. It is set in place so that it can move. Therefore, the basket 120 is free to compress in the axial direction. Can be expanded. Axial compression causes radial expansion. Similarly axis Directional expansion causes radial compression. Basket 120 is collection chamber 1 14 and when the cut is made. At a point the flared proximal end 124 of the basket 120 abuts the cutter and thus The proximal end of basket 120 can be translated along cutter 104. It is designed to be something that people can use. Free proximal end 1 of basket 120 The axial stroke of 24 causes the braided basket to radially move across the open face of cutter 104. It should be selected to be sufficiently expansive to provide relief.

As cutter 104 advances, proximal end 123 of braided basket 120 Contact with the drive tube 10. The distal end R123 of the braided basket 120 is a guide wire. Because it is fixed in place on the ear, its free proximal end R124 is connected to the drive tube. 10, the braid compresses axially and expands radially. cause The basket 120 and its braid 125 are fully compressed. so that it has a radial width that is the same as or slightly larger than the cut surface 105 of the cutter 104. dimensions have been determined.

Therefore, the braided basket 120 is pulled against the cutter. , serves as a cap to hold the excised atheroma 990 portion within the cutting assembly. do. At this time, the cutter 104 is preferably mounted on the actuator assembly 3. into position in relation to the braided basket 120 via retaining means 46. Fixed. The compressed diameter of the braid is approximately 0.5 mm, while its The expanded diameter of is approximately 2-3 millimeters.

In this experimental embodiment, the braided basket has an expandable portion in the previously described embodiment. to push the cutter 104 out of its housing 106 as the cutter was doing. You can see that it is not functioning as a fixing device that promotes. however This embodiment maintains the removed portion of the atheroma within the collection chamber 114. It is extremely effective in Therefore, the actuators shown in FIGS. 6 and 7 Tuator assembly 3 can be used to control cutting assembly 102. Ru. The only difference in the proximity actuator assembly is that the latter embodiment is The advantage is that there is no need for expansion means 76 on the proximal end of the wire.

FIG. 10 shows a catheter for capping the collection chamber 214 and an atherotomy catheter. Another variation uses a high-pressure balloon for both purposes to anchor the distal end of the Figure 3 illustrates a form embodiment. In this embodiment, the guide wire is also subcutaneously injected. It has the shape of an immigration tube 208. High pressure balloon 220 is described in the previous embodiments. The guide tube 208 was installed at approximately the same location where the basket described was placed. It is sealably mounted near the distal end. The balloon 220 is connected to the artery 9 Dimensions large enough to engage the wall of 8, but small enough not to stretch it. It has been decided. Aperture 226 near the distal end of hypodermic tube 208 has a high The subcutaneous injection lumen 228 within the pressure balloon 220 is vented. Preferably a hypodermic injection tube 208 is 0. oio inch to 0.015 inch (0.25 to 0.375 mm It has an outer diameter of meters).

Balloon 220 is preferably at least 80 psi (5,000 psi) using saline solution. 6kg/co? ) can be inflated to a pressure of To inflate the balloon can be used, but there is a risk of embolism if the balloon inadvertently ruptures. Gases are discouraged as much as possible as they can be very dangerous and cause damage to other parts of the body. do not have.

The balloon anchoring method is similar to the braided basket described in the previous embodiment. also serves as a cap for the collection chamber within the cutting assembly 202 in the same manner as can be adapted to do so. Therefore, the cutter 204 is The cutting process is completed in this position, and the atheroma excised part is placed inside the cutter. It will lock up the minutes. The device is then removed and at least partially inflated. Hold the cut balloon against the cutter to retain the cut out plaque.

Balloon limits the cutting stroke and/or forms a seal for cutter 204 In an anticipated embodiment, the expandable protective sheath 230 and the balloon It can also be placed around the balloon to prevent the cutter from damaging the balloon itself.

In the illustrated embodiment, the protective coating 230 is in the form of a braided mesh. Ru. This mesh material is receptive within the region of the blood vessel and rotates with the cutter 204. It can be made of a material that does not easily cut when it comes into contact with the material. For example: Stainless steel is a suitable material for forming this mesh.

The rigid cutter described above works great for cutting relatively narrow atheroma. demonstrate. However, because the length of the collection chamber 14 is relatively short, these All have relatively limited collection capacity. The allowable length of a rigid cutter is determined first by this limited by the tortuousness of the artery through which the cutter must pass. It will be done. Therefore, from each inch to 1 inch (12.7 to 25.4 mm! J meters) The length of the rigid structure is suitable for cleaning relatively straight blood vessels. but coronal When smaller blood vessels such as arteries are encountered, this rigid structure can be much smaller. must be.

The length of the collection chamber is a major concern when attempting to remove large occlusions. becomes. The shorter the collection chamber, the greater the number of washes required. each The collection chamber is short because irrigation requires insertion and withdrawal of the catheter. , increasing both the risk of infection and the time required for surgery.

Therefore, it is desirable to use flexible collection chambers.

Now, with reference to FIGS. 11 and 12, extend the flexible collection tube 314. An alternative embodiment of a cutter assembly is described. Such a design , making it easier to clear large areas of blockages in only one or fewer passes . The cutter assembly 302 includes an annular cutter 304, a drive tube connector 313, and a It includes an elongated flexible collection tube 314 running between the two tubes.

As in the previous embodiment, the cutter assembly 302 includes a flexible drive tube 10. Proximity actuator via flexible guiding means 7 including a flexible tubular member 12 passing therethrough. is connected to the data data means 3. The driving tube 10 has a guide wire 308 inside it. It has a hollow center through which it can pass. Braided Basquera) 320 shaped The holding means are adapted in this embodiment to be activated individually. subordinate The guide wire 308 is a subcutaneous injector with a very narrow lumen running coaxially with the tube. It's a tube.

The structure and operation of cutter assembly 302 is the same as described above for cutter assembly 2. It's like that. However, it is adapted to collect much larger resected atheroma sections. I'm forced to. As before, cutter 304 is in the form of an annular ring. Drive The drive connector 313 directly engages the drive tube 10 and includes an annular raised portion 330. I'm reading. A flexible collection chamber 314 extends between the cutter 304 and the connector 313. running and hermetically receiving each at its respective ends. Connector raised part 3 30 directly abuts collection chamber 314. Therefore, the drive tube 10 rotates. When rotated, the drive tube 313, collection tube 314 and cutter 304 all move simultaneously. Rotate to .

Collection tube 314 includes those disclosed in co-pending application no. 834.947. It can be made from any flexible material. However, one preferred The embodiment is a braided type housing. The braided structure makes the fibers at least Braided into a single layer braid and then coated with fibers between the braided fibers Formed by filling gaps and increasing the strength of a braided tube or capillary . Thus, by way of example, the braided tube may have a thickness of 2 mils to 3 mils, preferably about 2 mils. ．． Constructed from a suitable fiber, such as 5 mil thick stainless steel. Good too. The stainless steel fibers are then coated with a polymer such as epoxy or polyurethane. Can be coated with plastic. This is the fiber of polyurethane bath This is done by immersing it in the water. Let the polyurethane dry and harden and still One obtains a generally cylindrical tube that retains its shape while being flexible. According to this structure The cutter assembly 302 advances through a highly flexible but tortuous blood vessel. There are no twists or crooked sips in between.

One of the main benefits of the flexibility of this cutting assembly is that it Widespread damage within some of the smaller blood vessels in the human body, such as the coronary arteries. The point is that it can be used to remove plaque buildup. A within the coronary artery Because telomes are the leading cause of heart attacks and the need for coronary bypass surgery Of particular importance is the ability to clean the coronary arteries.

The same proximity actuator assembly as disclosed in FIGS. , for use in controlling the flexible cutting assembly 302 disclosed herein. is possible. However, a flexible collection chamber is disclosed herein. It is understood that any of the embodiments described can be used. Should.

A version of the cutter assembly according to the invention called a lateral cutting atherotomy device Yet another embodiment will be described with reference to FIGS. 13 and 14. teeth Atheroma tends to develop asymmetrically around the arterial wall. many In some cases, one wall is heavily covered with plaque while the opposite wall of the artery is heavily covered with plaque. The surface is virtually clean. In such cases, relatively clean parts of the arterial wall It is undesirable to expose the exposed parts to the cutter blade.

The structure of the lateral cutting atherotomy device is similar in most respects to the previously described embodiments. The same is true. However, the housing 406 is such that at least the cutting blade 405 is The asymmetrical length that extends forward as long as it can run freely against the It has a coating 433. Similar to those previously described, housing 406 provides access to blood vessels. It completely encapsulates the cutter 404 when it is retracted for insertion. Covering 433 When the cutter 404 is advanced, one side of the cutter 404 is exposed and the other side is exposed. The sides are shaped asymmetrically at their distal ends so as to remain within the area of the covering 433. It's been cut off. To facilitate the cutting process to the proper length, the tubular member 12 is In other words, the housing 406 is adapted to translate with the cutter 404 during the cutting stroke. It is being Similarly, a mechanism for withdrawing the cutter from the cutter is also provided.

The cutter can be attached via a variety of mounting techniques, as will be readily appreciated by those skilled in the art. into the sheathing part and then allowing the housing to translate with the cutter. is possible.

For example, a suitable mounting technique for retracting a cutter may be a tubular extension over the proximal actuator assembly that wraps around the inlet of the means; It is possible that

Additionally, an extension sleeve is secured to the proximal end of tubular member 12.

This extension sleeve is shaped so that it can slide the tubular extension over the proximal actuator. The dimensions are determined so that they can be connected together. O-ring placed around the tubular extension seals the connection between the extension sleeve and the tubular extension to prevent backflow of blood. child According to the construction, the length of the tubular member 12 is such that the sleeve proximal The cutter 404 is positioned within the open portion of the sheathing and the sleeve is When slid forward, the cutter retracts into a fully protected portion of the housing 406. The dimensions are as follows. The cutter assembly is inserted into the artery and the atheroma is removed. Once properly positioned adjacent, the clinician pulls the sleeve posteriorly, thus releasing the cover. expose the ta. At this time, actuator plunger 53 (shown in figure j46) (such as the one shown in FIG. It is made to match.

Preferably, a covering 433 is provided to further prevent the cutter from damaging the arterial wall. Rounded tip 43 that curls up at its distal end to wrap around the lower part of cutting blade 405 Form 4. In this way, the sharp cutting blade 405 scratches the healthy part of the artery wall. Or there is less chance of getting hurt again. The actual shape of the asymmetric coating may vary considerably. sell. A typical shape is shown in FIG.

FIGS. 15 and 16 show that for a flexible tubular member of a given size, Alternative housing adapted to accommodate a cutter 5 (14) of larger dimensions It shows the arrangement. This embodiment corresponds in all respects to the embodiment shown in FIG. Same as Mr. However, unlike housing 6, housing 506 is a tubular member. It is not an extension of 12. Rather, the proximal side of cutter 504 when fully retracted abuts against the distal side of the tubular member 2. Accordingly, the housing 506 has a tubular section. It is a thin-walled tube that houses the distal end of the material 12 and the retracted cutter 504. housing 506 can be made of any thin-walled material compatible with use in the blood stream. can. Typical suitable materials include various plastics and stainless steel. There's steel.

3mm to 4mm to facilitate larger diameter cutters It may be desirable to use flexible guiding means with an outer diameter of . like this In embodiments, the diameter of the annular cutter 504 is also between 3 and 4 millimeters. .

To facilitate the introduction of a cutter of this size into the coronary artery, the California Re d wood C1ty Devices for Vascular In- For standard coronary artery guides, such as those made by tervention. It may be desirable to make the flexible guiding means 7 in the form of a catheter. this is , for the purpose of introduction by using a stiff guide wire 508 in its proximal section. It can be easily straightened. For example, at the end of the guiding wire By making 10cm to 20cm flexible, it provides the required rigidity while still being flexible. The ivy assembly 502 may be able to pass through tortuous blood vessels.

Yet another embodiment of the cutter assembly of the present invention is shown in FIGS. As shown and described in FIG. In this embodiment, the retaining means in the form of a bullet-shaped portion attached to the guide wire 608 near the distal end of the guide wire 608. . The bullet portion 620 itself is centered around the guide wire 608 and soldered. It is attached to it by all conventional means. Bullet-shaped portion 62 0 has an internal collecting cavity 632 and a more proximal It has a leading surface 633 that widens. The actual shape will be adjusted to suit the specific application area. Although variable, one of the primary concerns is the desired size of the collection cavity 632. It is. The radius dimension of the proximal end 624 of the bullet portion 620 is the radius of the cutter 604. slightly smaller than the value.

The cutter 604 is supported by the distal end of the drive tube 10 and is housed with an annular cutting blade 605. Contains a collection chamber 614. As is the case with all of the previously mentioned embodiments. In addition, the cutter 604 is optionally equipped as shown in FIGS. 11 and 12. A flexible collection chamber may be provided.

The operation of the bullet cutter will now be described with particular reference to FIGS. 20 to 22.

A guide wire 608 with an attached bullet-shaped portion 620 is inserted into the occluded artery. inserted through the atheroma and positioned so that the bullet-shaped portion 620 is just in front of the atheroma. be kicked.

A cutter assembly 602 is then inserted into the artery over the guidewire 608; The cutting blade 605 is positioned just slightly behind the proximal side of the bullet-shaped portion 620. be advanced to. The actual distance between two component elements is Both dimensions of the atheroma depend on factors such as size. For example, main coronary In the environment of an atherotomy catheter to be used intravenously, the bullet-shaped portion 62α is positioned approximately 4 cm or 5 cm from the distal tip of cutter 604. It will be.

Once the cutter is properly positioned, the proximity actuator assembly (not shown) The overlying fixing means are activated and the flexible guide wire 608 and drive tube 10 begin to move in translation together. Accordingly, the cutter 604 and the bullet portion 620 At this time, they advance simultaneously through the obstruction. Preferably, the cutter 604 moves forward. The guide wire 608 and the bullet-shaped portion 6 rotate at a relatively high speed when 20 does not rotate at all.

As the cutter assembly advances, the cutter 604 becomes smaller than the bullet portion 620. Take thin shavings from the atheroma to be wide or wide. removal of atheroma The cut portions fill the space between the bullet-shaped portion 620 and the cutter 604 as well as their respective collection chambers 622 and 614. Once the passage is complete, the doctor The master continues to pull back the guiding wire 608 until the bullet-shaped portion 620 is against the cutter 604. This allows the scraped part of the atheroma to be excised and scraped off. A cap body is provided for holding the product within the device. Selectively automate cutter 604 A wire retraction means 645, such as a spring-loaded mechanism, is created to dynamically retract the bullet. It is also clear that it is possible to

Another embodiment of the invention is shown in FIGS. 23-25. this The cutter assembly 702 includes a cutter assembly 702 that has an annular cutting edge 705 on its distal end. It is similar to the cutter assembly described above in that it includes 704. inside the cutter is equipped with a collection chamber 714. In this embodiment, a flexible spring A guide wire 708 having a tip 722 is also provided. However, this In this embodiment, the device is supported by guide wire 708. Does not include means of holding.

The atherotomy device described herein has cutters of various dimensions. there is a possibility. For use within the bloodstream, a 12 French to 3 French capacitor is recommended. equipment with a diameter of This makes it ideal for surgical procedures on large diameter blood vessels. From the above, arterial blood vessels An atherotomy device is provided which is particularly effective for removing material from an atheroma in the body. It is clear that A special advantage of this device is that such surgical Atheroma removed using targeted ablation techniques can be opened using traditional vessel cleaning techniques. It is said that the possibility of recurrence is lower than that of atheroma that has been removed.

Although only some embodiments of the invention have been described, the invention or which may be implemented in numerous other specific ways without departing from the scope. It should be understood that In particular, certain disclosed proximity actuator Assemblies are equipped with drive tubes, guide wires and tubulars required for specific tasks. It was noted that this could be significantly modified to effect the movement of members. stomach. Similarly, the features of the various disclosed cutting assemblies also vary depending on the particular application. Can be replaced to suit the field. Accordingly, the examples and embodiments include- and should not be considered as having a restrictive meaning, and the present invention is not limited to this document. without being limited to the details given in, which may vary within the scope of the appended claims. be.

FIG.-8 FIG, -10 FIG.-23 FIG.-24 international search report III+-111-14--^eel<ml+-Kun-Ha, PC? /υ5B81 0211!4

Claims (34)

[Claims] 1. In an atheroma device for removing atheroma material from blood vessels, - a flexible tubular member adapted for insertion into a blood vessel; - a flexible tubular member disposed within the tubular member; flexible drive means for rotational and axial movement therein; - a cutter supported by flexible drive means, which cutter extends forward; - a flexible element extending anteriorly into the blood vessel from the cutter; - a cutter for collecting the removed atheroma material into the atherotomy device; Collection means supported on a front flexible element (furthermore, such collection means may include a semi- (includes a radially expandable expandable member); an atherotomy device including an atherotomy device; 2. The flexible member includes a guide for guiding the cutter to travel axially within the blood vessel. Atherotomy according to claim 1, characterized in that it is a guiding wire. Device. 3. The expandable member should resist slipping while the cutter is cutting the atheroma. claim, characterized in that it is radially expandable so as to press against the wall of the blood vessel; The atherotomy device according to item 1. 4. Claimed item characterized in that said collecting means includes an inflatable balloon. The atherotomy device according to scope 2. 5. The guide wire runs axially through the balloon to facilitate inflation of the balloon. Atherotomy according to claim 4, characterized in that it has a lumen. Device. 6. with an expandable protective sheath that covers all parts of the balloon that come into contact with the cutting surface. The atheroma incision device according to claim 4. 7. Claim characterized in that the protective covering is formed of braided material. The atherotomy device according to item 6. 8. The guiding wire has a lumen running axially therethrough, and the expansion means includes the guiding wire. disposed within the wire and connected within the guide wire for expansion and contraction of the expandable member; includes an expansion wire adapted to move axially in relation to Claims with expansion means for expanding the expandable member, characterized in that: The atherotomy device according to item 2. 9. The expandable member forms a braided basket formed of a plurality of braided wires. The atherotomy device according to claim 2, characterized in that: 10. It is noted that the braided basket is formed from 10 to 50 wires. 10. The atherotomy device according to claim 9, wherein: 11. Claims characterized in that the cutter includes a collection chamber. The atherotomy device according to item 1. 12. In an atherotomy device for removing atheroma material from blood vessels , - a flexible tubular member adapted to be inserted into a blood vessel; - rotation and rotation in the tubular member; A flexible drive (notably a flexible drive) disposed within said tubular member for the drive device is tubular and has one passage extending therein), - a flexible drive device; a cutter supported at the distal end of the moving means, such cutter extending forwardly; having a cutting surface), - supported on the proximal end of the flexible tubular member and having a cut surface with the tubular member; Rotates the cutting device in relation to the axis of the cutter independent of the axial movement of the tubular member means coupled to a flexible drive for extending and retracting in the direction; - a flexible guiding wire mounted for axial movement within a passage within the drive means; (Note that the guiding wire extends forward from the cutter) and - A guiding wire to facilitate the collection of material removed from the atheroma by the cutter. a retaining means supported by the ear. 13. The retaining means includes an expandable portion movable between a retracted position and an expanded position. material and the expandable member radially between this retracted and expanded position. and in the contracted position, the retention means is folded to facilitate insertion of the device into the blood vessel. Claim 12, characterized in that it includes expansion means for making it The atherotomy device described in Section. 14. Claim 1, wherein the expandable member is an expandable balloon. The atherotomy device according to item 13. 15. Claim 1, characterized in that the expandable member is an expandable basket. The atherotomy device according to item 3. 16. the guide wire has a lumen extending therethrough; and a means for dilation. The guide wire is placed within the lumen of the guide wire to expand and retract the expandable basket. includes an expansion wire attached for axial movement in relation to the The atherotomy device according to claim 15, characterized in that: 17. The basket has a first end fixed to the guide wire and a first end attached to the guide wire. a second end mounted for axial translation; The end of the basket is adapted to connect with a flexible drive means for radially expanding the basket. Atherosclerosis according to claim 16, characterized in that it is adapted to Mummotomy device. 18. The basket is characterized by being formed of braided strands (upline) The atherotomy device according to claim 17. 19. The braided strands are made of stainless steel and the basket has 16 to 32 strands. According to claim 13, characterized in that it is formed of book strands. atherotomy device. 20. The retaining means includes a rigid member having a collection cavity facing the cutter. The atherotomy device according to claim 12, characterized in that: . 21. The retaining means may include means for facilitating blood vessel flow therein. The atherotomy device according to claim 12, characterized in that: 22. Claims characterized in that the cutter includes a collection chamber. The atherotomy device according to clause 12. 23. In an atheroma device for removing atheroma material from blood vessels, - a flexible tubular member, - a tubular flexible tube disposed within said tubular member for rotational movement within said tubular member; drive means, - a cutter supported by the distal end of the flexible drive means (wherein such cutter is (having a forwardly extending cutting surface), - arranged within the drive means and axially therein; A flexible guiding wire that is movably attached (note that such guiding wire is (extending beyond the distal end of the blade and being rotationally uncoupled therefrom); - on the cutter to facilitate the collection of material removed from the atheroma by the cutter; a retention means supported distally to the guide wire; and - means for translating the cutter and the holding means relative to each other; equipment containing. 24. The retaining means may include a rigid member having a smaller diameter than the cutter. The atherotomy device according to claim 23, characterized in that: 25. The rigid member is used to retain material removed from the atheroma by the cutter. a collection cavity extending from the proximal end of the claimant; Atherotomy device according to item 24. 26. a cutter supported by a distal end of a flexible tubular drive means; An appliance having a flexible guide wire with an expandable member attached near the distal end. At least a portion of the atheroma is removed from the blood vessel using a teloma dissection device. In this method, - at least a portion of the expandable member is positioned distally to the portion of the atheroma to be removed; advancing the guide wire to a location within the blood vessel so that it is placed; Advance the cutter within the vessel to a position proximal to the portion of the atheroma to be removed. step, - pass through the atheroma towards the expandable member to remove a portion of the atheroma; advancing the cutter; and - expanding the expandable member radially within the blood vessel. A method comprising steps. 27. Adequate atherectomy to provide a relatively good flow path within the blood vessel through the atheroma. The claim is made to remove more atheromatous areas until the loamy areas are removed. The method according to claim 26, which involves the step of repeating the step described in scope 44. Law. 28. The atherotomy device also includes a housing to accommodate the cutter. and that the cutter is in relation to the housing while being advanced. Claim 26, further comprising the step of rotating the cutter by rotating the cutter. The method described in section. 29. The step further includes the step of ejecting the cutter from the housing while being advanced. 29. The method according to claim 28, characterized in that: 30. that the expansion step is performed before the cutting step and that the expandable member characterized by being adapted to resist slippage of the cutter while cutting the 29. The method according to claim 28, wherein: 31. Claims comprising the step of contacting the cutter with the expandable member. The method according to paragraph 28. 32. including retaining the removed portion of the atheroma within an atherotomy device; 32. The method according to claim 31, characterized in that: 33. a flexible tubular member disposed within the tubular member and adapted for rotational movement therein; a cutter supported at the distal end of a flexible tubular drive means attached to the flexible drive; a flexible member mounted for axial passage through and axial movement within the means; a guiding wire (with a flexible element supporting a retaining means near its distal end); Remove at least a portion of the atheroma from the blood vessel using an atherotomy device with a In the method for removing, - inserting a guiding wire and a retaining means into the blood vessel; - the atheroma to be removed; advancing the retention means within the blood vessel to a desired position close to the tissue; - the cutter to a location within the blood vessel at a selected distance to the holding means; the stage of inducing - Remove parts of the atheroma at regular intervals. rotating the cutter while simultaneously advancing the holding means and the cutter therethrough; - collecting the removed part of the atheroma, and - collecting the atheroma from the blood vessel. retrieving the collected portion of the system. 34. The step of collecting a portion of the atheroma involves collecting it within the atherotomy device. Place the holding hand so that it is in contact with the cutter to hold the atheroma material. Claim 33, characterized in that the step of drawing out the steps is included. the method of.