Vascular device for valve leaflet apposition

ES 2 234 852 T3

DESCRIPTION

Vascular device for valve leaflet juxtaposition.

Background

Technical sector

The present application relates to a vascular device and more particularly, although not exclusively, to a vascular device for bringing together the leaflets of the valves of the veins with a view to treating a insufficiency of the venous valves.

Previousities

Veins in the body carry blood to the heart, and arteries carry blood away from the heart. Veins have leaflet-shaped one-way valve structures arranged annularly along the inner wall of the vein which open to allow blood flow to the heart and close to prevent back flow. That is, when blood flows through the vein, pressure forces the valve leaflets to separate as they flex in the direction of blood flow and move toward the interior wall of the vessel, creating an opening between them. for blood flow. However, the flakes do not normally bend in the opposite direction and therefore return to a closed position to prevent blood flow in the opposite direction, ie, retrograde, after pressure is released. The leaflet structures, when properly functioning, extend radially inward in the direction of mutual approximation such that the tips come into contact with each other to block the back flow of blood.

In the condition of insufficiency of the venous valves, the valve leaflets do not function properly as they thicken and lose flexibility, resulting in their inability to extend sufficiently radially inward to allow their tips to sufficiently contact each other. yes with a view to avoiding retrograde blood flow. Retrograde blood flow causes increased hydrostatic pressure in the residual valves and the weight of the blood dilates the vessel wall. Such retrograde blood flow, commonly referred to as reflux, leads to swelling and varicose veins, causing great discomfort and pain in the patient. This retrograde blood flow, if left untreated, can also cause ulcers of the skin and subcutaneous tissue due to venous stasis. In general, there are two types of venous valve insufficiency: primary and secondary. Primary insufficiency of the venous valves is typically a birth condition, in which the vein is simply too large relative to the leaflets such that the leaflets cannot adequately come into contact to prevent back flow. Secondary insufficiency of the venous valves is more common, which is caused by clots that gel and heal, thus changing the configuration of the leaflets, that is, thickening said leaflets so that a "stump-like" configuration is created. . Venous valve insufficiency can occur in the superficial venous system, such as the saphenous veins of the leg, or in the deep venous system, such as the femoral and popliteal veins that run along the back of the knee. towards the groin.

A common method of treating venous valve insufficiency is to place an elastic stocking around the patient's leg to apply external pressure to the vein, forcing the walls to move radially inward to cause the leaflets are placed in juxtaposition. Although sometimes satisfactory, the fitted stocking is quite uncomfortable, especially in hot weather, as the stocking must be constantly worn to keep the flakes in juxtaposition. In addition, the elastic stocking influences the physical appearance of the patient, thus potentially presenting an adverse psychological effect. Sometimes, this physical and / or psychological discomfort has the consequence that the patient removes the stocking, thus avoiding adequate treatment.

Another method of treatment has been developed to avoid the discomfort of the stocking. This method involves major surgery that requires the implantation of a cuff internally of the body, directly around the vein. This surgery requires a large incision, resulting in a prolonged recovery time for the patient, healing, and carries the risks, for example, anesthesia, inherent in surgery.

Another invasive method of surgery involves selective valve leaflet repair, referred to as valvuloplasty. In one of the methods, sutures are used to bring the free edges of the valve cusp closer together. This procedure is complicated and has the same disadvantages as the major surgery described above.

For this reason, it would be advantageous to provide a method and device for minimally invasive treatment of venous valve insufficiency without the need for an external stocking or internal cuff. In this way, such a device would avoid the physical and psychological discomfort of an external stocking while avoiding the risk, complexity and expense of surgically implanted sleeves. Advantageously, such a device would be inserted minimally invasively, that is, intravascularly, and would function to effectively bring the valve leaflets closer together so that they were placed in juxtaposition.

In US-A-5 609 598 a device according to the preamble of claim 1 is disclosed.

Resume

According to one aspect of the present invention there is provided a vascular device comprising a tubular member and a plurality of vessel coupling members, the device being movable from a folded insertion position having a first diameter to a second expanded position having a second diameter larger than the first diameter, the plurality of vessel coupling members extending outward with respect to the tubular member to securely engage the inner wall of a vessel upon expansion of the device toward the second expanded position, pulling the inner wall of the vessel, the coupling organs to the vessels, radially inward as the device moves from the second expanded position to a first position

ES 2 234 852 T3 having a third diameter, said third diameter being greater than the first diameter and less than the second diameter.

The device may be comprised of shape memory material and the first expanded position may correspond substantially to the memorized position of the device.

The device may be comprised of shape memory material and may initially be movable from the collapsed position to the first expanded position in response to its exposure to body temperature, and may subsequently be moved from the first expanded position to the second expanded position. by means of an expandable organ.

Alternatively, the device may be comprised of shape memory material and may be movable from the folded position to the first expanded position by exposure to body temperature and its expansion by an expandable organ, substantially simultaneously.

As a further alternative, the device can be expanded to the second expanded position through mechanical means positioned within the device.

The device can be moved to the second expanded position by expanding a balloon positioned within the device.

The vessel coupling members may have sharp ends and may extend from a distal portion and from a proximal portion of the tubular member.

Each of the vessel coupling members may include a sharp end and a barb, said sharp ends limiting the axial movement of the vessel wall and the barbs limiting radial movement of the vessel wall to improve retention (fixation). of the glass.

In the folded position, an intermediate part of the tubular member may include a plurality of longitudinal strips with a gap between adjacent strips, the vessel coupling members being formed by respective cuts in the longitudinal strips, the longitudinal strips bending radially outward. upon expansion of the device.

The vessel coupling members may extend from a proximal portion and a distal portion of the tubular member and may include hooks, the hooks extending substantially parallel to a longitudinal axis of the device in the folded position and substantially perpendicular to the longitudinal axis. in the expanded position.

The device may include a plurality of longitudinal strips, each of the longitudinal strips ending at opposite ends in one of the vessel coupling members.

The device may include a plurality of longitudinal strips and may further include a substantially straight slot formed in each of the longitudinal strips in the folded position of the device, each slot transforming substantially into a diamond shape when the device is moved to the first position. expanded.

The longitudinal strips may be connected by transverse ribs, said ribs being in substantial axial alignment.

According to another aspect of the present invention there is provided a vascular system comprising:

a balloon catheter having an elongated shaft and an expandable balloon; and a vascular device mounted on the expandable balloon and composed of shape memory material and having a folded position and a memorized position, the vascular device being expandable to an expanded position to engage the walls of the vessels and being able to substantially revert to the memorized position to move the walls radially inward.

The vascular device of the system may first be expandable to the memorized condition in response to its exposure to body temperature and subsequently may be expanded to the expanded position by balloon inflation.

Alternatively, the vascular device may be expandable to the expanded position when the device is substantially simultaneously exposed to body temperature and the balloon inflates.

The vascular device can be connected to the balloon. The system may further comprise a pair of loop sutures connecting the vascular device to the balloon, the sutures being separable from the vascular device upon expansion of the balloon to a predetermined size.

The present invention overcomes the problems and deficiencies of the prior art by providing an intravascular device which radially inwardly displaces the vessel wall adjacent to the vein valve to displace the valve leaflets into juxtaposition.

Brief description of the drawings

A preferred form (s) of the present disclosure is described herein with reference to the drawings, in which:

Figure 1 is a perspective view of a first embodiment of the vascular device of the present invention shown in the expanded configuration; Figure 2 is a side view of the vascular device of Figure 1 in the expanded configuration; Figure 3 is another side view of the vascular device in the expanded configuration, rotated 45 degrees from Figure 2;

Figure 4 is a front view of the vascular device of Figure 1 in the expanded configuration;

Figure 5 is a perspective view of the vascular device of Figure 1 shown in the folded configuration to be applied within the vessel;

Figure 6 is a side view of the vascular device of Figure 1 in the folded configuration;

Figure 7 is another side view of the vascular device in the folded configuration, rotated 45 degrees from Figure 6;

Figure 8 is a perspective view of an alternative embodiment of the vascular device of the present invention shown in the expanded configuration;

Figure 9A is a side view of the vascular device of Figure 8 shown in the expanded configuration;

Figure 9B is a side view similar to Figure 9A except that it shows an alternative embodiment in which the vessel coupling members extend at an angle towards the vessel wall;

Figure 10 is a perspective view of the vascular device of Figure 8 in the folded configuration to be applied within the vessel;

Figure 11 is a side view of the device

ES 2 234 852 T3 vascular of Figure 8 in the folded configuration; Figure 12 illustrates a method of insertion of the vascular device of Figure 1 showing the delivery catheter inserted directly into the popliteal vein in an antegrade direction;

Figure 13 illustrates an alternative method of inserting the vascular device of Figure 1 through the jugular vein for retrograde insertion into the popliteal vein;

Figure 14 illustrates another method of inserting the vascular device of Figure 1 showing the delivery catheter inserted through the right femoral vein to retrograde access to the popliteal vein;

Figure 15 illustrates yet another method of inserting the vascular device of Figure 1 showing a contralateral approach in which the delivery catheter is inserted through the left femoral vein to advance around the iliac vein in view of its retrograde insertion. in the right popliteal vein;

Figure 16 shows a side view of the delivery catheter for the vascular device of Figure 1, with the vessel wall shown in section, illustrating antegrade insertion of the delivery catheter into the popliteal vein;

Figure 17 is a view similar to Figure 16 showing initial removal of the sheath in the direction of the arrow to partially expose the vascular device of Figure 1;

Figure 18 is a view similar to Figure 16 showing the vascular device of Figure 1 expanded within the vessel, in a position anterior (with respect to blood flow) to that of the valve leaflets, after the valve leaflets have been the cover completely removed;

Figure 19 is a view similar to Figure 16, showing the vascular device of Figure 1 expanded by a balloon such that the vessel coupling members penetrate the vessel wall and immobilize it;

Figure 20 is a view similar to Figure 16, after the balloon has deflated and the catheter has been removed from the vessel, showing the vascular device returned to its original position by pulling the vessel wall closed and shifting the valve leaflets so that they are in juxtaposition;

Figures 21A to 21C are cross-sectional views of the vascular device of Figure 1 showing its interaction with the vessel wall during application and placement, in which Figure 21A corresponds to the initial position of the vascular device in Figure 18 in which the vessel coupling members have not penetrated the vessel wall (for the sake of clarity the balloon has been omitted);

Figure 21B corresponds to the position of the vascular device in Figure 19 in which the balloon has been inflated to radially expand the device to a second expanded position in order to allow the vessel coupling members to penetrate the wall of the vessel. Cup; and Figure 21C corresponds to the position of the vascular device in Figure 20 in which the balloon has deflated and the device returns to the first expanded position displacing the vessel wall radially inward;

Figure 22 shows a side view of the delivery device for the vascular device of Figure 1, with the vessel wall shown in section, alternatively illustrating the retrograde insertion of the delivery device into the popliteal vein;

Figure 23 is a view similar to Figure 22 showing initial removal of the sheath in the direction of the arrow to partially expose the vascular device of Figure 1;

Figure 24 is a view similar to Figure 22 showing the vascular device of Figure 1 expanded within the vessel, in a position anterior to that of the valve leaflets in the direction of blood flow, after the sheath is has fully extracted;

Figure 25 is a view similar to Figure 22, showing the vascular device of Figure 1 expanded by a balloon such that the vessel coupling members penetrate and immobilize the vessel wall;

Figure 26 is a view similar to Figure 22, after the balloon has deflated and the catheter has been removed from the vessel, showing the vascular device returned to its original position by pulling the vessel wall closed and shifting the valve leaflets into juxtaposition;

Figure 27 is a side view of an alternative embodiment of the vascular device in the expanded position shown within a vessel (the vessel wall is shown in section);

Figure 28 is a view similar to Figure 27 showing a balloon expanding the vascular device so that the hooks penetrate the wall of the vessel;

Figure 29 is an enlarged view of the hook of the device of Figure 27 embedded in the wall of the vessel;

Figure 30 shows a side view of the delivery catheter for the vascular device of Figure 1, with the vessel wall shown in section, illustrating as a further alternative, the antegrade insertion of the delivery catheter into the popliteal vein for positioning of the vascular device after the leaflets of the valves according to the direction of advance of the blood flow;

Figure 31 is a view similar to Figure 30 showing initial removal of the sheath in the direction of the arrow to partially expose the vascular device of Figure 1;

Figure 32 is a side view of an alternative embodiment of the application system of the present invention that has clamping means, said view being similar to Figure 23 in that it shows the vascular device expanded within the vessel, before the leaflets of the valves according to the direction of advance of the blood flow, after the sheath has been removed;

Figure 33 is a view similar to Figure 32, showing the vascular device of Figure 1 expanded by a balloon so that the organs for coupling to the vessels penetrate the wall of the vessel and immobilize it, and the holding means for balloon expansion; and Figure 34 is a cross-sectional view of the vascular device of Figure 1 with the clamping means of Figure 32 shown in expansion toward the substantially memorized position.

ES 2 234 852 T3 simultaneous with balloon expansion.

Detailed description of preferred embodiments

Referring now in detail to the drawings in which the same reference numerals identify similar components or the same components throughout the various views, Figures 1 to 7 illustrate a first embodiment of the vascular device of the present invention and Figures 8 to 11 illustrate a second embodiment of the vascular device of the present invention. The devices, generally designated 10 and 100, expand to engage the inner wall of the vessel and contract to pull the vessel walls radially inward. By pulling the vessel wall radially inward, the leaflets of the valves located within the vessel are pulled closer together in order to obtain a functional condition.

Figures 1 to 4 illustrate the vascular device 10 of the first embodiment in the expanded configuration and Figures 5 to 7 illustrate the vascular device 10 in the folded configuration. The vascular device 10 is preferably composed of a shape memory material, such as a nickel-titanium alloy commonly known as Nitinol, so that in its memorized configuration said material takes the shape shown in Figure 1. Characteristically, this shape memory material exhibits some stiffness in the austenitic state and more flexibility in the martensitic state. To facilitate its passage from the delivery catheter, the shape memory device is held in a folded configuration within an delivery sheath as described in more detail below, where it is cooled by a saline solution to keep the device below its transition temperature. The cold saline solution maintains the temperature-dependent device in a relatively softer condition than the martensitic state within the sheath. This facilitates the exit of the device 10 from the sleeve as otherwise frictional contact would occur between the device and the interior wall of the sleeve if the device were maintained in a rigid, ie austenitic condition. When device 10 is released from the sheath toward the target site, it is heated by body temperature, thereby transitioning, in response to this temperature change, to an expanded austenitic condition.

Preferably, device 10 is formed from a tubular member, preferably by laser cutting. Device 10 includes a proximal part 12, and an intermediate part 14 and a distal part 16. In the expanded condition, the device 10 has four substantially diamond-shaped cells 17 that form the substantially diamond-shaped openings 18 in the proximal portion 12 and four substantially diamond-shaped cells 15 that form the substantially diamond-shaped openings 20 diamond distal 16. The end zones 19 of the cells 18, and the end zones 21 of the cells 20 are bent outwards with respect to the plane of the rest of the cell, in a direction away from the longitudinal axis of the vascular device 10. This situation more adequately allows the vessel coupling members, described below, to be coupled to the vessel walls.

Intermediate portion 14 is formed by four substantially diamond-shaped cells that form substantially diamond-shaped openings 22 arranged around a 360 degree arc of cylindrical tubular member 10, with a longitudinal strip 24 extending through to bisect each cell. . In this way, symmetrical bisected cells 23 are formed. Each longitudinal strip 24 has a vessel engaging member 28 extending therefrom to engage the vessel wall as will be described later. In the expanded condition, the longitudinal strip 24 is bent radially outward, away from the longitudinal axis of the vascular device 10, to allow the central vessel-engaging members 28 (to be described later) to engage the inner wall of the vessel. and ensure the same.

The geometry of vascular device 10 can also be appreciated by reference to the folded configuration of vascular device 10 shown in Figures 5 to 7. As shown, device 10 is cylinder-shaped with a reduced diameter. Each longitudinal strip 24 has a cutout section 27 to form the vessel coupling member 28. Longitudinal strip 24 has a progressively narrowing width "w" at its opposite ends 29 that connect with the armature. Longitudinal groove 30 on each side of strip 24 is substantially straight and has enlarged oval shaped areas 32 at opposite ends. The outer wall 34 of each longitudinal groove 30, that is, the wall of the groove 34 that is further apart from the longitudinal strip 24, is attached to the outer wall 34 of a contiguous longitudinal groove 30 by means of a transverse rib 36. Each rib 36 forms a vertex of a cell 15 and a vertex of a cell 17 when in expansion. The openings 18 and 20 of the cells in the folded configuration as shown in Figure 6, have, respectively, an elongated and tapered part 20a, 18a, and a widened part 20b, 18b with flared areas 20c, 18c, for forming the diamond-shaped openings presented by the bent end areas 21, 19 when the device 10 is expanded. The flared areas 20c, 18c allow the formation of said bent areas 21, 19.

A vessel coupling member extends from the frame of each of cells 15 and 17. Preferably, the vessel attachment member is hook-shaped with a piercing point and a barb.

More specifically, a vessel coupling member 40 extends outward and distal to the frame of each of the four cells 15 in the distal portion 16 of device 10. In the folded configuration of device 10, each member 40 preferably extends generally parallel to the longitudinal axis of vascular device 10 and substantially in the same plane as corresponding rib 36 at the opposite end.

Similarly, vessel coupling members 42 extend outward and proximal to the armature of each of the four cells 17 in proximal portion 12 of device 10. In the folded configuration of device 10, each member 42 preferably extends generally parallel to the longitudinal axis of vascular device 10 and in the same plane as the corresponding rib 36 at the opposite end.

ES 2 234 852 T3

The four organs 28 for coupling to the vessels formed in the central (intermediate) part 14 in the flattened configuration are arranged substantially parallel to the longitudinal axis of the device 10 and in the same plane as the longitudinal strip 24 from which they are formed. .

Each of the vessel coupling members 28, 40, and 42 are preferably hook-shaped with a penetrating tip 29, 41, and 43 to pierce the vessel wall and a barb 31, 45, and 47, respectively, to help immobilize the wall of the vessel. Sharp penetrating tips 29, 41, 43 penetrate the vessel wall in a radial direction and hold the vessel against axial movement with respect to device 10; barbs 31, 45, 47 limit radial movement of the vessel relative to device 10, thereby securely immobilizing (holding) the vessel wall relative to the radial inward movement described below.

It should be understood that although four vessel coupling organs 42, 40, 28 extending from proximal and distal cells 17, 15 and from central longitudinal strips 24, respectively, may be provided, a smaller or larger number of organs may be provided. coupling to the vessels provided they perform the vessel immobilization function as described in more detail below.

As vascular device 10 expands, members 28, 40, and 42 move to a memorized shape orientation, bent outward at an angle, preferably approximately 90 degrees, relative to longitudinal axis "A" of device 10. , with zones 19 and 21 bending out of plane to increase the distance that the organs can extend from the center in the direction of the vessel wall. Longitudinal strips 24 are bent radially outward, and members 28 are bent outward at an angle, preferably approximately 90 degrees, relative to the longitudinal axis, to engage the vessel wall. Although 90 degree angles are shown, other angles are obviously contemplated. Note that due to the geometry of the device 10, the outer edge tips move axially inward, shortening the length of the device, and the central strut (strip) 24 bends radially outward. The bending extends the radial reach of the device 10. Note also that in the expanded configuration, the tips of the vessel coupling members end at substantially the same distance with respect to the longitudinal axis of the device 10. Preferably, the length of the end hooks is the same as the length of the center hooks; the bent areas 19,21 absorb the bending of the strut 24. Due to the laser cut configuration, foreshortening, that is, the reduction in length of the device in response to expansion, is reduced.

By way of example, to be used, for example, in a dilated 14 mm unhealthy vessel, the length of the vascular device 10 in the folded configuration could be approximately 3 cm and the outer diameter approximately 3.5 mm. In the memorized expanded configuration, the length is reduced to approximately 2.8 cm and the cross-sectional dimension increases to approximately 12 mm, 15.5 mm if the 1.7 mm hooks are included. Note that the change in length is primarily due to the bending strip and bent areas as the amount of foreshortening is minimized. These dimensions are given by way of example as the present invention evidently contemplates other dimensions and their use in different sized vessels is also contemplated.

An alternative preferred embodiment of the vascular device of the present invention is shown in Figures 8 to 11, with Figures 8 and 9 showing the device in the expanded configuration and Figures 10 and 11 showing the folded configuration for application to the vessel.

Turning first to Figures 10 and 11, device 100 is preferably laser cut from a cylindrical tube, forming a series, for example ten, of symmetrical longitudinal strips 102 ending at opposite ends with members 110 , 112 coupling to the vessels. Each strip 102 has a longitudinal slot 104 formed therein having a uniform width throughout its length. The adjoining strips 102 are joined by means of transverse ribs or struts 106, creating a gap 108, 109 on each side of the ribs 106 between the strips 102. Consequently, the device can be considered to form a column, centrally located, of grooves 104 with ribs 106 in axial alignment and grooves 104 in axial alignment.

Preferably, the vessel coupling members 110 and 112 are in the form of hooks as described above in the first embodiment, each vessel attachment member 110 having a penetrating tip 114 and a barb 116 and each member 112 having a Penetrating point 118 and a barb 119. Penetrating tips 114 and 118 penetrate the vessel wall and prevent axial movement while barbs 116, 119 limit radial movement. As shown, in the folded configuration, the vessel coupling members 110, 112 are substantially parallel to the longitudinal axis of the device 100, being arranged in the same plane as the respective longitudinal strip 102.

As shown, the cylindrical tubular member forms ten longitudinal strips 102 with ten hooks 110 at the proximal end 105 and ten hooks 112 at the distal end 107. Although ten longitudinal strips and ten vessel coupling members are shown at each end It should be appreciated that fewer or more longitudinal strips and vessel coupling members can be used. On the other hand, it is not necessary for all the longitudinal strips to end in vessel coupling members, as long as a sufficient number of strips have the vessel attachment members to adequately securely fix the vessel.

The structure of vascular device 100 is shown in its first expanded configuration in Figures 8 and 9. Vascular device 100, like device 10, is comprised of a shape memory material, such as Nitinol, so that in its configuration memorized takes the form shown in Figure 8. The shape memory device is held in a folded configuration within a sleeve as described in more detail below, where it is cooled by a saline solution to keep the device below its transition temperature. When device 100 is applied to the target site

ES 2 234 852 T3 and is released from the sheath, it is heated by body temperature, thereby transitioning, in response to this temperature change, to an expanded austenitic condition. Maintaining the device in its softened martensitic state within the sleeve facilitates application to the vessel as otherwise frictional contact would occur between the device 100 and the interior walls of the application sleeve if the device were held within the sheath in its austenitic condition.

When expanding, longitudinal grooves 104 form substantially diamond shaped cells 120 with substantially diamond shaped openings 122. As expansion occurs, vessel engagement members 110 and 112 extend at an angle, preferably approximately 90 degrees, relative to the longitudinal axis of vascular device 10 to allow vessel engagement members 110 and 112 vessels are attached to the vessel wall and securely fix the vessel wall (see, for example, Figure 9A). However, the possibility is also contemplated that the vessel engaging members 110 ', 112' extend at a different angle, eg, approximately 60 degrees, as shown in the alternate embodiment of Figure 9B.

As the device is moved from the folded configuration to the expanded configuration, it shortens its axial length as the diameter is reduced. For example, in one embodiment the length of the vascular device 100 in the folded configuration is approximately 1.8 cm and the diameter is approximately 3.5 mm. In the expanded configuration, the length is reduced to approximately 1 cm, mainly due to the upward bending of the hooks as foreshortening is minimized, and the diameter in the memorized expanded configuration increases to approximately 12 mm (15.5 if hook length of 1.75mm is included). These dimensions are provided by way of example as other dimensions are obviously contemplated.

Returning to the method of use of the vascular devices of the present invention, the insertion of the vascular device 10 will be described, it being understood that the vascular device 100 would be inserted in the same way and would expand and retract in the same way as the device 10.

There are several different methods of inserting the vascular device of the present invention to treat insufficiency of the venous valves of the popliteal or saphenous vein. Figures 12-15 illustrate examples of some of these approaches by illustrating various access vessels for delivery devices to reach these veins. In Figure 12, the catheter 200 is placed in the popliteal vein "P" in the leg "G" of the patient and advanced to an area adjacent to the leaflets "T" to deploy the vascular device before the leaflets according to the forward direction of blood flow. In this way, the delivery catheter is applied in an antegrade manner, the tip extending after the "T" leaflets, according to the direction of advancement of blood flow, to deploy said device just before (defined in relation to the direction of flow sanguineous) than the flakes.

In the approach of Figure 13, catheter 210 is inserted through the right jugular vein "J", in which it will be advanced through the superior and inferior vena cava, passing through the iliac vein "I", at through the femoral vein "F" and into the popliteal vein "P" through the leaflets "L" in a retrograde manner, that is, opposite to the direction of blood flow. In this way, the delivery catheter 210 would extend through the area of ​​the flakes just before said flakes in the direction of advance of the blood flow. In Figure 14, catheter 220 is positioned in the right femoral vein "F", where it will be advanced in a retrograde manner toward the popliteal vein "P" in the manner previously described with respect to Figure 13.

In the contralateral approach of Figure 15, catheter 230 is inserted through the left femoral vein "H" where it will be advanced around the iliac vein "I" and through the left femoral vein "F" into the popliteal vein "P".

Each of the delivery catheters 200, 210, 220 and 230 has respective tubes 202, 212, 222 and 232, with a stopcock 204, 214, 224 and 234 to control the infusion of saline solution through the catheter with in view of maintaining vascular device 10 (or device 100) in the cooled martensitic folded configuration for application. Inflation port 206, 216, 226, and 236 provides the infusion of fluid to inflate the balloon that is mounted on the catheter shaft and positioned within device 10. The outer sheath of the delivery catheter slides relative to the catheter shaft. to expose the vascular device. Guidewire access 208, 218, 228, and 238 allows the insertion of a conventional guidewire (not shown) to guide the delivery catheter intravascularly to the target site. A conventional access or introductory sheath (not shown) would be inserted through the skin and into the access vessel, and the respective delivery catheter would be inserted into the access vessel through the introductory sheath.

Figures 16 and 20 illustrate the steps of the method of inserting vascular device 10 in an antegrade manner, intravascularly, into the popliteal vein "P". The catheter or delivery sheath 200 is inserted over a conventional guidewire (not shown) such that the distal tip 201 of the catheter shaft extends ahead of, that is, after, in the direction of advancement of flow, the leaflets L of the valves extending annularly from the wall "V" of the vessel as shown in Figure 16. As can be seen, since there is a gap "a" between the flaps "L" of the valves, the valve cannot function properly because said flaps cannot be properly closed to prevent back flow. Furthermore, due to the malfunction of the valve, as shown the vessel wall becomes dilated when the weight and pressure of the back flow of the blood push the vessel wall outward.

Once the position of the sheath 200 has been confirmed by phlebography, intravascular ultrasound, or other means, the sheath 205 is withdrawn with respect to the catheter tip 201 in the direction of the arrow in Figure 17, revealing the Vascular device 10. When sheath 205 has been completely removed to expose device 10, said device is heated by body temperature and transitions to its austenitic phase.

ES 2 234 852 T3 and to the first memorized expanded configuration of Figure 18.

Next, a balloon member 240 is inflated on catheter shaft 209 which is positioned within device 10, by introducing fluid through swelling lumen 206 (Figure 12) to further expand device 10 to a second expanded configuration shown in Figure 19. That is, the device expands to a diameter greater than the diameter in its memorized configuration of Figure 18 so that the vessel coupling members 28, 40 and 42 will couple to the "V" wall of the vessel with the tips penetrators and barbs penetrating said wall of the vessel to hold it firmly and fix it securely. This fixation limits both radial and axial movement of the vessel to improve immobilization by device 10.

After immobilization of the vessel wall as shown in Figure 19, the balloon deflates (and catheter 200 is withdrawn), resulting in contraction of device 10 from the second expanded configuration to its memorized configuration. Preferably, device 10 will once again have substantially the same diameter as the first expanded (memorized) configuration. When contracted, the device 10, due to the coupling of the vessel coupling members to the inner wall of the vessel, pulls the vessel wall radially inward, thereby pulling the leaflets radially inward in the direction of the vessel. position of Figure 20 to close gap "a". As can be appreciated, the vessel wall is no longer dilated and the valve leaflets have approached sufficiently such that their tips come into contact to block the back flow and therefore their function is restored. The device 10 remains within the cup, maintaining the approach of the cup wall in order to maintain the correct operation of the flakes.

The varying diameters of vascular device 10 can also be appreciated by reference to the cross-sectional views of Figures 21A through 21C. The application device has been removed for the sake of clarity. More specifically, Figure 21A corresponds to the initial position of the vascular device 10 of Figure 18 in which the device 10 has been applied to the target vessel, and has expanded to the first expanded (memorized) configuration although the coupling members the vessels have not penetrated the vessel wall. It should be appreciated that in this configuration, the vessel coupling members may or may not be in contact with the vessel wall, although in either case they do not fully penetrate the vessel and securely fix said vessel at the same level as in the second position. As shown, by way of example, the dilated health-damaging vessel may have an internal diameter D1 of approximately 14mm. For the sake of clarity, the balloon is not shown in Figure 21A.

Figure 21B corresponds to the position of the vascular device in Figure 19 in which the balloon has been inflated to radially expand the device 10 to a second expanded position in order to allow the vessel coupling members to penetrate the wall. vessel and immobilize (securely fix) it. In this configuration, the vessel wall is further expanded to a diameter D2 of approximately 16mm, as the device expands to a diameter of approximately 16mm, with the hooks extending an additional 2mm so that the device expands to 20mm. mm.

Figure 21C corresponds to the position of vascular device 10 in Figure 20 in which the balloon has deflated and the device has contracted to displace the vessel wall radially inward. Preferably, the internal diameter of the vessel wall will be approximately 12mm to close the gap between the flakes. Preferably, the diameter of vascular device 10 returns to the same diameter as in Figure 21A, eg, approximately 12mm. As can be seen, the device 10 rests against the wall V of the vessel.

Figures 22-26 illustrate retrograde insertion of vascular device 10. In this approach, the delivery catheter, eg, catheter 210, is inserted in a direction opposite to blood flow so that tip 211 extends ahead of the leaflets "L" of the valves in the popliteal vein "P" and the catheter 210 is positioned so that the device 10 will deploy before the leaflets according to the direction of advancement of blood flow. In other respects, the deployment of the device 10 is the same as in Figures 16-20. That is, the sleeve 215 of the application device 210 retracts in the direction of the arrow in Figure 23, to expose the device. 10. Retracting and fully withdrawing the sleeve 215 to expose the device to the warmer body temperature allows the device to expand to its (first) memorized (expanded) configuration of Figure 24. The subsequent expansion of the balloon 250 (Figure 25) causes the organs 42, 28, 40 for coupling to the vessels to penetrate the vessel wall and immobilize it so that when the balloon deflates, the device 10 returns to the memorized configuration. of Figure 26 by pulling the vessel wall inward and moving the flaps "L" of the valves to close them mutually in juxtaposition so that the tips can come into contact. Variable diameters would also correspond to the previously described cross sections of Figures 21A through 21C.

As can be appreciated, device 10 and device 100 are both symmetrical so that herein the "proximal" and "distal" portions are so identified for convenience.

Figures 27 through 29 illustrate an alternative embodiment of the vascular device generally designated 300. This shape memory device 300 is illustrated and described in Provisional Patent Application No. 60 / 214,120, filed June 6, 2000. Device 300 is placed within vessel V, for example, the popliteal vein, to approximate the “L” leaflets which, as shown in Figure 27, are not working properly because the L1 tips are separated from each other. . In their first expanded configuration corresponding to their memorized shape in Figure 27, the hooks 314 have not penetrated the vessel wall. Device 300 is formed of struts 302 as described in detail in application 60 / 214,120. The hooks 314, attached to the struts 302 by the area 304 are crescent-shaped and have ends 306 finished in points with

ES 2 234 852 T3 parts 308 with a beard.

In the expanded configuration of Figure 28, balloon 322 on delivery device axis 324 has expanded device 300 such that hooks 314 penetrate and securely engage vessel wall "V". The balloon would then deflate and the device 300 would return to its first expanded configuration by shifting the vessel walls radially inward and displacing the valve leaflets so that they would be placed in juxtaposition in the same manner as described above with respect to to vascular device 10.

Figures 30 and 31 illustrate an alternative method of placement of the vascular device. In this method, the vascular device 10 (or vascular device 100) is positioned after (with respect to the direction of blood flow) the leaflets of the valves. The delivery catheter 210 'is inserted in the same antegrade manner as described above with respect to Figure 16, except that it is advanced after sufficiently past the leaflets L of the valves to allow the application of the device 10 in an advanced position according to the direction of blood flow. Once positioned as shown in Figure 31, sleeve 215 'is pulled out in the direction of the arrow, allowing device 10 to expand to its memorized configuration. The vascular device 10 would then be further expanded by means of a balloon and then allowed to contract to its memorized configuration in the same manner as in Figures 18 to 20, the only difference being that the device 10 would clamp the vessel wall. then, depending on the direction of blood flow, of the valve leaflets to pull said vessel wall radially inward with a view to moving the leaflets into juxtaposition.

It should be appreciated that device 10 or device 100 could also be applied in a retrograde manner as shown in Figures 13-15 to position the device after, according to the direction of blood flow, the L-flakes.

Figures 32 through 34 illustrate an alternative application system and method for vascular device 10 (or device 100 which can be applied in the same manner). In this method, exposure of the vascular device to body temperature and balloon expansion occur substantially simultaneously. To facilitate placement, a clamping system is provided to connect the vascular device to the balloon.

More specifically, balloon 250 'has a pair of sutures 252 attached to it in a proximal and distal portion which wrap around vascular device 10 to form a suture loop to connect the balloon and device. Although two sutures are shown, the use of one suture or more than two sutures to connect balloon 250 'to vascular device 10 is contemplated. Additionally, other fastening systems such as perforated strips may be used.

In the position of Figure 32, the sutures (of which only one is shown, the other suture still within the sheath 215 ') loosely wrap the device. When the sleeve 215 'is retracted in the direction of the arrow, the balloon inflates. In this way, when the sleeve 215 'is fully extracted, the device expands to the position of Figure 33, without the intermediate stage required in the methods described above, that is, without the stage of Figure 24 which allows in The device expands to the memorized configuration first. As the balloon expands, the pressure against the sutures 252 breaks the loops of the sutures, thereby releasing them from the vascular device 10. In this manner, when balloon 250 'is deflated and withdrawn with delivery catheter 210' relative to the body, sutures 252 are also removed. Upon deflation, the vascular device 10 returns to its memorized configuration to pull the vessel wall radially inward in the manner described above with a view to assuming a position as in Figure 26.

Note that it is also contemplated that balloon 250 'may be inflated first within the sheath, then removing the sheath to expose vascular device 10 to body temperature.

Additionally, the fastening system can also be used with the sequential deployment method of Figures 16-20 and Figures 22-26. The fastening system, for example sutures, would help prevent axial movement and aid in centering. the balloon relative to the vascular device 10.

Although the above description contains many specific details, such specific details should not be construed as limitations on the scope of the description, but merely as exemplifications of preferred embodiments thereof. For example, instead of a balloon to expand the device to its second condition / expanded diameter, mechanical means such as an expandable wire frame can be used. Furthermore, instead of moving the sheath to expose the vascular device, the catheter can be advanced relative to the sheath or both the catheter and the sheath can be moved relative to each other in opposite directions. Those skilled in the art will envision many other possible variations that are included within the scope of the description as defined in the claims appended thereto.