Vascular device with valve for approximating vessel wall

This application is a partial continuation of US Patent Application No. 09 / 877,639 dated June 8, 2001, and a partial continuation of US Patent Application No. 09 / 877,480 dated June 8, 2001. Both applications claim the priority of US Provisional Patent Application No. 60 / 214,120 dated June 26, 2000. The entire contents of these three patent applications are incorporated herein by reference.

The present application relates to a vascular therapeutic device, and more particularly to a vascular device (vascular therapeutic device) for arranging a valve for treating venous valve insufficiency in the vicinity of the blood vessel wall.

Veins in the body carry blood to the heart, and arteries carry blood from the heart. The veins have a one-way valve structure in the form of leaflets formed in a ring along this inner wall, which opens to allow blood flow to the heart and back. Close to prevent flow). That is, as blood flows through the veins, the valvular lobules are pushed by pressure to bend in the direction of blood flow and move toward the inner wall of the blood vessel, creating an opening for blood flow between the valvular lobules. However, the valvular lobules usually do not bend in the opposite direction and therefore return to the closed position after the pressure drops, preventing blood from flowing in the opposite direction or direction. When functioning properly, the valvular lobule structure extends radially inward with each other so that their tips are in contact with each other to prevent backflow of blood.

In the state of venous valve insufficiency, the valve leaflets do not function properly due to thickening and loss of flexibility, so the tips of the valve leaflets are in good contact with each other and retrograde blood. It cannot extend sufficiently inward in the radial direction so that flow) can be prevented. The backflow of blood creates static pressure in the other valves, and the weight of the blood dilates the vessel wall. The retrograde flow of blood, commonly referred to as reflux, causes swelling and dilated tortuous veins, causing great discomfort and pain in the patient. If such retrograde blood flow remains untreated, venous ulcers of the skin and subcutaneous tissue develop. In general, there are two types of venous valve insufficiency: primary and secondary. Primary venous valve insufficiency is generally congenital, in which the veins are too large with respect to the lobule and the lobule is only inadequately contacted to prevent reflux. More common is secondary venous valve insufficiency caused by gelling and scarring clots, which causes the leaflets to deform or thicken into a "stump-like" shape. Venous valve insufficiency occurs in the superficial venous system, such as the saphenous veins of the legs, or in the deep venous system, such as the femoral and popliteal veins, which extend along the back of the knee to the inguinal region.

A common treatment for venous valve insufficiency is to place compression stockings around the patient's leg to apply pressure to the veins and press the vessel wall inward in the radial direction to push the lobules into juxtaposed positions. Tight stockings are very uncomfortable, especially in the warmer months, as stockings must be worn all the time to keep the leaflets in a juxtaposed position, although this can sometimes work. Compression stockings also affect the physical appearance of the patient, which can potentially have a negative psychological effect. This physical and / or mental discomfort sometimes causes patients to take off their stockings, which prevents adequate treatment. Other treatments have been developed to avoid the discomfort of stockings. This method is a major operation in the body that requires a cuff to be transplanted directly around the veins. This surgery requires a large incision that produces a scar that requires a long healing time and carries risks such as, for example, paralysis that is specific to the surgery. Another invasive surgical method is a method of selective repair of valvular lobules called valvuloplasty. One method uses sutures to bring the free edges of the valvular apex into contact. This surgery is complex and has the same drawbacks as the major surgery described above.

Patent Document 1 (see Patent Document 1 below) and Patent Document 2 (see Patent Document 2 below) owned by the Applicant and incorporated in the present application do not require extracorporeal stockings or internal cuffs and venous valve insufficiency. The least invasive treatment methods and instruments for treating the disease are disclosed. Such treatment devices avoid the physical and psychological discomfort of extracorporeal stockings, as well as the risk, complexity and high cost of surgically transplanted cuffs. This instrument is minimally invasive or intravascularly inserted and effectively positions the valvular lobe in a juxtaposed position. The device first expands against the vessel wall to grab the vessel wall and then contracts to pull the vessel wall inward in the radial direction, which pulls the lobules together toward the functional position.

<patcit num="1"><text>U.S. Patent Application No. 09 / 877,639</text></patcit><patcit num="2"><text>U.S. Patent Application No. 09 / 877,480</text></patcit><patcit num="3"><text>US Provisional Patent Application No. 60 / 214,120 dated June 6, 2000</text></patcit>

<p> The present invention uses the instruments of these applications of the prior art to pull the vessel wall inward in the radial direction to correct the dilation of the vessel wall, but in patients who may become scarred or incapacitated. Rather than relying on the existing valve leaflets of the patient, it has a replacement valve as a replacement for the patient's valve leaflets. Thus, venous valve insufficiency can be treated with minimal invasive advantage by pulling the vessel wall inward to replace the patient's valve.</p>

<p> The present invention provides a vascular device with a plurality of vascular engaging members and valves. The vascular device of the present invention can move from a contraction insertion position having a first diameter to a second expansion position having a second diameter larger than the first diameter. The plurality of vascular engaging members extend outward from the vascular device and reliably engage the inner wall of the blood vessel when the vascular device expands to the second expansion position. The vascular engaging member pulls the inner wall of the vessel radially inward as the vascular device moves from the second dilated position to the first dilated position having a third diameter. The third diameter is larger than the first diameter and smaller than the second diameter. In the first expanded position, the valve can move between an open position that allows blood to flow through the valve and a closed position that prevents blood flow. The vascular device is preferably formed of a shape memory material and the first enlarged position substantially coincides with the shape memory position of the vascular device. The vascular device is expanded to a second expansion position by a expandable device such as a balloon placed within the vascular device. In one embodiment, the vascular device can first move from the contraction position to the first expansion position in response to exposure to body temperature and then by the expandable member from the first expansion position to the second expansion position. To. In another embodiment, the vascular device can move from the contraction position to the second expansion position due to substantially simultaneous exposure to body temperature and expansion by the expandable member.</p><p> The present invention also comprises a balloon catheter with an elongated shaft and an expandable balloon, and a vascular device mounted on the expandable balloon with first and second swelling positions, the vascular device being a blood vessel. A closed position and blood that can be expanded to an enlarged position that engages the wall and can substantially return to the first position that moves the vessel wall inward in the radial direction, and is connected to the vascular device and prevents blood flow. Provided is a vascular system characterized by further having a valve that can move to and from an open position that allows flow through. The vascular device can be expanded to the enlarged position and engaged with the vascular wall, and can substantially return to the first position to move the vascular wall inward in the radial direction. The vascular device in one embodiment is formed of a shape memory material and can first expand to a memory state in response to exposure to body temperature and then to an expanded position by inflating the balloon. Alternatively, the vascular device can be expanded to the expanded position when it is exposed to body temperature substantially simultaneously and the balloon is inflated. The vascular device is made of stainless steel in other embodiments and is expanded below its elastic limit by a balloon so that the vascular device can return to its primary position.</p><p> In the vascular device and vascular system, the vascular device can be detachably connected to the balloon. The valve is attached to the distal end of the vascular device and is placed downstream of the vascular device when placed inside the patient's body. Alternatively, the valve is attached to the proximal end of the vascular device and is placed within the central portion of the vascular device when placed within the patient's body. The valve is preferably substantially conical. Alternatively, the valve can be configured in the form of a duck bill valve. In one embodiment, the longitudinal axis of the valve is offset from the longitudinal axis of the vascular device. The valve may be provided with a plurality of blood drainage openings that penetrate the side wall. A reinforcing ring can be provided adjacent to the distal opening.</p><p> The present invention is also a method of treating venous valve insufficiency, in which a delivery device and a vascular device equipped with a replacement valve are inserted into a target blood vessel adjacent to the area of the removal portion of the valve leaflet, and a vascular device. To reduce the diameter of the vascular device and move the vascular wall inward in the radial direction to reduce the dilation of the vascular and implant a replacement valve. Provided is a method characterized by including steps. The method can further be provided with a step of removing at least a portion of the patient's venous valve lobules prior to insertion of the vascular device. In one embodiment, the method of the invention further comprises placing the vascular device at the first dilated diameter before placing the vascular device at the dilated diameter, where the first dilated diameter is greater than the dilated diameter and of the vasculature. The step of reducing the diameter returns the diameter of the vascular device to a diameter substantially equal to the first enlarged diameter. In this embodiment, the step of placing the vascular device at the first enlarged diameter allows the vascular device to be exposed from the sheath of the delivery device and return to its memory shape in response to the vascular device being warmed by body temperature. It is preferable to include a step of performing. In this embodiment, the step of arranging the vascular device to the first enlarged diameter preferably includes the step of inflating the balloon placed in the vascular device.</p><p> Alternatively, the step of placing the vascular device in an enlarged diameter is configured to release the vascular device from the delivery device, allowing the vascular device to return to a shape memory state and inflating the balloon substantially simultaneously. it can. The delivery device can be inserted into the popliteal or saphenous vein via the jugular or femoral vein.</p><p>(Replacement Valve) In another aspect, in a replacement valve having a support structure and a valve attached to the support structure, the valve has a substantially conical shape and the valve is in a closed position. When in, it points away from the longitudinal axis, and when the valve is in the open position, it has a distal opening that aligns with the longitudinal axis. In one embodiment, the valve is attached to the proximal end of the support structure, and in other embodiments, the valve is attached to the distal end of the support structure. The valve may be provided with a plurality of discharge openings formed in the side wall adjacent to the proximal end.</p>

Hereinafter, preferred embodiments of the present invention will be described with reference to the accompanying drawings. Referring here to the accompanying drawings, the same reference numbers are used for similar components throughout several drawings, and FIGS. 1-7 show the first embodiment of the vascular device of the present invention. 8 to 11 show a second embodiment of the vascular device of the present invention. Vascular instruments, collectively referred to by reference numbers 10 and 100, are expanded to engage the inner wall of the vessel and contracted to pull the vessel wall inward in the radial direction. By pulling the vessel wall inward in the radial direction, the valvular lobules in the vessel are pulled together with the functional state.

1 to 4 show the vascular device 10 of the first embodiment in the enlarged shape, and FIGS. 5 to 7 show the vascular device 10 in the contracted shape. The vascular device 10 is preferably made of a shape memory material such as a nickel-titanium alloy commonly known as Nitinol®, which has the shape shown in FIG. This shape memory material is characterized by exhibiting rigidity in the austenite state and higher flexibility in the martensite state. To allow easy passage through the delivery catheter, the shape memory device is maintained in a contracted shape within the delivery sheath as described in more detail below, in which case the device is cooled with saline and the device transitions. Maintained below temperature. Cold saline keeps the device relatively flexible when the temperature-dependent device is in a martensitic state within the sheath. This facilitates removal of the instrument 10 from the sheath. This is because if the device is maintained in a rigid or austenitic state, frictional contact occurs between the device and the inner wall of the sheath. When the device 10 is released from the sheath to the target site, the device is warmed by the body temperature, and in response to this temperature change, the austenite transitions to an expanded state.

The instrument 10 is preferably formed from a tubular member, preferably by laser cutting. Instrument 10 has a proximal portion 12, an intermediate portion 14, and a distal portion 16. In the expanded state, the instrument 10 is substantially diamond-shaped in the distal lateral portion 16 with four substantially diamond-shaped cells 17 forming a substantially diamond-shaped opening 18 in the proximal portion 12. It has four substantially diamond-shaped cells 15 and which form an opening 20 of the. The end region 19 of the cell 17 and the end region 21 of the cell 17 are bent outward from the plane of the other cell in a direction away from the longitudinal axis of the vascular device 10. This allows the vessel engaging member to better engage the vessel wall, as described below. The intermediate portion 14 is formed by four substantially diamond-shaped cells forming a substantially diamond-shaped opening 22 arranged around a 360 ° arc of the cylindrical tubular member 10 with a longitudinal strip 24. Each cell is extended to divide it into two equal parts. Thus, four symmetric cells 23 that are bisected are formed. Each longitudinal strip 24 has a vascular engagement member 28 extending from it, which engages the vascular wall as described below. In the expanded state, the longitudinal strip 24 buckles radially outward away from the longitudinal axis of the vascular device 10 (discussed below) to engage and secure the vascular inner wall.

The geometric shape of the vascular device 10 can also be understood by referring to the contraction shape of the vascular device shown in FIGS. 5 to 7. As shown, the instrument 10 has a cylindrical shape with a small diameter. Each longitudinal strip 24 has a cutout 27 for forming the vascular engagement member 28. The longitudinal strip 24 is tapered to a width "W" at both ends 29 connected to the frame structure. The longitudinal slots 30 on both sides of the strip 24 are substantially straight, with oblong regions 32 at both ends of the slots 30. The outer wall 34 of each longitudinal slot 30, i.e. the wall 34 of the slot 34 away from the longitudinal strip 24, is joined to the outer wall 34 of the adjacent longitudinal slot 30 by lateral ribs 36. Each rib 36, when expanded, forms one vertex in cell 15 and one vertex in cell 17. As shown in FIG. 6, the contracted cell openings 18 and 20 have narrow portions 20a and 18a, respectively, and wide portions 20b and 18b with expansion regions 20c and 18c, respectively, and the instrument 10 is enlarged. At that time, it forms a diamond-shaped opening with curved edge regions 21 and 19. The extended regions 20c and 18c allow the formation of such bent regions 21 and 19.

The vascular engaging member extends from the frame structure of each of the cells 15 and 17. The vessel engaging member is preferably in the form of a hook with a puncture tip and a barb. More specifically, the vascular engagement member 40 extends outwardly and distally from each frame of the four cells 15 in the distal portion 16 of the instrument 10. When the instrument 10 is in a contracted shape, each vascular engaging member 40 extends substantially parallel to the longitudinal axis of the vascular device 10 and is in substantially the same plane as the corresponding rib 36 at the opposite end. It is preferable to have it. Similarly, the vascular engagement member 42 extends outwardly and proximally from the frame structure of each of the four cells 17 in the proximal portion 12 of the vascular device 10. When the device 10 is in a contracted shape, each vascular engaging member 42 extends approximately parallel to the longitudinal axis of the vascular device 10 and is in the same plane as the corresponding rib 36 at the opposite end. preferable. The four vascular engaging members 28 formed in the intermediate portion (central portion) 14 in a contracted shape are substantially parallel to the longitudinal axis of the instrument 10 and in the longitudinal direction in which the vascular engaging member 28 is formed. It is provided in the same plane as the strip 24.

Each of the vessel engaging members 28, 40, 42 was provided with puncture tips 29, 41, 43 to puncture the vessel wall and barb 31, 45, 47 to assist in holding the vessel wall, respectively. It is preferably in the shape of a hook. Sharp puncture tips 29, 41, 43 puncture the vessel wall radially and retain the vessel against axial movement with respect to instrument 10. On the contrary, 31, 45, 47 restrict the radial movement of the vessel with respect to the instrument 10 so that the vessel wall can be moved radially inward, as described below. Hold (grip) fixedly together. The four vascular engagement members 42, 40, 28 have been described as extending from the proximal and distal cells 17, 15 and the central longitudinal strip 24, respectively, as described in more detail below. It should be noted that less than four or more vascular engagement members can be provided as long as the vascular retention function can be achieved.

As the vascular device 10 expands, members 28, 40, 42 are moved in the outwardly bent shape memory direction at an angle (preferably about 90 °) with respect to the longitudinal axis "A" of the device 10. , The end regions 19, 21 are bent to increase the distance from the plane, so that the members 28, 40, 42 can move from the center to the vessel wall. The longitudinal strip 24 buckles radially outward and the member 28 bends outward at an angle (preferably about 90 ° with respect to the longitudinal axis) to engage the vessel wall. The 90 ° angle is shown, but it is clear to consider other angles. Note that the geometry of the instrument 10 causes the points on the outer edge to move inward in the axial direction to shorten the instrument and the central strut (strip) 24 to buckle outward in the radial direction. It should also be noted that in the enlarged shape, the tip of the vessel engaging member terminates approximately equidistant from the longitudinal axis of the instrument 10. Preferably, the length of the end hook is equal to the length of the intermediate hook, and the bend areas 19 and 21 adapt to the buckling of the struts 24. The laser-cut shape reduces the shortening or reduction in length of the instrument in response to enlargement. For example, when used for a 14 mm blood vessel dilated by a lesion, the contractile vascular device 10 has a length of about 3 cm and an outer diameter of about 3.5 mm. In the memorized enlarged shape, the length is shortened to about 2.8 cm and the cross-sectional dimension is increased to about 12 mm, and if the 1.7 mm hook is included, it is increased to 15.5 mm. Note that the amount of foreshortening is minimized, so the length variation is mostly due to buckling strips and bend regions. Since other dimensions are conceivable in the present invention, these dimensions are merely exemplary and may be considered for use in blood vessels of different sizes.

8 to 11 show other preferred embodiments of the vascular device according to the invention, FIGS. 8 and 9 show the device in an enlarged shape, and FIGS. 10 and 11 show the blood vessel. The contraction shape for distribution to is shown. First, as shown in FIGS. 10 and 11, the vascular instrument 100 is preferably a cylinder forming a series (eg, 10) symmetrical longitudinal strips 102 terminating at both ends with vascular engaging members 110, 112. Laser cut from the tube. Each strip 102 has a longitudinal slot 104, which has a uniform width over its entire length. The strips 102 adjacent to each other are connected by lateral ribs or struts 106, and gaps 108 and 109 are created between the strips 102 on both sides of the ribs 106. Thus, the appliance 100 can be considered to form one centrally located column of slot 104, with axially aligned ribs 106 and axially aligned slots 104.

The vessel engaging members 110, 112 are preferably configured in the form of hooks as described above in the first embodiment, and each vessel engaging member 110 has a puncture tip 114 and a barb 116. Each vessel engaging member 112 has a puncture tip 118 and a reverse eye 119. The puncture tips 114, 118 puncture the vessel wall and prevent axial movement while the inverted eyes 116, 119 limit radial movement. In the contracted form, the vascular engaging members 110, 112 are substantially parallel to the longitudinal axis of the instrument 100 and are in the same plane as their respective longitudinal strips 102. As shown, a cylindrical tubular member is formed on 10 longitudinal strips 102 with 10 hooks 110 at the proximal end 105 and 10 hooks 112 at the distal end 107. Although 10 longitudinal strips and 10 vascular engagement members are shown at each end, it will be appreciated that fewer or more longitudinal strips and vascular engagement members can be used. Further, it is not always necessary to terminate all the longitudinal strips to the blood vessel engaging member, and the blood vessel engaging member may be provided on a sufficient number of strips for fixing the blood vessel.

8 and 9 show the structure of the vascular device 100 in its first enlarged shape. Like the vascular device 10, the vascular device 100 is made of a shape memory material such as Nitinol (registered trademark), and its memory shape has a shape as shown in FIG. The shape memory device is maintained in a contracted shape in the sheath and kept below its transition temperature by being cooled by saline in the sheath, as described in more detail below. When the device 100 is distributed to the target site and released from the sheath, it is warmed by body temperature, thereby transitioning to an austenite expansion state in response to this temperature change. Maintaining the device in softened martensite in the sheath facilitates the distribution of the device into the blood vessel. This is because if the instrument 100 is maintained in the sheath in an austenite state rather than in its martensite state, frictional contact will occur between the device and the inner wall of the delivery sheath. When expanded, slot 104 forms a substantially diamond-shaped cell 120 with a substantially diamond-shaped opening 122. When expanded, the vascular engaging members 110, 112 are placed at an angle (preferably about 90 °) with respect to the vascular device 10 so that the vascular engaging members 110, 112 engage and immobilize the vessel wall. (See, for example, Figure 9A). However, as shown in other embodiments of FIG. 9B, it is also possible to consider arranging the vessel engaging members 110', 112' at different angles (eg, about 60 °).

As the instrument moves from a contracted shape to an enlarged shape, the instrument shortens its axial length as its diameter increases. For example, in one embodiment, the vascular device 100 in contracted form has a length of about 1.8 cm and a diameter of about 3.5 mm. In the enlarged shape, the length was shortened to about 1 cm mainly due to the bending of the hook when fore shortening was minimized, and the diameter in the shape-memory enlarged shape was about 12 mm (including the hook length of 1.75 mm). In some cases, it increases to 15.5 mm). These dimensions are exemplary and it is clear that other dimensions can be considered. Although the insertion of the vascular device 10 will be described with respect to the method of using the vascular device of the present invention, it should be understood that the vascular device 100 is inserted in the same manner as the vascular device 10 and is expanded and retracted in the same manner. There are several different methods of inserting the vascular device of the present invention for the treatment of popliteal or saphenous venous valve insufficiency. Figures 12-15 illustrate some of these approaches by exemplifying the various access vessels for delivery devices that reach these veins. As shown in FIG. 12, the catheter 200 is placed in the popliteal vein "P" of the patient's leg "G" and advanced into the area adjacent to the valve lobe "L", a vascular device upstream of the lobe. To place. Thus, the delivery catheter is distributed in an antegrade manner, the tip extends downstream of the lobule "L" and the instrument is placed just upstream of the lobule (upstream is defined with respect to the direction of blood flow). ..

In the approach of FIG. 13, catheter 210 is inserted through the right jugular vein "J". Catheter 210 is advanced through the superior and inferior vena cava and enters the popliteal vein "P" through the iliac vein "I" and the femoral vein "F" in a retrograde manner (ie, in the opposite direction of blood flow). Pass through the leaflet "L". The delivery catheter 210 is thus placed through the lobular region just upstream of the lobule. In FIG. 14, the catheter 220 is placed within the right femoral vein F and is retrogradely advanced into the popliteal vein P in the manner described above with respect to FIG.

In the contralateral approach of FIG. 15, the catheter 230 is inserted through the left femoral vein "H", in which case the catheter 230 bypasses the iliac vein "I" and through the left femoral vein "F". It is advanced into the popliteal vein "P". Each of the delivery catheters 200, 210, 220 and 230 has tubes 202, 212, 222 and 232, respectively. Stopcocks 204, 214, 224, 234 control the infusion of saline through the catheter to maintain the vascular device 10 (or vascular device 100) in a cooled martensite contraction shape for delivery. .. Inflatable ports 206, 216, 226, 236 provide fluid injection to inflate a balloon mounted on the catheter shaft and located within instrument 10. The outer sheath of the delivery catheter slides against the catheter shaft, exposing the vascular device. The guide wire port can be inserted with a conventional guide wire (not shown) for guiding the delivery catheter to the target site in the blood vessel. A conventional access sheath or introduction sheath (not shown) is inserted into the access vessel through the skin, and each delivery catheter is inserted into the access vessel through the introduction sheath.

16 to 20 show a method step of inserting the vascular device 10 into the popliteal vein "P" in an intravascular antegrade manner. The catheter or delivery sheath 200 is inserted over a conventional guide wire (not shown) so that the distal tip 201 of the catheter shaft extends annularly from the vessel wall "V", as shown in FIG. It is located on the downstream side of the valve leaflet "L". As you can see, the valve cannot function properly because there is a gap "a" between the valve leaflets "L". This is because the valve leaflets do not close properly to prevent regurgitation. Also, when the valve is dysfunctional, the vessel wall is extruded and dilated as shown by the weight and pressure of reflux blood. Once the position of the sheath 200 has been confirmed by venography, endovascular ultrasound or other means, the sheath 205 is pulled out with respect to the catheter tip 201 in the direction of the arrow in FIG. 17 to expose the vascular device 10. .. When the sheath 205 is fully retracted to expose the device 10, the device is warmed by body temperature and transitions to its austenite phase and the first memory magnified shape shown in FIG.

Next, the balloon member 240 of the catheter shaft located in the device 10 is expanded into the second enlarged shape shown in FIG. 19 by introducing a fluid through the expansion lumen 206 (FIG. 12). That is, the instrument is expanded to a diameter larger than the diameter of the memory shape of FIG. 18, which causes the vessel engaging members 28, 40, 42 to engage the vessel wall "V" with sharp tips and reverses on the vessel wall. Puncture and securely grip and fix the vessel wall. This fixation limits the radial and axial movement of the vessel and enhances retention by the instrument 10. After the vessel wall is retained as shown in FIG. 19, the balloon contracts (and the catheter 200 is removed), which causes the instrument 10 to contract from its second enlarged shape to its memory shape. Instrument 10 preferably returns to substantially the same diameter as the first (memory) enlarged shape. When contracted, the instrument 10 pulls the vessel wall inward in the radial direction because the vessel engaging member and the inner wall of the vessel are engaged, which causes the valvular lobe to move inward in the radial direction to the position shown in FIG. Attracted to close the gap "a". As will be understood, the vessel wall is no longer dilated, which allows the valve leaflets to be in close proximity to the leaflet tips. This blocks the regurgitation of blood flow and restores valve leaflet function. Instrument 10 is retained within the vessel to maintain proximity to the vessel wall and maintain proper functioning of the valvular lobe.

The change in diameter of the vascular device 10 can also be understood by referring to the cross-sectional views of FIGS. 21A-21C. Delivery equipment has been removed for clarity. More specifically, FIG. 21A coincides with the initial position of the vascular device 10 in FIG. 18, although here the device 10 is distributed to the target vessel provided and magnified into the first enlarged (memory) shape. , The vessel engaging member has not yet punctured the vessel wall. In this shape, the vessel engaging member may or may not be in contact with the vessel wall, but in any case, it completely punctures and anchors the vessel to the same extent as in the second position. Not. As shown, for example, a blood vessel dilated by a lesion has an inner diameter D1 of about 14 mm. In FIG. 21, balloons are not shown for clarity. FIG. 21B coincides with the position of the vascular device of FIG. 19, where the balloon is inflated to radially expand the device 10 to the second expansion position, puncturing and holding the vascular engagement member into the vessel wall. (Fixed). In this shape, the vessel wall is further expanded to a diameter of about 16 mm, D2, and when the instrument is expanded to a diameter of about 16 mm, the hook extends an additional 2 mm, so the instrument is expanded to 20 mm. FIG. 21C corresponds to the position of the vascular device 10 in FIG. 20, where the balloon is contracted and the device is contracted, causing the vessel wall to move inward in the radial direction. The inner wall of the blood vessel is preferably about 12 mm in order to close the gap between the valve leaflets. The diameter of the vascular device 10 preferably returns to the same diameter as in FIG. 21A (eg, about 12 mm). As you can see, instrument 10 is in contact with the vessel wall "V".

22 to 26 show the retrograde insertion of the vascular device 10. In this approach, a delivery catheter, such as the catheter 210, is inserted in the direction opposite to the direction of blood flow, so that the tip 211 extends past the valve lobe "L" of the popliteal vein "P". The catheter 210 is positioned such that the instrument 10 is located upstream of the valvular lobe. The arrangement of the appliance 10 can be performed in the same manner as in FIGS. 16 to 20 otherwise. That is, the sheath 215 of the delivery device 210 is retracted in the direction of the arrow in FIG. 23 to expose the device 10. When the device is exposed to body temperature by completely retracting and removing the sheath 215, the device is magnified into the memory (first enlargement) shape of FIG. Continuing to expand the balloon 250 (FIG. 25), the vessel engaging members 42, 28, 40 puncture and hold the vessel wall, and when the balloon is contracted, the instrument 10 returns to the memory shape of FIG. Pull inward and pull the valve leaflets to the juxtaposed position so that the tips of the valve leaflets "L" can come into contact. This diameter change is also consistent with the cross-sectional views of FIGS. 21A-21C. As will be appreciated, each of instrument 10 and instrument 100 is symmetrical and therefore, for convenience, they are identified by the representations of "proximal" and "distal" parts.

27-29 show other embodiments of the vascular device, all of which are referred to by reference number 300. This shape memory device 300 is illustrated and described in a document incorporated herein by reference (see Patent Document 3 above). Instrument 300 is placed within the blood vessel "V" (eg, popliteal vein) and brings the valve leaflets closer together, as shown in FIG. 27, which does not function properly due to the distant tip L1 of the valve leaflets "L". .. In its first enlarged shape, which matches the memory shape of FIG. 27, hook 314 has not yet punctured the vessel wall. The instrument 300 is formed by the struts 302 disclosed in detail in Patent Document 3 above. Hook 314 secured to struts 302 in region 304 has a tip 306 that is crescent-shaped and has a scrotum 308. In the enlarged shape of FIG. 28, the balloon 322 attached to the shaft 324 of the delivery device enlarges the device 300 so as to puncture and fixedly engage the hook 314 vessel wall V. Then, when the balloon is contracted and the instrument 300 returns to its first enlarged shape, the vessel wall is pulled inward in the radial direction and the valve leaflets are juxtaposed in the same manner as described above in connection with the vascular instrument 10. Moved to position.

30 and 31 show other methods of placement of vascular instruments. In this method, the vascular device 10 (or vascular device 100) is placed downstream of the valvular lobe (downstream in the direction of blood flow). The delivery catheter 200 is inserted in the same antegrade manner as described above with respect to FIG. 16 except that the delivery catheter 200 is advanced enough to pass through the valve leaflet "L" to allow downstream delivery of the instrument 10. .. Once positioned as shown in FIG. 31, the sheath 205 is pulled out in the direction of the arrow, allowing the instrument 10 to expand into its memory shape. The vascular device 10 is then further enlarged by the balloon and then allowed to contract to its memory shape in the same manner as in FIGS. 18-20. One difference is that the instrument 10 grabs the vessel wall downstream of the valve leaflet and pulls the vessel wall inward in the radial direction to move the valve leaflet to the juxtaposition position. It should also be noted that instrument 10 or instrument 100 can be distributed in a retrograde manner as shown in FIGS. 13-15 and the instrument can be positioned downstream of the valve leaflet L.

32 to 34 show other delivery systems and methods for vascular device 10 (or device 100 that can be distributed in the same manner). In this method, the exposure of the vascular device to body temperature and the enlargement of the balloon occur at substantially the same time. A restraint system is provided to connect the vascular device to the balloon for ease of placement. More specifically, the balloon 250'has a pair of sutures 252 attached in the proximal and distal portions, the suture wrapping around the vascular device 10 to hold the balloon and device together. Form a loop of suture to connect. Two sutures are shown, but one or more sutures can be used to connect the balloon 250'to the vascular device 10. Other restraint systems such as perforated strips can also be used. At the position of FIG. 32, the suture (only one suture is shown, the other suture is in the sheath 215') loosely surrounds the instrument. When the sheath 215'is retracted in the direction of the arrow, the balloon is inflated. Thus, when the sheath 215'is fully retracted, the instrument is without the intermediate steps required in the above method (ie, the step of FIG. 24 that allows the instrument to first expand to a memory shape). Expand to the position of. As the balloon expands, the pressure acting on the suture 252 breaks the suture loop, thereby releasing the suture from the vascular device 10. When the balloon 250'is contracted in this way and pulled out of the body with the delivery catheter 210', the suture 252 is also removed. Due to the contraction of the balloon, the vascular device 10 returns to its memory shape, pulls the vascular wall inward in the radial direction in the above-described manner, and takes a position similar to that in FIG.

Note that it is also possible to expose the vascular device 10 to body temperature by first inflating the balloon 250'into the sheath and then pulling out the sheath. The restraint system can also be used in the continuous placement methods of FIGS. 16-20 and 22-26. The restraint system (eg, suture) assists in preventing axial movement and assists in centering the balloon with respect to the vascular device 10. Other restraint systems (eg, straps) can be used to openly connect the vascular device to the balloon. Apart from shape memory, vascular devices can be made of stainless steel or polymers. Such a vascular device can be expanded by the balloon below its elastic limit and thus can return to its smaller shape after the balloon has contracted. The vascular device is also constructed in the form of a braided structure, the end (single or more) of which is expanded by pressing or compressing to engage the vascular wall, and then the vascular device is released to release the vascular device. It can be returned to its elongated, smaller diameter position and closer to the vessel wall.

(Vascular Instrument with Replacement Valve) The above embodiments of FIGS. 1-34 illustrate and show a vascular instrument that moves the vessel wall inward in the radial direction to bring the patient's existing valve lobe closer. is there. In another aspect of the invention, the replacement valve is attached to a vascular device that is inserted into the blood vessel rather than having the valve leaflets in close proximity. Thus, the vascular device is inserted and expanded or contracted as described above, moving the dilated vascular wall inward in the radial direction and leaving a replacement valve attached to the implanted vascular device in the vessel. This replacement valve can be used as a total replacement in which the patient's valve leaflets are removed, or can be placed upstream or downstream of the patient's valve leaflets, leaving the dysfunctional valve leaflets in place. Various embodiments of the valve structure used in combination with the vascular device are detailed and illustrated below in FIGS. 38-48. For simplicity, FIGS. 38-48 schematically show vascular devices, but it will be appreciated that any of the above vascular devices can be used for a variety of valve structures. The valve can be attached to the proximal, distal or intermediate ends of the vascular device.

First, referring to FIGS. 35A-37, the vascular device 400 is substantially the same as the vascular device 100 of FIG. 9A, except that the valve 450 is provided. For this reason, different reference numbers are used for the valves. The valve 450 has a conical shape and is fixed to the vascular device 400 by various techniques such as integral molding or suturing of the vascular device 400 to the frame. A pair of elongated supports 455 extend from the vascular device 400 into the valve 450, which expands to close the valve and move inward to open the valve. The valve 450 is shown to be attached to the distal end and extend downstream of the instrument 400 with respect to blood flow. Although the drawing shows the valve 450 in the open position, the valve 450 contracts to the closed position by expanding the support 455 and operates like a duck bill valve. In one modification, instead of providing the support 455, the valve 450 can be configured to function in the same manner as described in connection with other conical valves (eg, valve 500). Although optional, a reinforcing ring described later may be provided. As shown in FIG. 37A, the valve 450 can have a multi-layer structure in which the outer layer 452 is made of one material and the inner layer is made of another material. The valve materials that can be used will be described later. The vascular engaging member 451 can be arranged substantially vertically as shown in FIG. 36A or at an angle as described above in connection with FIG. 9B (vessel engaging member 451 of FIG. 36B). See ). Also, although the vascular engagement member of FIG. 35A is slightly longer and bent in a different region than the instrument of FIG. 9A, the instrument of FIG. 9A can be provided with valve 450 or other valve structures disclosed herein. Will be understood.

Here, with reference to FIGS. 38-47, the vascular device is shown schematically for ease of understanding and is indicated by the symbol "D" in each drawing, but vascular device 100 is preferably used. You will understand what you can do. First referring to FIGS. 38A and 38B, the valve 500 has a conical shape and has an open proximal end 504 and an open distal end 502. This conical shape causes a backflow of blood that closes the valve. When the valve 500 is in the position shown in FIG. 38A, the distal opening faces the vessel wall and is pressed against the vessel wall, preventing flow through the valve 500. The force of blood during systole of the heart straightens the distal end 502 and occupies the position in Figure 38B, allowing blood to flow through the valve. As shown, the valve 500 is located distal to instrument D, so that valve 500 is located downstream of the device's blood flow. 39A and 39B show modified forms of the valve structure of FIG. 38, which are the same as the valve 500, except that the valve 520 is attached to the proximal end E of the vascular device D. The valve 520 is mounted along the perimeter at points E1, E2 ... and extends upward through the central position of the appliance "D". Reinforcing ring 526 assists in keeping valve 520 in the open position in Figure 39B. FIG. 39A shows the valve 520 in the closed position and FIG. 39B shows the valve in the open position allowing blood to flow through the valve. In both positions, the valve is located within the vascular instrument D.

In the embodiment of FIG. 40, the valve 550 is attached to the distal end of the vascular device D and has a plurality of leaflets or petal bodies 552 around the valve 550. The leaflets fold inward to approach each other in the closed position of Figure 40A, preventing blood flow. Blood pressure during systole of the heart pushes the lobules to the open position shown in Figure 40B. In the embodiments of FIGS. 41A and 41B, the valve 560 has a conical shape similar to that of the valves of FIGS. 38 and 39, but is offset from the longitudinal central axis of the vascular device D. Further, the eccentric valve 560 is different from the valves 500 and 520 in that the proximal side portion is provided with a plurality of slits 562 that allow the outflow of blood and reduce the generation of blood. That is, during diastole of the heart, the slit expands into a large hole as shown in FIG. 41A, and blood flows out through the hole. Reinforcing ring 566 assists in holding the distal end open as described above.

Duckville valve 570 is shown in the embodiments of FIGS. 42-44. The valve 570 is attached to the distal end of vascular device D and is moved by blood flow to the open position shown in FIG. 43 to allow blood to flow. 42 and 44 show the valve closing position. The proximal region of valve 570 is slightly tapered. Like all valves described above, the valve 570 can be attached to the proximal, distal or intermediate part of the vascular device. 45 to 47 show the placement stage of the vascular device of the present invention. FIG. 45 shows, for example, the placement of the vascular device of FIG. 41 within the popliteal vein P and the femoral vein F, although any vascular device with any valve structure has a similar embodiment. It will be understood that it can be placed. Also, although the placement of two vascular instruments is shown, it will be appreciated that only one vascular device D (schematically shown) or three or more vascular devices can be used. In FIG. 46A, the vascular device and valve 560 are introduced through the introduction sheath 600 in the contracted position. The instrument is held within the delivery catheter 604. After the catheter 604 is introduced into the surgical site through the introduction sheath 600, the pusher 606 pushes the instrument towards the end of the catheter 604 and then retracts. The catheter is then retracted to release the instrument, which can be expanded into the memory shape shown in FIG. 46C and held in the blood vessel. Alternatively, a pusher can be used to fully advance the instrument from catheter 604.

If repositioning of the instrument is desired, the gripper 610 in the delivery catheter 604 is inserted through the introduction sheath 600. The prong or finger 612 is advanced from the outer tube 614 of the gripper 610, or the outer tube 614 is moved proximally to expose the prong 612. The outer tube 614 is then slightly advanced to tighten the prong 612, which causes the prong 612 to grab the vascular device d and pull it to a more proximal position, as shown in FIG. 47C. Next, take out the gripper 610. Note that FIGS. 47A-47C show the valve 560 in the open position. In the embodiments of FIGS. 48-49, the valve 700 has the same duckbill valve form as the valves of FIGS. 42-44, except that it is reinforced with metal wires or struts 701. The vascular device is in the form of a coated stent 702, with the metal stent 703 embedded within the implant material 704. The valve may be provided with a blood drain slit 706 as shown.

(Replacement Valve) The present invention also contemplates other uses of various valve structures as replacement valves without the need to use a vascular device that moves the vessel wall inward in the radial direction. The patient's valve can be removed or left in place, and the replacement valve of the invention is located upstream or downstream of the patient's valve. In such applications, the valve is attached to a support structure such as a shape memory stent and is maintained in an open position within the vessel holding the valve. 50 and 51 show an example of a form of support structure that holds the valve. More specifically, in the embodiments of FIGS. 50 and 51, a valve 750 is attached to a rolled cylindrical ring or metal band 752 instead of a metal frame structure. Ring 752 is made of shape memory material and its storage position is the enlarged position in FIGS. 50 and 51. The valve 750 is the same as the valve 500 in FIG. 38A, except that it has a large reinforcing ring 754 and is cylindrical rather than conical.

In the embodiment of FIGS. 52-54, the valve 800 has a plurality of discharge holes 802, which function in a manner similar to the discharge slit 562 of the valve 560 of FIGS. 38 and 39. The overlapping cylindrical support member 806 is shown in the contracted distribution position in FIG. 54B and in the enlarged position in FIG. 54A. The valve 800 is offset longitudinally with respect to the cylindrical member 806. In the embodiment of FIG. 55, the valve 850 is in the form of a duck bill valve and extends from a cylindrical support member 856. The valves 850, 800, 750 can be used with any of the vascular devices described above. Conversely, any of the above valves can be used with cylindrical supports 752, 806. The valve can also be attached to the proximal, distal or intermediate ends of the vascular device. The valve can be attached to vascular instruments, frame structures and cylinders by suturing, integral molding or other techniques. Valves can be made of a variety of materials such as PET, PTFE, polycarbonate, polyurethane, porcine intestinal submucosa, collagen and other biocompatible materials. The surface of the valve and / or vascular device can optionally be coated with an antiplatelet substance, an antithrombin / anticoagulant, a 2b / 2a coating, a receptor, a heparin coating, an endothelial cell coating, or the like.

Although the above description includes many special configurations, these special configurations do not limit the scope of the present invention and should be construed as merely examples of preferred embodiments of the present invention. For example, instead of a balloon that expands the vascular device to its second enlarged diameter / state, mechanical means such as an expandable wireframe can also be used. Alternatively, 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 in opposite directions. Those skilled in the art will be able to consider many other modifications that are contained within the scope and / or spirit defined by the claims of the present application.

<figref num="1">It is a perspective view which shows the place where the 1st Embodiment of the vascular apparatus by this invention is in an enlarged state.</figref><figref num="2">It is a side view which shows the place where the vascular device of FIG. 1 is in an enlarged state.</figref><figref num="3">It is another side view which shows the vascular instrument of FIG. 1 rotated 45 ° with respect to the position of FIG.</figref><figref num="4">It is a front view which shows the place where the vascular device of FIG. 1 is in an enlarged state.</figref><figref num="5">FIG. 5 is a perspective view showing a state in which the vascular device of FIG. 1 is in a contracted state for supplying into a blood vessel.</figref><figref num="6">It is a side view which shows the place where the vascular device of FIG. 1 is in a contracted state.</figref><figref num="7">It is another side view which shows the vascular instrument of FIG. 1 rotated 45 ° with respect to the position of FIG.</figref><figref num="8">It is a perspective view which shows the place where the other embodiment of the vascular apparatus according to this invention is in an enlarged state.</figref><figref num="9A">It is a side view which shows the place where the vascular device of FIG. 8 is in an enlarged state.</figref><figref num="9B">FIG. 9A is a side view similar to FIG. 9A, except that it shows another embodiment in which the vessel engaging member extends into the vessel wall at an angle.</figref><figref num="10">FIG. 5 is a perspective view showing a state in which the vascular device of FIG. 8 is in a contracted state for distribution into a blood vessel.</figref><figref num="11">It is a side view which shows the place where the vascular device of FIG. 8 is in a contracted state.</figref><figref num="12">It is a figure which shows the delivery catheter which is inserted directly into a popliteal vein in the forward direction by one insertion method of the vascular device of FIG.</figref><figref num="13">It is a figure which shows the other insertion method of the vascular device of FIG. 1 which performs the retrograde insertion into the popliteal vein through the jugular vein.</figref><figref num="14">FIG. 5 shows a delivery catheter inserted through the right femoral vein for retrograde access to the popliteal vein by another insertion method of the vascular device of FIG.</figref><figref num="15">Yet another method of inserting the vascular device in Figure 1 is a contralateral approach in which a delivery catheter is inserted through the right femoral vein to advance around the iliac vein for retrograde insertion into the right popliteal vein ( It is a drawing which shows contralateral approach).</figref><figref num="16">It is a side view of the delivery catheter of the vascular device of FIG. 1, which shows the blood vessel wall in cross section and shows the retrograde insertion of the delivery catheter into the popliteal vein.</figref><figref num="17">It is a side view similar to FIG. 16, and shows a place where the sheath is first pulled out in the direction of the arrow in order to expose a part of the vascular device of FIG.</figref><figref num="18">A side view similar to FIG. 16 showing the vasculature of FIG. 1 magnified within the vessel upstream of the valvular lobe (upstream with respect to blood flow) after the sheath is fully retracted. ..</figref><figref num="19">It is a side view similar to FIG. 16, and shows the vascular device of FIG. 1 in which the vascular engaging device is enlarged by a balloon to puncture the vascular wall and hold the vascular wall.</figref><figref num="20">A side view similar to FIG. 16 after the balloon is contracted and the catheter is withdrawn from the vessel, the vascular device is returned to its original position, the vessel wall is pulled together and the valvular lobe is moved to the juxtaposed position. It shows the place where it is being made.</figref><figref num="21A">It is a cross-sectional view showing the interaction with the blood vessel wall during distribution and placement of the blood vessel device of FIG. 1, and shows the initial position of the blood vessel device of FIG. 18 in a state where the blood vessel engaging device has not yet punctured the blood vessel wall. (Balloons are omitted for clarity).</figref><figref num="21B">FIG. 1 is a cross-sectional view showing the interaction with the vascular wall during distribution and placement of the vascular device of FIG. 1, in which the balloon is inflated to radially expand the vascular device to the second enlarged position and the vascular engaging device. It shows the position of the vascular device in FIG. 19 in a state of being punctured into the blood vessel wall.</figref><figref num="21C">FIG. 1 is a cross-sectional view showing the interaction with the vascular wall during distribution and placement of the vascular device of FIG. 1, in which the balloon is contracted and the vascular device is returned to the first enlarged position to move the vascular wall inward in the radial direction. It shows the position of the vascular device in FIG. 20 in the state of being squeezed.</figref><figref num="22">It is a side view of the delivery catheter of the vascular device of FIG. 1, which shows the blood vessel wall in cross section and shows the retrograde insertion of the delivery catheter into the popliteal vein.</figref><figref num="23">It is a side view similar to FIG. 22, showing that the sheath is first pulled out in the direction of the arrow in order to expose a part of the vascular device of FIG.</figref><figref num="24">It is a side view similar to FIG. 22, showing the vascular device of FIG. 1 enlarged in the blood vessel on the upstream side of the valve lobe after the sheath is completely pulled out.</figref><figref num="25">It is a side view similar to FIG. 22, and shows the vascular device of FIG. 1 in which the vascular engaging device is enlarged by a balloon to puncture the vascular wall and hold the vascular wall.</figref><figref num="26">A side view similar to FIG. 22 after the balloon is contracted and the catheter is withdrawn from the vessel, the vascular device is returned to its original position, the vessel wall is pulled together and the valve lobe is moved to the juxtaposed position. It shows the place where it is being made.</figref><figref num="27">FIG. 5 is a side view showing another embodiment of a vascular device in an enlarged position within a vessel (the vessel wall is shown in cross section).</figref><figref num="28">It is a side view similar to FIG. 27, and shows a place where the vascular device is enlarged by a balloon so that the hook punctures the blood vessel wall.</figref><figref num="29">It is an enlarged view which shows the hook of the vascular device of FIG. 27 embedded in the blood vessel wall.</figref><figref num="30">FIG. 1 is a side view of the delivery catheter of the vascular device of FIG. 1, another embodiment in which the vascular wall is shown in cross section and the delivery catheter is retrogradely inserted into the popliteal vein to position the vascular device downstream of the valvular lobe. It shows.</figref><figref num="31">It is the same side view as FIG. 30, and shows the place where the sheath is first pulled out in the direction of the arrow in order to expose a part of the vascular device of FIG.</figref><figref num="32">A side view similar to FIG. 23 showing another embodiment of the delivery system of the invention with a restraint, the vascular device enlarged in the blood vessel upstream of the valvular lobe after the sheath has been withdrawn. It shows.</figref><figref num="33">It is a side view similar to FIG. 32, and the blood vessel of FIG. 1 in which the blood vessel engaging member is enlarged by the balloon to puncture the blood vessel wall, hold the blood vessel wall, and the restraint is cut by the expansion of the balloon. It indicates an instrument.</figref><figref num="34">It is a cross-sectional view of the vascular device of FIG. 1 and shows that the restraint of FIG. 32 is expanded to the memory position substantially at the same time as the expansion of the balloon.</figref><figref num="35A">It is a perspective view of the vascular device of the present invention to which the replacement valve of the first embodiment is attached, and shows the place where the vascular device is in the enlarged position and the valve is in the open position.</figref><figref num="35B">It is a side view which shows the place where the vascular device of FIG. 35A is in a contraction position.</figref><figref num="36A">It is a side view which shows the place where the vascular device of FIG. 35A is in the enlarged position.</figref><figref num="36B">FIG. 6 is a side view showing a vascular device similar to FIG. 36A, except that it shows another embodiment of a vascular device with a tilted vascular engagement member.</figref><figref num="37A">It is a cross-sectional view which shows the vascular instrument of FIG. 36A.</figref><figref num="37B">It is sectional drawing which shows the vascular instrument of FIG.</figref><figref num="38A">It is a perspective view which shows the place where the replacement valve by the 2nd Embodiment of this invention is in a closed position which prevents blood flow, and the vascular apparatus is shown schematicly.</figref><figref num="38B">FIG. 38 is a perspective view showing the valve of FIG. 38A in the open position to allow blood flow.</figref><figref num="39A">It is a perspective view which shows the place where the replacement valve by the 3rd Embodiment of this invention is in a closed position which prevents blood flow, and the vascular apparatus is shown schematicly.</figref><figref num="39B">FIG. 39A is a perspective view showing the valve in FIG. 39A in the open position to allow blood flow.</figref><figref num="40A">It is a perspective view which shows the place where the replacement valve by the 4th Embodiment of this invention is in a closed position which prevents blood flow, and the vascular apparatus is shown schematicly.</figref><figref num="40B">FIG. 40A is a perspective view showing the valve in FIG. 40A in the open position to allow blood flow.</figref><figref num="41A">It is a perspective view which shows the place where the replacement valve by the 5th Embodiment of this invention which a drainage slit is formed is in a closed position which prevents blood flow, and the vascular apparatus is shown schematicly.</figref><figref num="41B">FIG. 41 is a perspective view showing the valve of FIG. 41A in the open position to allow blood flow.</figref><figref num="42">FIG. 5 is a perspective view showing a replacement valve according to a sixth embodiment of the present invention in the form of a duck bill valve in a closed position to prevent blood flow, and a vascular device is schematically shown.</figref><figref num="43">FIG. 4 is a perspective view showing the valve of FIG. 42 in an open position that allows blood flow.</figref><figref num="44">It is a top view which shows the valve of FIG. 42.</figref><figref num="45">FIG. 5 is a schematic showing two vascular devices with offset valves of FIG. 41 inserted into the patient's popliteal and femoral veins.</figref><figref num="46A">In one of the continuous insertion steps of a vascular device, a Figure 41 offset valve inserted into the popliteal vein is schematically shown, showing the delivery catheter and valve advancing through the introduction sheath. ..</figref><figref num="46B">Figure 41 Offset valve inserted into the popliteal vein is outlined in one of the continuous insertion steps of the vascular device, showing the pusher being pulled out of the delivery catheter to release the vascular device. It is a thing.</figref><figref num="46C">In one of the continuous insertion stages of the vascular device, a Figure 41 offset valve inserted into the popliteal vein is outlined, where the delivery catheter is pulled out to enlarge and place the vascular device. It shows.</figref><figref num="47A">It is a drawing showing a gripper and an outer tube inserted through an introduction sheath to access a vascular device in one of the continuous steps of inserting a gripper for reducing a vascular device.</figref><figref num="47B">It is one of the continuous steps of inserting a gripper for reducing a vascular device, and is a drawing showing a prong being advanced from an outer tube toward a vascular device.</figref><figref num="47C">It is a drawing which shows that the vascular device is grasped and moved to a different position on the proximal side by a prong in one of the continuous steps of inserting a gripper for reducing the vascular device.</figref><figref num="48A">It is sectional drawing of the 7th Embodiment of the replacement valve of this invention provided with a reinforcing body, and shows the place where the coated stent is arranged.</figref><figref num="48B">It is a perspective view of the replacement valve of FIG. 48A in which a part of the coated stent is broken, and shows the place where the replacement valve is in the closed position.</figref><figref num="48C">The drawing is similar to FIG. 48A, except that the replacement valve is in the open position.</figref><figref num="49A">It is a top view which shows the vascular instrument and the replacement valve of FIG.</figref><figref num="49B">It is sectional drawing which follows the BB of FIG. 49A.</figref><figref num="50">It is a perspective view of the 1st Embodiment of the vascular apparatus which forms the form of the expandable cylinder to which the replacement valve of 8th Embodiment is attached, and shows the place where the replacement valve is in a closed position.</figref><figref num="51">FIG. 5 is a perspective view showing the replacement valve of FIG. 50 in an open position that allows blood flow.</figref><figref num="52">It is a perspective view of the vascular device to which the replacement valve of the ninth embodiment is attached, and shows the place where the replacement valve is in the open position.</figref><figref num="53">It is a top view which shows the vascular instrument and the replacement valve of FIG.</figref><figref num="54A">It is a bottom view which shows the place where the vascular device of FIG. 52 is in an enlarged position.</figref><figref num="54B">FIG. 5 is a bottom view showing a position where the vascular device of FIG. 52 is in the retracted position.</figref><figref num="55">FIG. 5 is a cross-sectional view showing a tenth embodiment of a replacement valve in the form of an expandable cylinder provided with a duck bill valve.</figref>

Code description

10 Vascular Instrument 23 Cell 24 Longitudinal Strip (Central Strut) 28 Vascular Engagement Member 36 Rib 40 Vascular Engagement Member 42 Vascular Engagement Member 450 Valve 526 Reinforcement Ring 570 Duckville Valve 600 Introductory Sheath 604 Delivery Catheter 606 Pusher