Implantable vascular device Number:7,520,894 from the United States Patent and Trademark Office (PTO) owispatent

Title: Implantable vascular device

Abstract: A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame using heat or pressure welding crimping, adhesive, or other techniques to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

Patent Number: 7,520,894 Issued on 04/21/2009 to Pavcnik,   et al.

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Inventors:	Pavcnik; Dusan (Portland, OR), Keller; Frederick S. (Portland, OR), Rosch; Josef (Portland, OR), Osborne; Thomas A. (Bloomington, IN), Bates; Brian L. (Bloomington, IN), Dixon; Christopher G. (Bloomington, IN), Hoffa; Andrew K. (Bloomington, IN), Leonard, II; Raymond B. (Bloomington, IN), Obermiller; Joseph F. (Bloomington, IN), DeFord; John A. (Cleveland, OH), Roberts; Joseph W. (St. Paul, MN)
Assignee:	Cook Incorporated (Bloomington, IN) Cook Biotech Incorporated (West Lafayette, IN) Oregon Health & Science University (Portland, OR)
Appl. No.:	11/165,600
Filed:	June 22, 2005

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Related U.S. Patent Documents

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	Application Number	Filing Date	Patent Number	Issue Date
	09777091	Feb., 2001	7452371
	60180002	Feb., 2000

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Current U.S. Class:	623/1.26 ; 623/2.12
Current International Class:	A61F 2/24 (20060101); A61F 2/06 (20060101)
Field of Search:	623/1.24,1.26,2.12-2.19,900

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References Cited [Referenced By]

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Primary Examiner: Willse; David H
Assistant Examiner: Blanco; Javier G
Attorney, Agent or Firm: Woodard, Emhardt, Moriarty, McNett & Henry LLP

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Parent Case Text

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CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of regular U.S. utility application Ser. No. 09/777,091 filed Feb. 5, 2001 now U.S. Pat. No. 7,452,371, which claims priority to provisional application Ser. No. 60/180,002, filed Feb. 3, 2000 and regular U.S. utility application Ser. No. 09/324,382, filed Jun. 2, 1999, issued as U.S. Pat. No. 6,200,336, each of which is hereby incorporated by reference in its entirety.

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Claims

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What is claimed is:

1. A medical product, comprising: a stentless valve having a plurality of membranes deliverable by catheter through a body lumen, the plurality of membranes implantable in the body lumen in the absence of a stent and thereupon movable between a first position and a second position, wherein the membranes are movable in response to fluid flow through the lumen, wherein the stentless valve is compressible and percutaneously deliverable, and wherein the stentless valve is formed as a single piece.

2. The medical product of claim 1, also comprising an expandable delivery device upon which said membranes are mounted, said expandable delivery device configured to expand to force the membranes into the wall of the body lumen for delivery of the stentless valve.

3. The medical product of claim 1, wherein said membranes are configured to flex in response to fluid flow in the body lumen.

4. The medical product of claim 1, wherein said membranes are configured to invert their shape in response to fluid flow in the body lumen.

5. The medical product of claim 2, also including one or more barbs attached to the stentless valve and configured to embed in the body lumen upon expansion of the expandable delivery device, and further wherein the expandable delivery device is a balloon.

6. The medical product of claim 1, wherein the membranes are formed of a polymer.

7. The medical product of claim 6, wherein the polymer is polytetrafluoroethylene.

8. The medical product of claim 6, wherein the membranes are formed of Dacron.

9. The medical product of claim 1, comprising two membranes.

10. The medical product of claim 1, wherein the membranes are generally triangular in shape.

11. A method comprising: providing a stentless valve in a body lumen, the stentless valve having a plurality of membranes delivered by catheter through the body lumen, the plurality of membranes implanted in the body lumen in the absence of a stent and thereupon movable between a first position and a second position, wherein the membranes are movable in response to fluid flow through the lumen, wherein the stentless valve is compressible and percutaneously deliverable, and wherein the stentless valve is formed as a single piece.

12. The method of claim 11, wherein one or more barbs are attached to the stentless valve and extend into a wall of the body lumen.

13. The method of claim 11, wherein the membranes are flexible.

14. The method of claim 11, wherein the membranes are configured to invert their shape in response to fluid flow in the body lumen.

15. A method of controlling flow in a body lumen, the method comprising: moving a plurality of membranes of a stentless valve between a first position and a second position in response to the direction of fluid flow through the lumen, the plurality of membranes delivered by catheter through the body lumen and implanted in the lumen in the absence of a stent, wherein said plurality of membranes in said first position restricts fluid flow through the lumen in a first direction, and wherein said plurality of membranes in said second position permits fluid flow through the lumen in the first direction, wherein the stentless valve is compressible and percutaneously deliverable, and wherein the stentless valve is formed as a single piece.

16. The method of claim 15, also comprising expanding an expandable delivery member upon which said plurality of membranes are mounted so as to force said plurality of membranes against a wall of the body lumen for delivery of the stentless valve.

17. The method of claim 15, wherein said moving comprises inverting the shape of the plurality of membranes.

18. The method of claim 15, wherein the plurality of membranes in said second position and a portion of the body lumen form a cup for trapping the fluid.

19. The method of claim 15, wherein the stentless valve includes one or more attached barbs configured to embed in the body lumen upon expansion of the expandable delivery member.

20. The method of claim 17, wherein said inversion in shape is relative to the radial axis of the body lumen.

21. The method of claim 15, wherein said moving is in response to fluid flow in the body lumen.

22. A medical product, comprising: a stentless valve having a plurality of leaflets free from any separate support frame and deliverable by catheter through a body lumen, the plurality of leaflets implantable in a body lumen and movable between a first position and a second position, wherein the leaflets are movable in response to fluid flow through the lumen, wherein the stentless valve is compressible and percutaneously deliverable, and wherein the stentless valve is formed as a single piece.

23. The medical product of claim 22, wherein said leaflets are configured to flex in response to fluid flow in the body lumen.

24. The medical product of claim 22, wherein said leaflets are configured to invert their shape in response to fluid flow in the body lumen.

25. The medical product of claim 22, also including one or more barbs attached to the stentless valve and configured to embed in the body lumen.

26. The medical product of claim 22, wherein the leaflets are formed of a polymer.

27. The medical product of claim 26, wherein the polymer is polytetrafluoroethylene.

28. The medical product of claim 26, wherein the leaflets are formed of Dacron.

29. The medical product of claim 22, comprising two leaflets.

30. The medical product of claim 22, wherein the leaflets are generally triangular in shape.

31. A method comprising: providing a stentless valve to be implanted in a body lumen, the valve having a plurality of leaflets free from any separate support frame and deliverable by catheter through the body lumen, the plurality of leaflets compressible and percutaneously implantable in the body lumen and movable between a first position and a second position, wherein the leaflets are movable in response to fluid flow through the lumen, and wherein the stentless valve is formed as a single piece.

32. The method of claim 31, wherein the valve includes one or more barbs extending into a wall of the body lumen.

33. The method of claim 31, wherein the leaflets are flexible.

34. The method of claim 31, wherein the leaflets are configured to invert their shape in response to fluid flow in the body lumen.

35. A method of controlling flow in a body lumen, the method comprising: moving a plurality of membranes of a stentless valve between a first position and a second position in response to the direction of fluid flow through the lumen, wherein the valve is delivered by catheter through the body lumen and implanted in the body lumen free from any separate support frame, wherein said plurality of membranes in said first position restricts fluid flow through the lumen in a first direction, and wherein said plurality of membranes in said second position permits fluid flow through the lumen in the first direction, wherein the stentless valve is compressible and percutaneously deliverable, and wherein the stentless valve is formed as a single piece.

36. The method of claim 35, wherein said moving comprises inverting the shape of the plurality of membranes.

37. The method of claim 35, wherein the plurality of membranes in said second position and a portion of the body lumen form a cup for trapping the fluid.

38. The method of claim 35, wherein one or more barbs are attached to the stentless valve and extend into a wall of the body lumen.

39. The method of claim 36, wherein said inversion in shape is relative to the radial axis of the body lumen.

40. The method of claim 35, wherein said moving is in response to fluid flow in the body lumen.

41. A method for treating a patient comprising: providing a stentless valve anchored in a body lumen of the patient in the absence of a separate support frame, the valve comprising one or more leaflets and lacking radial expandability sufficient to anchor itself to the wall of the body lumen, wherein the valve is delivered by catheter to the body lumen, wherein the stentless valve is compressible and percutaneously deliverable, and wherein the stentless valve is formed as a single piece.

42. The method of claim 41, wherein the valve is anchored in the body lumen by barbs attached to the valve and extending into the vessel wall.

43. The method of claim 41, wherein the valve comprises a frame integral with said leaflets.

44. The method of claim 41, wherein said leaflets include edge portions incorporating one or more materials or agents that increase the stiffness or resiliency of the edge portions.

45. The method of claim 41, wherein said valve comprises a plurality of leaflets.

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Description

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TECHNICAL FIELD

This invention relates to medical devices, more particularly, to intraluminal devices.

BACKGROUND OF THE INVENTION

As minimally invasive techniques and instruments for placement of intraluminal devices have developed over recent years, the number and types of treatment devices have proliferated as well. Stents, stent grafts, occlusion devices, artificial valves, shunts, etc., have provided successful treatment for a number of conditions that heretofore required surgery or lacked an adequate solution altogether. Minimally invasive intravascular devices especially have become popular with the introduction of coronary stents to the U.S. market in the early 1990s. Coronary and peripheral stents have been proven to provide a superior means of maintaining vessel patency. In addition, they have subsequently been used as filter, occluders, or in conjunction with grafts as a repair for abdominal aortic aneurysm, with fibers or other materials as occlusion devices, and as an intraluminal support for artificial valves, among other uses.

Some of the chief goals in designing stents and related devices include providing sufficient radial strength to supply sufficient force to the vessel and prevent device migration. An additional concern in peripheral use, is having a stent that is resistant to external compression. Self-expanding stents are superior in this regard to balloon expandable stents which are more popular for coronary use. The challenge is designing a device that can be delivered intraluminally to the target, while still being capable of adequate expansion. Self-expanding stents usually require larger struts than balloon expandable stents, thus increasing their profile. When used with fabric or other coverings that require being folded for placement into a delivery catheter, the problem is compounded.

There exists a need to have a basic stent, including a fabric or biomaterial covering, that is capable of being delivered with a low profile, while still having a sufficient expansion ratio to permit implantation in larger vessels, if desired, while being stable, self-centering, and capable of conforming to the shape of the vessel. There is a further need to have a intraluminal valve that can be deployed in vessels to replace or augment incompetent native valves, such as in the lower extremity venous system to treat patients with venous valve insufficiency. Such a valve should closely simulate the normal functioning valve and be capable of permanent implantation with excellent biocompatibility.

SUMMARY OF THE INVENTION

The foregoing problems are solved and a technical advance is achieved in an illustrative implantable valve that is deployed within a bodily passage, such as a blood vessel or the heart, to regulate or augment the normal flow of blood or other bodily fluids. The valve includes a covering having oppositely facing curvilinear-shaped surfaces (upper and lower) against which fluid traveling in a first or second direction within the bodily passage exerts force to at least partially open or close the valve. At least one outer edge of the covering resiliently engages and exerts force against the wall of the vessel and has arcuate shape that provides at least a partial seal against the wall.

In one aspect of the invention, the covering comprises a plurality of leaflets, each leaflet having a body extending from a wall-engaging outer edge to a free edge which is cooperable with one or more opposing leaflets to prevent flow in one direction, such as retrograde flow, while at least a portion of the leaflets having sufficient flexibility, when in situ to move apart, thereby creating a valve orifice that permits flow in the opposite direction, such as normal blood flow. The outer edge of each leaflet is adapted to engage and resilient exert force against a wall of the bodily passage such that it extends in both a longitudinal and circumferential directions along the vessel wall to at least partially seal a portion of the vessel lumen, while the free edge of each leaflet traverses the passageway across the diameter of the vessel.

In another aspect of the invention, the valve includes a frame that is covered by a piece of biocompatible material, preferably an Extracellular Collagen Matrix (ECM) such as small intestinal submucosa (SIS) or another type of submucosal-derived tissue. Other potential biomaterials include allographs such as harvested native valve tissue. The material is slit or otherwise provided with an opening along one axis to form two triangular valve leaflets over a four-sided frame. In the deployed configuration, the leaflets are forced open by normal blood flow and subsequently close together in the presence of backflow to help eliminate reflux. Other configurations include a two-leaflet valve having an oval or elliptically shaped frame, and valves having three or more legs and associated leaflets, which provide a better distribution of the load exerted by the column of fluid acting on the leaflets.

In still another aspect of the invention, the frame of the device is modified by placing one or more of the bends under tension which results in the frame assuming a second shape that has superior characteristics of placement within the vessel. One method of adjusting the shape includes forming the bends in the wire at an initial angle, e.g., 150.degree., that is larger than the desired final angle, e.g., 90.degree. for a four-sided valve, so when the frame is constrained into the final configuration, the sides are arcuate and bow outward slightly. The curvature of the sides allows the sides to better conform to the rounded countours of the vessel wall when the valve is deployed. In devices having a full or partial covering of material over the frame, a second method of modifying the shape is to use the material to constrain the frame in one axis. One such embodiment includes a four-sided valve with two triangular-shaped halves of material, such as SIS, where the material constrains the frame in a diamond shape. This puts the bend of the frame under stress or tension which permits better positioning within the vessel. It also allows the diagonal axis of the frame with the slit or orifice to be adjusted to the optimal length to properly size the frame for the vessel such that the leaflets open to allow sufficient flow, but do not open to such a degree that they contact the vessel wall. The potential benefits of both adding tension to the bends to bow the sides and constraining the frame into a diamond shape using the covering, can be combined in a single embodiment or employed separately.

In still another aspect of the present invention, the device includes a frame that in one embodiment, is formed from a single piece of wire or other material having a plurality of sides and bends each interconnecting adjacent sides. The bends can be coils, fillets, or other configurations to reduce stress and improve fatigue properties. The single piece of wire is preferably joined by an attachment mechanism, such as a piece of cannula and solder, to form a closed circumference frame. The device has a first configuration wherein the sides and bends generally lie within a single, flat plane. In an embodiment having four equal sides, the frame is folded into a second configuration where opposite bends are brought in closer proximity to one another toward one end of the device, while the other opposite ends are folded in closer proximity together toward the opposite end of the device. In the second configuration, the device becomes a self-expanding stent. In a third configuration, the device is compressed into a delivery device, such as a catheter, such that the sides are generally beside one another. While the preferred embodiment is four-sided, other polygonal shapes can be used as well. The frame can either be formed into a generally flat configuration, or into the serpentine configuration for deployment. Besides rounded wire, the frame can comprise wires of other cross-sectional shapes (e.g., oval, delta, D-shape), or flat wire. Additionally, the frame can be molded from a polymer or composite material, or formed from a bioabsorbable material such as polyglycolic acid and materials with similar properties. Another method is to laser cut the frame out of a metal tube, such as stainless steel or nitinol. Still yet another method is to spot weld together, or otherwise attach, a series of separate struts that become the sides of a closed frame. In further alternative embodiments, the frame can be left with one or more open gaps that are bridged by the material stretched over the remainder of the frame. The frame can also be formed integrally with the covering, typically as a thickened or strengthened edge portion that gives the device sufficient rigidity to allow it to assume the deployed configuration in the vessel. To prevent the frame from radially expanding within the vessel beyond the point which would be considered safe or desirable, the device can be formed into the serpentine configuration and a circumferentially constraining mechanism, such as a tether, strut, sleeve, etc., placed around the device, or built into the frame, to expand or unfold during deployment of the device to limit its expansion to a given diameter, such as that which is slightly larger than the vessel into which it is placed to allow anchoring, but not permit the device to exert to great a force on the vessel wall.

In another aspect of the present invention, one or more barbs can be attached to the frame for anchoring the device in the lumen of a vessel. The barbs can be extensions of the single piece of wire or other material comprising the frame, or they can represent a second piece of material that is separately attached to the frame by a separate attachment mechanism. An elongated barb can be used to connect additional devices with the second and subsequent frames attached to the barb in a similar manner. Additional barbs can be secured to the device from cannulae placed over the frame. In embodiments in which the frame is formed as a single piece, such as when cut from a sheet of material or injection molded, the barbs can be formed as integral extensions of the frame.

In still another aspect of the present invention, a covering, which can be a flexible synthetic material such as DACRON, or expanded polytetrafluorethylene (ePTFE), or a natural or collagen-based material, such as an allographic tissue (such as valvular material) or a xenographic implant (such as SIS), can be attached to the device with sutures or other means to partially, completely, or selectively restrict fluid flow. When the covering extends over the entire aperture of the frame, the frame formed into the second configuration functions as an vascular occlusion device that once deployed, is capable of almost immediately occluding an artery. An artificial valve, such as that used in the lower legs and feet to correct incompetent veins, can be made by covering half of the frame aperture with a triangular piece of material. The artificial valve traps retrograde blood flow and seals the lumen, while normal blood flow is permitted to travel through the device. In related embodiments, the device can be used to form a stent graft for repairing damaged or diseased vessels. In a first stent graft embodiment, a pair of covered frames or stent adaptors are used to secure a tubular graft prosthesis at either end and seal the vessel. Each stent adaptor has an opening through which the graft prosthesis is placed and an elongated barb is attached to both frames. In another stent graft embodiment, one or more frames in the second configuration are used inside a sleeve to secure the device to a vessel wall.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 depicts a top view of one exemplary embodiment of the present invention;

FIG. 2 depicts a pictorial view of the embodiment of FIG. 1;

FIG. 3 depicts a top view and enlarged, partial cross-sectional views of a second exemplary embodiment of the present invention;

FIG. 4 depicts a side view of the embodiment of FIG. 3 deployed in a vessel;

FIG. 5 depicts a enlarged partial view of the embodiment of FIG. 1;

FIG. 6 depicts a partially-sectioned side view of the embodiment of FIG. 1 inside a delivery system;

FIG. 7 depicts a top view of a third embodiment of the present invention;

FIG. 8 depicts a side view of the embodiment of FIG. 7 deployed in a vessel;

FIGS. 9-11 depict enlarged partial views of other embodiments of the present invention;

FIG. 12 depicts a top view of a fourth embodiment of the present invention;

FIGS. 13-14 depicts side views of the embodiment of FIG. 12;

FIG. 15 depicts a top view of a fifth embodiment of the present invention;

FIG. 16 depicts a side view of the embodiment of FIG. 15;

FIG. 17 depicts a side view of a sixth embodiment of the present invention;

FIG. 18 depicts an enlarged pictorial view of a seventh embodiment of the present invention;

FIG. 19 depicts a top view of an eighth embodiment of the present invention;

FIG. 20 depicts a top view of a first embodiment of a multi-leaflet intraluminal valve of the present invention;

FIG. 21 depicts a top view of a second embodiment of a multi-leaflet intraluminal valve;

FIG. 21A depicts a partial top view of another embodiment of leaflets of the present invention;

FIG. 21B depicts a top view of another embodiment of leaflet of the present invention;

FIGS. 22-23 depict side views of the embodiment of FIG. 21 when deployed in a vessel;

FIGS. 24-25 depict pictorial views of the embodiments of FIG. 21 when deployed in a vessel;

FIG. 26-26A depict the method of attaching the covering to the embodiment of FIG. 21;

FIG. 27 depicts a pictorial view of the basic valve of FIG. 21 upon deployment with an alternative leaflet embodiment;

FIGS. 28-31 depict top views of selected embodiments of the present invention, made using the method shown in FIG. 28;

FIG. 32 depicts a pictorial view of an embodiment of a stent graft that includes stent adaptors of the present invention;

FIG. 33 depicts a delivery system for deploying an embodiment of the present invention; and

FIG. 34 depicts a pictorial view of the present invention having returned to the first configuration following formation into the second configuration;

FIGS. 35-36 depict top views of a three-leg valve embodiment of the present invention, before and after being constrained;

FIG. 37 depicts a pictorial view of the embodiment of FIG. 35 in the deployed configuration;

FIGS. 38-39 depict top views of four-leg valve embodiments of the present invention, before and after being constrained;

FIG. 40 depicts a pictorial view of the embodiment of FIG. 38 in the deployed configuration;

FIG. 41 depicts a top view of a frame formed from a sheet of material;

FIG. 41A depicts a detail view of the embodiment of FIG. 41;

FIG. 42 depicts a top view of a third embodiment of an intraluminal valve;

FIG. 43 depicts a pictorial view a frame embodiment formed into a deployed configuration;

FIG. 44 depicts a top view of an embodiment of implantable valve having an integrally formed frame and covering;

FIG. 45 depicts a cross-sectional view taken along line 45-45 of FIG. 44;

FIG. 46 depicts a cross-sectional view of a second embodiment of valve having an integrally formed frame and covering;

FIG. 47 depicts a top view of an intraluminal valve embodiment having an open frame;

FIGS. 48-49 depict a pictorial views of an intraluminal valve embodiments that includes a circumferentially constraining mechanism; and

FIG. 50 depicts a top view of the embodiment of FIG. 22.

DETAILED DESCRIPTION

The invention is further illustrated by the following (preceding) pictorial embodiments, which in no way should be construed as further limiting. The present invention specifically contemplates other embodiments not illustrated but intended to be included in the appended claims. FIGS. 1-11, 18-19 are directed to a basic stent frame; FIGS. 12-14 are directed to a single-leaflet valve; FIGS. 15-16 are directed to an occluder (or filter); FIGS. 17 and 32 are directed to a stent adaptor for a stent graft, FIG. 20-27, 35-40, 42-50 are directed to a multi-leaf valve; and FIG. 28-31 are directed to a constrained frame which can be used to form any of the other embodiments.

FIG. 1 depicts a top view of one embodiment of the medical device 10 of the present invention comprising a frame 11 of resilient material, preferably metal wire made of stainless steel or a superelastic alloy (e.g., nitinol). While round wire is depicted in each of the embodiments shown herein, other types, e.g., flat, square, triangular, D-shaped, delta-shaped, etc. may be used to form the frame. In the illustrative embodiment, the frame comprises a closed circumference 62 of a single piece 59 of material that is formed into a device 10 having a plurality of sides 13 interconnected by a series of bends 12. The depicted embodiment includes four sides 13 of approximately equal length. Alternative embodiments include forming a frame into any polygonal shape, for example a pentagon, hexagon, octagon, etc. One alternative embodiment is shown in FIG. 19 that includes a four-sided frame 11 having the general shape of a kite with two adjacent longer sides 66 and two adjacent shorter sides 67. In the embodiment of FIG. 1, the bends 12 interconnecting the sides 13 comprise a coil 14 of approximately one and a quarter turns. The coil bend produces superior bending fatigue characteristics than that of a simple bend 40, as shown in FIG. 9, when the frame is formed from stainless steel and most other standard materials. The embodiment of FIG. 9 may be more appropriate, however, if the frame is formed from nitinol (NiTi) or other superelastic alloys, as forming certain type of bends, such as coil 14, may actually decrease fatigue life of a device of superelastic materials. Therefore, the bend 12 should be of a structure that minimizes bending fatigue. Alternative bend 12 embodiments include an outward-projecting fillet 41 as shown in FIG. 10, and an inward-projecting fillet 42 comprising a series of curves 63, as shown in FIG. 11. Fillets are well known in the stent art as a means to reduce stresses in bends. By having the fillet extend inward as depicted in FIG. 11, there is less potential trauma to the vessel wall.

When using stainless steel wire, the size of the wire which should be selected depends on the size of device and the application. An occlusion device, for example, preferably uses 0.010'' wire for a 10 mm square frame, while 0.014'' and 0.016'' wire would be used for 20 mm and 30 mm frames, respectively. Wire that is too stiff can damage the vessel, not conform well to the vessel wall, and increase the profile of the device when loaded in the delivery system prior to deployment.

Returning to FIG. 1, the single piece 59 of material comprising the frame 11 is formed into the closed circumference 62 by securing the first and second ends 60,61 with an attachment mechanism 15 such as a piece of metal cannula. The ends 60,61 of the single piece 59 are then inserted into the cannula 15 and secured with solder 25, a weld, adhesive, or crimping to form the closed frame 11. The ends 60,61 of the single piece 59 can be joined directly without addition of a cannula 15, such as by soldering, welding, or other methods to join ends 61 and 62. Besides joining the wire, the frame could be fabricated as a single piece of material 59, by stamping or cutting the frame 11 from another sheet (e.g., with a laser), fabricating from a mold, or some similar method of producing a unitary frame.

The device 10 depicted in FIG. 1 is shown in its first configuration 35 whereby all four bends 20,21,22,23 and each of the sides 13 generally lie within a single flat plane. To resiliently reshape the device 10 into a second configuration 36, shown in FIG. 2, the frame 11 of FIG. 1 is folded twice, first along one diagonal axis 94 with opposite bends 20 and 21 being brought into closer proximity, followed by opposite bends 22 and 23 being folded together and brought into closer proximity in the opposite direction. The second configuration 36, depicted in FIG. 2, has two opposite bends 20,21 oriented at the first end 68 of the device 10, while the other opposite bends 22,23 are oriented at the second end 69 of the device 10 and rotated approximately 90.degree. with respect to bends 20 and 21 when viewed in cross-section. The medical device in the second configuration 36 can be used as a stent 44 to maintain an open lumen 34 in a vessel 33, such as a vein, artery, or duct. The bending stresses introduced to the frame 11 by the first and second folds required to form the device 10 into the second configuration 36, apply force radially outward against the vessel wall 70 to hold the device 10 in place and prevent vessel closure. Absent any significant plastic deformation occurring during folding and deployment, the device in the second configuration 36 when not with the vessel or other constraining means, will at least partially return to the first configuration 25, although some deformation can occur as depicted in FIG. 34, depending on the material used. It is possible to plastically form the stent into this configuration which represents an intermediate condition between the first configuration (which it also can obtain) and the second configuration. It is also possible to plastically deform the device 10 into the second configuration 36, such that it does not unfold when restraint is removed. This might be particularly desired if the device is made from nitinol or a superelastic alloy.

The standard method of deploying the medical device 10 in a vessel 33, depicted in FIG. 6, involves resiliently forming the frame 11 into a third configuration 37 to load into a delivery device 26, such as a catheter. In the third configuration 37 the adjacent sides 13 are generally beside each other in close proximity extending generally along the same axis. To advance and deploy the device from the distal end 28 of the delivery catheter 26, a pusher 27 is placed into the catheter lumen 29. When the device 10 is fully deployed, it assumes the second configuration 36 within the vessel as depicted in FIG. 2. The sides 13 of the frame, being made of resilient material, conform to the shape of the vessel wall 70 such that when viewed on end, the device 10 has a circular appearance when deployed in a round vessel. As a result, sides 13 are arcuate or slightly bowed out to better conform to the vessel wall.

A second embodiment of the present invention is depicted in FIG. 3 wherein one or more barbs 16 are included to anchor the device 10 following deployment. As understood, a barb can be a wire, hook, or any structure attached to the frame and so configured as to be able to anchor the device 10 within a lumen. The illustrative embodiment includes a first barb 16 with up to three other barbs 17,71,72, indicated in dashed lines, representing alternative embodiments. As depicted in detail view A of FIG. 3, the barb combination 38 that comprises barbs 17 and 18, each barb is an extension of the single piece 59 of material of the frame 11 beyond the closed circumference 59. The attachment cannula 15 secures and closes the single piece 59 of material into the frame 11 as previously described, while the first and second ends 60,61 thereof, extend from the cannula 15, running generally parallel with the side 13 of the frame 11 from which they extend, each preferably terminating around or slightly beyond respective bends 20,23. To facilitate anchoring, the distal end 19 of the barb 16 in the illustrative embodiment contains a bend or hook.

Optionally, the tip of the distal end 19 can be ground to a sharpened point for better tissue penetration. To add a third and fourth barb as shown, a double ended barb 39 comprising barbs 71 and 72 is attached to the opposite side 13 as defined by bends 21 and 22. Unlike barb combination 38, the double barb 39, as shown in detail view B of FIG. 3, comprises a piece of wire, usually the length of barb combination 38, that is separate from the single piece 59 comprising the main frame 11. It is secured to the frame by attachment mechanism 15 using the methods described for FIG. 1. FIG. 4 depicts barb 17 (and 18) engaging the vessel wall 70 while the device 10 is in the second, deployed configuration 36. While this embodiment describes up to a four barb system, more than four can be used.

FIG. 7 depicts a top view of a third embodiment of the present invention in the first configuration 35 that includes a plurality of frames 11 attached in series. In the illustrative embodiment, a first frame 30 and second frame 31 are attached by a barb 16 that is secured to each frame by their respective attachment mechanisms 15. The barb 16 can be a double-ended barb 39 as shown in FIG. 3 (and detail view B) that is separate from the single pieces 59 comprising frames 30 and 31, or the barb may represent a long extended end of the one of the single pieces 59 as shown in detail view A of FIG. 3. Further frames, such as third frame 32 shown in dashed lines, can be added by merely extending the length of the barb 16. FIG. 8 depicts a side view of the embodiment of FIG. 7 in the second configuration 36 as deployed in a vessel 33.

FIGS. 12-18 depict embodiments of the present invention in which a covering 45 comprising a sheet of fabric, collagen (such as small intestinal submucosa), or other flexible material is attached to the frame 11 by means of sutures 50, adhesive, heat sealing, "weaving" together, crosslinking, or other known means. FIG. 12 depicts a top view of a fourth embodiment of the present invention while in the first configuration 35, in which the covering 45 is a partial covering 58, triangular in shape, that extends over approximately half of the aperture 56 of the frame 11. When formed into the second configuration 36 as shown in FIGS. 13-14, the device 10 can act as an artificial valve 43 such as the type used to correct valvular incompetence. FIG. 13 depicts the valve 43 in the open configuration 48. In this state, the partial covering 58 has been displaced toward the vessel wall 70 due to positive fluid pressure or flow in a first direction 46, e.g., normal venous blood flow, thereby opening a passageway 65 through the frame 11 and the lumen 34 of the vessel 33. As the muscles relax, producing flow in a second, opposite direction 47, e.g., retrograde blood flow 47, as shown in FIG. 14, the partial covering 58 acts as a normal valve by catching the backward flowing blood and closing the lumen 34 of the vessel. In the case of the artificial valve 43, the partial covering 58 is forced against the vessel wall to seal off the passageway 65, unlike a normal venous valve which has two leaflets, which are forced together during retrograde flow. Both the artificial valve 43 of the illustrative embodiment and the normal venous valve, have a curved structure or cusp that facilitates the capture of the blood and subsequent closure. In addition to the triangular covering, other possible configurations of the partial covering 58 that result in the cupping or trapping of fluid in one direction can be used. Selecting the correct size of valve for the vessel ensures that the partial covering 58 properly seals against the vessel wall 70. If the lumen 34 of the vessel is too large for the device 10, there will be retrograde leakage around the partial covering 58.

FIG. 15 depicts a top view of a fifth embodiment of the present invention in the first configuration 35, whereby there is a full covering 57 that generally covers the entire aperture 56 of the frame 11. When the device 10 is formed into the second configuration 36, as depicted in FIG. 16, it becomes useful as an occlusion device 51 to occlude a duct or vessel, close a shunt, repair a defect, or other application where complete or substantially complete prevention of flow is desired. As an intravascular device, studies in swine have shown occlusion to occur almost immediately when deployed in an artery or the aorta with autopsy specimens showing that thrombus and fibrin which had filled the space around the device. The design of the present invention permits it to be used successfully in large vessels such as the aorta. Generally, the occlusion device should have side 13 lengths that are at least around 50% or larger than the vessel diameter in which they are to be implanted.

FIGS. 17-18 depict two embodiments of the present invention in which the device 10 functions as a