Implantable frame with variable compliance

• US 20050228486A1
• Filed: 04/11/2005
• Published: 10/13/2005
• Est. Priority Date: 04/13/2004
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Flagle, Jacob A., Agnew, Charles W.
• Granted Patent: US 7,582,110 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. Embodiments of the invention relate to medical devices comprising a frame having a compliance that can change upon implantation of the medical device within the lumen of a body vessel. Controlled fracture or bioabsorption of frame material can, in some embodiments, increase the compliance of a frame after implantation. Medical devices comprising a frame and one or more valve members adapted to regulate fluid flow in a body vessel, such as a vein, are also provided.

Claims

1. A medical device for implantation in a body vessel, comprising an implantable frame having a frame portion configured to increase the compliance of the frame during a Flat Plate Fatigue Test, where the frame has a first compliance measured with a Radial Force Gauge before performing a Flat Plate Fatigue Test and a second compliance measured with a Radial Force Gauge after performing the Flat Plate Fatigue Test;

and where the second compliance is greater than the first compliance.

2. The medical device of claim 1, wherein the frame portion fractures during the Flat Plate Fatigue Test.

3. The medical device of claim 1, wherein the frame portion comprises a bioabsorbable material.

4. The medical device of claim 3, wherein the bioabsorbable material is selected from the group consisting of:

poly(L-lactic acid), polylactic acid, poly(glycolic acid), poly(epsilon-caprolactone), poly(dimethyl glycolic acid), poly(hydroxy butyrate), poly(p-dioxanone), polydioxanone, PEO/PLA, poly(lactide-co-glycolide), poly(hydroxybutyrate-co-valerate), poly(glycolic acid-co-trimethylene carbonate), poly(epsilon-caprolactone-co-p-dioxanone), poly-L-glutamic acid or poly-L-lysine, polylactic acid, polylactide, polyglycolic acid, polyglycolide, polyhydroxyvalerate, cellulose, chitin, dextran, fibrin, casein, fibrinogen, starch, collagen, hyaluronic acid, hydroxyethyl starch, gelatin.

5. The medical device of claim 1, wherein the frame comprises a material selected from the group consisting of:

a shape memory material, a superelastic material, a stainless steel, a cobalt-chromium alloy, a NiTi alloy, MP35N, gold, tantalum, platinum, platinum iridium, and a carbon fiber.

6. The medical device of claim 1, wherein the frame is expandable from a first compressed configuration to a second expanded configuration.

7. The medical device of claim 1, wherein the medical device further comprises a means for orienting the frame within a body vessel.

8. The medical device of claim 1, where the medical device further comprises a remodelable material attached to a frame.

9. The medical device of claim 1, wherein the medical device comprises an extracellular matrix material attached to the frame.

10. The medical device of claim 1, wherein the medical device comprises SIS attached to the frame.

11. The medical device of claim 1, further comprising a means for regulating fluid flow in the lumen of the body vessel.

12. A medical device for implantation in a body vessel, comprising:

(a) an expandable implantable frame moveable from a compressed tubular configuration to an expanded tubular configuration;

having a frame portion configured to increase the compliance of the frame during a Flat Plate Fatigue Test, where the frame has a first compliance in the expanded tubular configuration measured with a Radial Force Gauge before performing a Flat Plate Fatigue Test and a second compliance in the expanded configuration measured with a Radial Force Gauge after performing the Flat Plate Fatigue Test; and

where the second compliance is greater than the first compliance; and

(b) a sheet of remodelable material attached to a portion of the frame.

13. The medical device of claim 12, wherein the frame has a longitudinal axis and the frame comprises a sinusoidal annular member surrounding the longitudinal axis;

the annular member comprising a plurality of alternating struts and bends.

14. The medical device of claim 12, wherein at least two sides of the remodelable material are attached to the frame, and the remodelable material is maintained at a first tension when the implantable frame is in the expanded configuration before the Flat Plate Fatigue Test, and where the remodelable material is maintained at a second tension after the Flat Plate Fatigue Test;

where the second tension is less than the first tension.

15. The medical device of claim 12, wherein the frame comprises a bioabsorbable material and bioabsorption of the bioasorbable material increases the compliance of the frame along the first direction.

16. The medical device of claim 12, where the remodelable material is a first valve member, the valve member responsive to the flow of fluid through a body vessel to permit fluid flow through said vessel in a first direction and substantially prevent fluid flow through said vessel in a second, opposite direction.

17. The medical device of claim 15, wherein the valve member is a leaflet comprising a free edge that is flexible to move in response to fluid flow through the body vessel.

18. The medical device of claim 15, wherein the valve member comprises a material selected from the group consisting of:

an ECM material, polypropylene, polyurethane, expanded polytetrafluoroethylene, polyurethane, polyethylene terphthalate, silicone, latex, polyethylene, polypropylene, polycarbonate, nylon, polytetrafluoroethylene, polyimide, and polyester.

19. The medical device of claim 15, wherein the valve member is formed from polyurethane and about 1-5% polydimethylsiloxane.

20. A method of making a medical device for implantation in a body vessel, comprising the step of attaching a first valve member to a frame,

(a) the frame having a longitudinal axis and a first compliance in a first direction, where:

(i) the frame comprises a frame portion adapted to increase the compliance of the frame in the first direction after a desired period of implantation within the body vessel; and

(ii) the frame comprises a first strut and a second strut joined by a bend; and

(b) the valve member comprising a leaflet having a free edge responsive to the flow of fluid through the frame, the valve member permitting fluid flow through said vessel in a first direction and substantially preventing fluid flow through said vessel in a second, opposite direction.

21. A method of treating a subject, comprising the step of:

delivering the medical device to a point of treatment in a body vessel;

the medical device comprising;

(a) a frame for implantation within a body vessel,

(i) the frame having a longitudinal axis and a first compliance in a first direction,

(ii) the frame comprising a frame portion adapted to increase the compliance of the frame in the first direction after a desired period of implantation within the body vessel;

(iii) the frame comprising a first strut and a second strut joined by a bend; and

(b) a first valve member attached to the frame, the valve member responsive to the flow of fluid through the frame, the valve member being adapted to permit fluid flow through said vessel in a first direction and substantially prevent fluid flow through said vessel in a second, opposite direction.