Implantable device with remodelable material and covering material

• US 20070162103A1
• Filed: 12/18/2006
• Published: 07/12/2007
• Est. Priority Date: 02/05/2001
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Agnew, Charles, Case, Brian
• Granted Patent: US 8,038,708 B2
• Time in Patent Office: Days
• US Class Current: 623/1.130
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0078 hyperboloidal

Abstract

Medical devices for implantation within a body vessel can include a remodelable material, such as an extracellular matrix material, positioned within a lumen defined by an outer covering material. The covering material is preferably substantially non-remodelable, and can be supported by a radially expandable frame. The medical device can also include a valve means positioned within the covering material. The valve means can include one or more valve leaflets formed from the remodelable material, and a separate valve support frame. One or more therapeutic agents can be associated with the remodelable material or the covering material.

Claims

1. An implantable radially expandable medical device moveable from a radially compressed state to a radially expanded state, and having an interior surface defining an interior lumen and an exterior surface, the medical device comprising:

a. a substantially non-remodelable covering material configured as a tubular sleeve having an abluminal side defining at least a portion of the exterior surface of the medical device and a luminal side defining a portion of the interior lumen of the medical device; and

b. a remodelable material positioned within the portion of the interior lumen defined by the covering material.

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

poly(ethylene terephthalate) (PET), polyester, poly(tetrafluoroethylene), nylon, polyurethane, expanded polytetrafluroethylene (ePTFE), and copolymers thereof.

3. The medical device of claim 1, wherein the covering material comprises poly(ethylene terephthalate) (PET) or polyester.

4. The medical device of claim 1, further comprising a radially expandable support frame attached to the covering material.

5. The medical device of claim 4, wherein the support frame comprises a nickel-titanium alloy or stainless steel.

6. The medical device of claim 4, support frame includes a plurality of ring structures attached to the abluminal side of the covering material;

the ring structures each comprising a serpentine configuration of struts and bends forming the ring structure.

7. The medical device of claim 6, wherein the medical device further comprises a valve attached to the covering material and positioned at least partially within the interior lumen of the medical device the valve comprising a valve leaflet comprising the remodelable material;

and wherein the support frame comprises a first ring structure and a second ring structure independently attached to the covering material, wherein the valve means is positioned between the first ring structure and the second ring structure.

8. The medical device of claim 1, wherein the medical device further comprises a valve means positioned at least partially within the interior lumen of the medical device, the valve means comprising a valve leaflet comprising the remodelable material.

9. The medical device of claim 8, wherein the remodelable material is an extracellular matrix material.

10. The medical device of claim 8, wherein the valve means comprises a first valve leaflet including a first valve leaflet free edge and a first portion of the remodelable material attached to a valve support frame, wherein the valve support frame is positioned within the portion of the interior lumen defined by the covering material.

11. The medical device of claim 10, wherein the valve means further comprises a second valve leaflet defining a second valve leaflet free edge and comprising a second portion of the remodelable material attached to the valve support frame;

wherein the second valve leaflet free edge is positioned in opposition to the first valve leaflet free edge to cooperatively define at least a portion of a valve orifice, the first valve leaflet and the second valve leaflet comprising flexible portions moveable in response to fluid within the interior lumen so as to permit fluid to flow in a substantially unidirectional manner through the valve orifice within the interior lumen.

12. The medical device of claim 8, wherein the valve means comprises two or more valve leaflets attached to a valve support frame, wherein each leaflet extends from a flexible free edge and a leaflet base edge distal to the flexible free edge, the leaflet base edge being attached to the valve support frame and the leaflet free edge moveable relative to the valve support frame;

a. wherein at least a portion of each leaflet base edge is also attached to the covering material and each leaflet free edge is moveable relative to the covering material;

b. where the implantable valve comprises a valve orifice defined by at least two flexible leaflet free edges, where the valve orifice permits fluid to flow in a first direction through the implantable valve when each valve leaflet is in the open position, and where each leaflet free edge is moveable in response to fluid flow contacting the leaflet free edge.

13. The medical device of claim 12, wherein each valve leaflet has (n) edges and (n−

1) edges of each valve leaflet contact the covering material to form a sinus region between the valve leaflet and the covering material;

where (n) is an integer equal to 2 or greater.

14. The medical device of claim 8, wherein the valve means comprises a tubular body formed from the remodelable material, positioned within the covering material defining a cylindrical interior lumen extending between a tapered end and a non-tapered end;

where the tapered end comprises a flexible valve orifice moveable between an open position permitting fluid flow in a first direction through the interior lumen and a closed position substantially preventing fluid flow into the interior lumen, the valve orifice moveable in response to fluid flow contacting the tapered end.

15. A method of treatment comprising the steps of:

a. providing an intralumenal valve moveable from a radially compressed configuration to a radially expanded configuration, the valve comprising;

i. a substantially non-remodelable covering material configured as a tubular sleeve having an abluminal side defining at least a portion of the exterior surface of the medical device and a luminal side defining the interior lumen of the medical device;

ii. a radially expandable support frame attached to the covering material; and

iii. a valve means comprising a remodelable material, the remodelable material positioned within the interior lumen defined by the covering material.

b. introducing the intralumenal valve within a body vessel in the radially compressed configuration;

c. positioning the intralumenal valve at a point of treatment within the body vessel; and

d. radially expanding the intralumenal valve at the point of treatment to the radially expanded configuration in a manner effective to secure the intralumenal valve at the point of treatment.

16. The method of claim 15, wherein the valve means comprises one or more moveable valve leaflets comprising the remodelable material;

wherein the valve means is positioned within the interior lumen of the medical device.

17. The method of claim 16, wherein the valve means further comprises a valve support frame, and wherein each valve leaflet is attached to the valve support frame.

18. The method of claim 17, wherein each valve leaflet comprises a free edge that is unattached to the valve support frame and moveable relative to the valve support frame in response to the flow of fluid within the interior lumen of the medical device.

19. The method of claim 18, wherein the covering material comprises a material selected from the group consisting of:

polyester, poly(tetrafluoroethylene) (PTFE), poly(ethylene terephthalate) (PET), nylon, expanded polytetrafluroethylene (ePTFE) and copolymers thereof.

20. A method of manufacturing a radially expandable medical device comprising:

a. providing a radially expandable valve comprising a valve support frame and at least one valve leaflet comprising a remodelable material attached to the valve support frame;

b. attaching a covering material configured as a tube comprising a substantially non-remodelable material to the valve support frame so as to enclose the at least one valve leaflet, the covering material having an exterior surface and an interior surface;

c. attaching a support frame comprising a plurality of ring support structures to the covering material.