Artificial prostheses with preferred geometries

• US 20070100435A1
• Filed: 10/25/2006
• Published: 05/03/2007
• Est. Priority Date: 04/24/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian, Paul, Ram, Hoffman, Grant
• Granted Patent: US 7,717,952 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 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
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Implantable medical devices, such as intraluminally implantable stents and valves, are provided having certain preferred shapes. Preferably, a portion of the implantable medical device can define a sinus region having a preferred geometry. The sinus region can have one or more preferred geometric configurations described herein, for example to mitigate or prevent thrombosis within a body vessel. The medical device can include a valve means, such as one or more valve leaflets positioned within the sinus region. The implantable medical devices can be delivered from a catheter within a body vessel, and are preferably expandable from a compressed configuration to a radially expanded configuration. The implantable frames can be self-expanding or balloon expandable. Portions of the medical device, such as the implantable frame or a valve leaflet, are optionally coated with one or more bioactive materials.

Claims

1. An implantable valve comprising:

a. a frame defining a lumen extending between a proximal end and a distal end along a longitudinal axis, the frame comprising a substantially annular distal frame end with a first diameter at the distal end and a sinus-forming frame portion proximal to the distal end, the sinus-forming frame portion having a maximum diameter of about 10% to about 200% larger than the first diameter; and

b. a valve leaflet attached to the frame within the lumen, the valve leaflet defining a sinus region within the lumen between the valve leaflet and the frame, the valve leaflet having a length measured from a base attached to the frame to a flexible free edge, the free edge moveable in response to fluid flow through the lumen.

2. The implantable valve of claim 1, wherein the maximum diameter of the frame is positioned between the distal and proximal end such that the longitudinal distance from the distal end to the maximum diameter of the sinus-forming frame portion is less than the longitudinal distance from the proximal end to the distal end of the frame.

3. The implantable valve of claim 2, wherein the longitudinal distance from the distal end of the frame to the longitudinal position of the maximum diameter of the sinus-forming frame portion is about 30-40% of the distance between the distal end of the frame to the proximal end of the frame.

4. The implantable valve of claim 1, wherein the valve leaflet has a length that is between about 10% to about 100% of the diameter at the distal end of the frame.

5. The implantable valve of claim 1, wherein the maximum diameter of the sinus region is approximately equal to a distance measured along the longitudinal axis of the frame from the free edge of the valve leaflet to the distal end of the sinus region.

6. The implantable valve of claim 1, wherein the distance measured along the longitudinal axis of the frame from the base of the valve leaflet to the maximum diameter of the sinus region is equal to between about 50% and 150% of the length of the value leaflet.

7. The implantable valve of claim 1, wherein distance measured along the longitudinal axis of the frame from the maximum diameter to the distal end of the sinus region is between about 10% and about 200% of the leaflet length.

8. The implantable valve of claim 1, wherein the frame further comprises a bioactive material releasably attached to at least a portion of the implantable valve.

9. The implantable valve of claim 1, wherein the sinus-forming frame portion has a maximum diameter of about 60% to about 70% larger than the first diameter, the implantable valve defines the sinus region between the valve leaflet and the sinus-forming frame portion, the sinus region positioned between the proximal frame end and the distal frame end, the distal frame end having a substantially annular shape, the sinus region having a maximum diameter that is about 60% to about 70% greater than the first diameter and about 10% to about 200% larger than the second diameter.

10. The implantable valve of claim 1, wherein the frame is radially moveable from a compressed state to a radially expanded state;

wherein the leaflet length is between about 20% to about 50% of the first diameter;

wherein the distal frame end has a substantially annular shape having a second diameter;

wherein the frame defines a sinus region positioned between the proximal frame end and the distal frame end;

wherein the first diameter is substantially equal to the second diameter;

wherein the maximum diameter of the sinus region is about 60% to about 70% larger than the first diameter and the second diameter;

wherein the maximum diameter of the sinus region is approximately equal to a distance measured along the longitudinal axis of the frame from the free edge of the valve leaflet to the distal end of the sinus region; and

wherein the distance measured along the longitudinal axis of the frame from the free edge of the valve leaflet to the maximum diameter of the sinus region is equal to about 20% to about 40% of the first diameter.

11. An implantable valve comprising a frame and a valve means attached to the frame;

wherein the frame is radially symmetrical along a longitudinal axis and is moveable from a compressed configuration to a radially expanded configuration, and wherein the frame comprises a substantially cylindrical proximal frame portion including the proximal frame end, a substantially cylindrical distal frame portion including the distal frame end and a sinus frame portion defining a sinus region, the sinus frame portion being positioned between and connected to the proximal frame portion and the distal frame portion;

wherein the proximal frame portion and the distal frame portion have a first diameter and wherein at least a portion of the sinus frame portion has a maximum diameter that is about 10% to about 200% larger than the first diameter; and

wherein at least a portion of the valve means defines a portion of the sinus region.

12. The implantable valve of claim 11, wherein the length of the sinus region measured along the longitudinal axis of the frame from the distal end of the proximal frame portion to the proximal end of the distal frame portion, is approximately equal to the maximum diameter of the sinus frame portion.

13. The implantable valve of claim 11, wherein distance measured along the longitudinal axis of the frame from the most proximal portion of the sinus region having the maximum diameter to the distal end of the sinus region is between about 10% and about 200% of the leaflet length.

14. The implantable valve of claim 11, wherein the length of the proximal frame portion measured along the longitudinal axis of the frame is about 50% to about 100% of the first diameter of the proximal frame portion.

15. The implantable valve of claim 11, wherein the valve means comprises one or more valve leaflets attached to the frame at a leaflet base and extending along a leaflet length from the leaflet base to a leaflet free edge distal to the leaflet base, the leaflet length being about 10% to about 100% of the first diameter of the proximal frame portion.

16. The implantable valve of claim 11, wherein at least a portion of the sinus frame portion has a maximum diameter that is about 60% to about 70% larger than the first diameter;

and wherein at least a portion of the valve means defines a portion of the sinus region.

17. A method of manufacturing a venous valve, the method comprising the steps of:

a. providing a frame defining a lumen extending between a proximal end and a distal end along a longitudinal axis, the frame comprising a substantially annular distal frame end with a first diameter at the distal end and a sinus-forming frame portion proximal to the distal end, the sinus-forming frame portion having a maximum diameter of about 10% to about 200% larger than the first diameter; and

b. attaching a valve leaflet comprising an extracellular matrix material to the frame within the lumen, the valve leaflet configured and positioned to define a sinus region within the lumen between the valve leaflet and the frame, the valve leaflet having a length measured from a base attached to the frame to a flexible free edge, the free edge moveable in response to fluid flow through the lumen.

18. The method of claim 17, wherein attaching the valve leaflet reduces the radius of the frame in at least one direction.

19. A method of treating a venous valve related condition comprising the steps of:

a. providing an implantable valve comprising;

a frame defining a lumen extending between a proximal end and a distal end along a longitudinal axis, the frame comprising a substantially annular distal frame end with a first diameter at the distal end and a sinus-forming frame portion proximal to the distal end, the sinus-forming frame portion having a maximum diameter of about 10% to about 200% larger than the first diameter; and

a valve leaflet attached to the frame within the lumen, the valve leaflet defining a sinus region within the lumen between the valve leaflet and the frame, the valve leaflet having a length measured from a base attached to the frame to a flexible free edge, the free edge moveable in response to fluid flow through the lumen;

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

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

d. radially expanding the intralumenal medical device at the point of treatment to the radially expanded configuration in a manner effective to place the frame in contact with the wall of the body vessel.

20. The method of claim 19, wherein the frame is a self-expanding frame and the valve leaflet comprises an extracellular matrix material, the method further comprising the steps of:

selecting a frame having a maximum diameter that is at least 10% larger than the diameter of the body vessel at the point of treatment.