Implantable Frame and Valve Design

• US 20090138069A1
• Filed: 11/26/2008
• Published: 05/28/2009
• Est. Priority Date: 11/28/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Hoffman, Grant T.
• Granted Patent: US 8,057,532 B2
• Time in Patent Office: Days
• US Class Current: 623/1.130
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

Implantable prosthetic valves comprising support frames are provided. The support frames may include a plurality of symmetrically arrayed interconnected U-shaped member structures. Preferred support frames are tubular structures enclosing a longitudinal axis and including a plurality of U-shaped member structures facing a distal or a proximal end of the support frame. Each U-shaped member structure may be connected to a single longitudinally adjacent U-shaped member facing in an opposite longitudinal direction, as well as two laterally adjacent U-shaped members.

Claims

1. A radially-expandable implantable medical device having a support frame moveable from a radially expanded configuration to a radially compressed configuration, the support frame in the expanded configuration defining a lumen extending from a proximal end to a distal end along a longitudinal axis and defining a plurality of openings in communication with the lumen, the support frame comprising:

a first member pair of circumferentially adjacent members joined at a first distal point positioned at the distal end of the support frame and at a first proximal point positioned at the proximal end of the support frame, each member of the first pair having a divergent portion joined to a convergent portion, with the divergent portion extending circumferentially away from the proximal point and the divergent portion extending circumferentially toward the distal point, the first pair of circumferentially adjacent members defining a first opening in the support frame;

a second member pair of circumferentially adjacent members joined at a second distal point positioned at the distal end of the support frame and at a second proximal point positioned at the proximal end of the support frame, each member of the second member pair having a divergent portion joined to a convergent portion, with the divergent portion extending circumferentially away from the distal point and the divergent portion extending circumferentially toward the proximal point, the first pair of circumferentially adjacent members defining a second opening in the support frame;

the first member pair connected to the second member pair by a first pair of transverse connecting members each extending from the divergent portion of the first member pair to a convergent portion of the second member pair;

the first opening being opposably positioned across the lumen with respect to the second opening.

2. The medical device of claim 1, wherein the first opening has four sides.

3. The medical device of claim 1, wherein the second opening has four sides.

4. The medical device of claim 3, wherein the first opening is congruent to the second opening.

5. The medical device of claim 4, where the first opening and the second opening each have a petal-like shape or a diamond-like shape.

6. The medical device of claim 1, wherein the support frame further comprises one or more additional transverse connecting members extending between the first member pair and the second member pair.

7. The medical device of claim 1, wherein the first member pair, the second member pair and the first pair of transverse connecting members has a substantially uniform first cross-sectional area.

8. The medical device of claim 7, wherein the support frame further comprises one or more additional transverse connecting members extending between the first member pair and the second member pair, the additional transverse connecting members having a substantially uniform second cross-sectional area that is different from the first cross-sectional area.

9. The medical device of claim 8, wherein the additional transverse connecting member comprise a biodegradable material.

10. The medical device of claim 9, wherein the first member pair, the second member pair and the first pair of transverse connecting members comprise a biocompatible metal.

11. The medical device of claim 1, wherein the first member pair, the second member pair and the first pair of transverse connecting members comprise a shape-memory alloy.

12. A radially-expandable implantable prosthetic valve moveable from a radially expanded configuration to a radially compressed configuration, the prosthetic valve in the expanded configuration defining a lumen extending from a proximal end to a distal end along a longitudinal axis and defining a plurality of openings in communication with the lumen, the prosthetic valve comprising:

(a) a support frame including a first joined member pair defining a first opening connected to a second member pair defining a second opening by a pair of curvilinear transverse connecting members,

the first member pair of circumferentially adjacent members joined at a first distal point positioned at the distal end of the support frame and at a first proximal point positioned at the proximal end of the support frame, each member of the first member pair having a divergent portion joined to a convergent portion at a first inflection point, with the divergent portion extending circumferentially away from the proximal point and the divergent portion extending circumferentially toward the distal point, the first pair of circumferentially adjacent members defining a first opening in the support frame having a diamond-like or petal-like shape;

the second member pair of circumferentially adjacent members joined at a second distal point positioned at the distal end of the support frame and at a second proximal point positioned at the proximal end of the support frame, the second member pair being substantially congruent to the first member pair with each member of the second member pair having a divergent portion joined to a convergent portion at a second inflection point, the divergent portion extending circumferentially away from the proximal point and the divergent portion extending circumferentially toward the distal point, the first pair of circumferentially adjacent members defining a second opening in the support frame, the first distal point and the first proximal point each being opposably positioned across the lumen with respect to the second distal point or the second proximal point, respectively;

the first member pair connected to the second member pair by a first pair of curvilinear transverse connecting members each extending from the divergent portion of the first member pair to a convergent portion of the second member pair and having a third inflection point therebetween;

the first opening being substantially congruent and opposably positioned across the lumen with respect to the second opening; and

(b) a means for regulating fluid flow through the lumen attached to the support frame.

13. The prosthetic valve of claim 12, wherein the means for regulating fluid flow is a valve leaflet attached to the support frame and moveable within the lumen to regulate fluid flow therein.

14. The prosthetic valve of claim 13, wherein the means for regulating fluid flow is a valve leaflet comprising a first edge attached to a first curvilinear transverse connecting member of the support frame and a second edge attached to a first curvilinear transverse connecting member of the support frame, the valve leaflet being positioned within the lumen, wherein the valve leaflet prevents or permits fluid flow through the lumen.

15. The artificial valve prosthesis of claim 13, wherein the valve leaflet comprises a material of small intestine submucosa.

16. The medical device of claim 12, wherein the support frame further comprises one or more additional transverse connecting members extending between the first member pair and the second member pair.

17. The medical device of claim 12, wherein the first member pair, the second member pair and the first pair of transverse connecting members has a substantially uniform first cross-sectional area.

18. The medical device of claim 17, wherein the support frame further comprises one or more additional transverse connecting members extending between the first member pair and the second member pair, the additional transverse connecting members having a substantially uniform second cross-sectional area that is different from the first cross-sectional area.

19. The medical device of claim 18, wherein the first member pair, the second member pair and the first pair of transverse connecting members comprise a shape-memory metal.

20. A method of treating a subject, the method comprising:

(a) loading an artificial valve prosthesis in a compressed configuration into a delivery catheter, the artificial valve prosthesis including a support frame having

a first member pair of circumferentially adjacent members joined at a first distal point positioned at the distal end of the support frame and at a first proximal point positioned at the proximal end of the support frame, each member of the first pair having a divergent portion joined to a convergent portion, with the divergent portion extending circumferentially away from the proximal point and the divergent portion extending circumfrerentially toward the distal point, the first pair of circumferentially adjacent members defining a first opening in the support frame;

a second member pair of circumferentially adjacent members joined at a second distal point positioned at the distal end of the support frame and at a second proximal point positioned at the proximal end of the support frame, each member of the second member pair having a divergent portion joined to a convergent portion, with the divergent portion extending circumferentially away from the distal point and the divergent portion extending circumfrerentially toward the proximal point, the first pair of circumferentially adjacent members defining a second opening in the support frame;

the first member pair connected to the second member pair by a first pair of transverse connecting members each extending from the divergent portion of the first member pair to a convergent portion of the second member pair;

the first opening being opposably positioned across the lumen with respect to the second opening;

(b) inserting the delivery catheter into a body vessel;

(c) translating the delivery catheter to a treatment site;

(d) deploying the artificial valve prosthesis by securably placing the artificial valve prosthesis in an expanded configuration at the treatment site to treat the subject; and

(e) withdrawing the delivery catheter from the body vessel.