Implantable medical device with constrained expansion

• US 7,128,759 B2
• Filed: 05/19/2004
• Issued: 10/31/2006
• Est. Priority Date: 05/19/2003
• 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., Hoffa, Andrew K., Garrison, Michael L., Osborne, Thomas A.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Matthews, Wiliam H
• Application Number:
  US10/849,639
• Publication Number:
  US 20040243222A1
• Time in Patent Office: 895 Days
• Field of Search: 623/1.1, 623 111- 114, 623 124- 129, 623/1.36
• US Class Current: 623/1.24
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

Medical devices for implantation in a body vessel are provided. A medical device according to the invention comprises a support structure and one or more graft members comprising a valve portion and a constraining portion. The support structure has a first, unexpanded configuration and a second, expanded configuration. The constraining portion is adapted to substantially prevent the support structure from achieving the second, expanded configuration. The valve portion is adapted to permit fluid flow through a body vessel in a first direction and substantially prevent fluid flow through the vessel in a second, opposite direction.

Claims

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

a support structure having a first, unexpanded configuration and a second, expanded configuration; and

a graft member connected to the support structure and comprising a valve portion and a constraining portion, the valve portion 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, and the constraining portion comprising a gathered portion of the graft member that includes first and second non-contiguous regions of the graft member held adjacent one another by a connecting mechanism, the constraining portion adapted to substantially prevent the support structure from achieving the second, expanded configuration.

2. The medical device of claim 1, wherein the gathered portion defines a passageway adapted to permit a controlled amount of fluid flow through said body vessel in the second, opposite direction.

3. The medical device of claim 1, wherein the graft member comprises an extracellular matrix material.

4. The medical device of claim 1, wherein the graft member comprises small intestine submucosa.

5. The medical device of claim 1, wherein the graft member defines an edge substantially free of the support structure, the edge cooperating with a portion of the support structure to define an opening adapted to permit a controlled amount of fluid flow through said body vessel in the second, opposite direction.

6. The medical device of claim 5, wherein the edge is defined by the constraining portion of the graft member.

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

a support structure having a first, unexpanded configuration and a second, expanded configuration; and

a graft member connected to the support structure and comprising a valve portion and a constraining portion, the valve portion 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, and the constraining portion comprising a gathered portion of the graft member and adapted to substantially prevent the support structure from achieving the second, expanded configuration;

wherein the gathered portion defines a passageway adapted to permit a controlled amount of fluid flow through said body vessel in the second, opposite direction; and

further comprising a cannula disposed in the passageway.

8. The medical device of claim 7, wherein the cannula comprises a distal end disposed near the valve portion of the graft member and a proximal end disposed near the constraining portion of the graft member, and wherein the proximal end defines an opening angulated with respect to the graft member.

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

a support structure; and

first and second graft members connected to the support structure, each of the graft members comprising a valve portion and a constraining portion, the valve portions being disposed substantially opposite one another and adapted to cooperatively permit fluid flow through said vessel in a first direction and substantially prevent fluid flow through said vessel in a second, opposite direction;

wherein at least one of the constraining portions comprises a gathered portion of one of the first and second graft members, the gathered portion including first and second non-contiguous regions of the graft member held adjacent one another by a connecting mechanism;

wherein the constraining portions cooperate to substantially prevent the support structure from achieving the second, expanded configuration.

10. The medical device of claim 9, wherein the gathered portion defines a passageway adapted to permit a controlled amount of fluid flow through said body vessel in the second, opposite direction.

11. The medical device of claim 9, wherein the graft member comprises an extracellular matrix material.

12. The medical device of claim 9, wherein the graft member comprises small intestine submucosa.

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

a support structure; and

first and second graft members connected to the support structure, each of the graft members comprising a valve portion and a constraining portion, the valve portions being disposed substantially opposite one another and adapted to cooperatively permit fluid flow through said vessel in a first direction and substantially prevent fluid flow through said vessel in a second, opposite direction;

wherein at least one of the constraining portions comprises a gathered portion of one of the first and second graft members;

wherein the constraining portions cooperate to substantially prevent the support structure from achieving the second, expanded configuration;

wherein the gathered portion defines a passageway adapted to permit a controlled amount of fluid flow through said body vessel in the second, opposite direction; and

further comprising a cannula disposed in the passageway.

14. The medical device of claim 13, wherein the cannula comprises a distal end disposed near the valve portion of the graft member and a proximal end disposed near the constraining portion of the graft member, and wherein the proximal end defines an opening angulated with respect to the graft member.

15. A prosthetic valve for implantation in a body vessel, comprising:

a support structure having a first, unexpanded configuration and a second, expanded configuration;

a first valve leaflet connected to the support structure and comprising a first valve portion and a first constraining portion comprising a gathered portion of the first valve leaflet that includes first and second non-contiguous regions of the first valve leaflet held adjacent one another by a first connecting mechanism; and

a second valve leaflet connected to the support structure and comprising a second valve portion and a second constraining portion comprising a gathered portion of the second valve leaflet that includes third and fourth non-contiguous regions of the second valve leaflet held adjacent one another by a second connecting mechanism;

wherein the first and second valve portions cooperatively regulate fluid flow through said body vessel; and

wherein the first and second constraining portions cooperatively prevent the support structure from achieving the second, expanded configuration.