Prosthetic heart valves, scaffolding structures, and systems and methods for implantation of same

• US 7,785,341 B2
• Filed: 02/25/2005
• Issued: 08/31/2010
• Est. Priority Date: 02/27/2004
• Status: Expired due to Fees

• Current Assignee: AorTx, Inc. (Johnson & Johnson)
• Original Assignee: AorTx, Inc. (Johnson & Johnson)
• Inventors: Ginn, Richard, Heneveld, Scott, Forster, David C., Walsh, Brandon
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US11/066,124
• Publication Number:
  US 20050203614A1
• Time in Patent Office: 2,013 Days
• Field of Search: 623 111- 154
• US Class Current: 606/194
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.

Claims

1. A medical apparatus, comprising an elongate delivery device configured to deliver a prosthetic heart valve, the delivery device comprising a gripper comprising a plurality of fingers, and a tubular member comprising an inner lumen and a plurality of longitudinal slots in the periphery of a distal portion thereof, the longitudinal slots being adapted to allow extension of the prosthetic heart valve therethrough

wherein said gripper is slidably disposed within the inner lumen of said tubular member and said plurality of fingers have a first position within the interior of the distal end of the tubular member and a second position extending outward from the distal end of the tubular member, and wherein the plurality of fingers are fixedly coupled to the gripper such that the plurality of fingers remain in a fixed position with respect to each other.

2. The delivery device of claim 1, wherein said gripper is an elongate member defining a longitudinal axis, and each of said plurality of fingers extends from a first end of said gripper generally parallel to said longitudinal axis.

3. The delivery device of claim 1, wherein said gripper comprises three or more fingers.

4. The delivery device of claim 1. wherein each of said plurality of fingers comprises a generally cylindrical member extending from a first end of said gripper.

5. The delivery device of claim 1, wherein said tubular member comprises a rigid material.

6. The delivery device of claim 1, wherein said tubular member comprises a flexible material.

7. The delivery device of claim 1, further comprising a prosthetic heart valve retained by the fingers of said gripper.

8. The delivery device of claim 7, wherein said prosthetic heart valve is located within the interior of the tubular member when the fingers of said gripper are in the first position.

9. The delivery device of claim 7, wherein at least a portion of said prosthetic heart valve extends through at least one of the longitudinal slots in the periphery of said tubular member.

10. The delivery device of claim 1, wherein the longitudinal slots are arranged so as to define a plurality of elongate tab-like members in the periphery of the distal portion of the tubular member.

11. The delivery device of claim 1, wherein the plurality of fingers are configured to retain the prosthetic heart valve such that the heart valve can be positioned within the inner lumen of the tubular member, the fingers being further configured to disengage from the heart valve to deploy the heart valve in a patient'"'"'s body.

12. The delivery device of claim 11, wherein the fingers are configured to disengage from the heart valve such that the delivery device is fully removable from the patient'"'"'s body while the heart valve is deployed within the patient'"'"'s body.

13. The delivery device of claim 11, further comprising the prosthetic heart valve.

14. The delivery device of claim 13, wherein each of the plurality of fingers is adapted to extend along the entire length of the heart valve.

15. The delivery device of claim 11, wherein each of the plurality of fingers is cylindrical.

16. The delivery device of claim 11, wherein the tubular member comprises a plurality of elongate segments in the periphery of the distal portion, the elongate segments being spaced apart such that one of the plurality of longitudinal slots exists between each adjacent pair of elongate segments, the elongate segments extending parallel to a longitudinal axis of the tubular member.

17. The delivery device of claim 16, wherein each of the plurality of fingers is adapted to extend along the entire length of the heart valve.

18. The delivery device of claim 17, wherein each of the plurality of fingers is cylindrical.

19. The delivery device of claim I, wherein the tubular member comprises a plurality of elongate segments in the periphery of the distal portion, the elongate segments being spaced apart such that one of the plurality of longitudinal slots exists between each adjacent pair of elongate segments, the elongate segments extending parallel to a longitudinal axis of the tubular member.

20. A delivery device for a prosthetic heart valve, comprising:

a catheter having a proximal end, a distal end, and defining a longitudinal axis, the distal end of said catheter comprising a gripper having a plurality of rigid, elongate restraining members near its distal end, and

an outer member having an inner lumen and a plurality of longitudinal slots in the periphery of a distal portion thereof, wherein said gripper is slidably disposed within the inner lumen of said outer member,

wherein each restraining member extends generally parallel to the longitudinal axis of the catheter and has a proximal portion that is attached to the gripper and a distal portion that is not attached to the gripper, thereby defining a central region located internally of the plurality of restraining members and a longitudinal space between each adjacent pair of restraining members, and wherein the plurality of restraining members are fixedly coupled to the gripper such that the plurality of restraining members remain in a fixed position with respect to each other and wherein the plurality of restraining members are adapted to retain the prosthetic heart valve.

21. The delivery device of claim 20, wherein said plurality of restraining members are moveable between a first position within the interior of a distal end of the outer member and a second position extending outward from the distal end of the outer member.

22. The delivery device of claim 21, further comprising a prosthetic heart valve retained by the restraining members of said gripper.

23. The delivery device of claim 22, wherein said prosthetic heart valve is located within the interior of the outer member when the restraining members of said gripper are in the first position.

24. The delivery device of claim 23, wherein at least a portion of said prosthetic heart valve extends through at least one of the longitudinal slots in said outer member.

25. The delivery device of claim 20, wherein said gripper comprises three or more restraining members.

26. The delivery device of claim 20, wherein each of said plurality of restraining members comprises a generally wire-like loop extending from a first end of said gripper.

27. The delivery device of claim 20, wherein said outer member comprises a rigid tube.

28. The delivery device of claim 20, wherein said outer member comprises a flexible tube.

29. The delivery device of claim 20, further comprising a prosthetic heart valve retained by the restraining members of said gripper.

30. The delivery device of claim 20, wherein the proximal portion of each restraining member is securely attached to the gripper.

31. The delivery device of claim 20, wherein the gripper is configured such that the plurality of restraining members maintain their position with respect to each other.

32. The delivery device of claim 20, wherein the longitudinal slots are arranged so as to define a plurality of elongate tab-like members in the periphery of the distal portion of the outer member.

33. A delivery device for a prosthetic heart valve, comprising:

a gripper comprising a plurality of fingers fixedly coupled to the gripper such that the plurality of fingers remain in a fixed position with respect to each other, and

a tubular member comprising an inner lumen and a plurality of elongate segments in the periphery of a distal portion thereof, the elongate segments being spaced apart such that a longitudinal slot exists between each adjacent pair of elongate segments, the elongate segments extending parallel to a longitudinal axis of the tubular member,

wherein said gripper is slidably disposed within the inner lumen of said tubular member and said plurality of fingers are configured to retain a prosthetic heart valve such that the heart valve can be positioned within the inner lumen of the tubular member, the fingers being further configured to disengage from the heart valve to deploy the heart valve in a patient'"'"'s body.