Delivery and retrieval systems for collapsible/expandable prosthetic heart valves

• US 9,180,004 B2
• Filed: 01/08/2009
• Issued: 11/10/2015
• Est. Priority Date: 01/16/2008
• Status: Active Grant

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories), OVAL Limited (Arthur J Gallagher & Company)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Alkhatib, Yousef F.
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US12/735,273
• Publication Number:
  US 20100286768A1
• Time in Patent Office: 2,497 Days
• Field of Search: 623/2.1, 623/2.11, 623/1.11
• US Class Current: 1/1
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires

Abstract

A system for delivering a collapsible and re-expandable prosthetic heart valve into a patient includes a valve support structure (140) around which the valve (10) is disposed in a collapsed condition. A sheath structure (110) surrounds the collapsed valve, but can be moved relative to the valve to uncover it for expansion at the desired implant site in the patient. The sheath structure may be variously mounted and moved to deploy the valve in various ways. For example, the sheath structure may include multiple parts, each of which can be moved separately to separately deploy various parts of the valve. The apparatus may have other aspects, such as the ability to reverse deployment of the valve, the ability to pass other instrumentation through the valve delivery apparatus, the ability to be smoothly withdrawn from the patient after deployment of the valve, etc.

Claims

1. Apparatus for delivering a collapsible and re-expandable prosthetic heart valve to an implant site in a patient comprising:

a valve support structure around which a valve is externally disposed in a collapsed condition;

a sheath structure surrounding the valve on the valve support structure, wherein the sheath structure includes a first sheath part coaxial with the valve support structure that covers a first axial part of the valve in a collapsed condition and a second sheath part coaxial with the valve support structure axially moveable relative to the first sheath part thereby separating the first sheath part from the second sheath part; and

means for moving the first and second sheath parts in a direction relative to the valve support structure to uncover the valve in the collapsed condition for expansion at the implant site, the valve having first and second surface portions that face in respective opposite first and second directions along an axis around which the valve is disposed on the valve support structure, and the valve support structure having third and fourth surface portions that respectively face in the second and first directions, the first and third surface portions being positioned adjacent to and facing one another, and the second and fourth surface portions being positioned adjacent to and facing one another to substantially prevent relative movement of the valve and the valve support structure along said axis while the valve is disposed around the valve support structure in the collapsed condition, wherein the third and fourth surface portions define a recess therebetween configured for receiving therein a portion of the valve in the collapsed condition.

2. The apparatus defined in claim 1 wherein the first sheath part covers a first axial end part of the valve in the collapsed condition, and the second sheath part covers a second axial end part of the valve in the collapsed condition.

3. The apparatus defined in claim 2 wherein the means for moving makes possible movement of one of the sheath parts relative to the other sheath part.

4. The apparatus defined in claim 3 wherein the means for moving comprises:

first means for moving the first sheath part in a first direction that is away from the second axial end part of the valve; and

second means for moving the second sheath part in a second direction that is away from the first axial end part of the valve.

5. The apparatus defined in claim 2 wherein the first and second sheath parts partly overlap one another.

6. The apparatus defined in claim 2 wherein one of the axial end parts of the valve includes valve leaflets, and wherein the other axial end part of the valve includes valve frame structure without leaflets.

7. The apparatus defined in claim 1 wherein the valve support structure engages the valve in the collapsed condition to substantially prevent the valve from rotating about the valve support structure.

8. The apparatus defined in claim 1 further comprising:

means for drawing a portion of the valve that has been uncovered by the sheath structure radially inwardly toward the valve support structure.

9. The apparatus defined in claim 1 wherein the means for moving additionally allows the sheath structure to be again moved relative to the valve support structure after expansion of the valve so that the sheath structure covers the valve support structure.

10. The apparatus defined in claim 1 wherein the valve support structure defines a passageway that extends from a first location that is proximal of the valve to a second location that is distal of the valve, with the first location being closer to an operator of the apparatus than the second location.

11. The apparatus defined in claim 1 wherein the valve support structure defines a passageway for fluid communication from a location that is proximal of the valve to the valve, with said location being closer to an operator of the apparatus than the valve.

12. The apparatus defined in claim 1 further comprising:

a distal tip structure secured to a portion of the sheath structure that is most distant from an operator of the apparatus, the distal tip structure having a vent from inside the sheath structure to outside the apparatus for facilitating deairing of an interior of the sheath structure.

13. The apparatus defined in claim 1 further comprising:

a distal tip structure secured to a portion of the sheath structure that is most distant from an operator of the apparatus; and

a shaft for allowing the distal tip structure and said portion of the sheath structure to be moved distally away from the valve support, wherein the shaft includes an articulation proximal to said portion of the sheath structure.

14. The apparatus defined in claim 1, wherein the valve includes a frame, the recess configured for receiving therein a portion of the frame.

15. The apparatus defined in claim 1, wherein the valve support structure includes elements that extend radially outward at least into a tubular geometric shape.

16. Apparatus for delivering a collapsible and re-expandable prosthetic heart valve to an implant site in a patient comprising:

a valve support structure around which the valve supported by a frame is externally disposed in a collapsed condition, the valve support structure having axially spaced proximal and distal portions opposing one another along an axis, with the proximal portion being closer than the distal portion to an operator of the apparatus, a recess formed between the proximal and distal portions configured for receiving a portion the frame therein to substantially prevent relative movement of the valve and the valve support structure along said axis while the valve is disposed around the valve support structure in the collapsed condition;

a sheath structure-surrounding the valve on the valve support structure, wherein the sheath structure includes a first sheath part coaxial with the valve support structure that covers a first axial part of the valve in a collapsed condition and a second sheath part coaxial with the valve support structure axially moveable relative to the first sheath part thereby separating the first sheath part from the second sheath part; and

means for moving the first sheath part in a distal direction and the second sheath part in a proximal direction relative to the valve support structure to completely uncover the valve in the collapsed condition for expansion at the implant site.

17. The apparatus defined in claim 16 wherein:

the second sheath part is arranged surrounding the first sheath part; and

second means for moving the second sheath part in a proximal direction relative to the valve support structure to uncover the first sheath part.

18. The apparatus defined in claim 16 wherein the valve support structure includes elements that extend radially outwardly into a tubular geometric shape in which a frame structure of the collapsed valve is disposed, said elements being positioned to interfere with motion of the valve, parallel to a longitudinal axis of the tubular geometric shape, relative to the valve support structure.

19. The apparatus defined in claim 16 wherein the means for moving comprises an articulation proximal of the sheath structure but distal of the valve support structure when the means for moving has moved the sheath structure to completely uncover the valve.

20. The apparatus defined in claim 16 further comprising:

a distal tip structure secured to a distal end of the sheath structure, the distal tip structure defining a vent from inside the sheath structure to outside of the apparatus.

21. The apparatus defined in claim 16, wherein the distal and proximal portions each comprise a face facing each other and arranged perpendicular to said axis.

22. The apparatus defined in claim 16, wherein the recess circumscribes the valve support structure.

23. Apparatus for delivering a collapsible and re-expandable prosthetic heart valve to an implant site in a patient comprising:

a valve support structure around which a valve is externally disposed in a collapsed condition;

a sheath structure surrounding the valve on the valve support structure, the sheath structure including a first sheath part that covers a first axial end part of the valve in the collapsed condition, and a second sheath part that covers a second axial end part of the valve in the collapsed condition; and

means for moving the sheath structure relative to the valve support structure to uncover the valve for expansion at the implant site and to make possible movement of one of the sheath parts relative to the other sheath part, the valve having first and second surface portions that face in respective opposite first and second directions along an axis around which the valve is disposed on the valve support structure, and the valve support structure having third and fourth surface portions that respectively face in the second and first directions, the first and third surface portions being positioned adjacent to and facing one another, and the second and fourth surface portions being positioned adjacent to and facing one another to substantially prevent relative movement of the valve and the valve support structure along said axis while the valve is disposed around the valve support structure in the collapsed condition, wherein the third and fourth surface portions define a recess therebetween configured for receiving therein a portion of the valve in the collapsed condition.

24. Apparatus for delivering a collapsible and re-expandable prosthetic heart valve to an implant site in a patient comprising:

a valve support structure around which a valve is externally disposed in a collapsed condition, the valve support structure defining a passageway that extends from a first location that is proximal of the valve to a second location that is distal of the valve, with the first location being closer to an operator of the apparatus than the second location;

a sheath structure surrounding the valve on the valve support structure; and

means for moving the sheath structure relative to the valve support structure to uncover the valve for expansion at the implant site, the valve having first and second surface portions that face in respective opposite first and second directions along an axis around which the valve is disposed on the valve support structure, and the valve support structure having third and fourth surface portions that respectively face in the second and first directions, the first and third surface portions being positioned adjacent to and facing one another, and the second and fourth surface portions being positioned adjacent to and facing one another to substantially prevent relative movement of the valve and the valve support structure along said axis while the valve is disposed around the valve support structure in the collapsed condition, wherein the third and fourth surface portions define a recess therebetween configured for receiving therein a portion of the valve in the collapsed condition.

25. Apparatus for delivering a collapsible and re-expandable prosthetic heart valve to an implant site in a patient comprising:

a valve support structure around which a valve is externally disposed in a collapsed condition, the valve support structure defining a passageway for fluid communication from a location that is proximal of the valve to the valve, with said location being closer to an operator of the apparatus than the valve;

a sheath structure surrounding the valve on the valve support structure; and

means for moving the sheath structure relative to the valve support structure to uncover the valve for expansion at the implant site, the valve having first and second surface portions that face in respective opposite first and second directions along an axis around which the valve is disposed on the valve support structure, and the valve support structure having third and fourth surface portions that respectively face in the second and first directions, the first and third surface portions being positioned adjacent to and facing one another, and the second and fourth surface portions being positioned adjacent to and facing one another to substantially prevent relative movement of the valve and the valve support structure along said axis while the valve is disposed around the valve support structure in the collapsed condition, wherein the third and fourth surface portions define a recess therebetween configured for receiving therein a portion of the valve in the collapsed condition.

26. Apparatus for delivering a collapsible and re-expandable prosthetic heart valve to an implant site in a patient comprising:

a valve support structure around which a valve is externally disposed in a collapsed condition;

a sheath structure surrounding the valve on the valve support structure;

a distal tip structure secured to a portion of the sheath structure that is most distant from an operator of the apparatus, the distal tip structure having a vent from inside the sheath structure to outside the apparatus for facilitating deairing of an interior of the sheath structure; and

means for moving the sheath structure relative to the valve support structure to uncover the valve for expansion at the implant site, the valve having first and second surface portions that face in respective opposite first and second directions along an axis around which the valve is disposed on the valve support structure, and the valve support structure having third and fourth surface portions that respectively face in the second and first directions, the first and third surface portions being positioned adjacent to and facing one another, and the second and fourth surface portions being positioned adjacent to and facing one another to substantially prevent relative movement of the valve and the valve support structure along said axis while the valve is disposed around the valve support structure in the collapsed condition, wherein the third and fourth surface portions define a recess therebetween configured for receiving therein a portion of the valve in the collapsed condition.

27. Apparatus for delivering a collapsible and re-expandable prosthetic heart valve to an implant site in a patient comprising:

a valve support structure around which a valve is externally disposed in a collapsed condition;

a sheath structure surrounding the valve on the valve support structure;

a distal tip structure secured to a portion of the sheath structure that is most distant from an operator of the apparatus;

a shaft for allowing the distal tip structure and said portion of the sheath structure to be moved distally away from the valve support, wherein the shaft includes an articulation proximal to said portion of the sheath structure; and

means for moving the sheath structure relative to the valve support structure to uncover the valve for expansion at the implant site, the valve having first and second surface portions that face in respective opposite first and second directions along an axis around which the valve is disposed on the valve support structure, and the valve support structure having third and fourth surface portions that respectively face in the second and first directions, the first and third surface portions being positioned adjacent to and facing one another, and the second and fourth surface portions being positioned adjacent to and facing one another to substantially prevent relative movement of the valve and the valve support structure along said axis while the valve is disposed around the valve support structure in the collapsed condition, wherein the third and fourth surface portions define a recess therebetween configured for receiving therein a portion of the valve in the collapsed condition.

28. Apparatus for delivering a collapsible and re-expandable prosthetic heart valve to an implant site in a patient comprising:

a valve support structure around which the valve supported by a frame is externally disposed in a collapsed condition, the valve support structure having axially spaced proximal and distal portions opposing one another along an axis, with the proximal portion being closer than the distal portion to an operator of the apparatus, a recess formed between the proximal and distal portions configured for receiving a portion the frame therein to substantially prevent relative movement of the valve and the valve support structure along said axis while the valve is disposed around the valve support structure in the collapsed condition;

a first sheath structure-surrounding the valve on the valve support structure;

a second sheath structure surrounding the first sheath structure;

first means for moving the second sheath structure in a proximal direction relative to the valve support structure to uncover the first sheath structure; and

second means for moving the first sheath structure in a distal direction relative to the valve support structure to completely uncover the valve for expansion at the implant site.

29. Apparatus for delivering a collapsible and re-expandable prosthetic heart valve to an implant site in a patient comprising:

a valve support structure around which the valve supported by a frame is externally disposed in a collapsed condition, the valve support structure having axially spaced proximal and distal portions opposing one another along an axis, with the proximal portion being closer than the distal portion to an operator of the apparatus, a recess formed between the proximal and distal portions configured for receiving a portion the frame therein to substantially prevent relative movement of the valve and the valve support structure along said axis while the valve is disposed around the valve support structure in the collapsed condition;

a sheath structure-surrounding the valve on the valve support structure; and

means for moving the sheath structure in a distal direction relative to the valve support structure to completely uncover the valve for expansion at the implant site, the means for moving comprising an articulation proximal of the sheath structure but distal of the valve support structure when the means for moving has moved the sheath structure to completely uncover the valve.

30. Apparatus for delivering a collapsible and re-expandable prosthetic heart valve to an implant site in a patient comprising:

a valve support structure around which the valve supported by a frame is externally disposed in a collapsed condition, the valve support structure having axially spaced proximal and distal portions opposing one another along an axis, with the proximal portion being closer than the distal portion to an operator of the apparatus, a recess formed between the proximal and distal portions configured for receiving a portion the frame therein to substantially prevent relative movement of the valve and the valve support structure along said axis while the valve is disposed around the valve support structure in the collapsed condition;

a sheath structure-surrounding the valve on the valve support structure;

a distal tip structure secured to a distal end of the sheath structure, the distal tip structure defining a vent from inside the sheath structure to outside of the apparatus, and

means for moving the sheath structure in a distal direction relative to the valve support structure to completely uncover the valve for expansion at the implant site.