Prosthetic heart valve and delivery apparatus

• US 8,652,202 B2
• Filed: 04/23/2009
• Issued: 02/18/2014
• Est. Priority Date: 08/22/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Alon, David, Benichou, Netanel, Meiri, Oded
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US12/429,040
• Publication Number:
  US 20100049313A1
• Time in Patent Office: 1,762 Days
• Field of Search: 623/1.11, 623/1.12, 623/2.11, 623 212- 215, 623 217- 219, 606/200
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Embodiments of the present disclosure provide a prosthetic heart valve and a heart valve delivery apparatus for delivery of the prosthetic heart valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. In one embodiment, a self-expanding valve comprises an expandable stent that is shaped to maintain the valve in the aortic annulus against axial without anchors or retaining devices that engage the surrounding tissue. A delivery apparatus for delivering s self-expanding prosthetic valve can be configured to allow controlled and precise deployment of the valve from a valve sheath so as to minimize or prevent jumping of the valve from the valve sheath.

Claims

1. An assembly for delivering a prosthetic heart valve via a patient'"'"'s vasculature, comprising:

a prosthetic heart valve comprising a collapsible and expandable annular frame and a collapsible and expandable valve member mounted within the annular frame the valve member comprising a tricuspid valve configuration formed with pericardial tissue and configured for allowing blood flow in only one direction when in an expanded condition;

a heart valve delivery apparatus comprising;

a handle portion;

a first shaft having a proximal end portion and a distal end portion, the proximal end portion being connected to the handle portion;

a flexible second shaft extending through the first shaft, the second shaft and the first shaft being adapted to extend through the patient'"'"'s vasculature; and

a valve sheath having a proximal end portion coupled to the distal end portion of the first shaft, the valve sheath also having a distal end portion extending distally past the distal end portion of the first shaft, the distal end portion of the valve sheath defining a distal opening;

wherein the valve is in a compressed state and is disposed within the valve sheath, which extends over the entire length of the valve and retains the valve in the compressed state for delivery to the heart through the patient'"'"'s vasculature;

wherein when the valve is retained in a compressed state within the sheath, the sheath is in a distal position relative to the first shaft, wherein the second shaft is configured such that rotation of the second shaft relative to the first shaft and the sheath is effective to cause relative longitudinal movement between the sheath and the first shaft and between the sheath and the valve to cause the valve to be deployed outwardly through the distal opening of the sheath for deployment in the heart, and wherein the relative longitudinal movement between the sheath and the first shaft is effective to position the sheath at a proximal position relative to the first shaft in which the distal end of the sheath is proximal to the deployed valve.

2. The assembly of claim 1, wherein rotation of the second shaft causes the sheath to move longitudinally in a proximal direction toward the handle portion relative to the second shaft, the first shaft and the valve to advance the valve from the sheath for deployment in the heart, wherein the longitudinal movement of the sheath is effective to cause the sheath to slide over an outer surface of the first shaft in the proximal direction.

3. The assembly of claim 2, wherein the handle portion comprises a rotatable knob coupled to the second shaft and configured to rotate the second shaft relative to the sheath and the first shaft upon rotation of the knob.

4. The assembly of claim 3, wherein the handle portion comprises a first gear disposed on the second shaft and a second gear engaging the first gear and coupled to the knob to transmit rotational movement of the knob to the first gear and therefore the second shaft.

5. The assembly of claim 2, wherein the sheath comprises a threaded portion and a distal end portion of the second shaft comprises a threaded portion that engages the threaded portion of the sheath such that rotation of the second shaft threaded portion relative to the sheath threaded portion causes the sheath to move longitudinally relative to the second shaft, the first shaft and the valve so as to advance the valve from the distal opening of the sheath for deployment in the heart.

6. The assembly of claim 5, wherein the threaded portion of the sheath comprises an internally threaded portion of the sheath and the threaded portion of the second shaft distal end portion comprises an externally threaded portion.

7. The assembly of claim 6, wherein the externally threaded portion comprises an externally threaded cylindrical shaft.

8. The assembly of claim 6, wherein the externally threaded portion comprises a portion of a coiled shaft.

9. The assembly of claim 6, wherein the threaded portion of the second shaft comprises a plurality of axially spaced-apart screws disposed on a flexible shaft portion, the screws being configured to engage the threaded portion of the sheath.

10. The assembly of claim 1, further comprising a valve-retaining mechanism for coupling the valve to the delivery apparatus, the valve-retaining mechanism forming a releasable connection between the valve and the delivery apparatus, which connection can be released after the valve is advanced from the sheath.

11. The assembly of claim 10, wherein:

the frame of the valve comprises a plurality of angularly spaced posts each having a respective opening in an end portion thereof;

the valve-retaining mechanism comprises a first fork and a second fork, the first fork having a plurality of prongs, each having an opening, an end portion of each post of the frame extending radially inwardly through a corresponding opening of a prong of the first fork, the second fork having a plurality of prongs, each extending through an opening in a respective post of the frame and extending across an adjacent opening of a prong of the first fork along an inner surface of the prong of the first fork such that the post of the frame is blocked from being removed from the opening in the corresponding prong of the first fork, thereby connecting the frame to the valve-retaining mechanism, the second fork being movable longitudinally relative to the first fork to remove the prongs of the second fork from the openings in the frame posts, which allows the end portions of the posts to be withdrawn from the openings in the prongs of the first fork so as to release the connection between the valve and the valve-retaining mechanism.

12. The assembly of claim 11, wherein the second fork is co-axially positioned with respect to the first fork and wherein an end portion of each prong of the second fork is positioned between and engaged by an end portion of a corresponding frame post and a corresponding prong of the first fork.

13. The assembly of claim 12, wherein:

the shafts are movable longitudinally relative to each other;

the first fork is coupled to the distal end portion of the first shaft and the second fork is coupled to a distal end portion of the second shaft such that longitudinal movement of the second shaft in the proximal direction is effective to move the second fork in the same direction to remove its prongs from the openings in the stent posts to release the connection between the valve and the valve-retaining mechanism.

14. The assembly of claim 1, further comprising a valve-retrieval device adapted to be advanced over the first shaft while at least the distal end portion of the first shaft is in the patient'"'"'s vasculature, the valve-retrieval device comprising a radially expandable distal end portion that is adapted to extend over the valve when expanded and cause the expanded valve to compress for retrieving the valve back into the sheath.

15. The assembly of claim 1, further comprising a motor housed within the handle portion, the motor being configured to rotate the second shaft to effect deployment of the valve from the sheath upon activation of the motor.

16. The assembly of claim 15, wherein the motor comprises a two-way motor configured to rotate the second shaft in two directions.

17. An assembly for delivering a prosthetic, stented heart valve via a patient'"'"'s vasculature, comprising:

a prosthetic heart valve comprising a collapsible and expandable annular stent and a collapsible and expandable valve member mounted within the annular stent, the valve member comprising a tricuspid valve configuration formed with pericardial tissue and configured for allowing blood flow in only one direction when in an expanded condition;

a first elongated shaft having a distal end portion;

a second elongated shaft extending through the first shaft;

a valve sheath having a proximal end portion and a distal end portion, the proximal end portion of the sheath coupled to the distal end portion of the first shaft, the distal end portion of the sheath extending distally past the distal end portion of the first shaft, the distal end portion of the valve sheath defining a distal opening;

wherein the valve is in a compressed state and is disposed within the valve sheath, which extends over the entire length of the valve and retains the valve in the compressed state;

wherein the second shaft is configured such that rotation of the second shaft relative to the first shaft and the sheath is effective to cause the sheath to slide over the first shaft in a proximal direction away from the distal end portion of the first shaft to cause the valve to be deployed outwardly opening of the sheath for deployment in the heart; and

a valve-retaining mechanism coupling the valve to the distal end portion of the first shaft;

wherein the valve-retaining mechanism comprises a first fork and a second fork, each fork having a plurality of angularly spaced prongs, each prong of the first fork cooperating with a corresponding prong of the second fork to form a releasable connection with the stent of the valve, the second fork being movable relative to the first fork to release each connection formed by the prongs and the stent;

wherein the valve-retaining mechanism is configured to retain each connection with the stent of the valve after the valve is deployed from the valve sheath, and the valve-retaining mechanism also being configured such that the second fork is moveable relative to the first to release each connection upon movement longitudinal movement of the second shaft relative to the first shaft.

18. The assembly of claim 17, wherein:

the stent has a plurality of angularly spaced posts each having a respective opening in an end portion thereof;

each prong of the first fork has an opening, an end portion of each post of the stent extending radially inwardly through a corresponding opening of a prong of the first fork, the second fork having a plurality of prongs, each extending through an opening in a respective post of the stent and extending across an adjacent opening of a prong of the first fork such that the post of the stent is blocked from being removed from the opening in the corresponding prong of the first fork, thereby forming a releasable connection between the stent and the valve-retaining mechanism, the second fork being movable longitudinally relative to the first fork to remove the prongs of the second fork from the openings in the stent posts, which allows the end portions of the posts to be withdrawn from the openings in the prongs of the first fork so as to release each connection formed by the prongs and the stent.

19. The assembly of claim 17, wherein the prongs of the first and second forks are configured to transmit longitudinal and rotational movement of the second shaft to the valve to effect corresponding longitudinal and rotational movement, respectively, of the valve when the prongs are connected to the valve.

20. The assembly of claim 17, wherein the valve-retaining mechanism is configured to retain each releasable connection with the stent of the valve when the valve is expanded from a compressed state to an expanded state when deployed from the sheath in the patient'"'"'s body until the second fork is moved relative to the first fork to release each connection formed by the prongs and the stent.

21. The assembly of claim 17, wherein the first fork is connected to the distal end portion of the first shaft and the second fork is connected to a distal end portion of the second shaft, wherein moving the second shaft relative to the first shaft is effective to move the second fork relative to the first fork to release each connection formed by the prongs and the stent.