Systems and Methods For Placement of Valve Prosthesis System

• US 20080208328A1
• Filed: 10/10/2007
• Published: 08/28/2008
• Est. Priority Date: 02/23/2007
• Status: Abandoned Application

• Current Assignee: Endovalve, Inc. (Micro Interventional Devices, Inc.), Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Original Assignee: Endovalve, Inc. (Micro Interventional Devices, Inc.), Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Inventors: Castro, Salvatore, Lamphere, David G., Herrmann, Howard C., Antocci, Joseph D., Abesames, Gregorio Ramon M.
• Application Number:
  US11/870,001
• Publication Number:
  US 20080208328A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments

Abstract

Valve prosthesis systems and methods/systems for placement of such valve prostheses are provided that facilitate efficient, reliable and minimally invasive delivery modalities. The placement systems and methods permit remote manipulation and positioning of the valve prosthesis such that desirable placement relative to anatomical structures, e.g., the heart annulus, may be achieved. The valve prosthesis includes a resilient ring, a plurality of leaflet membranes mounted with respect to the resilient ring, and a plurality of positioning elements movably mounted with respect to the flexible ring. The delivery system includes a first elongate element that terminates at the valve prosthesis and is manipulable by an operator to remotely rotate the positioning elements relative to the flexible ring. A second elongate element terminates at the valve prosthesis and is manipulable by an operator to remotely advance the valve prosthesis downward into an anatomical annulus. The second elongate element may be manipulated to remotely advance the valve prosthesis into the anatomical annulus to assume a position for supporting post-implantation function of the valve prosthesis in situ. The first elongate element may be further manipulated to remotely rotate the positioning element relative to the flexible ring to cause the positioning element to engage tissue associated with the anatomical annulus and to thereby maintain the post-implantation position of the valve prosthesis in situ. Methods for valve prosthesis deployment are also provided.

Claims

1. A method of implanting a valve prosthesis with respect to an anatomical annulus, the method comprising:

providing, in a vicinity of the anatomical annulus;

a valve prosthesis including a resilient ring, a plurality of leaflet membranes mounted with respect to the resilient ring, and a plurality of positioning elements movably mounted with respect to the flexible ring;

a first elongate element terminating at the valve prosthesis and manipulable by an operator to remotely rotate the positioning elements relative to the flexible ring; and

a second elongate element terminating at the valve prosthesis and manipulable by an operator to remotely advance the valve prosthesis downward into the anatomical annulus;

manipulating the first elongate element to remotely rotate the positioning elements relative to the flexible ring

manipulating the second elongate element to remotely advance the valve prosthesis into the anatomical annulus to assume a position within the anatomical annulus suitable for supporting post-implantation function of the valve prosthesis in situ; and

manipulating the first elongate element to remotely further rotate the positioning element relative to the flexible ring to cause the positioning element to engage tissue associated with the anatomical annulus for maintaining the post-implantation position of the valve prosthesis in situ.

2. The method according to claim 1, wherein the first elongate element includes one or more filaments and the second elongate element is a delivery tube.

3. A delivery system for percutaneous delivery of a valve prosthesis, comprising:

a valve prosthesis including a flexible ring, a plurality of leaflet members mounted with respect to the flexible ring, and a plurality of positioning elements (i) mounted with respect to the flexible ring for engaging tissue at an anatomical location, and (ii) rotatable relative to the flexible ring to facilitate delivery and implantation of the valve prosthesis;

a first elongate element defining an internal lumen for accommodating a guide wire, the first elongate element being detachably mounted with respect to the valve prosthesis and manipulable by an operator to remotely position the valve prosthesis with respect to tissue at the anatomical location;

one or more second elongate elements manipulable by an operator to remotely rotate the plurality of positioning elements with respect to the flexible ring; and

a third elongate element manipulable by an operator to remotely decouple the first elongate element from the valve prosthesis after implantation thereof;

wherein for purposes of being so manipulated, each of the second elongate element and the third elongate element is adapted to translate with respect to the first elongate element when at least partially disposed together with the first elongate element within a central lumen of a delivery catheter.

4. The delivery system in accordance with claim 3, wherein the first elongate element includes a delivery tube, the second elongate element includes a flexible cable, and wherein the flexible cable is at least partially contained within the delivery tube.

5. The delivery system in accordance with claim 3, wherein the first elongate element includes a delivery tube, the third elongate element includes a flexible sleeve, and the delivery tube is at least partially contained within the flexible sleeve.

6. The delivery system in accordance with claim 3, wherein the third elongate element terminates in a tool capable of coupling the first elongate element and the valve prosthesis together, and wherein the third elongate element is manipulable to decouple the first elongate element from the valve prosthesis at least in part by rendering the tool incapable of continuing to couple the first elongate element and the valve prosthesis.

7. The delivery system in accordance with claim 6, wherein the third elongate element is manipulable to decouple the first elongate element from the valve prosthesis by removing the tool from a corresponding interface between the first elongate element and the valve prosthesis.

8. The delivery system in accordance with claim 7, wherein the tool at least partially surrounds a corresponding portion of the valve prosthesis and is operable to engage and hold the corresponding portion against the first elongate element.

9. The delivery system in accordance with claim 8, wherein the tool is a force-bearing loop of a flexible cable.

10. The delivery system in accordance with claim 7, wherein the tool at least partially surrounds a corresponding portion of the first elongate element and is operable to engage and hold the corresponding portion against the valve prosthesis.

11. The delivery system in accordance with claim 10, wherein the tool is a collar and the corresponding portion of the first elongate element is a finger, the finger being associated with a spring bias and being adapted to engage the valve prosthesis upon the collar overcoming the spring bias.

12. The delivery system in accordance with claim 3, wherein the third elongate element terminates in a tool capable of preventing the first elongate element and the valve prosthesis from becoming decoupled, and wherein the third elongate element is manipulable to decouple the first elongate element from the valve prosthesis at least in part by rendering the tool incapable of continuing to prevent the first elongate element and the valve prosthesis from becoming decoupled.

13. The delivery system in accordance with claim 12, wherein the tool is at least partially surrounded by a corresponding portion of the first elongate element and is operable to block movement of the corresponding portion away from the valve prosthesis.

14. The delivery system in accordance with claim 12, wherein the tool is a collar and the corresponding portion of the first elongate element is a finger, the finger being associated with a spring bias and being adapted to disengage the valve prosthesis when the collar no longer blocks movement of the finger away from the valve prosthesis and upon a concurrent defeat of the spring bias.

15. The delivery system in accordance with claim 14, wherein the third elongate element is manipulable to decouple the first elongate element from the valve prosthesis at least in part by removing the collar from a vicinity of the finger.

16. The delivery system in accordance with claim 14, wherein the third elongate element further includes a flexible cable extending upward from the force-bearing ring and extending alongside the first elongate element, and wherein the third elongate element is manipulable to decouple the first elongate element from the valve prosthesis at least in part by employing the flexible cable to pull the collar away from a vicinity of the finger.

17. The delivery system in accordance with claim 3, wherein the third elongate element includes a flexible cable terminating in a loop in a vicinity of the valve prosthesis for transmitting a force to at least one of the first elongate element and the valve prosthesis.

18. The delivery system in accordance with claim 17, wherein the flexible cable is adapted to transmit a coupling force whereby the loop thereof engages the valve prosthesis for pulling the valve prosthesis against the first elongate element, and wherein the third elongate element is manipulable to remotely decouple the first elongate element from the valve prosthesis via an operator withdrawing the coupling force, such that the loop of the flexible cable is caused to cease so engaging the valve prosthesis.

19. The delivery system in accordance with claim 17, wherein the flexible cable is adapted to transmit a decoupling force, whereby the loop engages a coupling element of the first elongate element for pulling the coupling element away from a corresponding coupling element of the valve prosthesis, and wherein the third elongate element is manipulable to remotely decouple the first elongate element from the valve prosthesis via an operator applying the decoupling force, such that the loop of the flexible cable is caused to engage the coupling element.

20. The delivery system in accordance with claim 3, wherein the third elongate element terminates in a displaceable ring at least partially surrounding the first elongate element in a vicinity of the valve prosthesis.

21. The delivery system in accordance with claim 20, wherein the displaceable ring is effective to maintain the first elongate element and the valve prosthesis in coupled engagement, and wherein the third elongate element further includes a flexible sleeve extending upward from the force-bearing ring, and at least partially surrounding the first elongate element.

22. The delivery system in accordance with claim 20, wherein the displaceable ring is effective to prevent the first elongate element and the valve prosthesis from being disengaged, and wherein the third elongate element further includes a flexible cable extending upward from the displaceable ring, extending alongside the first elongate element.

23. A tool for facilitating percutaneous delivery of a valve prosthesis to an anatomical location, comprising:

a body defining a longitudinal axis, a distal end disposed on the longitudinal axis, and a proximal end disposed on the longitudinal axis opposite the distal end;

a first actuator mounted with respect to the body at one of the distal end thereof and the proximal end thereof, the first actuator being configured to receive and engage a first elongate element manipulable to remotely rotate a positioning element associated with a valve prosthesis, and being reciprocally actuatable with respect to the body for manipulating the first elongate element by causing the first elongate element to translate with respect to a delivery tube along the longitudinal axis; and

a second actuator mounted with respect to the body at the other of the distal end thereof and the proximal end thereof, the second actuator being configured to receive and engage a second elongate element manipulable to remotely detach the delivery tube from the valve prosthesis, and being reciprocally actuatable with respect to the body for manipulating the second elongate element by causing the second elongate element to translate with respect to the delivery tube along the longitudinal axis.

24. The tool according to claim 23, wherein the valve prosthesis includes a flexible ring, a plurality of leaflet members mounted with respect to the flexible ring, and a plurality of positioning elements (i) mounted with respect to the flexible ring for engaging tissue associated with the anatomical structure and (ii) rotatable relative to the flexible ring to facilitate delivery and implantation of the valve prosthesis.

25. The tool according to claim 24, further comprising a delivery tube detachably coupled to the valve prosthesis and defining an internal lumen for accommodating a guide wire.