COLLAPSIBLE/ EXPANDABLE PROSTHETIC HEART VALVE DELIVERY SYSTEM AND METHODS

• US 20110257734A1
• Filed: 10/29/2009
• Published: 10/20/2011
• Est. Priority Date: 10/30/2008
• Status: Active Grant

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Chalekian, Aaron J.
• Granted Patent: US 9,119,715 B2
• 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 2/2427 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Abstract

A system for delivering a medical implant includes an expandable member at least partially positioned inside the medical implant and operable to radially expand at least a portion of the medical implant to an expanded condition, first and second grasping mechanisms each adapted to grasp a portion of the medical implant, and a displacement mechanism operatively coupled to the first and second grasping mechanisms and configured to move the first and second grasping mechanisms between an inner position in which the first and second grasping mechanisms are relatively close to one another, and an outer position in which the first and second grasping mechanisms are relatively distant to one another. The movement of the first and second grasping mechanisms from the outer position to the inner position at least partially collapses the medical implant from the expanded condition to enable the medical implant to be repositioned if necessary.

Claims

1. A system for delivering and positioning a medical implant, comprising:

an expandable member at least partially positioned inside a medical implant and operable to radially expand at least a portion of the medical implant to an expanded condition;

a first grasping mechanism adapted to grasp a first portion of the medical implant;

a second grasping mechanism adapted to grasp a second portion of the medical implant; and

a displacement mechanism operatively coupled to the first and second grasping mechanisms and configured to move the first and second grasping mechanisms between an inner position in which the first and second grasping mechanisms are relatively close to one another, and an outer position in which the first and second grasping mechanisms are relatively distant to one another;

wherein movement of the first and second grasping mechanisms from the outer position to the inner position at least partially collapses the medical implant from the expanded condition.

2. The system according to claim 1, wherein the displacement mechanism includes a displacement sheath surrounding at least a portion of the first and second grasping mechanisms, the displacement sheath being configured to move longitudinally along the first and second grasping mechanisms between a proximal position and a distal position.

3. The system according to claim 2, wherein movement of the displacement sheath from the proximal position to the distal position moves the first and second grasping mechanisms from the outer position to the inner position, and movement of the displacement sheath from the distal position to the proximal position moves the first and second grasping mechanisms from the inner position to the outer position.

4. The system according to claim 1, wherein the expandable member includes a balloon.

5. The system according to claim 1, wherein the expandable member includes a plurality of balloons.

6. The system according to claim 1, wherein at least one of the first and second grasping mechanisms includes a jaw section having an outer jaw member and an inner jaw member, the outer and inner jaw members being adapted to move between an open position in which the outer and inner jaw members are spaced apart from one another, and a closed position in which the outer and inner jaw members are relatively close to one another.

7. The system according to claim 6, wherein the inner jaw member is resiliently biased away from the outer jaw member.

8. The system according to claim 6, wherein the inner jaw member is at least partly made of a shape memory material.

9. The system according to claim 6, further comprising an engagement sheath surrounding at least a portion of the at least one grasping mechanism, the engagement sheath being translatable along the at least one grasping mechanism between a proximal position and a distal position.

10. The system according to claim 9, wherein movement of the engagement sheath from the proximal position to the distal position moves the outer and inner jaw members from the open position to the closed position, and movement of the engagement sheath from the distal position to the proximal position moves the outer and inner jaw members from the closed position to the open position.

11. The system according to claim 6, wherein the inner jaw member includes at least one protrusion extending toward the outer jaw member.

12. The system according to claim 11, wherein a free end of the at least one protrusion includes a hook.

13. The system according to claim 1, further comprising third and fourth grasping mechanisms each adapted to grasp at least a portion of the medical implant.

14. The system according to claim 12, wherein the third grasping mechanism is positioned between the first and second grasping mechanisms and the fourth grasping mechanism is diametrically opposed to the third grasping mechanism.

15. The system according to claim 1, wherein the expandable member includes two balloons having inflated and deflated conditions, the balloons in the inflated condition defining spaces between the balloons and the medical implant, the first and second grasping mechanisms being positioned in the spaces.

16. A system for delivering and positioning a prosthetic heart valve inside a patient'"'"'s body, comprising:

a first grasping mechanism adapted to grasp a first portion of a prosthetic heart valve, the first grasping mechanism including a first jaw section;

a second grasping mechanism adapted to grasp a second portion of the prosthetic heart valve, the second grasping mechanism including a second jaw section;

a tubular member assembled over a portion of the first and second grasping mechanisms and movable between a distal position in which the first and second grasping mechanisms are relatively close to one another, and a proximal position in which the first and second grasping mechanisms are relatively distant to one another;

an inflatable member at least partially positioned inside the prosthetic heart valve and operable to radially expand the prosthetic heart valve to an expanded condition; and

a conduit disposed in fluid communication with the inflatable member for supplying an inflation fluid to the inflatable member.

17. The system according to claim 16, wherein the conduit is adapted to receive a guidewire.

18. A method of delivering and positioning an expandable medical implant inside a patient'"'"'s body, comprising:

providing a medical implant in a collapsed condition with a first expandable member inside the medical implant;

maneuvering the medical implant to a first position in the patient'"'"'s body proximate a desired position;

radially expanding the first expandable member such that the medical implant partially expands and portions of the periphery of the medical implant engage tissue in the first position;

radially collapsing a portion of the medical implant;

repositioning the medical implant to a second position relative to the desired position; and

radially expanding the collapsed portion of the medical implant so that portions of the periphery of the medical implant engage tissue in the second position.

19. The delivery and positioning method according to claim 18, further comprising:

removing the first expandable member from the patient'"'"'s body;

positioning a second expandable member at least partially within the medical implant in the second position; and

radially expanding the second expandable member such that the medical implant expands and substantially the entire periphery of the medical implant engages tissue in the second position.