Implant Delivery and Deployment System and Method

• US 20090240326A1
• Filed: 04/28/2009
• Published: 09/24/2009
• Est. Priority Date: 10/26/2005
• Status: Active Grant

• Current Assignee: Cardiosolutions, Inc.
• Original Assignee: Cardiosolutions, Inc.
• Inventors: Polgar, Stephen R., St. John, Robert J., Wilson, Jonathan E.
• Granted Patent: US 8,216,302 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

An implant delivery system comprising a catheter including at least one lumen, an implant configured to be received in the lumen, and a latching mechanism configured to be received in the implant. The latching mechanism may be configured to releasably couple the implant to a delivery wire and to transmit a torque through the delivery wire to cause at least a portion of the implant to rotate. The an implant may comprise a shaft, a spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position, a garage configured to couple the spacer to a first end region of the shaft, and at least one anchor mechanism. The garage may define a cavity configured to receive the latching mechanism and to increase rotational and translational stability of the latching mechanism.

Claims

1. An implant delivery system comprising:

a catheter including at least one lumen;

an implant configured to be received in said lumen; and

a latching mechanism configured to be received in said implant, said latching mechanism further configured to releasably couple said implant to a delivery wire and to transmit a torque through said delivery wire to cause at least a portion of said implant to rotate.

2. The implant delivery system of claim 1, wherein said implant comprises a shaft, a spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through said heart valve in a closed position, at least one anchor mechanism coupled to a first end region of said shaft.

3. The implant delivery system of claim 2, wherein said latching mechanism comprises a first and at least a second latch pin configured to engage with each other to form a connection, wherein said first latching pin is coupled to said delivery wire and said second latching pin is configured to be coupled to said implant.

4. The implant delivery system of claim 3, further comprising a sleeve defining lumen having a distal end region configured to receive at least a portion of said delivery wire and said first and said second latching pins.

5. The implant delivery system of claim 4, wherein said lumen of said sleeve is further to substantially prevent movement of said first latching pin relative to said second latching pin when said first and said second latching pins are received in said distal end region.

6. The implant delivery system of claim 5, wherein said implant further comprises garage configured to couple said spacer to said shaft, said garage defining a cavity configured to receive said distal end region of said sleeve to increase rotational and translational stability of said sleeve.

7. The implant delivery system of claim 6, wherein sleeve is configured to be retracted to expose at least one of said latching pins from said distal end region and to decouple said first latching pin from said second latching pin.

8. The implant delivery system of claim 5, wherein said distal end region of said sleeve further comprises at least one opening configured to provide a passageway between said lumen of said sleeve and said spacer of said implant.

9. The implant delivery system of claim 5, further comprising an anchoring having a first end coupled to said second latching pin and a second end coupled to said anchoring mechanism.

10. The implant delivery system of claim 9, wherein said anchoring mechanism comprises a cavity configured to at least partially receive a helical screw.

11. The implant delivery system of claim 10, wherein said anchoring mechanism further comprises a threaded region secured within said cavity, said threaded region having a thread pitch and size substantially corresponding to a first threaded region of said helical screw.

12. The implant delivery system of claim 11, wherein said helical screw further comprises a second threaded region disposed proximate said anchoring wire, said second threaded region configured to not pass through said threaded insert.

13. An implant comprising:

a shaft;

a spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through said heart valve in a closed position;

a garage configured to couple said spacer to a first end region of said shaft, said garage defining a cavity configured to receive a latching mechanism and to increase rotational and translational stability of said latching mechanism; and

at least one anchor mechanism coupled to a second end region of said shaft.

14. The implant of claim 13, wherein said anchor mechanism comprises a cavity configured to at least partially receive a helical screw, said helical screw coupled to a first end of an anchoring wire, wherein a second end of said helical screw is coupled to a latching pin configured to be received in said cavity of said garage.

15. The implant of claim 14, wherein said anchoring mechanism further comprises a threaded region secured within said cavity, said threaded region having a thread pitch and size substantially corresponding to a first threaded region of said helical screw.

16. The implant of claim 15, wherein said helical screw further comprises a second threaded region disposed proximate said anchoring wire, said second threaded region configured to not pass through said threaded insert.

17. The implant of claim 13, wherein said anchoring mechanism further comprises a pledget configured to stimulate ingrowth of tissue.

18. A method of delivering an implant within a heart, said implant including a shaft, a spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through said heart valve in a closed position, and at least one anchor mechanism coupled to a first end region of said shaft, said method comprising.

providing a delivery wire having a first latch pin;

coupling said first latch pin to a second latch pin disposed within said implant;

advancing a distal end of a sleeve over said first and said second latch pins to prevent movement of said first and said second latch pins;

percutaneously delivering a catheter proximate said heart;

loading said implant and said distal end of said sleeve into said catheter; and

advancing said implant and said distal end of said sleeve through said catheter.

19. The method of claim 18, further comprising rotating said delivery wire and transmitting torque through said first and said second pins to cause said anchoring mechanism to engage tissue within said heart.

20. The method of claim 19, further comprising:

retracting said distal end of said sleeve to expose at least one of said first and second pins; and

decoupling said first and said second latching pins.