Trans-apical implant systems, implants and methods

• US 9,232,998 B2
• Filed: 03/15/2013
• Issued: 01/12/2016
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Cardiosolutions, Inc.
• Original Assignee: Cardiosolutions, Inc.
• Inventors: Wilson, Jonathan E., Robertson, Jack, Seguin, Christopher, Murphy, John
• Primary Examiner(s): SEVERSON, RYAN J
• Application Number:
  US13/838,752
• Publication Number:
  US 20140277404A1
• Time in Patent Office: 1,033 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• 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
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

A trans-apical implant includes a spacer defining spacer cavity configured to be expanded from a retracted position, a shaft extending from the spacer, the shaft defining an inflation lumen fluidly coupled to the spacer cavity and configured to be fluidly coupled to an expansion medium source, and a spacer valve assembly disposed within at least one of the spacer or shaft, the spacer valve assembly configured to allow selectively allow an expansion medium to flow into the spacer cavity to be selectively expand the spacer from a retracted position to an expanded position.

Claims

1. An implant comprising:

a spacer defining a spacer cavity configured to be expanded from a retracted position;

a shaft extending from said spacer, said shaft defining an inflation lumen fluidly coupled to said spacer cavity and configured to be fluidly coupled to an expansion medium source;

a spacer valve assembly disposed within at least one of said spacer or shaft, said spacer valve assembly configured to selectively allow an expansion medium to flow into said spacer cavity to selectively expand said spacer from a retracted position to an expanded position; and

an anchor assembly configured to be advanced over said shaft and secured to a portion thereof, said anchor assembly further configured to be secured to an exterior surface of a patient'"'"'s heart.

2. The implant of claim 1, wherein said anchor assembly comprises a compression connection configured to apply a radially compressive force against said shaft to secure said anchor assembly to said shaft.

3. The implant of claim 2, wherein said anchor assembly further comprises an anchor support defining at least one arm over which a suture is stitched.

4. An implant comprising:

a spacer defining a spacer cavity configured to be expanded from a retracted position;

a shaft extending from said spacer, said shaft defining an inflation lumen fluidly coupled to said spacer cavity and configured to be fluidly coupled to an expansion medium source; and

a spacer valve assembly disposed within at least one of said spacer or shaft, said spacer valve assembly configured to selectively allow an expansion medium to flow into said spacer cavity to selectively expand said spacer from a retracted position to an expanded position;

wherein said spacer valve assembly further comprises a plunger configured to be slidably disposed within said inflation lumen, wherein said plunger, when in a first position, is configured to allow said expansion medium to flow into said spacer cavity, and wherein said plunger, when in a second position, is configured to seal said spacer cavity.

5. The implant of claim 4, wherein a portion of said inflation lumen includes a taper which decreases over a length thereof, wherein said plunger is configured to selectively seal and unseal against said inflation lumen depending on the location of said plunger with respect to said taper.

6. The implant of claim 4, wherein plunger is coupled to a plunger wire extending through said inflation lumen in said shaft and beyond a proximal end of said shaft, wherein said plunger wire is configured to selectively move said plunger within said inflation lumen.

7. The implant of claim 6, wherein said plunger wire is threadedly coupled to said plunger.

8. An implant delivery system comprising:

an introducer including at least one lumen;

an implant configured to be received in said lumen, said implant comprising a spacer and a shaft, wherein said spacer defines a spacer cavity configured to be expanded from a retracted position while disposed within said lumen of said introducer, and wherein said shaft extends from said spacer and defines an inflation lumen fluidly coupled to said spacer cavity and configured to be fluidly coupled to an expansion medium source; and

an anchor assembly configured to be advanced over said shaft and secured to a portion thereof, said anchor assembly further configured to be secured to an exterior surface of a patient'"'"'s heart.

9. The implant delivery system of claim 8, wherein said anchor assembly comprises a compression connection configured to apply a radially compressive force against said shaft to secure said anchor assembly to said shaft.

10. The implant delivery system of claim 9, wherein said anchor assembly further comprises an anchor support defining at least one arm over which a suture is stitched.

11. The implant delivery system of claim 8, wherein said implant further comprises a spacer valve assembly configured to allow said spacer cavity to be selectively expanded.

12. The implant delivery system of claim 11, wherein said spacer valve assembly further comprises a plunger configured to be slidably disposed within said inflation lumen, wherein said plunger, when in a first position, is configured to allow said expansion medium to flow into said spacer cavity, and wherein said plunger, when in a second position, is configured to seal said spacer cavity.

13. The implant delivery system of claim 12, wherein a portion of said inflation lumen includes a taper which decreases over a length thereof, wherein said plunger is configured to selectively seal and unseal against said inflation lumen depending on the location of said plunger with respect to said taper.

14. The implant delivery system of claim 12, wherein said plunger is coupled to a plunger wire extending through said inflation lumen in said shaft and beyond a proximal end of said shaft, wherein said plunger wire is configured to selectively move said plunger within said inflation lumen.

15. The implant delivery system of claim 14, wherein said plunger wire is threadedly coupled to said plunger.

16. A method of trans-apically delivering an implant within a heart, said implant including a shaft and a spacer configured to interact with at least a portion of at least one cusp of a mitral valve to at least partially restrict a flow of blood through said heart valve in a closed position, said method comprising:

trans-apically advancing an introducer through an incision in an apex of said heart into a left ventricle;

advancing said introducer through said mitral valve into a left atrium;

advancing said implant through a lumen, defined by said introducer, into said left atrium, wherein said shaft extends within said lumen from said spacer and beyond said incision in said heart;

introducing an expansion medium through said shaft to expand said spacer;

locating said spacer within said mitral valve to reduce mitral regurgitation;

removing said introducer from said heart; and

securing said implant to an external surface of said heart proximate to said apex.

17. The method of claim 16, further comprising:

advancing an anchor assembly over said shaft until said anchor assembly abuts said exterior surface of said heart; and

stitching said anchor assembly to tissue proximate said apex.

18. The method of claim 16, wherein introducing said expansion medium through said shaft to expand said spacer comprises selectively moving a plunger disposed within at least one of said spacer or said shaft to selective seal said spacer.