Trans-apical implant systems, implants and methods

• US 9,833,316 B2
• Filed: 12/08/2015
• Issued: 12/05/2017
• 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:
  US14/962,729
• Publication Number:
  US 20160089237A1
• Time in Patent Office: 728 Days
• 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:

an expandable spacer having a resilient flexible wall and defining a spacer cavity configured to be expanded from a retracted position to an expanded 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

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 fitting 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 the compression fitting comprises a clamp ring, a collar and a nut.

4. 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.

5. The implant of claim 4, wherein said anchor assembly further comprises a pledget material disposed on at least one arm.

6. The implant of claim 1, further comprising 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, to flow out of said spacer cavity to selectively deflate said spacer, or a combination thereof.

7. The implant delivery system of claim 6, 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 or out of said spacer cavity, and when in a second position, said plunger is configured to seal said spacer cavity.

8. The implant of claim 7, 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.

9. The implant of claim 8, wherein said plunger wire is threadedly coupled to said plunger.

10. The implant of claim of claim 6, further comprising an inflation handle assembly comprising an inflation port fluidly coupled to said inflation lumen.

11. The implant of claim 10, wherein said inflation port is configured to be secured to an inflation source.

12. The implant of claim 11, wherein the inflation source is selected from the group consisting of a plunger and a syringe.

13. An implant delivery system comprising:

an introducer including at least one lumen;

an implant configured to be received in said lumen, said implant comprising an expandable spacer and a shaft; 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;

wherein said spacer comprises a resilient flexible wall and defines a spacer cavity configured to be expanded from a retracted position to an expanded position, 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.

14. The implant delivery system of claim 13, 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.

15. The implant delivery system of claim 13, wherein said anchor assembly further comprises an anchor support defining at least one arm over which a suture is stitched.

16. The implant delivery system of claim 13, wherein said anchor assembly further comprises a pledget material disposed on at least one arm.

17. The implant delivery system of claim 13, further comprising 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, to flow out of said spacer cavity to selectively deflate said spacer, or a combination thereof.

18. The implant delivery system of claim 17, 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 or out of said spacer cavity, and wherein said plunger, when in a second position, is configured to seal said spacer cavity.

19. The implant delivery system of claim of claim 13, further comprising an inflation handle assembly comprising an inflation port fluidly coupled to said inflation lumen and is configured to be secured to an inflation source.