Mitral valve spacer and system and method for implanting the same

• US 9,545,305 B2
• Filed: 08/18/2014
• Issued: 01/17/2017
• Est. Priority Date: 06/14/2013
• Status: Active Grant

• Current Assignee: Cardiosolutions, Inc.
• Original Assignee: Cardiosolutions, Inc.
• Inventors: Wilson, Jonathan E., Murphy, John, Robertson, Jack, Seguin, Christopher
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US14/461,549
• Publication Number:
  US 20140371846A1
• Time in Patent Office: 883 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.36
• US Class Current: 1/1
• 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
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A heart valve implant is disclosed herein. The heart valve implant comprises an inflatable valve body, a shaft, an anchor assembly and an inflation (injection) port. Also disclosed herein, are methods of trans-apically and trans-septally delivering a heart valve implant within a heart such that the valve body can be inflated in situ to partially or completely restrict blood flow through a heart valve in a closed position. The inflation (injection) port permits inflation of the valve body with an adjustable amount of an inflation fluid to attain a desired degree of inflation of the valve body when disposed within the heart valve.

Claims

1. A mitral valve implant comprising:

an inflatable valve body defining a cavity;

a shaft extending from the inflatable valve body to a terminal end, said shaft comprising a lumen in fluid communication with said cavity; and

an anchor assembly coupled to the shaft between the inflatable valve body and an inflation port, said anchor assembly comprising a passageway, a compression fitting, and an anchor support, said anchor support comprising one or more arms extending outwardly from the passageway, wherein each of the one or more arms extends less than 360°

around the passageway;

wherein the inflation port is coupled to the terminal end of the shaft, and the inflation port comprising one or more lumens in fluid communication with the shaft lumen; and

wherein the inflatable valve body in an inflated state is sized for at least partial placement in a mitral valve so as to at least partially restrict a flow of blood through the mitral valve in a closed position of the mitral valve.

2. The mitral valve implant of claim 1, wherein the inflation port further comprises a pierceable septum configured to fluidly seal the inflation port.

3. The mitral valve implant of claim 1, wherein the inflation port is configured to be secured subdermally via placement of the inflation port below the dermis but superficial to deeper tissue.

4. The mitral valve implant of claim 1, wherein each of the one or more arms defines an opening.

5. The mitral valve implant of claim 1, wherein the inflatable valve body is partially or completely inflated with an inflation fluid when said inflatable valve body is at least partially placed in the mitral valve.

6. The mitral valve implant of claim 1, further comprising one or more radiopaque markers on the shaft at or near the inflatable valve body.

7. The mitral valve implant of claim 1, wherein the shaft lumen in fluid communication with the inflatable valve body comprises one or more openings.

8. The mitral valve implant of claim 1, wherein the shaft comprises a first region having a first stiffness and a second region having a second stiffness;

and wherein the first region of the shaft is configured to be located within a heart and the second region of the shaft is configured to be located outside the heart.

9. The mitral valve implant of claim 8, wherein the first region of the shaft exhibits a stiffness greater than a stiffness of the second region of the shaft.

10. The mitral valve implant of claim 1, wherein the anchor assembly is configured to be secured to an exterior surface of a heart.

11. The mitral valve implant of claim 1, wherein the inflatable valve body at least partially expands from a collapsed state to the inflated state when the inflatable valve body is partially inflated with an inflation fluid.

12. The mitral valve implant of claim 1, further comprising one or more radiopaque markers.