Heart anchor device

• US 9,681,948 B2
• Filed: 01/23/2007
• Issued: 06/20/2017
• Est. Priority Date: 01/23/2006
• Status: Active Grant

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Rosenberg, Meir, Levi, Tamir, Ben-Amotz, Ori, Benbenisti, Eyal, Shafrir, Roey, Cohen, Itshak, Rozy, Yoram, Harel, Tamar, Kopelman, Doron
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US12/223,080
• Publication Number:
  US 20150039084A1
• Time in Patent Office: 3,801 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00035 pH
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/00853 low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442

Abstract

A medical implant including an anchor portion including a plurality of arms adapted to engage an internal tissue wall of a body from two opposite faces, wherein the anchor portion is configured such that at least one of the arms does not have an entirely overlapping arm on the other side of the wall and an opening portion adapted to define an opening for blood flow through the internal tissue wall, when the anchor portion engages the wall.

Claims

1. A medical implant, comprising:

an anchor portion comprising a first plurality of arms adapted to engage a face of an atrial septum of a body and a second plurality of arms adapted to engage an opposing face of the atrial septum, wherein the anchor portion is configured such that at least one of the arms of the first plurality does not have an entirely overlapping arm in the second plurality on the opposing face of the atrial septum, and wherein the anchor portion does not penetrate the atrial septum; and

an opening portion adapted to define an opening for blood flow through the atrial septum, when the anchor portion engages the atrial septum.

2. A medical implant according to claim 1, wherein the opening portion is adapted to radially expand in changing from a collapsed state to a deployed state.

3. A medical implant according to claim 1, wherein a largest end to end extent of the anchor portion in a deployed state is at least twice the largest end to end extent of the opening defined by the opening portion.

4. A medical implant according to claim 1, wherein the first and second pluralities of arms are formed of a super-elastic material.

5. A medical implant according to claim 1, wherein the opening portion comprises a ring surrounding the defined opening.

6. A medical implant according to claim 1, wherein the anchor portion and opening portion are configured to have a low profile of less than 3 millimeters in a deployed state not on a tissue wall.

7. A medical implant according to claim 1, wherein the first and second pluralities of arms comprise flexible elongate elements.

8. A medical implant according to claim 1, wherein the first and second pluralities of arms comprise petals.

9. A medical implant according to claim 1, wherein in the deployed state at least one of the arms of the first plurality of arms does not have a partially overlapping arm from the second plurality of arms.

10. A medical implant according to claim 1, wherein the first and second pluralities of arms are configured to surround the opening in a deployed state and wherein most of the arms in the first plurality of arms are neighbored along a line surrounding the opening by two arms in the second plurality of arms.

11. A medical implant according to claim 1, wherein most of the arms of the first plurality of arms do not have arms overlapping them in the second plurality of arms, in the deployed state.

12. A medical implant according to claim 1, wherein the anchor portion and the opening portion are comprised in a single element.

13. A medical implant according to claim 1, wherein the opening is configured to remain clear from elements mounted therein.

14. A medical implant according to claim 1, comprising a valve mounted on the anchor portion in a manner which regulates flow through an opening defined by the opening portion.

15. A medical implant according to claim 14, wherein the valve is formed together with the anchor portion from a same sheet, wire or tube.

16. A medical implant according to claim 14, wherein the valve is at least partially formed from a different material from the anchor portion.

17. A medical implant according to claim 14, comprising a sensor mounted on the anchor portion.

18. A medical implant according to claim 1, wherein portions of the implant are covered by ePTFE or polyurethane.

19. A medical implant according to claim 1, wherein the first and second pluralities of arms are arranged alternately around the opening, such that each arm of the first plurality of arms is neighbored by an arm of the second plurality of arms on one side and another arm of the second plurality of arms on the opposite side.

20. A medical implant according to claim 1, wherein the medical implant has a collapsed state and a deployed state and wherein the opening portion is adapted to apply a radial force when released from the collapsed state.

21. A medical implant according to claim 1, wherein at least one of the arms of the first or second plurality of arms comprises a wire with a curved shape.

37. A method for delivering the medical implant of claim 1, the method comprising:

creating an orifice in the atrial septum of the body via a transeptal puncture tool; and

deploying the medical implant within the orifice such that the anchor portion engages the atrial septum and the opening portion defines an opening for blood flow through the orifice of the atrial septum.

38. A method according to claim 37, wherein the transseptal puncture tool comprises a needle and a dilator catheter.

39. A method according to claim 37, wherein deploying the medical implant within the orifice comprises percutaneously deploying the medical implant such that the medical implant self-expands within the orifice and expands the orifice.

22. A medical implant, comprising:

an anchor portion adapted to attach to an atrial septum of a body without penetrating the atrial septum, the anchor portion comprising a plurality of arms adapted to be located on opposite sides of the attachment to the atrial septum by including parts adapted to be located on opposite sides of the atrial septum; and

an opening portion adapted to define an opening for blood flow when deployed within the body, which opening has a length of less than 3 millimeters, in which blood passing through the opening comes in contact with the implant.

23. An implant according to claim 22, wherein the plurality of arms located on opposite sides of the attachment to the atrial septum do not entirely overlap with one another.

24. An implant according to claim 22, wherein the anchor portion comprises a plurality of elongate elements extending radially from the opening portion, wherein a first group of the elongate elements are adapted to be located on one side of the atrial septum and a second group of the elongate elements is adapted to be located on a second side of the atrial septum.

25. An implant according to claim 24, wherein each of the first and second groups comprises at least three elongate elements.

26. An implant according to claim 24, wherein at least some of the elongate elements comprise petal shaped elements.

27. An implant according to claim 24, wherein at least some of the elongate elements comprise hoof shaped elements.

28. An implant according to claim 22, wherein the anchor portion and opening portion are formed from a single piece.

29. An implant according to claim 22, wherein the anchor portion and opening portion are configured to have in a deployed state a low profile of less than 3 millimeters.

30. An implant according to claim 22, comprising a skirt surrounding the opening defined by the opening portion.

31. An implant according to claim 22, comprising a closure unit adapted to block blood flow through the opening.

32. An implant according to claim 31, wherein the closure unit is part of a valve which controls the extent of blood flow through the opening.

33. A medical implant, comprising:

an anchor portion adapted to attach to an atrial septum of a body without penetrating the atrial septum; and

an opening portion adapted to define an opening for blood flow when deployed within the body, which opening has a length of less than 3 millimeters, in which blood passing through the opening comes in contact with the implant,

wherein the opening portion is adapted to cover less than 20% of the perimeter of the opening it defines.

34. A medical implant, comprising:

an anchor portion adapted to attach to an atrial septum of a body without penetrating the atrial septum; and

an opening portion adapted to define an opening for blood flow when deployed within the body, which opening has a length of less than 3 millimeters, in which blood passing through the opening comes in contact with the implant,

wherein the anchor portion is configured to engage the atrial septum such that a length in which blood passing through the opening comes in contact with the implant is less than 1 millimeter thicker than the atrial septum.

35. A medical implant, comprising:

an anchor portion adapted to attach to an atrial septum of a body without penetrating the atrial septum; and

an opening portion adapted to define an opening for blood flow when deployed within the body, which opening has a length of less than 3 millimeters, in which blood passing through the opening comes in contact with the implant,

wherein the anchor portion and opening portion are configured to have a low profile of less than 15% of an end to end extent of the anchor portion in a deployed state.

36. A medical implant, comprising:

an anchor portion adapted to attach to an atrial septum of a body without penetrating the atrial septum; and

an opening portion adapted to define an opening for blood flow when deployed within the body, which opening has a length of less than 3 millimeters, in which blood passing through the opening comes in contact with the implant,

wherein in the deployed state, the implant does not include parts within the opening defined by the opening portion, beyond parts of the opening portion defining the opening.