Anchor for medical implant placement and method of manufacture

• US 7,317,951 B2
• Filed: 07/24/2004
• Issued: 01/08/2008
• Est. Priority Date: 07/25/2003
• Status: Active Grant

• Current Assignee: UIM Pressure Implant Incorporated
• Original Assignee: Integrated Sensing Systems Incorporated
• Inventors: Najafi, Nader, Schneider, Richard Lee, Goetzinger, David J.
• Primary Examiner(s): DROESCH, KRISTEN L
• Application Number:
  US10/898,053
• Publication Number:
  US 20050065589A1
• Time in Patent Office: 1,263 Days
• Field of Search: 600/375, 607126-128
• US Class Current: 607/126
• 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 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 2017/00606 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 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

An anchor and procedure for placing a medical implant, such as for monitoring physiological parameters. The anchor includes a central body in which a medical implant can be received. Arms and members extend radially from first and second ends, respectively, of the central body. Each member defines a leg extending toward distal portions of the arms to provide a clamping action. The anchor and its implant are placed by coupling first and second guidewires to first and second portions of the anchor, placing an end of a delivery catheter in a wall where implantation is desired, inserting the anchor in the catheter with the guidewires to locate the anchor within the wall, deploying the arms of the anchor at one side of the wall followed by deployment of the members at the opposite side of the wall, and thereafter decoupling the guidewires from the anchor.

Claims

1. An anchor for a medical implant, the anchor comprising:

a central body comprising an annular-shaped body and having an axis, a bore for receiving the medical implant, and first and second ends in oppositely-disposed first and second axial directions, respectively, along the axis of the central body, the bore having an opening at the first end of the central body for receiving the medical implant in the second axial direction;

means for retaining the medical implant within the bore of the central body;

a plurality of arms and a plurality of members extending from the central body;

a first ring spaced axially from the annular-shaped body in the second axial direction, the members extending radially from the first ring;

a second ring between the first ring and the annular-shaped body; and

struts securing the second ring to the annular-shaped body, the medical implant being disposable within the annular-shaped body and the struts and securable therein by the retaining means;

the anchor having a deployed configuration wherein;

the arms extend substantially radially from the first end of the central body, each of the arms having a distal portion extending in the second axial direction relative to the central body; and

the members extend radially from the central body, each of the members defining a leg extending in the first axial direction toward the distal portions of the arms.

2. An anchor according to claim 1, wherein the retaining means is disposed at the first end of the central body and partially closes the opening of the bore to secure the medical implant within the bore.

3. An anchor according to claim 1, wherein each of the arms and members lies in a plane parallel to the axis of the central body.

4. An anchor according to claim 1, wherein each of the arms is axially aligned with a corresponding one of the members, and the distal portions of the arms oppose the legs of the members.

5. An anchor according to claim 1, wherein the anchor has not more than three of the arms and not more than three of the members.

6. An anchor according to claim 1, wherein the distal portions of the arms are pads oriented substantially transverse to the axis of the central body.

7. An anchor according to claim 1, wherein the first ring is secured to the central body by the members.

8. An anchor according to claim 7, wherein the first ring comprises means for coupling a guidewire thereto.

9. An anchor according to claim 8, wherein the coupling means comprises at least one element selected from the group consisting of cam slots, threads, snaps, snap latches, latch fingers, spring latches, latch fingers with a catheter sheet for releasing the latch, guidewires, catheters, dissolvable glues, temporary glues, thermal glues, heated shape memory latches, unheated shape memory latches, heated mechanical means, piezoelectric release systems, hydraulic coupling systems, pneumatic coupling systems, and magnetic coupling systems.

10. An anchor according to claim 1, wherein the second ring is spaced axially from the second end of the central body.

11. An anchor according to claim 10, wherein the second ring comprises means for coupling a guidewire thereto.

12. An anchor according to claim 11, wherein the coupling means comprises at least one element selected from the group consisting of cam slots, threads, snaps, snap latches, latch fingers, spring latches, latch fingers with a catheter sheet for releasing the latch, guidewires, catheters, dissolvable glues, temporary glues, thermal glues, heated shape memory latches, unheated shape memory latches, heated mechanical means, piezoelectric release systems, hydraulic coupling systems, pneumatic coupling systems, and magnetic coupling systems.

13. An anchor according to claim 1, wherein each of the first and second rings comprises means for coupling a guidewire thereto.

14. An anchor according to claim 13, wherein the coupling means of the second ring comprises threads and the coupling means of the first ring comprises a cam slot.

15. An anchor according to claim 1, wherein the first ring comprises means for coupling a guidewire thereto.

16. An anchor according to claim 1, wherein the second ring comprises means for coupling a guidewire thereto.

17. An anchor according to claim 1, wherein the central body, the arms, and the members are integral portions of a monolithic body.

18. An anchor according to claim 17, wherein laser cutting of a tube is used to produce the integral portions of the monolithic body.

19. An anchor according to claim 1, wherein the central body, the arms, the members, and the first ring are integral portions of a monolithic body.

20. An anchor according to claim 1, wherein the central body, the arms, the members, and the struts are integral portions of a monolithic body, and the second ring is metallurgically joined to the struts.

21. An anchor according to claim 20, wherein laser cutting of a tube is used to produce the integral portions of the monolithic body.

22. An anchor according to claim 1, wherein one or more of the following are integral portions of a monolithic body:

the central body, the arms, the members, the struts, and the first ring.

23. An anchor according to claim 1, wherein the annular-shaped body, the arms, and the second ring are integral portions of a first monolithic body, and the members and the first ring are integral portions of a second monolithic body which is joined or coupled to the first monolithic body.

24. An anchor according to claim 23, wherein laser cutting of at least one tube is used to produce the integral portions of the first and second monolithic body.

25. An anchor according to claim 1, wherein at least the arms and the members are formed of a shape-memory material.

26. A method of manufacturing the anchor according to claim 1, the method comprising the step of machining a monolithic body to form the central body, the arms, and the members.

27. A method of manufacturing the anchor according to claim 1, the method comprising the steps of:

machining a first monolithic tubular body to form the central body and the arms;

machining a second monolithic tubular body to form the members; and

attaching the second monolithic body to the first monolithic body.

28. A method according to claim 27, wherein the machining step is a laser cutting operation.

29. An anchor according to claim 1, wherein the implant is received within and secured to the central body, and the implant is communicatively connected to a medical device.

30. An anchor according to claim 29, wherein the medical device is a pacemaker.

31. An anchor according to claim 29, wherein the implant is communicatively connected to the medical device by a communication connection selected from the group consisting of electrical wires, pacemaker leads, flexible cables, optical connectors, ultrasonic pads, and electrophysiology signals.

32. An anchor for a cardiovascular implant, the anchor comprising:

a central body in which the cardiovascular implant is received, the central body having an axis and first and second ends in oppositely-disposed first and second axial directions, respectively, along the axis of the central body;

a plurality of arcuate arms extending from the first end of the central body;

a first ring spaced axially from the second end of the central body;

a plurality of arcuate members extending from the first ring toward the central body;

a second ring spaced axially from the second end of the central body and located between the central body and the first ring; and

means for securing the second ring to the central body;

wherein the cardiovascular implant is disposed within the central body and the securing means so that an axial end thereof axially abuts the second ring, and the anchor has a deployed configuration wherein the arcuate arms extend substantially radially from the first end of the central body, each of the arcuate arms has a distal portion extending in the second axial direction relative to the central body, the arcuate members extend radially from the second end of the central body, and each of the arcuate members defines a leg extending in the first axial direction toward the distal portions of tile arcuate arms.

33. An anchor according to claim 32, wherein the anchor further comprises means disposed at the first end of the central body for abutting an axial end of the cardiovascular implant opposite the axial end of the cardiovascular implant abutting the second ring.

34. An anchor according to claim 32, wherein each of the arcuate arms and arcuate members lies in a plane containing the axis of the central body.

35. An anchor according to claim 34, wherein each of the arcuate arms is axially aligned with a corresponding one of the arcuate members, and the distal portions of the arcuate arms oppose the legs of the arcuate members.

36. An anchor according to claim 32, wherein the anchor has not more than three of the arcuate arms and not more than three of the arcuate members.

37. An anchor according to claim 32, wherein the distal portions of the arcuate arms are oriented substantially transverse to the axis of the central body.

38. An anchor according to claim 32, wherein the first ring comprises means for coupling a guidewire thereto.

39. An anchor according to claim 32, wherein the second ring comprises means for coupling a guidewire thereto.

40. An anchor according to claim 32, wherein two or more of the following are integral portions of a monolithic body:

the central body, the arcuate arms, the arcuate members, the first ring, the second ring, and the securing means.

41. An anchor according to claim 32, wherein the central body, the arcuate arms, the second ring, and the securing means are integral portions of a monolithic body.

42. An anchor according to claim 41, wherein the securing means comprise a plurality of struts extending from the second end of the central body.

43. An anchor according to claim 41, wherein laser cutting of a tube is used to produce the integral portions of the monolithic body.

44. An anchor according to claim 32, wherein the central body, the arcuate arms, the second ring, and the securing means are integral portions of a first monolithic body, and the arcuate members and the first ring are integral portions of a second monolithic body which is joined or coupled to the first monolithic body.

45. An anchor according to claim 44, wherein laser cutting of a tube is used to produce the integral portions of the first and second monolithic bodies.

46. An anchor according to claim 32, wherein at least the arcuate arms and the arcuate members are formed of a shape-memory material.

47. A method of manufacturing the anchor according to claim 32, the method comprising the step of machining a monolithic body to form the central body, the arms, the second ring, and the securing means.

48. A method according to claim 47, wherein the machining step is a laser cutting operation.

49. A method of manufacturing the anchor according to claim 32, the method comprising the step of machining a monolithic body to form the members and the first ring.

50. A method according to claim 49, wherein the machining step is a laser cutting operation.

51. A method of manufacturing the anchor according to claim 32, the method comprising the steps of:

machining a first monolithic body to form the central body, the arms, the second ring, and the securing means;

machining a second monolithic body to form the members and the first ring; and

attaching the second monolithic body to the first monolithic body.

52. A method according to claim 51, wherein each of the machining steps is a laser cutting operation.