Method and anchor for medical implant placement, and method of anchor manufacture

• US 20050065589A1
• Filed: 07/24/2004
• Published: 03/24/2005
• 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.
• Granted Patent: US 7,317,951 B2
• Time in Patent Office: Days
• 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 in which the medical implant is received, the central body having an axis and first and second ends in oppositely-disposed first and second directions, respectively, along the axis of the central body;

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

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

2. An anchor according to claim 1, wherein the anchor further comprises a fingers on the central body, the fingers gripping the medical implant for securing the medical implant to the anchor.

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 anchor further comprises a ring spaced axially from the second end of the central body and secured to the central body by the members.

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

9. An anchor according to claim 1, wherein the anchor further comprises a ring spaced axially from the second end of the central body, and struts securing the ring to the central body, the medical implant being disposed within the central body and the struts.

10. An anchor according to claim 9, wherein the ring comprises means for securing a guidewire thereto.

11. An anchor according to claim 1, wherein the central body comprises an annular-shaped body, a first ring spaced axially from the annular-shaped body, and a second ring between the first ring and the annular-shaped body, wherein the second end of the central body is defined by the first ring such that the members extend radially from the first ring.

12. An anchor according to claim 11, wherein the central body further comprises struts securing the ring to the annular-shaped body, the medical implant being disposed within the annular-shaped body and the struts.

13. An anchor according to claim 11, wherein the first ring comprises means for securing a guidewire thereto.

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

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

16. An anchor according to claim 15, wherein laser cutting of a tube is used to produce the integral portions of the monolithic body.

17. An anchor according to claim 7, wherein the central body, the arms, the members, and the ring are integral portions of a monolithic body.

18. An anchor according to claim 9, wherein the central body, the arms, the members, and the struts are integral portions of a monolithic body, and the ring is metallurgically joined to the struts.

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

20. An anchor according to claim 11, 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 ring.

21. An anchor according to claim 20, 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.

22. An anchor according to claim 21, wherein laser cutting of at least one tube is used to produce the integral portions of the first and second monolithic body.

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

39. 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.

40. 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.

41. A method according to claim 40, wherein the machining step is a laser cutting operation.

24. 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 directions, respectively, along the axis of the central body;

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

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

a plurality of arcuate members extending radially from the first ring toward the central body, each of the arcuate members defining a leg extending in the first direction toward the distal portions of the arcuate arms;

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.

25. An anchor according to claim 24, wherein the anchor further comprises fingers on the first end of the central body, the fingers gripping the cardiovascular implant for securing the cardiovascular implant to the anchor.

26. An anchor according to claim 24, wherein each of the arcuate arms and arcuate members lies in a plane containing the axis of the central body.

27. An anchor according to claim 26, 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.

28. An anchor according to claim 24, wherein the anchor has not more than three of the arcuate arms and not more than three of the arcuate members.

29. An anchor according to claim 24, wherein the distal portions of the arcuate arms are oriented substantially transverse to the axis of the central body.

30. An anchor according to claim 24, wherein the first ring comprises means for securing a guidewire thereto.

31. An anchor according to claim 24, wherein the second ring comprises means for securing a guidewire thereto.

32. An anchor according to claim 24, 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.

33. An anchor according to claim 24, wherein the central body, the arcuate arms, the second ring, and the securing means are integral portions of a monolithic body.

34. An anchor according to claim 33, wherein the securing means comprise a plurality of struts extending from the second end of the central body.

35. An anchor according to claim 33, wherein laser cutting of a tube is used to produce the integral portions of the monolithic body.

36. An anchor according to claim 24, 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.

37. An anchor according to claim 36, wherein laser cutting of a tube is used to produce the integral portions of the first and second monolithic bodies.

38. An anchor according to claim 24, wherein at least the arcuate arms and the arcuate members are formed of a shape-memory material.

42. A method of manufacturing the anchor according to claim 24, the method comprising the step of machining a monolithic body to form the central body, the arms, the second ring, and the securing means.

43. A method according to claim 42, wherein the machining step is a laser cutting operation.

44. A method of manufacturing the anchor according to claim 24, the method comprising the step of machining a monolithic body to form the members and the first ring.

45. A method according to claim 44, wherein the machining step is a laser cutting operation.

46. A method of manufacturing the anchor according to claim 24, 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.

47. A method according to claim 46, wherein each of the machining steps is a laser cutting operation.

48. A method of placing a medical implant, the method comprising the steps of:

coupling at least a first guidewire to a first portion of an anchor in which the medical implant is received and coupling at least a second guidewire to a second portion of the anchor, the anchor having an axis that is coaxial with the first and second guidewires;

placing an end of a delivery catheter through an internal wall of a human body;

inserting the anchor in the delivery catheter with the first and second guidewires so as to place the anchor within the internal wall and a plurality of arms extending from the anchor are released from the end of the delivery catheter;

retracting the first and second guidewires through the delivery catheter so that the arms of the anchor contact a first side of the internal wall;

retracting the delivery catheter to release a plurality of members extending substantially radially from the anchor, each of the members defining a leg contacting an oppositely-disposed second side of the internal wall so as to secure the anchor and the medical implant received therein to the internal wall;

decoupling the first guidewire from the first portion of the anchor; and

then

decoupling the second guidewire from the first portion of the anchor.

49. A method according to claim 48, wherein the first and second portions of the anchor are interconnected by the members, and the members are collapsed before placing the anchor in the delivery catheter by moving the first and second guidewires in opposite directions.

50. A method according to claim 48, further comprising the step of securing the medical implant to the anchor with fingers on the anchor.

51. A method according to claim 48, wherein the arms are axially aligned with the members so that the arms oppose the legs of the members.

52. A method according to claim 48, wherein the first and second guidewires are decoupled from the first and second portions of the anchor by moving a member disposed within the first and second guidewires.

53. A method according to claim 52, wherein fingers couple the first and second portions to the first and second guidewires during the insertion step, and movement of the member releases the fingers so as to decouple the first and second portions from the first and second guidewires.

54. A method according to claim 48, wherein the first and second portions are latched together after the arms contact the first side of the internal wall.

55. A method according to claim 48, wherein the first and second portions are latched together before the first and second portions are decoupled from the first and second guidewires.

56. A method according to claim 48, wherein the first and second portions are latched together after placing the anchor within the internal wall by moving a member disposed within the first and second guidewires.

57. A method according to claim 48, wherein the medical implant is a cardiovascular implant and the internal wall is a portion of a cardiovascular organ.

58. A method according to claim 57, wherein the internal wall is an atrial septum.

59. A method according to claim 57, wherein placement of the medical implant is used in a procedure performed to diagnose, monitor, and/or treat a cardiovascular disease.

60. A method according to claim 48, wherein placement of the medical implant is used in a procedure performed to diagnose, monitor, and/or treat an internal organ.