Delivery system, method, and anchor for medical implant placement

• US 8,696,693 B2
• Filed: 12/06/2010
• Issued: 04/15/2014
• Est. Priority Date: 12/05/2009
• Status: Active Grant

• Current Assignee: UIM Pressure Implant Incorporated
• Original Assignee: Integrated Sensing Systems Incorporated
• Inventors: Najafi, Nader, Goetzinger, David Joseph, Morgan, Catherine Hook, Baranowski, Jacek Ryszard
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US12/960,961
• Publication Number:
  US 20110303229A1
• Time in Patent Office: 1,226 Days
• Field of Search: 606/142, 606/151, 606/157, 606/158, 606/213, 606/215, 606/216
• US Class Current: 606/151
• CPC Class Codes: A61B 2560/066 catheters therefor
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence

Abstract

An anchor for a medical implant, methods of manufacturing the anchor, and procedures for placing a medical implant, such as for diagnosing, monitoring and/or treating cardiovascular diseases. The anchor has a base portion with first and second longitudinal ends and a cage therebetween. The anchor further has flexible arms, flexible legs, features for securing the medical implant within the cage of the base portion, and a coupler portion connected to and spaced apart from the second longitudinal end of the base portion. The anchor is adapted to have a deployed configuration in which the arms and legs radially project away from the base portion, the arms axially project toward the second longitudinal end of the base portion, and the legs axially project toward the first longitudinal end of the base portion. Convex surfaces of the arms and legs are adapted to clamp the anchor to a wall.

Claims

1. An anchor for a medical implant, the anchor having a deployed configuration wherein the anchor comprises:

a base portion having a longitudinal axis and comprising first and second longitudinal ends in oppositely-disposed first and second longitudinal directions, respectively, of the anchor, and a cage between the first and second longitudinal ends;

a coupler portion connected to and spaced apart from the second longitudinal end of the base portion in the second longitudinal direction of the anchor;

a plurality of flexible arms radially projecting away from the first longitudinal end of the base portion and axially projecting toward the second longitudinal end of the base portion, each arm having a span portion terminating in a distal portion of the arm, the distal portion having a semispherical shape that defines a convex surface facing the second longitudinal direction; and

a plurality of flexible legs connected to the coupler portion and to the second longitudinal end of the base portion, each leg projecting radially away from the longitudinal axis of the anchor and axially projecting toward the first longitudinal end of the base portion, each leg having a first span portion adjoining the second longitudinal end of the base portion, a second span portion adjoining the coupler portion, and an intermediate portion therebetween, the intermediate portion having a semispherical shape that defines a convex surface facing the first longitudinal direction; and

means for securing the medical implant within the cage of the base portion so that at least a portion of the implant is between the first and second longitudinal ends of the base portion.

2. The anchor according to claim 1, wherein at least some of the convex surfaces of the arms are axially aligned with and oppose at least some of the convex surfaces of the legs.

3. The anchor according to claim 1, wherein each of the convex surfaces of the arms is axially aligned with and opposes a corresponding one of the convex surfaces of the legs.

4. The anchor according to claim 1, wherein the span portion of each arm comprises a plurality of spaced-apart beams that adjoin the distal portion of the arm.

5. The anchor according to claim 1, wherein each of the first and second span portions of each leg comprises a plurality of spaced-apart beams that adjoin the intermediate portion of the leg.

6. The anchor according to claim 5, wherein each of the second span portions of each leg comprises at least one strut that is transverse to the longitudinal axis of the anchor and adjoins the spaced-apart beams.

7. The anchor according to claim 1, wherein the securing means comprises first and second sets of fingers extending from, respectively, the first and second longitudinal ends of the base portion in the first and second longitudinal directions.

8. The anchor according to claim 7, wherein each finger of the first and second sets of fingers comprises a plurality of spaced-apart beams that merge and define a radially-inward projecting appendage.

9. The anchor according to claim 7, wherein the first and second sets of fingers define first and second cage portions that are contiguous with the cage defined by the base portion.

10. The anchor according to claim 9, further comprising the medical implant secured within the first cage defined by the base portion and within the first and second cage portions defined by the first and second sets of fingers.

11. The anchor according to claim 1, further comprising a catheter connected to the anchor with the coupler portion.

12. The anchor according to claim 11, wherein the coupler portion comprises means for articulating movement of the anchor relative to the catheter in directions transverse to the longitudinal axis of the anchor.

13. The anchor according to claim 12, wherein the articulating means comprises longitudinal slots defined in the coupler portion, each of the longitudinal slots having a recess therein and being contiguous with an end of the coupler portion farthest from the base portion, and the catheter comprises connectors received in the longitudinal slots and engaging the recesses in the longitudinal slots.

14. The anchor according to claim 1, wherein the base portion, the coupler portion, the arms, the legs, and the securing means are a unitary structure without metallurgical or mechanical joints therebetween.

15. The anchor according to claim 14, wherein the unitary structure is formed of a shape-memory nickel-titanium alloy.

16. The anchor according to claim 14, wherein the securing means comprises fingers extending from the first longitudinal end of the base portion in the first longitudinal direction, the fingers defining a cage portion that is contiguous with the cage defined by the base portion, each of the fingers defines a radially-inward projecting appendage, and in the stowed configuration the appendages of the fingers are surrounded by the distal portions of the arms.

17. The anchor according to claim 1, wherein the arms and the legs are sufficiently flexible to enable being elastically deformed to acquire a stowed configuration of the anchor in which the arms extend parallel to the longitudinal axis of the anchor from the first longitudinal end of the base portion and the legs extend parallel to the longitudinal axis of the anchor between the coupler portion and the second longitudinal end of the base portion.

18. The anchor according to claim 17, wherein in the stowed configuration the convex surfaces of the distal portions of the arms face radially outward from the longitudinal axis of the anchor and the distal portions of the arms project radially inward over the cage at the first longitudinal end of the base portion.

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

cutting a unitary tubular body to form the base portion, the coupler portion, the arms, the legs, and the securing means; and

then

deforming the arms, the legs, and the securing means.

20. The method according to claim 19, wherein the unitary tubular body is formed of a shape-memory nickel-titanium alloy.

21. A delivery system comprising the anchor of claim 1, the delivery system further comprising:

a catheter connected to the coupler portion of the anchor; and

means for articulating movement of the anchor relative to the catheter in directions transverse to the longitudinal axis of the anchor.

22. The delivery system according to claim 21, wherein the articulating means comprises longitudinal slots defined in the coupler portion, each of the longitudinal slots having a recess therein and being contiguous with an end of the coupler portion farthest from the base portion, and the catheter comprises connectors received in the longitudinal slots and engaging the recesses in the longitudinal slots.

23. The delivery system according to claim 22, wherein the connectors of the catheter are operable to decouple from the coupler portion by moving in radially outward directions from the coupler portion to disengage the recesses of the longitudinal slots.

24. The delivery system according to claim 22, wherein the articulating means further comprises means for causing differential movement of the connectors to cause articulation of the anchor relative to the catheter.

25. The delivery system according to claim 21, further comprising a sheath in which the catheter is telescopically received.

26. The delivery system according to claim 25, wherein the anchor is stowed within the sheath and the arms and the legs of the anchor are sufficiently flexible to be elastically deformed to acquire a stowed configuration of the anchor in which the arms extend parallel to the longitudinal axis of the anchor from the first longitudinal end of the base portion and the legs extend parallel to the longitudinal axis of the anchor between the coupler portion and the second longitudinal end of the base portion.

27. The delivery system according to claim 26, wherein in the stowed configuration the convex surfaces of the distal portions of the arms face radially outward from the longitudinal axis of the anchor and the distal portions of the arms project radially inward over the cage at the first longitudinal end of the base portion.

28. A method of delivering and implanting a medical implant, the method comprising the steps of:

coupling the anchor of claim 1 to a longitudinal end of a catheter and securing the medical implant within the cage of the anchor with the securing means;

placing the catheter within a sheath so that the arms and the legs of the anchor are elastically deformed to acquire a stowed configuration of the anchor in which the arms extend parallel to the longitudinal axis of the anchor from the first longitudinal end of the base portion, the convex surfaces of the distal portions of the arms face radially outward from the longitudinal axis of the anchor, the distal portions of the arms project radially inward over an end surface of the implant, and the legs extend parallel to the longitudinal axis of the anchor between the coupler portion and the second longitudinal end of the base portion;

placing a longitudinal end of the sheath through an internal wall of a human body;

with the anchor positioned within the longitudinal end of the sheath, moving the catheter in the first longitudinal direction of the anchor to deploy the arms so that the convex surfaces of the arms engage a distal surface of the internal wall; and

securing the anchor and the medical implant within the cage of the anchor to the internal wall by moving the sheath in the second longitudinal direction of the anchor to deploy the legs so that the convex surfaces of the legs engage a proximal surface of the internal wall, wherein the internal wall is clamped between the convex surfaces of the arms and legs of the anchor.

29. The method according to claim 28, wherein the anchor is coupled to the catheter by connectors of the catheter that are received in longitudinal slots in the coupler portion and engage recesses of the longitudinal slots.

30. The method according to claim 29, further comprising articulating the anchor relative to the catheter by causing differential movement of the connectors.

31. The method according to claim 29, further comprising decoupling the anchor from the catheter by causing the connectors of the catheter to move in radially outward directions from the coupler portion to disengage the recesses of the longitudinal slots.

32. The method according to claim 31, further comprising recoupling the catheter with the anchor by causing the connectors of the catheter to move in radially inward directions toward the coupler portion to re-engage the recesses of the longitudinal slots.

33. The method according to claim 32, wherein the recoupling step is performed after the catheter and the sheath have been removed from the human body.

34. The method according to claim 28, wherein the securing of the anchor and the medical implant to the internal wall placement is part of at least one procedure chosen from the group consisting of diagnosing a disease of an internal organ, monitoring a disease of an internal organ, and treating a disease of an internal organ.

35. The method according to claim 34, further comprising wirelessly communicating with the medical implant using a reader unit external to the human body.

36. The method according to claim 35, wherein the medical implant is a cardiovascular implant and the internal wall is a portion of a cardiovascular organ.

37. The method according to claim 35, wherein the internal organ is a heart and the internal wall is a septum of the heart.

38. The method according to claim 28, wherein the procedure is chosen from the group consisting of diagnosing a cardiovascular disease, monitoring a cardiovascular disease, and treating a cardiovascular disease.

39. The method according to claim 38, further comprising wirelessly communicating with the medical implant using a reader unit external to the human body.

40. The method according to claim 39, wherein the cardiovascular disease is congestive heart failure or congenital heart disease.