Cardiovascular anchoring device and method of deploying same

• US 7,149,587 B2
• Filed: 09/26/2003
• Issued: 12/12/2006
• Est. Priority Date: 09/26/2002
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Eigler, Neal L., Wardle, John L.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): FILOSI, TERRI LYNN
• Application Number:
  US10/672,443
• Publication Number:
  US 20040116992A1
• Time in Patent Office: 1,173 Days
• Field of Search: 607/27, 607126-128, 607130-132, 607/116, 607/119, 600/375, 604/175, 606/213
• US Class Current: 607/126
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

An anchoring device and a delivery method thereof can effectively provide a means for securing an implant to a wall of an internal organ within a patient in a variety of clinical applications. In one embodiment, an anchoring device used to retain a cardiac pressure measurement device is provided. The device is implanted in the body by deforming it to a small cross section profile, sliding it through a low profile delivery device and ejecting from the delivery device at a targeted site. The anchoring mechanism, when ejected from the delivery device, reverts back to pre-formed configuration and engages opposite sides of an organ wall, thereby anchoring the implant in the organ wall.

Claims

1. An implantable device, comprising:

a proximal anchor comprising a proximal ring, a distal ring, and at least one helical leg extending from the proximal ring and the distal ring;

a distal anchor having at least one leg; and

an implant configured to be supported by the proximal and distal anchors,

wherein the proximal and distal anchors are configured to be movable between a collapsed delivery position and an expanded position in which the proximal and distal anchors secure the implant to a wall of an organ within a patient.

2. The device of claim 1, wherein the implant is a diagnostic tool.

3. The device of claim 2, wherein the diagnostic tool comprises apparatus operable to measure one or more physiological parameters.

4. The device of claim 2, wherein the diagnostic tool comprises apparatus operable to measure pressure.

5. The device of claim 2, wherein the diagnostic tool comprises apparatus operable to measure oxygen levels.

6. The device of claim 2, wherein the diagnostic tool comprises apparatus operable to measure electrical activity.

7. The device of claim 1, wherein the implant is a therapeutic tool.

8. The device of claim 7, wherein the therapeutic tool comprises apparatus operable to deliver one or more pharmaceutical agents to the patient.

9. The device of claim 7, wherein the therapeutic tool comprises apparatus operable to deliver one or more electrical signals to the patient.

10. The device of claim 1, wherein the implant is selected from the group consisting of one or more of the following:

stimulating electrodes, ultrasound transducers, drug delivery systems, pacing leads, and electrocardiogram leads.

11. The device of claim 1, wherein the implant is a sensor.

12. The device of claim 11, wherein the sensor is a sensing electrode, oxygen partial pressure sensor or an oxygen saturation sensor.

13. The device of claim 11, wherein the sensor is a pressure sensor.

14. The device of claim 11, wherein the sensor comprises a pressure sensing face configured to measure a fluid pressure in a left atrium of a patient'"'"'s heart.

15. The device of claim 14, wherein the proximal and distal anchors are configured to support the sensor such that the pressure sensing face is substantially coplanar with a distal side of an atrial septum wall.

16. The device of claim 14, wherein the proximal and distal anchors are configured to support the sensor such that the pressure sensing face is spaced distally from a plane of a distal side of an atrial septum wall.

17. The device of claim 14, wherein the proximal and distal anchors are configured to support the sensor such that the pressure sensing face is spaced proximally from a plane of an atrial septum wall.

18. The device of claim 11, wherein the sensor is configured to attach to an electrical lead.

19. The device of claim 11, wherein the sensor comprises a cylindrical body with at least one annular groove configured to engage a portion of the proximal anchor or a portion of the distal anchor in order to retain the proximal or distal anchor against axial movement relative to the sensor.

20. The device of claim 1, wherein said proximal anchor comprises at least three legs.

21. The device of claim 1, wherein the at least one proximal anchor leg passes through substantially a whole number of complete circles between the proximal ring and the distal ring of the proximal anchor.

22. The device of claim 1, wherein said at least one proximal anchor leg has a lower spring force than said at least one distal anchor leg.

23. The device of claim 22, wherein the proximal anchor leg and the distal anchor leg are configured to secure the implant to organ walls with varying thicknesses.

24. The device of claim 1, wherein said anchoring device is made from a biocompatible material selected from the group consisting of:

nickel titanium alloys, stainless steel, ELGILOY, and MP35N.

25. The device of claim 1, wherein the proximal anchor, the distal anchor and the implant comprise interlocking structures configured to rigidly secure the proximal anchor, the distal anchor and the implant to one another.

26. The device of claim 1, wherein at least one member of the group consisting of the proximal anchor, the distal anchor and the implant comprises one or more radiopaque markers configured to facilitate visualization under fluoroscopy.

27. The device of claim 26, wherein a portion of an element comprising said one or more radiopaque markers is coated with a polymeric material adapted to prevent galvanic corrosion.

28. The device of claim 26, wherein said one or more radiopaque markers are placed in low flex zones.

29. The device of claim 28, wherein tips of the at least one distal anchor leg comprise said one or more radiopaque markers.

30. The device of claim 28, wherein the proximal ring of the proximal anchor comprises said one or more radiopaque markers.

31. The device of claim 28, wherein the distal ring of the proximal anchor comprises said one or more radiopaque markers.

32. The device of claim 1, wherein the distal anchor comprises a plurality of legs comprising slots configured to promote tissue overgrowth.

33. A system for diagnosing and/or treating a condition in a patient, the system comprising:

an implant configured to be implanted within a patient;

a proximal anchor comprising at least one helical leg configured to expand from a compressed state to a relaxed state, the at least one helical leg comprising a proximal base and a distal end;

a distal anchor comprising at least one distal leg configured to expand from a compressed state to an expanded state;

wherein the proximal anchor and the distal anchor are configured to sandwich an atrial septum wall between the distal end of the at least one helical leg and the at least one distal anchor leg and to support the implant in the septum wall; and

a delivery catheter configured to deploy the implant, the proximal anchor, and the distal anchor in the septum wall.

34. The system of claim 33, wherein the implant is a diagnostic tool.

35. The system of claim 34, wherein the diagnostic tool comprises apparatus operable to measure one or more parameters selected from the group consisting of:

pressure, oxygen and electrical activity.

36. The system of claim 34, further comprising a retrieval device configured to grasp the proximal ring of the proximal anchor in the relaxed state, and to retract the proximal ring of the proximal anchor proximally relative to the distal ring, thereby returning the proximal anchor to the compressed state.

37. The system of claim 36, wherein the retrieval device comprises a cylindrical body with a plurality of distally-extending grasping hooks.

38. The system of claim 36, wherein the retrieval device comprises a distal ring with at least one distally-extending grasping hook, a proximal ring, and at least one helical leg extending between the proximal ring and the distal ring.

39. The system of claim 36, wherein the retrieval device comprises a push/pull ribbon.

40. The system of claim 36, wherein the retrieval device comprises an internal diameter configured to allow the retrieval device to pass over a sensor lead.

41. The system of claim 33, wherein the implant is a therapeutic tool.

42. The system of claim 41, wherein the therapeutic tool comprises apparatus operable to deliver one or more pharmaceutical agents to the patient.

43. The system of claim 41, wherein the therapeutic tool comprises apparatus operable to deliver one or more electrical pulses to the patient.

44. The system of claim 33, wherein the proximal anchor further comprises a proximal ring and a distal ring attached to opposite ends of the at least one helical leg.

45. The system of claim 44, wherein the at least one helical leg passes through substantially a whole number of complete circles between the proximal ring and the distal ring of the proximal anchor.

46. The system of claim 44, wherein the proximal ring and/or the distal ring of the proximal anchor comprise the radiopaque marker.

47. The system of claim 33, wherein said proximal anchor comprises at least three legs.

48. The system of claim 33, wherein said at least one proximal anchor leg has a lower spring force than said at least one distal anchor leg.

49. The system of claim 48, wherein the at least one helical leg and the at least one distal anchor leg are configured to secure the implant to organ walls with varying thicknesses.

50. The system of claim 33, wherein said anchoring device is made from a biocompatible material selected from the group consisting of:

nickel titanium alloys, stainless steel, ELGILOY, and MP35N.

51. The system of claim 33, wherein the implant comprises a pressure sensor with a pressure sensing face configured to measure a fluid pressure in a left atrium of a patient'"'"'s heart.

52. The system of claim 51, wherein the proximal and distal anchors are configured to support the sensor such that the pressure sensing face is substantially coplanar with a distal side of an atrial septum wall.

53. The system of claim 51, wherein the proximal and distal anchors are configured to support the sensor such that the pressure sensing face is spaced distally from a plane of a distal side of an atrial septum wall.

54. The system of claim 51, wherein the proximal and distal anchors are configured to support the sensor such that the pressure sensing face is spaced proximally from a plane of an atrial septum wall.

55. The system of claim 33, wherein the proximal anchor, the distal anchor and the implant comprise interlocking structures configured to rigidly secure the proximal anchor, the distal anchor and the implant to one another.

56. The system of claim 33, wherein the implant is configured to attach to an electrical lead.

57. The system of claim 33, wherein at least one member of the group consisting of the proximal anchor, the distal anchor and the implant comprises a radiopaque marker configured to facilitate visualization under fluoroscopy.

58. The system of claim 57, wherein a portion of an element comprising a radiopaque marker is coated with a polymeric material adapted to prevent galvanic corrosion.

59. The system of claim 57, wherein the radiopaque marker is placed in one or more low flex zones.

60. The system of claim 59, wherein the at least one distal anchor leg comprises the radiopaque marker.

61. The system of claim 33, wherein the implant comprises a sensor.

62. The system of claim 33, wherein the implant comprises a pressure sensor having a cylindrical body with at least one annular groove configured to engage a portion of the proximal anchor or a portion of the distal anchor in order to retain the proximal or distal anchor against axial movement relative to the sensor.

63. The system of claim 33, wherein the distal anchor comprises a plurality of legs having slots configured to promote tissue overgrowth.