DEVICE AND METHOD FOR POSITIONING AN ELECTRODE IN TISSUE

• US 20120323253A1
• Filed: 08/29/2011
• Published: 12/20/2012
• Est. Priority Date: 09/28/2010
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Inventors: Garai, Ellis, Swaminathan, Aravind
• Granted Patent: US 9,855,421 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

A device for positioning an electrode in tissue includes: a lead body having a distal portion; an electrode array coupled to the lead distal portion; an anchoring element having an anchor tip and being operable in a first configuration in which the anchor tip is retracted within the lead and in a second configuration in which the anchor tip is extended outside the lead and configured to fixate within the tissue; and a displacement mechanism that is actuated to bias the electrode array or the anchoring element toward the tissue. A method for positioning an electrode in tissue includes: navigating, to the tissue, a lead with an electrode array, an anchoring element with a distal anchor tip, and a displacement mechanism; biasing the electrode array and anchoring element towards the tissue with the displacement mechanism; and deploying the anchoring element, and verifying fixation of the anchor tip within the tissue.

Claims

1. A device configured to position an electrode in tissue in a body, comprising:

an elongate body having a distal portion;

an electrode array coupled to the distal portion of the elongate body;

an anchoring element disposed within the elongate body and having a distal anchor tip, wherein the anchoring element is movable between a first configuration in which the anchor tip is substantially retracted within the elongate body, and a second configuration in which the anchoring element is at least partially extended outside the elongate body, the anchoring element being configured to fixate within the tissue when in the second configuration; and

a displacement mechanism, disposed at least partially circumferentially around the distal portion of the elongate body, configured to selectively bias at least one of the electrode array and the anchoring element.

2. The device of claim 1, wherein the distal portion of the elongate body defines an aperture proximate to the electrode array, wherein in the second configuration the anchor tip is configured to be at least partially extended through the aperture.

3. The device of claim 1, wherein the distal portion of the elongate body includes an atraumatic tip.

4. The device of claim 3, wherein the atraumatic tip is configured to radially expand under compression.

5. The device of claim 1, wherein the electrode array includes a plurality of electrodes.

6. The device of claim 5, wherein at least a portion of the plurality of electrodes is arranged serially along the length of the distal portion of the elongate body.

7. The device of claim 1, wherein the electrode array includes stimulation electrodes.

8. The device of claim 1, wherein:

in the first configuration, the anchoring element is positioned at a first anchoring element position within the elongate body; and

in the second configuration, the anchoring element is positioned at a second anchoring element position longitudinally displaced from the first anchoring element position.

9. The device of claim 8, wherein the anchoring element is configured to be repetitively moved between the first configuration and the second configuration.

10. The device of claim 8, further comprising an actuator telescopically disposed within the elongate body, wherein the actuator is configured to engage the anchoring element to move the anchoring element from the first anchoring element position to the second anchoring element position.

11. device of claim 10, wherein the actuator is configured to abut at least a portion of the anchoring element.

12. The device of claim 10, wherein the actuator is configured to be rotationally decoupled from the anchoring element.

13. The device of claim 10, further comprising a sleeve coupled to the anchoring element and telescopically engaged within the elongate body.

14. The device of claim 13, wherein the actuator is configured to be telescopically engaged within the sleeve and freely rotatable within the sleeve such that rotation of the actuator does not correspond to rotation of the anchoring element.

15. The device of claim 13, wherein the sleeve is coupled to the actuator.

16. The device of claim 10, wherein at least a portion of the actuator defines a cut longitudinally along and circumferentially around the actuator.

17. The device of claim 10, further comprising a housing coupled to the elongate body.

18. The device of claim 17, wherein the housing includes a slide coupled to the actuator, the slide having a first slide position corresponding to the first anchoring element position and the first configuration of the anchoring element, and a second slide position corresponding to the second anchoring element position and the second configuration of the anchoring element.

19. The device of claim 18, wherein the slide is spring-loaded and biased towards the second slide position.

20. The device of claim 17, wherein the housing includes a trigger release selectively engaged with the actuator, wherein when the trigger release is disengaged from the actuator, the actuator is free to travel from the first slide position to the second slide position.

21. The device of claim 20, wherein the housing includes a reload switch that retracts the slide from the second slide position to the first slide position.

22. The device of claim 17, wherein the housing is selectively decoupleable from the elongate body.

23. The device of claim 22, wherein the actuator is selectively decoupleable from the anchoring element.

24. The device of claim 22, wherein the actuator is further selectively decoupleable from the elongate body.

25. The device of claim 1, wherein the anchor tip is at least partially curled when the anchoring element is in the second configuration.

26. The device of claim 25, wherein when the anchoring element is in the second configuration, the anchor tip has an approximately uniform radius of curvature.

27. The device of claim 1, wherein the elongate body defines a channel within which the anchoring element is disposed, such that the channel restricts the anchoring element to a particular rotational orientation.

28. The device of claim 1, further comprising a second anchoring element disposed within the elongate body and having a second distal anchor tip.

29. The device of claim 28, wherein the first and second anchor tips are at least one of longitudinally distributed along the distal portion of the elongate body and circumferentially distributed around the distal portion of the elongate body.

30. device of claim 1, wherein the anchoring element includes a conductive material such that the anchoring element is operable as an electrode.

31. The device of claim 1, wherein the displacement mechanism is configured to be selectively expandable.

32. The device of claim 31, wherein the displacement mechanism includes an inflatable balloon.

33. The device of claim 32, wherein the inflatable balloon includes an elastic tube sealed around the distal portion of the elongate body.

34. The device of claim 32, wherein the inflatable balloon is configured to expand only on a side of the elongate body.

35. The device of claim 1, further comprising an electrical subsystem configured to signal when the anchoring element is in the second configuration and fixated in the tissue.

36. The device of claim 35, wherein the electrical subsystem includes a circuit that is configured to be triggered when the anchoring element is in the second configuration.

37. The device of claim 36, wherein the electrical subsystem is configured to signal when at least one anchor tip is in contact with the electrode array or when at least one anchor tip is not in contact with the electrode array.

38. The device of claim 1, further including a septum configured to prohibit a substantial pressure differential between an internal portion of the elongate body and a region outside the elongate body.

39. A device configured to position an electrode in tissue in a body, comprising:

an elongate tubular body having a distal portion with a wall that defines at least one aperture;

a stimulation ring electrode array coupled to the distal portion of the elongate body proximate to the aperture;

a plurality of nitinol anchoring elements disposed within the elongate body and each having a distal anchor tip, wherein each anchoring element is selectively operable in two configurations;

a first configuration wherein the anchoring element is at a first anchoring element position and the anchor tip is at least partially uncurled and substantially retracted within the elongate body;

a second configuration wherein the anchoring element is at a second anchoring element position and the anchor tip is at least partially extended through the aperture outside the elongate body in a curled loop and configured to fixate within the tissue;

a balloon, coupled at least partially circumferentially around the distal portion of the elongate body, that is selectively expandable to bias the electrode array and the anchoring elements toward the tissue;

an actuator, telescopically disposed within the elongate body, that is abuttingly engaged with the anchoring element to actuate the anchoring element between the first and second anchoring element positions; and

a handle coupled to the elongate body, wherein the handle includes a spring-loaded slide coupled to the actuator and has first and second slide positions corresponding to the first and second anchoring element positions, respectively.

40. A method for positioning an electrode in a body, comprising:

navigating to a location adjacent to a bodily tissue an elongate body with an electrode array, at least one anchoring element with a distal anchor tip, and a displacement mechanism;

moving the electrode array and the at least one anchoring element towards the tissue by actuating the displacement mechanism;

deploying the at least one anchoring element; and

verifying fixation of the anchor tip within the tissue.

41. The method of claim 40, wherein actuating the displacement mechanism includes expanding the displacement mechanism in a direction substantially opposite of anchoring element deployment.

42. The method of claim 41, wherein actuating the displacement mechanism includes inflating a balloon.

43. The method of claim 40, wherein verifying fixation of the anchor tip within the tissue includes releasing contrast fluid from the elongate body and viewing the contrast fluid flow under fluoroscopy.

44. The method of claim 40, wherein verifying fixation of the anchor tip within the tissue includes receiving an electrical signal that signifies when the anchoring element is in the second configuration and fixated in the tissue.

45. The method of claim 44, wherein verifying fixation of the anchor tip within the tissue includes measuring impedance across distal contact points intended to be in contact with the tissue.

46. The method of claim 40, further comprising verifying position of the electrode array relative to the tissue.

47. The method of claim 40, further comprising deactivating the displacement mechanism after the verifying step.

48. A device for positioning an electrode in tissue in a body, comprising:

an elongate body having a distal portion;

an electrode array coupled to the distal portion of the elongate body; and

a plurality of anchoring elements each disposed within the elongate body and having a distal anchor tip, wherein each anchoring element is selectively operable in two configurations;

a first configuration wherein the anchor tip is substantially retracted within the elongate body; and

a second configuration wherein at least a portion of the anchoring element is at least partially extended outside the distal portion of the elongate body and configured to fixate within the tissue.

49. The device of claim 48, wherein when the anchoring elements are in the second configuration, the anchor tips of the anchoring elements are distributed on at least two locations longitudinally along and at least two locations circumferentially around the distal portion of the elongate body.