Device and method for positioning an electrode in tissue

• US 9,855,421 B2
• Filed: 08/29/2011
• Issued: 01/02/2018
• 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
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US13/219,874
• Publication Number:
  US 20120323253A1
• Time in Patent Office: 2,318 Days
• Field of Search: 606129, 607126, 607128, 607130
• 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, wherein the distal portion of the elongate body includes an atraumatic tip formed from a soft, compressible material which reduces the risk of tissue penetration;

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 distal anchor tip is substantially retracted within the elongate body, and a second configuration in which the anchoring element extends at least partially from one side of the elongate body, the anchoring element being configured to penetrate and fixate within the tissue adjacent to said one side of the elongate body when in the second configuration; and

a selectively expandable displacement mechanism on a side of the distal portion of the elongate body opposite to said one side and configured to selectively bias both the electrode array and the anchoring element in a direction toward the tissue when the selectively expandable displacement mechanism is expanded on the side of the elongate body opposite to said one side.

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 distal anchor tip is configured to be at least partially extended through the aperture.

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

4. The device of claim 3, wherein at least a portion of the plurality of electrodes is arranged serially along a length of the distal portion of the elongate body.

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

6. 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.

7. The device of claim 6, wherein the anchoring element is configured to be repetitively moved between the first configuration and the second configuration.

8. The device of claim 6, 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.

9. The device of claim 8, wherein the actuator is configured to abut at least a portion of the anchoring element.

10. The device of claim 8, wherein the actuator is configured to be rotationally decoupled from the anchoring element.

11. The device of claim 8, further comprising a sleeve coupled to the anchoring element and telescopically engaged within the elongate body.

12. The device of claim 11, 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.

13. The device of claim 11, wherein the sleeve is coupled to the actuator.

14. The device of claim 8, wherein at least a portion of the actuator defines a cut longitudinally along and circumferentially around the actuator.

15. The device of claim 8, further comprising a housing coupled to the elongate body.

16. The device of claim 15, 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.

17. The device of claim 16, wherein the slide is spring-loaded and biased towards the second slide position.

18. The device of claim 16, 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.

19. The device of claim 18, wherein the housing includes a reload switch that retracts the slide from the second slide position to the first slide position.

20. The device of claim 15, wherein the housing is selectively decoupleable from the elongate body.

21. The device of claim 20, wherein the actuator is selectively decoupleable from the anchoring element.

22. The device of claim 20, wherein the actuator is further selectively decoupleable from the elongate body.

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

24. The device of claim 23, wherein when the anchoring element is in the second configuration, the distal anchor tip has an approximately uniform radius of curvature.

25. 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.

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

27. The device of claim 26, wherein the distal anchor tip and the second distal anchor tip 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.

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

29. The device of claim 1, wherein the selectively expandable displacement mechanism includes an inflatable balloon.

30. The device of claim 29, wherein the inflatable balloon includes an elastic tube sealed around the distal portion of the elongate body.

31. The device of claim 29, wherein the inflatable balloon is configured to expand only on a side of the elongate body.

32. 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.

33. The device of claim 32, wherein the electrical subsystem includes a circuit that is configured to be triggered when the anchoring element is in the second configuration.

34. The device of claim 33, wherein the electrical subsystem is configured to signal when the anchor tip is in contact with the electrode array or when the the anchor tip is not in contact with the electrode array.

35. 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.

36. 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 rotationally displaced from the first anchoring element position.

37. The device of claim 1, wherein the selectively expandable displacement mechanism comprises an expandable and retractable ring, a scaffold, or a coil.

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

an elongate tubular body having at least one lumen disposed axially therethrough and a distal portion with a wall that defines at least one aperture on one side thereof;

at least one stimulation electrode coupled to the distal portion of the elongate body proximate to the at least one aperture;

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

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

a second configuration wherein each anchoring element is at a second anchoring element position and the distal anchor tip at least partially extends through an aperture to form a curled loop configured to penetrate and fixate within the tissue adjacent to said one side of the elongate body;

a balloon, coupled at least partially circumferentially around the distal portion of the elongate tubular body on a side opposite to that of the at least one aperture, that is selectively expandable to bias the at least one stimulation electrode and the plurality of anchoring elements toward the tissue when the balloon is expanded on the side opposite to that of the at least one aperture; and

an actuator shaft coupled to the anchoring element to actuate the anchoring element between the first and second anchoring element positions, wherein the actuator shaft is slidably mounted in the at least one lumen to axially and selectively displace the anchoring elements to extend the distal anchor tips to curl through the at least one aperture and to retract distal anchor tips to uncurl in the at least one lumen.

39. The device of claim 38, wherein the at least one stimulation electrode comprises a ring electrode.

40. The device of claim 38, wherein the at least one stimulation electrode comprises a planar, circular, or elliptical electrode.

41. The device of claim 38, further comprising a handle coupled to the elongate body.

42. The device of claim 41, wherein the handle includes a slide coupled to the actuator shaft, the slide having first and second slide positions corresponding to the first and second anchoring element positions, respectively.

43. The device of claim 42, wherein the slide is spring-loaded.

44. The device of claim 38, wherein each of the plurality of anchoring elements comprises a shape memory alloy.

45. The device of claim 44, wherein the shape memory alloy comprises nitinol.