Device on lead to prevent perforation and/or fixate lead

• US 8,239,039 B2
• Filed: 08/30/2005
• Issued: 08/07/2012
• Est. Priority Date: 08/30/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Zarembo, Paul E., Zhang, Yongxing, Finlay, Matthew, Bodner, Jeffrey P.
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US11/215,786
• Publication Number:
  US 20070050003A1
• Time in Patent Office: 2,534 Days
• Field of Search: 607/116, 607/119, 607/122, 607/126, 607/127, 607/128, 607/131
• US Class Current: 607/116
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

This document discusses, among other things, a lead body extending longitudinally along a lead axis, a driver axially displaceable relative to the lead body, and a driven member coupled to the lead body and displaceable away from the lead axis. The driven member at least partially defines an expandable passage having at least one internal dimension. The driver is displaceable into the expandable passage and has at least one outer dimension that is larger than the at least one internal dimension of the expandable passage. An example method includes disposing a first member having a first cross-section in a lead assembly having a lead axis, an expandable passage, and a displaceable member proximate the expandable passage. The method further includes urging the first member into the expandable passage in the lead assembly, and urging the displaceable member away from the lead axis to expand the expandable passage.

Claims

1. A lead assembly configured for implantation within a blood vessel, the lead assembly comprising:

a lead body defining a lead body lumen and extending longitudinally along a lead body axis with threads coupled to the lead body;

at least one conductor extending within the lead body from a proximal end toward a distal end of the lead body;

a driver disposed within the lead body lumen and axially displaceable relative to the lead body axis, the driver rotatable and axially displaceable on the threads; and

a driven member integral with the lead body and displaceable away from the lead body axis, the driven member at least partially defining an expandable passage, the driver displaceable-from an opening into the expandable passage and through the expandable passage, the driver having at least one outer dimension that is larger than at least one internal dimension of the expandable passage, with the driven member including at least one weaker portion, the driven member to deform at the weaker portion to define an expanded exterior diameter that is larger than a non-expanded exterior diameter of the driven member when the at least one outer dimension of the driver is disposed in the expandable passage;

wherein when the driven member defines the expanded exterior diameter, the driven member is configured to engage the vessel in order to fixate the lead assembly in the vessel while resisting perforation of the vessel by the lead assembly.

2. The lead assembly of claim 1, wherein the driven member is located at a distal end of the lead assembly.

3. The lead assembly of claim 2, further comprising a fixation helix connected to the driver and engageable into a tissue surface of a body.

4. The lead assembly of claim 3, wherein the driver includes a blunt surface proximate the fixation helix, at least a portion of the blunt surface on the driver contactable against the tissue surface.

5. The lead assembly of claim 4, wherein the driven member includes a blunt surface proximate the distal end of the lead assembly, at least a portion of the blunt surface contactable against the tissue surface.

6. The lead assembly of claim 1, wherein the driven member has a driver engagement surface inclined toward the lead axis and contactable against a surface on the driver.

7. The lead assembly of claim 6, comprising a bendable wall portion coupled to the driven member.

8. The lead assembly of claim 6, wherein the driven member includes an inwardly-extending protrusion including the driver engagement surface, the protrusion sealing the expandable passage.

9. The lead assembly of claim 1, wherein the lead assembly includes a vessel wall engagement surface engageable against an inner wall of the blood vessel, the vessel wall engagement surface outwardly displaceable by the driver.

10. The lead assembly of claim 9, wherein the lead body includes a cavity, the driver disposed in the cavity, the driven member integral with the lead body proximate the cavity and including the vessel wall engagement surface.

11. The lead assembly of claim 9, wherein the lead assembly further comprises at least one tooth engageable against the inner wall of the blood vessel.

12. The lead assembly of claim 11, wherein the lead body includes a compressible material proximate the tooth, the tooth disposed in the compressible material and at least partially retracted into the lead body when the compressible material is not compressed, and the tooth at least partially extended from the lead body when the compressible material is compressed.

13. The lead assembly of claim 1, further comprising helical internal threads coupled to the lead body, the driver including a helical member engageable on the threads and a pusher displaceable into the expandable passage.

14. The lead assembly of claim 1, wherein the driver includes a structure engageable with a portion of the driven member, the driver fixateable in a particular position with respect to the driven member by engagement of the structure with the portion of the driven member.

15. The lead assembly of claim 1, comprising a plurality of driven members contactable by the driver and displaceable away from the lead axis, each of the plurality of driven members including an engagement surface inclined toward the lead axis and slidable against the driver.

16. The lead assembly of claim 1, further comprising a conductor extending through a lumen in the lead body and an electrode electrically coupled to the conductor and situated proximate the driven member.

17. The lead assembly of claim 1, wherein the threads are disposed along an interior of the lead body.

18. A lead assembly for implantation within a blood vessel, the lead assembly comprising:

a lead body defining a lumen and extending longitudinally along a lead body axis from a proximal end to a distal end;

a conductor extending within the lead body from the proximal end in a direction toward the distal end of the lead body;

a displaceable member integral with the lead body and displaceable away from the lead body axis, the displaceable member at least partially defining an expandable passage with the displaceable member including at least one weaker portion;

a means for urging the displaceable member away from the lead body axis, the means for urging displaceable from an opening into the expandable passage and through the expandable passage, the means for urging having at least one outer dimension that is larger than at least one internal dimension of the expandable passage, the displaceable member to deform at the weaker portion to define an expanded exterior diameter that is larger than a non-expanded exterior diameter of the displaceable member when the at least one outer dimension of the means for urging is disposed in the expandable passage; and

a fixation structure coupled to the means for urging disposed proximate the distal end of the lead body, with the displaceable member having an outer surface to contact a tissue surface proximate the fixation structure,

wherein when the displaceable member defines the expanded exterior diameter, the displaceable member is configured to engage the tissue surface in order to fixate the lead assembly to the tissue surface while resisting perforation of the tissue surface by the lead assembly.

19. The lead assembly of claim 18, wherein the lead assembly includes a stretchable tube, the displaceable member including a portion of the stretchable tube, the means for urging the displaceable member away from the lead axis configured to expand at least a portion of the stretchable tube away from the lead axis.

20. The lead assembly of claim 19, wherein the stretchable tube includes a portion having a first wall and a second wall that is thicker than the first wall, the displaceable member including at least a portion of the second wall.

21. The lead assembly of claim 18, wherein the displaceable member includes a protrusion that extends toward the lead axis, and the means for urging the displaceable member away from the lead axis is configured to push against the protrusion.

22. The lead assembly of claim 21, wherein the means for urging the displaceable member away from the lead axis further includes threads coupled to the lead body, a driver engageable on the threads, and a pusher coupled to the driver and contactable against the protrusion, wherein turning the driver on the threads moves the driver and pusher axially relative to the lead body to urge the pusher against the protrusion.

23. The lead assembly of claim 18, wherein the means for urging the displaceable member away from the lead axis includes threads connected to the lead body and a helical member engageable on the threads.

24. The lead assembly of claim 23, further comprising a tube coupled to the helical member, a portion of the tube extending from a distal end of the helical member and contacting the displaceable member.

25. The lead assembly of claim 23, wherein the helical member includes a first helical portion defining a gap between adjacent turns of the helical member, the means for urging the displaceable member away from the lead axis further comprising an interference member that extends through a portion of the gap between turns of the helical member and interferes with the threads.

26. The lead assembly of claim 23, wherein the helical member includes a first portion engageable on the threads and a second portion configured to interfere with the threads to urge the displaceable member away from the lead axis.

27. The lead assembly of claim 26, wherein the first portion has a first pitch and the second portion has a second pitch smaller than the first pitch.

28. The lead assembly of claim 18, wherein the displaceable member includes a flexible sleeve proximate the fixation structure and the means for urging the displaceable member away from the lead axis includes a means for folding the sleeve outwardly away from the lead axis, an outer surface of the sleeve contactable against the tissue wall to prevent perforation of the wall by the lead assembly.

29. The lead assembly of claim 28, wherein the sleeve includes a first end abutted against the lead body and a second end abuttable against the tissue wall.

30. A method for expanding a driven member of a lead assembly, comprising:

disposing a driver axially into a lumen of a tubular lead body of the lead assembly along a lead body axis, the lead body including a conductor extending within the lead body from a proximal end in a direction toward a distal end;

disposing the driver along threads of the lead body and into an internal passage of driven member integral with the lead body and expanding the driven member away from the lead body axis, with expanding the driven member including;

deforming the driven member at a weaker portion of the driven member by disposing the driver into the expandable passage, with an outer dimension of the driver being disposed into a portion of the expandable passage including an internal passage dimension smaller than the outer dimension; and

expanding an exterior diameter of the driven member to a dimension larger than a non-expanded exterior diameter of the driven member, such that the driven member engages a blood vessel in order to fixate the lead assembly in the vessel while resisting perforation of the vessel by the lead assembly.

31. The method of claim 30, wherein the lead assembly includes a plurality of displaceable members and disposing the driver into the expandable passage includes disposing the driver against the plurality of displaceable members, wherein the plurality of displaceable members are displaced away from the lead axis.

32. The method of claim 31, further comprising engaging an outer surface of the lead assembly proximate the displaceable member against an inner wall of the blood vessel.

33. The method of claim 32, further comprising engaging a tooth on the outer surface of the lead assembly on the inner wall of the blood vessel.

34. The method of claim 30, wherein a fixation helix is coupled to the driver, the method further comprising engaging the fixation helix into a tissue wall and contacting the driver and displaceable member against the tissue wall.

35. The method of claim 34, wherein the fixation helix has a pitch and the lead assembly includes an internal helical protrusion having approximately the same pitch as the fixation helix, the at least one corresponding cross-sectional dimension of the expandable passage including an inner diameter of the internal helical protrusion, the fixation helix disposable in a gap defined by the internal helical protrusion, and the disposing the displaceable member away from the lead axis including urging the driver against the internal helical protrusion.

36. The method claim 30, wherein disposing the driver along threads includes driving a helix shaped fixation mechanism into an anchor location.

37. The method of claim 30, wherein the lead assembly includes internal threads and a portion of the driver includes external threads, wherein the disposing the driver into the expandable passage includes advancing the driver on the internal threads.

38. The method of claim 30, wherein a tooth is at least partially embedded in an outer surface of the lead assembly, and the disposing the driven member away from the lead axis pushes a portion of the tooth out of the lead assembly.