Subcutaneous Leads and Methods of Implant and Explant

• US 20120029335A1
• Filed: 07/29/2011
• Published: 02/02/2012
• Est. Priority Date: 07/29/2010
• Status: Active Grant

• Current Assignee: Cameron Incorporated (Schlumberger NV)
• Original Assignee: Cameron Incorporated (Schlumberger NV)
• Inventors: Sudam, Abdulkader, Fonte, Tim, Kerkow, Todd, Marcovecchio, Alan
• Granted Patent: US 9,974,944 B2
• Time in Patent Office: Days
• US Class Current: 600/374
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes

Abstract

New and/or alternative designs for implantable leads that have fixation structures to keep leads at a desired location after implant. Fixation structure may take several forms that create distally located fixation for use primarily in subcutaneous implantation. Some examples include new and/or alternative methods of implanting such leads. Some examples also include fixation structures, such as a suture sleeve, that can be attached to a lead for fixation thereof. Some further examples show methods of implanting a subcutaneous lead, and others include methods of extracting implanted subcutaneous leads.

Claims

1. An implantable lead electrode for subcutaneous implantation in a patient and adapted for use in a cardiac stimulus or monitoring system, the lead electrode comprising:

a distal region having at least one electrode and a distal tip; and

a proximal region coupled to the distal region, such that at least one electrical connector couples the proximal region electrically to the at least one electrode;

characterized by the distal tip including at least two flexible arms located distal of the at least one electrode and making up the distal tip, the flexible arms each including an attachment feature therethrough for use during implantation, such that a coupling element can pass through the attachment feature and bind the flexible arms together during implantation.

2. The implantable lead electrode as in claim 1 wherein the flexible arms are formed of a material adapted for curing by application of ultraviolet light.

3. The implantable lead electrode as in claim 1 wherein the attachment features are suture holes.

4. The implantable lead electrode as in claim 1 wherein the attachment features include a durable membrane configured to allow suturing therethrough.

5. The implantable lead electrode as in claim 1 wherein the attachment features include a flexible mesh configured to encourage tissue ingrowth and allow suturing therethrough.

6. The implantable lead electrode as in claim 1 wherein the flexible arms define an outer diameter, and the at least one electrode has an outer diameter, such that the diameter of the flexible arms is less than or equal to that of the at least one electrode.

7. The implantable lead electrode as in claim 1 wherein the flexible arms are secured together with a coating material that dissolves in response to contact with liquid during implantation, such that the implantable lead electrode can be implanted while the flexible arms are secured together with the coating material and, once implanted, the flexible arms can be separated and secured to tissue.

8. A combination suture sleeve and implantable lead electrode for subcutaneous implantation in a patient and adapted for use in a cardiac stimulus or monitoring system, the lead electrode comprising:

a distal region having at least one electrode and a distal tip; and

a proximal region coupled to the distal region, such that at least one electrical connector couples the proximal region electrically to the at least one electrode;

the suture sleeve comprising a body defining a bore and a flexible member having attachment features thereon for attachment to subcutaneous tissue;

characterized by the region of the lead electrode including a suture sleeve receiving area having an outer diameter sized to movably fit in the bore of the suture sleeve and a stopper at a distal end of the suture sleeve receiving area to prevent the suture sleeve from sliding distally beyond the suture sleeve receiving area during use.

9. The combination of claim 8 wherein the suture sleeve is comprised of a shrinkable material such that, before use, the suture sleeve can be passed over the stopper into the suture sleeve receiving area and, subsequently, the suture sleeve can be shrunk such that the suture sleeve can no longer pass over the stopper.

10. The combination of claim 8 wherein the distal region includes first and second electrodes, the first electrode being disposed at the distal tip, and the second electrode being disposed proximal of the first electrode, wherein the suture sleeve receiving area extends between the first and second electrodes.

11. The combination of claim 10 wherein the first electrode includes a proximal end which forms the stopper by virtue of greater outer diameter than a portion of the suture sleeve receiving area adjacent thereto, and wherein the second electrode includes a distal end which forms a proximal stop preventing the suture sleeve from moving proximal thereof, thus bounding movement of the suture sleeve during use between the first and second electrodes.

12. An implantable lead electrode for subcutaneous implantation in a patient and adapted for use in a cardiac stimulus or monitoring system, the lead electrode comprising:

a distal region having at least one electrode and a plurality of flexible attachment elements each including an attachment feature; and

a proximal region coupled to the distal region, such that at least one electrical connector couples the proximal region electrically to the at least one electrode;

characterized by the flexible attachment elements being wrapped about the distal region in a pre-implant configuration such that, during implantation of the implantable lead electrode, the flexible attachment elements can be un-wrapped from the distal region for attachment to subcutaneous tissue.

13. The implantable lead electrode of claim 12 further comprising a removable sheath for covering the flexible attachment elements and maintaining them in a wrapped configuration during an implant procedure.

14. The implantable lead electrode of claim 12 wherein the distal region having at least one electrodes includes a first electrode disposed near a distal tip of the implantable lead electrode and a second electrode proximal of the first electrode to define a wrap region therebetween, wherein the flexible elements are disposed between the first and second electrodes such that, when wrapped, the flexible elements are wrapped around the wrap region.

15. The implantable lead electrode of claim 12 further comprising a dissolvable coating configured to maintain the flexible elements in a wrapped configuration during implantation and allowing unwrapping of the flexible elements once implanted.

16. An implantable lead electrode for subcutaneous implantation in a patient and adapted for use in a cardiac stimulus or monitoring system, the lead electrode comprising:

a distal region having at least one electrode and an anchoring structure; and

a proximal region coupled to the distal region, such that at least one electrical connector couples the proximal region electrically to the at least one electrode;

characterized by the anchoring structure being relatively inflexible and sized such that it cannot be passed through subcutaneous tissue without extensive dissection so that, in order to implant the lead electrode, the proximal region must be pulled through tissue without passing the distal region more than minimally into a tissue pocket by pulling the proximal region.

17. The implantable lead electrode of claim 16 wherein the anchoring structure is generally in the form of a Y having first and second arms each including an attachment feature.

18. The implantable lead electrode of claim 16 wherein the anchoring structure is generally in the form of a Y having first and second arms each having no attachment features for suturing to tissue.

19. An implantable lead electrode for subcutaneous implantation in a patient and adapted for use in a cardiac stimulus or monitoring system, the lead electrode comprising:

a distal region having at least one electrode and an anchoring structure; and

a proximal region coupled to the distal region, such that at least one electrical connector couples the proximal region electrically to the at least one electrode;

characterized by the anchoring structure being relatively flexible in an initial, unimplanted state and comprising a curable or thermoformable material to allow curing of the anchoring structure once implanted to become rigid.

20. An implantable lead electrode for subcutaneous implantation in a patient and adapted for use in a cardiac stimulus or monitoring system, the lead electrode comprising:

a distal region having at least one electrode and an anchoring structure; and

a proximal region coupled to the distal region, such that at least one electrical connector couples the proximal region electrically to the at least one electrode;

characterized by the anchoring structure including a tissue ingrowth region adapted to encourage tissue ingrowth to achieve chronic tissue attachment.

21. The implantable lead electrode of claim 20 wherein the tissue ingrowth region includes a plurality of silicone ridges.

22. The implantable lead electrode of claim 20 wherein the tissue ingrowth region includes a mesh.

23. The implantable lead electrode of claim 20 wherein the tissue ingrowth region includes a roughened surface.

24. A combination implantable lead electrode system comprising:

a permanent attachment feature for permanent implant in a subcutaneous region of a patient'"'"'s chest, the permanent attachment feature including a lead coupler and an anchor; and

a lead electrode including an implant attachment feature configured for coupling to the lead coupler.

25. The combination of claim 24 wherein the lead coupler comprises a snap fit part, and the implant attachment feature is sized and shaped to snap fit with the lead coupler.

26. The combination of claim 24 wherein the anchor comprises a mesh.

27. The combination of claim 24 wherein the anchor comprises a bone screw.

28. The combination of claim 24 wherein the anchor comprises a screw configured for attachment to cartilage in an intercostal space.