ELECTRODE INSERTION TOOLS, LEAD ASSEMBLIES, KITS AND METHODS FOR PLACEMENT OF CARDIAC DEVICE ELECTRODES

• US 20140200592A1
• Filed: 03/18/2014
• Published: 07/17/2014
• Est. Priority Date: 08/01/2006
• Status: Active Grant

• Current Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Original Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Inventors: O'Connor, Stephen A.P.
• Granted Patent: US 9,216,284 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• 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 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

Insertion tools, lead assemblies, kits, and methods for placement of cardiac device electrodes. In some embodiments, an insertion tool having a proximal end and a distal, dissecting end includes a structure configured to receive or engage a structure on a lead assembly. Some embodiments include a lead assembly having an end including a structure configured for engaging the distal end of an associated insertion tool. Some embodiments include kits or systems including both an insertion tool and a lead assembly, each having a structure for engaging the other. In these embodiments, the engaging structures may take several forms including threads, small posts, circular or semi-circular receiving members, and/or a slot. Some embodiments also include methods for placement of cardiac device electrodes with the assistance of an associated insertion tool, wherein the cardiac device electrodes are associated with a lead assembly having an end configured to engage a distal, dissecting portion of an associated insertion tool.

Claims

1. A tool for use in subcutaneous insertion of a lead electrode assembly, the tool comprising:

a proximal end having a handle;

a distal end including a dissecting tip shaped for separating subcutaneous tissue to form a channel therethrough, and an engaging structure disposed adjacent to the dissecting tip; and

a shaft extending between the proximal and distal ends;

wherein the engaging structure is configured to directly engage a portion of an associated lead assembly.

2. The tool of claim 1, wherein the distal end further comprises a dissecting portion proximal to the engaging structure, the dissecting portion shaped to further separate subcutaneous tissue relative to the dissecting tip such that, when the engaging structure is used to secure the lead electrode assembly thereto, and the handle is pulled in a proximal direction, the dissecting portion reduces drag on the lead assembly.

3. The tool of claim 2, wherein the dissecting tip, engaging structure, and dissecting portion generally form a conical portion with a discontinuity at the engaging structure, the discontinuity extending at least partly about the conical portion.

4. The tool of claim 3, wherein the discontinuity extends wholly around the conical portion.

5. The tool of claim 3, wherein the engaging structure includes a threaded portion.

6. The tool of claim 3, wherein the engaging structure includes a transversely extending structure.

7. The tool of claim 6, wherein the transversely extending structure forms a ridge and a slot.

8. The tool of claim 3, wherein the engaging structure includes a circular protrusion having axial flexibility.

9. The tool of claim 3, wherein the engaging structure includes a circular protrusion having at least one slot extending therethrough.

10. The tool of claim 1, further comprising means for locking the tool in an engaged configuration relative to a lead assembly configured to engage the engaging structure of the tool.

11. The tool of claim 1, further comprising a locking member coupled to a control mechanism disposed relative to the handle, the locking member configured to lock the tool in an engaged position in response to actuation by the control mechanism.

12. The tool of claim 1, further comprising a locking member coupled to means for controlling the locking member, the means for controlling the locking member accessible at or near the handle, the locking member configured to lock the tool in an engaged configuration relative to a lead assembly when actuated by the means for controlling.

13. The tool of claim 1, wherein a shoulder is defined between the distal end and the shaft proximally adjacent the distal end, wherein the shoulder is shaped for non-traumatic passage in a proximal direction through subcutaneous tissue.

14. A method of implanting a lead assembly for a cardiac stimulus system, the method comprising:

creating a first incision and a second incision;

providing an introducer tool having a proximal end with a handle and a distal end having a dissecting tip and a lead engagement structure for engaging an associated lead assembly;

advancing the introducer tool into the first incision toward the second incision such that the dissecting tip dissects subcutaneous tissue and the lead engagement structure is exposed to subcutaneous tissue and fluids;

exposing at least the lead engagement structure at the second incision;

providing a lead assembly having at least a distal end with a tool engagement structure configured to engage the lead engagement structure;

securing the distal end of the lead assembly to the distal end of the introducer tool by twisting engagement of the lead engagement structure to the tool engagement structure; and

pulling the introducer tool handle to draw a portion of the lead assembly into the subcutaneous tissue between the first and second incisions.

15. The method of claim 14, further comprising:

withdrawing the introducer tool via the first incision to draw a distal portion of the lead assembly out of the first incision, leaving a proximal portion of the lead assembly in the subcutaneous tissue between the first and second incisions;

creating a third incision;

advancing the introducer tool into the third incision toward the first incision such that the dissecting tip dissects subcutaneous tissue and the lead engagement structure is exposed to subcutaneous tissue and fluids;

exposing at least the lead engagement structure at the first incision;

securing the distal end of the lead assembly to the distal end of the introducer tool by twisting engagement of the lead engagement structure to the tool engagement structure; and

pulling the introducer tool handle to draw a portion of the lead assembly into the subcutaneous tissue between the first and third incisions.

16. The method of claim 14, wherein the introducer tool includes a locking mechanism and the method further comprises engaging the locking mechanism to keep the introducer tool and the lead assembly secured at their distal ends.

17. A lead assembly for a cardiac stimulus system, the lead assembly comprising:

a distal end comprising at least a first electrode and a distal tip; and

a proximally extending shaft including an electrical conductor coupled to the first electrode;

wherein the distal end further comprises an engagement structure configured for direct engagement with an associated introducer tool and a receiving portion for receiving the distal end of the associated introducer tool such that, when an associated introducer tool is received in the receiving portion, the distal tip of the lead assembly extends over and around a portion of the associated introducer tool.

18. The lead assembly of claim 17, wherein the engagement structure includes threads.

19. The lead assembly of claim 17, wherein the engagement structure includes one or more tabs extending into the receiving portion from an outer sheath near the distal tip.

20. The lead assembly of claim 17, wherein the engagement structure includes one or more slots adjacent a disk, the slots sized and configured to receive corresponding tabs on the associated introducer tool.