OPEN CHANNEL IMPLANT TOOLS HAVING AN ATTACHMENT FEATURE AND IMPLANT TECHNIQUES UTILIZING SUCH TOOLS

• US 20150133951A1
• Filed: 02/28/2014
• Published: 05/14/2015
• Est. Priority Date: 11/12/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Seifert, Kevin R., Olson, Nathan L., Poindexter, Rebecca L.
• Granted Patent: US 10,118,027 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion

Abstract

Implant tools and techniques for implantation of a medical lead, catheter or other component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An implant tool for implanting a medical lead may include a shaft having a proximal end, a distal end, an open channel that extends from near the proximal end to the distal end, and an attachment feature configured to couple to the medical lead. Such an implant tool provides a user with the versatility to use the same implant tool to either pull the lead through a tunnel formed via the implant tool or push the lead through the tunnel via the open channel in the implant tool.

Claims

1. An implant tool for implanting a medical lead, the implant tool comprising:

a shaft having a proximal end and a distal end, wherein the shaft includes;

an open channel that extends from near the proximal end to the distal end; and

an attachment feature configured to couple to the medical lead.

2. The implant tool of claim 1, further comprising a handle adjacent to the shaft.

3. The implant tool of claim 2, wherein the handle is removable.

4. The implant tool of claim 3, wherein the handle is configured to couple to at least one of the proximal end of the shaft and the distal end of the shaft.

5. The implant tool of claim 2, wherein the handle includes a lumen configured to receive a portion of the shaft, the lumen and shaft creating an interference fit that couples the shaft to the handle.

6. The implant tool of claim 1, wherein the attachment feature comprises a hook feature located along a surface of the shaft that is opposite an opening of the channel, the hook feature being configured to couple to a feature of the medical lead.

7. The implant tool of claim 6, wherein the shaft has a thickness and the hook feature extends through the thickness shaft such that there is an opening through the surface of the shaft.

8. The implant tool of claim 6, wherein the shaft has a thickness and the hook feature does not extends through the thickness of the shaft.

9. The implant tool of claim 1, wherein the attachment feature comprises a round recess that extends into the proximal end of the shaft, wherein the recess is sized to receive and couple to a portion of the medical lead.

10. The implant tool of claim 9, wherein the recess is sized to receive and couple to a terminal pin of a connector on the proximal end of lead.

11. The implant too of claim 9, wherein the attachment feature further comprises a slit that extends across the diameter of the proximal end of the shaft and into the proximal end of the shaft.

12. The implant tool of claim 9, wherein the recess of the proximal end of the shaft and the portion of the medical lead are coupled via an interference fit.

13. The implant tool of claim 1, wherein the open channel includes at least one guide along an inner surface of the shaft forming the open channel, the guide being configured to receive a portion of an implantable medical lead.

14. The implant tool claim 1, wherein the shaft includes a plurality of markings that identify locations that coincide with locations of features of the medical lead when the medical lead is placed within the open channel such that a distal end of the lead is located at the distal end of the shaft.

15. The implant tool of claim 14, wherein the markings identify locations that coincide with locations of electrodes of the medical lead when the medical lead is placed within the open channel such that the distal end of the lead is located at the distal end of the shaft.

16. The implant tool of claim 1, wherein the implant tool is formed of at least one of a molded polymer and a metal.

17. The implant tool of claim 1, wherein a thickness of the shaft is uniform along a length of shaft from the proximal end to the distal end.

18. The implant tool of claim 1, wherein a first thickness of the shaft toward the distal end is not substantially the same as a second thickness of the shaft at the proximal end.

19. The implant tool of claim 1, wherein a first thickness of the shaft along sides of the shaft forming the open channel is less than a thickness of the shaft along a bottom of the shaft.

20. The implant tool of claim 1, wherein the open channel has a width that is greater than or equal to an outer diameter of the implantable medical lead.

21. The implant tool of claim 20, wherein the open channel further includes a depth that is greater than or equal to the outer diameter of the implantable medical lead.

22. The implant tool of claim 1, wherein the shaft is a curved shaft, the curved shaft having a radius of curvature of between three (3) and five (5) inches.

23. A method for implanting a medical electrical lead within a patient, the method comprising:

creating a first incision at a first location near a center of a torso of the patient;

creating a second incision at a second location on a left side of the torso of the patient;

introducing an implant tool into the patient via one of the first incision and the second incision, the implant tool including a handle and a shaft having a proximal end, a distal end, an open channel extending from near the proximal end to the distal end, and an attachment feature;

advancing the shaft of the implant tool through the subcutaneous tissue from the incision in which the implant tool was introduced into the patient to the other one of the first incision and the second incision;

attaching a lead to the attachment feature of the implant tool; and

withdrawing the implant tool from the patient to pull the lead along the path created between the first incision and the second incision.

24. The method of claim 23, wherein the attachment feature is located at or near the proximal end of the shaft of the implant tool and the handle is initially adjacent to the proximal end of the implant tool, further wherein advancing the shaft of the implant tool through the subcutaneous tissue comprises advancing the distal end of the shaft through the subcutaneous tissue, the method further comprising:

after advancing the distal end of the shaft of the implant tool through the subcutaneous tissue, removing the handle from the proximal end of the shaft of the implant tool to expose the attachment feature; and

reattaching the handle to the distal end of the shaft of the implant tool prior to withdrawing the lead insertion tool from the patient,

wherein withdrawing the implant tool from the patient comprises pulling the implant tool via the handle to pull proximal end of the shaft and the lead along the path created between the first incision and the second incision.

25. The method of claim 23, wherein the attachment feature is located at or near the proximal end of the shaft of the implant tool and the handle is initially adjacent to the proximal end of the implant tool, further wherein advancing the shaft of the implant tool through the subcutaneous tissue comprises advancing the distal end of the shaft through the subcutaneous tissue, the method further comprising:

after advancing the distal end of the shaft of the implant tool through the subcutaneous tissue, removing the handle from the proximal end of the shaft of the implant tool to expose the attachment feature,

wherein withdrawing the implant tool from the patient comprises pulling the distal end of the shaft to pull the proximal end of the shaft and the lead along the path created between the first incision and the second incision.

26. The method of claim 23, wherein the attachment feature is located at or near the distal end of the shaft of the implant tool, and further wherein:

advancing the shaft of the implant tool through the subcutaneous tissue comprises advancing the distal end of the shaft through the subcutaneous tissue from the incision in which the implant tool was introduced into the patient to the other one of the first incision and the second incision; and

withdrawing the implant tool from the patient comprises withdrawing the implant tool from the patient to pull the distal end of the shaft and the lead along the path created between the first incision and the second incision.

27. The method of claim 23, further comprising:

introducing the implant tool into the first incision at the first location near the center of the torso of the patient;

advancing the implant tool within the patient from the first location to a third location superior to the first location;

introducing the distal end of the lead into the open channel of the shaft near the handle of the implant tool;

advancing the lead along the open channel of the shaft of the implant tool from the first incision to the third location; and

withdrawing the implant tool toward the first incision to remove the implant tool while leaving the lead in place along the path from the third location to the first incision.

28. The method of claim 23, wherein advancing the implant tool within the patient from the first location to the third location superior to the first location comprises advancing the implant tool underneath a skin and above one or both of a ribcage and a sternum of the patient from the first location to the third location superior to the first location.

29. The method of claim 23, wherein advancing the implant tool within the patient from the first location to the third location superior to the first location comprises advancing the implant tool underneath a sternum from the first location to the third location superior to the first location.

30. The method of claim 23, wherein attaching the medical lead to the attachment feature of the implant tool comprises pushing a terminal pin of a connector of the medical lead into a recess forming the attachment feature of the shaft.

31. The method of claim 23, wherein the shaft includes a plurality of markings that identify locations that coincide with locations of features of the medical lead when the medical lead is placed within the open channel, the method further comprising:

prior to creating the first and second incision, placing the implant tool on the skin of the patient such that the markings of the shaft coinciding with locations of features of the medical lead are located at a desired location; and

placing landmarks on the skin of the patient corresponding with a desired tunneling path to thereby place the features of the medical lead at the desired location.