IMPLANT TOOLS WITH ATTACHMENT FEATURE AND MULTI-POSITIONAL SHEATH AND IMPLANT TECHNIQUES UTILIZING SUCH TOOLS

• US 20150133954A1
• Filed: 03/04/2014
• 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., Christopherson, Roger A., Olson, Nathan L., Poindexter, Rebecca L.
• Granted Patent: US 9,610,436 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• 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: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61M 25/0662 Guide tubes
• 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 implantable component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An example implant tool for implanting a medical lead includes a rod and a sheath configured to be placed on the rod. The rod includes a handle, a shaft having a proximal end adjacent to the handle and a distal end, and an attachment feature toward the distal end of the shaft, the attachment feature configured to couple to the medical lead. The sheath is configured to be placed in multiple positions along the rod including a first position in which the sheath does not interact with the attachment feature and second position in which the sheath does interact with the attachment feature.

Claims

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

a rod that includes;

a handle;

a shaft having a proximal end adjacent to the handle and a distal end; and

an attachment feature toward the distal end of the shaft, the attachment feature configured to couple to the medical lead; and

a sheath configured to be placed on the rod, wherein the sheath includes a body having proximal end and a distal end, and further wherein the sheath is configured to be placed in multiple positions along the rod including a first position in which the sheath does not interact with the attachment feature and second position in which the sheath does interact with the attachment feature.

2. The implant tool of claim 1, wherein the attachment feature comprises a hook feature configured to receive an attachment feature of the medical lead, wherein in the first position the sheath does not cover the hook feature and in the second position the sheath does cover the hook feature.

3. The implant tool of claim 1, wherein the attachment feature comprises a recess that extends into the distal end of the shaft of the rod, the recess being configured to receive and couple to a portion of the medical lead, wherein in the first position the sheath does not extend beyond the distal end of the shaft of the rod and in the second position the sheath does extend beyond the distal end of the shaft of the rod.

4. The implant tool of claim 3, wherein the recess is configured to receive and couple to a terminal pin of a connector on the proximal end of the medical lead.

5. The implant tool of claim 1, wherein the sheath includes a handle at the proximal end of the body, wherein the handle of the sheath is configured to lock the sheath in the multiple positions.

6. The implant tool of claim 5, wherein the handle of the sheath includes at least a first groove and a second groove spaced apart from one another by a distance, wherein the first and second grooves are shaped to receive a portion of the handle of the rod such that when the portion of the handle of the rod is placed within the first groove the sheath is locked in the first position and when the portion of the handle of the rod is placed within the second groove the sheath is locked in the second position.

7. The implant tool of claim 1, wherein the multiple positions include a third position in which the sheath extends beyond the distal end of the shaft of the rod.

8. The implant tool of claim 1, wherein the sheath includes an opening that extends along the body of the sheath from the proximal end to the distal end, wherein an inner channel of the sheath is accessible via the opening.

9. The implant tool of claim 1, wherein the sheath comprises a splittable sheath having one or more score lines.

10. The implant tool of claim 1, wherein the sheath comprises a slittable sheath.

11. The implant tool of claim 1, wherein the shaft of the rod has a diameter that is greater than a diameter of the medical lead and the body of the sheath has an inner diameter that is less than or equal to the diameter of rod such that the sheath and shaft of the rod create an interference fit.

12. The implant tool of claim 11, wherein the sheath is held in the multiple positions along the shaft of the rod via the interference fit.

13. The implant tool of claim 1, wherein at least one of the shaft of the rod and the body of the sheath includes one or more markings that identify locations that coincide with locations of features of the medical lead when the medical lead is placed within the sheath such that a distal end of the medical lead is located at the distal end of the body of the sheath.

14. The implant tool of claim 13, wherein the markings identify locations that coincide with locations of one or more electrodes of the medical lead when the medical lead is placed within the sheath such that a distal end of the medical lead is located at the distal end of the body of the sheath.

15. A method for implanting a medical electrical lead using a rod having a handle, a shaft having a proximal end adjacent to the handle and a distal end, and an attachment feature toward the distal end of the shaft, the attachment feature configured to couple to the medical lead, and a sheath configured to be placed on the shaft of the rod, the sheath having body defining a channel, the medical electrical lead having a proximal end including a connector mechanism configured to connect to an implantable medical device and a distal end including one or more electrodes, the method comprising:

creating a first incision at a first location on a torso of a patient;

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

introducing the rod, with the sheath placed on the rod at a first position in which the sheath does not interact with the attachment feature of the rod, into the patient via the first incision;

advancing the rod from the first incision to the second incision to create a first path between the first incision and the second incision;

attaching an attachment feature of the medical electrical lead to the attachment feature of the rod;

advancing the sheath to a second position in which the sheath does interact with the attachment feature of the rod after attaching the attachment feature of the medical electrical lead to the attachment feature of the rod;

withdrawing the rod from the patient to pull the medical electrical lead along the path between the first incision to the second incision;

retracting the sheath to the first position such that the sheath no longer interacts with the attachment feature of the rod; and

removing the attachment feature of the medical electrical lead from the attachment feature of the rod.

16. The method of claim 15, wherein:

creating the first incision comprises creating a first incision at a first location on a left side of the torso of the patient, and

creating the second incision comprises creating a second incision at a second location near a center of the torso of the patient.

17. The method of claim 16, further comprising:

introducing the rod, with the sheath placed on the rod, into the second incision at the second location near the center of the torso of the patient;

advancing the rod within the patient from the second location to a third location superior to the second location to create a second path between the second location and the third location;

withdrawing the rod toward the second incision to remove the rod from the patient while leaving the sheath in place along the second path between the third location to the second location;

advancing the lead within the channel of the sheath from the second incision to the third location; and

removing the sheath from the lead while leaving the lead in place along the second path between the third location to the second location.

18. The method of claim 17, wherein advancing the rod within the patient from the second location to the third location superior to the second location comprises advancing the implant tool subcutaneously within the patient from the second location to the third location superior to the first location.

19. The method of claim 17, wherein advancing the rod within the patient from the second location to the third location superior to the second location comprises advancing the implant tool substernally within the patient from the second location to the third location superior to the first location.

20. The method of claim 15, wherein the attachment feature of the rod comprises a hook feature and further wherein:

introducing the rod, with the sheath placed on the rod at the first position in which the sheath does not interact with the attachment feature of the rod comprises introducing the rod, with the sheath placed on the rod at the first position in which the sheath does not cover the hook feature of the rod, and

advancing the sheath to the second position in which the sheath does interact with the attachment feature of the rod comprises advancing the sheath to the second position in which the sheath covers the hook feature of the rod.