Minimally invasive method to implant a subcutaneous electrode

• US 10,617,402 B2
• Filed: 07/13/2016
• Issued: 04/14/2020
• Est. Priority Date: 07/22/2015
• Status: Active Grant

• Current Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Original Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Inventors: Reddy, G. Shantanu, Tockman, Bruce A.
• Primary Examiner(s): Holwerda, Kathleen S
• Application Number:
  US15/208,707
• Publication Number:
  US 20170020551A1
• Time in Patent Office: 1,371 Days
• Field of Search: 606129, 606185
• 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 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3201 Scissors for biopsy A61B10/02
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• 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 2017/003 Steerable
• CPC Class Codes: A61B 2017/0212 Cushions or pads, without holding arms, as tissue retainers, e.g. for retracting viscera
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

Methods and tool kits for implanting a lead subcutaneously. Examples include tool kits and methods for establishing first and second subcutaneous tunnels at an angle relative to one another to facilitate introduction of a lead to the subcutaneous space. In an example, a first insertion tool is used to establish a first subcutaneous tunnel, and a second insertion tool, with or without the use of a blunt dissector, sheath, guidewire, or steering mechanism, is used to initiate or form the second subcutaneous tunnel. Such methods and tool kits may reduce the number of incisions needed to implant a subcutaneous lead along a subcutaneous path having a curve therein.

Claims

1. A method of implanting a subcutaneous defibrillation lead in a patient comprising:

making a first incision;

inserting a first insertion tool having a distal end and a proximal end via the first incision and directing the first insertion tool to a target location to establish a first subcutaneous tunnel from the incision toward the target location, the first subcutaneous tunnel extending along a first axis;

extending a second insertion tool from within the first insertion tool, wherein the distal end of the first insertion tool lies on the first axis when the second insertion tool is extended from at or near the distal end of the first insertion tool along a second axis at an angle of at least 30 degrees from the first axis, to form at least a portion of a second subcutaneous tunnel along the second axis;

wherein the second insertion tool comprises a proximal end with a handle and a distal end, and the step of extending the second insertion tool includes using a blunt dissector removably placed within the second insertion tool to dissect tissue, wherein the second insertion tool is used to determine the direction in which the blunt dissector is directed.

2. The method of claim 1 wherein the first insertion tool is a powered tool having an ultrasonic transducer to facilitate tunneling through tissue, and the step of inserting the first insertion tool comprises activating the ultrasonic transducer.

3. The method of claim 1 wherein the second insertion tool is steerable and includes a steering control at the proximal end thereof, and the step of extending the second insertion tool includes steering the distal end thereof in a desired direction toward the second axis.

4. The method of claim 1 wherein the second insertion tool includes a deployable cutter for facilitating advancement of the second insertion tool, and the step of extending the second insertion tool comprises using the deployable cutter to direct the second insertion tool along the second axis.

5. The method of claim 1 wherein the second axis is at an angle of about 90 degrees from the first axis.

6. The method of claim 1 wherein the first axis generally extends along a transverse plane of the patient, and the second axis generally extends along a sagittal or parasagittal plane of the patient.

7. The method of claim 1 wherein the first subcutaneous tunnel extends from approximately the left axilla toward the sternum, and the second subcutaneous tunnel extends from a location 1-5 cm left and superior to the xiphoid toward the manubrium in a direction generally parallel to the sternum.

8. The method of claim 1 wherein the blunt dissector is configured for longitudinal strength but not lateral strength.

9. The method of claim 1 wherein the second insertion tool is steerable and includes a steering control at the proximal end thereof, and the step of extending the second insertion includes steering the distal end thereof in a desired direction toward the second axis with the blunt dissector therein.

10. The method of claim 1 further comprising advancing the blunt dissector from the distal end of the second insertion tool to form the second subcutaneous tunnel such that:

the first insertion tool extends from the first incision to the target location;

the second insertion tool extends from the distal end of the first insertion tool along a curve to the start of the second subcutaneous tunnel; and

the blunt dissector extends from the start of the second subcutaneous tunnel to a distal end thereof.

11. The method of claim 10 wherein the blunt dissector is provided with a lumen therein for advancement or placement of a guidewire, and the method further comprises:

advancing the guidewire through the lumen to near or at the distal end of the second subcutaneous tunnel;

removing at least the blunt dissector while keeping the guidewire in a desired place;

advancing a lead over the guidewire to a desired lead position; and

removing the guidewire.

12. The method of claim 10 wherein the blunt dissector is provided with a lumen for advancement or placement of a guidewire, and the step of advancing the blunt dissector is performed with the guidewire contained in the lumen of the dissector and the method further comprises:

removing at least the blunt dissector over the guidewire while keeping the guidewire in a desired place;

advancing a lead over the guidewire to a desired lead position; and

removing the guidewire.

13. The method of claim 10 wherein the step of advancing the blunt dissector is performed with a tearable sheath thereover, and the method further comprises:

removing at least the blunt dissector while keeping the sheath in a desired place;

advancing a lead within the tearable sheath to a desired lead position; and

removing the tearable sheath over the lead.

14. The method of claim 1 further comprising:

advancing the second insertion tool such that a distal tip thereof is at or near a desired position;

advancing the first insertion tool over the second insertion tool such that the distal end of the first insertion tool is at or near the desired position;

removing the second insertion tool from within the first insertion tool;

inserting a lead having a proximal end and a distal end such that the distal end thereof is at or near the desired position; and

removing the first insertion tool over the lead.

15. The method of claim 14 further comprising:

anchoring the lead such that its distal end will remain at or near the desired position; and

closing the first incision such that the method is completed without making a second incision.

16. The method of claim 1 wherein the first insertion tool is generally straight.

17. The method of claim 1 wherein, when the second insertion tool exits the first insertion tool, the first insertion tool is generally straight.