Electrode placement apparatus and methods

Patent metadata

Field	Value
Publication number	US-2022032047-A1
Application number	US-202117379440-A
Country	US
Kind code	A1
Filing date	Jul 19, 2021
Priority date	Jul 30, 2020
Publication date	Feb 3, 2022
Grant date	—

Abstract

Apparatus and methods for placement of electrodes into selected tissue, such as the septal wall separating the left and right ventricles, with, in some cases, access to the septal wall from the right ventricle. Torque sleeves may be used to provide for rotation as needed.

First claim

1 . A medical electrode kit comprising:
a delivery catheter extending along a catheter axis from a proximal catheter end to a distal catheter end, the delivery catheter comprising a delivery lumen extending from a distal opening at the distal catheter end towards the proximal catheter end; a catheter fixation structure located at the distal catheter end, the catheter fixation structure configured to attach the distal catheter end to tissue; a first lead assembly located in the delivery catheter lumen, the first lead assembly comprising:
a push tube comprising a tube lumen extending from a distal tube opening proximally towards a proximal tube end, the push tube located within the delivery lumen extending along the catheter axis, and
a first lead comprising a first electrode positioned at the distal tube opening and a first conductor attached to the first electrode, the first conductor extending proximally away from the first electrode and towards the proximal tube end; and
a second lead extending from a distal end to a proximal end along a second lead axis, the second lead comprising:
a second lead body comprising a first lead lumen extending from a lead opening at the distal end of the second lead proximally towards the proximal end of the second lead,
a lead fixation structure located at the distal end of the second lead, the lead fixation structure configured to attach the distal end of the second lead to tissue, and
a second electrode exposed on an exterior surface of the second lead body, the second electrode located between the distal end of the second lead and the proximal end of the second lead, wherein the second electrode is configured to be spaced away from tissue to which the lead fixation structure is attached;
wherein the second lead is configured for advancement over the first conductor of the first lead distally towards the first electrode after the push tube and the delivery catheter are both removed from the first conductor in a proximal direction, and wherein the first conductor is located in the first lead lumen when the second lead is advanced over the first conductor towards the first electrode.

2 . A kit according to claim 1 , wherein the catheter fixation structure on the delivery catheter comprises a delivery catheter helix configured to advance into tissue when the delivery catheter is rotated about the catheter axis.

3 . A kit according to claim 2 , wherein the delivery catheter helix comprises a helically coiled wire.

4 . A kit according to claim 1 , wherein the first electrode is configured for advancement into tissue upon application of a translational pushing force delivered along the catheter axis to the first lead using the push tube.

5 . A kit according to claim 4 , wherein the first electrode is configured to resist removal from tissue in a proximal direction along the first conductor.

6 . A kit according to claim 1 , wherein the first electrode comprises a tapered body comprising a base larger than a distal tip, wherein the first conductor is attached to the tapered body proximate the base.

7 . A kit according to claim 1 , wherein the first conductor extends proximally from the first electrode through the tube lumen of the push tube.

8 . A kit according to claim 1 , wherein the lead fixation structure comprises a second lead helix configured to advance into tissue when the second lead is rotated about the first conductor of the first lead.

9 . A kit according to claim 8 , wherein the second lead helix comprises a helically coiled wire.

10 . A kit according to claim 1 , wherein the kit further comprises:
a torque sleeve comprising a sleeve lumen extending along a sleeve axis extending from a distal sleeve end to a proximal sleeve end, wherein the second lead is located in the sleeve lumen of the torque sleeve; and a clamp assembly located in a clamping section of the sleeve lumen proximate the distal sleeve end, wherein the clamp assembly is configured to couple the torque sleeve to the second lead when in a clamped state such that rotation of the torque sleeve about the first conductor causes corresponding rotation of the second lead, and wherein the clamp assembly is configured to decouple the torque sleeve from the second lead when the clamp assembly is in an unclamped state such that the torque sleeve is configured to be advanced over the second lead towards the distal end of the second lead.

11 . A kit according to claim 10 , wherein the clamp assembly prevents translational movement of the torque sleeve along the second lead body away from the first electrode when the clamp assembly is in the clamped state.

12 . A kit according to claim 10 , wherein the clamping section of the sleeve lumen comprises a tapered diameter that increases when moving in the proximal direction away from the distal sleeve end, and wherein the clamp assembly comprises:
a split ring configured to clamp an exterior surface of the medical lead when the split ring is located at a distal end of the clamping section, a clamp actuator attached to the split ring, the clamp actuator extending proximally away from the split ring and towards the proximal sleeve end, wherein the clamp actuator is configured to move the split ring towards a proximal end of the clamping section, and further wherein the clamp assembly is in the unclamped state when the split ring is located at the proximal end of the clamping assembly.

13 . A kit according to claim 12 , wherein the clamp actuator is configured to move the split ring towards the distal sleeve end within the clamping section to move the clamping assembly from the unclamped state to the clamped state.

14 . A kit according to claim 12 , wherein the clamp actuator comprises a wire attached to the split ring and extending proximally through the sleeve lumen away from the clamping section.

15 . A medical therapy system comprising:
an implantable medical device (IMD) configured to provide pacing of a patient's heart; and a medical electrode kit for according to claim 1 , wherein the first lead and the second lead are configured to be connected to the IMD.

16 . An implanted medical therapy system comprising:
an implantable medical device (IMD) configured to provide pacing of a patient's heart, wherein the IMD is subcutaneously implanted in the patient; and wherein the first lead and the second lead of a medical electrode kit according to claim 1 are implanted in the patient and connected to the IMD.

17 . An implanted medical therapy system according to claim 16 , wherein the first lead and the second lead do not pierce or extend into the left ventricle.

18 . An implanted medical therapy system according to claim 16 , wherein the first electrode of the first lead is positioned to stimulate the right bundle branch.

19 . An implanted medical therapy system according to claim 16 , wherein the first electrode of the first lead is positioned to stimulate the left bundle branch.

20 . An implanted medical therapy system according to claim 16 , wherein the second electrode of the second lead is located in the right ventricle.

21 . A method of implanting a medical electrode system, the method comprising:
advancing a distal catheter end of a delivery catheter into a right ventricle of a patient's heart; securing a catheter fixation structure at the distal catheter end of the delivery catheter at a selected location on the septal wall of the patient's heart after advancing the distal catheter end into the right ventricle;

Assignees

• Medtronic Inc

Inventors

• Fraysse Estelle
• Verbeek Maurice

Classifications

• A61M2025/0286

  anchored in the skin by suture or other skin penetrating devices · CPC title

• A61M25/04

  in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)} · CPC title

• A61N1/0573 Primary

  chacterised by means penetrating the heart tissue, e.g. helix needle or hook · CPC title

• A61N1/057 Primary

  Anchoring means; Means for fixing the head inside the heart · CPC title

• A61M2210/125

  Heart · CPC title