Systems and methods for implanting a medical device using an active guidewire

Patent metadata

Field	Value
Publication number	US-11529522-B2
Application number	US-202017007696-A
Country	US
Kind code	B2
Filing date	Aug 31, 2020
Priority date	Aug 31, 2020
Publication date	Dec 20, 2022
Grant date	Dec 20, 2022

Abstract

Systems and methods for implanting a lead. The system includes an active guidewire having proximal and distal ends. The distal end includes a guidewire anchor that is configured to be attached to a target SOI. The active guidewire is configured to be utilized to electrically map the target SOI by at least one of delivering stimulation energy through the active guide wire to the target SOI or sensing an evoked response at the target SOI from the guidewire. The system also includes a lead having a lead body with proximal and distal ends and with a lumen extending between the proximal and distal ends. The distal end of the lead body is configured to receive the proximal end of the active guidewire. The lumen is configured to permit the lead body to be advanced over the active guidewire.

First claim

What is claimed is:

1. A system for implanting a lead, comprising:
an active guidewire having proximal and distal ends, the distal end configured to be located proximate to a target site of interest (SOI) within or proximate to a chamber of the heart, the distal end including a guidewire anchor configured to be attached to the target SOI:
an external programmer device configured to be connected to the active guide wire and to electrically map the target SOI by at least one of:
delivering a pacing pulse, as stimulation energy through the active guide wire, to the target SOI; or
sensing an evoked response at the target SOI from the guidewire; and

a lead having a lead body with proximal and distal ends and with a lumen extending along the lead body between the proximal and distal ends, the distal end of the lead body configured to receive the proximal end of the active guidewire, the lumen configured to permit the lead body to be advanced over the active guidewire until the distal end of the lead body is proximate the target SOI.

2. The system of claim 1 , wherein the external programmer device is further configured to repeat at least one of the delivering or sensing operations multiple times to obtain additional measurements to electrically map the target SOI.

3. The system of claim 1 , wherein the target SOI represents a HIS, the guidewire anchor configured to attach the distal end of the active guidewire into a wall of the heart proximate the HIS, the external programmer device configured to deliver a HIS paced event as the pacing pulse and to sense the evoked response to determine whether HIS capture was achieved based on the HIS paced event.

4. The system of claim 1 , wherein the target SOI represents a left bundle branch, the guidewire anchor configured to attach the distal end of the active guidewire a predetermined depth into a septa wall separating the right and left ventricles, the external programmer device configured to deliver the pacing pulse through the distal end of the active guidewire to the left bundle branch.

5. The system of claim 1 , wherein the target SOI represents a pacing site, wherein the external programmer device is configured to both deliver the pacing pulse, as the stimulation energy, through the guidewire to the target SOI and sense the evoked response at a sensing site within or proximate the heart separate from the pacing site.

6. The system of claim 1 , wherein the target SOI represents a sensing site and wherein the external programmer device is configured to sense the evoked response at the sensing site following delivery of a pacing pulse at a pacing site within or proximate the heart separate from the sensing site.

7. The system of claim 1 , further comprising:
a catheter configured to be advanced to or proximate the chamber of the heart having the target SOI, the catheter having a lumen with a size dimensioned to receive the active guidewire, the size of the lumen in the catheter being smaller than an outer dimension of the lead body, such that the lead does not fit through the lumen of the catheter.

8. The system of claim 7 , wherein the catheter comprises at least one electrode positioned proximate to a distal end of the catheter, the at least one electrode configured to at least one of deliver stimulation energy to the target SOI or sense an evoked response at the target SOI.

9. The system of claim 1 , wherein the lead includes a lead anchor coupled to the distal end of the lead body, the lead anchor defining an anchor passage that is aligned with the lumen of the lead body, the anchor passage sized to permit the lead anchor to slide over the active guidewire as the lumen is advanced over the active guidewire.

10. The system of claim 1 , wherein the lead anchor includes a helical screw that wraps about the anchor passage.

11. A method of implanting a lead, the method comprising:
advancing an active guidewire to a target site of interest (SOI) within or proximate to a chamber of the heart;
electrically mapping the target SOI utilizing the active guidewire and an external programmer device by at least one of delivering a pacing pulse, as stimulation energy through the active guide wire, to the target SOI or sensing an evoked response at the target SOI from the guidewire;
fixating a distal end of the active guidewire at the target SOI; and
advancing a lead over the active guidewire until a distal end of the lead is located proximate the target SOI.

12. The method of claim 11 , wherein the fixating the distal end of the active guidewire is performed before the electrically mapping the target SOI utilizing the active guidewire.

13. The method of claim 11 , wherein the target SOI represents a HIS bundle region, the fixating the distal end includes attaching the distal end of the active guidewire into a wall of the heart proximate the HIS bundle region, and the electrically mapping includes delivering a HIS paced event as the pacing pulse, the method further comprising assessing whether capture of the HIS bundle region was achieved based on the HIS paced event.

14. The method of claim 11 , wherein the target SOI represents a left bundle branch, wherein the fixating the distal end includes submerging the distal end of the active guidewire a predetermined depth into a septa wall separating the right and left ventricles, and wherein the electrically mapping includes delivering the pacing pulse through the distal end of the active guidewire to the left bundle branch.

15. The method of claim 11 , wherein the target SOI represents a pacing site and wherein the electrical mapping includes both:
delivering the pacing pulse, as the stimulation energy, through the guidewire to the target SOI; and
sensing the evoked response at a sensing site within or proximate the heart separate from the pacing site.

16. The method of claim 11 , wherein the target SOI represents a sensing site and wherein the electrical mapping includes sensing the evoked response at the sensing site following delivery of a pacing pulse at a pacing site within or proximate the heart separate from the sensing site.

17. The method of claim 11 , further comprising prior to advancing the active guidewire:
advancing a J-tip guidewire, obturator, and catheter to or proximate the chamber of the heart having the target SOI;
withdrawing the obturator and J-tip guidewire;
inserting the active guidewire through the catheter to the target SOI; and
withdrawing the catheter before advancing the lead over the active guidewire.

18. The method of claim 11 , wherein the advancing the active guidewire further comprises advancing the active guidewire through the right atrium and through the right ventricle, forcing the distal end of the active guidewire through a septa wall separating the right and left ventricles, advancing the distal end of the active guidewire through the left ventricle and submerging the distal end of the active guidewire into a wall of the left ventricle proximate the Purkinje fiber.

19. The method of claim 11 , wherein the target SOI represents at least one of an atrial pacing site, a His bundle pacing site, a left bundle branch pacing site, a right bundle branch pacing site, and LV wall pacing site proximate the LV Purkinje fibers.

20. The method of claim 11 , further comprising fixating a distal end of the lead to tissue at the target SOI and removing the guidewire by withdrawing the active guidewire along a lumen within the lead.

Assignees

• Pacesetter Inc

Inventors

• Bornzin Alexander R
• Bornzin Gene A
• Somogyi Zoltan
• Li Wenwen
• Min Xiaoyi

Classifications

• A61N1/0573 Primary

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

• A61N1/371 Primary

  Capture, i.e. successful stimulation · CPC title

• A61M2025/09125

  Device for locking a guide wire in a fixed position with respect to the catheter or the human body · CPC title

• A61M2025/09175

  having specific characteristics at the distal tip · CPC title