Delivery of cardiac stimulation devices

• US 10,426,952 B2
• Filed: 04/24/2017
• Issued: 10/01/2019
• Est. Priority Date: 07/21/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Kveen, Graig L., Saholt, Douglas R., Hastings, Roger N., Gunderson, Richard C.
• Primary Examiner(s): Dietrich, Joseph M
• Application Number:
  US15/495,612
• Publication Number:
  US 20170224983A1
• Time in Patent Office: 890 Days
• CPC Class Codes: A61M 2025/0095 being one or more needles protruding from the distal tip and which are not used for injection nor for electro-stimulation, e.g. for fixation purposes
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Some embodiments of an electrical stimulation system employ wireless electrode assemblies to provide pacing therapy, defibrillation therapy, or other stimulation therapy. In certain embodiments, the wireless electrode assemblies may include a guide wire channel so that each electrode assembly can be advanced over a guide wire instrument through the endocardium. For example, a distal tip portion of a guide wire instrument can penetrate through the endocardium and into the myocardial wall of a heart chamber, and the electrode assembly may then be advanced over the guide wire and into the heart chamber wall. In such circumstances, the guide wire instrument (and other portions of the delivery system) can be retracted from the heart chamber wall, thereby leaving the electrode assembly embedded in the heart tissue.

Claims

1. A method of implanting a wireless electrode assembly into a heart, comprising:

advancing a device through a cardiovascular system of a patient to an implantation site of a wall of a heart;

observing, on an electrocardiogram (ECG), electrical activity of the heart using a sensing electrode on the device and in electrical communication with the ECG;

determining, before penetration of the wall of the heart by a wireless electrode assembly, if the implantation site is suitable for receipt of the wireless electrode assembly based on the observed electrical activity of the heart on the ECG; and

thereafter, deploying the wireless electrode assembly at the implantation site if based on determining, before penetration of the wall of the heart by the wireless electrode assembly, that the implantation site is suitable for receipt of the wireless electrode assembly such that the wireless electrode assembly is fully implanted and anchored into the wall of the heart, the wireless electrode assembly including a body sized to be positioned within a chamber of the heart, the body containing circuitry for delivering electrical stimulation to heart wall tissue from a first electrode of the wireless electrode assembly, through the heart wall tissue, and to a second electrode of the wireless electrode assembly.

2. The method of claim 1, further comprising:

anchoring a delivery catheter at the implantation site, and

wherein the wireless electrode assembly is deployed from a distal end of the delivery catheter.

3. The method of claim 1, wherein the device is a guidewire.

4. The method of claim 3, wherein the wireless electrode assembly includes a guidewire lumen through which the guidewire is slidably disposed.

5. The method of claim 3, further comprising a pulse generator electrically coupled to a proximal portion of the guidewire configured to transmit a test stimulation signal to the sensing electrode, wherein the step of determining, before penetration of the wall of the heart by the wireless electrode assembly, if the implantation site is suitable for receipt of the wireless electrode assembly further includes using the pulse generator to transmit the test stimulation signal to verify that the implantation site is suitable for receipt of the wireless electrode assembly.

6. The method of claim 1, further comprising, advancing the device through an atrial septum of the heart to reach the implantation site.

7. The method of claim 6, wherein the implantation site is in the left ventricle.

8. The method of claim 6, further comprising advancing the device through a guide sheath positioned through the atrial septum.

9. The method of claim 1, wherein the wireless electrode assembly is advanced to the implantation site within a distal end region of a delivery catheter.

10. The method of claim 9, wherein the delivery catheter is advanced into a proximal end of a delivery sheath after the wireless electrode assembly is positioned in the distal end region of the delivery catheter.

11. A method of implanting a wireless electrode assembly into a heart, comprising:

advancing a device through a cardiovascular system of a patient to an implantation site of a wall of a heart;

sensing local electrical activity of the heart at the implantation site with a sensing electrode on the device;

observing the local electrical activity of the heart on an electrocardiogram (ECG) that is in electrical communication with the sensing electrode;

determining, before penetration of the wall of the heart by a wireless electrode assembly, if the implantation site is suitable for receipt of the wireless electrode assembly based on the observed local electrical activity of the heart on the ECG; and

thereafter, deploying the wireless electrode assembly at the implantation site based on determining, before penetration of the wall of the heart by the wireless electrode assembly, that the implantation site is suitable for receipt of the wireless electrode assembly such that the wireless electrode assembly is fully implanted and anchored into the wall of the heart, the wireless electrode assembly including a body sized to be positioned within a chamber of the heart, the body containing circuitry for delivering electrical stimulation to heart wall tissue from a first electrode of the wireless electrode assembly, through the heart wall tissue, and to a second electrode of the wireless electrode assembly.

12. The method of claim 11, wherein the wireless electrode assembly is advanced to the implantation site within a distal end region of a delivery catheter.

13. The method of claim 12, wherein the delivery catheter is advanced into a proximal end of a delivery sheath after the wireless electrode assembly is positioned in the distal end region of the delivery catheter.

14. The method of claim 12, further comprising:

anchoring a delivery catheter at the implantation site, and

wherein the wireless electrode assembly is deployed from a distal end of the delivery catheter.

15. The method of claim 11, wherein the device is a guidewire.

16. The method of claim 15, wherein the wireless electrode assembly includes a guidewire lumen through which the guidewire is slidably disposed.

17. The method of claim 15, further comprising a pulse generator electrically coupled to a proximal portion of the guidewire configured to transmit a test stimulation signal to the sensing electrode, wherein the step of determining, before penetration of the wall of the heart by the wireless electrode assembly, if the implantation site is suitable for receipt of the wireless electrode assembly further includes using the pulse generator to transmit the test stimulation signal to verify that the implantation site is suitable for receipt of the wireless electrode assembly.

18. The method of claim 11, further comprising, advancing the device through an atrial septum of the heart to reach the implantation site.

19. The method of claim 18, wherein the implantation site is in the left ventricle.

20. The method of claim 18, further comprising advancing the device through a guide sheath positioned through the atrial septum.