Leadless cardiac stimulation systems

• US 7,647,109 B2
• Filed: 03/07/2005
• Issued: 01/12/2010
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Kveen, Graig, Pikus, Michael J., Hastings, Roger N., Sadasiva, Anupama
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Heller; Tammie K.
• Application Number:
  US11/075,376
• Publication Number:
  US 20060085042A1
• Time in Patent Office: 1,772 Days
• Field of Search: 607/30, 607/32, 607/60, 607/61
• US Class Current: 607/32
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrode assemblies that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Also disclosed are various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Claims

1. A system comprising:

a percutaneous first intravascular elongate member configured with a proximal end and a distal end and sized and shaped to define a lumen passing therethrough;

a percutaneous second intravascular elongate member configured with a proximal end and a distal end;

a wireless electrostimulation electrode assembly configured with a mechanical coupling to the distal end of the second intravascular elongate member, wherein when the wireless electrostimulation electrode assembly is detachably mechanically coupled to the second intravascular elongate member, the second intravascular elongate member and the wireless electrostimulation electrode assembly are sized and shaped to be passable through the lumen;

wherein the second intravascular elongate member is configured to intravascularly and percutaneously deliver at least a portion of the wireless electrostimulation electrode assembly from within a heart through an endocardium and into a myocardium of the heart;

wherein the wireless electrostimulation electrode assembly includes a tissue attachment mechanism configured to secure at least a portion of the wireless electro stimulation electrode assembly to the myocardium, the tissue attachment mechanism including a distally extending helical tine, and a plurality of radially extending curled tines, the helical tine configured to penetrate through the endocardium and into the myocardium, and the plurality of curled tines configured to penetrate into the myocardium without penetrating the epicardial wall; and

wherein the curled tines include a retracted configuration and a user-actuatable extended configuration, and wherein the curled tines are configured to be in the retracted configuration when the helical tine is introduced into the myocardium, and wherein the curled tines are user-actuatable to radially extend after the helical tine has been introduced into the myocardium.

2. The system of claim 1, wherein the second intravascular elongate member is configured at the distal end with a detachment mechanism sized and shaped to release the wireless electrostimulation electrode assembly from the second intravascular elongate member at a targeted endocardial site proximate the myocardium.

3. The system of claim 2, wherein the detachment mechanism includes a threaded member sized and shaped to releasably engage a portion of the wireless electrostimulation electrode assembly.

4. The system of claim 2, wherein the detachment mechanism includes an adjustable locking member sized and shaped to releasably engage a portion of the wireless electrostimulation electrode assembly.

5. The system of claim 1, wherein the first intravascular elongate member includes a steering mechanism configured to direct the distal end of the first intravascular elongate member to a selected endocardial site proximate to the myocardium.

6. The system of claim 5, wherein the first intravascular elongate member includes a distal end electrode configured to sense an electrocardiogram at the selected endocardial site proximate to the myocardium.

7. The system of claim 1, comprising an intravascular access catheter configured with a proximal end and a distal end and sized and shaped to define a lumen passing therethrough, wherein the first intravascular elongate member comprises an intravascular delivery catheter sized and shaped to be passable through the lumen of the intravascular access catheter.

8. The system of claim 7, comprising an imaging device configured to image the distal end of the intravascular access catheter.

9. The system of claim 8, wherein the imaging device comprises an ultrasonic transducer.

10. The system of claim 1, wherein the first intravascular elongate member comprises a delivery catheter configured with at least one catheter distal tip electrode, wherein the tip electrode is configured to sense electrical activity at an endocardial site, proximate the myocardium, targeted for implant of at least a portion of the wireless electrostimulation electrode assembly.

11. The system of claim 10, wherein the delivery catheter includes a steering mechanism configured to direct the distal end of the delivery catheter to a selected endocardial site proximate to the myocardium.

12. The system of claim 1, wherein the second intravascular elongate member comprises a push rod instrument configured to manipulate the implantable wireless electrostimulation electrode assembly, wherein the push rod instrument is configured with a mechanical coupling to the implantable wireless electrostimulation electrode assembly, and wherein the push rod instrument and wireless electrostimulation electrode assembly are:

(1) detachably coupled; and

(2) sized and shaped to be rotationally and longitudinally movable through the lumen of the first intravascular elongate member.

13. The system of claim 1, wherein the wireless electrostimulation electrode assembly comprises a conductive coil sized and shaped to wirelessly receive energy from a magnetic field, wherein the wireless electrostimulation electrode assembly is configured to deliver energy received from the magnetic field as a specified-electrostimulation waveform to a targeted myocardial site without storing the received magnetic energy in a battery.

14. A system comprising:

a percutaneous first intravascular elongate member configured with a proximal end and a distal end and sized and shaped to define a lumen passing therethrough;

a percutaneous second intravascular elongate member configured with a proximal end and a distal end; and

a wireless electrostimulation electrode assembly configured with a mechanical coupling to the distal end of the second elongate member, wherein when the wireless electrostimulation electrode assembly is detachably mechanically coupled to the second intravascular elongate member, the second intravascular elongate member is;

(1) sized and shaped to be passable through the lumen; and

(2) configured to intravascularly and percutaneously deliver at least a portion of the wireless electrostimulation electrode assembly from within a heart through an endocardium and into a myocardium,

wherein the second intravascular elongate member is configured at the distal end with a detachment mechanism sized and shaped to release the wireless electrostimulation electrode assembly from the second intravascular elongate member at a targeted endocardial site proximate the myocardium, the detachment mechanism including a threaded member sized and shaped to releasably engage a portion of the wireless electrostimulation electrode assembly,

wherein the wireless electrostimulation electrode assembly includes a tissue attachment mechanism configured to secure at least a portion of the wireless electro stimulation electrode assembly to the myocardium, the tissue attachment mechanism including a distally extending helical tine, and a plurality of radially extending curled tines, the helical tine configured to penetrate through the endocardium and into the myocardium, and the plurality of curled tines configured to penetrate into the myocardium without penetrating the epicardial wall, and

wherein the curled tines include a retracted configuration and a user-actuatable extended configuration, and wherein the curled tines are configured to be in the retracted configuration when the helical tine is introduced into the myocardium, and wherein the curled tines are user-actuatable to radially extend after the helical tine has been introduced into the myocardium.

15. The system of claim 14, wherein the first intravascular elongate member comprises a delivery catheter that includes at least one catheter tip electrode configured to sense electrical activity at the distal tip of the delivery catheter, the catheter tip electrode being configured proximate to the distal end to sense an electrocardiogram at an endocardial site, proximate the myocardium, targeted for implantation of the wireless electrostimulation electrode assembly.

16. The system of claim 15, wherein the delivery catheter includes a steering mechanism configured to direct the distal end of the first intravascular elongate member to a selected endocardial site proximate to the myocardium.

17. The system of claim 15, comprising:

an intravascular access catheter configured with a lumen extending between a proximal opening and a distal opening, wherein the delivery catheter is sized and shaped to be passable from the proximal opening, through the lumen, and out of the distal opening of the intravascular access catheter.

18. The system of claim 15, comprising an electrical lead coupled to the catheter tip electrode and extending through the length of the delivery catheter to the proximal end, the electrical lead comprising electrically conductive material configured to conduct the electrocardiogram sensed by the catheter tip electrode.

19. The system of claim 15, comprising a second catheter tip electrode configured proximate to the distal opening of the delivery catheter, the first and second catheter tip electrodes configured to provide a bipolar electrocardiogram.

20. The system of claim 15, wherein the distal tip of the delivery catheter comprises a tissue attachment device configured to secure the distal tip of the delivery catheter to an endocardial wall of the heart chamber.

21. The system of claim 14, wherein the second intravascular elongate member comprises a push rod instrument configured to manipulate the implantable wireless electrostimulation to the implantable wireless electrostimulation electrode assembly, and wherein the push rod instrument and wireless electrostimulation electrode assembly are:

(1) detachably coupled; and

(2) sized and shaped to be rotationally and longitudinally-movable through the lumen of the first intravascular elongate member.

22. The system of claim 14, wherein the wireless electrostimulation electrode assembly comprises a conductive coil sized and shaped to wirelessly receive energy from a magnetic field, wherein the wireless electrostimulation electrode assembly is configured to deliver energy received from the magnetic field as a specified electrostimulation waveform to a targeted myocardial site without storing the received magnetic energy in a battery.

23. A system comprising:

a percutaneous first intravascular elongate member configured with a proximal end and a distal end and sized and shaped to define a lumen passing therethrough, wherein the first intravascular elongate member includes a steering mechanism configured to direct the distal end of the first intravascular elongate member to a selected endocardial site proximate to a myocardium, and the first intravascular elongate member includes a distal end-electrode configured to sense an electrocardiogram at the selected endocardial site proximate to the myocardium;

a percutaneous second intravascular elongate member configured with a proximal end and a distal end; and

a wireless electrostimulation electrode assembly configured with a mechanical coupling to the distal end of the second intravascular elongate member, wherein when the wireless electrostimulation electrode assembly is attached to the second intravascular elongate member, the second intravascular elongate member is;

(1) sized and shaped to be passable through the lumen; and

(2) configured to intravascularly and percutaneously deliver at least a portion of the wireless electrostimulation electrode assembly from within a heart through an endocardium and into the myocardium, and

wherein the wireless electrostimulation electrode assembly includes a tissue attachment mechanism configured to secure at least a portion of the wireless electrostimulation electrode assembly to the myocardium, the tissue attachment mechanism including a distally extending helical tine, and a plurality of radially extending curled tines, the helical tine configured to penetrate through the endocardium and into the myocardium, and the plurality of curled tines configured to penetrate into the myocardium without penetrating the epicardial wall, and

wherein the curled tines include a retracted configuration and a user-actuatable extended configuration, and wherein the curled tines are configured to be in the retracted configuration when the helical tine is introduced into the myocardium, and wherein the curled tines are user-actuatable to radially extend after the helical tine has been introduced into the myocardium.

24. The system of claim 23, wherein the second intravascular elongate member comprises a push rod instrument configured to manipulate the implantable wireless electrostimulation electrode assembly, wherein the push rod instrument is configured with a mechanical coupling to the implantable wireless electrostimulation electrode assembly, and wherein the push rod instrument and wireless electrostimulation electrode assembly are:

(1) detachably coupled; and

(2) sized and shaped to be rotationally and longitudinally movable through the lumen of the first intravascular elongate member.

25. The system of claim 24, wherein the push rod instrument includes a detachment mechanism configured at the distal end configured to release the wireless electrostimulation electrode assembly from the push rod instrument after delivery of the wireless electrostimulation electrode assembly to the myocardium.

26. The system of claim 25, wherein the detachment mechanism includes an adjustable locking member sized and shaped to releasably engage a portion of the electrode assembly.

27. The system of claim 23, wherein the first intravascular elongate member comprises a delivery catheter and the electrode at the distal end of the first intravascular elongate member comprises an electrode configured at the distal tip of the delivery catheter.

28. The system of claim 27, comprising an electrical lead coupled to the catheter tip electrode and extending through the length of the delivery catheter to the proximal end, the electrical lead comprising electrically conductive material configured to conduct the electrocardiogram sensed by the catheter tip electrode.

29. The system of claim 27, comprising a second catheter tip electrode configured proximate to the distal opening of the delivery catheter, the first and second catheter tip electrodes configured separate to provide a bipolar electrocardiogram.

30. The system of claim 27, wherein the distal tip of the delivery catheter comprises a tissue attachment device configured to secure the distal tip of the delivery catheter to an endocardial wall of the heart chamber.

31. The system of claim 27, comprising an intravascular access catheter configured with a lumen extending between a proximal opening and a distal opening, wherein the delivery catheter is sized and shaped to be passable from the proximal opening, through the lumen, and out of the distal opening of the intravascular access catheter.

32. The system of claim 23, wherein the wireless electrostimulation electrode assembly comprises a conductive coil sized and shaped to wirelessly receive energy from a magnetic field, wherein the wireless electrostimulation electrode assembly is configured to deliver energy received from the magnetic field as a specified electrostimulation waveform to a targeted myocardial site without storing the received magnetic energy in a battery.