Leadless cardiac stimulation systems

• US 8,478,408 B2
• Filed: 03/08/2007
• Issued: 07/02/2013
• Est. Priority Date: 10/20/2004
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Hastings, Roger N., Drassler, William J., Lafontaine, Daniel M., Smith, Scott R., Sadasiva, Anupama
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US11/683,577
• Publication Number:
  US 20070150037A1
• Time in Patent Office: 2,308 Days
• Field of Search: 607/116, 607/119, 607/125, 604/508
• US Class Current: 607/32
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 Anchoring means
• 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 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/37512 Pacemakers
• 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 electrodes that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Each of the electrodes contains a source of electrical energy for pacing the myocardium and is adapted to receive electromagnetic energy from a source outside the myocardium. The system also includes a source adapted for placement outside the myocardium and that uses locally measured electrocardiograms to synchronize pacing of the heart by sending electromagnetic commands to the electrodes to pace the myocardium surrounding the electrodes. Also disclosed is various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Claims

1. A catheter delivery system for implantation of wireless electrode assemblies into the myocardium, comprising:

an elongate tube having a proximal end and a distal end and having a lumen passing therethrough;

a first elongate member having a proximal end and a distal end, the distal end configured to attach to a wireless electrode assembly, wherein the first elongate member comprises a detachment mechanism to detach the wireless electrode assembly from the first elongate member following delivery of the wireless electrode assembly into a heart wall from within a chamber of the heart, wherein the first elongate member and the attached wireless electrode assembly are passable through the tube, the first elongate member sized, shaped and positionable for delivering the wireless electrode assembly to the interior of the heart through the tube via an intravascular route, and wherein the wireless electrode assembly is sized, shaped and positionable for being implanted entirely within myocardial tissue of the heart wall; and

a second elongate member configured to controllably extend a tissue attachment mechanism from within a housing of the wireless electrode assembly into the surrounding myocardial tissue, the attachment mechanism configured to securely anchor the wireless electrode assembly within the myocardial tissue.

2. The catheter delivery system of claim 1 in which said elongate tube contains a steering mechanism to aid in placement of the distal end of the tube against a selected site on the wall of the heart.

3. The catheter delivery system of claim 2, wherein the first elongate member is configured to insert the wireless electrode assembly into the myocardial heart wall tissue in a direction approximately parallel to a face of the heart wall tissue.

4. The catheter delivery system of claim 1 in which the elongate tube contains an electrode at its distal end for sensing a local electrocardiogram at a selected site on the wall of the heart.

5. The catheter delivery system of claim 1, wherein the tissue attachment mechanism includes a controllably extendable tine configured to extend radially outward from the wireless electrode assembly in response to actuation by the second elongate member.

6. The catheter delivery system of claim 1, further comprising the wireless electrode assembly, and wherein the wireless electrode assembly is configured to provide an electrostimulation to the myocardial tissue.

7. A method of delivering a wireless electrode assembly to a location within a patient proximate the myocardium, the method comprising:

delivering an elongate tube having a proximal end and a distal end and a lumen therethrough to a site within the interior of the heart proximate the myocardium, via an intrasvascular route;

delivering a wireless electrode assembly, attached to a first elongate member through the lumen of the elongate tube and into the myocardial tissue of the heart wall proximate the distal end of the elongate tube, wherein the wireless electrode assembly is implanted entirely within the myocardial tissue of the heart wall;

using a second elongate member, controllably extending a tissue attachment mechanism from within a housing of the wireless electrode assembly into the surrounding myocardial tissue, the attachment mechanism configured to securely anchor the wireless electrode assembly within the myocardial tissue;

controllably detaching the first elongate member from the wireless electrode assembly; and

removing the tube and the first elongate member from the patient.

8. The method of claim 7 in which a local electrocardiogram is measured at the distal end of the elongate tube to determine the suitability of the site proximate the myocardium for pacing.

9. The method of claim 7 in which the first elongate member includes a second tube threaded over a rod attached to the wireless electrode assembly, inside the lumen of the elongate tube, and wherein the first elongate member abuts the proximal end of the wireless electrode assembly to push the assembly through the lumen.

10. The method of claim 7 in which a short burst of current is applied to the first elongate member to heat and detach the first elongate member at a spot on the first elongate member having relatively high electrical resistance.

11. The method of claim 7, wherein the controllably extending a tissue attachment mechanism includes controllably extending a tine radially outward from the housing of the wireless electrode assembly in response to actuation by the second elongate member.

12. The catheter delivery system of claim 7, wherein the delivering the wireless electrode assembly includes inserting the wireless electrode assembly into the myocardial heart wall tissue in a direction approximately parallel to a face of the heart wall tissue.

13. A system, comprising:

a wireless electrode assembly configured to provide an electrostimulation to myocardial tissue of the heart wall;

a catheter delivery apparatus, including;

an elongate tube having a proximal end and a distal end and having a lumen passing therethrough;

a first elongate member having a proximal end and a distal end, the distal end configured to attach to the wireless electrode assembly;

a second elongate member configured to controllably extend a tissue attachment mechanism from within a housing of the wireless electrode assembly into the surrounding myocardial tissue, the attachment mechanism configured to securely anchor the wireless electrode assembly within the myocardial tissue;

wherein the first elongate member comprises a detachment mechanism to detach the wireless electrode assembly from the first elongate member following delivery of the wireless electrode assembly into the heart wall from within a chamber of the heart;

wherein the first elongate member and the attached wireless electrode assembly are passable through the tube;

and wherein the first elongate member is sized, shaped and positionable for delivering the wireless electrode assembly to the interior of the heart through the tube via an intravascular route; and

wherein the wireless electrode assembly is sized, shaped and positionable for being implanted entirely within the myocardial tissue of the heart wall.