Cardiac stimulation system

• US 10,022,538 B2
• Filed: 10/02/2013
• Issued: 07/17/2018
• Est. Priority Date: 12/09/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Drasler, William J., Pikus, Michael J., Hastings, Roger, Smith, Scott R., Lafontaine, Daniel M., Saholt, Douglas R., Kveen, Graig L., Willard, Martin R.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US14/044,094
• Publication Number:
  US 20140039591A1
• Time in Patent Office: 1,749 Days
• Field of Search: 607 33, 607 36, 607126
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Some embodiments of pacing systems employ wireless electrode assemblies to provide pacing therapy. The wireless electrode assemblies may wirelessly receive energy via an inductive coupling so as to provide electrical stimulation to the surrounding heart tissue. In certain embodiments, the wireless electrode assembly may include one or more biased tines that shift from a first position to a second position to secure the wireless electrode assembly into the inner wall of the heart chamber.

Claims

1. A system, comprising:

a wireless electrode assembly comprising;

a body;

an electrode to electrically stimulate tissue, the electrode immovably fixed to the body;

a circuit coupled to the electrode and configured to deliver to the electrode electrical energy to stimulate the tissue, the circuit housed within the body; and

wherein the body is sized and shaped for percutaneous delivery into contact with heart wall tissue, the body including a proximally-located portion and a fixation device configured to securely anchor the wireless electrode assembly to a tissue site;

wherein the wireless electrode assembly is configured to be securely anchored to the tissue site using the fixation device in response to user manipulation of the wireless electrode assembly using a first elongate member configured to engage the proximally-located portion of the body of the wireless electrode assembly;

wherein the fixation device comprises a curved tine biased to shift from a loaded configuration to an outwardly extending configuration, wherein in the loaded configuration, the curved tine is oriented in a distal direction, wherein the curved tine includes a base immovably fixed to the body in both the loaded configuration and the outwardly extending configuration;

wherein in the outwardly extending configuration, the curved tine includes a first region extending from the base in a distal direction and a second region extending in a proximal direction to a tip of the curved tine, the first and second regions separated by an apex of curvature, wherein the curved tine is configured to engage the heart wall tissue and hinder migration of the wireless electrode assembly; and

wherein the base of the curved tine and the electrode both remain immovably fixed to the body while the curved tine shifts from the loaded configuration to the outwardly extending configuration.

2. The system of claim 1, further comprising

the first elongate member;

and

a second elongate member defining a lumen;

wherein the first elongate member comprises an actuator rod sized and shaped to deliver the wireless electrode assembly to the tissue site through the lumen; and

wherein the curved tine is oriented in the distal direction while located within the lumen defined by the second elongate member.

3. The system of claim 1, wherein the proximally-located portion of the body of the wireless electrode assembly comprises a keyed cross-sectional shape configured to be engaged by the first elongate member.

4. The system of claim 3, further comprising the first elongate member;

wherein the first elongate member includes an interior tubular wall comprising one or more respective slots configured to engage one or more respective keyed portions comprising the keyed cross sectional shape of the body of the wireless electrode assembly; and

wherein the first elongate member is configured to rotate the body of the wireless electrode assembly using the engagement of the one or more respective keyed portions in response to user rotation of the first elongate member.

5. The system of claim 4, wherein the fixation device comprises at least one tine extending from the body;

wherein the body of the wireless electrode assembly comprising the keyed cross-sectional shape includes the tine extending from the body; and

wherein the tine is sized and shaped to be engaged by a corresponding slot in the interior tubular wall of the first elongate member.

6. The system of claim 1, wherein the body of the wireless electrode assembly comprises a polygonal shape and wherein the first elongate member is configured to engage the polygonal shape.

7. The system of claim 6, wherein the polygonal shape includes a hexagonal shape.

8. The system of claim 1, wherein the electrode is sized and shaped for insertion into myocardial tissue.

9. The system of claim 1, wherein at least one of the body or the electrode, is sized and shaped to conically taper to a sharp tip, located at a forward distal end of the wireless electrode assembly, to permit penetration and insertion into the heart wall.

10. The system of claim 1, wherein the wireless electrode assembly is configured to provide electrical energy to the electrode in response to a wireless signal from a transmitter configured to sense cardiac electrical activity, the wireless transmitter at a different location than the wireless electrode assembly and outside the heart.

11. The system of claim 1, wherein the circuit comprises:

an internal coil configured to inductively couple with a wireless transmitter located at a different location than the wireless electrode assembly; and

an electrical charge storage device configured to be charged by current inductively generated by the internal coil.

12. The system of claim 1, wherein the wireless electrode assembly is configured to provide electrical energy to the electrode in response to a wireless signal from a transmitter configured to sense cardiac electrical activity, the transmitter located at a different location than the wireless electrode assembly and outside the heart.

13. The system of claim 1, wherein the wireless electrode assembly comprises an intravascularly-deliverable wireless electrode assembly sized and shaped to fit entirely within a heart;

and

wherein the heart wall includes an inner heart wall.

14. The system of claim 1, wherein the fixation device is configured to partially deploy before the wireless electrode assembly fully exits a distal opening of a lumen defined by a second elongate member through which the wireless electrode assembly is configured to be delivered.

15. The system of claim 1, wherein the curved tine includes a rectangular cross section.

16. A method, comprising:

delivering an intravascularly-deliverable wireless electrode assembly to a tissue site via an intravascular route using a first intravascularly-deliverable elongate member configured to engage a proximally-located portion of the intravascularly-deliverable wireless electrode assembly, the intravascularly-deliverable wireless electrode assembly comprising;

a body;

an electrode to electrically stimulate tissue, the electrode immovably fixed to the body;

a circuit coupled to the electrode and configured to deliver to the electrode electrical energy to stimulate the tissue, the circuit housed within the body; and

wherein the body is sized and shaped for percutaneous transluminal delivery into contact with inner heart wall tissue via an intravascular route and to fit entirely within a heart, the body including a fixation device configured to securely anchor the wireless electrode assembly to a tissue site; and

securely anchoring the intravascularly-deliverable wireless electrode assembly to the tissue site using the fixation device in response to user manipulation of the wireless electrode assembly, using the first intravascularly-deliverable elongate member;

wherein the fixation device comprises a curved tine biased to shift from a loaded configuration to an outwardly extending configuration, wherein in the loaded configuration, the curved tine is oriented in a distal direction, wherein the curved tine includes a base immovably fixed to the body in both the loaded configuration and the outwardly extending configuration;

wherein the outwardly extending configuration, the curved tine includes a first region extending from the base in a distal direction and a second region extending in a proximal direction to a tip of the curved tine, the first and second regions separated by an apex of a curvature, wherein the curved tine is configured to engage the heart wall tissue and hinder migration of the wireless electrode assembly; and

wherein the base of the curved tine and the electrode both remain immovably fixed to the body while the curved tine shifts from the loaded configuration to the outwardly extending configuration.

17. The method of claim 16, comprising partially deploying the fixation device before the wireless electrode assembly fully exits a distal opening of a lumen defined by a second elongate member through which the wireless electrode assembly is delivered.

18. An implantable medical device for implanting in a heart chamber, comprising:

a wireless electrode assembly including;

a body member having a proximal end and a distal end and a length measured from the proximal end to the distal end, the body member being configured to be positioned entirely within a chamber of a heart;

an electrode immovably fixed to the distal end of the body member;

a circuit positioned within the body member, the circuit electrically coupled to the electrode to delivery electrical energy to the electrode to stimulate cardiac tissue; and

a plurality of tines, configured to engage cardiac tissue, wherein each of the plurality of tines has a base portion immovably fixed to the body member and a tip opposite the base portion, wherein each of the plurality of tines is biased to move from a constrained, loaded configuration in which the base portion is immovably fixed to the body member and the tip of each of the plurality of tines is pointed distally to an unconstrained, curved configuration in which the base portion is immovably fixed to the body member and the tip of each of the plurality of tines is pointed proximally;

wherein in the unconstrained, curved configuration, the curved tine engages the heart wall tissue and hinders migration of the wireless electrode assembly; and

wherein the base portion of the curved tine and the electrode both remain immovably fixed to the body while the curved tine shifts from the loaded configuration to the unconstrained configuration.