IMPLANTABLE MEDICAL DEVICES WITH SEPARATE FIXATION MECHANISM

• US 20140276929A1
• Filed: 03/12/2014
• Published: 09/18/2014
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Foster, Arthur J., Tockman, Bruce Alan, Bustillo, Anne-Marie, Liu, Lili, Simms, Howard D. Jr.
• Granted Patent: US 9,694,172 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• 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 1/0595 Temporary leads

Abstract

Devices or methods such as for stimulating excitable tissue or sensing physiologic response or other signals that can use separate fixation mechanism is described. An implantable apparatus can include a modular electrostimulation electrode assembly that can include a first module and a second module that can be end user-attachable to each other and end user-detached from each other. The first module can include an electrostimulation electrode fixation support member that can be laid flat against or otherwise conform to a surface of a heart, and can define a centrally located open portal such as for permitting electrode access to the surface of the heart. The second module can include an electrostimulation electrode that can be inserted through the portal of the fixation support member such as to contact the surface of the heart such as to deliver chronic electrostimulation to the heart.

Claims

1. An implantable apparatus comprising:

a modular electrostimulation electrode assembly including;

a first module, including an electrostimulation electrode fixation support member that is sized, shaped, or otherwise configured to lay flat or otherwise conform against a surface of a heart of a subject, the fixation support member defining a centrally located open portal that is sized, shaped, or otherwise configured for permitting electrode access to the surface of the heart therethrough, wherein the first module includes a first coupler feature;

a second module, including an electrostimulation electrode that is sized, shaped, or otherwise configured to contact the surface of the heart through the centrally located open portal of the fixation support member, wherein the second module includes a second coupler feature; and

wherein the first and second coupler features are sized, shaped, or otherwise configured to be end user-attached securely to each other and end user-detached from each other to respectively attach the first and second modules to each other and detach the first and second modules from each other.

2. The apparatus of claim 1, wherein the second module includes a housing that includes at least one of an electrostimulation generation circuit or a cardiac signal sensing circuit.

3. The apparatus of claim 1, wherein the fixation support member includes a ring that is sized, shaped, or otherwise configured to lay flat or otherwise conform against a surface of a heart of a subject, the ring defining the centrally located open portal that is sized, shaped, or otherwise configured for permitting electrode access to the surface of the heart therethrough.

4. The apparatus of claim 1, wherein the fixation support member includes an outward extending active fixation member that is sized, shaped, or otherwise configured to be oriented toward and to engage the surface of the heart.

5. The apparatus of claim 4, wherein the active fixation member includes a pair of rotationally-oriented barbs that are sized, shaped, or otherwise configured to engage the heart when the fixation support member is rotated with respect to the heart.

6. The apparatus of claim 1, wherein the fixation support member includes a suture retention feature.

7. The apparatus of claim 1, wherein the first and second coupler features are sized, shaped, or otherwise configured to snap-fit together.

8. The apparatus of claim 1, wherein the first and second coupler features are sized, shaped, or otherwise configured to rotate or otherwise slide into engagement with each other.

9. The apparatus of claim 1, wherein at least a portion of the fixation support member is textured or porous on a scale configured to permit tissue ingrowth.

10. The apparatus of claim 1, wherein at least a portion of the fixation support member includes a fabric configured to permit at least one of suturing therethrough or tissue ingrowth therein.

11. The apparatus of claim 1, comprising a cable, configured to be connected to the second module and configured to be connected to a separate implantable apparatus.

12. The apparatus of claim 1, comprising a temporary third module, including:

an electrostimulation electrode that is sized, shaped, or otherwise configured to be inserted through the portal of the fixation support member to contact the surface of the heart;

a third coupler feature that is sized, shaped, or otherwise configured to permit the third module to be temporarily end user-attached to the first module and end user-detached from the first module;

a cable extending outward from at least a portion of the third module, the cable sized, shaped, or otherwise configured to be capable of being connected to an external pacing system analyzer (PSA) circuit to determine an electrostimulation threshold value of the electrostimulation electrode at a particular location on the heart; and

an at least partially elongated delivery member, sized, shaped, or otherwise configured to allow the third module to be temporarily end user-attached to the first module and end user-detached from the first module such that the electrostimulation electrode of the third module is capable of being inserted through the portal of the fixation support member to contact the surface of the heart, and to allow the fixation support member to be secured to a surface of the heart at a desired location.

13. The apparatus of claim 1, wherein the electrostimulation electrode of the second module includes:

a first electrode, configured to be located toward the center of the portal of the electrode fixation support member when the second module is coupled to the first module; and

a second electrode, located more laterally from the center of the portal of the electrode fixation support member than the first electrode when the second module is coupled to the first module.

14. The apparatus of claim 13, wherein the second electrode includes a ring-like electrode extending circumferentially about the first electrode and spaced apart from the first electrode.

15. The apparatus of claim 14, wherein the ring-like second electrode is segmented into a plurality of individually addressable electrodes.

16. A method comprising:

attaching a first module including a fixation support member to a temporary third module including an electrostimulation electrode located within a portal of the fixation support member when the first and third modules are attached;

positioning the attached first and third modules at a position at a heart of a subject and testing an electrostimulation threshold at the position;

when a desired value of the electrostimulation threshold is obtained, affixing the first module at the position at the heart, then releasing the third module from the first module;

affixing a second module to the first module, the second module including an electrostimulation electrode configured for chronically delivering electrostimulation to the heart at the position at the heart; and

delivering electrostimulation to the heart at the position at the heart using the electrostimulation electrode of the second module.

17. The method of claim 16, wherein the affixing the first module at the position at the heart comprises deploying an active fixation device while the first module remains at the position at the heart at which the electrostimulation threshold was tested and determined to meet the desired value.

18. The method of claim 17, wherein the deploying an active fixation device comprises rotating the first module to engage a rotationally-oriented barb with tissue of the heart.

19. The method of claim 16, wherein affixing the first module at the position at the heart comprises suturing the first module at the position at the heart.

20. The method of claim 16, wherein affixing the second module to the first module comprises at least one of snap-fitting the second module to the first module or rotationally slidably engaging the second module to the first module.