Implantable medical devices with separate fixation mechanism

• US 9,694,172 B2
• Filed: 03/12/2014
• Issued: 07/04/2017
• 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: Liu, Lili, Simms, Jr., Howard D., Bustillos, Anne-Marie, Foster, Arthur J., Tockman, Bruce Alan
• Primary Examiner(s): Moran, Edward
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US14/207,112
• Publication Number:
  US 20140276929A1
• Time in Patent Office: 1,210 Days
• 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 a fixation support member that is configured to fix the first module to a surface of a heart of a subject, the fixation support member defining a centrally located open portal that is 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 configured to contact the surface of the heart through the centrally located open portal of the fixation support member when the first module is coupled to the second module, wherein the second module includes a second coupler feature;

wherein the first and second coupler features are 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; and

wherein the second module is configured to remain attached to the first module via the first and second coupler features to provide electro-stimulation to the heart of the subject, and/or sense cardiac signals, via the electrostimulation electrode until such time as the end user detaches the second module from the first module and removes the second module from the heart of the subject while leaving the first module attached to the heart via the fixation support member of the first module.

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 defines a ring that defines the centrally located open portal that is 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 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 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 configured to snap-fit together.

8. The apparatus of claim 1, wherein the first and second coupler features are 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 to promote 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, further comprising a cable, configured to be connected to the second module and to a separate implantable apparatus.

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

an electrostimulation electrode that is 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 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 configured to be connectable 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, 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 insertable 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 second module includes:

the electrostimulation electrode, configured to be located toward the center of the portal of the fixation support member of the first module 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 fixation support member than the electrostimulation 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 electrostimulation electrode and spaced apart from the electrostimulation electrode.

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