Leadless implantable device with detachable fixation

• US 10,737,102 B2
• Filed: 01/26/2018
• Issued: 08/11/2020
• Est. Priority Date: 01/26/2017
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Webb, Erin Kristen, Swackhamer, Bryan J., Sachs, Dana
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US15/881,466
• Publication Number:
  US 20180207434A1
• Time in Patent Office: 928 Days
• Field of Search: 607 9
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• 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 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An implantable medical device (IMD) may include a fixation module, and a device module that is configured to be releasably connected to the fixation module. The device module may have a proximal end and a distal end, and may include a power source and a controller that is operably coupled to the power source. The controller may be configured to sense cardiac electrical activity via two or more electrodes and/or deliver pacing pulses via two or more electrodes. The device module may include a first part of a releasable connector while the fixation module may include a second part of the releasable connector, wherein the first part of the releasable connector and the second part of the releasable connector cooperate to releasably connect the device module with the fixation module.

Claims

1. An implantable medical device (IMD) comprising:

a device module having a proximal end and a distal end, the device module comprising;

a power source;

a controller operably coupled to the power source, the controller configured to sense cardiac electrical activity via two or more electrodes and deliver pacing pulses via two or more electrodes;

a first part of a releasable connector;

a fixation module comprising;

a plurality of fixation for anchoring the fixation module to the patient'"'"'s heart;

a second part of the releasable connector, wherein the first part of the releasable connector and the second part of the releasable connector cooperate to releasably connect the device module with the fixation module; and

the device module having one or more first fluoroscopic markers and the fixation module having one or more second fluoroscopic markers, wherein the one or more first fluoroscopic markers and the one or more second fluoroscopic markers are arranged so that a predefined rotational alignment between one or more of the first fluoroscopic markers and one or more of the second fluoroscopic markers confirms that the releasable connector is in a fully connected state.

2. The IMD of claim 1, wherein the device module further comprises a proximal electrode and a distal electrode each operatively coupled to the controller, wherein the distal electrode is disposed on an elongated post extending distally from the first part of the releasable connector, and wherein the fixation module defines an aperture through which the elongated post extends to support the distal electrode on a distal side of the fixation module when the releasable connector is in the fully connected state.

3. The IMD of claim 1, wherein the device module further comprises a proximal electrode and a distal terminal each operatively coupled to the controller, and wherein the fixation module comprises a distal electrode on a distal side of the fixation module, and wherein the distal terminal of the device module is operatively coupled to the distal electrode of the fixation module when the releasable connector is in the fully connected state.

4. The IMD of claim 1, wherein the releasable connector comprises:

one or more locking tabs;

one more locking slots;

wherein the one or more locking tabs are configured to be moved into the one or more locking slots against a bias mechanism, after which the one or more locking tabs are configured to be rotated relative to the one or more locking slots until one or more of the locking tabs are pushed into one or more retaining recesses by the bias mechanism, at which time the releasable connector is in the fully connected state.

5. The IMD of claim 4, wherein at least one of the locking tabs and a location of at least one of the retaining recesses are marked by a corresponding one or more of the first fluoroscopic markers and/or one or more of the second fluoroscopic markers.

6. The IMD of claim 4, wherein the bias mechanism comprises a silicon spring seal situated between the device module and the fixation module.

7. The IMD of claim 1, wherein the releasable connector comprises:

one or more receivers;

one or more catches that are biased to extend into and catch one or more of the receivers to form an interference connection when the releasable connector is in the fully connected state.

8. The IMD of claim 7, wherein the first part of a releasable connector includes the one or more receivers and the second part of a releasable connector includes the one or more catches.

9. The IMD of claim 7, wherein the releasable connector further comprises a seal for sealing the one or more receivers and the one or more catches from an external environment when the releasable connector is in the fully connected state.

10. The IMD of claim 7, wherein the releasable connector further comprises one or more electrical contacts for making an electrical connection between the first part of a releasable connector and the second part of a releasable connector.

11. An implantable leadless cardiac pacemaker (LCP) configured to pace a patient'"'"'s heart from a position within a cardiac chamber, the LCP comprising:

a fixation module configured for engagement with the cardiac chamber and a device module that is releasably securable to the fixation module for deployment within the cardiac chamber;

the fixation module comprising;

a fixation module housing;

a plurality of locking slots;

one or more retaining recesses;

an aperture configured to accommodate an electrode carried by the device module;

one or more fixation module fluoroscopic markers each marking a corresponding one of the plurality of locking slots or one or more retaining recesses of the fixation module;

the device module comprising;

a device module housing;

a plurality of locking tabs that are configured to cooperate with the locking slots of the fixation module to releasably secure the device module to the fixation module by inserting the plurality of locking tabs into the locking slots against a bias mechanism, and then rotating the device module relative to the fixation module until one or more of the locking tabs are pushed into one or more of the retaining recesses of the fixation module by the bias mechanism;

one or more device module fluoroscopic markers each marking a corresponding one of the plurality of locking tabs of the device module;

wherein the one or more device module fluoroscopic markers are arranged relative to the one or more fixation module fluoroscopic markers so that a predefined alignment between one or more of the fixation module fluoroscopic markers and one or more of the device module fluoroscopic markers at least partially confirms that the device module is fully secured to the fixation module;

a power source disposed within the device module housing;

a first electrode disposed on the device module housing and a second electrode disposed on an elongated post extending distally of the plurality of locking tabs, the elongated post configured to extend through the aperture in the fixation module housing to place the second electrode in a position where the second electrode can contact cardiac tissue when the device module is engaged with the fixation module and the LCP is implanted; and

a controller disposed within the device module housing and operably coupled to the power source, the controller configured to sense cardiac electrical activity and to deliver pacing pulses via one or more of the first electrode and the second electrode.

12. The LCP of claim 11, wherein the fixation module further comprises a plurality of fixation tines that are configured to extend distally into the patient'"'"'s cardiac tissue and then back proximally to hook the patient'"'"'s cardiac tissue to thereby anchor the fixation module to the patient'"'"'s heart.

13. The LCP of claim 11, wherein the bias mechanism comprises a resilient seal that is configured to engage corresponding mating surface on the fixation module housing and the device module housing.

14. The LCP of claim 11, wherein one or more of the locking tabs of the device module include one or more of the device module fluoroscopic markers, and wherein the fixation module comprises one or more of the fixation module fluoroscopic markers secured relative to the fixation module housing, the one or more fixation module fluoroscopic markers are configured to indicate a relative rotational orientation of the fixation module relative to the locking tabs of the device module under fluoroscopy.

15. An implantable leadless cardiac pacemaker (LCP) configured to pace a patient'"'"'s heart from a position within a cardiac chamber, the LCP comprising:

a fixation module configured for engagement with the cardiac chamber and a device module that is releasably securable to the fixation module for deployment within the cardiac chamber;

the device module comprising;

a device module housing;

an elongated post extending distally from the device module housing, the elongated post comprising one or more receivers and one or more electrical contacts disposed on a side of the elongated post;

the fixation module comprising;

a fixation module housing;

one or more electrodes on a distal side of the fixation module housing;

a post receiving aperture for receiving the elongated post of the device module;

one or more catches that are biased to extend into and catch one or more of the receivers of the elongated post when the elongated post is received by the post receiving aperture; and

one or more electrical contacts for making an electrical connection with one or more of the electrical contacts on the side of the elongated post when the elongated post is received by the post receiving aperture, wherein one or more of the electrical contacts of the fixation module are operatively coupled to one or more of the electrodes on the distal side of the fixation module housing; and

one or more fluoroscopic markers for indicating if the elongated post is sufficiently received by the post receiving aperture to be in a fully connected state.

16. The LCP of claim 15, further comprising a seal for providing a seal between the elongated post of the device module and the fixation module for sealing the one or more electrical contacts of the fixation module from an external environment when the elongated post is received by the post receiving aperture.

17. The LCP of claim 15, wherein the one or more receivers comprise one or more grooves formed in an outer surface of the elongated post.

18. The LCP of claim 17, wherein the one or more catches comprise a coil spring that is biased to extend into and catch one or more of the grooves of the elongated post.

19. The LCP of claim 17, wherein the one or more catches comprise a leaf spring that is biased to extend into and catch one or more of the grooves of the elongated post.