SINGLE-CHAMBER LEADLESS INTRA-CARDIAC MEDICAL DEVICE WITH DUAL-CHAMBER FUNCTIONALITY

• US 20140107723A1
• Filed: 10/16/2012
• Published: 04/17/2014
• Est. Priority Date: 10/16/2012
• Status: Abandoned Application

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Hou, Wenbo, Min, Xiaoyi, Karst, Edward
• Application Number:
  US13/653,248
• Publication Number:
  US 20140107723A1
• Time in Patent Office: Days
• US Class Current: 607/28
• 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 1/371 Capture, i.e. successful 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

A leadless implantable medical device (LIMD) comprises a housing configured to be implanted entirely within a single local ventricular chamber of the heart near a local apex region. A base on the housing is configured to be secured to tissue of interest, while a distal electrode is provided on the base and extends outward such that, when the device is implanted in the local chamber, the distal electrode is configured to engage the distal apex region at a distal activation site within the conduction network of the adjacent ventricular chamber.

Claims

1. A leadless intra-cardiac medical device (LIMD), comprising:

a housing configured to be implanted entirely within a single local ventricular chamber of the heart near a local apex region, the local apex region constituting part of a conduction network of the local ventricular chamber;

wherein the housing defines a base configured to be secured to tissue of interest;

a distal electrode connected to the base and extending outward therefrom such that, when the device is implanted in the local ventricular chamber, the distal electrode engages a distal apex region at a distal activation site within a conduction network of an adjacent ventricular chamber; and

a controller within the housing adapted to cause stimulus pulses to be delivered through the distal electrode to the distal apex region, such that stimulus pulses delivered at the distal apex region are timed to cause contraction of the adjacent ventricular chamber in a predetermined relation to contraction of the local ventricular chamber.

2. The device of claim 1, wherein the controller is configured to control delivery of the stimulus pulses from the distal electrode in accordance with a VVI pacing mode, a VDD pacing mode, a VDDR pacing mode, or a bi-ventricular pacing mode.

3. The device of claim 1, further comprising a proximal electrode provided at a first position proximate on the base such that, when the device is implanted in the local chamber, the proximal electrode is configured to engage tissue at a local activation site within the conduction network of the local ventricular chamber

4. The device of claim 3, wherein the controller is configured to control delivery, from the local and distal electrodes, of the stimulus pulses to a left ventricle and a right ventricle, respectively, while the device is entirely located in the right ventricle.

5. The device of claim 1, wherein the adjacent ventricular chamber constitutes a left ventricle, the distal apex region being physiologically responsive to distal activation events originating in the left ventricle.

6. The device of claim 3, wherein proximal electrode represents a surface bump type electrode that passively engages the local apex region.

7. The device of claim 1, wherein the distal electrode includes an elongated straight body with a stem that is secured to the base and with an outer end that has an active electrode area distal from the base.

8. The device of claim 1, wherein the distal electrode is formed of a flexible material such that a body of the distal electrode bends relative to the base during cardiac events and an outer end of the distal electrode moves with tissue at the distal activation site.

9. The device of claim 1, wherein the base experiences linear and rotational movement that differs from linear and rotational movement experienced at an outer end of the distal electrode, the outer end of the distal electrode moving with respect to the base such that the outer end of the distal electrode moves with tissue at the distal activation site.

10. The device of claim 1, wherein the housing includes a body and an electrode guide formed along one side of the body, the guide extending from the base upward, the guide including a passage that is shaped and dimensioned to slidably receive a stylet, the stylet having an outer end configured to retain the distal electrode during implantation.

11. A method for implanting a leadless intra-cardiac medical device (LIMD), the device having a base with a distal electrode provided thereon, said method comprising;

advancing the device to an implant site that is located entirely within a single local ventricular chamber of the heart at a local apex region, the local ventricular chamber having a local apex region that constitutes part of a conduction network of the local ventricular chamber, an adjacent ventricular chamber having a distal apex region, with respect to the local ventricular chamber, that constitutes part of a conduction network of the adjacent ventricular chamber;

positioning the distal electrode to engage the distal apex region at a distal activation site within the conduction network of the distal ventricular chamber;

actively securing the device to the local apex region; and

configuring a controller within the housing to cause stimulus pulses to be delivered through the distal electrode to the distal apex region, such that stimulus pulses are timed to cause contraction of the adjacent ventricular chamber in a predetermined relation to contraction of the local ventricular chamber.

12. The method of claim 11, wherein the introducer has a distal end that is open to permit the device to be deployed there through once the device is actively secured to the tissue of interest.

13. The method of claim 11, further comprising securing a pusher tool to a proximal end of the device within the introducer, utilizing the pusher tool to guide the device into position, and utilizing the pusher tool to rotate the device to actively secure a fixation mechanism on the base of the device to the tissue of interest.

14. The method of claim 11, further comprising performing a capture test to evaluate whether at least one of the distal electrode is electrically coupled to the conduction network of the adjacent ventricular chambers.

15. The method of claim 11, further comprising engaging a proximal electrode with right atrial wall tissue of the local ventricular chamber.

16. The method of claim 11, wherein the distal activation site is physiologically responsive to distal activation events originating in the left ventricle.

17. The method of claim 11, further comprising:

during an initially securing stage of implantation, retaining a stylet and the distal electrode retracted into a passage within the housing, while rotating the LIMD to secure a fixation mechanism to tissue of interest;

once the fixation mechanism is secured in place, during an electrode delivery stage, extending the stylet and electrode from an open proximal end of the passage, advancing the stylet by a desired distance, and in a desired direction, until an outer end of the electrode is proximate to the distal activation site.

18. The method of claim 17, further comprising:

once the distal electrode is advanced to the distal activation site, removing the stylet while retaining the distal electrode in an advanced position with the outer end of the electrode held at the distal activation site.

19. The method of claim 11, further comprising forming the distal electrode of a flexible material that is not configured to undergo direct insertion forces along a length thereof during implantation.