Dual-chamber leadless intra-cardiac medical device with intra-cardiac extension

• US 8,634,912 B2
• Filed: 01/17/2012
• Issued: 01/21/2014
• Est. Priority Date: 11/04/2011
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Bornzin, Gene A., Mouchawar, Gabriel A., Min, Xiaoyi, Poore, John W., Karst, Edward, Samade, Richard, Somogyi, Zoltan, Theret, Didier
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US13/352,136
• Publication Number:
  US 20130116741A1
• Time in Patent Office: 735 Days
• Field of Search: 607/9, 607/119, 607/123, 607/124
• US Class Current: 607/9
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• 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 1/3688 configured for switching the pacing mode, e.g. from AAI to DDD
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A leadless intra-cardiac medical device includes a housing that is configured to be implanted entirely within a single local chamber of the heart. A first electrode is provided on the housing at a first position such that when the housing is implanted in the local chamber, the first electrode engages the local wall tissue at a local activation site within the conduction network of the local chamber. An intra-cardiac extension is coupled to the housing and configured to extend from the local chamber into an adjacent chamber of the heart. A stabilization arm of the intra-cardiac extension engages the adjacent chamber. A second electrode on the intra-cardiac extension engages distal wall tissue at a distal activation site within the conduction network of the adjacent chamber.

Claims

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

a housing configured to be implanted entirely within a single local chamber of the heart;

a base on the housing, the base configured to be secured to the local chamber;

a first electrode provided on the housing at a first position such that, when the housing is implanted in the local chamber, the first electrode is configured to engage wall tissue at a local activation site within a conduction network of the local chamber;

an intra-cardiac extension having a proximal end, a distal end and an extension body extending there between, the proximal end coupled to the housing and located in the local chamber, the extension body including a stabilization arm provided at the distal end thereof, the extension body being sufficient in length to extend from the local chamber into an adjacent chamber, the extension body including an active interim-segment located at an intermediate point along the extension body;

wherein the stabilization arm includes a stabilizer end-segment located at the distal end and extending in a first lateral direction to engage a first region of the heart, the active interim-segment extending in a second lateral direction to engage a second region of wall tissue of the adjacent chamber;

a second electrode provided on the active interim-segment of the extension body, the second electrode configured to engage wall tissue at a distal activation site within a conduction network of the adjacent chamber; and

a controller, within the housing, configured to cause stimulus pulses to be delivered, in a dual chamber synchronous manner, through the first and second electrodes to the local and distal activation sites, respectively.

2. The device of claim 1, wherein the controller is configured to control delivery of the stimulus pulses from the first and second electrodes in accordance with a DDD pacing mode to a right atrium and right ventricle, while the housing is entirely located in one of the right atrium and right ventricle.

3. The device of claim 1, wherein the controller is configured to control delivery of the stimulus pulses from the first and second electrodes in accordance with a DDD pacing mode to a left atrium and left ventricle, while the housing is entirely located in one of the left atrium and left ventricle.

4. The device of claim 1, wherein the active interim-segment is located between the stabilization arm and the proximal end, the active interim-segment and the stabilization arm extend into and engage opposed areas of the local wall tissue of the local chamber.

5. The device of claim 1, wherein the extension body is comprised of a flexible material having a pre-formed, memorized, permanent implanted state that is shaped to conform to select anatomical contours in the heart and to bias the active interim-segment and stabilization arm against the wall tissue at regions of interest.

6. The device of claim 1, further comprising an anode electrode on the housing, the controller configured to cause stimulus pulses to be delivered between the anode electrode and the first electrode to stimulate the local chamber.

7. The device of claim 1, further comprising an anode electrode on the housing, and a sensing circuit configured to sense between the anode and the second electrode.

8. The device of claim 1, further comprising a third electrode, the second and third electrodes located on the active interim-segment, the second and third electrodes being electrically separated from one another and configured to operate in at least one of a bipolar sensing mode and a bipolar pacing mode.

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

a housing configured to be implanted entirely within a single local chamber of the heart;

a base on the housing, the base configured to be secured to the local chamber;

a first electrode provided on the housing at a first position such that, when the housing is implanted in the local chamber, the first electrode is configured to engage wall tissue at a local activation site within a conduction network of the local chamber;

an intra-cardiac extension having a proximal end, a distal end and an extension body extending there between, the proximal end coupled to the housing and located in the local chamber, the extension body including a stabilization arm provided at the distal end thereof, the extension body being sufficient in length to extend from the local chamber into an adjacent chamber, the extension body including an active interim-segment located at an intermediate point along the extension body;

a second electrode provided on the active interim-segment of the extension body, the second electrode configured to engage wall tissue at a distal activation site within a conduction network of the adjacent chamber; and

a controller, within the housing, configured to cause stimulus pulses to be delivered, in a dual chamber synchronous manner, through the first and second electrodes to the local and distal activation sites, respectively;

wherein the active interim-segment is pre-formed in a curved shape having a trough, the second electrode and a third electrode located on the extension body in the trough, the curved shape configured to following a contour of an interior of a right atrial appendage.

10. The device of claim 9, wherein the first and second regions represent a superior vena cava and a right atrial appendage of the right atrium, respectively.

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

a housing configured to be implanted entirely within a single local chamber of the heart;

a base on the housing, the base configured to be secured to the local chamber;

a first electrode provided on the housing at a first position such that, when the housing is implanted in the local chamber, the first electrode is configured to engage wall tissue at a local activation site within a conduction network of the local chamber;

an intra-cardiac extension having a proximal end, a distal end and an extension body extending there between, the proximal end coupled to the housing and located in the local chamber, the extension body including a stabilization arm provided at the distal end thereof, the extension body being sufficient in length to extend from the local chamber into an adjacent chamber, the extension body including an active interim-segment located at an intermediate point along the extension body;

a second electrode provided on the active interim-segment of the extension body, the second electrode configured to engage wall tissue at a distal activation site within a conduction network of the adjacent chamber; and

a controller, within the housing, configured to cause stimulus pulses to be delivered, in a dual chamber synchronous manner, through the first and second electrodes to the local and distal activation sites, respectively;

wherein the controller is configured to time delivery of the stimulus pulses at the distal activation site to cause contraction of the adjacent chamber in a predetermined relation to contraction of the local chamber.

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

a housing configured to be implanted entirely within a single local chamber of the heart;

a base on the housing, the base configured to be secured to the local chamber;

a first electrode provided on the housing at a first position such that, when the housing is implanted in the local chamber, the first electrode is configured to engage wall tissue at a local activation site within a conduction network of the local chamber;

an intra-cardiac extension having a proximal end, a distal end and an extension body extending there between, the proximal end coupled to the housing and located in the local chamber, the extension body including a stabilization arm provided at the distal end thereof, the extension body being sufficient in length to extend from the local chamber into an adjacent chamber, the extension body including an active interim-segment located at an intermediate point along the extension body;

a second electrode provided on the active interim-segment of the extension body, the second electrode configured to engage wall tissue at a distal activation site within a conduction network of the adjacent chamber; and

a controller, within the housing, configured to cause stimulus pulses to be delivered, in a dual chamber synchronous manner, through the first and second electrodes to the local and distal activation sites, respectively;

wherein the stabilization arm includes a flexible stabilizer end-segment wrapped into at least one turn.

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

a housing configured to be implanted entirely within a single local chamber of the heart;

a base on the housing, the base configured to be secured to the local chamber;

a first electrode provided on the housing at a first position such that, when the housing is implanted in the local chamber, the first electrode is configured to engage wall tissue at a local activation site within a conduction network of the local chamber;

an intra-cardiac extension having a proximal end, a distal end and an extension body extending there between, the proximal end coupled to the housing and located in the local chamber, the extension body including a stabilization arm provided at the distal end thereof, the extension body being sufficient in length to extend from the local chamber into an adjacent chamber, the extension body including an active interim-segment located at an intermediate point along the extension body;

a second electrode provided on the active interim-segment of the extension body, the second electrode configured to engage wall tissue at a distal activation site within a conduction network of the adjacent chamber; and

a controller, within the housing, configured to cause stimulus pulses to be delivered, in a dual chamber synchronous manner, through the first and second electrodes to the local and distal activation sites, respectively; and

further comprising a conductor wire extending within the extension body from the housing to the second electrode, the conductor terminating at the second electrode, the stabilization arm being void of electrodes and conductor wires.

14. A method for implanting a leadless intra-cardiac medical device (LIMD), the LIMD including a housing with a base, a first electrode provided on the housing, an intra-cardiac extension having a proximal end, a distal end and an extension body extending there between, the proximal end coupled to the, the extension body including a stabilization extension provided at the distal end of the intra-cardiac extension, and an active interim-segment located at an intermediate point along the extension body between the stabilization extension and the proximal end of the intra-cardiac extension, a second electrode provided on the active interim-segment, the method comprising:

guiding the housing, utilizing an introducer, to a local activation site within a conductive network of the local chamber;

positioning the first electrode to engage wall tissue at the local activation site within the conductive network of the local chamber;

actively securing the housing to tissue of interest at the local activation site by applying rotational force to the stabilization extension which causes an active fixation member on the housing to become securely affixed to the wall tissue;

guiding the active interim-segment, utilizing the introducer, to a distal activation site within a conductive network of an adjacent chamber;

positioning the second electrode to engage tissue of interest at the distal activation site within the conductive network of the adjacent chamber; and

configuring a controller within the housing to cause stimulus pulses to be delivered, in a dual chamber synchronous manner, through the first electrode to the local activation site, and through the second electrode to the distal activation site.

15. The method of claim 14, wherein the active interim-segment further comprises a third electrode electrically separated from the second electrode, the method further comprising configuring the controller to operate in at least one of a bipolar sensing mode and a bipolar pacing mode using the second and third electrodes.

16. The method of claim 15, wherein the active interim-segment is pre-formed in a curved shape having a trough, the second and third electrodes located in the trough, the curved shape configured to following a contour of an interior of a right atrial appendage.

17. The method of claim 14, further comprising:

loading the IMD into a sheath of the introducer such that a memorized, pre-formed shape of the intra-cardiac extension is changed to a temporary, extended or dilated introducer state; and

after securing the housing to the tissue of interest, at least partially retracting the introducer such that, as the intra-cardiac extension is discharged from a distal end of the sheath, thereby allowing the intra-cardiac extension to return to the memorized, pre-formed shape.

18. The method of claim 14, further comprising performing an auto capture test to determine whether stimulus pulses delivered from the first electrode at the local activation site capture the local chamber.

19. The method of claim 14, further comprising performing a sensing test to determine whether far-field signals sensed at least partially by the first electrode are rejected as far-field signals.

20. The method of claim 14, further comprising, when the active interim-segment exits from the introducer, permitting the active interim-segment to bend into a curved shape sufficient to extend into and engage a contour of an interior of the heart or vessel.

21. The method of claim 14, further comprising guiding the stabilization extension to engage a first region of the heart, the first region representing at least one of a superior vena cava, an inferior vena cava, a coronary sinus, and a pulmonary artery.

22. The method of claim 14, wherein the stabilization arm includes a stabilizer end-segment that is pre-formed to wrap into at least one turn that is predisposed to radially expand to a diameter sufficient to fit against an interior of at least one of a superior vena cava, an inferior vena cava, a coronary sinus, and a pulmonary artery.

23. The method of claim 14, further comprising configuring the controller to control delivery of the stimulus pulses from the first and second electrodes in accordance with a DDD pacing mode to a right atrium and right ventricle, while the housing is entirely located in right side of the heart.

24. The method of claim 14, further comprising configuring the controller to control delivery of the stimulus pulses from the first and second electrodes in accordance with a DDD pacing mode to a left atrium and left ventricle, while the housing is entirely located in left side of the heart.