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

• US 20130116738A1
• Filed: 01/17/2012
• Published: 05/09/2013
• Est. Priority Date: 11/03/2011
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Samade, Richard, Karst, Edward, Bornzin, Gene A., Poore, John W., Somogyi, Zoltan, Theret, Didier, Dalal, Nirav
• Granted Patent: US 8,798,740 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• 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 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A leadless intra-cardiac medical device (LIMD) includes a housing configured to be implanted entirely within a single local chamber of the heart.

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, the local chamber having local wall tissue that constitutes part of a conduction network of the local chamber;

a base on the housing, the base configured to be secured to tissue of interest, an adjacent chamber having distal wall tissue, with respect to the local chamber, that constitutes part of a conduction network of the adjacent chamber,

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

a second electrode provided at a second position on the base and extending outward such that, when the device is implanted in the local chamber, the second electrode configured to engage wall tissue at a distal activation site within the conduction network of the adjacent chamber; and

a controller within the housing to cause stimulus pulses to be delivered, in a synchronous manner, through the first and second electrodes to the local and distal activation sites, respectively, such that stimulus pulses delivered at the distal activation site are timed to cause contraction of the adjacent chamber in a predetermined relation to contraction of the local chamber.

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 or a DDDR pacing mode.

3. The device of claim 1, wherein the tissue of interest represents a portion of the triangle of Koch, the second electrode is configured to engage the distal activation site which is in the ventricular vestibule, the first electrode is configured to engage the local activation site which is in the triangle of Koch, the first and second electrodes delivering stimulus pulses to the triangle of Koch and the ventricular vestibule to initiate activation in a right atrium and right ventricle, respectively.

4. The device of claim 1, wherein the controller is configured to control delivery, from the first and second electrodes, of the stimulus pulses to a right atrium and a right ventricle, while the device is entirely located in one of the right atrium and right ventricle.

5. The device of claim 1, wherein the adjacent chamber constitutes at least one of a left atrium, a right ventricle and a left ventricle, the distal activation site being physiologically responsive to distal activation events originating in the at least one of left atrium, right ventricle and left ventricle.

6. The device of claim 1, wherein at least one of the first and second electrodes represent surface bump type electrodes that passively engage the wall tissue.

7. The device of claim 1, wherein the base includes mounting elements to secure the first and second electrodes to the housing in an electrically isolated manner.

8. The device of claim 1, wherein the second electrode has different first and second cross-sections at proximal and distal ends thereof.

9. The device of claim 1, wherein the second electrode includes a conductive wire that has different first and second iso-diameters at the proximal and distal ends thereof.

10. The device of claim 1, wherein the base includes at least one of spikes and a serrated edge to facilitate active fixation to the septum.

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

guiding the device, utilizing an introducer, to an activation site that is located entirely within a single local chamber of the heart and proximate to tissue of interest, the local chamber having local wall tissue that constitutes part of a conduction network of the local chamber, an adjacent chamber having distal wall tissue, with respect to the local chamber, that constitutes part of a conduction network of the adjacent chamber;

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

positioning the second electrode to engage wall tissue at a distal activation site within the conduction network of the adjacent chamber;

actively securing the device to the tissue of interest; and

configuring a controller within the housing to cause stimulus pulses to be delivered through the first and second electrodes to the local and distal activation sites, respectively, such that stimulus pulses delivered at the distal activation site are timed to cause contraction of the adjacent chamber in a predetermined relation to contraction of the local 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 member 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 first and second electrodes are electrically coupled to at least one of the conduction networks of the local and adjacent chambers.

15. The method of claim 11, wherein positioning the first and second electrodes comprises engaging the first electrode with right atrial wall tissue, orienting the device at an acute angle to the wall tissue and diagonally screwing the second electrode into the wall tissue such that the second electrode extends into a ventricular vestibule.

16. The method of claim 15, further comprising implanting the device at the distal activation site that constitutes wall tissue of at least one of a left atrium, a right ventricle and a left ventricle, the distal activation site being physiologically responsive to distal activation events originating in the at least one of left atrium, right ventricle and left ventricle.

17. The method of claim 11, further comprising providing a steroid proximate a base of the device and least one of the first and second electrodes, the steroid configured to at least one of promote healing, promote growth to the at least one of first and second electrodes and reduce scarring.

18. The method of claim 11, wherein the first electrode is a bump electrode and positioning the first electrode comprises passively locating the bump electrode against the wall tissue at the first activation site.

19. The method of claim 11, wherein the second electrode is a helical electrode and actively securing the device comprises screwing the helical electrode into wall tissue at the distal activation site.

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

a housing configured to be implanted entirely within a single local chamber of the heart, the local chamber having local wall tissue that constitutes part of a conduction network of the local chamber;

a base on the housing, the base configured to be secured to tissue of interest that separates the local chamber from an adjacent chamber, the adjacent chamber having distal wall tissue, with respect to the local chamber, that constitutes part of a conduction network of the adjacent chamber;

a first electrode provided on the base and extending outward such that, when the device is implanted in the local chamber, the first electrode is configured to engage wall tissue at a distal activation site within the conduction network of the adjacent chamber;

an extension arm provided on the housing and extending outward from the housing;

a second electrode provided on the extension arm and located such that, when the extension arm is positioned in the local chamber, the second electrode is configured to engage wall tissue at a local activation site within the conduction network of the local chamber; and

a controller within the housing to cause stimulus pulses to be delivered, in a synchronous manner, through the first and second electrodes to the distal and local activation sites, respectively, such that stimulus pulses delivered at the distal activation site are timed to cause contraction of the adjacent chamber in a predetermined relation to contraction of the local chamber.

21. The device of claim 20, wherein the housing further comprising a stabilizer arm having a distal end that extends outward from the housing, the stabilizer arm having a pusher cup located at the distal end, the stabilizer arm having a core structure that is torque and compression resistant such that when the pusher tool is rotated or moved longitudinally, the stabilizer arm conveys rotation and longitudinal force from the pusher tool to the housing.

22. The device of claim 20, wherein the housing further comprising a stabilizer arm joined to a top end of the housing, the extension arm having the second electrode located on a distal end thereof to extend into and engage the local wall tissue in an appendage area of the local chamber, the stabilizer arm having a distal end that extends to and engages an opposed stabilization area of the local chamber.

23. The device of claim 20, wherein the housing further comprises a stabilizer arm, the extension arm and stabilizer arm pivotally joined to a hinge assembly located at a top end of the housing.

24. The device of claim 20, wherein the housing further comprises a stabilizer arm, the extension arm and stabilizer arm securely joined to a top end of the housing, the extension arm and stabilizer arm being biased to flare outward away from one another when in a deployed position such that distal ends of the stabilization and extension arms engage the local chamber in opposed areas remote from the base of the housing.

25. The device of claim 20, wherein the housing is elongated along a longitudinal axis, the housing being joined to the extension arm such that the extension arm moves between an introduction contracted position substantially in-line with the longitudinal axis of the housing and a deployed flared position that projects at an acute angle from the longitudinal axis of the housing to position the first electrode against the local wall tissue.

26. A method for implanting a leadless intra-cardiac medical device (LIMD) the device having a housing with a base and with an extension arm, the extension arm extending outward from the housing, the device having a first electrode provided on the base and a second electrode provided on the extension arm, said method comprising:

guiding the device, utilizing an introducer, to an activation site that is located entirely within a single local chamber of the heart and proximate to tissue of interest, the local chamber having local wall tissue that constitutes part of a conduction network of the local chamber, an adjacent chamber having distal wall tissue, with respect to the local chamber, that constitutes part of a conduction network of the adjacent chamber; and

actively securing the device to the septum;

positioning the first electrode to engage wall tissue at a distal activation site within the conduction network of the adjacent chamber;

positioning the second electrode to engage wall tissue at a local activation site within the conduction network of the local chamber; and

configuring a controller within the housing to cause stimulus pulses to be delivered through the first and second electrodes to the distal and local activation sites, respectively, such that stimulus pulses delivered at the distal activation site are timed to cause contraction of the adjacent chamber in a predetermined relation to contraction of the local chamber.

27. The method of claim 26, further comprising deploying the extension arm to engage the local wall tissue in an appendage area of the local chamber.

28. The method of claim 26, wherein the device further comprises a stabilizer arm joined to the housing, and further comprising deploying the extension arm to extend into and engage the local wall tissue in an appendage area of the local chamber, deploying a distal end of the stabilizer arm to extend to and engage an opposed stabilization area of the local chamber.

29. The method of claim 26, wherein the device further comprises a stabilizer arm on the housing, and further comprising extending the stabilizer arm to engage a superior vena cava of the heart.

30. The method of claim 26, wherein the device further comprises a stabilizer arm, and further comprising connecting a pusher tool to a distal end of the stabilizer arm, and joining a proximal end of the stabilizer arm to the housing, wherein the stabilizer arm has a core structure that is torque and compression resistant such that when the pusher tool is rotated or moved longitudinally, the stabilizer arm conveys rotation and longitudinal force from the pusher tool to the housing.

31. The method of claim 26, 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 member on the base of the device to the septum.

32. The method of claim 26, further comprising implanting the device such that the first electrode engages the distal activation site which is in the ventricular vestibule and the second electrode engage the local activation site which is in the right atrial appendage.