Trans septal implantable medical device

• US 10,391,319 B2
• Filed: 08/17/2017
• Issued: 08/27/2019
• Est. Priority Date: 08/19/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Shuros, Allan Charles, Hartemink, Christopher A.
• Primary Examiner(s): Dietrich, Joseph M
• Application Number:
  US15/679,757
• Publication Number:
  US 20180050208A1
• Time in Patent Office: 740 Days
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• 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
• CPC Class Codes: A61N 1/378 Electrical supply
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

An implantable medical device (IMD) includes a housing that is configured to be positioned at least in part in a chamber of a heart, and in some cases, in a right ventricle (RV) proximate an RV facing side of the ventricular septum of the heart. When so provided, an RV electrode may be fixed relative to the housing to be proximate the RV facing side of the ventricular septum. An LV electrode may be spaced a distance from the RV electrode and the housing such that the LV electrode is positioned at least partially within the ventricular septum. An LV electrode position adjustment assembly may be used to adjust the depth at which the LV electrode is positioned within the ventricular septum.

Claims

1. An implantable medical device (IMD) configured for deployment at a ventricular septum of a patient'"'"'s heart, the ventricular septum of the patient'"'"'s heart having a right ventricle (RV) facing side and a left ventricle (LV) facing side, the IMD comprising:

a housing having a proximal end and a distal end, the housing configured to fit within the right ventricle (RV) of the patient'"'"'s heart with the distal end of the housing proximate the RV facing side of the ventricular septum once the IMD is implanted in the patient'"'"'s heart;

a power source disposed within the housing;

circuitry disposed within the housing and operatively coupled to the power source;

a first RV electrode adjacent the distal end of the housing and positioned to be facing the RV facing side of the ventricular septum once the IMD is implanted, the first RV electrode operatively coupled with the circuitry in the housing;

a second RV electrode spaced proximally of the first RV electrode, the second RV electrode operatively coupled with the circuitry in the housing;

an LV electrode positioned distally of the first RV electrode and extends at least partially through the ventricular septum once the IMD is implanted, the LV electrode operatively coupled with the circuitry in the housing; and

an LV electrode position adjustment assembly for adjusting a distance that the LV electrode is positioned distally of the first RV electrode, wherein the LV electrode position adjustment assembly comprises a coupling secured relative to the housing, wherein the coupling is configured to mate with a separate adjustment tool that can move the coupling relative to the housing to adjust the distance that the LV electrode is positioned distally of the first RV electrode.

2. The IMD of claim 1, wherein the LV electrode position adjustment assembly comprises a fixation helix extending distally from the housing, with the LV electrode positioned on the fixation helix, the fixation helix including a proximal shaft portion extending through a lumen of the housing and terminating in the coupling such that rotating the coupling rotates the fixation helix relative to the housing and causes the fixation helix to thread itself into the ventricular septum.

3. The IMD of claim 1, wherein the LV electrode position adjustment assembly comprises:

an inner shaft operatively coupled to the coupling; and

an outer shaft threadedly engaged with the inner shaft and configured to not rotate relative to the housing, wherein rotation of the inner shaft via the coupling results in translation of the outer shaft relative to the housing, wherein the LV electrode is secured relative to the outer shaft and translates with the outer shaft.

4. The IMD of claim 3, wherein at least a portion of the outer shaft has a cross-sectional profile that engages a complementary engagement portion of the housing to prevent rotation of the outer shaft relative to the housing.

5. The IMD of claim 4, wherein the cross-sectional profile comprises a non-circular cross-sectional profile and the complementary engagement portion of the housing comprises a distal opening in a lumen that receives at least part of the outer shaft.

6. The IMD of claim 3, wherein the coupling comprises a rotatable tether loop coupled to a proximal end of the inner shaft, such that rotating the rotatable tether loop rotates the inner shaft relative to the outer shaft, thereby causing the outer shaft to translate in response.

7. The IMD of claim 3, further comprising a spring contact disposed within the housing and operably coupled with the circuitry, the spring contact making sliding electrical contact with a portion of the outer shaft that is electrically coupled with the LV electrode.

8. The IMD of claim 1, further comprising one or more fixation tines that are configured to extend into the ventricular septum and curve over to anchor the IMD in place relative to the ventricular septum.

9. The IMD of claim 1, wherein the LV electrode serves as an antenna for communication purposes.

10. The IMD of claim 1, wherein the IMD comprises a dual chamber leadless cardiac pacemaker (LCP), and the LCP senses electrical activity on one side of the ventricular septum and delivers an actionable response on the other side of the ventricular septum.

11. An implantable medical device (IMD) configured for deployment within a heart chamber of a patient'"'"'s heart, near a septum of the patient'"'"'s heart, the septum of the patient'"'"'s heart having a first chamber facing side facing the heart chamber and a second opposing chamber facing side, the IMD comprising:

a housing configured to be positioned at least in part in the heart chamber proximate the first chamber facing side of the septum once the IMD is implanted in the patient'"'"'s heart;

a power source disposed within the housing;

circuitry disposed within the housing and operatively coupled to the power source;

one or more first chamber electrodes fixed relative to the housing and positioned to be proximate the first chamber facing side of the heart chamber once the IMD is implanted, the one or more first chamber electrodes operatively coupled with the circuitry in the housing;

a lumen defined by the housing;

an outer shaft that extends through the lumen and is translatable relative to the lumen;

a second chamber electrode disposed at or near a distal end of the outer shaft, the second chamber electrode operably coupled with the circuitry disposed within the housing; and

an inner shaft threadedly engaged with the outer shaft such that the inner shaft may be rotated relative to the outer shaft in order to effect translation of the outer shaft relative to the housing, the outer shaft translatable between a retracted position in which the second chamber electrode is proximate the first chamber facing side of the septum and an extended position in which the second chamber electrode extends at least partially into the septum.

12. The IMD of claim 11, wherein at least a portion of the outer shaft has a cross-sectional profile that engages a complementary engagement portion of the housing to prevent rotation of the outer shaft relative to the housing.

13. The IMD of claim 12, wherein the inner shaft extends proximally through the lumen and terminates in coupling such that rotating the coupling rotates the inner shaft relative to the outer shaft.

14. The IMD of claim 11, further comprising one or more fixation tines that are configured to extend into the septum and curve over to anchor the IMD in place relative to the septum.

15. The IMD of claim 11, further comprising a spring contact disposed within the housing and operably coupled with the circuitry, the spring contact making sliding electrical contact with a portion of the outer shaft that is electrically coupled with the second chamber electrode.

16. The IMD of claim 11, wherein the power source comprises a battery.

17. The IMD of claim 11, wherein the IMD comprises a dual chamber leadless cardiac pacemaker (LCP).

18. A method of facilitating dual chamber pacing of a heart, the method comprising:

advancing a leadless cardiac pacemaker (LCP) to a position proximate a first side of a septum of the heart, the LCP including a housing and two first chamber electrodes disposed relative to the housing, the LCP further including a second chamber electrode and an electrode position adjustment assembly with a coupling for adjusting a position of the second chamber electrode relative to the housing;

mating an adjustment tool to the coupling of the electrode position adjustment assembly;

manipulating the adjustment tool to move the coupling relative to the housing to adjust the position of the second chamber electrode relative to the housing; and

deploying a fixation mechanism to secure the LCP relative to the septum.

19. The method of claim 18, further comprising:

testing for capture of the heart prior to deploying the fixation mechanism;

moving the LCP to a different position proximate the first side of the septum if capture is not achieved; and

testing for capture again.

20. The method of claim 18, further comprising:

testing for capture with the second chamber electrode positioned at a first distance relative to the housing;

manipulating the adjustment tool to move the coupling relative to the housing to adjust the distance that the second chamber electrode is positioned a second distance relative to the housing; and

testing for capture again.