Intra-cardiac implantable medical device

• US 8,670,842 B1
• Filed: 12/14/2012
• Issued: 03/11/2014
• Est. Priority Date: 12/14/2012
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bornzin, Gene A., Poore, John W., Somogyi, Zoltan, Min, Xiaoyi, Theret, Didier, Karaelias, Elaine
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US13/715,732
• Time in Patent Office: 452 Days
• Field of Search: 607/125
• US Class Current: 607/125
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• 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 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• 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 2001/058 Fixing tools

Abstract

An intra-cardiac implantable medical device (IIMD) system may include a housing and an intra-cardiac (IC) device extension. The housing may be configured to be implanted entirely within a local chamber of the heart. The housing includes a base configured to be secured to the local chamber. The IC device extension may include a proximal end, a distal end, and an extension body extending there between. The proximal end may be coupled to the housing and configured to be located in the local chamber. The extension body may include an IE orientation segment connected to a chamber transition segment that is sufficient in length to extend from the local chamber into an adjacent chamber. The IE orientation segment is configured to be lodged within the adjacent chamber in order to stabilize the system within heart.

Claims

1. An intra-cardiac implantable medical device (IIMD) system, comprising:

a housing configured to be implanted entirely within a local chamber of the heart, wherein the housing includes a base configured to be secured to the local chamber; and

an intra-cardiac (IC) device extension including a proximal end, a distal end, and an extension body extending there between, the proximal end coupled to the housing and configured to be located in the local chamber, the extension body including an IIMD-to-electrode (IE) orientation segment connected to a chamber transition segment that is sufficient in length to extend from the local chamber into an adjacent chamber proximate an inferior vena cava, wherein at least a portion of the IE orientation segment is configured to be lodged within the adjacent chamber proximate the inferior vena cava in order to stabilize the system within heart.

2. The system of claim 1, wherein the housing is configured to be securely anchored within the local chamber, and the IC device extension is configured to be securely lodged between wall portions of the adjacent chamber.

3. The system of claim 1, wherein the IE orientation segment comprises a right atrial appendage (RAA) stabilization segment connected to an inferior vena cava (IVC) stabilization segment through a spanning segment, wherein the RAA stabilization segment is configured to be proximate an RAA of the heart and the IVC stabilization segment is configured to be proximate the inferior vena cava of the heart.

4. The system of claim 3, wherein the RAA stabilization segment comprises an RAA fixation mechanism having at least one electrode configured to abut into a portion of the RAA.

5. An intra-cardiac implantation system comprising:

an intra-cardiac implantable medical device (IIMD) configured to be implanted into a heart, the IIMD including;

a housing configured to be implanted entirely within a local chamber of the heart, wherein the housing includes a base configured to be secured to the local chamber; and

an intra-cardiac (IC) device extension including an extension proximal end, an extension distal end, and an extension body extending there between, the extension body including a IIMD-to-electrode (IE) orientation segment connected to a chamber transition segment that is sufficient in length to extend from the local chamber into an adjacent chamber; and

an introducer assembly configured to implant the IIMD into the heart, the introducer assembly comprising;

a sheath having a sheath proximal end and a sheath distal end, wherein an internal passage is defined between the sheath proximal and distal ends, wherein the housing and the IC device extension are configured to be moved through the sheath distal end, and wherein the IC device extension is in a collapsed state while in the sheath; and

a shape-adjusting member positioned within or over a portion of the sheath, wherein the shape-adjusting member is configured to be selectively transitioned between a navigation state, in which the sheath is configured to be navigated through vasculature of the patient, and an at-rest state, in which the sheath distal end is configured to be directed toward an implantation site within the heart.

6. The system of claim 5, wherein the introducer assembly further comprises a guide member operatively connected to the shape-adjusting member, wherein the guide member is configured to selectively transition the shape-adjusting member between the navigation and at-rest states.

7. The system of claim 6, wherein the guide member comprises one or both of a guide wire or guide tube.

8. The system of claim 7, wherein the one or both of a guide wire or guide tube are positioned within a central passage of the shape-adjusting member.

9. The system of claim 5, wherein the introducer assembly further comprises a removal wire connected to the shape-adjusting member, wherein the removal wire is configured to remove the shape-adjusting member from the sheath.

10. The system of claim 5, wherein the introducer assembly is configured to implant the IIMD into the heart such that the housing is located in the local chamber, and the IE orientation segment is lodged within the adjacent chamber in order to stabilize the IIMD within heart.

11. The system of claim 5, wherein the introducer assembly is configured to implant the IIMD into the heart such that the housing is securely anchored within the local chamber, and the IC device extension is securely lodged between wall portions of the adjacent chamber.

12. The system of claim 5, wherein the IE orientation segment comprises a right atrial appendage (RAA) stabilization segment connected to an inferior vena cava (IVC) stabilization segment through a spanning segment.

13. The system of claim 12, wherein the introducer assembly is configured to implant the IIMD into the heart so that the RAA stabilization segment is proximate an RAA of the heart and the IVC stabilization segment is proximate an IVC of the heart.

14. The system of claim 13, wherein the RAA stabilization segment comprises an RAA fixation mechanism having at least one electrode configured to abut into a portion of the RAA.

15. The system of claim 13, wherein the RAA stabilization segment comprises the distal end configured to abut into the RAA, and wherein the IVC stabilization segment comprises an arcuate curved segment configured to abut into a wall portion of the right atrium opposite the RAA.

16. An intra-cardiac implantation method configured to implant an intra-cardiac implantable medical device (IIMD) into a heart, wherein the IIMD includes a housing configured to be implanted entirely within a local chamber of the heart, and an intra-cardiac (IC) device extension including a proximal end, a distal end, and an extension body extending there between, wherein the extension body includes an IE orientation segment connected to a chamber transition segment that is sufficient in length to extend from the local chamber into an adjacent chamber, the method comprising:

navigating an introducer assembly having a sheath through vasculature;

adjusting a shape of the introducer assembly with a shape-adjusting member within the adjacent chamber so that a sheath distal end of the introducer assembly is directed toward an implantation site;

holding the shape-adjusting member in position within the sheath;

sliding the sheath over the shape-adjusting member;

urging the sheath distal end into the implantation site;

pushing the housing of the IIMD through the sheath distal end into the implantation site;

anchoring the housing into the implantation site;

removing the sheath from the IIMD;

deploying the extension body within the heart during the removing operation; and

stabilizing the IIMD within the heart through the anchoring and deploying operations.

17. The method of claim 16, further comprising initially positioning the housing and the IC device extension within the sheath distal end of the introducer assembly before the navigating operation, wherein the positioning operation comprises collapsing the IC device extension within the sheath distal end.

18. The method of claim 16, wherein the adjusting operation comprises curving the shape-adjusting member so that the sheath distal end is directed toward an implantation site within the local chamber.

19. The method of claim 16, wherein the adjusting operation comprises transitioning the shape-adjusting member from a navigation state to an at-rest state.

20. The method of claim 19, wherein the adjusting operation comprises transitioning the shape-adjusting member from the navigation state to the at-rest state through a guide member.

21. The method of claim 16, further comprising removing the shape-adjusting member from the sheath after the adjusting operation.

22. The method of claim 16, wherein the anchoring operation comprises anchoring the housing in the local chamber.

23. The method of claim 22, wherein the securing operation comprises lodging the IE orientation segment within the adjacent chamber in order to stabilize the IIMD within heart.

24. The method of claim 22, wherein the securing operation comprises lodging the IC device between wall portions of the adjacent chamber.

25. The method of claim 16, wherein the stabilizing operation comprises positioning an RAA stabilization segment of the IE orientation segment proximate a right atrial appendage of the heart, and positioning an IVC stabilization segment of the IE orientation segment proximate an inferior vena cava of the heart.