Systems and methods for fixating transvenously implanted medical devices

• US 8,798,770 B2
• Filed: 12/28/2011
• Issued: 08/05/2014
• Est. Priority Date: 05/17/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Reddy, G. Shantanu
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US13/338,924
• Publication Number:
  US 20120101553A1
• Time in Patent Office: 951 Days
• Field of Search: 607/1, 607115-116, 607/119, 607122-123, 607126-128, 600/375
• US Class Current: 607/122
• 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 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37516 Intravascular implants
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A transvenously implantable medical device (TIMD) includes an electrical lead and a control module. The electrical lead includes one or more electrodes and is adapted for transvenous implantation. The electrical lead is also pre-biased to expand from a collapsed state to an expanded state to mechanically engage an internal wall of a blood vessel. The control module is secured to and in electrical communication with the electrical lead. The control module includes a signal management component and a power component disposed in a housing adapted for implantation into the blood vessel. The control module is adapted for at least one of stimulating and sensing a physiologic response using the one or more electrodes of the electrical lead.

Claims

1. An implantable medical device comprising:

an electrical lead including an elongate lead body having a first end and an opposite second end, the elongate lead body including an outer insulating layer, a conductor disposed within the outer insulating layer, and a plurality of ring electrodes being coupled circumferentially about the elongate lead body, the ring electrodes being spaced apart from each other along the elongate lead body, the elongate lead body being configured to expand from a collapsed delivery state to an expanded state to secure the implantable medical device at an implantation site within a blood vessel in a vasculature of the heart; and

a control module secured to and in electrical communication with the electrical lead, the control module being configured to be disposed within the blood vessel and including a proximal end, a distal end, a signal management component and a power component disposed in a housing adapted for implantation into the vasculature of the heart, wherein the first end or the second end of the elongate lead body is affixed to and extends from the distal end of the control module;

wherein the elongate lead body is adapted to expand from a collapsed state that is substantially straight to an expanded state having curvatures to fixate the control module within the blood vessel at the implantation site and is adapted to place one or more of the plurality of ring electrodes in electrical communication with a wall of the blood vessel at the implantation site.

2. The device of claim 1, wherein the control module is adapted for wireless communication.

3. The device of claim 1, wherein the elongate lead body further includes an inner insulating layer, wherein the conductor is disposed between the outer insulating layer and the inner insulating layer, and wherein the inner insulating layer defines a lumen that is configured to accommodate a straightening member in order to adapt the electrical lead for implantation by straightening the elongate lead body thereby causing the elongate lead body to assume the collapsed delivery state.

4. The device of claim 3, wherein the control module further includes a lumen axially aligned with the lumen in the elongate lead body and configured to accommodate the straightening member.

5. The device of claim 1, further comprising an electrode disposed on the electrical lead body and coupled to the conductive layer.

6. The device of claim 3, wherein the elongate lead body is configured to expand from a collapsed state to an expanded state to mechanically engage tissue at an implantation site in the vasculature of the heart upon removal of the straightening member.

7. The device of claim 1, further comprising a plurality of spaced-apart electrodes disposed on the electrical lead body and coupled to the conductive layer.

8. The device of claim 1, further comprising a second electrical lead adapted to expand from a collapsed state to an expanded state to mechanically engage tissue at the implantation site, wherein the control module is in electrical communication with the second electrical lead.

9. The device of claim 1, wherein the electrical lead and the control module are adapted for implantation using a catheter.

10. The device of claim 1, wherein the control module is adapted for at least one of stimulating and sensing a physiologic response using the electrical lead.

11. A method of implanting an implantable medical device comprising:

providing an implantable medical device comprising;

an electrical lead including an elongate lead body having a first end and an opposite second end, the elongate lead body including an outer insulating layer, a conductor disposed within the outer insulating layer, and a plurality of ring electrodes coupled circumferentially about the elongate lead body, the ring electrodes being spaced apart from each other along the elongate lead body, the elongate lead body being configured to expand from a collapsed state that is substantially straight to an expanded state having curvatures to secure the implantable medical device within a blood vessel at an implantation site in a vasculature of the heart; and

a control module secured to and in electrical communication with the electrical lead, the control module being disposed within the blood vessel and including a proximal end, a distal end, a signal management component and a power component disposed in a housing adapted for implantation into the vasculature of the heart, wherein the first end or the second end of the elongate lead body is affixed to and extends from the distal end of the control module;

collapsing the elongate lead body to its collapsed delivery state;

positioning the implantable medical device in the blood vessel at the implantation site within the vasculature of the heart such that the control module is fixed within the blood vessel and one or more of the plurality of ring electrodes is placed in electrical communication with a wall of the blood vessel; and

allowing the elongate lead body to expand to its expanded state to secure the implantable medical device at the implantation site.

12. The method of claim 11, wherein the elongate lead body further includes an inner insulating layer, wherein the conductor is disposed between the outer insulating layer and the inner insulating layer, and wherein the lumen is configured to accommodate a straightening member in order to cause the elongate lead body to assume its collapsed delivery state.

13. The method of claim 12, wherein collapsing the elongate lead body includes inserting the straightening member into the lumen of the elongate lead body.

14. The method of claim 13, wherein the control module further includes a lumen aligned with the lumen of the elongate lead body configured to accommodate the straightening member, and wherein the method further comprises inserting the straightening member into the lumen of the control module.

15. The method of claim 11, wherein allowing the elongate lead body to expand includes allowing the elongate lead body to assume a substantially arcuate expanded shape.

16. The method of claim 11, wherein allowing the elongate lead body to expand includes allowing the elongate lead body to assume a substantially sinusoidal expanded shape.

17. The method of claim 11, wherein allowing the elongate lead body to expand includes allowing the elongate lead body to assume a substantially helical expanded shape.