Systems and methods for fixating transvenously implanted medical devices

• US 8,103,359 B2
• Filed: 05/17/2007
• Issued: 01/24/2012
• 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): Layno, Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US11/750,185
• Publication Number:
  US 20080288039A1
• Time in Patent Office: 1,713 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. A transvenously implantable medical device comprising:

an electrical lead including an elongate lead body, the elongate lead body including an inner insulative sheath, an outer insulative sheath and a conductive layer disposed between the inner insulative sheath and the outer insulative sheath, the inner insulative sheath defining a lumen that is configured to accommodate a straightening member in order to adapt the electrical lead for transvenous implantation, the elongate lead body being pre-biased to expand from a collapsed state to an expanded state to mechanically engage an internal wall of a blood vessel upon removal of the straightening member;

a control module secured to and in electrical communication with the electrical lead, the control module including a signal management component and a power component disposed in a housing adapted for implantation into the blood vessel; and

a lumen extending through the control module to accommodate the straightening member.

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

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

4. The device of claim 1, wherein the elongate lead body defines a substantially arcuate shape in the expanded state.

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 1, wherein the conductive layer comprises a coil.

7. 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.

8. The device of claim 1, wherein the control module is adapted for stimulating cardiac tissue.

9. 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.

10. 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 the internal wall of the blood vessel, wherein the control module is in electrical communication with the second electrical lead.

11. A transvenously implantable medical device comprising:

a straightening member;

an electrical lead including an elongate lead body, the elongate lead body including an inner insulative sheath, an outer insulative sheath and a conductive layer disposed between the inner insulative sheath and the outer insulative sheath, the inner insulative sheath defining a lumen that is configured to accommodate the straightening member in order to adapt the electrical lead for transvenous implantation, the elongate lead body being pre-biased to expand from a collapsed state to an expanded state to mechanically engage an internal wall of a blood vessel upon removal of the straightening member;

a control module secured to and in electrical communication with the electrical lead, the control module including a signal management component and a power component disposed in a housing adapted for implantation into the blood vessel, the control module including a lumen extending therethrough to accommodate the straightening member.

12. The device of claim 11, wherein the control module is adapted for wireless communication.

13. The device of claim 11, wherein the electrical lead and the control module are adapted for transvenous implantation using a catheter.

14. The device of claim 11, wherein the elongate lead body defines a substantially arcuate shape in the expanded state.

15. The device of claim 11, wherein the conductive layer comprises a coil.

16. The device of claim 11, wherein the control module is adapted for at least one of stimulating and sensing a physiologic response using the electrical lead.

17. The device of claim 11, wherein the control module is adapted for stimulating cardiac tissue.

18. The device of claim 11, further comprising a plurality of spaced-apart electrodes disposed on the electrical lead body and coupled to the conductive layer.

19. The implantable medical device of claim 11, further comprising a second electrical lead adapted to expand from a collapsed state to an expanded state to mechanically engage the internal wall of the blood vessel, wherein the control module is in electrical communication with the second electrical lead.