SYSTEMS AND METHODS FOR FIXATING TRANSVENOUSLY IMPLANTED MEDICAL DEVICES

• US 20120101553A1
• Filed: 12/28/2011
• Published: 04/26/2012
• Est. Priority Date: 05/17/2007
• Status: Active Grant

• Current Assignee: Reddy G. Shantanu
• Original Assignee: Reddy G. Shantanu
• Inventors: Reddy, G. Shantanu
• Granted Patent: US 8,798,770 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• 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, the elongate lead body including an outer insulating layer and a conductor disposed within the outer insulating layer, 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 in a patient'"'"'s body; and

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 patient'"'"'s body.

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

7. 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.

8. An 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 implantation, the elongate lead body being configured to expand from a collapsed state to an expanded state to mechanically engage tissue at an implantation site in a patient'"'"'s body 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 patient'"'"'s body, the control module including a lumen extending therethrough to accommodate the straightening member.

9. The device of claim 8, wherein the control module is adapted for wireless communication.

10. The device of claim 8, wherein the electrical lead and the control module are adapted for implantation using a catheter.

11. The device of claim 8, wherein the control module is adapted for at least one of stimulating and sensing a physiologic response using the electrical lead.

12. The device of claim 8, further comprising a plurality of spaced-apart electrodes disposed on the electrical lead body and coupled to the conductive layer.

13. The implantable medical device of claim 8, further comprising a second electrical lead adapted to expand from a collapsed state to an expanded state to mechanically engage a portion of the patient'"'"'s body, wherein the control module is in electrical communication with the second electrical lead.

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

providing an implantable medical device comprising;

an electrical lead including an elongate lead body, the elongate lead body including an outer insulating layer and a conductor disposed within the outer insulating layer, 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 in a patient'"'"'s body; and

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 patient'"'"'s body;

collapsing the elongate lead body to its collapsed delivery state;

positioning the implantable medical device at an implantation site within the patient'"'"'s body; and

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

15. The method of claim 14, 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.

16. The method of claim 15, wherein collapsing the elongate lead body includes inserting the straightening member into the lumen of the elongate lead body.

17. The method of claim 16, 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.

18. The method of claim 14, wherein allowing the elongate lead body to expand includes allowing the elongate lead body to assume a substantially arcuate expanded shape.

19. The method of claim 14, wherein allowing the elongate lead body to expand includes allowing the elongate lead body to assume a substantially sinusoidal expanded shape.

20. The method of claim 14, wherein allowing the elongate lead body to expand includes allowing the elongate lead body to assume a substantially helical expanded shape.