Systems and methods for fixating transvenously implanted medical devices

• US 9,827,426 B2
• Filed: 07/21/2014
• Issued: 11/28/2017
• 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): Carey, Michael
• Application Number:
  US14/336,308
• Publication Number:
  US 20140336668A1
• Time in Patent Office: 1,226 Days
• Field of Search: 607122, 607 1, 607115, 607116, 607119, 607123, 607126, 607127, 607128
• 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 system comprising:

a straightening member adapted for facilitating delivery of an implantable medical device into a vein of the coronary sinus of a heart;

the implantable medical device comprising;

a power component disposed within a housing adapted for implantation in the vein of the coronary sinus of the heart;

a conductor adapted for implantation in the vein, secured to and in electrical communication with the power component and extending distally from the power component;

a plurality of electrodes coupled to the conductor such that each electrode is in electrical connection with the conductor;

an elongate member disposed about the conductor and including a lumen configured to receive the straightening member, wherein at least a portion of the elongate member is configured to transition from an arcuate, expanded shape to a non-arcuate, non-expanded shape when the straightening member is inserted in the lumen of the elongated member in order to facilitate delivery of the implantable medical device into the vein of the coronary sinus of the heart, and to transition from the non-arcuate, non-expanded shape to the arcuate, expanded shape when the straightening member is withdrawn from the lumen of the elongated member in order to facilitate anchoring of the implantable medical device within the vein of the coronary sinus of the heart after delivery.

2. The implantable medical device system of claim 1, wherein the arcuate, expanded shape of the elongate member is a helical shape.

3. The implantable medical device system of claim 1, wherein the arcuate, expanded shape of the elongate member is a coiled shape.

4. The implantable medical device system of claim 1, wherein the arcuate, expanded shape of the elongate member is one of an undulating shape, a sinusoidal shape and a circular shape.

5. The implantable medical device system of claim 1, wherein the elongate member is adapted to form the arcuate expanded shape within the vein such that one or more of the plurality of electrodes are placed in electrical communication with a wall of the vein.

6. The implantable medical device system of claim 1, wherein the plurality of electrodes includes a tip electrode.

7. The implantable medical device system of claim 1, wherein the straightening member is configured to straighten and maintain the elongate member in the non-expanded shape while the straightening member remains within the lumen of the elongated member.

8. A method for delivering an implantable medical device, wherein the implantable medical device includes a power component disposed within a housing configured for implantation in a vein of a patient, a conductor configured for implantation in the vein of the patient and secured to and in electrical communication with the power component and extending distally from the power component, a plurality of electrodes coupled to the conductor such that each electrode is in electrical connection with the conductor, and an elongate member disposed about the conductor and including a lumen, wherein at least a portion of the elongate member is configured to transition between an arcuate, expanded shape and a non-arcuate, non-expanded shape, the method comprising:

with a straightening member inserted in the lumen of the elongated member to maintain the elongate member in the non-arcuate, non-expanded shape, positioning the power component, the elongated member and the conductor within a vein of a coronary sinus of a heart;

a; and

withdrawing the straightening member from the lumen of the elongated member to transition the elongated member from the non-arcuate, non-expanded shape to the arcuate, expanded shape to facilitate anchoring of the implantable medical device within the vein with one or more of the plurality of electrodes placed in electrical contact with a wall of the vein.

9. The method of claim 8, further comprising inserting the straightening member into the lumen of the elongated member before positioning the power component, the elongated member and the conductor within the vein of the coronary sinus of the heart.

10. The method of claim 8, wherein withdrawing the straightening member comprises proximally moving the straightening member relative to the elongated member.

11. The method of claim 8, further comprising using a secondary member to press against the implantable medical device while the straightening member is withdrawn from the lumen of the elongated member.

12. The method of claim 8, wherein positioning the power component, the elongated member and the conductor within the vein of the coronary sinus of the heart comprises deploying together the power component, the elongated member, the conductor and the straightening member from a distal end of a guide catheter.