Implantable intravascular device for defibrillation and/or pacing

• US 7,734,343 B2
• Filed: 05/31/2006
• Issued: 06/08/2010
• Est. Priority Date: 06/04/2003
• Status: Expired due to Fees

• Current Assignee: Nuxcel2 LLC
• Original Assignee: Synecor LLC
• Inventors: Ransbury, Terrance, Williams, Michael S.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US11/443,841
• Publication Number:
  US 20060224225A1
• Time in Patent Office: 1,469 Days
• Field of Search: 607/36, 607 1- 2, 607 4- 5, 607/9, 607115-116, 607119-120, 607122-123, 607/126, 361/299.1, 361/299.2, 361/329, 361/749, 606/129
• US Class Current: 607/4
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• 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 1/37205 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 1/37516 Intravascular implants
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation

Abstract

The present application describes an intravascular implantable pacing and/or defibrillation system. The described system includes a pulse generator that is implantable within a blood vessel and proportioned to blood flow through the blood vessel, and at least one lead attachable to the pulse generator. During implantation, the pulse generator is introduced into a patient'"'"'s vasculature, advanced to a desired vessel and anchored in place within the vessel. The lead or leads are placed within the heart or surrounding vessels as needed to deliver electrical pulses to the appropriate location.

Claims

1. A method of implanting an intravascular implantable device into a vasculature of a patient, comprising:

creating an access to a vasculature of a patient;

introducing a guidewire into the access and advancing the guidewire through the vasculature toward a heart of the patient;

advancing an intravascular implantable device over the guidewire until it is fully within the vasculature of the patient, the intravascular implantable device including an elongated enclosure containing a battery and electronic components, the enclosure flexible about a longitudinal axis at one or more points;

anchoring the intravascular implantable device within the vasculature at a target anchor location;

withdrawing the guidewire from the patient.

2. The method of claim 1, wherein creating the access to the vasculature of the patient comprises creating a femoral access to the vasculature of the patient.

3. The method of claim 1, wherein creating the access to the vasculature of the patient comprises creating a subclavian access to the vasculature of the patient.

4. The method of claim 1, wherein creating the access to the vasculature of the patient comprises making an incision in the vasculature of the patient and inserting an introducer through the incision and into the vasculature.

5. The method of claim 1, wherein the intravascular implantable device further includes a cardiac lead coupled to the elongated enclosure, the method further comprising advancing the lead along the guidewire to a target lead location.

6. The method of claim 5, wherein advancing the lead along the guidewire comprises pushing the lead through the vasculature with a pusher.

7. The method of claim 6, wherein the pusher defines an axial hollow core, and pushing the lead through the vasculature with a pusher further comprises inserting the guidewire through the hollow core of the pusher.

8. The method of claim 5, wherein the lead includes a cuff portion for receiving the guidewire, and the method further comprises inserting the guidewire through the cuff.

9. The method of claim 8, wherein pushing the lead comprises pushing the cuff portion.

10. The method of claim 5, wherein advancing the lead is performed prior to advancing the intravascular implantable device.

11. The method of claim 5, wherein advancing the intravascular implantable device is performed prior to advancing the lead.

12. The method of claim 5, further comprising fixating the lead at the target lead location.

13. The method of claim 1, wherein the enclosure is segmented along the longitudinal axis into modules with one or more hinge zones between adjacent modules, and advancing the intravascular implantable device comprises bending the hinge zones as the enclosure is advanced within the vasculature.

14. A system for implanting an intravascular implantable device into a vasculature of a patient, comprising:

a guidewire adapted to be passed through an access to a vasculature of a patient and guided through the vasculature of the patient toward a heart of the patient;

an intravascular implantable device including an elongated enclosure containing a battery and electronic components, the enclosure flexible about a longitudinal axis at one or more points, the device adapted to fit over the guidewire and to be fully inserted into the vasculature of the patient;

an anchor device for anchoring the intravascular implantable device within the vasculature of the patient at a target anchor location.

15. The system of claim 14, wherein the intravascular implantable device further includes a lead extending from an end of the intravascular implantable device.

16. The system of claim 15, wherein the lead comprises a cuff portion for receiving the guidewire.

17. The system of claim 16, the system further comprising a pusher adapted to push the lead at the cuff portion over the guidewire through the vasculature to a target lead location.

18. The system of claim 14, wherein the enclosure of the intravascular implantable device is segmented along the longitudinal axis into modules with one or more hinge zones between adjacent modules, such that the hinge zones bend as the enclosure is advanced within the vasculature.

19. A method, comprising:

providing an intravascular implantable device, the intravascular implantable device including an elongated enclosure containing a battery and electronic components, the enclosure flexible about a longitudinal axis at one or more points, the device further including a means for receiving a guidewire; and

providing a set of instructions for implanting the intravascular implantable device into the vasculature of the patient, the instructions including the steps of;

introducing a guidewire through an access to the vasculature and advancing the guidewire through the vasculature toward a heart of the patient;

advancing the intravascular implantable device over the guidewire until the intravascular implantable device is fully within the vasculature of the patient; and

anchoring the intravascular implantable device within the vasculature at a target anchor location.

20. The method of claim 19, wherein the instructions further include the step of withdrawing the guidewire from the patient.