Implantable intravascular device for defibrillation and/or pacing

• US 20040249417A1
• Filed: 06/04/2003
• Published: 12/09/2004
• Est. Priority Date: 06/04/2003
• Status: Active Grant

• Current Assignee: Nuxcel2 LLC
• Original Assignee: Synecor LLC
• Inventors: Williams, Michael S., Ransbury, Terrance
• Granted Patent: US 7,082,336 B2
• Time in Patent Office: Days
• 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 a pacing and/or defibrillation device, comprising the steps of:

introducing a pulse generator into the vasculature of a patient and advancing the pulse generator to a target vessel;

anchoring the pulse generator within the target vessel; and

positioning a lead within the cardiovascular system, the lead attachable to the pulse generator.

2. The method of claim 1 wherein the target vessel is the superior vena cava.

3. The method of claim 1 wherein the target vessel is the inferior vena cava.

4. The method of claim 1 wherein the lead includes an electrode and the positioning step includes positioning the electrode within a vessel.

5. The method of claim 4 wherein the vessel is the left subclavian.

6. The method of claim 4 wherein the vessel is the superior vena cava.

7. The method of claim 1 wherein the lead includes an electrode and the positioning step includes positioning the electrode within a chamber of the heart.

8. The method of claim 7 wherein the chamber is the right ventricle.

9. The method of claim 7 wherein the chamber is the right atrium.

10. The method of claim 7 wherein the chamber is the left ventricle.

11. The method of claim 1 wherein the heart includes a coronary sinus, wherein the lead includes an electrode, and wherein the positioning step includes positioning the electrode within the coronary sinus.

12. The method of claim 1 wherein the lead is a first lead and wherein the method further includes positioning a second lead within the cardiovascular system, the second lead attachable to the pulse generator.

13. The method of claim 12 wherein each of the first and second leads includes an electrode, and wherein the positioning steps include positioning the electrode of the first lead within a vessel, and positioning the electrode of the second lead within a chamber of the heart.

14. The method of claim 12 wherein each of the first and second leads includes an electrode, and wherein the positioning steps include positioning the electrode of the first lead within a chamber of the heart, and positioning the electrode of the second lead within another chamber of the heart.

15. The method of claim 12 wherein each of the first and second leads includes an electrode, and wherein the positioning steps include positioning the electrode of the first lead within a vessel, and positioning the electrode of the second lead within a coronary sinus of the heart.

16. The method of claim 1 wherein the anchoring step includes positioning an anchor within the target vessel adjacent to the pulse generator, and expanding the anchor into contact with a wall of the target vessel such that expansion of the anchor engages the pulse generator between a portion of the anchor and the wall.

17. The method of claim 16 wherein the anchor substantially minimizes blood flow between the anchor and the device.

18. The method of claim 16 wherein the anchor includes a tubular member having end sections and an intermediate section between the end sections, and wherein the anchoring step includes positioning the intermediate section adjacent to the device, and radially expanding at least a portion of the end sections into contact with the vessel.

19. An intravascular pacing and/or defibrillation system, comprising:

a pulse generator implantable within a blood vessel, the pulse generator proportioned to allow blood flow through the blood vessel; and

at least one lead attachable to the pulse generator.

20. The system of claim 19 wherein the pulse generator has a diameter of approximately 10 mm or less.

21. The system of claim 19 wherein the pulse generator includes at least one flexible region, the region sufficiently flexible to permit bending of the pulse generator during positioning of the pulse generator through a blood vessel.

22. The system of claim 21 wherein the pulse generator includes an elongate array of rigid segments, and flexible regions between adjacent rigid segments.

23. The system of claim 19 wherein:

the pulse generator includes a plurality of components including a battery, a capacitor, and electronic components;

the pulse generator includes a housing containing at least a portion of the components, and

the pulse generator further includes a coil coupled to the housing, the coil including at least a portion of the components.

24. The system of claim 19 wherein the coil includes the capacitor.

25. The system of claim 19 wherein the coil includes the battery.

26. The system of claim 19 further including an anchoring sleeve, the anchoring sleeve positionable within a vessel at a location adjacent to the pulse generator, and moveable to an expanded position to engage the pulse generator against the vessel wall.

27. The system of claim 26 wherein the anchor is proportioned to allow blood flow through the vessel when used to engage the pulse generator against a vessel wall.

28. The system of claim 19 further including a lead anchoring sleeve, the lead anchoring sleeve positionable within a vessel at a location adjacent to the lead, and moveable to an expanded position to engage the lead against the vessel wall.

29. The system of claim 19 wherein the anchor is proportioned to allow blood flow through the vessel when used to engage the lead against a vessel wall.

30. The system of claim 19 wherein the pulse generator includes a non-thrombogenic surface.

31. The system of claim 19 wherein the lead includes a non-thrombogenic surface.