Intravascular electrophysiological system and methods

• US 7,529,589 B2
• Filed: 06/04/2004
• Issued: 05/05/2009
• Est. Priority Date: 06/04/2003
• Status: Active Grant

• Current Assignee: Nuxcel2 LLC
• Original Assignee: Synecor LLC
• Inventors: Holbrook, Kevin, Williams, Michael S., Glenn, Richard A., Fifer, Daniel W., Ransbury, Terrance
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T.
• Application Number:
  US10/862,113
• Publication Number:
  US 20050043765A1
• Time in Patent Office: 1,796 Days
• Field of Search: 607/4, 607/14, 607/126, 607/36, 607/115, 607/122
• US Class Current: 607/119
• 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 1/37512 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 electrode 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 electrode or electrodes 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 device, comprising:

providing a pulse generator disposed in a single elongate device body, wherein the pulse generator is a self-powered, self-contained device with circuitry that automatically detects electrophysiological conditions and, in response, generates and delivers electrophysiological pulses through at least one electrode coupled to the pulse generator;

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 at least one electrode within the cardiovascular system.

2. The method of claim 1, wherein the target vessel is a vein.

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

4. The method of claim 2, wherein the target vessel is the inferior vena cava.

5. The method of claim 1, wherein the target vessel is an artery.

6. The method of claim 1, wherein the positioning step includes positioning the electrode within a vessel.

7. The method of claim 6, wherein the vessel is a vein.

8. The method of claim 7, wherein the vessel is the left subclavian.

9. The method of claim 7, wherein the vessel is the superior vena cava.

10. The method of claim 7, wherein the vessel is the inferior vena cava.

11. The method of claim 7, wherein the vessel is the middle cardiac vein.

12. The method of claim 7, wherein the vessel is selected from the group of vessels consisting of the pulmonary vein, hepatic vein, renal vein, axillary vein, lateral thoracic vein, internal thoracic vein and splenic vein.

13. The method of claim 6, wherein the vessel is an artery.

14. The method of claim 1, wherein the electrode is on the elongate device body, and wherein the introducing step includes the positioning step.

15. The method of claim 14, wherein the electrode is a first electrode and wherein the elongate device body includes at least one second electrode positioned on the elongate device body at a location remote from the first electrode.

16. The method of claim 1, wherein the anchoring step placing an anchor in contact with the pulse generator and expanding an anchor into contact with a wall of the target vessel.

17. The method of claim 16, 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.

18. The method of claim 16, wherein the anchor is coupled to the pulse generator before the pulse generator is introduced into the target vessel.

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

20. The method of claim 16, wherein the anchor is introduced as a separate component from the pulse generator.

21. The method of claim 20, wherein the elongate device body includes a plurality of generally rigid segments and at least one flexible segment defined between a first rigid segment and a second rigid segment along a longitudinal length of the elongate device body and the step of introducing causes the at least one flexible segment to bend as the elongate device body is introduced into the vasculature of the patient.

22. A method of implanting an intravascular device, comprising:

providing a pulse generator disposed in a single elongate device body, wherein the pulse generator is a self-powered, self-contained device with circuitry that automatically detects electrophysiological conditions and, in response, generates and delivers electrophysiological pulses through at least one electrode coupled to the pulse generator;

introducing the 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 the at least one electrode within the cardiovascular system,

wherein the positioning step includes positioning the electrode within a chamber of the heart.

23. The method of claim 22, wherein the chamber is the right ventricle.

24. The method of claim 22, wherein the chamber is the right or left atrium.

25. The method of claim 22, wherein the chamber is the left ventricle.

26. A method of implanting an intravascular device, comprising:

providing a pulse generator disposed in a single elongate device body, wherein the pulse generator is a self-powered, self-contained device with circuitry that automatically detects electrophysiological conditions and, in response, generates and delivers electrophysiological pulses through at least one electrode coupled to the pulse generator;

introducing the 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 the at least one electrode within the cardiovascular system,

wherein the positioning step includes positioning the electrode within the coronary sinus of the heart.

27. A method of implanting an intravascular device, comprising:

providing a pulse generator disposed in a single elongate device body, wherein the pulse generator is a self-powered, self-contained device with circuitry that automatically detects electrophysiological conditions and, in response, generates and delivers electrophysiological pulses through at least one electrode coupled to the pulse generator;

introducing the 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 the at least one electrode within the cardiovascular system,

wherein the electrode is a first electrode and wherein the method further includes positioning a second electrode within the cardiovascular system, the second electrode electrically coupled to the pulse generator.

28. The method of claim 27, wherein the positioning steps include positioning the first electrode within a vessel, and positioning the second electrode within a chamber of the heart.

29. The method of claim 27, wherein the positioning steps include positioning the first electrode within a chamber of the heart, and positioning the second electrode within another chamber of the heart.

30. The method of claim 27, wherein the positioning steps include positioning the first electrode within a vessel, and positioning the second electrode within a coronary sinus of the heart.

31. The method of claim 27, wherein the positioning steps include positioning the first and second electrodes within blood vessels.

32. The method of claim 31, wherein the first and second electrodes are positioned in separate blood vessels.

33. A method of implanting an intravascular device, comprising:

introducing a pulse generator into the vasculature of a patient and advancing the pulse generator to a target vessel, wherein the pulse generator is disposed in an elongate device body;

anchoring the pulse generator within the target vessel; and

positioning at least one electrode within the cardiovascular system, the electrode coupled to the pulse generator, wherein the at least one electrode is on a lead coupled to the device body, and wherein the positioning step includes positioning at least a portion of the lead within the cardiovascular system.

34. The method of claim 33, wherein the electrode is a first electrode and wherein the device body includes at least one second electrode.

35. A method of implanting an intravascular device, comprising:

introducing a pulse generator into the femoral vein of a patient, the pulse generator being disposed in an elongate device body having a plurality of segments with at least one flexible portion defined between a first segment and a second segment along a longitudinal length of the device body and including at least one electrode, such that the at least one flexible portion bends as the device body is introduced into the femoral vein;

advancing the pulse generator to at least the vena cava of the patient; and

anchoring the pulse generator within the venous vasculature of the patient.

36. The method of claim 35, wherein anchoring the pulse generator includes expanding an anchor in contact with the pulse generator and a wall of the venous vasculature.

37. The method of claim 36, wherein the anchor is coupled to the pulse generator before the pulse generator is introduced into the femoral vein.

38. The method of claim 36, wherein the anchor is introduced into the femoral vein as a separate component from the pulse generator.

39. A method of implanting an intravascular device, comprising:

introducing a pulse generator into the femoral vein of a patient, the pulse generator being disposed in an elongate device body and including at least one electrode, wherein a lead having at least one electrode is operably coupled to and extends from an end of the pulse generator

advancing the pulse generator to at least the vena cava of the patient;

anchoring the pulse generator within the venous vasculature of the patient; and

positioning the at least one electrode of the lead within a chamber of the heart.

40. The method of claim 39, wherein at least one electrode is on the elongate device body, and wherein advancing the pulse generator includes positioning the at least one electrode on the elongate device body in the venous vasculature of the patient.

41. A method of implanting an intravascular device, comprising:

introducing a pulse generator into the femoral vein of a patient, the pulse generator being disposed in a single elongate device body and operably coupled to at least two electrodes

advancing the pulse generator to at least the vena cava of the patient; and

anchoring the pulse generator within the venous vasculature of the patient,

such that the pulse generator automatically detects an electrophysiological condition and, in response, generates and delivers an electrical pulse between the at least two electrodes as a defibrillation pulse of approximately 0.1-50 joules of energy.

42. The method of claim 41, wherein the electrical pulse delivers a defibrillation pulse of approximately 5-35 joules of energy.

43. The method of claim 41, wherein the elongate device body of the pulse generator has a length of approximately 10-60 cm and a diameter of less than 10 mm, and wherein advancing the pulse generator positions the elongate device body entirely within the venous vasculature of the patient.

44. A method of providing implants and instructions for implanting an intravascular device, comprising:

providing a pulse generator disposed in an elongate device body having a plurality of segments with at least one flexible portion defined between a first segment and a second segment along a longitudinal length of the device body and including at least one electrode; and

providing instructions for implanting the pulse generator including;

introducing the pulse generator into the femoral vein of a patient such that the at least one flexible portion bends as the device body is introduced into the femoral vein;

advancing the pulse generator to at least the vena cava of the patient; and

anchoring the pulse generator within the venous vasculature of the patient.

45. The method of claim 44, wherein providing instructions includes anchoring the pulse generator so as to expand an anchor in contact with the pulse generator and a wall of the venous vasculature.

46. The method of claim 45, wherein providing the pulse generator includes providing a pulse generator with the anchor coupled to the pulse generator.

47. The method of claim 45, wherein providing the pulse generator includes providing an anchor as a separate component from the pulse generator.

48. A method of providing implants and instructions for implanting an intravascular device, comprising:

providing a pulse generator disposed in an elongate device body and including at least one electrode and a lead having at least one electrode operably coupled to and extending from an end of the pulse generator, and

providing instructions for implanting the pulse generator including;

introducing the pulse generator into the femoral vein of a patient;

advancing the pulse generator to at least the vena cava of the patient;

anchoring the pulse generator within the venous vasculature of the patient; and

positioning the at least one electrode of the lead within a chamber of the heart.

49. The method of claim 48, wherein providing the pulse generator includes providing a pulse generator with at least one electrode on the elongate device body, and wherein providing instructions includes positioning the at least one electrode on the elongate device body in the venous vasculature of the patient.

50. A method of providing implants and instructions for implanting an intravascular device comprising:

providing a pulse generator that is disposed in a single elongate device body and operably coupled to at least two electrodes; and

providing instructions for implanting the pulse generator including;

introducing the pulse generator into the femoral vein of a patient;

advancing the pulse generator to at least the vena cava of the patient;

anchoring the pulse generator within the venous vasculature of the patient; and

configuring the pulse generator to automatically detect an electrophysiological condition and, in response, generates and deliver an electrical pulse between the at least two electrodes as a defibrillation pulse of approximately 0.1-50 joules of energy.

51. The method of claim 50, wherein providing instructions further includes configuring the pulse generator to deliver a defibrillation pulse of approximately 5-35 joules of energy.

52. The method of claim 50, wherein providing the pulse generator include a pulse generator wherein the elongate device body has a length of approximately 10-60 cm and a diameter of less than 10 mm, and wherein providing instructions includes advancing the pulse generator to position the elongate device body within the venous vasculature of the patient.