Implantable pressure sensor with pacing capability

• US 20060064135A1
• Filed: 09/08/2005
• Published: 03/23/2006
• Est. Priority Date: 10/14/1997
• Status: Abandoned Application

• Current Assignee: Data Sciences U K Limited (International Business Machines Corporation)
• Original Assignee: Transoma Medical, Inc.
• Inventors: Brockway, Brian P.
• Application Number:
  US11/223,587
• Publication Number:
  US 20060064135A1
• Time in Patent Office: Days
• US Class Current: 607/17
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation

Abstract

Devices and methods for left ventricular or biventricular pacing plus left ventricular pressure measurement. For example, a pacing lead having a combined electrode and pressure sensor assembly may be used for left ventricular (LV) pacing and pressure measurement. The assembly may include one or more electrodes, a pressure sensor, and a pressure transmission catheter. Such a pacing lead is particularly suitable for biventricular pacing and may be incorporated into a cardiac resynchronization therapy (CRT) system, for example.

Claims

1. A method of treating a heart, comprising:

providing an electrode and sensor assembly including one or more electrodes, a pressure sensor and a pressure transmission catheter; and

positioning the electrode and sensor assembly proximate an outside surface of the heart such that the one or more electrodes reside on or in a wall of the heart, and the pressure transmission catheter is exposed to a heart chamber to provide fluid communication between the heart chamber and the pressure sensor.

2. A method as in claim 1, further comprising contacting the outside surface of the heart with the electrode.

3. A method as in claim 1, further including delivering the electrode and sensor assembly through an access tube extending into a pericardial space of the heart.

4. A method as in claim 3, further comprising delivering the electrode and sensor assembly via a transthoracic approach.

5. A method as in claim 1, further comprising delivering an electrical stimulus to the heart via the electrode.

6. A method as in claim 5, further comprising measuring endocardial pressure utilizing the pressure sensor and the pressure transmission catheter.

7. A method as in claim 6, wherein the electrical stimulus is delivered as a function of the measured endocardial pressure.

8. A method as in claim 7, wherein the electrical stimulus is delivered to a ventricle of the heart.

9. A method as in claim 1, further comprising contacting an epicardium of the heart with the electrode.

10. A method as in claim 1, further comprising contacting tissue under an epicardium of the heart with the electrode.

11. A method as in claim 1, further comprising piercing a wall of the heart with a trocar to form a hole.

12. A method as in claim 11, further comprising advancing a distal end of the pressure transmission catheter through the hole.

13. A method as in claim 12, wherein the pressure transmission catheter has a length that is greater than a thickness of the wall of the heart.

14. A method as in claim 1, further comprising piercing a wall of the heart with the electrode.

15. A method as in claim 1, further comprising advancing the electrode and sensor assembly through a pericardial space proximate the heart.

16. A method as in claim 1, further comprising advancing the electrode and sensor assembly into a thoracic cavity of a body.

17. A method as in claim 1, further comprising positioning a conductor to extend through the thoracic cavity of the body without extending through any blood vessel.

18. A method as in claim 1, further comprising positioning a conductor connected to the electrode and sensor assembly within the thoracic cavity and outside any blood vessels.

19. A method as in claim 1, further comprising the steps of:

connecting the conductor to a pulse generator; and

implanting the pulse generator in a pectoral region of a patient.

20. A method as in claim 19, further comprising positioning a conductor connected to the electrode and sensor assembly within a thoracic cavity of a body and outside the heart.

21. A method as in claim 1, further comprising:

providing a conductor connected to the electrode and sensor assembly;

providing a pulse generator; and

connecting the conductor to the pulse generator.

22. A method of treating a heart, comprising:

providing an electrode and sensor assembly including an electrode and a pressure sensor;

advancing the electrode and sensor assembly through a pericardial space proximate the heart; and

positioning the electrode and sensor assembly proximate an outside surface of the heart.

23. A method as in claim 22, further comprising delivering an electrical stimulus to the heart via the electrode.

24. A method as in claim 23, further comprising measuring endocardial pressure utilizing the pressure sensor.

25. A method as in claim 24, wherein the electrical stimulus is delivered as a function of the measured endocardial pressure.

26. A method as in claim 22, further comprising contacting an epicardium of the heart with the electrode.

27. A method as in claim 22, further comprising contacting tissue under the epicardium with the electrode.

28. A system for pacing a heart, comprising:

a left ventricular lead adapted to connect with a pulse generator the left ventricular lead being configured to pace a left ventricle of the heart; and

the left ventricular lead being configured to measure pressure in the left ventricular of the heart.

29. The system of claim 28, further comprising a pulse generator connected to the left ventricular lead.

30. The system of claim 29, further comprising a right ventricular lead connected to the pulse generator and configured to pace the right ventricle.

31. The system of claim 28, wherein the left ventricular lead comprises a distal portion comprising an electrode, a pressure sensor and a pressure transmission catheter.

32. The system of claim 31, wherein the pressure transmission catheter has a first length and the electrode has a second length that is different from the first length.

33. The system of claim 32, wherein the first length is greater than the second length.

34. The system of claim 33, wherein the first length is greater than a thickness of a wall of the heart and the second length is less than the thickness of the wall of the heart.

35. The system of claim 34, wherein the wall of the heart is an outer wall of the heart.

36. The system of claim 34, wherein the wall of the heart is a left ventricular free wall of the heart.

37. The system of claim 31, wherein the electrode is disposed about the pressure transmission catheter.

38. The system of claim 31, wherein the electrode is more rigid than the pressure transmission catheter.

39. The system of claim 31, wherein the electrode is sufficiently rigid to penetrate a wall of the heart.

40. The system of claim 31, wherein the electrode comprises a first material and the pressure transmission catheter comprises a second material different from the first material.

41. The system of claim 40, wherein the first material comprises an electrically conductive material and the second material comprises an electrically insulating material material.

42. The system of claim 40, wherein the first material comprises a metallic material and the second material comprises a polymeric material.

43. The system of claim 40, wherein the first material comprises a metallic material and the second material comprises a non-metallic material.

44. The system of claim 40, wherein the second material is more flexible than the first material.

45. The system of claim 40, wherein the first material has a first modulus of elasticity and the second material has a second modulus of elasticity that is smaller than the first modulus of elasticity.

46. A method of pacing a left ventricle of a patient'"'"'s heart, comprising:

providing a pacing lead having a distal portion with one or more electrodes, a pressure sensor and a pressure transmission catheter;

positioning the pacing lead with respect to the heart such that the electrode is in a position to pace the left ventricle, the pressure transmission catheter passes through at least a portion of a wall of the heart into the left ventricle, and the pressure sensor resides outside the heart.

47. A method as in claim 46, wherein the position to pace the left ventricle is proximate a left ventricular free wall of the heart.

48. An apparatus, comprising:

a housing defining a cavity and an opening communicating with the cavity;

a diaphragm disposed over the cavity;

a pressure transducer disposed in the cavity;

a fluid disposed in the cavity for transferring pressure applied to the diaphragm to the pressure transducer; and

a covering disposed over the housing and the diaphragm.

49. The apparatus of claim 48, wherein the housing comprises a first material and the covering comprises a second material different from the first material.

50. The apparatus of claim 49, wherein the first material has a first thromboemboli forming characteristic and the second material has a second thromboemboli forming characteristic different from the first thromboemboli forming characteristic.

51. The apparatus of claim 49, wherein blood in contact with the first material is more likely to clot than blood in contact with the second material.

52. The apparatus of claim 48, wherein the housing and the diaphragm comprise metallic materials and the covering comprises a non-metallic material.

53. The apparatus of claim 48, wherein the housing and the diaphragm comprise metallic materials and the covering comprises a polymeric material.

54. The apparatus of claim 48, wherein the covering comprises a fabric.

55. The apparatus of claim 48, wherein the covering comprises a coating.

56. An apparatus, comprising:

a shaft having a wall defining a lumen and a laterally oriented port communicating with the lumen; and

a membrane extending over the laterally oriented port.

57. The apparatus of claim 56, further including a cover disposed over the membrane.

58. The apparatus of claim 57, wherein the cover comprises ePTFE.

59. The apparatus of claim 57, wherein the cover comprises a fabric.

60. The apparatus of claim 56, further including a gel plug disposed in the lumen proximate the laterally oriented port.

61. The apparatus of claim 60, further comprising a pressure sensor disposed in fluid communication with the lumen and a pressure transmitting fluid disposed in the lumen for transferring pressure between the gel plug and the pressure sensor.

62. The apparatus of claim 60, wherein a gel material of the gel plug extends into the laterally oriented port.

63. The apparatus of claim 56, further including an axially oriented port communicating with the lumen.

64. The apparatus of claim 63, wherein the membrane overlays the laterally oriented port and leaves the axially oriented port exposed.

65. The apparatus of claim 56, wherein the shaft comprises a first material and the membrane comprises a second material different from the first material.

66. The apparatus of claim 65, wherein the second material comprises an elastomeric material and the first material comprises a non-elastomeric material.

67. The apparatus of claim 65, wherein the second material is more flexible than the first material.

68. The apparatus of claim 65, wherein the first material has a first modulus of elasticity and the second material has a second modulus of elasticity that is smaller than the first modulus of elasticity.

69. The apparatus of claim 56, wherein the lumen has a first cross-sectional area and the laterally oriented port has a second cross-sectional area that is greater than the first cross-sectional area.