Method and apparatus for locating and detecting vascular plaque via impedence and conductivity measurements, and for cryogenically passivating vascular plaque and inhibiting vascular plaque progression and rupture

• US 20030149368A1
• Filed: 01/03/2003
• Published: 08/07/2003
• Est. Priority Date: 10/24/2000
• Status: Abandoned Application

• Current Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Original Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Inventors: Hennemann, Willard W., Wittenberger, Dan, Urick, Michael, Mihalik, Teresa, Carroll, Sean, Santoianni, Domenic, Luckge, Claudia
• Application Number:
  US10/336,663
• Publication Number:
  US 20030149368A1
• Time in Patent Office: Days
• US Class Current: 600/483
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/6853 with a balloon

Abstract

A method and apparatus for detecting plaque proximate an area of a human body is described, the method comprising the steps of moving one or more electrically sensitive sensors substantially near an area where plaque may be present, obtaining electrical signal readings from the sensors, and determining the presence or absence of plaque. The presence or absence of the plaque corresponds to the electrical signal readings. Another aspect of the invention provides a method for inhibiting plaque formation and passivating plaque formed on a lumenal surface of a body lumen. A cooling device is positioned at the lumenal surface at a point proximate to a plaque formation. The lumenal surface is cooled at the point proximate to the plaque formation to inhibit the progression of plaque formation in which the lumenal surface is cooled to a temperature of less than about zero degrees Celsius. As another aspect, a method is provided for reducing the risk of plaque rupture in a vessel. A catheter is inserted into a patient'"'"'s vessel. The catheter is manipulated to a region of the vessel proximate to a plaque formation such that an outer surface of the catheter is positioned at tissue proximate to the plaque formation. The catheter is activated such that the outer surface of the catheter cools the contacting tissue to a temperature of less than about zero degrees Celsius.

Claims

1. A method for locating and detecting plaque proximate an area of a human body, the method comprising the steps of sensing and analyzing electrical signals proximate the area.

2. The method of claim 1 wherein the area is a body lumen.

3. The method of claim 2 wherein the body lumen is a blood vessel.

4. The method of claim 3, wherein the blood vessel is one of an artery or a vein graft.

5. The method of claim 3, wherein the blood vessel is a coronary artery.

6. The method of claim 1 further comprising the step of, if plaque is detected, treating the plaque.

7. The method of claim 6 wherein the step of treating the plaque includes use of a beneficial agent.

8. The method of claim 7 wherein the beneficial agent comprises a thermal agent.

9. The method of claim 7 wherein the beneficial agent comprises a cooling agent.

10. The method of claim 7 wherein the beneficial agent includes ultraviolet radiation for treating the plaque.

11. The method of claim 7 wherein the beneficial agent comprises a pharmaceutical agent for treating the plaque.

12. The method of claim 7 wherein the beneficial agent comprises RF waves for treating the plaque.

13. The method of claim 7 wherein the beneficial agent is a gene or gene product.

14. The method of claim 7 wherein the beneficial agent contains cells or extracellular matrix derived from human or animal tissue.

15. The method of claim 1 further comprising the step of removing foreign bodies present due to plaque rupture.

16. The method of claim 15 wherein the step of removing foreign bodies is performed by a laser.

17. The method of claim 15 wherein the step of removing foreign bodies is performed by a conventional surgical incision.

18. The method of claim 15 wherein the step of removing foreign bodies is performed by radiotherapy.

19. The method of claim 1 further comprising the steps of trapping and removing foreign bodies present due to plaque rupture.

20. The method of claim 1 wherein the electrical signals comprise passive electrical conductivity measurements.

21. The method of claim 1 wherein the electrical signals comprise active electrical measurements responsive to electrical signals emitted by the sensor proximate the area.

22. The method of claim 1 wherein the electrical signals represent the conductivity of the surrounding area.

23. The method of claim 1 wherein the electrical signals represent the impedance of the surrounding area.

24. The method of claim 1 wherein the step of detecting electrical signals proximate the area of the human body comprises the steps of:

moving one or more electrically sensitive sensors substantially near the area;

obtaining electrical signal readings from the one or more sensors;

analyzing the readings; and

determining the presence or absence of plaque, the presence or absence of the plaque corresponding to the electrical signal readings.

25. The method of claim 24 further comprising the step of enhancing the electrical signal readings to more accurately determine if plaque is present.

26. The method of claim 25 wherein the step of enhancing the electrical signal readings comprises the step of overlaying the detected electrical signals with a fluoroscopic image.

27. The method of claim 1 wherein the plaque is vulnerable plaque.

28. The method of claim 1 wherein the step of detecting electrical signals proximate the area of the human body comprises the steps of:

positioning one or more stationary electrically sensitive sensors substantially near the area;

obtaining electrical signal readings from the one or more sensors;

analyzing the readings; and

determining the presence or absence of plaque, the presence or absence of the plaque corresponding to the electrical signal readings.

29. A device for detecting plaque proximate a surrounding area of a human body, the device comprising:

one or more sensors for detecting electrical signals proximate the area; and

a treatment device for treating the plaque, the treating device coupled to the one or more sensors.

30. The device of claim 29 wherein the treatment device is a cooling device.

31. The device of claim 30 wherein the cooling device is a catheter.

32. The device of claim 31 wherein the catheter includes a tip, the tip being positioned at a point proximate the plaque, and wherein the cooling is performed by delivering a refrigerant to the tip.

33. The device of claim 31 wherein the catheter is a drill-tipped catheter.

34. The device of claim 31 wherein the catheter includes an inflatable balloon that contacts the surrounding area and dilates the plaque.

35. The device of claim 34 wherein the inflatable balloon further includes a stent surrounding the inflatable balloon wherein the stent is expandable by the balloon and is placed proximate the surrounding area.

36. The device of claim 29 wherein the area is a body lumen.

37. The device of claim 36 wherein the body lumen is a blood vessel.

38. The device of claim 37, wherein the blood vessel is one of an artery or a vein graft.

39. The device of claim 37, wherein the blood vessel is a coronary artery.

40. The device of claim 29 wherein the electrical signals comprise passive electrical conductivity measurements.

41. The device of claim 29 wherein the electrical signals comprise active electrical measurements responsive to electrical signals emitted by the one or more sensors proximate the area.

42. The device of claim 29 wherein the electrical signals represent the conductivity of the surrounding area.

43. The device of claim 29 wherein the electrical signals represent the impedance of the surrounding area.

44. The device of claim 29 wherein the electrical signals are overlayed on a fluoroscopic image to more accurately determine if plaque is present.

45. The device of claim 32 further comprising a beneficial agent to treat the plaque.

46. The device of claim 45 wherein the beneficial agent is supplied to tissue proximate the plaque via the catheter tip.

47. The device of claim 45 wherein the beneficial agent comprises a thermal agent.

48. The device of claim 45 wherein the beneficial agent comprises a cooling agent.

49. The device of claim 45 wherein the beneficial agent comprises a pharmaceutical agent for treating the plaque.

50. The device of claim 45 wherein the beneficial agent comprises ultraviolet radiation for treating the plaque.

51. The device of claim 45 wherein the beneficial agent includes RF waves for treating the plaque.

52. The device of claim 29 further comprising a filtering apparatus for trapping and removing foreign bodies present due to plaque rupture.

53. The device of claim 29 wherein the plaque is vulnerable plaque.

54. The device of claim 29 wherein the one or more sensors are coupled to an interior surface of the treatment device.

55. The device of claim 29 wherein the one or more sensors are coupled to an exterior surface of the treatment device.

56. An apparatus for detecting and treating vulnerable plaque proximate an area of a body lumen the apparatus comprising:

one or more electrically sensitive sensors for detecting impedance of the area of the body lumen, the presence or absence of the vulnerable plaque corresponding to the detected impedance; and

a steerable catheter coupled to the one or more sensors, the catheter including a tip, the tip being maneuvered to a point proximate to the vulnerable plaque, and wherein the catheter delivers a beneficial agent to the area to treat tissue identified as the vulnerable plaque.

57. A method for treating vulnerable plaque formed on an interior lumenal surface of a body lumen comprising the steps of:

positioning a cooling device within an interior lumenal surface at a point proximate to a plaque formation; and

cooling the lumenal surface at the point proximate to the plaque formation to inhibit the progression of plaque formation wherein the lumenal surface is cooled to a temperature of less than about zero degrees Celsius.

58. A method for inhibiting plaque formation and passivating plaque formed on an interior lumenal surface of a body lumen comprising the steps of:

inserting a catheter into a patient'"'"'s vessel;

manipulating the catheter to a region of the vessel proximate to a plaque formation such that an outer surface of the catheter is positioned at tissue proximate to the plaque formation; and

activating the catheter such that the outer surface of the catheter cools the tissue in a temperature range from about zero degrees Celsius to about minus one hundred and twenty degrees Celsius thereby reducing inflammation of the tissue.

59. The method of claim 58 wherein the cooling of the tissue stimulates the tissue to increase collagen synthesis.

60. The method of claim 58 wherein the tissue is cooled for a period of time ranging from about ten seconds to about sixty minutes.

61. The method of claim 58 wherein the tissue is cooled to a temperature of about minus fifty degrees Celsius for about two minutes.

62. The method of claim 58, wherein the catheter includes an inflatable balloon, and further comprising the steps of;

inflating the balloon such that an outer surface of the balloon contacts tissue proximate to the plaque formation;

inserting the catheter to an occluded region of the vessel; and

inflating the balloon to dilate the occluded region of the vessel.

63. The method of claim 62 further including the step of perfusing fluid in the vessel to maintain fluid flow in the vessel by one of perfusing fluid around the inflated balloon and by perfusing fluid through a lumen within the inflated balloon.