Catheter with physiological sensor

• US 6,296,615 B1
• Filed: 03/05/1999
• Issued: 10/02/2001
• Est. Priority Date: 03/05/1999
• Status: Expired due to Term

• Current Assignee: Data Sciences U K Limited (International Business Machines Corporation)
• Original Assignee: Data Sciences U K Limited (International Business Machines Corporation)
• Inventors: Brockway, Brian P., Zwiers, Lynn M., Drexler, Mark J., Mills, Perry A.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/264,147
• Time in Patent Office: 942 Days
• Field of Search: 600/486, 600/485, 600/466, 600/467, 600/468, 600/433, 600/434, 600/435, 604/27, 604/28
• US Class Current: 600/486
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/283 Invasive

Abstract

The disclosed embodiments present improved catheters with physiological sensors. In one embodiment, the catheter includes, generally, a pressure transducer/electronics assembly connected to a pressure transmission catheter. The pressure transmission catheter includes a hollow tube made from a low compliance material. The distal end of the hollow tube is filled with a gel-like material or plug which acts as a barrier between the catheter liquid and the target fluid. The hollow tube is partially filled with a low viscosity liquid and is in fluid communication with the gel-like material and the pressure transducer. The pressure of the target fluid is transmitted to the liquid in the hollow tube through the gel-like material and/or the wall of the distal tip and is fluidically transmitted to the pressure transducer. The pressure transmission catheter is capable of being inserted into a vessel lumen or inserted into a lumen of a therapeutic or diagnostic catheter for biomedical applications. This provides the ability to directly measure the pressure effects of the treatment catheter. In another embodiment, the distal end of the pressure transmission catheter may be electrically conductive so as to detect and transmit an electric signal. Thus, in this embodiment, the catheter can be used to detect a physiological signal.

Claims

1. A catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, the pressure transducer coupled to the proximal end;

a gel-like material positioned in the lumen at the distal end;

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material; and

a ruggedized tip disposed at the distal end of the hollow tube.

2. The catheter according to claim 1, wherein the hollow tube comprises a material selected from the group consisting of polyamide, polyimide, impregnated plastic, polytetra fluorethylene, polyethylene, polyurethane, polyvinyl chloride, and polypropylene.

3. The catheter according to claim 1, wherein the hollow tube comprises a metal selected from the group consisting of 316 stainless steel, Nitinol, titanium, MP35N, and MP52.

4. The catheter according to claim 1, wherein the distal end further comprises a thin-wall portion.

5. The catheter according to claim 1, wherein the at least one liquid is selected from the group consisting of water, saline, fluorinated hydrocarbon, silicone oils, alcohols, and propylene glycol dispersed in water.

6. The catheter according to claim 1, wherein the gel-like material comprises a non-toxic and minimally thrombogenic material.

7. The catheter according to claim 1, wherein the gel-like material further comprises an anti-thrombogenic substance selected from the group consisting of heparin and warfarin.

8. The catheter according to claim 1, wherein at least a portion of the hollow tube is electrically conductive.

9. The catheter according to claim 8, wherein the hollow tube is substantially covered with an insulating material.

10. The catheter according to claim 1, wherein the distal end includes an electrically conductive portion which acts as an electrode for detecting an electric signal.

11. The catheter according to claim 10, and further including a conductor that is coupled to the electrically conductive portion and disposed along the length of the hollow tube.

12. The catheter according to claim 1, wherein the ruggedized tip comprises ribs dividing the lumen into a plurality of lumens at the distal end.

13. The catheter according to claim 1, wherein the ruggedized tip comprises a stent inserted into the lumen at the distal end of the hollow tube.

14. The catheter according to claim 13, wherein the stent comprises a braided wire tube.

15. The catheter according to claim 13, wherein the stent comprises an expanded metal mesh tube.

16. The catheter according to claim 1, wherein the distal end further comprises a plurality of semi-circumferential elongated holes.

17. The catheter according to claim 1, wherein the ruggedized tip comprises:

a mesh-like feature formed in the distal end of the hollow tube; and

a compliant membrane disposed over the outer surface of the mesh-like feature.

18. A guidewire catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, the pressure transducer coupled to the proximal end;

a gel-like material positioned in the lumen at the distal end;

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material; and

a flexible tip disposed at the distal end of the hollow tube.

19. The catheter according to claim 18, wherein the hollow tube comprises a material selected from the group consisting of polyamide, polyimide, impregnated plastic, polytetra fluorethylene, polyethylene, polyurethane, polyvinyl chloride, and polypropylene.

20. The catheter according to claim 18, wherein the hollow tube comprises a metal selected from the group consisting of 316 stainless steel, Nitinol, titanium, MP35N, and MP52.

21. The catheter according to claim 18, wherein the distal end further comprises a thin-wall portion.

22. The catheter according to claim 18, wherein the at least one liquid is selected from the group consisting of water, saline, fluorinated hydrocarbon, silicone oils, alcohols, and propylene glycol dispersed in water.

23. The catheter according to claim 18, wherein the gel-like material comprises a non-toxic and minimally thrombogenic material.

24. The catheter according to claim 18, wherein the gel-like material further comprises an anti-thrombogenie substance selected from the group consisting of heparin and warfarin.

25. The catheter according to claim 18, wherein at least a portion of the hollow tube is electrically conductive.

26. The catheter according to claim 25, wherein the hollow tube is substantially covered with an insulating material.

27. The catheter according to claim 18, wherein the distal end includes an electrically conductive portion which acts as an electrode for detecting an electric signal.

28. The catheter according to claim 27, and further including a conductor that is coupled to the electrically conductive portion and disposed along the length of the hollow tube.

29. The catheter according to claim 18, wherein the distal end further comprises a plurality of semi-circumferential elongated holes.

30. The catheter according to claim 18, wherein the flexible tip comprises:

a coil having a first end and a second end; and

a rounded head,

wherein the rounded head is coupled to the first end of the coil, and the second end of the coil is coupled to the distal end of the hollow tube.

31. The catheter according to claim 18, wherein the flexible tip comprises:

a coil having a first end and a second end;

a rounded head;

a cone-shaped insert having a plurality of holes; and

wherein the rounded head is attached to the first end of the coil, and the second end of the coil is attached to the cone-shaped insert and wherein the cone-shaped insert is inserted into the distal end of the hollow tube.

32. A catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, the pressure transducer coupled to the proximal end;

a gel-like material positioned in the lumen at the distal end;

at least two liquids disposed within the hollow tube to provide a pressure communication link between the gel-like material and the pressure transducer.

33. The catheter according to claim 32, wherein the at least two liquids comprise:

a first liquid in communication with the pressure transducer; and

a second liquid which substantially fills the lumen and is in communication with the gel-like material and the first liquid, and wherein the first liquid and the second liquid are not soluble with each other.

34. The catheter according to claim 32, wherein the hollow tube comprises a material selected from the group consisting of polyamide, polyimide, impregnated plastic, polytetra fluorethylene, polyethylene, polyurethane, polyvinyl chloride, and polypropylene.

35. The catheter according to claim 32, wherein the hollow tube comprises a metal selected from the group consisting of 316 stainless steel, Nitinol, titanium, MP35N, and MP52.

36. The catheter according to claim 32, wherein the distal end further comprises a thin-wall portion.

37. The catheter according to claim 32, wherein the at least two liquids are selected from the group consisting of water, saline, fluorinated hydrocarbon, silicone oils, alcohols, and propylene glycol dispersed in water.

38. The catheter according to claim 32, wherein the gel-like material comprises a non-toxic and minimally thrombogenic material.

39. The catheter according to claim 32, wherein the gel-like material further comprises an anti-thrombogenic substance selected from the group consisting of heparin and warfarin.

40. The catheter according to claim 32, wherein at least a portion of the hollow tube is electrically conductive.

41. The catheter according to claim 40, wherein the hollow tube is substantially covered with an insulating material.

42. The catheter according to claim 32, wherein the distal end includes an electrically conductive portion which acts as an electrode for detecting an electric signal.

43. The catheter according to claim 42, and further including a conductor that is coupled to the electrically conductive portion and disposed along the length of the hollow tube.

44. The catheter according to claim 32, and further including a ruggedized tip including ribs separating the lumen into a plurality of lumens at the distal end.

45. The catheter according to claim 32, wherein the distal end further comprises a stent inserted into the lumen of the distal end of the hollow tube.

46. The catheter according to claim 45, wherein the stent comprises a braided wire tube.

47. The catheter according to claim 45, wherein the stent comprises an expanded metal mesh tube.

48. The catheter according to claim 32, wherein the distal end further comprises a plurality of semi-circumferential elongated holes.

49. The catheter according to claim 32, and further comprising a flexible tip comprising:

a coil having a first end and a second end;

a rounded head; and

wherein the rounded head is coupled to the first end of the coil, and the second end of the coil is coupled to the distal end of the hollow tube.

50. The catheter according to claim 32, and further comprising a flexible tip comprising:

a coil having a first end and a second end;

a rounded head;

a cone-shaped inset having a plurality of holes; and

wherein the rounded head is attached to the first end of the coil, and the second end of the coil is attached to the cone-shaped insert and wherein the cone-shaped insert is inserted into the distal end of the hollow tube.

51. A system, comprising:

a sensing catheter that includes a sensor for sensing a physiological parameter;

the sensing catheter including an electrical output signal related to the sensed physiological parameter;

a control system coupled to the electrical output signal of the sensing catheter;

a therapeutic catheter includinig at least one input that receives an input from the control system based on the output signal of the sensing catheter; and

wherein the therapeutic catheter includes a hollow tube having a lumen for receiving the sensing catheter and placing the sensor of the sensing catheter in a position to sense the physiological parameter.

52. The system of claim 51, wherein the therapeutic catheter comprises an intra-aortic balloon catheter having a balloon and wherein the control system provides a feed-back control loop that controls the inflation/deflation of the balloon based on signals from the sensing catheter.

53. The system of claim 52, wherein the signals from the sensing catheter include a pressure signal.

54. The system of claim 52, wherein the signals from the sensing catheter include an electrocardiogram (ECG) signal.

55. The system of claim 51, wherein the sensing catheter includes:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, the proximal end in communication with the pressure transducer;

a gel-like material positioned in the lumen at the distal end; and

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material.

56. The system of claim 51, wherein the therapeutic catheter further includes a reference electrode coupled to an exterior of the hollow tube of the therapeutic catheter.

57. A catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow, metal tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, wherein the hollow, metal tube comprises a metal selected from the group consisting of 316 stainless steel, Nitinol, titanium, MP35N, and MP52, the pressure transducer coupled to the proximal end;

a gel-like material positioned in the lumen at the distal end; and

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material.

58. A catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow, metal tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, the pressure transducer coupled to the proximal end;

a gel-like material positioned in the lumen at the distal end; and

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material, wherein the at least one liquid is selected from the group consisting of water, saline, silicone oils, alcohols, and propylene glycol dispersed in water.

59. A catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow, metal tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, the pressure transducer coupled to the proximal end;

a gel-like material positioned in the lumen at the distal end, wherein the gel-like material comprises a non-toxic and minimally thrombogenic material; and

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material.

60. A catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow, metal tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, the pressure transducer coupled to the proximal end;

a gel-like material positioned in the lumen at the distal end, wherein the gel-like material further comprises an anti-thrombogenic substance selected from the group consisting of heparin and warfarin; and

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material.

61. A catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow, metal tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, wherein the hollow tube is substantially covered with an insulating material, the pressure transducer coupled to the proximal end;

a gel-like material positioned in the lumen at the distal end; and

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material.

62. A catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, a portion of the distal end comprising at least one rib separating the lumen into a plurality of smaller lumens, the pressure transducer coupled to the proximal end;

a gel-like material positioned in the lumen at the distal end; and

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material.

63. A catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, the distal end, the pressure transducer coupled to the proximal end;

a gel-like material positioned in the lumen at the distal end;

a stent coupled to the distal end of the hollow tube; and

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material.

64. The catheter according to claim 63, wherein the stent coupled to the distal end of the hollow tube comprises a stent coupled to the lumen of the distal end of the hollow tube.

65. The catheter according to claim 63, wherein the stent coupled to the distal end of the hollow tube comprises the stent coupled to the outer surface of the distal end of the hollow tube.

66. The catheter according to claim 63, wherein the stent coupled to the distal end of the hollow tube comprises a stent imbedded into the distal end of the hollow tube.

67. The catheter according to claim 63, wherein the stenit comprises a braided wire tube.

68. The catheter according to claim 63, wherein the stent comprises an expanded metal mesh tube.

69. The catheter according to claim 63, wherein the stent comprises a perforated tube.

70. A catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, the hollow tube further comprises a plurality of holes proximate the distal end, the pressure transducer is coupled to the proximal end;

a gel-like material positioned in the lumen at the distal end and at the plurality of holes; and

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material.

71. The catheter according to claim 70, wherein the plurality of holes are of semi-circumferential elongated shape.

72. The catheter according to claim 70, wherein the plurality of holes form a mesh-like structure.

73. The catheter according to claim 70, further comprising a compliant membrane disposed over the plurality of holes.

74. A catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow, metal tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end;

a gel-like material positioned in the lumen at the distal end;

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material; and

a flexible tip comprising;

a coil having a first end and a second end;

a rounded head; and

wherein the rounded head is coupled to the coil first end of the coil, and the second end of the coil is coupled to the distal end of the hollow tube.

75. A catheter, comprising:

a pressure transducer that provides a signal which varies as a function of pressure;

a hollow, metal tube having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end;

a gel-like material positioned in the lumen at the distal end;

at least one liquid which fills the lumen and is in communication with the pressure transducer and the gel-like material; and

a flexible tip comprising;

a coil having a first end and a second end;

a rounded head;

a cone-shaped insert having a plurality of holes; and

wherein the rounded head is attached to the first end of the coil, and the second end of the coil is attached to the cone-shaped insert and wherein the cone-shaped insert is inserted into the distal end of the hollow tube.