Method and apparatus for regional and whole body temperature modification

• US 6,497,721 B2
• Filed: 12/15/2000
• Issued: 12/24/2002
• Est. Priority Date: 02/10/1993
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Ginsburg, incapacited, Robert, Machold, Timothy R., Dineen, Michael T.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/739,427
• Publication Number:
  US 20010047196A1
• Time in Patent Office: 739 Days
• Field of Search: 607/96, 607/105, 607/106, 607/113, 604/113
• US Class Current: 607/106
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/00095 high, i.e. heat conducting
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/0086 with a thermostat
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/0097 Blankets with active heating or cooling sources warming mats A61F7/08
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1086 : having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2205/366 : by liquid heat exchangers
• CPC Class Codes: A61M 2206/10 : Flow characteristics
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 25/00 : Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

Methods and apparatus for temperature modification of selected body regions including an induced state of local hypothermia of the brain region for neuroprotection. A heat exchange catheter is provided with heat transfer fins projecting or extending outward from the catheter which may be inserted into selected blood vessels or body regions to transfer heat with blood or fluid in the selected blood vessels or body regions. Another aspect of the invention further provides methods and apparatus for controlling the internal body temperature of a patient. By selectively heating or cooling a portion of the catheter lying within a blood vessel, heat may be transferred to or from blood flowing within the vessel to increase or decrease whole body temperature or the temperature of a target region. Feed back from temperature sensors located within the patient'"'"'s body allow for control of the heat transfer from the catheter to automatically control the temperature of the patient or of the target region within the patient. The apparatus may include a blood channeling sleeve that directs body fluid over a heat exchanger where the body fluid'"'"'s temperature is altered, and then is discharged out the distal end of the sleeve to a desired location, for example, cooled blood to the brain for neuroprotection. The catheter may be used alone or in conjunction with other heat exchangers to cool one region of a patient'"'"'s body while heating another.

Claims

1. A method for lessening the severity of damage to neural tissue located within the body of a mammalian patient after said neural tissue has become ischemic or has been otherwise affected by a disease, disorder or trauma which can cause subsequent damage, infraction, hemorrhage or necrosis of said tissue, said method comprising the steps of:

A. selecting a portion of the body comprising the brain which contains the tissue, said portion of the body receiving a flow of a body fluid;

B. providing a heat exchange catheter device which comprises;

i) an elongate, flexible catheter having a proximal end, a distal end, and an insertion portion for insertion into a patient'"'"'s body ii) at least one fluid lumen through which a thermal exchange fluid may be circulated and iii) a heat exchanger located a first location on the catheter along a length of said insertion portion which is less than the entire length of said insertion portion, said heat exchanger being operative to exchange heat between body fluid which flows in heat exchange proximity to said heat exchanger and thermal fluid which is circulated through said catheter;

C. inserting the catheter into a fluid-containing body structure of the patient and positioning the catheter such that fluid flowing through the body structure will pass in heat exchange proximity to the heat exchanger before reaching the selected body portion;

D. circulating a heat portion exchange fluid through the fluid lumen of the catheter device, such that body fluid will pass in heat exchange proximity to the heat exchanger, said heat exchange fluid being at a temperature other than the body fluid, whereby the temperature of the body fluid will be altered, and will subsequently flow to said neural tissue;

E. maintaining the catheter in said position and with the heat transfer fluid at said temperature for a sufficient time to alter the temperature of the neutral tissue, and;

F. maintaining the selected portion of the body in Step A at a temperature different than that of the rest of the patient'"'"'s body by wrapping at least a portion of the patient'"'"'s body below the head in warming blankets.

2. The method of claim 1 wherein the fluid containing body structure recited in Step C is a blood vessel and the body fluid recited in Step A is blood.

3. The method of claim 2 wherein the blood vessel is an artery.

4. The method of claim 2 wherein the blood vessel is a vein.

5. The method of claim 1 wherein the catheter device provided in Step B further comprises iv) a blood channeling sleeve formed about a segment of said catheter whereon said heat exchanger is located such that a blood flow space exists between said catheter and said blood channeling sleeve, said blood channeling sleeve having a blood inlet located proximal to at least a portion of the heat exchanger and a blood outlet located distal to at least a portion of said heat exchanger, and wherein the catheter is positioned in Step C such that blood which exits the blood outlet will flow to a blood vessel which perfuses said neural tissue.

6. The method of claim 5 wherein the catheter is further positioned in Step C such that the blood outlet is within a first blood vessel which leads to said neural tissue and the blood inlet is within a second blood vessel, blood from the second blood vessel being thereby channeled through the blood channeling sleeve in heat exchanging proximity to the heat exchanger, and subsequently flowing into said first blood vessel to cool said neural tissue.

7. The method of claim 6 wherein the neural tissue is located in the brain and the first blood vessel is selected from the group consisting of:

right common carotid artery;

left common carotid artery;

innominate artery;

right internal carotid artery; and

,

left internal carotid artery.

8. The method of claim 7 wherein the second blood vessel is the aorta.

9. The method of claim 8 wherein the blood inlet of the blood channeling sleeve is located within the descending aorta.

10. The method of claim 6 wherein at least a portion of the blood channeling sleeve is located in said first blood vessel, and has an outer diameter that is approximately as large as the luminal diameter of the first blood vessel other than through the blood flow space between the catheter and the blood channeling sleeve.

11. The method of claim 10 wherein the first blood vessel is a branch vessel which emanates from the arch of the aorta and the second blood vessel is the aorta.

12. The method of claim 6 wherein at least a portion of the blood channeling sleeve is located in said first blood vessel, said blood channeling sleeve having a shoulder between said blood inlet and said blood outlet, said shoulder sized to cause at least a partial occlusion between said first blood vessel and said second blood vessel to prevent blood flowing from said second blood vessel to said first blood vessel other than through said blood channeling sleeve.

13. The method of claim 1 further comprising the steps of:

G. providing a second heat exchange catheter device which comprises;

     1) an elongate, flexible catheter having a proximal end and a distal end, ii) a heat exchanger located at a first location on the catheter, said heat exchanger being operative to exchange heat between blood which flows in heat exchanging proximity to said heat exchanger and the heat exchanger;

H. inserting the second catheter into the patient'"'"'s vasculature and positioning it at a second location such that which has cooled the neural tissue in Step D of the method will subsequently flow in heat exchange proximity to the heat exchanger of the second catheter; and

,

I. adding heat to said blood.

14. The method of claim 1 wherein the catheter device provided in Step A further comprises a wording lumen and wherein the positioning of the catheter in Step C is accomplished by advancing the catheter over a previously inserted guide wire such that the guide wire extends through the working lumen of the catheter.

15. The method of claim 1 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

G. infusing a medicament through the working lumen of the catheter to deliver said medicament to the neural tissue.

16. The method of claim 15 wherein the medicament is selected from the group of medicaments consisting of:

a thrombolytic agent;

an anticoagulant;

neuro-protectant;

a barbiturate;

a anti-seizure agent;

an oxygenated perfusate;

a vaso-dilator;

an agent which prevents vaso-spasm;

an agent which inhibits platelet activation; and

,

an agent which deters the adhesion of platelets.

17. The method of claim 1 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

G. infusing a radiographic contrast agent through the working lumen of the catheter to permit imaging in the area of said neural tissue.

18. The method of claim 1 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

G. passing a therapeutic apparatus through the working lumen of the catheter and using such therapeutic apparatus to perform a therapeutic task.

19. The method of claim 18 wherein the therapeutic apparatus passed through the working lumen of the catheter in Step G is selected from the group of therapeutic apparatus consisting of:

an angioplasty catheter;

an embolectomy catheter;

an occlusion member delivering catheter;

an electro-cautery device; and

,

a microcatheter.

20. The method of claim 1 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

G. passing a diagnostic device through the working lumen of the catheter and using such diagnostic device to perform a diagnostic procedure.

21. The method of claim 20 wherein the diagnostic device is selected from the group consisting of:

an angiographic catheter;

a sensor.

22. The method of claim 1 wherein the neural tissue is brain tissue which has become ischemic or has suffered hypoxic insult due to a stroke.

23. The method of claim 1 wherein the neural tissue is brain tissue which has suffered hypoxic insult due to cardiac arrest.

24. A method for lessening the severity of damage to neural tissue located within the body of a mammalian patient after said neural tissue has become ischemic or has been otherwise affected by a disease, disorder or trauma which can cause subsequent damage, infarction, hemorrhage or necrosis of said tissue, said method comprising the steps of:

A. selecting a portion of the body which contains the tissue, said portion receiving a flow of a body fluid;

B. providing a heat exchange catheter device which comprises;

i) an elongate, flexible catheter having a proximal end, a distal end, and an insertion portion for insertion into a patient'"'"'s body ii) at least one fluid lumen through which a thermal exchange fluid may be circulated and iii) a heat exchanger located a first location on the catheter along a length of said insertion portion which is less than the entire length of said insertion portion, said heat exchanger being operative to exchange heat between body fluid which flows in heat exchange proximity to said heat exchanger and the thermal fluid which is circulated through said catheter;

C. inserting the catheter into a fluid-containing body structure of the patient and positioning the catheter such that fluid flowing through the body structure will pass in heat exchange proximity to the heat exchanger before reaching the selected body portion;

D. circulating a heat exchange fluid through the fluid lumen of the catheter device, such that body fluid will pass in heat exchange proximity to the heat exchanger, said heat exchange fluid being at a temperature other than the body fluid, whereby the temperature of the body fluid will be altered, and will subsequently flow to said neural tissue;

E. maintaining the catheter in said position and with the heat transfer fluid at said temperature for sufficient time to alter the temperature of the neural tissue;

F. providing a second heat exchange catheter device which comprises;

1) an elongate, flexible catheter having a proximal end and a distal end, ii) a heat exchanger located at a first location on the catheter, said heat exchanger being operative to exchange heat between blood which flows in heat exchanging proximity to said heat exchanger and the heat exchanger;

G. inserting the second catheter into the patient'"'"'s vasculature and positioning it at a second location such that blood which has cooled the neural tissue in Step D of the method will subsequently flow in heat exchange proximity to the heat exchanger of the second catheter; and

,

H. adding heat to said blood.

25. The method of claim 24 wherein the fluid containing body structure recited in Step C is a blood vessel and the body fluid recited in Step A is blood.

26. The method of claim 25 wherein the blood vessel is an artery.

27. The method of claim 25 wherein the blood vessel is a vein.

28. The method of claim 24 wherein the body portion in Step A is the brain.

29. The method of claim 28 further comprising the step of:

I. maintaining the selected portion of the body in Step A at a temperature different than that of the rest of the patient'"'"'s body.

30. The method of claim 29 wherein Step I comprises wrapping at least a portion of the patient'"'"'s body below the head in warming blankets.

31. The method of claim 24 wherein the catheter device provided in Step B further comprises iv) a blood channeling sleeve formed about a segment of said catheter whereon said heat exchanger is located such that a blood flow space exists between said catheter and said blood channeling sleeve, said blood channeling sleeve having a blood inlet located proximal to at least a portion of the heat exchanger and a blood outlet located distal to at least a portion of said heat exchanger, and wherein the catheter is positioned in Step C such that blood which exists the blood outlet will flow to a blood vessel which perfuses said neural tissue.

32. The method of claim 31 wherein the catheter is further positioned in Step C such that the blood outlet is within a first blood vessel which leads to said neural tissue and the blood inlet is within a second vessel, blood from the second blood vessel being thereby channeled through the blood channeling sleeve in heat exchanging proximity to the heat exchanger, and subsequently flowing into said first blood vessel to cool said neural tissue.

33. The method of claim 32 wherein the neural tissue is located in the brain and the first blood vessel is selected from the group consisting of:

right common carotid artery;

left common carotid artery;

innominate artery;

right internal carotid artery; and

,

left internal carotid artery.

34. The method of claim 33 wherein the second blood vessel is the aorta.

35. The method of claim 34 wherein the blood inlet of the blood channeling sleeve is located within the descending aorta.

36. The method of claim 32 wherein at least a portion of the blood channeling sleeve is located in said first blood vessel, and has an outer diameter that is approximately as large as the luminal diameter of the first blood vessel such that blood is substantially prevented from entering the first blood vessel other than through the blood flow space between the catheter and the blood channeling sleeve.

37. The method of claim 36 wherein the first blood vessel is a branch vessel which emanates from the arch of the aorta and the second blood vessel is the aorta.

38. The method of claim 32 wherein at least a portion of the blood channeling sleeve is located in said first blood vessel, said blood channeling sleeve having a shoulder between said blood inlet and said blood outlet, said shoulder sized to cause at least a partial occlusion between said first blood vessel and said second blood vessel to prevent blood flowing from said second blood vessel to said first blood vessel other than through said blood channeling sleeve.

39. The method of claim 24 wherein the catheter device provided in Step A further comprises a working lumen and wherein the positioning of the catheter in Step B is accomplished by advancing the catheter over a previously inserted guide wire such that the guide wire extends through the working lumen of the catheter.

40. The method of claim 24 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

I. infusing a medicament through the working lumen of the catheter to deliver said medicament to the neural tissue.

41. The method of claim 40 wherein the medicament is selected from the groups of medicaments consisting of:

a thrombolytic agent;

an anticoagulant;

a neuro-proctectant;

a barbiturate;

a anti-seizure agent;

an oxygenated perfusate;

a vaso-dilator;

an agent which prevents vaso-spasm;

an agent which inhibits platelet activation; and

,

an agent which deters the adhesion of platelets.

42. The method of claim 24 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

I. infusing a radiographic contrast agent through the working lumen of the catheter to permit imaging in the area of said neural tissue.

43. The method of claim 24 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

I. passing a therapeutic apparatus through the working lumen of the catheter and using such therapeutic apparatus to perform a therapeutic task.

44. The method of claim 43 wherein the therapeutic apparatus passed through the working lumen of the catheter in Step I is selected from the group of therapeutic apparatus consisting of:

an angioplasty catheter;

an embolectomy catheter;

an occlusion member delivering catheter;

an electro-cautery device; and

,

a microcatheter.

45. The method of claim 24 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

I. passing a diagnostic device through the working lumen of the catheter and using such diagnostic device to perform a diagnostic procedure.

46. The method of claim 45 wherein the diagnostic device is selected from the group consisting of:

an angiographic catheter and

a sensor.

47. The method of claim 24 wherein the neural tissue is brain tissue which has become ischemic or has suffered hypoxic insult due to a stroke.

48. The method claim 24 wherein the neural tissue is brain tissue which has suffered hypoxic insult due to cardiac arrest.

49. A method for lessening the severity of damage to neural tissue located within the body of a mammalian patient after said neural tissue has become ischemic or has been otherwise affected by a disease, disorder or trauma which can cause subsequent damage, infarction, hemorrhage or necrosis of said tissue, said method comprising the steps of:

A. selecting a portion of the body containing the tissue, which portion receives a flow of a body fluid;

B. providing a heat exchange catheter device which comprises;

i) an elongate, flexible catheter having a proximal end, a distal end, and an insertion portion for insertion into a patient'"'"'s body ii) at least one fluid lumen through which a thermal exchange fluid may be circulated iii) a heat exchanger located a first location on the catheter along a length of said insertion portion which is less than the entire length of said insertion portion, said heat exchanger being operative to exchange heat between body fluid which flows in heat exchange proximity to said heat exchanger and the thermal fluid which is circulated through said catheter and iv) a blood channeling sleeve formed about a segment of said catheter whereon said heat exchanger is located such that blood flow space exists between said catheter and said blood channeling sleeve, said blood channeling sleeve having a blood inlet located proximal to at least a portion of the heat exchanger and a blood outlet located distal to at least a portion of said heat exchanger;

C. inserting the catheter into fluid-containing body structure of the patient and positioning the catheter such that fluid flowing through the body structure will pass in heat exchange proximity to the heat exchanger before reaching the selected body portion and wherein the catheter is positioned such that blood which exits the blood outlet will flow to a blood vessel which perfuses said neural tissue;

D. circulating a heat exchange fluid through the fluid lumen of the catheter device, such that body fluid will pass in heat exchange proximity to the heat exchanger, said heat exchange fluid being at a temperature other than the body fluid, whereby the temperature of the body fluid will be altered, and will subsequently flow to said neural tissue;

E. maintaining the catheter in said position and with the heat transfer fluid at said temperature for a sufficient to alter the temperature of the neural tissue.

50. The method of claim 49 wherein the fluid containing body structure recited in Step C is a blood vessel and the body fluid recited in Step A is blood.

51. The method of claim 50 wherein the blood vessel is an artery.

52. The method of claim 50 wherein the blood vessel is a vein.

53. The method of claim 49 wherein the body portion in Step A is the brain.

54. The method of claim 53 further comprising:

F. maintaining the selected portion of the body in Step A at a temperature different than that of the rest of the patient'"'"'s body.

55. The method of claim 54 wherein Step F comprises wrapping at least a portion of the patient'"'"'s body below the head in warming blankets.

56. The method of claim 49 wherein the catheter is further positioned in Step B such that the blood outlet is within a first blood vessel which leads to said neural tissue and the blood inlet is within a second blood vessel, blood from second blood vessel being thereby channeled through the blood channeling sleeve in heat exchanging proximity to the heat exchanger, and subsequently flowing into said first blood vessel to cool said neural tissue.

57. The method of claim 56 wherein the neural tissue is located in the brain and the first blood vessel is selected from the group consisting of:

right common carotid artery;

left common carotid artery;

innominate artery;

right internal carotid artery; and

,

left internal carotid artery.

58. The method of claim 57 wherein the second blood vessel is the aorta.

59. The method of claim 58 wherein the blood inlet of the blood channeling sleeve is located within the descending aorta.

60. The method of claim 57 wherein at least a portion of the blood channeling sleeve is located in said first blood vessel, said blood channeling sleeve having a shoulder between said blood inlet and said blood outlet, said shoulder sized to cause at least a partial occlusion between said first blood vessel and said blood vessel to prevent blood flowing from said second blood vessel to said first blood vessel other than through said blood channeling sleeve.

61. The method of claim 56 wherein at least a portion of the blood channeling sleeve is located in said first blood vessel, and has an outer diameter that is approximately as large as the luminal diameter of the first blood vessel such that blood is substantially prevented from entering the first blood vessel other than through the blood flow space between the catheter and the blood channeling sleeve.

62. The method of claim 61 wherein the first blood vessel is a branch vessel which emanates from the arch of the aorta and the second blood vessel is the aorta.

63. The method of claim 49 further comprising the steps of:

F. providing a second heat exchange catheter device which comprises;

i) an elongate, flexible catheter having a proximal end and a distal end, ii) a heat exchanger located at first location on the catheter, said heat exchanger being operative to exchange heat between blood which flows in heat exchanging proximity to said heat exchanger and the heat exchanger;

G. inserting the second catheter into the patient'"'"'s vasculature and positioning it at a second location such that blood which has cooled the neural tissue in Step D of the method will subsequently flow in heat exchange proximity to heat exchanger of the second catheter; and

,

H. adding heat to said blood.

64. The method of claim 49 wherein the catheter device provided in Step A further comprises a working lumen and wherein the positioning of the catheter in Step B is accomplished by advancing the catheter over a previously inserted guide wire such that the guide wire extends through the working lumen of the catheter.

65. The method of claim 49 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

F. infusing a medicament through the working lumen of the catheter to deliver said medicament to the neural tissue.

66. The method of claim 65 wherein the medicament is selected from the group of medicaments consisting of:

thrombolytic agent;

an anticoagulant;

a neuro-protectant;

a barbiturate;

a anti-seizure agent;

an oxygenated perfusate;

a vaso-dilator;

an agent which prevents vaso-spasm;

an agent which inhibits platelet activation; and

,

an agent which deters the adhesion of platelets.

67. The method of claim 49 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

F. infusing a radiographic contrast agent through the working lumen of the catheter to permit imagining in the area of said neural tissue.

68. The method of claim 49 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

F. passing a therapeutic apparatus through the working lumen of the catheter and using such therapeutic apparatus to perform a therapeutic task.

69. The method of claim 68 wherein the therapeutic apparatus passed through the working lumen of the catheter in Step D is selected from the group of therapeutic apparatus consisting of:

an angioplasty catheter;

an embolectomy catheter;

an occlusion member delivering catheter;

an electro-cautery device; and

,

a microcatheter.

70. The method of claim 49 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

F. passing a diagnostic device through the working lumen of the catheter and using such diagnostic device to perform a diagnostic procedure.

71. The method of claim 70 wherein the diagnostic device is selected from the group consisting of:

an angiographic catheter;

a sensor.

72. The method of claim 49 wherein the neural tissue is brain tissue which has become ischemic or has suffered hypoxic insult due to a stroke.

73. The method of claim 49 wherein the neural tissue is brain tissue which has suffered hypoxic insult due to cardiac arrest.