SYSTEMS AND METHODS FOR INTRAVASCULAR COOLING

• US 20090018504A1
• Filed: 06/20/2008
• Published: 01/15/2009
• Est. Priority Date: 12/22/2005
• Status: Active Grant

• Current Assignee: Hybernia Medical, LLC
• Original Assignee: Hybernia Medical, LLC
• Inventors: Lin, Erwin, Pile-Spellman, John
• Granted Patent: US 8,343,097 B2
• Time in Patent Office: Days
• US Class Current: 604/113
• CPC Class Codes: A61F 2007/0059 with an open fluid circuit
• 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 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

Methods and systems for infusing a cooled infusate to a target location in a patient are described. A temperature of the blood and infusate admixture upstream of the catheter as well as at other locations along the catheter may be monitored and a feedback system utilized to control the volume, temperature, and/or infusion rate of the infusate so as to achieve a predetermined temperature at the target location. Control may also be based on the patient'"'"'s native vessel flow rate. The system may monitor or calculate hematocrit upstream of the catheter and adjust infusion so as to provide sufficient oxygenation of the blood and infusate admixture. The system may also monitor reflux of the infusate past a distal end of the catheter and reduce infusion upon the detection of reflux.

Claims

1. A device, comprising:

an insertion device adapted to fluidicly communicate with a source of an infusate; and

a controller adapted to control at least one of (a) a temperature of the infusate, (b) an infusion rate of the infusate through the insertion device, and (c) a volume of the infusate passing through the insertion device in a downstream direction, in accordance with a temperature of a blood and infusate mixture downstream relative to an infusate exit location of the insertion device while the insertion device is placed in a blood vessel of a patient with a downstream flow of blood for infusion of the infusate, and in accordance with at least one of (a) a temperature of the infusate at least one of at and adjacent the exit location, (b) a temperature upstream and adjacent the exit location, and (c) a core body temperature of the patient.

2. The device according to claim 1, further comprising a plurality of temperature sensors, wherein the controller is adapted to receive signals from the temperature sensors, at least one of the temperature sensors is positioned downstream relative to the infusate exit location and is adapted to measure a temperature of the infusate and blood mixture;

and at least another one of the temperature sensors is adapted to measure at least one of (a) a temperature of the infusate adjacent the exit location, (b) a temperature upstream and adjacent the exit location, and (c) a core body temperature of the patient.

3. The device according to claim 2, wherein the temperature sensors are at least one of (a) connected to the insertion device, (b) connected to a second device, and (c) connected to both the insertion device and the second device.

4. The device according to claim 3, wherein the second device is at least one of (a) arranged adjacent to the insertion device, (b) connected to the insertion device, and (b) arranged so as to extend through the insertion device.

5. The device according to claim 1, wherein the controller is adapted to control at least one of (a) the temperature of the infusate, (b) the infusion rate of the infusate through the insertion device, and (c) the volume of the infusate passing through the insertion device to at least one of detect and control a temperature of the infusate and blood mixture.

6. The device according to claim 3, wherein the temperature sensors are connected to a wire adapted to support the temperature sensors in the blood vessel.

7. The device according to claim 1, further comprising one of a pump and a valve controlled by the controller and adapted to provide infusate from the infusate source through the insertion device.

8. The device according to claim 1, further comprising a heat exchanger controlled by the controller and adapted to control the temperature of the infusate.

9. The device according to claim 1, wherein the insertion device is a catheter.

10. The device according to claim 9, further comprising a guide catheter adapted to be disposed about the catheter.

11. The device according to claim 1, further comprising an insulator disposed about the insertion device.

12. The device according to claim 10, wherein the guide catheter is configured to enlarge from a first low profile to a second larger profile so as to at least one of create and increase in size an insulating annular space between the catheter and the guide catheter.

13. The device according to claim 2, wherein the temperature sensor adapted to measure temperature upstream and adjacent the exit location is located about 0.2 cm to about 5 cm upstream the exit location.

14. The device according to claim 1, wherein the controller is further adapted to control at least one of (a) the infusion rate of the infusate through the insertion device and (b) a volume of infusate passing through the insertion device in accordance with a hematocrit downstream of the exit location.

15. The device according to claim 1, wherein the controller is further adapted to calculate at least one of (a) a dilution of the blood and (b) a hematocrit downstream the exit location using a base whole body hematocrit of the patient (Hat) and the dilution of the blood (dF).

16. The device according to claim 15, wherein the controller is further adapted to calculate at least one of (a) a dilution of the blood and (b) a hematocrit downstream the exit point using the equation (Hct)*(1−

dF), wherein dF=(infusion rate)/(infusion rate+X), wherein X is an amount of blood per unit time at the core body temperature in the blood and infusate mixture and is represented by the equation X=(infusion rate*(T₁−

T₂)/(T₄−

T₁)), T₁ is a temperature of the blood and infusate mixture downstream the exit location, T₂ is a temperature of the infusate at least one of at and adjacent the exit point, T₃ is temperature adjacent to and upstream the exit point, and T₄ is the core body temperature of the patient.

17. The device according to claim 2, wherein the temperature sensors include a first temperature sensor positioned downstream relative to an infusate exit location of the catheter and adapted to measure a temperature of an infusate and blood mixture when the catheter is placed in a blood vessel of a patient for infusion of the infusate, a second temperature sensor adapted to measure a temperature of the infusate at least one of at and adjacent the exit location, a third temperature sensor adapted to measure a temperature outside the catheter upstream and adjacent the exit location, and a fourth temperature sensor adapted to measure a core body temperature of the patient.

18. The device according to claim 17, further comprising at least one of a heat exchanger and an infusate pump, the controller being adapted to receive signals from the temperature sensors and to control at least one of the heat exchanger and the pump in accordance with the signals from the plurality of temperature sensors.

19. The device according to claim 17, wherein the controller is further adapted to calculate at least one of (a) a dilution of the blood and (b) a hematocrit downstream the exit point using the equation (Hct)*(1−

dF), wherein Hct is a base whole body hematocrit of the patient, dF is the dilution of the blood and is represent by the following equation dF=(infusion rate)/(infusion rate+X), X is an amount of blood per unit time at the core body temperature in the blood and infusate mixture and is represented by the equation X=(infusion rate*(T₁−

T₂)/(T₄−

T₁)), T₁ is a temperature as measured by the first temperature sensor, T₂ is a temperature as measured by the second temperature sensor, T₃ is a temperature as measured by the third temperature sensor, and T₄ is a temperature as measured by the fourth temperature sensor.

20. The device according to claim 1, wherein the controller is adapted to calculate at least one parameter of the infusate at least one of at and adjacent the exit location.

21. The device according to claim 20, wherein the at least one parameter is a temperature of the infusate.

22. The device according to claim 21, wherein the controller is adapted to calculate the temperature of the infusate at least one of at and adjacent the exit location using at least one of (a) the temperature of the infusate outside the patient, (b) the infusion rate of the infusate through the insertion device, and (c) at least one of a surface area and thermal conductivity of the insertion device.

23. The device according to claim 1, further comprising a source of first infusate and a source of second infusate, the catheter being in fluid communication with the source of the first infusate and in fluid communication with the source of the second infusate, wherein the controller is adapted to control the temperature of the infusate by control of a relative proportion of the first infusate and second infusate passing through the catheter.

24. The device according to claim 23, further comprising at least one pump controlled by the controller and adapted to provide the first infusate from the source of first infusate and the second infusate from the source of second infusate through the catheter.

25. The device according to claim 23, further comprising a first heat exchanger controlled by the controller and adapted to control the temperature of the first infusate and a second heat exchanger controlled by the controller and adapted to control the temperature of the second infusate.

26. The device according to claim 1, wherein the controller is adapted to control the at least one of (a) the temperature of the infusate, (b) the infusion rate of the infusate through the insertion device, and (c) the volume of the infusate passing through the insertion device in accordance with a plateauing of a native vessel flow rate in the blood vessel.

65. The device according to claim 1, wherein the controller is adapted to control the at least one of (a) the temperature of the infusate, (b) the infusion rate of the infusate through the insertion device, and (c) the volume of the infusate passing through the insertion device in accordance with a native vessel blood flow rate in the blood vessel.

68. The device according to claim 1,

wherein the source of infusate includes a first pressurized reservoir of infusate at a first temperature and a second pressurized reservoir infusate at a second temperature different than the first temperature;

the device further comprising a first valve adapted to control flow of infusate from the first reservoir through the insertion device, and a second valve adapted to control flow of infusate from the second reservoir through the insertion device, the device configured to control the temperature of the infusate flowing through the insertion device via coordinated control of both the first valve and the second valve.

69. The device according to claim 1, wherein the controller is further adapted to accept as input a base whole body hematocrit of the patient (Hct) and to update the Hct based on the volume of infusion fluid passing through the insertion device into the patient and a volume of fluid output by the patient.

27. A device, comprising:

an insertion device adapted to fluidicly communicate with a source of an infusate;

a plurality of sensors; and

a controller adapted to receive signals from the sensors indicative of at least one parameter of a bodily fluid moving in a downstream direction and to control at least one of (a) at least one parameter of the infusate, (b) an infusion rate of the infusate flowing through the insertion device, and (c) a volume of the infusate passing through the insertion device, in accordance with the signals from the sensors;

wherein at least one of the sensors is positioned downstream relative to an infusate exit location of the insertion device; and

wherein at least another one of the sensors is adapted to measure at least one of (a) the at least one parameter of the infusate at least one of at and adjacent the exit location, (b) the at least one parameter upstream and adjacent the exit location, and (c) a core body temperature of the patient.

28. The device according to claim 27, wherein the controller is adapted to control at least one of the (a) the at least one parameter of the infusate, (b) the infusion rate of the infusate through the insertion device, and (c) the volume of the infusate passing through the insertion device to at least one of detect and control at least one parameter of a mixture of the bodily fluid and the infusate.

29. The device according to claim 27, wherein the at least one parameter of the infusate corresponds to the at least one parameter of the bodily fluid.

30. The device according to claim 27, wherein the at least one parameter of the infusate is different than the least one parameter of the bodily fluid.

31. An infusion method, comprising:

a) infusing an infusate into a patient through an insertion device in a downstream direction;

b) at least one of measuring and calculating at least one parameter of a bodily fluid; and

c) controlling at least one of (i) at least one parameter of the infusate, (ii) an infusion rate of the infusate through the insertion device, and (iii) a volume of the infusate passing through the insertion device, in accordance with at least one parameter of a blood and infusate mixture downstream relative to an infusate exit location of the insertion device when the insertion device is placed in a blood vessel of the patient for infusion of the infusate, and in accordance with at least one of (a) the at least one parameter of the infusate at the exit location, (b) the at least one parameter outside the insertion device upstream and adjacent the exit location, and (c) a core body temperature of the patient.

32. The infusion method according to claim 31, further comprising iteratively comparing the at least one parameter of the blood and infusate mixture downstream relative to the exit location to a target at least one parameter and decreasing at least one of the volume and infusion rate of infusate through the insertion device if the at least one parameter of the blood and infusate mixture downstream relative to the exit location falls below the target at least one parameter and increasing at least one of the volume and infusion rate of the infusate through the insertion device if the at least one parameter of the blood and infusate mixture downstream relative to the exit location is above the target at least one parameter.

33. The infusion method according to claim 31, further comprising iteratively comparing the at least one parameter upstream and adjacent the exit location to a predetermined minimum at least one parameter and reducing at least one of the volume and infusion rate of the infusate through the insertion device if the at least one parameter upstream and adjacent the exit location falls below the predetermined minimum at least one parameter.

34. The infusion method according to claim 31, further comprising iteratively comparing the at least one parameter of the blood and infusate mixture downstream relative to the exit location to a target at least one parameter and decreasing at least one of the volume and infusion rate of infusate through the insertion device if the at least one parameter of the blood and infusate mixture downstream relative to the exit location exceeds the target at least one parameter and increasing at least one of the volume and infusion rate of the infusate through the insertion device if the at least one parameter of the blood and infusate mixture downstream relative to the exit location falls below the target at least one parameter.

35. The infusion method according to claim 31, further comprising iteratively comparing the at least one parameter upstream and adjacent the exit location to a predetermined maximum at least one parameter and reducing at least one of the volume and infusion rate of the infusate through the insertion device if the at least one parameter upstream and adjacent the exit location exceeds the predetermined maximum at least one parameter.

36. The infusion method according to claim 31, wherein controlling step (c) includes controlling at least one of (i) a temperature of the infusate, (ii) the infusion rate of the infusate through the insertion device, and (iii) a volume of the infusate passing into the patient, in accordance with a temperature of a blood and infusate mixture downstream relative to an infusate exit location of the insertion device when the insertion device is placed in a blood vessel of the patient for infusion of the infusate, and in accordance with at least one of (a) a temperature of the infusate at the exit location, (b) a temperature upstream and adjacent the exit location, and (c) a core body temperature of the patient.

37. The infusion method according to claim 36, further comprising the step of using temperature sensors to measure at least one of (a) the temperature of the blood and infusate mixture, (b) the temperature of the infusate at least one of at and adjacent the exit location, (c) the temperature outside the insertion device upstream and adjacent the exit location, and (d) the core body temperature.

38. The infusion method according to claim 36, further comprising the step of calculating at least one of (a) the temperature of the infusate at least one of at and adjacent the exit location, (b) a dilution of the blood downstream relative to an infusate exit location of the insertion device, and (c) a hematocrit downstream relative to an infusate exit location of the insertion device.

39. The infusion method according to claim 36, further comprising calculating the dilution of the blood and the hematocrit downstream the exit location using the equation (Hct)*(1−

dF) where Hct is a base whole body hematocrit of the patient, wherein dF is the dilution of the blood and is represent by the following equation

dF=(infusion rate)/(infusion rate+X), wherein X represents the amount of blood per unit time at the core body temperature in the blood and infusate mixture and is represented by the equation X=(infusion rate*(T₁−

T₂)/(T₄−

T₁)), T₁ is a temperature of the blood and infusate mixture downstream the exit location, T₂ is a temperature of the infusate at least one of at and adjacent the exit location, T₃ is temperature adjacent to and upstream the exit location, and T₄ is the core body temperature of the patient.

40. The infusion method according to claim 36, further comprising iteratively comparing the temperature of the blood and infusate mixture downstream relative to the exit location to a target temperature and decreasing at least one of the volume and infusion rate of infusate through the insertion device if the temperature of the blood and infusate mixture downstream relative to the exit location falls one of below and more than a predetermined amount below the target temperature and increasing at least one of the volume and infusion rate of the infusate through the insertion device if the temperature of the blood and infusate mixture downstream relative to the exit location is above the target temperature.

41. The infusion method according to claim 36, further comprising iteratively comparing the temperature upstream and adjacent the exit location to a predetermined minimum temperature and reducing at least one of the volume and infusion rate of the infusate through the insertion device if the temperature upstream and adjacent the exit location falls below the predetermined minimum temperature.

42. The infusion method according to claim 41, wherein the predetermined minimum temperature corresponds to the core body temperature.

43. The infusion method according to claim 31, wherein the at least one of (i) the at least one parameter of the infusate, (ii) the infusion rate of the infusate through the insertion device, and (iii) the volume of the infusate passing through the insertion device is controlled in the controlling step so as to cause the blood and infusate mixture to at least one of reach and fall below a predetermined target temperature.

70. The method of claim 31, further comprising monitoring a base whole body hematocrit of the patient (Hct) and updating the Hct to reflect both the volume of infusion fluid passing through the insertion device into the patient and a volume of fluid output by the patient.

44. An infusion method comprising:

a) infusing an infusate into a system through an insertion device in a downstream direction;

b) measuring at least one parameter of a system fluid in the system including at least one of a fluid and gas; and

c) controlling at least one of (i) at least one parameter of the infusate, (ii) an infusion rate of the infusate through the insertion device, and (iii) a volume of the infusate passing into the system, in accordance with the at least one parameter of the system fluid upstream and adjacent an infusate exit location on the insertion device.

45. The infusion method according to claim 44, wherein the system is a patient and the system fluid is a bodily fluid.

46. The infusion method according to claim 44, wherein upstream and adjacent the exit location is about 0.2 cm to about 5 cm upstream the exit location.

47. The infusion method according to claim 44, further comprising iteratively comparing the at least one parameter upstream and adjacent the exit location to a predetermined minimum at least one parameter and reducing at least one of the volume and infusion rate of the infusate through the insertion device if the at least one parameter upstream and adjacent the exit location falls below the predetermined minimum at least one parameter.

48. The infusion method according to claim 44, further comprising iteratively comparing the at least one parameter upstream and adjacent the exit location to a predetermined maximum at least one parameter and reducing at least one of the volume and infusion rate of the infusate through the insertion device if the at least one parameter upstream and adjacent the exit location exceeds the predetermined maximum at least one parameter.

49. The infusion method according to claim 44, wherein the at least one parameter of the bodily fluid is a temperature of the bodily fluid and wherein the controlling step (b) includes controlling at least one of (i) a temperature of the infusate, (ii) the infusion rate of the infusate through the insertion device, and (iii) a volume of the infusate passing into the patient, in accordance with a temperature outside the insertion device upstream and adjacent the exit location.

50. The infusion method according to claim 49, wherein the predetermined minimum at least one parameter corresponds to a core body temperature of the patient.

51. The method according to claim 44, further comprising the step of increasing the infusion rate of the infusate until reflux is achieved.

52. The method according to claim 44, wherein the system is a patient, the system fluid is the patient'"'"'s blood, and the insertion device is inserted into a blood vessel of the patient, and further comprising the steps of:

increasing the infusion rate of the infusate until reflux is achieved; and

calculating at least one of (i) a native vessel flow rate in the blood vessel, (ii) a dilution factor of the blood in the blood vessel, (iii) a hematocrit of the blood and infusate mixture in the blood vessel, and (iv) a temperature of the blood and infusate mixture in the blood vessel in accordance with a determination as to when reflux occurs.

53. The method according to claim 44, wherein the system is a patient, the system fluid is the patient'"'"'s blood, and the insertion device is inserted into a blood vessel of the patient, and further comprising the steps of:

increasing the infusion rate of the infusate until reflux is achieved;

calculating a native vessel flow rate in the blood vessel;

monitoring a plateauing in the native vessel flow rate over time; and

at least one of stopping, maintaining, and reducing infusion of the infusate into the patient upon detection of a predetermined degree of plateauing in the native vessel flow rate.

54. An infusion method, comprising:

a) infusing an infusate into a system through an insertion device in a first direction, said system having at least one of a fluid and gas flowing therein in the first direction;

b) at least one of measuring and calculating at least one parameter of the at least one of a fluid and gas; and

c) controlling at least one of (i) at least one parameter of the infusate, (ii) an infusion rate of the infusate through the insertion device, and (iii) a volume of the infusate passing through the insertion device, in accordance with at least one parameter of a mixture of the infusate and the at least one of a fluid and gas at a position spaced a distance from the infusate exit location along the first direction when the insertion device is placed in the system for infusion of the infusate, and in accordance with at least one of (a) the at least one parameter of the infusate at the exit location, (b) the at least one parameter outside the insertion device, adjacent the exit location, and spaced away from the exit location along a second direction opposite the first direction, and (c) an average value of a parameter of the at least one of a fluid and gas in the system.

55. A device, comprising:

an elongate sensor support device adapted to be inserted into a patient and having one or more sensors connected to it along its length; and

a controller adapted to receive signals from the sensors and control at least one of (a) at least one parameter of an infusate infused into the patient through an insertion device in a downstream direction, (b) an infusion rate of the infusate, and (c) a volume of the infusate, in accordance with at least one parameter of a blood and infusate mixture downstream relative to an infusate exit location of the insertion device while the insertion device is placed in a blood vessel of a patient with a downstream flow of blood for infusion of the infusate, and in accordance with at least one of (a) at least one parameter of the infusate at least one of at and adjacent the exit location, (b) at least one parameter of the infusate upstream and adjacent the exit location, and (c) a core body temperature of the patient.

56. The device according to claim 55, wherein the controller is adapted to control a temperature of the infusate in accordance with (1) a temperature of a blood and infusate mixture downstream relative to the infusate exit location of the insertion device, and (2) at least one of (a) the temperature of the infusate at least one of at and adjacent the exit location, (b) the temperature of the infusate upstream and adjacent the exit location, and (c) a core body temperature of the patient.

57. A device, comprising:

an elongate sensor support device adapted to be inserted into a patient and having one or more sensors connected to it along its length; and

a controller adapted to receive signals from the sensors and control at least one of (a) at least one parameter of an infusate infused into the patient through an insertion device in a first direction, (b) an infusion rate of the infusate, and (c) a volume of the infusate, in accordance with at least one parameter of a blood and infusate mixture at a first position, said first position adjacent an infusate exit location on the insertion device and spaced a distance away from the infusate exit location along a second direction opposite the first direction.

58. The device according to claim 57, wherein the sensors are temperature sensors and the controller is adapted to receive temperature signals from the sensors and control at least one of (a) a temperature of the infusate infused into the patient through the insertion device in the first direction, (b) the infusion rate of the infusate, and (c) a volume of the infusate, in accordance with a temperature of the blood and infusate mixture at the first position.

59. A device, comprising:

an insertion device adapted to fluidicly communicate with a source of an infusate and positioned in a system filled with at least one of a fluid and gas flowing in a first direction;

a sensor located exterior to an internal lumen of the insertion device, the sensor located a distance away from an infusate exit location of the insertion device along a second direction opposite the first direction; and

a controller adapted to receive signals from the sensor indicative of at least one parameter of at least one of the fluid and gas to control at least one of (a) at least one parameter of the infusate, (b) an infusion rate of the infusate through the insertion device, and (c) a volume of the infusate passing through the insertion device in accordance with the signals from the sensor.

60. The device according to claim 59, wherein the controller is adapted to increase the infusion rate of the infusate until reflux is achieved.

61. The device according to claim 59, wherein the system is a patient'"'"'s vasculature filled with blood and the controller is adapted to detect reflux and to calculate at least one of (i) a native vessel flow rate in a blood vessel in which the insertion device is inserted, (ii) a dilution factor of the blood in the blood vessel, (iii) a hematocrit of the blood and infusate mixture in the blood vessel, and (iv) a temperature of the blood and infusate mixture in the blood vessel in accordance with a determination as to when reflux occurs.

62. The device according to claim 59, wherein the system is a patient'"'"'s vasculature filled with blood and the controller is adapted to calculate a native vessel flow rate in a blood vessel in which the insertion device is inserted and monitor a plateauing of the native vessel flow rate.

63. The device according to claim 62, wherein the controller is adapted to at least one of stop, maintain, and reduce infusion of the infusate into the patient upon detection of the plateauing of the native vessel flow rate.

64. The device according to claim 59, wherein the system is a patient'"'"'s vasculature filled with blood, the controller is adapted to calculate a native vessel flow rate in a blood vessel in which the insertion device is inserted, and the controller is adapted to control at least one of a temperature, the volume, and the flow rate of the infusate into the patient based on the native vessel flow rate.

66. A device, comprising:

an insertion device adapted to fluidicly communicate with a source of an infusate and to be placed in a blood vessel; and

a controller adapted to control at least one of (a) a temperature of the infusate, (b) an infusion rate of the infusate through the insertion device into the blood vessel, and (c) a volume of the infusate passing through the insertion device in a downstream direction into the blood vessel, in accordance a native vessel blood flow rate in the blood vessel.

67. An infusion method, comprising:

a) infusing an infusate into a patient through an insertion device in a downstream direction; and

b) controlling at least one of (i) at least one parameter of the infusate, (ii) an infusion rate of the infusate through the insertion device, and (iii) a volume of the infusate passing through the insertion device, in accordance with a flow rate of a bodily fluid in the downstream direction.