Method and apparatus for regional and whole body temperature modification

• US 6,527,798 B2
• Filed: 12/15/2000
• Issued: 03/04/2003
• Est. Priority Date: 02/10/1993
• Status: Expired due to Fees

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Ginsburg, Robert, Dineen, Michael T., Machold, Timothy R.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/739,134
• Publication Number:
  US 20010005791A1
• Time in Patent Office: 809 Days
• Field of Search: 607/96, 607/105-6, 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 catheter device which is insertable into an anatomical structure of a mammalian patient through which body fluid may flow to a target region of the patient, said catheter device being operative to effect in situ heat exchange with the body fluid to effect temperature alteration of the target region, said catheter device comprising:

an elongate flexible catheter having a proximal end and a distal end, the entire length of said flexible catheter being defined as the distance from its proximal end to its distal end;

at least one fluid lumen in through which said thermal exchange fluid may be circulated;

a heat exchanger located at a first location on the catheter, said heat exchanger being operative to exchange heat between body fluid in heat exchange proximity to said heat exchanger and heat exchange fluid circulating through said heat exchanger, said first location extending less than the entire length of the catheter;

a body-fluid channeling sleeve formed about a segment of said catheter including the first location at which at least a portion of said heat exchanger is located, said body fluid channeling sleeve defining a body fluid flow space between said body fluid channeling sleeve and said catheter, said body fluid channeling sleeve having a body fluid inlet located proximal to the heat exchanger and a body fluid outlet located distal to at least a portion of said heat exchanger, such that body fluid will enter the flow space through said body fluid inlet, will then flow through said flow space in heat exchange proximity to at least a portion of said heat exchanger, and then out of said body fluid outlet and to a conduit in fluid communication with said target region of the patient'"'"'s body.

2. The catheter device of claim 1 for controlling the temperature of a target region of the patient'"'"'s body to which a body fluid is flowing through a first anatomical conduit of a first diameter, and wherein said first anatomical conduit is connected to and in fluid communication with a second anatomical conduit of a second diameter larger than said first diameter, wherein said body-fluid channeling sleeve has a distal portion and a proximal portion, said body fluid outlet located on said distal portion and said body fluid inlet located on said proximal portion, said distal. portion is sized to be advanced into said first anatomical conduit while said proximal portion remains positioned within the second anatomical conduit, such that body fluid from said second anatomical conduit will enter the flow space through said body fluid inlet, will then flow through said flow space in heat exchange proximity to said heat exchanger, and then out of said body fluid outlet into said first conduit and thus to said target region of the patient'"'"'s body.

3. A catheter device as in claim 2 wherein the cross-sectional diameter of said distal portion of the blood channeling sleeve is smaller than the cross-sectional diameter of said proximal portion of the blood channeling sleeve.

4. A catheter device as in claim 2 wherein said distal portion has a shoulder formed thereon, said shoulder sized and configured to fit snugly within said anatomical conduit such that substantially all flow of said body fluid from said second anatomical conduit to said first anatomical conduit flows through said body fluid channeling sleeve.

5. The catheter device of claim 1 wherein the heat exchanger comprises:

at least one balloon through which said thermal exchange fluid is circulated, and said heat exchange fins comprise a plurality of lobes.

6. The catheter device of claim 1 wherein said at least one heat exchange fin comprises at least one outwardly extending longitudinal fin.

7. The catheter device of claim 1 wherein said at least one heat exchange fin comprises at least one outwardly extending annular fin.

8. The catheter device of claim 1 wherein said at least one heat exchange fin comprises at least one outwardly extending helical fin.

9. The catheter device of claim 1 wherein said at least one heat exchange fin comprises a plurality of outwardly extending protuberances.

10. The catheter device of claim 1, said catheter further comprising an insertion portion, said insertion portion for insertion into the patient, said insertion portion extending from the distal end to a point short of the proximal end;

and a working lumen, said working lumen extending through at least part of said insertion portion.

11. A system comprising the catheter device of claim 10 further in combination with:

a guide wire sized to be passable through said working lumnen.

12. A system comprising the catheter device of claim 10 further in combination with:

an apparatus for infusion of a medicament through said working lumen.

13. The system of claim 12 wherein s aid apparatus for infusion contains a medicament selected from the group of medicaments consisting of:

a thrombolytic agent;

an anticoagulant;

a neuro-protectant;

a barbiturate;

an anti-seizure agent;

an oxygenated perfusate;

a vaso-dilator;

an agent which prevents vaso-spasm;

an agent to prevent platelet activation; and

,

an agent to deter the adhesion of platelets.

14. A system comprising the catheter device of claim 10 further in combination with:

a diagnostic probe which is passable through said working lumen.

15. A system as in claim 14 wherein said diagnostic probe is selected from the group consisting of:

an angiographic catheter;

a temperature sensor;

a pressure sensor;

a blood gas sensor; and

an enzyme sensor.

16. A system comprising the catheter device of claim 10 further in combination with:

an apparatus for infusion of a radiographic contrast agent through said working lumen; and

,

an imaging apparatus for imaging the radiographic contrast agent which has been infused through said working lumen.

17. A system comprising the catheter device of claim 10 further in combination with a therapeutic apparatus which is passable through said working lumen.

18. The system of claim 17 wherein said therapeutic apparatus is selected from the group of therapeutic apparatus consisting of:

an angioplasty catheter;

an embolectomy catheter;

an occlusion member delivering catheter;

an embolization member delivering catheter;

an electro-cautery device; and

,

a microcatheter.

19. A catheter device as in claim 1 wherein said body fluid inlet is provided with valves, said valves operable between an open condition and a closed condition, said open condition permitting flow of body fluid into said blood channeling sleeve through said body fluid inlet, said closed condition preventing the flow of body fluid out of said blood channeling sleeve through said body fluid inlet.

20. A catheter device as in claim 1 wherein said catheter has a distal shaft portion, said distal shaft portion extending from within said blood channeling sleeve distal of said blood channeling sleeve, said distal shaft portion having a central lumen there through, said central lumen in fluid communication with said flow space at a first location and in fluid communication with said conduit in communication with said target region at a second location.

21. A catheter device as in claim 20 wherein said blood channeling sleeve is sealed around said distal shaft distal of said first location.

22. A catheter device for placement in a fluid containing portion of the body of a mammalian patient to effect in situ heat exchange, said catheter device comprising:

an elongate flexible catheter having a proximal end and a distal end, the entire length of said flexible catheter being defined as the distance from its proximal end to its distal end;

said flexible catheter having an insertion portion, said insertion portion for insertion into the patient, said insertion portion extending from the distal end to a point short of the proximal end;

a heat exchanger located at a first location on the catheter, said heat exchanger being operative to exchange heat between body fluid in heat exchange proximity to said heat exchanger and heat exchange fluid circulating through said heat exchanger, said first location extending less than the entire length of the catheter, said heat exchanger being curved and having an outer surface along its outer radius of curvature, and having an inner surface along its inner radius of curvature, said outer surface and said inner surface having substantially different thermal transmissivity.

23. A catheter device as in claim 22 wherein the upper surface is substantially more thermally transmissive than said lower surface.

24. A catheter device as in claim 23 sized and configured for placement along the curve of the aortic arch of a human patient such that blood flowing to the head region will pass in heat transfer proximity to the upper surface.

25. A system for controllably affecting the temperature of a patient, said system comprising:

a catheter device comprising an elongated flexible catheter having a proximal end, a distal end, and a heat exchanger operative to exchange heat between body fluid flowing in heat exchange proximity to said heat exchanger and heat exchanger fluid circulating through said heat exchanger,

a plurality of sensors that sense data from the patient, said data from at least one of said sensors including body temperature,

and a controller unit for receiving said signals from said sensor and controlling the operation of said catheter device to achieve and maintain a target body temperature in response to data from at least one of said sensors.

26. A system as in claim 25, further comprising a heat exchange unit, said heat exchange unit being operative to exchange heat with sad heat exchange fluid.

27. A system as in claim 26 wherein said heat exchange unit comprises a solid-state thermoelectric cooler.

28. A system as in claim 26 wherein said target parameter is a temperature, the sensor is a temperature sensor and said controller is operable to activate said heating unit.

29. A system as in claim 25, further comprising a plurality of catheter devices, said controller operable to control each of said catheter devices.

30. A system as in claim 29 wherein at least one catheter device imparts heat to said body fluid at a first location, and at least one catheter device removes heat from said body fluid at a second location.

31. A system for controllably affecting the temperature of a patient, said system comprising:

a plurality of catheter devices each comprising an elongate flexible catheter having a proximal end and a distal end, the entire length of said flexible catheter being defined as the distance from its proximal end to its distal end, said flexible catheter having an insertion portion, said insertion portion for insertion into the patient, said insertion portion extending from the distal end to a point short of the proximal end, a heat exchanger located at a first location on the catheter, said heat exchanger having heat exchange fins extending from the surface of said heat exchanger, said heat exchange fins comprising increased surface area for enhanced heat exchange, said heat exchanger being operative to exchange heat between body fluid in heat exchange proximity to said heat exchanger and heat exchange fluid circulating through said heat exchanger, said first location extending less than the entire length of the catheter;

a plurality of sensors each of which senses data from the patient and generates a signal in response thereto;

a manual input whereby an operator may specify a target parameter;

a controller unit for receiving the signals from the sensors and said target parameter, and controlling the operation of each of said catheter devices in response to said signals and in relation to said target parameter.

32. A system as in claim 31, further comprising a heat exchange unit, said heat exchange unit being operative to exchange heat with the heat exchange fluid.

33. A system as in claim 32 wherein said heat exchange unit comprises a solid-state thermoelectric cooler.

34. A system as in claim 32 wherein said target parameter is a temperature, the sensors comprise temperature sensors and the controller is operable to activate the heat exchange unit.

35. A system as in claim 31 wherein at least one of the catheter devices imparts heat to said body fluid at a first location and at least one of the catheter devices removes heat from said body fluid at a second location.