# Patent

## Title
Therapeutic heating and cooling via temperature management of a colon-inserted balloon

## Abstract

A method and apparatus is provided for heating or cooling at least a selected portion of a patient's body. The method begins by inserting a catheter having a balloon into the colon or stomach of the patient. A heated or chilled fluid is conducted through a supply lumen of the catheter and into the balloon. The fluid is evacuated from the balloon through a return lumen of the catheter.

## Background
RELATED APPLICATIONS
This application is a continuation of co-pending U.S. patent application Ser. No. 09/881,175, entitled “THERAPEUTIC HEATING AND COOLING VIA TEMPERATURE MANAGEMENT OF A COLON-INSERTED BALLOON” filed on Jun. 14, 2001 now U.S. Pat. No. 6,726,708, which is a continuation-in-part of U.S. application Ser. No. 60/211,406, entitled “THERAPEUTIC HEATING AND COOLING VIA TEMPERATURE MANAGEMENT OF A COLON-INSERTED BALLOON,” filed on Jun. 14, 2000.


BACKGROUND OF THE INVENTION
I. Field of the Invention
The present invention relates generally to the modification and control of the temperature of the body. More particularly, the invention relates to a method for controlling body temperature by heat transfer to a balloon.
II. Description of the Related Art
Organs in the human body, such as the brain, kidney and heart, are maintained at a constant temperature of approximately 37° C. Hypothermia can be clinically defined as a core body temperature of 35° C. or less. Hypothermia is sometimes characterized further according to its severity. A body core temperature in the range of 33° C. to 35° C. is described as mild hypothermia. A body temperature of 28° C. to 32° C. is described as moderate hypothermia. A body core temperature in the range of 24° C. to 28° C. is described as severe hypothermia.
Patients may require pre or post-operative cooling for a variety of reasons, including, for example, treatment of a malignant hypothermia crisis and induction of therapeutic hypothermia for neurosurgery.
Catheters have been developed which are inserted into the bloodstream of the patient in order to induce total body hypothermia. For example, U.S. Pat. No. 3,425,419 to Dato describes a method and apparatus of lowering and raising the temperature of the human body. The Dato invention is directed towards a method of inducing moderate hypothermia in a patient using a metallic catheter. The metallic catheter has an inner passageway through which a fluid, such as water, can be circulated. The catheter is inserted through the femoral vein and then through the inferior vena cava as far as the right atrium and the superior vena cava. The Dato catheter has an elongated cylindrical shape and is constructed from stainless steel.
Other less cumbersome catheters have been developed to provide cooling intravascularly. For example, a heat transfer element such as disclosed in U.S. Pat. No. 6,096,068, incorporated herein by reference in its entirety, may be placed in the feeding artery of an organ to absorb or deliver the heat from or to the blood flowing into the organ. The transfer of heat may cause either a cooling or a heating of the selected organ. The heat transfer element is small enough to fit within the feeding artery while still allowing a sufficient blood flow to reach the organ in order to avoid ischemic organ damage. By placing the heat transfer element within the feeding artery of an organ, the temperature of the organ can be controlled with less of an effect on the temperature of the remaining parts of the body. A similar heat transfer device, which is employed for whole body cooling and which may be disposed in the venous vasculature, is disclosed in U.S. application Ser. No. 09/373,112, also incorporated by reference in its entirety.
While the previously mentioned techniques provide significant thermal control, they require the insertion of a catheter into the vascular system to induce heat transfer between the catheter and the blood stream. This is a relatively invasive procedure, which has an associated level of risk.
Accordingly, it would be desirable to provide an effective, less invasive method and apparatus for heating or cooling all or part of a patient's body. It would also be desirable to provide an effective, less invasive method and apparatus for heating or cooling all or part of a patient's body that could be employed in emergency situations, such as on an ambulance.
SUMMARY OF THE INVENTION
The present invention provides a method and apparatus for heating or cooling at least a selected portion of a patient's body. The invention provides a method and device to transfer heat to or from the at least a selected portion in an efficient manner. The device has a high degree of flexibility and is collapsible, thereby affording an easy insertion procedure. The device allows a high surface area to increase heat transfer.
The method begins by inserting a balloon catheter through the anus into the colon of the patient. The system includes a supply lumen and an at least partially inflatable return lumen. The return lumen is coupled to the supply lumen so as to transfer working fluid between the two. A heated or chilled fluid is conducted through the supply lumen of the catheter and into the balloon. The fluid is evacuated from the balloon through the return lumen of the catheter. Heat transfer occurs between the working fluid and the tissue of the colon.
Variations of the system may include one or more of the following. The supply lumen and the return lumen may be made of a flexible material such as latex rubber or other plastics. The radii of the supply and return lumens may decrease in a distal direction such that the supply and return lumens are tapered when inflated. A wire may be disposed in the supply or return lumens to provide shape and strength when deflated.
The thickness of the return lumen, when inflated, may be less than about 1⁄2 mil. The length of the supply lumen may be between about 5 and 150 or more centimeters.
The system may further include a coaxial supply catheter having an inner catheter lumen coupled to the supply lumen and a working fluid supply configured to dispense the working fluid and having an output coupled to the inner catheter lumen. The working fluid supply may be configured to produce a pressurized working fluid at a temperature of between about −3° C. and 50° C. Higher or lower temperatures may be employed if desired.
In another aspect, the invention is directed to a method of changing the temperature of a body by heat transfer. The method includes inserting an inflatable heat transfer element into the colon of a patient and inflating the same by delivering a working fluid to its interior. The temperature of the working fluid is generally different from that of the colon tissue. The flexible, conductive heat transfer element preferably absorbs more than about 500 watts of heat.
The circulating may further include passing the working fluid in through a supply lumen and out through a return, coaxial lumen. The working fluid may be a liquid at or well below its boiling point, and furthermore may be aqueous.
Advantages of the invention include one or more of the following. The design criteria described above for the heat transfer element: small diameter when deflated, large diameter when inflated, high flexibility, and enhanced heat transfer rate through increases in the surface of the heat transfer element facilitate creation of a heat transfer element which successfully achieves patient cooling or heating. The process is relatively non-invasive. In addition, rapid cooling or heating to a precise temperature may be achieved. Further, treatment of a patient is not cumbersome and the patient may easily receive continued care during the heat transfer process. The device and method may be easily combined with other devices and techniques to provide aggressive multiple therapies. The device may employ the ubiquitous saline as a working fluid. The device has a very high surface area, particularly as the length may be on the order of a meter and the diameter on the order of 0.1 meters. Use of the device may not require the sedation of the patient. The power transferred during cooling could be as high as 600 to 1000 watts. Other advantages will become clear from the description below, including the figures and claims, as well as from the above.



BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
The novel features, objects, and advantages of the invention will become more apparent from the detailed description set forth below when taken in conjunction with the drawings in which like reference characters identify corresponding elements throughout.
FIGS. 1 and 2 show schematic diagrams of the digestive tract, FIG. 2 being an expanded view;
FIG. 3 shows a schematic diagram of a device according to an embodiment of the invention;
FIG. 4A shows a prior art heat exchange system;
FIG. 4B shows a heat exchange system constructed in accordance with an embodiment of the invention; and
FIGS. 5A and 5B show embodiments of an alternative embodiment of the invention in use within the stomach, showing both deflated and inflated states.



DETAILED DESCRIPTION OF THE INVENTION
The present invention provides a relatively non-intrusive method and apparatus for heating or cooling all or part of a patient's body. The invention achieves this result by circulating a heat transfer fluid through a balloon (not shown in FIG. 1) disposed in a patient's colon 11 (see FIG. 1). The colon 11 forms part of the large intestine 10. The rectum 13 forms the remaining part of the large intestine 10. The final stage in the digestive process is passage through the anus 15. The colon 11 has four parts: the ascending colon 23, the transverse colon 21, the descending colon 19, and the sigmoid colon 17. Various other components are also shown in FIG. 1.
FIG. 2 shows an enlarged view of the large intestine 10 and colon 11.
Heat transfer via the colon 11 is advantageous because the colon 11 is located in the abdominal cavity, is surrounded by a variety of organs, and in addition the tissues of the colon walls may be highly perfused with blood. Further, the abdominal cavity volume includes a substantial portion of the high blood flow vessels the aorta and the inferior vena cava. The working fluid absorbs heat from or delivers heat through the wall of the colon 11 and into the abdominal cavity and the arterial and venous vessels populating this area, thereby regulating the temperature of a patient's whole body or one or more selected organs. As a result, cooling of the internal organs and a considerable amount of blood can be accomplished without the invasive step of inserting a catheter directly into the vascular system.
The mechanism of heat transfer into and out of the catheter is via conduction. Once the tissue of the colon has a modified temperature, the mechanism of heat transfer may be via convection through the blood as well as by conduction through the tissue.
FIG. 3 shows one embodiment of the colon thermal control system constructed in accordance with the present invention. The system includes a catheter 100, a control system 26, and a circulation set (not shown) partially housed by a console 21. The control system 26 may be equipped with an output display and input keys to facilitate user interaction. The complexity of the console 21 depends on the application to which the same is put. For example, for a rewarming application, the console 21 may be a simple Mallinkrodt Blood and Fluid Warmer, as manufactured by Mallinkrodt Medical of St. Louis, Mo.
In the same way, for certain applications, such as for rewarming or maintaining normothermia during a surgery or other procedure, the nature of the heat exchanger used within the control system may be simple, such as a simple resistive heat exchanger or thermo-electric heat exchanger.
The catheter 100, which may employ a design similar to that of a large balloon catheter, for example, is configured for insertion into the colon. The proximal end of the catheter 100 includes a manifold 105 having an inlet port 102 and an outlet port 104 on its proximal end. The supply lumen 27 and the return lumen 25 are connected to a port located on the distal end of the manifold 105. At the catheter's distal end the supply and return lumens are fluidly coupled via an orifice 29. The catheter may have an inflated diameter of, e.g., 1-10 cm or another size as dictated by the requirements of the user.
The catheter 100 may be made of a very soft material so as to minimize tissue damage of the colon and other organs upon insertion. The same may be coated with various materials to minimize deleterious coating of undesired biological materials on the tip during or after insertion.
The supply and return lumens may be formed from a pair of concentric flexible tubes so that the supply lumen may be concentrically located within the annular return lumen. Of course, the same may also be non-coaxial as dictated by the requirements of the user. As shown in FIG. 3, when the catheter 100 is properly inserted into the colon its distal end may be located in the ascending colon 23. Fluid is conducted into the balloon, i.e., inflatable return lumen 25, from the supply lumen 27 via orifice 29.
As in a conventional Foley catheter for the urethra, the catheter 100 may include an additional anchoring balloon (not shown) near its proximal end to prevent its expulsion from the colon. The anchoring balloon may also serve the purpose of anchoring the catheter against movement caused by a pulsating working fluid supply, as may be the case if certain types of pumps are employed to drive the working fluid. The anchoring balloon may be inflated by a single inflation lumen, a dual inflation lumen, or other such lumen as are known.
The circulation set and console may include any of the features of such systems described in co-pending applications Ser. No. 60/247,203, filed Nov. 7, 2000, entitled “Improved Circulation Set for Temperature Controlled Catheter and Method of Using Same”, and Ser. No. 09/827,010, filed Apr. 5, 2001, entitled “Method and Apparatus for Regulating Patient Temperature by Irrigating the Bladder with a Fluid”, both of which are incorporated herein by reference in their entirety. These applications disclose one or more of the following: a fluid reservoir, a pump, a filter, a heat exchanger, a temperature and pressure sensor assembly, a supply line, and a return line. The supply line and return line are preferably comprised of one or more pieces of tubing, connectors, etc. joining the aforementioned components of the circulation set. The circulation set supplies, filters, circulates, and monitors the temperature and pressure of the heat transfer fluid for the catheter 100.
The pressure inside the balloon is preferably not higher than about 10 psi, and may be about 0 to 3 psi.
In one embodiment, the fluid reservoir is a modified IV bag made of PVC filled with saline. Considering the heat transfer expected, the flow rate of the saline may be about 10 to 100 cc/sec, or even higher. The temperature of the saline may vary such that in a cooling mode, the saline is maintained between about 0° C. and 5° C., whereas in heating the same is maintained between about 40° C. and 42° C. Other fluids may also be used according to the requirements of the user.
The fluid reservoir is used to prime the lines of the circulation set and the lumens of the catheter 100. For example, the system may be primed with 0.9% saline, and then the pump speed adjusted appropriately.
The heat exchanger, which is used to heat or chill the fluid supplied to the catheter, may be any of a variety of conventionally designed heat exchangers. As noted above, the heat exchanger may employ a resistive heater, a microwave heater, a thermoelectric device, a closed-circuit temperature control system, etc.
The temperature and pressure sensor assembly may include alarms that shut down the system if a dangerous situation arises. For example, a maximum safe temperature of working fluid may be about 50° C. If this temperature were exceeded, the system may be designed to shut itself down or even turn itself off. Alternatively, a high temperature may be allowed, but only for a short predetermined period of time insufficient to cause tissue damage.
A control system may be provided to accept a temperature feedback signal and to control the temperature of the working fluid thereby. Of course, it is noted that the location of the catheter 100, in the abdominal cavity, may have an associated time delay with respect to the patient temperature due to the slow mechanism of heat transfer (conduction) through the colon walls. Such a time lag may be expected to be about 10 to 20 minutes.
The fluid may be provided to the supply lumen in a continuous, constant flow or as a pulsed flow of fluid. The pulsed flow may be a flow that is either intermittently interrupted or simply reduced in rate on an intermittent basis. For example, the flow rate may be pulsed at a frequency of every few minutes. The present invention also contemplates more complex flow rate patterns such as periodic and aperiodic oscillatory patterns.
As the insertion of a rectal-type catheter is generally uncomplicated, and can be performed by nurses or emergency personnel, embodiments of the invention may be implemented on an emergency vehicle such as an ambulance. One aspect allowing this may be inclusion in certain embodiments of a compressed gas system to cool a circulating fluid. It is again noted that in heating embodiments a simple resistive heater may be employed.
Prior chiller units employing a closed cycle evaporative gas system were complicated, expensive, and difficult to simplify and miniaturize for use in a portable transportable system. Further, they required significant electrical power to operate. For example, referring to FIG. 4A, a prior art refrigeration system 200 is shown. Such a system is exceedingly well known, and includes a pump 202, a heat exchanger 204, a restriction valve 208, and an apparatus 206 to exhaust heat to a temperature bath. In this system, as is known, a liquid to gas heat exchanger transfers heat from the working fluid to the cold side of an evaporative chiller.
A system 201 according to an embodiment of the present invention is shown in FIG. 4B. In this figure, a source of compressed gas 218 is valvably coupled via valve 220 to an optional restriction valve 222 to a heat exchanger 224. A working fluid output for, e.g., cold working fluid, is labeled by outlet 214. A working fluid input for, e.g., hot working fluid, is labeled by inlet 216. An exhaust to the environment is shown as exhaust 226.
In system 201, a compressed gas from source 218 is expanded adiabatically through a valve. The expansion results in a reduced temperature gas that absorbs heat from the working fluid in the liquid-to-gas heat exchanger 224. The heated, expanded gas is then discarded to the environment via exhaust 226. An additional temperature reduction in the expanded gas may be achieved by the phase change from the storage pressure to the expanded pressure.
Gases which may be useful in embodiments of the invention employing adiabatic expansion include nitrogen, carbon dioxide, etc. Gases which may be useful in embodiments of the invention employing adiabatic expansion with a phase change include nitrous oxide.
Referring to FIGS. 5A and 5B, it should also be clear to one of skill in the art given the teaching herein that an analogous balloon 300 may be located in the stomach 301 to cool or heat that organ and thus the vasculature surrounding the stomach, leading to temperature management of all or a portion of the patient. A plurality of longitudinally spaced working fluid exits 306 may be disposed along a supply lumen 304 that is placed within a return lumen 302 having the approximate shape of a stomach 301. In such a way, the return lumen 302 when inflated takes the approximate shape of the stomach to enhance heat transfer. The temperature and pressure requirements of this embodiment may be approximately the same as that in the colon embodiment, although obviously this embodiment would be inserted through the esophagus. This embodiment may have the further advantage of being in close proximity to the liver, lungs, as well as other major arteries and veins. Thus, convection can rapidly become a major component of heat transfer and it is expected that power of up to or in excess of 1000 watts can be transferred.
While the invention herein disclosed is capable of obtaining the objects hereinbefore stated, it is to be understood that this disclosure is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended other than as described in the appended claims. For example, the invention can be used in a wide variety of settings, e.g., in the applications of general surgery, and in particular lengthy surgeries, orthopedic and back surgery, liver transplants, etc. Further, suction may be implemented on the return lumen in order to maintain even lower pressures inside the balloon, particularly when the flow rate of working fluid is increased to 10-200 cc/s. A guide wire may be used to place the catheter 100 in the desired location. While the colon embodiment shown spans the ascending, transverse, and descending colons for maximum power transferred, lower power requirements may be met by placing the catheter in less than the entire colon.

## Claims

1. A method for heating or cooling at least a selected portion of a body, said method comprising:
irrigating a balloon inserted into the colon with a heated or chilled fluid;
controlling at least one measurable parameter of the fluid irrigating the balloon;
evacuating the fluid from the balloon; and
monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the balloon,
wherein irrigating the balloon includes the step of irrigating the balloon with a flow of fluid, and
wherein the at least one measurable parameter is selected from the group consisting of the flow rate of the fluid and the pressure differential between the fluid flowing into and out of the balloon.

2. The method of claim 1, further comprising maintaining the pressure of the heated or chilled fluid in the balloon to between about 1 and 10 psi.

3. The method of claim 2, further comprising maintaining the pressure of the heated or chilled fluid in the balloon to between about 1 and 3 psi.

4. The method of claim 1, wherein the conducting includes delivering the heated or chilled fluid at a substantially constant rate.

5. The method of claim 4, wherein the substantially constant rate is between about 1 and 200 cc/sec.

6. A method for heating or cooling at least a selected portion of a body, said method comprising:
irrigating a balloon inserted into the colon with a heated or chilled fluid;
controlling at least one measurable parameter of the fluid irrigating the balloon;
evacuating the fluid from the balloon;
monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the balloon; and
controlling a flow rate, or pressure of the heated or chilled fluid based on a monitored patient temperature.

7. The method of claim 6, wherein said heated or chilled fluid comprises saline.