Thermal treatment apparatus

• US 6,849,063 B1
• Filed: 11/05/1999
• Issued: 02/01/2005
• Est. Priority Date: 03/11/1994
• Status: Expired due to Fees

• Current Assignee: Wit Ip Corporation
• Original Assignee: Wit Ip Corporation
• Inventors: Eshel, Uzi, Lazarovitz, Jacob, Crabtree, J. Graham
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): Dagostino, Sabrina
• Application Number:
  US09/433,952
• Time in Patent Office: 1,915 Days
• Field of Search: 604/65, 604/67, 604/113, 606/27, 606/28, 603/113
• US Class Current: 604/113
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0086 with a thermostat
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0296 Intervals of heating alternated with intervals of cooling
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: F04B 43/1253 by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing
• CPC Class Codes: F24H 1/121 using electric energy supply

Abstract

A temperature-setting device for providing a predetermined temperature to a quantity of fluid circulating therethrough, a thermal treatment apparatus including such device for selectively treating a targeted tissue adjacent a subject'"'"'s body cavity, and techniques using such thermal treatment apparatus are provided. The temperature-setting device comprises: an electrically conducting tubular element, a housing element for receiving the tubular element; and a transformer electrically connectable to the housing element. The tubular element functions as a resistor and heats the fluid circulating therethrough. Alternatively, the housing element comprises a thermal conducting member disposed within a bath of a cooling substance, the thermal conducting member having a recess for receiving the tubular element. The tubular element may alternately be placed in a housing element functioning as a heater and a housing element functioning as a cooler, thereby alternately heating or cooling the fluid circulating therethrough. The thermal treatment apparatus comprises: a temperature-setting device according to the present invention; a catheter insertable into a subject'"'"'s body cavity, the catheter including a thermal treating section for thermally treating a targeted tissue; a pump; thermal sensor assemblies; and an air trapping element.

Claims

1. Thermal treatment apparatus for selectively treating a targeted tissue adjacent a subject'"'"'s body cavity, comprising a closed system of circulating fluid and a controller for controlling said closed system, said closed system including:

(a) a temperature-setting device for providing a predetermined temperature to a quantity of fluid circulating therethrough, including;

(i) a tubular element having electrical conductivity and thermal conductivity configured to apply heat to circulating fluid as the circulating fluid flows therethrough, said tubular element having two ends connectable to electrically and thermally insulating tubular elements;

(ii) a housing element for receiving said tubular element, said housing element including fastening elements, said fastening elements including a connector member having electrical conductivity connectable to an electrical circuit; and

(iii) a transformer element operatively associated with said electrical circuit, said transformer element electrically connected to said controller;

(b) a catheter insertable into a body cavity, said catheter in fluid communication with said tubular element of said temperature-setting device, said catheter including a thermal treating section for thermally treating a targeted tissue adjacent said body cavity by circulating fluid of a predetermined temperature through said thermal treating section in a closed loop system, said catheter being disposable;

(c) a pump for pumping said fluid of predetermined temperature through said closed loop system, said pump in fluid communication with said tubular element of said temperature-setting device, said pump electrically connected to said controller; and

(d) a thermal sensor assembly for sensing the temperature of fluid circulating into said catheter, said thermal sensor assembly in communication with the fluid that circulates through said catheter, said thermal sensor assembly electrically connected to said controller.

2. The apparatus of claim 1, wherein said apparatus further includes a second thermal sensor assembly for sensing the tempetature of fluid circulating out of said catheter, said second thermal sensor assembly having two ends, one of said ends connectable to said catheter and the other of said ends connectable to said pump by means of said insulating tubular elements, said second thermal sensor assembly electrically connected to said controller.

3. The apparatus of claim 1, wherein said apparatus further includes an air trapping element for trapping air circulating in the system, said air trapping element comprising a hung container connectable to said closed system, said air trapping element being disposable.

4. The apparatus of claim 1, wherein said temperature-setting device further includes a sensor for sensing the temperature of said tubular element, said sensor electrically connected to said controller.

5. The apparatus of claim 4, wherein said controller controls the duty cycle of said transformer element according to the temperature sensed by said sensor.

6. The apparatus of claim 4, wherein said controller interrupts the operation of said transformer element, said electrical circuit and said closed system upon a certain value of temperature sensed by said sensor.

7. The apparatus of claim 4, wherein said housing element of said temperature-setting device features a recess for receiving said tubular element, and a contact between said tubular element and said sensor is established upon mounting of said tubular element in said recess under pressure.

9. The apparatus of claim 1, wherein said tubular element of said temperature-setting device, said insulating tubular elements and other tubular elements constituting the closed system are disposable.

15. The apparatus of claim 1, wherein said catheter includes a proximal end formed with an inflatable thermal treating section to be located within the body cavity, and a distal end to be located externally of the body cavity;

said catheter being formed with first and second passageways extending from said distal end to said inflatable thermal treating section for circulating fluid of a predetermined temperature through said inflatable thermal treating section.

16. The apparatus of claim 15, wherein said catheter further includes thermal insulation surrounding said first and second passageways from close to said distal end to close to said inflatable thermal section, said thermal insulation including a plurality of separate compartments containing a non-heated fluid, said compartments extending axially along the catheter, thereby the inflatable thermal treating section and the targeted tissue in its proximity may be heated to a desired temperature without correspondingly heating non-targeted tissues.

19. The apparatus of claim 1, wherein said pump includes:

(a) a housing formed with a substantially cylindrical cavity having an inner surface, said housing provided with a lid, said lid having a depending skirt removably engageable within said cylindrical cavity so as to form an inset lining around a part of said inner surface;

(b) a rotor rotatably mounted within said cylindrical cavity, said rotor carrying rollers; and

(c) a peristaltic tube, said peristaltic tube being disposable, such that, when said depending skirt is not engaged in said cylindrical cavity, the peristaltic tube may be easily inserted between said rollers and said inner surface and, when said depending skirt is engaged in said cylindrical cavity, the peristaltic tube is engaged between said rollers and said inset lining such that rotation of said rotor pumps fluid through the peristaltic tube.

30. A thermal treatment apparatus according to claim 1, wherein said tubular element of said temperature setting device is a single-use disposable element.

31. A thermal treatment apparatus according to claim 1, wherein said thermal apparatus is a closed loop system configured, in operation, to substantially continuously circulate between about 10-50 ml of thermally treated liquid.

8. Thermal treatment apparatus for selectively treating a targeted tissue adjacent a subject'"'"'s body cavity, comprising a closed system of circulating fluid and a controller for controlling said closed system, said closed system including:

(a) a temperature-setting device for providing a predetermined temperature to a quantity of fluid circulating therethrough, including;

(i) a tubular element having electrical conductivity and thermal conductivity configured to allow circulating fluid to flow therethrough;

(ii) a housing element for receiving said tubular element, said housing element comprising an electrical circuit operatively associated with said tubular element and a fastening member for anchoring said tubular element therein; and

(iii) a transformer element connectable to said electrical circuit, said transformer element electrically connected to said controller;

(b) a catheter insertable into a body cavity, said catheter in fluid communication with said tubular element of said temperature-setting device, said catheter including a thermal treating section for thermally treating a targeted tissue adjacent said body cavity by circulating fluid of a predetermined temperature through said thermal treating section, said catheter being disposable;

(c) a pump for pumping said fluid of predetermined temperature through said closed system, said pump in fluid communication with said tubular element of said temperature-setting device, said pump electrically connected to said controller; and

(d) a thermal sensor assembly for sensing the temperature of fluid circulating into and/or out of said catheter, said thermal sensor assembly electrically connected to said controller, wherein the voltage produced in said electrical circuit is between about 1-5 volts.

10. Thermal treatment apparatus for selectively treating a targeted tissue adjacent a subject'"'"'s body cavity by exchanging heat with said targeted tissue, comprising a closed system of circulating fluid and a controller for controlling said closed system, said closed system including:

(a) a temperature-setting device for providing a predetermined temperature to a quantity of fluid circulating through the closed system;

including

(i) a tubular element having thermal conductivity for receiving a quantity of circulating fluid; and

(ii) a housing element for receiving said tubular element, said housing element configured for exchanging heat with said tubular element, said housing element detachably connectable to said tubular element;

(b) a catheter insertable into a body cavity, said catheter in fluid communication with said tubular element of said temperature-setting device, said catheter including a thermal treating section for thermally treating a targeted tissue adjacent said body cavity by circulating fluid of a predetermined temperature through said thermal treating section, said catheter being disposable;

(c) a pump for pumping said fluid of predetermined temperature through said closed system, said pump in fluid communication with said tubular element of said temperature-setting device, said pump electrically connected to said controller; and

(d) a thermal sensor assembly for sensing the temperature of fluid circulating into and/or out of said catheter, said thermal sensor assembly in communication with said tubular element of said temperature-setting device, said thermal sensor assembly electrically connected to said controller.

11. The apparatus of claim 10, wherein said temperature-setting device includes a second housing element for receiving said tubular element, each of said housing elements being detachably connectable to a thermal source, said tubular element being transferable between said housing elements for controllably heating and cooling the fluid circulating therethrough.

12. The apparatus of claim 11, wherein said tubular element features substantially low electrical conductivity, and wherein said housing element includes connectors having substantially good electrical conductivity, said connectors being electrically connected to an electrical circuit, said connectors for receiving said tubular element, and wherein said second housing element is connected to a cooling source.

17. The apparatus of claim 10, wherein said catheter includes a proximal end formed with an inflatabe anchoring section for anchoring the catheter in the body cavity, a distal end to be located externally of the body cavity, and an inflatable thermal treating section adjacent said proximal end to be located near the targeted tissue;

said catheter being formed with first and second passageways extending from said distal end to said inflatable thermal treating section for circulating fluid of a predetermined temperature through said inflatable thermal treating section, and a third passageway extending from said distal end to said inflatable anchoring section for introducing unheated fluid into said inflatable anchoring section.

18. The apparatus of claim 17, wherein said catheter further includes thermal insulation surrounding said first and second passageways from close to said distal end to close to said inflatable thermal treating section, said thermal insulation including a plurality of separate compartments containing a non-heated fluid, said compartments extending axially along the catheter, thereby the inflatable thermal treating section and the targeted tissue in its proximity may be heated to a desired temperature without correspondingly heating non-targeted tissues.

32. A thermal treatment apparatus according to claim 10, wherein said tubular element and said insulating tubular elements are single-use disposable elements.

33. A thermal treatment apparatus according to claim 10, wherein said thermal apparatus is a closed loop system configured, in operation, to substantially continuously circulate between about 10-50 ml of thermally treated liquid.

13. Thermal treatment apparatus for selectively treating a targeted tissue adjacent a subject'"'"'s body cavity by heating and cooling said targeted tissue, comprising a closed loop system of circulating fluid and a controller for controlling said closed loop system, said closed loop system including:

(a) a temperature-setting device for heating and cooling a quantity of fluid circulating therethrough, including;

(i) a tubular element having thermal conductivity for selectively heating a quantity of circulating fluid flowing therethrough, said tubular element having two ends connectable to thermally insulating tubular elements;

(ii) a housing element for alternately heating and cooling said tubular element, said housing element including two thermal conducting plates, each having a recess, said recesses defining a tunnel for receiving said tubular element under pressure;

(iii) a heating source detachably connectable to said housing element; and

(iv) a cooling source detachably connectable to said housing element, said housing element configured for controllably heating and cooling said tubular element, thereby alternately heating and cooling the fluid circulating therethrough;

(b) a catheter insertable into a body cavity, said catheter connectable to said tubular element of said temperature-setting device by means of said insulating tubular element, said catheter including a thermal treating section for thermally treating a targeted tissue adjacent said body cavity by circulating fluid of a predetermined temperature through said thermal treating section, said catheter being disposable;

(c) a pump for pumping said fluid of predetermined temperature through said closed loop circulating fluid system, said pump connectable to said tubular element of said temperature-setting device by means of said insulating tubular element, said pump electrically connected to said controller; and

(d) a thermal sensor assembly for sensing the temperature of fluid circulating into and/or out of said catheter, said thermal sensor assembly comprising a thermal tube having two ends, one of said ends connectable to said catheter and the other of said ends connectable to said tubular element of said temperature-setting device by means of said insulating tubular elements, said thermal sensor assembly electrically connected to said controller.

14. The apparatus of claim 13, wherein said temperature-setting device comprises:

(a) a tubular element having relatively good thermal conductivity for receiving a quantity of circulating fluid, said tubular element having two ends connectable to thermally insulating tubular elements, said tubular element and said insulating tubular elements being disposable;

(b) a housing element for alternately heating and cooling said tubular element, said housing element comprising two thermal conducting plates, each having a recess, said recesses defining a tunnel for receiving said tubular element under pressure; and

(c) peletier heat pump elements detachably connectable to said thermal conducting plates,

said peletier heat pump elements alternately heating and cooling said thermal conducting plates, thereby alternately heating and cooling the fluid circulating through said tubular element.

20. Thermal treatment apparatus for selectively treating a targeted tissue adjacent a subject'"'"'s body cavity, comprising a closed system of circulating fluid and a controller for controlling said closed system, said closed system including:

(a) a temperature-setting device for providing a predetermined temperature to a quantity of fluid circulating therethrough, including;

(i) a tubular element having electrical conductivity and thermal conductivity for exchanging heat with a quantity of circulating fluid flowing therethrough;

(ii) a housing element for receiving said tubular element, said housing element including an electrical circuit operatively associate with said tubular element and a fastening member for anchoring said tubular element therein; and

(iii) a transformer element in communication with said electrical circuit, said transformer element electrically connected to said controller;

(b) a catheter insertable into a body cavity, said catheter in fluid communication with said tubular element of said temperature-setting device, said catheter including a thermal treating section for thermally treating a targeted tissue adjacent said body cavity by circulating fluid of a predetermined temperature through said thermal treating section, said catheter being disposable;

(c) a pump for pumping said fluid of predetermined temperature through said closed system, said pump in fluid communication with said tubular element of said temperature-setting device, said pump electrically connected to said controller; and

(d) a thermal sensor assembly for sensing the temperature of fluid circulating into said catheter, said thermal sensor assembly operatively associated with said tubular element of said temperature-setting device, said thermal sensor assembly electrically connected to said controller, wherein said thermal sensor assembly includes;

a thermal sensor;

a disposable metal tube connectible to the end of a passageway of the catheter to receive the fluid flowing therethrough;

a metal thermal coupling member formed with a recess on one face for receiving the thermal sensor therein, a recess on the opposite face complementary to the shape of the metal tube for receiving the metal tube therein, and a relatively then web between the two recesses; and

a cover pressing said metal tube to said thermal coupling member.

21. A closed loop thermal treatment apparatus for a body cavity, comprising:

(a) a catheter for insertion into the body cavity, said catheter being capable of circulating a quantity of circulating fluid;

(b) a temperature-setting device for setting a temperature of said fluid being received by said catheter, said temperature-setting device comprising;

(i) a tubular element, said tubular element being attached to said catheter such that fluid flows through said tubular element to said catheter; and

(ii) a power source operably associated with said tubular element to supply power to said tubular element such that said tubular element controllably heats the circulating fluid as the fluid flows therethrough; and

(c) a pump in fluid communication with said tubular element, said pump configured to drive said fluid through said tubular element; and

(d) an air trap in fluid communication with said circulating fluid for removing air from said circulating fluid.

22. The thermal treatment apparatus of claim 21, wherein said power source comprises a transformer, and wherein said temperature-setting device further comprises:

(a) a temperature sensor for sensing a temperature of said fluid, said temperature sensor being in communication with said tubular element; and

(b) a controller for controlling said transformer, said controller being connected to said temperature sensor and to said transformer such that said controller is able to control said transformer to controllably power said tubular element based on a desired target thermal treatment temperature and an actual sensed temperature of said fluid.

23. The thermal treatment apparatus of claim 21, further comprising:

(d) an inflatable thermal treating section configured to be placed within the body cavity, said inflatable thermal treating section being formed at one end portion of said catheter.

24. The thermal treatment apparatus of claim 23, wherein said catheter further features:

(i) a first passageway and a second passageway connected to said inflatable thermal treating section such that said fluid flows from said catheter into said inflatable thermal treating section.

27. The apparatus of claim 21, wherein said pump fixer features:

(i) a housing formed with;

(1) a substantially cylindrical cavity; and

(2) a lid, said lid having a depending shirt removably engageable within said cylindrical cavity;

(ii) a rotor rotatably mounted on a drive shaft within said cylindrical cavity, said rotor carrying rollers; and

(iii) a peristaltic tube connected to said tubular element, said peristaltic tube being engaged between said depending skirt and said rollers, such that a rotation of said rotor causes said fluid to flow from said peristaltic tube to said tubular element.

34. A thermal treatment apparatus according to claim 21, wherein said tubular element of said temperature setting device is a single-use disposable element.

35. A thermal treatment apparatus according to claim 21, wherein said thermal apparatus is a closed loop system configured, in operation, to substantially continuously circulate between about 10-50 ml of thermally treated liquid.

25. A thermal treatment apparatus for a body cavity, comprising:

(a) a catheter for insertion into the body cavity, said catheter being capable of receiving a quantity of circulating fluid, said catheter comprising;

(i) an inflatable thermal treating section configured to be placed within the body cavity, said inflatable thermal treating section being formed at one end portion of said catheter;

(ii) a first passageway and a second passageway connected to said inflatable thermal treating section such that said fluid flows from said catheter into said inflatable thermal treating section;

(b) a temperature-setting device for setting a temperature of said fluid being received by said catheter, said temperature-setting device comprising;

(i) a tubular element, said tubular element being attached to said catheter such that fluid flows through said tubular element to said catheter; and

(ii) a transformer electrically connected to said tubular element, said transformer configured to supply power to said tubular element such that said tubular element heats the fluid as the fluid flows therethrough; and

(c) a pump in fluid communication with said tubular element, said pump configured to drive said fluid through said tubular element; and

(d) an air trap in fluid communication with said circulating fluid for removing air from said circulating fluid;

wherein said catheter further comprises;

an insulating chamber forming an outer portion of said catheter, said insulating chamber surrounding at least a portion of said first passageway an at least a portion of said second passageway, substantially before said first passageway and said second passageway connect to said inflatable thermal treating section, said insulating chamber containing a non-heated fluid, such that substantially only said inflatable thermal treating section is able to radiate heat sufficient to thermally ablate tissue.

26. The apparatus of claim 25, wherein the temperature of said non-heated fluid of said insulating chamber is substantially lower than said temperature of said fluid flowing through said first passageway and said second passageway.

28. A closed loop thermal treatment apparatus for a body cavity, comprising:

(a) a catheter for insertion into the body cavity, said catheter being capable of receiving a quantity of circulating fluid;

(b) a temperature-setting device for setting a temperature of said circulating fluid being received by said catheter, said temperature-setting device comprising;

(i) a tubular element, said tubular element being attached to said catheter such that circulating fluid flows through said tubular element to said catheter; and

(ii) a transformer electrically connected to said tubular element, said transformer configured to supply power to said tubular element such that said tubular element heats the circulating fluid as the fluid flows therethrough; and

(c) a pump in fluid communication with said tubular element, said pump configured to drive said fluid through said tubular element; and

(d) an air trap in fluid communication with said circulating fluid for removing air from said circulating fluid,

wherein said air trap comprises a plurality of valves, such that said fluid flows into said air trap substantially only when said valves are open, said valves being open substantially only when the apparatus is being primed.

29. The apparatus of claim 28, wherein said catheter, said air trap, said tabular element and said pump form a substantially closed system when the apparatus is being primed, and alternatively wherein said catheter, said tubular element and said pump form a substantially closed system after the apparatus has been primed.