Device for hyperthermia treatment

• US 5,571,153 A
• Filed: 03/25/1996
• Issued: 11/05/1996
• Est. Priority Date: 09/20/1991
• Status: Expired due to Term

• Current Assignee: Wallsten Medical SA
• Original Assignee: Hans I. Wallsten
• Inventors: Wallsten, Hans I.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): HUANG, STEPHEN D
• Application Number:
  US08/616,042
• Time in Patent Office: 225 Days
• Field of Search: 604/96, 604/113, 604/114, 606/28, 606/31, 606/33, 607/98, 607/99, 607/104, 607/116, 607/138, 607/96, 607/105, 607/113
• US Class Current: 607/98
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/087 using semiconductors as heating element
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0074 PTC
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

Abstract

A device for hyperthermia treatment in a body cavity or duct which has a narrow access pathway includes an elongate distal section for insertion into the body cavity comprising a centrally-located heat-releasing element enclosed by an elastic enclosure. The heat-releasing element is either surrounded by an elongate housing or is shaped to form a housing. An axially opening inlet passage opens to the proximal part of the housing to supply a heat-transmitting fluid to the housing. The housing has an outlet port to allow fluid to flow from the housing to fill and expand the elastic enclosure to exert pressure on the walls of the body cavity and an inlet port which allows fluid to return into the housing, thus permitting circulation of the fluid during treatment which results in uniform heating of the fluid. The heat-releasing element is formed of an inherently heat self-regulating type material and is either a semi-conductor material of PTC-type having a Curie temperature or Trip point, or a ferromagnetic material having a Curie point in combination with a supply of energy based on magnetic induction.

Claims

1. A device for carrying out hyperthermia in a body cavity or duct having a narrow access path, the device comprising:

an elongate distal section insertable into a body cavity or duct, the elongate distal section including a centrally located, heat-releasing element, which is either surrounded by an elongate housing or is itself constituted by an elongate housing;

means for supplying energy to the heat-releasing element;

an elastic enclosure surrounding said elongate housing in a fluid-tight manner;

wherein the elongate housing has an axially operating inlet passage at a proximal part of the housing adapted to communicate with a source of fluid and an outlet port opening to the elastic enclosure for supplying a heat-transmitting fluid under pressure from the housing to the elastic enclosure for expansion of the elastic enclosure to accommodate and to exert a controlled pressure on walls of a cavity or duct in which the elongate housing is adapted to be inserted and which is adapted to surround the elongate housing; and

means for circulating the fluid in a circuit between the housing and the elastic enclosure, wherein the housing has an inlet port to receive fluid from the elastic enclosure and the heat-releasing element is disposed between the inlet port and the outlet port;

at least one first back valve arranged in the inlet port to allow fluid into the housing from the elastic enclosure, the at least one back valve having a flow resistance in an open position that is lower than a flow resistance through the housing, wherein said means for circulating the fluid in a circuit provides a reciprocating movement of a small quantity of fluid enclosed in the inlet passage after expansion of the elastic enclosure, wherein fluid moves through the inlet into the housing to absorb heat from the heat-releasing element and from the outlet port into the elastic enclosure to release absorbed heat; and

wherein the heat-releasing element is of an inherently self-regulating type and is selected from the group comprising a PCT semi-conductor material having a Curie temperature or Trip point, and a ferromagnetic material having a Curie point in combination with said means for the supply of energy being based on magnetic induction.

2. A device according to claim 1, wherein the device is configured for treatment of uterine disorders and the heat releasing element is of a semiconductor material and the material has a Trip or Curie point lying within the range about 60°

C. to about 90°

C.

3. A device according to claim 2, wherein the material has a Trip or Curie point lying within the range of about 70°

C. to about 80°

C.

4. A device according to claim 1, wherein the device is configured for treatment of prostatic disorders, and the material has a Trip or Curie point within a range about 45°

C. to about 65°

C.

5. A device according to claim 4, wherein said housing has an outer diameter of about 7-8 mm and has a flow capacity to release an amount of fluid to the elastic enclosure sufficient for a heat transfer of at least about 3 W/cm axial length of the housing at a predetermined treating temperature and at a voltage of 24 V.

6. A device according to claim 4 wherein the material has a Trip or Curie point within the range of about 48°

C. to about 56°

C.

7. A device according to claim 1, wherein the heat-releasing element comprises at least two axially and parallel arranged part-elements of a PTC semi-conductor material having substantially parallel surfaces, said part-elements being separated to form passages between and about the part-elements for a flow therethrough of the heat-transmitting fluid for effective and even heat-release to the heat-transmitting fluid.

8. A device according to claim 7, wherein the part-elements each have a thickness that is not greater than about 1.5 mm and that each part-element exhibits an energy generation at steady state of at least about 1 W/cm² exposed element surface at a voltage of about 24 V.

9. A device according to claim 1, wherein said means for internal circulation has a capacity at steady state conditions sufficient to exchange a fluid volume of the housing at a rate of least about 30 fluid volume equivalents per minute.

10. A device according to claim 1, wherein said elongate housing comprises a cylindrical element formed of a PTC semi-conductor material having a central duct for a flow of the heat-transmitting fluid.

11. A device according to claim 1, wherein said at least one back valve comprises a flap valve.

12. A device according to claim 1, wherein said PTC material is shaped for a packing degree in a range of about 35 to about 70% by volume.

13. A device according to claim 1, wherein said heat-releasing element comprises a ferromagnetic material and the means for supplying energy to the heat-releasing element comprises an induction coil intended to surround a body part containing said body cavity or canal.

14. A device according to claim 13, wherein the ferromagnetic material is elongated in a direction of a magnetic induction field.

15. A device according to claim 14, wherein said ferromagnetic material is is shaped to have a packing degree lying within it range of about 25 to about 60% by volume.

16. A device according to claim 14, wherein said elongate distal section comprises a central tubular element and a plurality of parallel, longitudinally extending bars, bands or wires of a ferromagnetic material essentially evenly distributed around said central tubular element and constituting said means for heat generation.

17. A device according to claim 14, wherein said ferromagnetic material is selected from a group consisting of nickel and copper, nickel and silica, iron and platinum or iron and palladium.

18. A device according to claim 1, wherein the means for circulating the fluid comprises a reciprocating piston.

19. A device for carrying out hyperthermia in a body cavity or duct having a narrow access path, the device comprising:

an elongate distal section insertable into a body cavity or duct, the elongate distal section including a centrally located, heat-releasing element, which is either surrounded by an elongate housing or is itself constituted by an elongate housing;

means for supplying energy to the heat-releasing element;

an elastic enclosure surrounding said elongate housing in a fluid-tight manner;

wherein the elongate housing has an axially operating inlet passage at a proximal part of the housing to supply a heat-transmitting fluid under pressure to the housing and an outlet port opening to the elastic enclosure to supply the heat-transmitting fluid under pressure from the housing to the elastic enclosure for expansion of the elastic enclosure to accommodate and to exert a controlled pressure on walls of a cavity or duct in which the elongate housing is adapted to be inserted and adapted to surround the elongate housing; and

means for circulating the fluid in a circuit between the housing and the elastic enclosure, wherein the housing has an inlet port to receive fluid from the elastic enclosure and the heat-releasing element is are disposed between the inlet port and the outlet port,

at least one first back valve arranged in the outlet, a flow resistance of the inlet port being higher than a flow resistance through the housing, said means for circulating the fluid providing a reciprocating movement of a small quantity of the fluid enclosed in the inlet passage after expansion of the elastic enclosure, wherein fluid moves through the inlet port into the housing to absorb heat from the heat-releasing element and from the outlet port into the elastic enclosure to release absorbed heat; and

wherein the heat-releasing element is of an inherently self-regulating type and is selected from the group comprising a PTC semi-conductor material of having a Curie temperature or Trip point, and a ferromagnetic material having a Curie point in combination with said means for the supply of energy being based on magnetic induction.

20. A device for carrying out hyperthermia in a body cavity or duct having a narrow access path, the device comprising:

an elongate distal section insertable into a body cavity or duct, the elongate distal section including a centrally located, heat-releasing element, which is either surrounded by an elongate housing or is itself constituted by an elongate housing;

means for supplying energy to the heat-releasing element;

an elastic enclosure surrounding said elongate housing in a fluid-tight manner;

wherein the elongate housing has an axially operating inlet passage at a proximal part of the housing to provide a heat-transmitting fluid under pressure to the housing and an outlet port opening to the elastic enclosure for supplying the heat-transmitting fluid from the housing to the elastic enclosure for expansion of the elastic enclosure to accommodate and to exert a controlled pressure on walls of a cavity or duct in which the elongate housing is adapted to be inserted and adapted to surround the elongate housing; and

means for circulating the fluid in a circuit between the housing and the elastic enclosure, wherein the housing has an inlet port to receive fluid from the elastic enclosure and the heat-releasing element is disposed between the inlet port and the outlet port;

oppositely operating back valves arranged in the inlet port and the outlet port, wherein said means for circulating the fluid in a circuit provides a reciprocating movement of a small quantity of fluid enclosed in the inlet passage after expansion of the enclosure, wherein fluid moves through the inlet port into the housing to absorb heat from the heat-releasing element and from the outlet port into the elastic enclosure to release absorbed heat; and

wherein the heat-releasing element is of an inherently self-regulating type and is selected from the group comprising a PCT semi-conductor material having a Curie temperature or Trip point, and a ferromagnetic material having a Curie point in combination with said means for the supply of energy being based on magnetic induction.

21. A device according to claim 20, wherein the device is configured for treatment of uterine disorders and the heat releasing element is of a semiconductor material and the material has a Trip or Curie point lying within a range about 60°

C. to about 90°

C.

22. A device according to claim 20, wherein the device is configured for treatment of prostatic disorders, and the material has a Trip or Curie point within a range about 45°

C. to about 65°

C.

23. A device according to claim 20, wherein the heat-releasing element comprises at least two axially and parallel arranged part-elements of PTC semiconductor material having substantially parallel surfaces, said part-elements being separated to form passages between and about the part-elements for a flow therethrough of the heat-transmitting fluid for effective and even heat-release to the heat-transmitting fluid.

24. A device according to claim 20, wherein said means for circulating the fluid has a capacity at steady state conditions sufficient to exchange a fluid volume of the housing at a rate of least about 30 fluid volume equivalents per minute.

25. A device according to claim 20, wherein said elongate housing comprises a cylindrical element formed of PTC semiconductor material having a central duct for a flow of the heat-transmitting fluid.

26. A device according to claim 20, wherein said means for circulating the fluid comprises one of a propeller and an axial pump wheel.

27. A device according to claim 20, wherein said means for circulating the fluid comprises a reciprocating piston having at least one axially directed aperture and at least one corresponding back valve, said piston providing axial flow of the fluid through said housing.

28. A device according to claim 20, wherein at least one of said back valves comprises a flap valve.

29. A device according to claim 20, wherein said PTC material is shaped for a packing degree in a range of about 35 to about 70% by volume.

30. A device for carrying out hyperthermia in a body cavity or duct having a narrow access path, the device comprising:

an elongate distal section insertable into a body cavity or duct, the elongate distal section including a centrally located, heat-releasing element, which is either surrounded by an elongate housing or is itself constituted by an elongate housing;

a flexible and elastic enclosure surrounding said elongate housing in a fluid-tight manner;

means for supplying energy to the heat-releasing element;

wherein the elongate housing has an axially operating first inlet passage at a proximal part of the housing and an outlet for supplying a heat-transmitting fluid under pressure from the housing to the elastic enclosure for expansion of the elastic enclosure to accommodate and to exert a controlled pressure on walls of a cavity or duct in which the elongate housing is adapted to be inserted surrounding the elongate housing;

wherein the elongate housing has an inlet port communicating with the elastic enclosure, the inlet port having a first back valve to allow flow into the housing only, the inlet port located on the housing so that the heat-releasing element is disposed between the inlet port and the outlet port;

a partition disposed in the housing between the heat-releasing element and one of the inlet port and the outlet port, the partition defining a chamber in the housing and having an axially directed aperture containing a second back valve which is oppositely acting relative to the first back valve placed in inlet port; and

means for circulating the fluid through the housing, said means providing a reciprocating movement of a small quantity of the pressurized fluid enclosed in the inlet passage after expansion of the enclosure, so that the fluid flows from the housing to the elastic enclosure through the outlet port and returns to the housing through the inlet port; and

wherein the heat-releasing element is of an inherently self-regulating type and comprises one of a PCT semi-conductor material having a Curie temperature or Trip point, and a ferromagnetic material having a Curie point in combination with said means for the supply of energy being based on magnetic induction.

31. A device for carrying out hyperthermia in a body cavity or duct having a narrow access path, the device comprising:

an elongate distal section insertable into a body cavity or duct, the elongate distal section including a centrally located, heat-releasing element, which is either surrounded by an elongate housing or is itself constituted by an elongate housing;

an elastic enclosure surrounding said elongate housing in a fluid-tight manner; and

means for supplying energy to the heat-releasing element;

wherein the elongate housing has an axially operating first inlet passage at a proximal part of the housing and an outlet port for supplying a heat-transmitting fluid under pressure from the housing to the elastic enclosure for expansion of the elastic enclosure to accommodate and to exert a controlled pressure on walls of a cavity or duct in which the elongate housing is adapted to be inserted surrounding the elongate housing;

wherein the elongate housing has an inlet port to receive fluid from the elastic enclosure, the inlet port located on the housing so that the heat-releasing element is disposed between the inlet port and the outlet port,

means for circulation of said fluid through the housing and the elastic enclosure, said means located between the inlet port and the outlet port and providing an axial flow of the fluid through the housing, wherein the fluid moves through the housing past the heat-releasing element for absorbing heat from the heat-releasing element and from the outlet port into the elastic enclosure to release absorbed heat;

wherein the heat-releasing element is of an inherently self-regulating type and is selected from the group comprising a PCT semi-conductor material having a Curie temperature or Trip point, and a ferromagnetic material having a Curie point in combination with said means for the supply of energy being based on magnetic induction.

32. A device according to claim 31, wherein said means for circulating the fluid comprises one of a propeller and an axial pump wheel.

33. A device according to claim 31, wherein said means for circulating the fluid comprises a reciprocating piston having at least one axially directed aperture and at least corresponding back valve, said piston providing axial flow of the medium through said housing.