Device and method for medical treatment

• US 6,302,904 B1
• Filed: 12/15/1999
• Issued: 10/16/2001
• Est. Priority Date: 12/17/1998
• Status: Expired due to Term

• Current Assignee: Wallsten Medical SA
• Original Assignee: Wallsten Medical SA
• Inventors: Bachmann, Michel, Henriksson, Pär, Wallstén, Hans I.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/461,053
• Time in Patent Office: 671 Days
• Field of Search: 607/96, 607/98, 607/99, 607/101, 607/102, 607/104, 607/105, 607/113, 607/114, 607/138, 606/191-194, 604/96-1-1
• US Class Current: 607/105
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2090/062 penetration depth

Abstract

A device for carrying out hyperthermia in a mammalin uterus cavity, including an elongate, rigid distal section (3) and a flexible and elastic bladder (9) encompassing said distal section which, together with said bladder, is intended for insertion into said uterus cavity, further including means (27) for the supply of a heat-transmitting medium under pressure for the expansion of said bladder (9) within said uterus cavity, and heating means (29) for heating said medium, the device further having an intermediate section (5) whose distal part when inserted is positioned in a cervix canal belonging to said uterus, and a proximal section (7) for operating the device, said distal and intermediate sections (3,5) containing at least a central tube (17), whose distal part is surrounded by said bladder and is provided with at least one outlet (19) for said medium within said bladder, and whose intermediate part is surrounded by an axially displacable tube (21;35), onto whose distal end (23;51) the proximal end (25) of said bladder (9) is attached, characterized by means (15;45) for determining the axial position of the distal end (23;51) of said axially displacable tube and thereby also the axial position of the proximal end (25) of said bladder (9) so that the length of said bladder (9) matches the depth of a cavity subject to treatment, and means (13;47) for locking said tube (21;35) with its distal end (25;51) in such matching position; and the invention also involves methods of thermal treatment of human uterus cavity linings and a device for thermal treatment of mammalian body cavities or ducts, such as urethras.

Claims

1. A method of thermal treatment of a human uterus cavity lining, comprising the steps:

a) estimating the depth of said cavity;

b) adjusting and securing the distance between the axial ends of the heat-emitting part of an elastic bladder to match said cavity depth;

c) inserting the bladder prepared as per step b) above into said cavity;

d) inflating said bladder by introducing a fluid therein under pressure to bring said bladder into contact with substantially all of said lining;

e) heating said fluid to a treatment temperature and maintaining said temperature for a period of time resulting in necrosis of substantially all of said lining; and

f) removing said fluid from said bladder and withdrawing the latter in a collapsed state from said cavity.

2. A method according to claim 1, wherein said distance is adjustable between a minimum length matching a minimal cavity depth and a maximum length matching a maximal cavity depth.

3. A method according to claim 2, wherein the distance given by said minimum length results in a prestretched position of the bladder.

4. A method according to claim 1, wherein said fluid is circulated within or through said bladder during treatment.

5. A method according to claim 1, wherein said fluid is heated inside said bladder.

6. A method according to claim 1, wherein said fluid is heated outside said bladder.

7. The method of claim 1, wherein said step of estimating the depth of said cavity further comprises the step of:

using a sound probe to measure the depth of the cavity plus a length of a cervical canal.

8. A method of thermal treatment of a human uterus cavity lining, comprising the steps:

a) estimating the depth of said cavity;

b) inserting an axially extended elastic bladder into said cavity;

c) adjusting and maintaining during treatment the distance between the axial ends of the heat-emitting part of said bladder to match said cavity depth;

d) inflating said bladder by introducing a fluid therein under pressure to bring said bladder into contact with substantially all of said lining;

e) heating said fluid to a treatment temperature and maintaining said temperature for a period of time resulting in necrosis of substantially all of said lining; and

f) removing said fluid from said bladder and withdrawing the latter in a collapsed state from said cavity.

9. A method according to claim 8, wherein said distance is adjustable between a minimum length matching a minimal cavity depth and a maximum length matching a maximal cavity depth.

10. The method of claim 8, wherein said step of estimating the depth of said cavity further comprises the step of:

using a sound probe to measure the depth of the cavity plus a length of a cervical canal.

11. A device for carrying out hyperthermia in a mammalian uterus cavity, comprising an elongate, rigid distal section and a flexible and elastic bladder encompassing said distal section which, together with said bladder, is intended for insertion into said uterus cavity, further comprising means for the supply of a heat-transmitting medium under pressure for the expansion of said bladder within said uterus cavity, and heating means for heating said medium, the device further comprising an intermediate section whose distal part when inserted is positioned in a cervix canal belonging to said uterus, and a proximal section for operating the device, said distal and intermediate sections containing at least a central tube, whose distal part is surrounded by said bladder and is provided with at least one outlet for said medium within said bladder, and whose intermediate part is surrounded by an axially displacable tube, onto whose distal end the proximal end of said bladder is attached, characterized by means for determining the axial position of the distal end of said axially displacable tube and thereby also the axial position of the proximal end of said bladder so that the heat-emitting length of said bladder matches the depth of a cavity subject to treatment, and means for locking said tube with its distal end in such matching position.

12. A device according to claim 11, wherein said displacable tube is axially displacable between a first position matching a minimal cavity depth and a second position matching a maximal cavity depth.

13. A device according to claim 12, wherein the distance given by said minimal depth results in a pre-stretched position of the bladder.

14. A device according to claim 11, comprising means generating circulation through said bladder.

15. A device according to claim 11, wherein said heating means is comprised by a heating element placed within said bladder.

16. A device according to claim 11, wherein said heating means is comprised by a heating element placed within said intermediate section.

17. A device according to claim 11, wherein said heating element is selected from elements of the type based on electric resistance heating, microwaves, laser and autocontrol.

18. A device according to claim 17, wherein said autocontrol type of element contains PTC or Curie point materials.

19. A device according to claim 11, characterized by a valve arranged at the distal end of said central tube by which air remaining in the system can be evacuated, said tube at its distal end being fixed to the distal wall of the bladder.

20. A device according to claim 11, characterized by an inlet passage for introducing said medium into the bladder, and by an outlet passage for said medium.

21. A device according to claim 20, wherein said outlet passage enables evacuation of air from the system in connection with such introduction of medium.

22. A device according to claim 21, characterized by a pulsating pressure means placed in said inlet passage, and by counteracting back valves placed in said inlet passage between said pulsation means and said bladder, one of said valves opening said inlet passage on a positive pulse, and the other valve opening connection between said outlet passage and said inlet passage on a negative pulse, thereby creating circulation of said medium through said bladder.

23. A device according to claim 20, characterized by a pulsating pressure means placed in said inlet passage, and by counteracting back valves placed in said inlet passage between said pulsation means and said bladder, one of said valves opening said inlet passage on a positive pulse, and the other valve opening connection between said outlet passage and said inlet passage on a negative pulse, thereby creating circulation of said medium through said bladder.

24. A device according to claim 20, characterized by a pressure sensing means connected to said outlet passage for measuring pressure inside the bladder during treatment.

25. A device according to claim 20, characterized by an intermediate tube concentric with and surrounding the central tube, said intermediate tube being connected at its distal end to the distal end of said axially displacable tube so as to move as a unit together with said axially displacable tube, the distal part of said outlet passage being formed by a gap defined between said central tube and the surrounding intermediate tube.

26. A device according to claim 25, wherein said axially displacable tube surrounds the intermediate tube with the formation of an annular gap acting as a thermal insulation to protect the cervical tissue from excessive heating.

27. A device according to claim 11, wherein said axially displacable tube surrounds the central tube with the formation of an annular gap acting as a thermal insulation to protect the cervical tissue from excessive heating.

28. A device for thermal treatment of a mammalian urethra, comprising an elongate, rigid distal section and a flexible and elastic bladder encompassing said distal section which, together with said bladder, is intended for insertion into said urethra, further comprising means for the supply of a heat-transmitting medium under pressure for the expansion of said bladder within said urethra, and heating means for heating said medium, the device further comprising an intermediate section, and a proximal section for operating the device, said distal and intermediate sections containing at least a central tube, whose distal part is surrounded by said bladder and is provided with at least one outlet for said medium within said bladder, and whose intermediate part is surrounded by an axially displacable tube, onto whose distal end the proximal end of said bladder is attached, characterized by means for determining the axial position of the distal end of said axially displacable tube and thereby also the axial position of the proximal end of said bladder so that the heat-emitting length of said bladder matches the area subject to treatment, and means for locking said tube with its distal end in such matching position.