EP0625893A1 - Heated balloon medical apparatus - Google Patents
Heated balloon medical apparatusInfo
- Publication number
- EP0625893A1 EP0625893A1 EP94900602A EP94900602A EP0625893A1 EP 0625893 A1 EP0625893 A1 EP 0625893A1 EP 94900602 A EP94900602 A EP 94900602A EP 94900602 A EP94900602 A EP 94900602A EP 0625893 A1 EP0625893 A1 EP 0625893A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- fluid
- access port
- lumen
- fluid access
- bladder
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
- A61F7/12—Devices for heating or cooling internal body cavities
- A61F7/123—Devices for heating or cooling internal body cavities using a flexible balloon containing the thermal element
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
- A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
- A61B2017/4216—Operations on uterus, e.g. endometrium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00559—Female reproductive organs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
- A61F2007/0054—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water
Definitions
- U.S. Patent No. 3,369,549 discloses a therapeutic device for applying heat or cold to body cavities comprising a capsule probe containing a heat exchanger and a flexible bladder that can be inflated to conform to a body cavity. Armao does not, however, disclose a control means for regulating the temperature and pressure of the flexible applicator, nor does he disclose cauterizing tissue in the cavity being treated.
- U.S. Patent No. 3,369,549 issued to Armao
- 4,160,455 to Law discloses a heater for heating fluid within a body cavity of an animal, e.g., for heating tumors by irrigation, comprises a container having inlet and outlet ports through which fluid in the cavity is passed by an external pump, and a heating element in the container to heat at least some of the fluid that passes through the container.
- Pumping can be achieved by a fluid filled pipe coupled to the container, either directly by or by way of a diaphragm, and to a bellows or like arrangement for cyclicly varying the pressure of the fluid in the pipe and container.
- a common problem associated with some of the above- described prior art devices is that a large volume of heated fluid, i.e., greater than about 30 cc is circulated through the system. In the event of balloon rupture, this volume of pressurized fluid would leave the confines of the balloon with possible adverse affects on the patient.
- Another problem associated with some of these prior art devices is the difficulty of maintaining sterility of the fluid when the fluid is heated in a remote heating unit.
- the present invention also provides an apparatus for thermally treating of the tissue lining of a body cavity, and, in particular, substantially the entirety of the endometrium of a mammalian uterus comprising: a catheter having a proximal end and a distal end and provided with a first lumen and a second lumen, said first lumen provided with a proximal fluid access port and a distal fluid access port, said second lumen provided with a proximal fluid access port and a distal fluid access port; a distendable bladder means attached to said distal end of said catheter for insertion into and distending the body cavity to be treated, said first lumen distal fluid access port and said second lumen distal fluid access port in fluid communication with the interior of said bladder; circulating means for circulating said inflation medium attached to said proximal end of said catheter, said first lumen proximal fluid access port and said second lumen proximal fluid access port in fluid communication with the interior of said circulating means; a fluid access port in fluid communication
- the present invention provides an apparatus for thermally treating the tissue lining of a body cavity, and in particular, substantially the entirety of the endometrium of a mammalian uterine comprising: a catheter having a proximal end and a distal end and provided with a first lumen and a second lumen, said first lumen provided with a proximal fluid access port and a distal fluid access port, said second lumen provided with a proximal fluid access port and a distal fluid access port; a distendable bladder means attached to said distal end of said catheter for insertion into and distending the body cavity to be treated, said first lumen distal fluid access port and said second lumen distal fluid access port in fluid communication with the interior of said bladder; a fluid access port in fluid communication with the interior of said apparatus for the introduction and extraction of an inflation medium into and out of said apparatus, said fluid access port provided with a fluid control means for controlling the flow of said inflation medium through said fluid access port; inflating means detachably connected to said fluid
- the present invention also provides an apparatus for thermally treating the tissue lining of a body cavity, and in particular, substantially the entirety of the endometrium of a mammalian uterine comprising: a catheter having a proximal end and a distal end and provided with a first lumen and a second lumen, said first lumen provided with a proximal fluid access port and a distal fluid access port, said second lumen provided with a proximal fluid access port and a distal fluid access port; a distendable bladder means attached to said distal end of said catheter for insertion into and distending the body cavity to be treated, said first lumen distal fluid access port and said second lumen distal fluid access port in fluid communication with the interior of said bladder; a distendable reservoir means attached to said proximal end of said catheter, said first lumen proximal fluid access port and said second lumen proximal fluid access port in fluid communication with the interior of said distendable reservoir means; a sterilized fluid medium permanently
- FIG. l depicts an apparatus having an internal pumping means constructed in accordance with the invention
- FIG. 2 depicts a fluid introduction and extraction means constructed in accordance with the invention
- the catheter 1 is thermally non-transmissive so that heated fluid 19 does not lose heat to the cooler fluid as it traverses the catheter 1 in first lumen 2 and second lumen 3. This also helps protect the tissue which comes in contact with the external surface of catheter 1.
- a means for insulating 11 may be applied to the external surface of catheter 1 to protect tissue which comes into contact with the external surface of catheter 1.
- An inflatable distendable bladder 10 is attached to the distal end 5 of dual lumen catheter 1 and forms a fluid tight seal with the external surface of dual lumen catheter l proximal to fluid access ports 7 and 9. It will be appreciated that the distendable bladder 10 could be integrally formed in the distal end 5 of the catheter 1.
- Distendable bladder 10 should preferably be maintained at or about 40 to 240 mmHg, and preferably about 75 mmHg, to minimize risk of rupture of the distendable bladder 10 and possible internal injury to the patient. Inflation of the distendable bladder 10 with a fluid 19 assures uniform contact of the distendable bladder 10 with the tissue to be treated.
- the fluid 19 then enters first lumen proximal access port 6 and traverses the first lumen 2 in a direction towards its distal end 5 and enters distendable bladder 10 via first lumen distal fluid access port 7. After circulating within distendable bladder 10, fluid 19 leaves distendable bladder 10 and enters second lumen 3 via second lumen distal fluid access port 9. The fluid 19 then traverses the second lumen 3 in a direction towards its proximal end 4 and leaves second lumen 3 via second lumen proximal fluid access port 8. The fluid 19 then enters internal pump means 12 via inlet port 13, and is recirculated. Temperature sensing means 15 measures the temperature of fluid 19 and displays the temperature at temperature display means 25 on control panel 23. Automatic temperature regulating means 50 may be provided between the temperature display means 25 and the heating control means 22 for automatically regulating the temperature of fluid 19.
- Fluid control means 29 is again manipulated to allow the fluid to be withdrawn through fluid access port 16.
- Manipulating the plunger 37 of syringe means 33 causes fluid 19 to be withdrawn from the interior of the apparatus 75 through fluid access port 16 and the distendable bladder 10 deflates. Upon deflation, the distendable bladder 10 of apparatus 75 may be safely withdrawn from the patient.
- the apparatus 75 may then be discarded or may be sterilized for subsequent use.
- the time and expense associated with sterilizing apparatus 75 may be warranted by the cost of the pumping means 12 which is contained within the apparatus 75.
- pumping means 18 can be repeatedly utilized in subsequent treatments and the flexible fluid conduit 78, dual lumen catheter 1', and distendable bladder 10' may be disposed of with a significant reduction in cost.
- the flexible fluid conduit 78, dual lumen catheter 1', and distendable bladder 10' may also be sterilized and used again if desired.
- the apparatus 90 is provided with a flexible fluid conduit 78 having an inlet port 76 and an outlet port 77. Inlet port 76 and outlet port 77 are in fluid communication with the interior of lumens 2' and 3' . A portion of fluid conduit 78 forms a fluid loop 79. External peristaltic pump means 18 communicates with the outer surface of external fluid loop 79 so as to pump the fluid 19 through flexible fluid conduit 78. A variety of means well known to those skilled in the art as suitable for this purpose may be employed to mechanically impinge upon external fluid loop 79, however, in a preferred embodiment a peristaltic pump available from A.S.F.
- a longitudinal member 100 having a first end 101 and a second end 102 is fixedly mounted on motor shaft 103 of motor 104 so that the longitudinal member 100 will turn in response to the rotation of the motor shaft 103.
- the motor 104 is activated by pump means control means 27' which provides electricity to motor 104 via lead 26' .
- the first end 101 of longitudinal member 100 may be provided with a first roller 105 and the second end 102 may be provided with a second roller 106 to reduce friction on the external surface of external fluid loop 79.
- the length of longitudinal member 100 and the diameter of rollers 105 and 106 is such that as longitudinal member 100 rotates, rollers 105 or 106, impinge upon and compress external fluid loop 79 to approximately one-half of its diameter.
- motor 104 When motor 104 is energized, longitudinal member 100 rotates and rollers 105 or 106 come into contact with and compress external fluid loop 79 against housing 107 so that fluid 19 is expelled from fluid conduit 78 via outlet port 77 and is drawn into fluid conduit 78 via inlet port 76.
- the distendable bladder 10' of apparatus 90 is positioned in the area to be treated and the treatment is performed as previously discussed.
- the external pumping means 18 is disconnected from the fluid loop 79 of flexible fluid conduit 78 before flexible conduit 78, catheter 1', and distendable bladder 10' are either disposed of or sterilized for subsequent use.
- the apparatus is a closed fluid apparatus 125 wherein fluid is neither introduced nor withdrawn from the interior of the apparatus. Thus, the integrity of the sterile field is maintained.
- a distendable reservoir 127 is attached at the proximal end 4" of catheter 1".
- the distendable reservoir 127 is made of a thermally transmissive material so that the fluid 19" can be heated by a heater 20" positioned external to the distendable reservoir 127.
- FIG. 5 shows the closed fluid apparatus 125 which is provided with a flexible fluid conduit 78" having an inlet port 76" and an outlet port 77".
- Inlet ports 76" and 77" are in fluid communication with the interior of distendable reservoir 127.
- a portion of fluid conduit 78" extends outside distendable reservoir 127 to form an external fluid loop 79".
- the external surface of fluid conduit 78" forms a fluid tight seal at its points of exit 80" and 81" from distendable reservoir 127.
- the temperature sensing means 15", pressure transducer 34" and heater 20" may be housed within the distendable reservoir 127, however, in a preferred embodiment they are mounted externally so as to minimize the one-time use cost.
- the trigger 130 is coupled to the pressure plate 128 via a ratchet means so that each pull of the trigger 130 causes the pressure plate 128 to be moved in small increments.
- ratchet control lever 131 is moved to a first position 132, pulling the trigger 130 causes pressure plate 128 to move in a direction towards distendable reservoir 127.
- ratchet control lever 131 is moved to a second position 133, pulling the trigger 130 causes pressure plate 128 to move in a direction away from distendable reservoir 127.
- a hinged lid 150 is provided to secure closed fluid apparatus 125 within breech 129 of housing means 126.
- a cord 152 houses leads 21", 24", 26" and 36" which communicate with control panel 23".
- the closed fluid apparatus 125 is removed from a sterile package and is inserted into housing means 126 as shown in FIG. 7.
- the closed fluid apparatus 125 is inserted into the breech 129 of housing means 126 so that temperature sensing means 15", pressure transducer 34" and heater 20" are in intimate contact with the external surface of distendable reservoir 127.
- Lid 150 is then lowered so as to secure the closed fluid apparatus 125 within the breech 129 of applicator means 126 as shown in FIG. 8.
- Heater 20" is then energized and the fluid 19" is heated to the desired temperature as measured by temperature sensing means 15" as previously discussed.
- Pump means 18" is also energized to circulate the fluid 19" as previously discussed.
- the closed fluid apparatus 125 is then inserted into the body cavity to be treated.
- Ratchet control lever 131 is moved to a first position 132 and trigger 130 is pulled so as to move the pressure plate 128 in a direction towards distendable reservoir 127 so as to impart a pressure on the fluid 19" within the reservoir 127.
- the fluid 19" takes the path of least resistance and enters distendable bladder 10" via lumens 2" and 3" of catheter 1" as shown in FIG. 8.
- the desired pressure has been reached, as measured by pressure transducer 34"
- the treatment commences.
- the closed fluid system 125 is then removed from the body cavity being treated.
- the lid 150 is lifted and the distendable reservoir 127 is removed from breech 129 and the closed fluid apparatus 125 may be discarded or may be sterilized for subsequent use.
- the housing means 126 is saved and can be used again in subsequent treatments.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Physics & Mathematics (AREA)
- Plasma & Fusion (AREA)
- Thermal Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Otolaryngology (AREA)
- Vascular Medicine (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Thermotherapy And Cooling Therapy Devices (AREA)
- External Artificial Organs (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
L'invention concerne un appareil (75) conçu pour traiter une muqueuse tissulaire d'une cavité du corps d'un mammifère, notamment un endomètre utérin, qui comprend une pompe (38) et une vessie dilatable (10) raccordée à un cathéter. L'appareil est introduit dans la cavité du corps et la vessie est dilatée par l'introduction d'un fluide non toxique sous pression. Le fluide est chauffé par un élément de chauffe (20). Une pompe (38) fait circuler le fluide à l'intérieur de la vessie dilatable pour permettre de maintenir le fluide à une température constante.An apparatus (75) for treating tissue lining of a mammalian body cavity, including a uterine endometrium, includes a pump (38) and an expandable bladder (10) connected to a catheter. The device is introduced into the body cavity and the bladder is dilated by the introduction of a non-toxic fluid under pressure. The fluid is heated by a heating element (20). A pump (38) circulates the fluid within the expandable bladder to maintain the fluid at a constant temperature.
Description
Claims
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US97518292A | 1992-11-12 | 1992-11-12 | |
US975182 | 1992-11-12 | ||
PCT/US1993/010838 WO1994010948A1 (en) | 1992-11-12 | 1993-11-10 | Heated balloon medical apparatus |
Publications (2)
Publication Number | Publication Date |
---|---|
EP0625893A1 true EP0625893A1 (en) | 1994-11-30 |
EP0625893A4 EP0625893A4 (en) | 1995-02-15 |
Family
ID=25522768
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP94900602A Withdrawn EP0625893A4 (en) | 1992-11-12 | 1993-11-10 | Heated balloon medical apparatus. |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP0625893A4 (en) |
JP (1) | JPH07503171A (en) |
AU (1) | AU5552194A (en) |
CA (1) | CA2127695A1 (en) |
WO (1) | WO1994010948A1 (en) |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6813520B2 (en) | 1996-04-12 | 2004-11-02 | Novacept | Method for ablating and/or coagulating tissue using moisture transport |
US5769880A (en) * | 1996-04-12 | 1998-06-23 | Novacept | Moisture transport system for contact electrocoagulation |
US7604633B2 (en) | 1996-04-12 | 2009-10-20 | Cytyc Corporation | Moisture transport system for contact electrocoagulation |
IL120674A (en) * | 1996-04-16 | 2001-03-19 | Argomed Ltd | Thermal treatment apparatus |
US8551082B2 (en) | 1998-05-08 | 2013-10-08 | Cytyc Surgical Products | Radio-frequency generator for powering an ablation device |
KR20010099922A (en) * | 1998-12-22 | 2001-11-09 | 노보스트 코포레이션 | Automated system for the radiation treatment of a desired area within the body of a patient |
US6443947B1 (en) * | 2000-03-01 | 2002-09-03 | Alexei Marko | Device for thermal ablation of a cavity |
JP3892438B2 (en) * | 2003-12-26 | 2007-03-14 | 株式会社日本メディックス | Heating balloon catheter device and its elastic tube device |
JP2010540028A (en) * | 2007-09-20 | 2010-12-24 | ボストン サイエンティフィック サイムド,インコーポレイテッド | Hand-held thermal ablation device |
JP5107788B2 (en) * | 2008-04-24 | 2012-12-26 | 株式会社カネカ | Balloon catheter and balloon catheter connector |
US20100004595A1 (en) * | 2008-07-01 | 2010-01-07 | Ethicon, Inc. | Balloon catheter systems for treating uterine disorders having fluid line de-gassing assemblies and methods therefor |
EP3785653A1 (en) * | 2011-04-12 | 2021-03-03 | Thermedical, Inc. | Devices for remote temperature monitoring in fluid enhanced ablation therapy |
US11918277B2 (en) | 2018-07-16 | 2024-03-05 | Thermedical, Inc. | Inferred maximum temperature monitoring for irrigated ablation therapy |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2190383A (en) * | 1936-08-29 | 1940-02-13 | Louis B Newman | Therapeutic apparatus |
US2190384A (en) * | 1937-07-06 | 1940-02-13 | Louis B Newman | Therapeutic bag |
US3154078A (en) * | 1962-02-12 | 1964-10-27 | Jr Edward O Goodrich | Catheter combination |
US4332254A (en) * | 1980-11-17 | 1982-06-01 | Advanced Catheter Systems, Inc. | System for filling and inflating and deflating a vascular dilating cathether assembly |
US4949718B1 (en) * | 1988-09-09 | 1998-11-10 | Gynelab Products | Intrauterine cauterizing apparatus |
US5084044A (en) * | 1989-07-14 | 1992-01-28 | Ciron Corporation | Apparatus for endometrial ablation and method of using same |
US5195965A (en) * | 1991-03-07 | 1993-03-23 | Shantha Totada R | Method and apparatus for localized treatment of human viral infections and cancers |
-
1993
- 1993-11-10 WO PCT/US1993/010838 patent/WO1994010948A1/en not_active Application Discontinuation
- 1993-11-10 JP JP6512311A patent/JPH07503171A/en active Pending
- 1993-11-10 EP EP94900602A patent/EP0625893A4/en not_active Withdrawn
- 1993-11-10 AU AU55521/94A patent/AU5552194A/en not_active Abandoned
- 1993-11-10 CA CA 2127695 patent/CA2127695A1/en not_active Abandoned
Non-Patent Citations (2)
Title |
---|
No further relevant documents disclosed * |
See also references of WO9410948A1 * |
Also Published As
Publication number | Publication date |
---|---|
EP0625893A4 (en) | 1995-02-15 |
AU5552194A (en) | 1994-06-08 |
CA2127695A1 (en) | 1994-05-26 |
WO1994010948A1 (en) | 1994-05-26 |
JPH07503171A (en) | 1995-04-06 |
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