CA1319072C - Intrauterine cauterizing apparatus and method - Google Patents
Intrauterine cauterizing apparatus and methodInfo
- Publication number
- CA1319072C CA1319072C CA614493A CA614493A CA1319072C CA 1319072 C CA1319072 C CA 1319072C CA 614493 A CA614493 A CA 614493A CA 614493 A CA614493 A CA 614493A CA 1319072 C CA1319072 C CA 1319072C
- Authority
- CA
- Canada
- Prior art keywords
- bladder
- fluid
- tubing
- control means
- distendable
- 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.)
- Expired - Lifetime
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Classifications
-
- 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
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00022—Sensing or detecting at the treatment site
- A61B2017/00084—Temperature
- A61B2017/00092—Temperature using thermocouples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00132—Setting operation time of a device
-
- 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
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
-
- 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
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Surgery (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Otolaryngology (AREA)
- Physics & Mathematics (AREA)
- Thermal Sciences (AREA)
- Vascular Medicine (AREA)
- Thermotherapy And Cooling Therapy Devices (AREA)
Abstract
ABSTRACT
A method and apparatus for effecting necrosis of a tissue lining of a mammalian body cavity, particularly a uterine endometrium, by introducing an applicator comprising a distendable bladder connected to a catheter into the uterus, distending the bladder by introducing a non-toxic fluid under pressure, heating the fluid by means located internal to the bladder to a temperature of 190° to 215°F and preferably 210°F for a period of 4 to 12 minutes and preferably 6 minutes and regulating said apparatus by means located external to the uterus, thereby cauterizing substantially the entirety of the tissue lining, particularly theendometrium.
A method and apparatus for effecting necrosis of a tissue lining of a mammalian body cavity, particularly a uterine endometrium, by introducing an applicator comprising a distendable bladder connected to a catheter into the uterus, distending the bladder by introducing a non-toxic fluid under pressure, heating the fluid by means located internal to the bladder to a temperature of 190° to 215°F and preferably 210°F for a period of 4 to 12 minutes and preferably 6 minutes and regulating said apparatus by means located external to the uterus, thereby cauterizing substantially the entirety of the tissue lining, particularly theendometrium.
Description
~i9~
BACXGROUND OF THE INVENTION
1. Field of the Inventio This inventlon relates to an apparatus and a method for cauterizing the tissue lining of a human body cavity, particularly the endometrium of the uterus.
More specifically, the apparatus and method of the present invention ensures effective cauterization oP the endometrium of a mammalian uterus without many of the disadvantages and dangerous features of known intrauterine cauterization techniques.
BACXGROUND OF THE INVENTION
1. Field of the Inventio This inventlon relates to an apparatus and a method for cauterizing the tissue lining of a human body cavity, particularly the endometrium of the uterus.
More specifically, the apparatus and method of the present invention ensures effective cauterization oP the endometrium of a mammalian uterus without many of the disadvantages and dangerous features of known intrauterine cauterization techniques.
2. The Prior Art The following terms as used herein have the meaning given below:
"Necrosis" means the death of cells in tissue.
"Endometrium'3 is that portion of the inner lining of the uterus to which an embryo normally attaches and excludes the portions of the uterine inner lining forming the cervix, to which the embryo usually does not attach.
Apparatus and methods for cauterization of the ~' ~
~ 3 ~
endometrium of a mammalian uterus, useful in sterilizatlon procedures and cancer treatments, are well known. Thermal and cryogenic treatments have been utilized in such cauterization techniques and typically involve either the direct or indirect application o~
heat or cold to the tissue to be treated.
For example, a laser hysteroscope has been used to cauterize the endometrial layer of the uteru~. This laser treatment suffers from several disadvantages. It requires the application of an intense amount of th~rmal energy to a relatively small area of tissue even though such a large amount of heat may not be necessary to effectively cauterize the tiss;ue. Further, this laser treatment requires the physician to continually ra-position the laser used in the treatment within the uterus in order to treat the entire endometrium. Such internal manipulation of a laser hysteroscope within the uterus of a patient is both difficult, requiring a significant level of skill to perform, and potentially dangerous. Accidental puncture of the uterine or tissue wall may result from manipulation o~ the laser scope within the uterus or body cavity, and tissue layers beneath the endometrium may be burned if a laser's beam is left focused on one area of tissue for too long a period of time.
A variety of alternatives to laser treatment in cauterizing the uterine endometrium are known. In U.S.
Patent No. 3,924,628, Droegemueller et al. disclose a ~3~7~
method and apparatus for necrosing tissue cells that utilizes an extendable bladder which is inserted in the uterus and filled with a circulating fluid or gas at cryogenic temperatures (referring to temperatures sufficiently low to cause cell necrosis). The bladder disclosed by Droegemueller et al. is maintained in substantially continuous contact with the inner surface of the uteri~e lining and achieves necrosis of substantially all of the uterine endometrium in a single treatment. Droegemueller et al. disclose the use of liquid nitrogen that vaporizes prior to introduction into the bladder, thereby pressurizing the bladder to a lsvel which ensures adequate contact with the uterus.
Other fluids disclosed by Droegemueller et al. as useful in their method include refrigerants such as freon.
Droegemueller et al.'s method and apparatus suffers from the disadvantage of employing cryo~enic ~luids which could prove toxic to a patient in the event of bladder rupture. Moreover, Droegemueller et al.'s apparatus does not allow regulating the pressure used to inflate the bladder. Another disadvantage of Droegemueller et al.'s technique is that cryogenic necrosis of the endometrium occurs at extremely low temperatures that pose a threat to tissue layers adjacent to ~he uterine endometrium. Droegemueller et al. and similar cryogenic techniques also require the use of expensive equipment such as compressors and insulated vessels associated with the storage and transmission of refrigerants.
X
7 ~
~ 4-Moreover, Droegemueller et al.'s technique may require warming of the bladder in order to remove it from the body and minimize tearing of the surrounding tissue which has adhered to the bladder during the freezing process.
In U.S. Patent No. 2,73~,508, Kozinski disclose~ a therapeutic apparatus for applying dry heat to body cavities comprising an applicator that is introduced in the body cavity while deflated and which is subsequently inflated and heated by means of circulating hot air.
Kozinski does not disclose an applicator which conforms to the shape of a body cavity. Further, given the lower heat transfer coefficients of gases as compared with liquid, treatment with Kozinski's apparatus should involve a long period of time in order to achieve necrosis, thereby exposing the patient to additional discomfort and risk. Moreover, Kozinski's apparatus does not provide for measurement and regulation of internal pressures and temperatures of the applicator introduced.
U.S. Patent No. 2,077,453, issued to Albright, disclo~es a therapeutic appliance comprising a relatively long tubular applicator which is shaped and formed generally to the passage into which it is to be inserted and which has relatively thin elastic rubber walls that transfer heat and which distend to fit irregularities of the treated areas upon application of internal pressure. Albright also discloses that fluIds such as heated water could be utilized as a heating means in his applicator. The applicator of Albrighk, like that of Kozinski, however, suffers from the disadvantage that the distension of its walls to con~orm to the irregularities of the endometrium is limited as Albright provides an integral rubber web which serves to prevent undue distension of the applicator. Moreover, Albright requires that the fluid be circulated throughout the apparatus. Albright also does not provide an apparatus that allows regulation of temperature and pressure of the fluid or other bladder inflation means.
U.S. Patent No. 3,369,549, issued to Armao, 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 bodylcavity. 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.
Other patents that disclose the use of thermal treatment of the interior lining of a body cavity include U.S. Patent Nos. 2,192,768; 2,466,042;
2,777,445; and 3,369,549.
SUMMARY AND OBJECTS OF THE INVENTION
It is an object of the present invention to provide a safe and efficacious method for cauterizing the tissue -6- ~ 3 ~
lining of a body cavity, particularly the endometrium of a uterus.
It is another object of the present invention to provide a relatively inexpensive and easy to replace applicator heated by a nontoxic fluid that can be used to effect cauterization of the uterine endometrium and which is controlled by means external to the applicator.
It is another object of the present invention to provide a non-fluid circulating apparatus for heating a fluid while it is in a bladder within the uterus and ~or introducing the fluid under pressure into the bladder so as to assure substantially uniform contact of the bladder with the endometrium.
It is still another object of the present invention to provide an apparatus for regulating the temperature and pressure of the fluid in the bladder while the bladder is within the uterus.
The present invention provides a method for effecting cauterization necrosis of the tissue lining of a mammalian body cavity comprising the steps of inserting a distendable hladder into the body cavity;
inflating said distendable bladder to a predetermined pressure with a fluid so that said distendable bladder is in contact with substantially all of the tissue lining for which necrosis is desired; heating said fluid by means of a heating element positioned internal to said distendable bladder; controlling the temperature and pressure of said fluid by control means connected to )~
~3~72 said distendable bladder; and maintaining said bladder so inflated with said fluid at a temperature for a period of time su~ficient to effect cauterization necrosis of substantially all of the tissue lining o~
the body cavity for which necrosis is desired.
The present invention also provides a method for effecting cauterization necrosis of an uterine endometrium comprising the steps of inserting a distendable bladder into the uterus; inflating said distendable bladder to a predetermined pressure with a fluid so that said distendable bladder is in contact with substantially all of the endometrium; heating said fluid by means of a heating element positioned internal to said distendable bladder, regulating the temperature and pressure of said fluid by control means connected to said distendable bladder; and maintaining said bladder so inflated with said fluid at a temperature for a period of time sufficient to effect cauterization necrosis of substantially all of the ut~rine endometrium.
The pres~nt invention further provides a method for cauterizing substantially the entirety of the endometrium of a.mammalian uterus by application within an inflatable bladder of a fluid at a pressure of 40 to 140 mmHg and preferably about 75 mmHg, heated to a temperature of 140 to 215F and preferably about 210F
for a period of 4 to 12 minutes, with a preference of around 6 minutes, thereby realizing substantial necrQ~i~
)~
13~9~
of substantially all of the uterine endometrium without significant damage to surrounding tissue.
The present invention also provides an apparatus for effecting necrosis of the tissue lining of a body cavity, and, in particular, substantially the entirety of the endometrium of a mammalian uterus comprising an applicator which comprises a catheter for insertion into the uterus, said catheter having a proximal end and a distal end, and a distendable bladder attached to said proximal end; inflating means connected to said distal end for distending said distendable bladder; heating means positioned internal to said distendable bladder for heating said distendable bladder; and control means for regulating the distending and heating o said distendable bladder.
The present invention provides an apparatus fox effecting cauterization necrosis of the tissue lining oP
a body cavity, and in particular, substantially the entirety of the endometrium of a mammalian uterine comprising maans for contacting the endometrium with an applicator comprising an inflatable bladder mounted on a length of rigid tubing attached to a length of flex$ble tubing; means for positioning the bladder in the uterus;
means for distending the inflatable bladder, so as to assure substantially uniform contact with the endometrium, by introduction of a fluid under pressure into the applicator from a fluid source positioned external to the uterus; means for heating the bladder, X
~3~a~
comprising heating the fluid by a heating element positioned internal to the bladder: control means positioned external to the uterus and connected to the applicator by the flexible tubing and at least one wire connected to the heating element for regulating the distendiny and heating of the bladder; and ~eans for disengaging the applicator from the control means so as to separate the applicator from the control means.
These and other objects of the present invention arP achieved by a method in which necrosis of the endometrium of a mammalian uterus may be achieved by insertion of an applicator comprising ri~id and flexible tubing and a readily distendable high strength bladder material into the uterus; introduction of a fluid through the tubing into the distendable bladder at a pressure of 40 to 140 mmHg ancl preferably about 75 ~mHg, thereby inflating the bladder so that it substantially conforms to the irregularities in the shape of the endometrium; the pressure o~ the fluid measured and regulated by means external to the uterus; heating the fluid to a temperature of 140 to 215F and preferably about 210F, for a period of 4 to 12 minutes, with a preference of around 6 minutes, by heating means positioned within the distendable bladder and regulated by control means external to the applicator, thereby cauterizing substantially the entirety of the uterine endometrium.
BRIEE DESCRIPTION OF THE DRAWINGS
. _ ~ 3 ~ 2 Fig. 1 depicts a distenclable bladder utili~ed in the method of the present invention which has been inserted into and inflated within a mammalian uterus.
Fig. 2 depicts placement of the distendable bladder within a mammalian uterus.
Fig. 3 is a view o~ an apparatus constructed in accordance with the invention that illustrates the applicator connections.
Fig. 4 depicts a system control unit.
Fig. 5 is a detail view o~ a pressure limiting and safety monitor.
Fiy. 6A is the vented~heating element shield utilized in the method of the present invention.
Fig. 6B is a cutaway view of the vented heating element shield showing the heating element and thermocouple.
Fig. 7 depicts a means for connecting and disconnecting the applicator.
DESCRIPTION OF A PREFERRED EMBODIMENT
Figure 1 shows an inflated distendable bladder 5 attached to rigid tubing 3 located within a human uterus 6. Inflation of the distendable bladder 5 with a fluid 25 assures uniform contact of the bladder with the endometrial tissue layer 27 of mammalian uterus 6.
The rigid tubing 3 and the attached distendable bladder 5 must be sufficiently small, when the distendable bladder is de~lated, so that it can be conveniently and safely inserted into the uterus 6 X
~ 3~9~
through a partially dilated cervix 22. The rigid tubing with the deflated bladder is aligned with the cervic~l canal after the cervix is exposed with a speculum and grasped with a tenaculum. After the distendable bladder 5 has been inserted, the distendable bladder 5 should be inflated to a pressure sufficient to ensure firm contact with the tissue to be necrosed, in this case the endometrial tissue layer on the interior uterine surface, but should preferably be maintained at or about 40 to 140 mmHg, and preferably about 75 mmHg, to minimize risk of rupture of the distendable bladder 5 and possible internal injury to the patient.
Distendable bladder 5 must be capable of withstanding high temperatures without rupturing, and preferably have as good a heat transfer characterist~c as is obtainable in such materials to provide efficient heating action. A di~tendable bladder of a heat curing rubber such as latex has been found satisfactory.
Fluid 25 preferably should be a sterile non-toxic fluid with a boiling point of at least 212F. A five percent dextrose in water solution has been found satisfactory.
As illustra~ed in Figure 2, the uninflated distendable bladder 5 attache* to rigid tubing 3 is inserted into the vagina 21, past the cervical os 22, throuyh the cervical canal 23, for placement in the uterine cavity 20. Placement may be aided by virtue o~
scale gradations 4 located on the rigid tubing 3 to ~3~72 indicate the depth of insertion of the bladder 5. ~igid tubing 3 is attached to a control unit 30 (shown in Flg.
"Necrosis" means the death of cells in tissue.
"Endometrium'3 is that portion of the inner lining of the uterus to which an embryo normally attaches and excludes the portions of the uterine inner lining forming the cervix, to which the embryo usually does not attach.
Apparatus and methods for cauterization of the ~' ~
~ 3 ~
endometrium of a mammalian uterus, useful in sterilizatlon procedures and cancer treatments, are well known. Thermal and cryogenic treatments have been utilized in such cauterization techniques and typically involve either the direct or indirect application o~
heat or cold to the tissue to be treated.
For example, a laser hysteroscope has been used to cauterize the endometrial layer of the uteru~. This laser treatment suffers from several disadvantages. It requires the application of an intense amount of th~rmal energy to a relatively small area of tissue even though such a large amount of heat may not be necessary to effectively cauterize the tiss;ue. Further, this laser treatment requires the physician to continually ra-position the laser used in the treatment within the uterus in order to treat the entire endometrium. Such internal manipulation of a laser hysteroscope within the uterus of a patient is both difficult, requiring a significant level of skill to perform, and potentially dangerous. Accidental puncture of the uterine or tissue wall may result from manipulation o~ the laser scope within the uterus or body cavity, and tissue layers beneath the endometrium may be burned if a laser's beam is left focused on one area of tissue for too long a period of time.
A variety of alternatives to laser treatment in cauterizing the uterine endometrium are known. In U.S.
Patent No. 3,924,628, Droegemueller et al. disclose a ~3~7~
method and apparatus for necrosing tissue cells that utilizes an extendable bladder which is inserted in the uterus and filled with a circulating fluid or gas at cryogenic temperatures (referring to temperatures sufficiently low to cause cell necrosis). The bladder disclosed by Droegemueller et al. is maintained in substantially continuous contact with the inner surface of the uteri~e lining and achieves necrosis of substantially all of the uterine endometrium in a single treatment. Droegemueller et al. disclose the use of liquid nitrogen that vaporizes prior to introduction into the bladder, thereby pressurizing the bladder to a lsvel which ensures adequate contact with the uterus.
Other fluids disclosed by Droegemueller et al. as useful in their method include refrigerants such as freon.
Droegemueller et al.'s method and apparatus suffers from the disadvantage of employing cryo~enic ~luids which could prove toxic to a patient in the event of bladder rupture. Moreover, Droegemueller et al.'s apparatus does not allow regulating the pressure used to inflate the bladder. Another disadvantage of Droegemueller et al.'s technique is that cryogenic necrosis of the endometrium occurs at extremely low temperatures that pose a threat to tissue layers adjacent to ~he uterine endometrium. Droegemueller et al. and similar cryogenic techniques also require the use of expensive equipment such as compressors and insulated vessels associated with the storage and transmission of refrigerants.
X
7 ~
~ 4-Moreover, Droegemueller et al.'s technique may require warming of the bladder in order to remove it from the body and minimize tearing of the surrounding tissue which has adhered to the bladder during the freezing process.
In U.S. Patent No. 2,73~,508, Kozinski disclose~ a therapeutic apparatus for applying dry heat to body cavities comprising an applicator that is introduced in the body cavity while deflated and which is subsequently inflated and heated by means of circulating hot air.
Kozinski does not disclose an applicator which conforms to the shape of a body cavity. Further, given the lower heat transfer coefficients of gases as compared with liquid, treatment with Kozinski's apparatus should involve a long period of time in order to achieve necrosis, thereby exposing the patient to additional discomfort and risk. Moreover, Kozinski's apparatus does not provide for measurement and regulation of internal pressures and temperatures of the applicator introduced.
U.S. Patent No. 2,077,453, issued to Albright, disclo~es a therapeutic appliance comprising a relatively long tubular applicator which is shaped and formed generally to the passage into which it is to be inserted and which has relatively thin elastic rubber walls that transfer heat and which distend to fit irregularities of the treated areas upon application of internal pressure. Albright also discloses that fluIds such as heated water could be utilized as a heating means in his applicator. The applicator of Albrighk, like that of Kozinski, however, suffers from the disadvantage that the distension of its walls to con~orm to the irregularities of the endometrium is limited as Albright provides an integral rubber web which serves to prevent undue distension of the applicator. Moreover, Albright requires that the fluid be circulated throughout the apparatus. Albright also does not provide an apparatus that allows regulation of temperature and pressure of the fluid or other bladder inflation means.
U.S. Patent No. 3,369,549, issued to Armao, 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 bodylcavity. 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.
Other patents that disclose the use of thermal treatment of the interior lining of a body cavity include U.S. Patent Nos. 2,192,768; 2,466,042;
2,777,445; and 3,369,549.
SUMMARY AND OBJECTS OF THE INVENTION
It is an object of the present invention to provide a safe and efficacious method for cauterizing the tissue -6- ~ 3 ~
lining of a body cavity, particularly the endometrium of a uterus.
It is another object of the present invention to provide a relatively inexpensive and easy to replace applicator heated by a nontoxic fluid that can be used to effect cauterization of the uterine endometrium and which is controlled by means external to the applicator.
It is another object of the present invention to provide a non-fluid circulating apparatus for heating a fluid while it is in a bladder within the uterus and ~or introducing the fluid under pressure into the bladder so as to assure substantially uniform contact of the bladder with the endometrium.
It is still another object of the present invention to provide an apparatus for regulating the temperature and pressure of the fluid in the bladder while the bladder is within the uterus.
The present invention provides a method for effecting cauterization necrosis of the tissue lining of a mammalian body cavity comprising the steps of inserting a distendable hladder into the body cavity;
inflating said distendable bladder to a predetermined pressure with a fluid so that said distendable bladder is in contact with substantially all of the tissue lining for which necrosis is desired; heating said fluid by means of a heating element positioned internal to said distendable bladder; controlling the temperature and pressure of said fluid by control means connected to )~
~3~72 said distendable bladder; and maintaining said bladder so inflated with said fluid at a temperature for a period of time su~ficient to effect cauterization necrosis of substantially all of the tissue lining o~
the body cavity for which necrosis is desired.
The present invention also provides a method for effecting cauterization necrosis of an uterine endometrium comprising the steps of inserting a distendable bladder into the uterus; inflating said distendable bladder to a predetermined pressure with a fluid so that said distendable bladder is in contact with substantially all of the endometrium; heating said fluid by means of a heating element positioned internal to said distendable bladder, regulating the temperature and pressure of said fluid by control means connected to said distendable bladder; and maintaining said bladder so inflated with said fluid at a temperature for a period of time sufficient to effect cauterization necrosis of substantially all of the ut~rine endometrium.
The pres~nt invention further provides a method for cauterizing substantially the entirety of the endometrium of a.mammalian uterus by application within an inflatable bladder of a fluid at a pressure of 40 to 140 mmHg and preferably about 75 mmHg, heated to a temperature of 140 to 215F and preferably about 210F
for a period of 4 to 12 minutes, with a preference of around 6 minutes, thereby realizing substantial necrQ~i~
)~
13~9~
of substantially all of the uterine endometrium without significant damage to surrounding tissue.
The present invention also provides an apparatus for effecting necrosis of the tissue lining of a body cavity, and, in particular, substantially the entirety of the endometrium of a mammalian uterus comprising an applicator which comprises a catheter for insertion into the uterus, said catheter having a proximal end and a distal end, and a distendable bladder attached to said proximal end; inflating means connected to said distal end for distending said distendable bladder; heating means positioned internal to said distendable bladder for heating said distendable bladder; and control means for regulating the distending and heating o said distendable bladder.
The present invention provides an apparatus fox effecting cauterization necrosis of the tissue lining oP
a body cavity, and in particular, substantially the entirety of the endometrium of a mammalian uterine comprising maans for contacting the endometrium with an applicator comprising an inflatable bladder mounted on a length of rigid tubing attached to a length of flex$ble tubing; means for positioning the bladder in the uterus;
means for distending the inflatable bladder, so as to assure substantially uniform contact with the endometrium, by introduction of a fluid under pressure into the applicator from a fluid source positioned external to the uterus; means for heating the bladder, X
~3~a~
comprising heating the fluid by a heating element positioned internal to the bladder: control means positioned external to the uterus and connected to the applicator by the flexible tubing and at least one wire connected to the heating element for regulating the distendiny and heating of the bladder; and ~eans for disengaging the applicator from the control means so as to separate the applicator from the control means.
These and other objects of the present invention arP achieved by a method in which necrosis of the endometrium of a mammalian uterus may be achieved by insertion of an applicator comprising ri~id and flexible tubing and a readily distendable high strength bladder material into the uterus; introduction of a fluid through the tubing into the distendable bladder at a pressure of 40 to 140 mmHg ancl preferably about 75 ~mHg, thereby inflating the bladder so that it substantially conforms to the irregularities in the shape of the endometrium; the pressure o~ the fluid measured and regulated by means external to the uterus; heating the fluid to a temperature of 140 to 215F and preferably about 210F, for a period of 4 to 12 minutes, with a preference of around 6 minutes, by heating means positioned within the distendable bladder and regulated by control means external to the applicator, thereby cauterizing substantially the entirety of the uterine endometrium.
BRIEE DESCRIPTION OF THE DRAWINGS
. _ ~ 3 ~ 2 Fig. 1 depicts a distenclable bladder utili~ed in the method of the present invention which has been inserted into and inflated within a mammalian uterus.
Fig. 2 depicts placement of the distendable bladder within a mammalian uterus.
Fig. 3 is a view o~ an apparatus constructed in accordance with the invention that illustrates the applicator connections.
Fig. 4 depicts a system control unit.
Fig. 5 is a detail view o~ a pressure limiting and safety monitor.
Fiy. 6A is the vented~heating element shield utilized in the method of the present invention.
Fig. 6B is a cutaway view of the vented heating element shield showing the heating element and thermocouple.
Fig. 7 depicts a means for connecting and disconnecting the applicator.
DESCRIPTION OF A PREFERRED EMBODIMENT
Figure 1 shows an inflated distendable bladder 5 attached to rigid tubing 3 located within a human uterus 6. Inflation of the distendable bladder 5 with a fluid 25 assures uniform contact of the bladder with the endometrial tissue layer 27 of mammalian uterus 6.
The rigid tubing 3 and the attached distendable bladder 5 must be sufficiently small, when the distendable bladder is de~lated, so that it can be conveniently and safely inserted into the uterus 6 X
~ 3~9~
through a partially dilated cervix 22. The rigid tubing with the deflated bladder is aligned with the cervic~l canal after the cervix is exposed with a speculum and grasped with a tenaculum. After the distendable bladder 5 has been inserted, the distendable bladder 5 should be inflated to a pressure sufficient to ensure firm contact with the tissue to be necrosed, in this case the endometrial tissue layer on the interior uterine surface, but should preferably be maintained at or about 40 to 140 mmHg, and preferably about 75 mmHg, to minimize risk of rupture of the distendable bladder 5 and possible internal injury to the patient.
Distendable bladder 5 must be capable of withstanding high temperatures without rupturing, and preferably have as good a heat transfer characterist~c as is obtainable in such materials to provide efficient heating action. A di~tendable bladder of a heat curing rubber such as latex has been found satisfactory.
Fluid 25 preferably should be a sterile non-toxic fluid with a boiling point of at least 212F. A five percent dextrose in water solution has been found satisfactory.
As illustra~ed in Figure 2, the uninflated distendable bladder 5 attache* to rigid tubing 3 is inserted into the vagina 21, past the cervical os 22, throuyh the cervical canal 23, for placement in the uterine cavity 20. Placement may be aided by virtue o~
scale gradations 4 located on the rigid tubing 3 to ~3~72 indicate the depth of insertion of the bladder 5. ~igid tubing 3 is attached to a control unit 30 (shown in Flg.
3) via flexible tubing 10.
Figure 3 depict~ the arrangement of control unit 30 and applicator end 1, comprising the distendable bladder 5, rigid tubing 3 and flexible tubing 10, and the interconnection of those elements. A fluid system 55 comprises that portion of the invention through which the fluid 25 travels, including a hypodermic barrel 14 or other fluid source (not shown), flexible tubing 10, rigid tubing 3, distendable bladder 5 and control unit 30. Manipulation of the hypodermic barrel 14 enables the operator of the system to control the amount of fluid 25 in the fluid system 55, inflation and deflation of the distendable bladder by adding or removing fluid, respectively, and pressure of the fluid 25 in the system. Hypodermic barrel 14 also provides protection for the patient by allowing fast and sa~e reduction of excessive pressures in the system that might build up through ~ome malfunction.
Manipulation of the hypodermic barrel 14 by depressing a plunger 60 causes fluid 25 to be introduced through 3-way stopcock 12 into the flexible tubing 10, and to the rigid tubing 3. The fluid 25 emerges from rigid tubing 3 and into distendable bladder 5I forcing distendable bladder 5 to expand into contac~ with the endometrial tissue layer 27 o~ the uterus 6. The fluid 25 is also directed along the flexible tubing to the ~3~9~2 control unit 30 allowing measurement of the fluid pressure within the bladdar by well known means.
Each of the parts of the fluid system 55 is in fluid communication providing constant fluid pressure within the entire fluid system 55 and allowing measurement of the pressure at the applicator end 1 via measurement of pressure of the end attached to the control unit 30.
Control unit 30 is connected to applicator end 1 via plastic sheath 15 which contains flexible tubing 10 and electrical sheath 16. Flexible tubing 10 is connected to a fluid joint 56 via pressure transducer 54, by well known means. Using a standard luer lock connector 19, pressure transducer 54 and hypodermic barrel 14 are connected to ~lexible tubing 10 via a readily available 3-way stopcc,ck 12. 3-way stopcock 12 may be used to isolate the hypodermic barrel 14 or othcr fluid source from ~he fluid system 55 once the desired fluid preæsure is reached.
Figure 4 depicts control unit 30, consisting o~
~luid temperature control 31, fluid pressure control 34, time control 38' and a power source (no~ shown). The control unit 30 includes a power switch 42 and fuse 41.
Fluid temperature is regulated by fluid temperature control 31 and is set by temperature set/reset button 33. The temperature of fluid 25 in the distendable applicator 5 is shown at temperature display 32.
Fluid pressure within the fluid system 55 is ~31~2 regulated by means of controls located on fluid pressure control panel 34. The upper limit for fluid pressure is controlled by high pressure set/reset button 35, with the lower limit controlled by low pressure set/reset button 36. Fluid pressure in mmHg is shown by LED
pressure display 37. Control unit 30 also has pressure indicator display 43, which upon introduction of fluid 25 into the ~luid system 55 provides an easy to see visual display of fluid pressure within the fluid system 55.
Time for the procedure .i.s shown at time display 38, which displays both lapsed time and time remaining for the procedure. Total time for the procedure may be easily set in minutes, seconds, and tenths of seconds using time set buttons 39 and may be cleared or reset using time clear/reset button 40.
A simplified means for d~termining whether the fluid 25 is within the preset.pressure range is depicted in Figure 5, which illustrates the pressure indicator display 43. The pressure indicator display 43 is comprised of a low pressure indicator 51, a high pressure indicator 52 and an optimum pressure indicator 53. As fluid 25 is introduced into the fluid system 55 by manipulation of hypodermic barrel 13, the pressure indicator display 43 is successively illuminated as various fluid pressures are reached. Low pressure indicator 51 i5 illuminated when fluid pressure is below the preset range. High pressure indicator 52 is 13~ 9 ~r~ 2 -:L5-illuminated when fluid pressure is above the preset range. Optimum pressure indicator 53 is illuminated when ~luid pressure is within the preset range.
These indicators allow the practitioner to readily reach the preset pressure range by varying the amount of fluid in the ~luid system via manipulation of the hypodermic barrel 14. A separate heating element indicator 55 is also provided to indicate when power i8 being provided to a heating element 44 located within the distendable applicator 5.
Two views of heating element 44 are shown in Figures 6A and 6B. Figure 6A is an external view of heating element 44, which comprises heating element coil shield 45 and ventilation holes 46.
Figure 6B is a cutaway v:iew of heating element 44, wherein wire leads 49 provide power from system control unit 30 to heating element coil 47 causing heating element coil 47 to heat the fluid 25 which comes into contact with the heating element coil 47 as the fluid 25 flows through the ventilation holes 46. Temperature o~
the fluid 25 is measured by thermocouple 48 and is displayed at temperature display 32. He~t element coil shield 45 prevents distendable bladder 5 from contaa~ing the heating element coil 47.
The applicator end 1 is designed to be easy to replace as shown in Figure 7, which depicts control unit end 30' and applicator end 1 of the inven~ion. control unit end 30' is composed of electrical sheath 16 which is attached on one end to control unit 30 and on the other end to male electrical connector 24, which allows transmittal of power to the heating element 44. Male electrical connector 24 is readily attached or disattached to female electrical connector 17 on the applicator end 1.
Control unit end 30' is also comprised of components from the fluid sys~em 55, including flexible tubing lO attached to 3-way s~opcock 12. 3-way stopcock 12 provides control over the introduction and removal o~
fluid 25 via hypodermic barrel 14. The applicator end 1 i5 easily connected or disconnected from the 3-way stopcock via a luer lock connector 19 attached to pressure transducer 54.
The invention will now be illustrated by the following example.
Example The cauterization procedure is preceded by screening against cancer of the affected region and physical condition within established norms. A PAP
smear and endometrial biopsy/ curettage must exclude cancer or precancerous lesions of the uterus and cervix.
If a fibroid uterus is present, an ultrasound should exclude ovarian masses. The uterine cavity must be 10 cm or less in length to be suitable for the small distendable bladder size.
The patient should be post menstrual or start on Danazol, or the equivalent which causes reduction in )~
~ 3~g372 -:L7-bleeding and a thin endometrium, at a rate of 800 ml daily, from the 5th day of ths previous menstrual period until two weeks after the procedure. She will undergo the procedure in the ambulatory surgery unit or out-patient facility where Valium and/or Demerol can be given intravenously if there is pain during the heating phase of the procedure.
The applicator will be inserted after a bimanual examination and speculum of the cervix. Dilation to 6 mm. may be required which may necessitate a local 1%
lidocane block of the cervix. Once in place the applicator stem protrudes from the vagina and consists of an electrical connecting plug and rigid tubing.
Placement of the applicator may be facilitated by distance markings on the rigid tubing indicating dapth of insertion.
Upon placement of the applicator it will be connected to a control unit v:La attachment of the electrical connector and flexible tubing attached to the rigid tubing to their counterparts extending from the control unit.
Subsequent to insertion of the applicator, the control unit will be powered on in order to allow the practitioner to set the system constraints. The temperature of the fluid in the bladder will be set at the temperature control panel and can be measured via the thermocouple located within the bladder. Fluid pressure constraints are set at the pressure control ~319~2 panel, and upon inflation of the distendable bladder by introduction of fluid to the fluid system by depressing the plunger on the hypodermic barrel, can be easily measured by looking at the pressure indicator lights located on the control unit.
The practitioner then proceeds to inflate the distendable bladder by rotating the lever on the 3-way stopcock in order to access the fluid source and depressing the plunger on the hypodermic barrel which may serve as the fluid source. The practi~ioner injects the fluid into the fluid system until the pressure indicator lights indicate that the fluid pressure i5 within the pre-set constraints. At that point, the practitioner manipulates the 3-way stopcock to close of~
access to the fluid system by the fluid remaining in the hypodermic barrel. Thus, the fluid is non-circulating during the heating portion of the procedure, in part allowing more precise measuremen~ of fluid temperature.
The volume of fluid necessary to in~late the bladder will vary from 3 to 20 ml in most cases in order to reach the pressure wherein the bladder is substantially in contact with all of the endometrium.
The practitioner then turns on the heatiny element in order to heat the fluid to a pre-set level. The heating element in the bladder is connected via the plug to a 12 volt system which will bring the fluid in the bladder to the level of boiling as needed for each particular local, i.e. 190 degrees farenheit in Mexico X
13~ ~72 City, and 212 degrees farenheit in New York City. Once that temperature level is reached, the system timer i8 activated to time the procedure and provide automatic turn off of the heating element at the end of a prs-~et periodO
Upon completi.on of the procedure, the 3-way stopcock is again manipulated to allow the fluid to bo withdrawn from the fluid system causing the distendable bladder to deflate. Upon deflation of the distendabls bladder, the applicator may be safely withdrawn from the patient. The coagulated endometrium is then removed from the endometrial cavity with a curette, leaving the underlying surface free to form adhesions with the other opposing surfaces of the endometrial cavity.
Figure 3 depict~ the arrangement of control unit 30 and applicator end 1, comprising the distendable bladder 5, rigid tubing 3 and flexible tubing 10, and the interconnection of those elements. A fluid system 55 comprises that portion of the invention through which the fluid 25 travels, including a hypodermic barrel 14 or other fluid source (not shown), flexible tubing 10, rigid tubing 3, distendable bladder 5 and control unit 30. Manipulation of the hypodermic barrel 14 enables the operator of the system to control the amount of fluid 25 in the fluid system 55, inflation and deflation of the distendable bladder by adding or removing fluid, respectively, and pressure of the fluid 25 in the system. Hypodermic barrel 14 also provides protection for the patient by allowing fast and sa~e reduction of excessive pressures in the system that might build up through ~ome malfunction.
Manipulation of the hypodermic barrel 14 by depressing a plunger 60 causes fluid 25 to be introduced through 3-way stopcock 12 into the flexible tubing 10, and to the rigid tubing 3. The fluid 25 emerges from rigid tubing 3 and into distendable bladder 5I forcing distendable bladder 5 to expand into contac~ with the endometrial tissue layer 27 o~ the uterus 6. The fluid 25 is also directed along the flexible tubing to the ~3~9~2 control unit 30 allowing measurement of the fluid pressure within the bladdar by well known means.
Each of the parts of the fluid system 55 is in fluid communication providing constant fluid pressure within the entire fluid system 55 and allowing measurement of the pressure at the applicator end 1 via measurement of pressure of the end attached to the control unit 30.
Control unit 30 is connected to applicator end 1 via plastic sheath 15 which contains flexible tubing 10 and electrical sheath 16. Flexible tubing 10 is connected to a fluid joint 56 via pressure transducer 54, by well known means. Using a standard luer lock connector 19, pressure transducer 54 and hypodermic barrel 14 are connected to ~lexible tubing 10 via a readily available 3-way stopcc,ck 12. 3-way stopcock 12 may be used to isolate the hypodermic barrel 14 or othcr fluid source from ~he fluid system 55 once the desired fluid preæsure is reached.
Figure 4 depicts control unit 30, consisting o~
~luid temperature control 31, fluid pressure control 34, time control 38' and a power source (no~ shown). The control unit 30 includes a power switch 42 and fuse 41.
Fluid temperature is regulated by fluid temperature control 31 and is set by temperature set/reset button 33. The temperature of fluid 25 in the distendable applicator 5 is shown at temperature display 32.
Fluid pressure within the fluid system 55 is ~31~2 regulated by means of controls located on fluid pressure control panel 34. The upper limit for fluid pressure is controlled by high pressure set/reset button 35, with the lower limit controlled by low pressure set/reset button 36. Fluid pressure in mmHg is shown by LED
pressure display 37. Control unit 30 also has pressure indicator display 43, which upon introduction of fluid 25 into the ~luid system 55 provides an easy to see visual display of fluid pressure within the fluid system 55.
Time for the procedure .i.s shown at time display 38, which displays both lapsed time and time remaining for the procedure. Total time for the procedure may be easily set in minutes, seconds, and tenths of seconds using time set buttons 39 and may be cleared or reset using time clear/reset button 40.
A simplified means for d~termining whether the fluid 25 is within the preset.pressure range is depicted in Figure 5, which illustrates the pressure indicator display 43. The pressure indicator display 43 is comprised of a low pressure indicator 51, a high pressure indicator 52 and an optimum pressure indicator 53. As fluid 25 is introduced into the fluid system 55 by manipulation of hypodermic barrel 13, the pressure indicator display 43 is successively illuminated as various fluid pressures are reached. Low pressure indicator 51 i5 illuminated when fluid pressure is below the preset range. High pressure indicator 52 is 13~ 9 ~r~ 2 -:L5-illuminated when fluid pressure is above the preset range. Optimum pressure indicator 53 is illuminated when ~luid pressure is within the preset range.
These indicators allow the practitioner to readily reach the preset pressure range by varying the amount of fluid in the ~luid system via manipulation of the hypodermic barrel 14. A separate heating element indicator 55 is also provided to indicate when power i8 being provided to a heating element 44 located within the distendable applicator 5.
Two views of heating element 44 are shown in Figures 6A and 6B. Figure 6A is an external view of heating element 44, which comprises heating element coil shield 45 and ventilation holes 46.
Figure 6B is a cutaway v:iew of heating element 44, wherein wire leads 49 provide power from system control unit 30 to heating element coil 47 causing heating element coil 47 to heat the fluid 25 which comes into contact with the heating element coil 47 as the fluid 25 flows through the ventilation holes 46. Temperature o~
the fluid 25 is measured by thermocouple 48 and is displayed at temperature display 32. He~t element coil shield 45 prevents distendable bladder 5 from contaa~ing the heating element coil 47.
The applicator end 1 is designed to be easy to replace as shown in Figure 7, which depicts control unit end 30' and applicator end 1 of the inven~ion. control unit end 30' is composed of electrical sheath 16 which is attached on one end to control unit 30 and on the other end to male electrical connector 24, which allows transmittal of power to the heating element 44. Male electrical connector 24 is readily attached or disattached to female electrical connector 17 on the applicator end 1.
Control unit end 30' is also comprised of components from the fluid sys~em 55, including flexible tubing lO attached to 3-way s~opcock 12. 3-way stopcock 12 provides control over the introduction and removal o~
fluid 25 via hypodermic barrel 14. The applicator end 1 i5 easily connected or disconnected from the 3-way stopcock via a luer lock connector 19 attached to pressure transducer 54.
The invention will now be illustrated by the following example.
Example The cauterization procedure is preceded by screening against cancer of the affected region and physical condition within established norms. A PAP
smear and endometrial biopsy/ curettage must exclude cancer or precancerous lesions of the uterus and cervix.
If a fibroid uterus is present, an ultrasound should exclude ovarian masses. The uterine cavity must be 10 cm or less in length to be suitable for the small distendable bladder size.
The patient should be post menstrual or start on Danazol, or the equivalent which causes reduction in )~
~ 3~g372 -:L7-bleeding and a thin endometrium, at a rate of 800 ml daily, from the 5th day of ths previous menstrual period until two weeks after the procedure. She will undergo the procedure in the ambulatory surgery unit or out-patient facility where Valium and/or Demerol can be given intravenously if there is pain during the heating phase of the procedure.
The applicator will be inserted after a bimanual examination and speculum of the cervix. Dilation to 6 mm. may be required which may necessitate a local 1%
lidocane block of the cervix. Once in place the applicator stem protrudes from the vagina and consists of an electrical connecting plug and rigid tubing.
Placement of the applicator may be facilitated by distance markings on the rigid tubing indicating dapth of insertion.
Upon placement of the applicator it will be connected to a control unit v:La attachment of the electrical connector and flexible tubing attached to the rigid tubing to their counterparts extending from the control unit.
Subsequent to insertion of the applicator, the control unit will be powered on in order to allow the practitioner to set the system constraints. The temperature of the fluid in the bladder will be set at the temperature control panel and can be measured via the thermocouple located within the bladder. Fluid pressure constraints are set at the pressure control ~319~2 panel, and upon inflation of the distendable bladder by introduction of fluid to the fluid system by depressing the plunger on the hypodermic barrel, can be easily measured by looking at the pressure indicator lights located on the control unit.
The practitioner then proceeds to inflate the distendable bladder by rotating the lever on the 3-way stopcock in order to access the fluid source and depressing the plunger on the hypodermic barrel which may serve as the fluid source. The practi~ioner injects the fluid into the fluid system until the pressure indicator lights indicate that the fluid pressure i5 within the pre-set constraints. At that point, the practitioner manipulates the 3-way stopcock to close of~
access to the fluid system by the fluid remaining in the hypodermic barrel. Thus, the fluid is non-circulating during the heating portion of the procedure, in part allowing more precise measuremen~ of fluid temperature.
The volume of fluid necessary to in~late the bladder will vary from 3 to 20 ml in most cases in order to reach the pressure wherein the bladder is substantially in contact with all of the endometrium.
The practitioner then turns on the heatiny element in order to heat the fluid to a pre-set level. The heating element in the bladder is connected via the plug to a 12 volt system which will bring the fluid in the bladder to the level of boiling as needed for each particular local, i.e. 190 degrees farenheit in Mexico X
13~ ~72 City, and 212 degrees farenheit in New York City. Once that temperature level is reached, the system timer i8 activated to time the procedure and provide automatic turn off of the heating element at the end of a prs-~et periodO
Upon completi.on of the procedure, the 3-way stopcock is again manipulated to allow the fluid to bo withdrawn from the fluid system causing the distendable bladder to deflate. Upon deflation of the distendabls bladder, the applicator may be safely withdrawn from the patient. The coagulated endometrium is then removed from the endometrial cavity with a curette, leaving the underlying surface free to form adhesions with the other opposing surfaces of the endometrial cavity.
Claims (21)
1. An apparatus for effecting necrosis of an uterine endometrium comprising:
an applicator comprising a catheter for insertion into the uterus via the cervical canal thereof, said catheter terminating in a rigid, axially closed proximal end portion and having an open distal end, and a distendable bladder defining an enclosure attached to said proximal end portion for insertion into and distending the uterus, and for contacting substantially all of said endometrium;
said distendable bladder projecting axially beyond the proximal end portion of the catheter when distended;
inflating means connected to said distal end for distending said distendable bladder;
heating means for heating said distendable bladder positioned internal to said distendable bladder; and control means for regulating the distending and heating of said distendable bladder.
an applicator comprising a catheter for insertion into the uterus via the cervical canal thereof, said catheter terminating in a rigid, axially closed proximal end portion and having an open distal end, and a distendable bladder defining an enclosure attached to said proximal end portion for insertion into and distending the uterus, and for contacting substantially all of said endometrium;
said distendable bladder projecting axially beyond the proximal end portion of the catheter when distended;
inflating means connected to said distal end for distending said distendable bladder;
heating means for heating said distendable bladder positioned internal to said distendable bladder; and control means for regulating the distending and heating of said distendable bladder.
2. The apparatus of claim 1, wherein said catheter is comprised of an external tubing, an internal tubing extending through said external tubing, and at least one wire extending through said distal end and connected to said heating means.
3. The apparatus of claim 2, wherein said inflating means comprises a fluid and a pump means connected to said internal tubing for pumping said fluid into said distendable applicator.
4. The apparatus of claim 3, wherein said heating means comprises:
a power source connected to said wire;
a heating element attached to said wire at said proximal end of the catheter and surrounded by said distendable bladder; and heating said fluid within said distendable bladder so as to heat said distendable bladder.
a power source connected to said wire;
a heating element attached to said wire at said proximal end of the catheter and surrounded by said distendable bladder; and heating said fluid within said distendable bladder so as to heat said distendable bladder.
5. The apparatus of claim 4, wherein said control means is external to the uterus and connected to said inner tubing and said wires.
6. The apparatus of claim 3, wherein said pumping means comprises a hypodermic barrel connected to said inner tubing.
7. The apparatus of claim 6, wherein said hypodermic barrel is connected to said inner tubing by a three-way valve.
8. The apparatus of claim 1, further comprising means for disengaging said applicator from said control means so that the applicator and the control means may be separated.
9. The apparatus of claim 1, wherein said distendable bladder is capable of resisting an internal pressure of at least 300 mmHg without rupturing and a temperature of at least 250- farenheit without carbonizing.
10. The apparatus of claim 9, wherein said distendable bladder is selected from the group comprising latex rubber.
11. The apparatus of claim 2, wherein said external tubing is selected from the group comprising Teflon type tubing.
12. The apparatus of claim 2, wherein said internal tubing is selected from the group comprising Teflon type tubing.
13. The apparatus of claim 1, wherein said control means comprises:
volume control means;
temperature control means;
pressure control means; and time control means.
volume control means;
temperature control means;
pressure control means; and time control means.
14. The apparatus of claim 13, wherein said temperature control means comprises:
a thermocouple internal to said distendable bladder for measuring the temperature of said fluid; and a temperature display attached to said thermocouple by at least one wire;
said temperature display further providing a means for setting the temperature of said heating means.
a thermocouple internal to said distendable bladder for measuring the temperature of said fluid; and a temperature display attached to said thermocouple by at least one wire;
said temperature display further providing a means for setting the temperature of said heating means.
15. The apparatus of claim 13, wherein said pressure control means comprises:
a pressure sensor connected to said applicator by said inner tubing; and a pressure display attached to said inner tubing;
said pressure display further providing a means for setting the pressure of said inflating means.
a pressure sensor connected to said applicator by said inner tubing; and a pressure display attached to said inner tubing;
said pressure display further providing a means for setting the pressure of said inflating means.
16. The apparatus of claim 13, wherein said time control means comprises a clock.
17. The apparatus of claim 16, wherein said clock is programmable and connected to said temperature control means.
18. The apparatus of claim 1, further comprising a positioning means for positioning said distendable bladder in the uterus.
19. The apparatus of claim 18, wherein said positioning means comprises scale gradations on said catheter for indicating depth of insertion of said distendable bladder into the uterus.
20. The apparatus of claim 3, wherein said fluid is non-circulating.
21. An apparatus for effecting necrosis of human uterine endometrium comprising:
a catheter for insertion into human uterus and comprising a length of flexible tubing having an open distal end and an axially closed, rigid proximal end portion;
a bladder means for insertion into and distending the uterus and attached to the proximal end portion, said bladder means extending beyond the proximal end of the catheter when distended;
inflating means connected to said distal end for introducing an inflation medium through said flexible tubing and into said bladder;
a heating means for heating said inflation medium to a temperature sufficient to effect tissue necrosis positioned internal to said bladder; and control means connected to said distal end for regulating inflation and heating of said bladder.
a catheter for insertion into human uterus and comprising a length of flexible tubing having an open distal end and an axially closed, rigid proximal end portion;
a bladder means for insertion into and distending the uterus and attached to the proximal end portion, said bladder means extending beyond the proximal end of the catheter when distended;
inflating means connected to said distal end for introducing an inflation medium through said flexible tubing and into said bladder;
a heating means for heating said inflation medium to a temperature sufficient to effect tissue necrosis positioned internal to said bladder; and control means connected to said distal end for regulating inflation and heating of said bladder.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA614493A CA1319072C (en) | 1989-09-29 | 1989-09-29 | Intrauterine cauterizing apparatus and method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA614493A CA1319072C (en) | 1989-09-29 | 1989-09-29 | Intrauterine cauterizing apparatus and method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1319072C true CA1319072C (en) | 1993-06-15 |
Family
ID=4140795
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA614493A Expired - Lifetime CA1319072C (en) | 1989-09-29 | 1989-09-29 | Intrauterine cauterizing apparatus and method |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1319072C (en) |
-
1989
- 1989-09-29 CA CA614493A patent/CA1319072C/en not_active Expired - Lifetime
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| NARC | Re-examination certificate | ||
| MKEX | Expiry |
Effective date: 20100615 |