Proctologic device for the therapeutic treatment of hemorrhoids

• US 4,227,535 A
• Filed: 04/02/1979
• Issued: 10/14/1980
• Est. Priority Date: 04/02/1979
• Status: Expired due to Term

• Current Assignee: Biosonics, Inc.
• Original Assignee: Biosonics, Inc.
• Inventors: Connor, Gerald I.
• Primary Examiner(s): Michell, Robert W.
• Assistant Examiner(s): Rose, Arthur S.
• Application Number:
  US06/026,036
• Time in Patent Office: 561 Days
• Field of Search: 128/401, 128/788, 128/34, 128/1, 128/1 B, 128/395, 128/303.17, 128/303.1, 128/399, 128/400, 128/402, 219/491, 219/494, 219/499, 340/573, 340/599, 340/532
• US Class Current: 607/113
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61F 2007/0028 Rectum
• CPC Class Codes: A61F 2007/0074 PTC
• CPC Class Codes: A61F 5/0093 Rectal devices, e.g. for the treatment of haemorrhoids
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

Abstract

A proctologic device is described for therapeutically treating hemorrhoids extending from the anal canal wall of a patient. The device includes an anal canal appliance for intimately contacting the anal canal wall and hemorrhoids. The appliance has sufficient length to extend from the anus to the rectum and sufficient diameter to intimately contact the wall tissues without overly stretching the sphincter muscles. The appliance contains an internal electrical resistor for generating heat in response to the application of electrical energy and a temperature transducer for sensing the temperature of the appliance in the anal canal. The device has a portable case containing an electrical energy storage battery and a control circuit for controlling the application of the electrical energy to the resistor to maintain the temperature of the appliance above body temperature. The control circuit has safety network for discontinuing the application of heat to the appliance should the sensed temperature fall below a preset low temperature or go above a preset elevated temperature.

Claims

1. A proctologic device for the therapeutic treatment of external and/or internal hemorrhoids projecting from the wall of a patient'"'"'s anal canal which extends from the anus to the rectum and is surrounded by sphincter muscles;

comprising;

an anal canal appliance for insertion into the anal canal through the anus;

said appliance having an elongated cylindrical body with an external heat transfer surface extending from a front end to a rear end for intimately contacting the anal canal wall and the projecting hemorrhoids;

said external heat transfer surface having a diameter sufficient to effectively transfer heat from the heat transfer surface to the anal canal wall and the hemorrhoids without painfully stretching the sphincter muscles;

said appliance having an electrical resistor heating element mounted internally within the cylindrical body for converting electrical energy to thermal energy to heat the heat transfer surface;

a source of electrical energy;

cable means extending between the source and the appliance for operatively connecting the source to the electrical resistor heating element;

a temperature transducer mounted in the appliance for sensing the temperature of the external heat transfer surface and for producing an electrical temperature signal corresponding to the temperature of the external heat transfer surface;

control means operatively connected to the source and responsive to the electrical temperature signal for automatically regulating the amount of electrical energy applied to the electrical resistor heating element to heat the external heat transfer surface and to maintain the external heat transfer surface at preset temperature above body temperature;

safety network means independent of said control means with a high temperature circuit responsive to the electrical temperature signal for automatically terminating the application of electrical energy to the electrical resistor heating element should the temperature sensed by the temperature transducer exceed a preset elevated temperature;

wherein the high temperature circuit includes a voltage comparator for receiving the electrical temperature signal and in comparing the voltage of the electrical temperature signal with a preset voltage of a reference signal corresponding to the preset elevated temperature to terminate the application of electrical energy to the electrical resistor heating element when the differential voltage between the electrical temperature signal and the reference signal reaches a preset value.

2. The proctologic device as defined in claim 1 wherein the safety network includes a low temperature circuit for automatically terminating the application of electrical energy to the electrical resistor heating element should the temperature sensed by the temperature transducer fall below a preset low temperature.

3. The proctologic device as defined in claim 2 wherein the control means includes an electrical switch, operatively interconnecting the source and the electrical resistor heating element and wherein the low temperature circuit includes a voltage comparator for receiving the electrical temperature signal and comparing the voltage of the electrical temperature signal with a preset voltage of a reference signal and for actuating the electrical switch to discontinue the application of the electrical energy to the electrical resistor heating element when the differential voltage between the electrical temperature signal and the reference signal approaches a preset value.

4. The proctologic device as defined in claim 1 wherein the control means includes an electrical switch operatively interconnecting the source and the electrical resistor heating element and wherein the safety network includes a low temperature circuit responsive to the electrical temperature signal and wherein the high temperature circuit and the low temperature circuit include respective voltage comparators operatively connected to the electrical switch for comparing the voltage of the electrical temperature signal with preset voltages of respective reference signals and for actuating the electrical switch to discontinue the application of the electrical energy to the electrical resistor heating element when the differential voltages between the electrical temperatures and the respective reference signals approach preset values.

5. The proctologic device as defined in claim 1 wherein the source of electrical energy includes portable batteries for supplying electrical energy and wherein the device further includes battery voltage monitoring means with warning means for generating a warning to the user when the battery voltage falls below a preset voltage.

6. The proctologic device as defined in claim 5 wherein the warning device includes a light source and wherein the battery voltage monitoring means includes an electronic network for periodically turning the light source off and on in a blinking fashion to warn the user when the battery voltage falls below a preset voltage.

7. The proctologic device as defined in claim 1 wherein the source of electrical energy includes portable batteries for supplying electrical energy and wherein the device further comprises a voltage regulation means operatively connected to the portable batteries for producing a regulated control signal having a preset voltage for utilization by the control means to control the application of the electrical energy to the electrical resistor heating element.

8. The proctologic device as defined in claim 7 wherein the voltage regulation means includes a manually operable electrical switch to turn the device on and off and wherein the voltage regulation means further includes a visual display network having a preset value resistor and a light source mounted in series with the manually operable electrical switch in which the light source is illuminated when the manual electrical switch is closed and wherein the light source is a light emitting diode in which the resistance of the light emitting diode in which the voltage drop across the light emitting diode is substantially constant and wherein the voltage regulation means includes a regulated voltage network in parallel with the light emitting diode for producing the regulated control signal with a preset voltage corresponding to the voltage drop across the light emitting diode.

9. A proctologic device for the therapeutic treatment of external and/or internal hemorrhoids projecting from the wall of a patient'"'"'s anal canal which extends from the anus to the rectum and is surrounded by sphincter muscles;

comprising;

an anal canal appliance for insertion into the anal canal through the anus;

said appliance having an elongated cylindrical metal envelope with an external heat transfer surface extending from a front end to a rear end for intimately contacting the anal canal and the projecting hemorrhoids;

said external heat transfer surface having a diameter sufficient to expand the anal canal and effectively transfer heat from the heat transfer surface to the anal canal wall and the hemorrhoids without painfully stretching the sphincter muscles;

said appliance having an electrical resistor heating element mounted internally within the cylindrical metal envelope for converting electrical energy to thermal energy;

said electrical resistor heating element comprising a cylindrical thermal insulative ceramic core mounted coaxially within the cylindrical metal envelope and an electrical resistor conductive material mounted on the insulative core;

a temperature transducer in direct engagement with the front end of the metal envelope to produce an electrical temperature signal corresponding directly to the temperature of the external heat transfer surface;

wherein the thermal insulation core is mounted within the metal envelope interposed between the electrical resistor conductive material and the transducer to form a thermal barrier to prevent direct heat transfer from the electrical resistor conductive material and the temperature transducer to minimize temperature sensing error;

a source of electrical energy;

a cable means extending between the source and the appliance for operatively connecting the source to the electrical resistor heating element;

control means operatively connected to the electrical energy source and responsive to the electrical temperature signal for automatically regulating the amount of electrical energy applied to the electrical resistor heating element to heat the external heat transfer surface and to maintain the external heat transfer surface at a preset temperature above body temperature to thereby relax the sphincter muscles and to facilitate the opening of vascular channels of the homorrhoids to facilitate shrinkage of the hemorrhoids.

10. The proctologic device as defined in claim 9 wherein the cylindrical insulative core is constructed of a ceramic material that is highly heat insulative to minimize direct heating of the temperature transducer from the electrical resistive wire.

11. The proctologic device as defined in claim 9 wherein the front end of the anal canal envelope is bulbous in shape to assist in the retention of the appliance in the anal canal.

12. The proctologic device as defined in claim 11 wherein the bulbous front end of the envelope has a diameter that is between 105% and 130% of the diameter of a central portion of the appliance.

13. The proctologic device as defined in claim 9 wherein the temperature transducer extends through the cylindrical insulative core and engages the front end of the envelope.