Disclosure of Invention
The present invention describes a therapeutic device for repairing target tissue beneath the superficial cells of a female vagina while cooling the superficial cells of the vagina. The treatment apparatus includes components that cooperate. In one embodiment, the device includes a handle and a treatment head, both of which may form part of a system that may include a power source, a refrigeration source, and a steering system.
The present invention provides a treatment device that is a component of a system for repairing target tissue beneath superficial cells of a female vagina (hereinafter referred to as a 'repair system').
The therapeutic device of the invention consists of a therapeutic head (1) and a handle (2), wherein the therapeutic head (1) is positioned at the top end of the handle (2) and is connected with the handle (2) through a connecting and fixing device (3), the shape of the end surface of the therapeutic head is selected from conical shape, spherical shape, hemispherical shape, elliptic shape and circular shape, and the therapeutic device further comprises one or more devices, namely one or more temperature sensors (11) for measuring the temperature of superficial cells or the temperature below the superficial cells; one or more direction sensors (7); one or more depth markers (8) are used to indicate the depth of the treatment head into the vagina.
In another embodiment, the therapeutic device of the present invention is composed of a therapeutic head (1) and a handle (2), the therapeutic head is located at the top end of the handle and is connected with the handle through a connecting and fixing device (3), the therapeutic device comprises one or more temperature sensors (11) for measuring the temperature of the surface cells or the temperature below the surface cells, and the therapeutic device further comprises one or more direction sensors (7) embedded on the handle or the therapeutic head. In one embodiment, the treatment apparatus further comprises one or more depth markers (8) for indicating the depth of the treatment head into the vagina. The end surface shape of the treatment head is selected from: rectangular, arcuate, conical, spherical, elliptical, hemispherical, or circular.
The distal surface of the treatment head (1) comprises one or more heat transfer sheets (4) comprising an inner wall and a surface for contact with superficial cells.
Wherein the end of the treatment head (1) is internally provided with an internal cooling chamber (5) which can cool the heat transfer sheet. The internal cooling chamber includes a plurality of nozzles (6) for spraying coolant onto the inner wall of the heat transfer fins. The internal cooling chamber includes a coolant return passage for discharging used coolant.
The heat transfer sheet includes at least one radio frequency electrode.
The distal surface of the treatment head may be completely covered by the heat transfer sheet or have one or more portions not covered by the heat transfer sheet.
The plurality of heat transfer sheets can be opened or closed in a specific order, or can be opened or closed in a clockwise or counterclockwise direction.
The heat transfer sheet may cool the superficial cells and simultaneously deliver energy to heat the target tissue.
In one embodiment, the treatment head is removably attachable to a handle of a repair system. For example, the treatment head may mate with the handle to receive power, radio frequency, coolant, and/or digital signals.
In one embodiment, the temperature sensors of the therapeutic device are thermocouples, e.g., each thermocouple comprises a first and second hinge, respectively. In one embodiment, the first hinge of the thermocouple is located on the handle of the repair system or between the heat transfer sheet and the handle. In another embodiment, the second hinge of the thermocouple is located at the end, proximal end, or center of the heat transfer sheet.
In one embodiment, the second hub of the thermocouple comprises a blunt tip that contacts the surface cell and is capable of measuring the temperature of the surface cell. Or the second hub of the thermocouple may comprise a probe capable of penetrating the surface cell to measure the temperature below the surface cell.
The orientation sensor is typically used to provide information to track the position of the treatment head. In one embodiment, the direction sensor tracks the position of the treatment head via an electromagnetic system or an optical system. The direction sensor can be placed in different positions, for example, embedded in the front or end of the handle, or embedded in a heat transfer sheet near the treatment head.
In one embodiment, the treatment apparatus comprises depth markings engraved on the treatment surface. For example, the depth-marked treatment surface may be rectangular, arcuate, conical, spherical, hemispherical, elliptical, or circular. In one embodiment, the depth markings comprise numbers.
In another embodiment, the depth markings on the treatment device or treatment surface comprise indentations or numerical markings. In another embodiment, the depth markings may be on multiple sides of the treatment apparatus.
In another embodiment, the invention provides a therapeutic device for repairing vaginal tissue of a female comprising a hand-held device (14) and a handle (2), wherein the hand-held device (14) is connected with the handle (2), the finger sleeve (12) is arranged at the top end of the hand-held device (14), the tail end of the hand-held device is provided with a ring sleeve (15), the finger sleeve is connected with a shell (13), the surface of the shell comprises at least one heat transfer sheet (4), and the therapeutic device further comprises one or more devices including one or more temperature sensors (11) as described above; one or more direction sensors (7) as described above; one or more depth markings (8) as described above. In one embodiment, the finger glove (12) is connected to the handle (2) by a wire (16) that transmits electrical power, radio frequency, coolant, or digital signals.
In one embodiment, the invention provides a therapeutic device for repairing female vaginal tissue with an electrode finger stall, the therapeutic device comprises a finger stall (12), a handle (2) and a connecting and fixing device (3), the finger stall (12) is positioned at the top end of the handle (2), the finger stall is connected with the connecting device (3) in the middle, the finger stall is connected with a shell (13), the surface of the shell comprises at least one heat transfer sheet (4), and the therapeutic device further comprises one or more devices such as one or more temperature sensors (11) as described above; one or more direction sensors (7) as described above; one or more depth markings (8) as described above.
The heat transfer sheet includes an inner wall and a surface in contact with the surface layer cells. In one embodiment, the heat transfer sheet comprises at least one radiofrequency electrode.
The shape of the surface of the housing (13) is selected from: rectangular, arcuate, elliptical, conical, hemispherical, spherical, or circular. In one embodiment, the housing (13) contains a cooling chamber (5) therein having a coolant delivery tube opposite the heat transfer sheet inner wall. The coolant delivery tube includes a plurality of nozzles (6) for spraying coolant onto the inner wall of the heat transfer fins.
In another embodiment, the present invention provides a system for repairing vaginal tissue in a female (referred to as a 'repair system'). In one embodiment, the system comprises a treatment head, a handle, and a comprehensive controller as described above, the comprehensive controller comprising a housing, a radio frequency generator and a cooling device within the housing, and a manipulator of the repair system.
Detailed Description
Therapeutic device for repairing vaginal tissue
In one embodiment, the therapeutic device for repairing female vaginal tissue of the present invention comprises a handle and a treatment head (see fig. 1-2), and is used for repairing target tissue under superficial cells of female vagina. The handle may be held by the hand of an operator, such as a physician. The handle may be connected to other auxiliary systems or as a stand-alone instrument. In one embodiment, the treatment head is removably attached to the handle. For example, the treatment head can be quickly attached to and detached from the handle.
Therapeutic head
In one embodiment, the treatment head comprises a housing and a treatment surface at a distal end, the housing comprising a central portion, the distal end of the treatment head being covered by one or more heat transfer sheets, each heat transfer sheet comprising an inner wall and a surface for contacting superficial cells. The heat transfer sheet may cool the superficial cells and simultaneously deliver energy to heat the target tissue. The treatment head housing forms an interior space that extends to the distal end of the treatment head. The middle portion of the housing allows the heat transfer fins to extend forwardly from the handle. The length of the therapeutic device can make the therapeutic surface at the end of the therapeutic head reach the deepest part of the treated vagina.
Heat transfer sheet
In one embodiment, the heat transfer sheet has an inner wall facing the inner space of the treatment head and a contact surface facing the outside of the treatment head and capable of contacting with superficial cells. The inner wall may be made of a metal such as copper, gold, silver or aluminum. The superficial cell-contacting surface may be made of a variety of materials, including but not limited to: polyimide, teflon (RTM), silicon nitride, polysilane, polysilazane, Kapton or similar polymers, antenna dielectrics, and other dielectric materials known in the art. Other conventional dielectric materials include polymers such as polyester, silicon, sapphire, diamond, Zirconium Toughened Alumina (ZTA), alumina, or other similar substances. In another embodiment, the heat transfer sheet is made of a hybrid material, which includes, but is not limited to: gold plated copper, copper polyimide, silicon/silicon nitride or other similar substances.
In one embodiment, the heat transfer sheet may be a radio frequency electrode, a microwave emitter, or an ultrasonic emitter. For example, the radiofrequency electrode is a capacitive electrode that is in contact with the superficial cells. In another embodiment, the radiofrequency electrodes can be monopolar or bipolar. In the monopolar mode, radio frequency current is passed through the body tissue from a return electrode attached to another part of the patient's body, which may be in the form of a conductive pad. The tip of the applicator may have a pair of monopolar electrodes, a bipolar electrode, or a plurality of bipolar electrodes.
In one embodiment, the electrodes of the heat transfer sheet may be coupled to a programmable integrated memory chip EEROM (read-only and erase-only memory, also known as EEPROM) housed within the treatment head. The chip may provide various information to the manipulator of the repair system, such as identification information or other operational or configuration parameters related to the rf electrodes. The parameters may include the type and size of the electrodes, the number of times the heat transfer sheet has heated, and the like.
Treatment surface of treatment head end (10)
In one embodiment, the treatment surface at the end of the treatment head is conical, spherical, hemispherical, or any other geometry suitable for use on a treatment surface. The heat transfer sheet is positioned at the tail end of the treatment head. For example, the heat transfer fins may be arranged on the treatment surface of the distal end of the treatment head in a conical, spherical, hemispherical, elliptical, circular, or other geometric shape. The practitioner of ordinary skill in the art can design treatment surfaces (conical, spherical, etc.) and heat transfer sheets of different sizes (e.g., small, medium, and large) at will to accommodate differences in the structure of the female reproductive organs.
The heat transfer fins (or electrodes) can be arranged in different patterns on the distal treatment surface of the treatment head (see fig. 1-2). For example, the heat transfer sheet may cover the entire treatment surface. In another embodiment, one or more portions of the treatment surface may be uncovered by the heat transfer sheet. The practitioner of ordinary skill in the art can optionally size the heat transfer sheet to meet the needs of the treatment, and configure the treatment head so that the treatment surface and heat transfer sheet properly cover the target tissue. In one embodiment, the heat transfer sheets are divided into groups and by inductive techniques, the operator can determine which group of heat transfer sheets has come into proper contact with the body tissue to deliver radiant energy to the heat transfer sheets.
In one embodiment, certain portions of the treatment surface are covered with an insulating material rather than a heat transfer sheet, and thus, these portions of the treatment surface are free of electrodes or heat transfer sheets (see FIGS. 1-2). This allows the user to avoid treatment of certain parts of the vagina during treatment, thereby improving the safety and efficacy of the treatment.
In another embodiment, the heat transfer sheet is spread over the entire treatment surface, but certain heat transfer sheets can be turned on/off to avoid treating certain parts of the vagina.
In another embodiment, multiple heat transfer sheets can be turned on/off in any order to treat the target tissue. For example, the plurality of heat transfer sheets may be opened and closed in a clockwise or counterclockwise direction. In another embodiment, the user can remotely control the opening and closing of particular heat transfer sheets in any order. In another embodiment, the user may use a software program to record which heat transfer sheet has been opened and closed to identify and separate untreated and treated areas. Cooling device
In one embodiment, the interior space of the distal end of the treatment head can house a cooling system to cool the heat transfer sheet. For example, the interior space includes a conduit to carry cryogen to a plurality of nozzles. There are a variety of refrigerants known in the art, such as 1,1,1, 2-tetrafluoroethane (R134A) which can be stored under high pressure. The nozzles are generally opposed to the inner wall of the heat transfer sheet. The refrigerant is sprayed from the nozzle onto the inner wall of the heat transfer sheet, and cools the heat transfer sheet during the process of changing from liquid to gas. Therefore, the surface (surface cell contact surface) of the heat transfer sheet can cool the surface cells of the target tissue.
Any suitable cryogen and internal cooling system may be used, as will be appreciated by those of ordinary skill in the art. In some embodiments, electricity may be used for cooling (e.g., by the peltier effect or other similar effect). Thus, in general, the cooling system of the treatment apparatus may comprise a cooling chamber. The cooling chamber may include one or more nozzles for spraying or applying the cryogen. The coolant may be sprayed on the inner wall of the heat transfer sheet in any form. For example, the spray pattern may be overlapping circles. In fig. 3, the heat transfer sheet is positioned on a conical treatment surface with the nozzle opposite the heat transfer sheet and the cryogen is sprayed in a conical pattern.
Therefore, generally, the cooling chamber has a plurality of nozzles for spraying the coolant onto the inner wall of the heat transfer sheet. Because the inner wall of the heat transfer sheet is thermally conductive, cooling the inner wall (although only a portion of the inner wall) also causes the outer surface of the heat transfer sheet to be cooled, thereby cooling the superficial tissue in contact with the heat transfer sheet.
Handle (CN)
Generally, the handle is long enough to be held with both hands. The handle may be fairly rigid (e.g., as compared to a flexible, flat cable). In one embodiment, the handle 1101 is elongated and includes a hand grip 1003 (see fig. 4). The handle may also include one or more controls, such as buttons (1005, see fig. 4), a roller ball, a dial, and the like. The control enables the operator to transfer energy to the heat transfer fins, spray coolant, or both. The handle may also include one or more indicators for displaying the status and orientation of the instrument, such as the treatment head. For example, the indicator may show whether the therapy head is connected; whether the refrigerant is used up; or whether the instrument is openable. In another embodiment, the indicator may indicate the temperature of the treatment head (e.g., heat transfer patch) and/or how long the instrument has been turned on. In some embodiments, the indicator includes one or more lights (e.g., light emitting diodes, etc.), color indications (including colored lights), textual indications (e.g., a display screen or display), and the like. The handle is usually fitted with the treatment head. In some embodiments, the treatment head and handle can be designed to be quickly or easily attached and detached.
In one embodiment, the handle or the treatment head, or both, include indicia indicating how deep into the vagina the instrument has been introduced. Thereby allowing the operator to maintain the depth required for the operation.
In one embodiment, the treatment head is a component designed to be used only once, while the handle is reusable. For example, the entire structure and components of the treatment head are sterilized and individually packaged to maintain sterilization until the package is opened and the treatment head is attached to the handle ready for use.
Electronic auxiliary system
The apparatus for repairing female vaginal tissue described above may be included in a larger electronic system having, for example, a radio frequency power source capable of providing power to the radio frequency electrodes, or a multiplexer operable by a digital controller or computer. When the controller is a data processor, such as a microprocessor of a computer, it may include a central processing unit via a system bus. The system may also have a keyboard, disk drive, or other stable storage system, display, and other peripheral components. There may also be program memory and data storage associated with the bus.
In another embodiment, the electronic assistance system may include an operator interface including an operator control and a display. The operator controls may be compatible with different types of imaging systems, which may include, for example, ultrasound or full resistance displays. The current and voltage can then be used to calculate the full resistance. The electronic assistant system may also include a preliminary diagnostic routine. Diagnostic procedures can use ultrasound and other means to determine the extent of treatment, and can be performed before and after treatment.
A practitioner of ordinary skill in the art can design a suitable electronic assistant system at will. In one embodiment, the circuitry, software and responses delivered to the controller allow the operation of the instruments described above for repairing vaginal tissue, such as varying power, fill factor, monopolar or bipolar energy delivery, flow rate and pressure, etc., as well as determining when a treatment procedure is complete by time, temperature and/or total resistance. Further, the controller can provide multitasking, monitor the continuity of the circuit, and determine which RF electrode has been activated. In another embodiment, the display may alert when the temperature or total resistance exceeds a predetermined value, and the RF energy delivered to one electrode is correspondingly reduced or forwarded to the other electrode.
System for repairing vaginal tissue
In one embodiment, a system for repairing vaginal tissue (referred to as a 'repair system') can include a handle, a single-use (or reusable) treatment head, a power source, a cooling system, and a controller. In some embodiments, the controller, power source, and cooling system may be integrated into a complex that may be mated to a handle and treatment head (see fig. 5A and 5B). The complex 1500 in this example comprises a display 1501 and a housing 1503 connected to a handpiece 1505 and a treatment head 1507 by a cable 1509. The cable may include tubing to provide and recover coolant, and may also connect a source of rf energy to the sensor on the treatment device. The whole system is light and small, and is easy to carry and use.
For example, in one embodiment, the repair system may include: a treatment head (for delivering radio frequency energy), a source of cryogen (e.g., cryogen), a handle, and a cable connecting the handle and treatment head to the source of cryogen, the power source, and/or a control system or controller.
In another embodiment, the handle is connected to an integrated controller via a cable, the controller including a cooling system and power source that can be controlled by the controller. The cable may include tubing to provide and recover coolant, and may also connect a source of rf energy to the sensor on the treatment device.
In one embodiment, the complex may include an opening into which a cryogen may be placed. For example, the cryogen may be a pressurized canister 1521 of cryogen. The can may be threaded or otherwise securely placed in the complex, but the cryogen may be sealed by any sealing means. The amount of cryogen may be measured by the repair system, and the display may show how much cryogen remains in the tank or repair system.
In one embodiment, the components of the integrated controller include a microprocessor (e.g., hardware, software, and/or firmware) for operating the system, any outputs (e.g., display, one or more speakers, etc.), the rf power supply, and the cooling system. These components may be individually housed in a modular manner within the housing of the complex.
The above-mentioned repair system, especially the integrated controller, has a small total weight and an occupied area, so that the whole system is convenient to carry and store. For example, the overall system weighs less than 50 pounds.
The repair system may also include one or more controllers for controlling the instruments. For example, a controller for controlling the delivery of energy by the treatment apparatus (e.g., an activation control) may also include one or more controllers for controlling the treatment process.
The controller may include a display that displays information about the procedure, coolant, treatment head, handpiece, and other system components. The information can be displayed on the front surface of the integrated controller and can also be transmitted through sound signals. The display can also display fault information (including error codes) for various system components (e.g., coolant status, skin contact, radio frequency generator status, etc.). In one embodiment, the display is a touch screen, allowing the user to select treatment parameters by touching the screen. In some embodiments, the system may include a keyboard, mouse, trackball, or the like.
In some embodiments, the activation control (e.g., button) is on the handle. In one embodiment, the system may include a wired or wireless foot pedal, or other off-handle control. In one embodiment, the foot pedal is connected to the integrated controller.
Temperature sensor
One factor that needs to be controlled during treatment is the temperature at the treatment site. This can be controlled by using a temperature sensor (e.g., a thermocouple). Temperature sensors, generally known to those skilled in the art, may be used. For example, a thermocouple detects temperature by comparing the temperature difference of two hinges, one of which is a reference hinge and the other of which is placed on the target site.
In one embodiment, one hinge of a thermocouple may be placed on the treatment electrode/heat transfer pad. For example, a thermocouple junction can be designed as a short, blunt probe to measure the temperature on the surface of the target tissue without the probe causing damage to the tissue (see FIG. 6). In another embodiment, to measure the temperature below the surface of the superficial cells, a thermocouple junction can be designed as a probe that can penetrate the superficial layers of the tissue and reach a specific depth in the target tissue to measure the temperature (see FIG. 6).
In one embodiment, the thermocouple junction in contact with the target tissue can be placed at the end of one or more heat transfer sheets, near the center of the heat transfer sheets, or near the proximal end of the handle.
In another embodiment, more than one pair of temperature measuring hinges are placed on the heat transfer sheet and in contact with the target tissue. This allows for measurement of relative temperature or monitoring of temperature between heat transfer sheets.
In one embodiment, a thermocouple reference hub that is not in contact with the tissue can be placed between the heat transfer sheet and the handle, or on the handle.
The data obtained from the temperature measurement can be fed to the control unit and displayed and/or used to generate an alarm if necessary. The data for temperature may also be used to assess the effectiveness of the treatment or to stop the treatment when the target temperature has been reached or exceeded. The alarm and information may be displayed graphically and/or audibly.
Direction sensor
In a general treatment procedure, the heat transfer sheet at the end of the treatment head can contact different parts of the lower vagina. A series of contact sites thus form a therapeutic field of vaginal surface cells. The heat transfer sheet (or treatment surface containing the heat transfer sheet) can be applied to the contact site or treatment area in a variety of ways. For example, the heat transfer fins may treat the contact site in a clockwise or counterclockwise direction or at a predetermined time interval. Since the treatment pattern may vary from person to person, or each time, the direction sensor may be mounted on the treatment apparatus to provide information to allow the operator to know the position of the treatment head. In one embodiment, the tissue repair system may have multiple sensors providing sensing information, which may be used individually or in combination.
Some inductive receiving systems known in the art can be used in the present invention. In one embodiment, the induction may be received by an electromagnetic induction system or an inductor such as an accelerometer or gyroscope. The sensor first records the initial position and then records the change in position by distance, angle, or other comparison (e.g., offset, pitch, or roll, etc.).
In another embodiment, the sensing may also be received by light. For example, optical discs may use light sources and reflection sensing to measure changes in position.
In one embodiment, the direction sensor may be placed at the top or distal end of the handle (fig. 7A-B). In another embodiment, the sensor can be placed in close proximity to a heat transfer patch on the treatment head (fig. 7C).
In one embodiment, the information sensed by the direction sensor can be processed and displayed to let the operator know the current position of the treatment head, the past position, the direction of treatment and other relevant information.
In another embodiment, the position sensing of the sensor can trigger an alarm to indicate whether the treatment head is approaching a new contact site, traversing a treated site, or has changed treatment direction.
Sensed information of the patient's treatment process can be stored for future comparison of treatments or other purposes.
The sensing information obtained by the direction sensor has various uses. For example, it can provide information on the specific position of the treatment device on the treatment site. During treatment, it may be necessary to change the manner of energy delivery, the amount of energy, the components of the cryogen or other ancillary treatment, etc. Thus, the position of the treatment device on the treatment site can be used for one or more purposes:
1. the position of the treatment implement may indicate whether treatment is required or any ancillary components are used. Thus, the position data of the treatment apparatus can be used to determine whether treatment should be started or stopped, and whether any adjunctive treatment materials (e.g., coolant) need to be used or stopped.
2. The position data of the treatment device can be used to vary how much energy is delivered or to assist in the treatment of material. These changes can improve the efficiency or safety of treatment. Therefore, the change of the position of the therapeutic device and the direction of the therapeutic device advancing to a specific part can be known, and various parameters of treatment can be changed.
3. The change of the treatment material and/or parameters can be entered directly into the controller of the treatment by a computer program or can be manipulated by the human hand if necessary.
Depth marking
In one embodiment, the tissue repair system described above is capable of treatment on vaginas of varying shapes and depths. The depth of the treatment surface at the distal end of the treatment device into the vagina or other tissue can affect the safety of the patient and/or the effectiveness of the treatment. Thus, the provision of indicia on the treatment device enables the operator to quickly know how deep the treatment surface/treatment device has been into the vagina. The position of the markers depends on the setting of the treatment apparatus itself.
In one embodiment, the indicia can cooperate with raised reference lines or other similar aids that can help the operator learn depth visually or tactilely. In another embodiment, the indicia may be recessed rather than raised. In another embodiment, the indicia may be raised on one side of the treatment head and recessed on the other. Any of the marker designs described above may be used on one or more sides of the treatment head to help the operator maintain a consistent depth as the treatment implement is rotated within the vagina.
When the treatment surface of the distal end of the treatment device is conical (or spherical, rounded, etc.), the depth markings (8) may be placed around the treatment surface or over portions of the treatment surface (fig. 8A), to aid in rotating or inserting the treatment device during treatment.
In one embodiment, the depth markings may display the depth of insertion of the therapeutic device in digital form (fig. 8A, 8B). The numeric indicia may include numbers and units of measure, such as inches, millimeters, or centimeters. These numbers can be printed on the treatment head and are flush with the surface of the treatment head. In another embodiment, the numbers may be raised or recessed to provide visual or tactile assistance.
The digital mark can also be printed on the therapy head with a color that is in bright contrast to the color of the therapy head. For example, if the treatment head is black in color, the indicia may be white, or the opposite. The contrast in color allows the depth of treatment to be readily seen.
In another embodiment, the numbers and indicia may be staggered in different colors to show different depths of insertion, for example, using three different colors to show light, medium, or dark.
In another embodiment, the numbers and indicia may be staggered in two different colors to serve as a security indicator. For example, green may be used to show a particular safe depth and red to show a dangerous depth. Other contrasting colors may also be used.
In summary, the markings on the treatment tip enable the operator to quickly determine the depth to which the tissue repair treatment tip has entered the target vaginal tissue. The markings and numerals are located on the treatment surface at the end of the treatment head. In another embodiment, the marker is located a point posterior on the treatment head. In another embodiment, the markers may be on multiple locations of the treatment head for added convenience.
Therapeutic device with electrode finger stall for repairing female vaginal tissue
In one embodiment, the therapeutic device comprises a hand-held device (14) and a handle (2), wherein the hand-held device (14) is connected with the handle (2), a finger sleeve (12) is arranged at the top end of the hand-held device (14), a loop (15) is arranged at the tail end of the hand-held device, the finger sleeve is connected with a shell (13), and the surface of the shell comprises at least one heat transfer sheet (4).
In one embodiment, the finger sleeve is attached to a short rod and a loop that fits over the wrist or arm of the operator (see the wrist band of FIG. 9), thereby allowing the instrument to be gripped. The apparatus can thus be moved into and out of the treatment site without loosening, thereby promoting safety, therapeutic efficacy and user comfort.
In one embodiment, the finger glove (12) is connected to the handle (2) by a wire (16) that transmits electrical power, radio frequency, coolant, or digital signals.
The surface shape of the housing (13) is selected from: rectangular, arcuate, elliptical, conical, hemispherical, spherical, or circular.
In another embodiment, the finger sleeve is attached directly to the handle, without a short rod and loop (fig. 10). Thus, the operator can remove the finger stall and hold the handle with his hand after placing the heat transfer sheet on the treatment site. The therapentic equipment contains finger stall (12), handle (2) and connecting device (3), and finger stall (12) are located handle (2) top, and the centre is connected by connecting device (3), and a shell (13) is connected to the finger stall, and the shell surface contains an at least heat transfer piece (4).
In one embodiment, the finger glove can be designed to fit different finger sizes for males and females. The finger stall can be achieved by matching with finger stalls and electrodes with different sizes, or inner rings with different inner diameters are added on the finger stall, and the finger stall can also be made of soft materials so as to adapt to different finger sizes. The finger stalls allow the doctor/operator/care giver to easily access the treatment site to achieve various advantages, such as accuracy and speed of treatment.
In one embodiment, the heat transfer sheet is part of a housing that contains a cooling chamber capable of cooling the heat transfer sheet. For example, the cooling chamber includes a conduit to carry coolant to a plurality of nozzles. There are a variety of refrigerants known in the art, such as 1,1,1, 2-tetrafluoroethane (R134A) which can be stored under high pressure. The heat transfer sheet comprises a surface in contact with the superficial cells and an inner wall opposite the cooling chamber. In one embodiment, the nozzles are opposite the inner wall of the heat transfer sheet. After being sprayed out from the nozzle, the refrigerant is sprayed onto the inner wall of the heat transfer sheet, and the heat transfer sheet is cooled in the process that the refrigerant is changed from liquid to gas. Therefore, the surface (surface cell contact surface) of the heat transfer sheet can cool the surface cells of the target tissue.
The method of treating the target tissue is to insert a finger into the finger stall and place a heat transfer patch over the treatment site. The heat transfer sheet may operate in a clockwise or counterclockwise direction at the treatment site. The heat transfer sheet can be sized at will by those of ordinary skill in the art to provide the best treatment.
In one embodiment, the heat transfer sheet may be a radio frequency electrode, a microwave emitter, or an ultrasonic emitter. In one embodiment, the radiofrequency electrode is a capacitive electrode in contact with the mucosal surface cells.