CN103301568A - A therapeutic device for repairing vaginal tissue with a temperature sensor or a depth marker - Google Patents

Abstract

The present invention provides a therapeutic device, which is used as a component in a system for repairing female vaginal tissue. The system transmits energy to heat the tissue below the vaginal surface cells and simultaneously cool the vaginal surface cells. In one embodiment, the therapeutic device includes a treatment head (1), a handle (2), a heat transfer sheet (4), a cooling device, and a temperature sensor (11) for measuring the temperature of the surface cells or below. In one embodiment, the therapeutic device further includes a depth mark for sensing the depth of insertion into the vagina.

Description

A therapeutic device for repairing vaginal tissue with a temperature sensor or a depth marker

technical field

The present invention relates to a therapeutic device for repairing vagina and vulval tissues by applying radiant energy.

Background technique

During childbirth, a woman's vaginal tissue is stretched; the effects of this stretching can be permanent, and many women have long-term medical consequences as a result. Due to the excessive relaxation and opening of the vagina, certain after-effects may affect certain aspects of sexual performance. Such relaxation usually occurs with the first vaginal delivery and tends to increase with more vaginal deliveries. The results of vaginal relaxation may include a reduction in pressure and friction during intercourse, thereby reducing sexual pleasure for women and their partners during intercourse. Certain surgical procedures can alleviate these problems. However, surgery is not very popular because of its risks.

Use of known systems and devices for treating the vagina, including those that use radiant energy to modify collagen, has not been as effective. This includes manipulation of the instrument and cooling of the treated tissue, the operation of known systems is not perfect. Additionally, existing systems do not ideally regulate the contact of the system with the patient's treated tissue. Finally, the known systems fall short of simplicity, lightness and ease of use. The invention described herein addresses the above deficiencies of known systems.

Detailed description of the invention

The apparatus and systems described here are used to repair target tissue beneath the surface cells of the female vagina while simultaneously cooling the vaginal surface cells. The system includes components that work together. In one embodiment, the device includes a handle and a treatment head, both of which may form part of a system that may additionally have a power source, a source of refrigeration, and a control system for manipulating the handle, treatment device, and power source.

In one embodiment, the present invention provides a treatment device that is a component of a system for repairing target tissue beneath the superficial cells of a woman's vagina (hereinafter referred to as the 'repair system'). The treatment device includes a treatment surface at the end of the treatment head, and the treatment surface includes one or more heat transfer sheets, each heat transfer sheet includes an inner wall and a surface in contact with surface cells. The heat transfer sheet cools the superficial cells while delivering energy to heat the target tissue. The treatment subcontains an internal cooling chamber (5) and one or more temperature sensors for measuring the temperature of the superficial cells or below. In one embodiment, the cooling chamber comprises refrigerant delivery tubes opposite the inner walls of the heat transfer fins.

In one embodiment, the treatment head is detachably attached to the handle of a prosthetic system and can be connected and transmitted by wires or cables to transmit power, radio frequency, refrigerant or digital signals.

In one embodiment, the inner cooling chamber (5) contains a plurality of nozzles (6) for spraying cooling liquid onto the inner walls of the heat transfer fins. In another embodiment, the inner cooling chamber further includes a refrigerant return channel to discharge the used refrigerant to a discharge port.

In one embodiment, the heat transfer sheet on the treatment face comprises at least one radio frequency electrode.

The treatment surface at the end of the treatment head can be designed in different sizes and shapes. For example, the treatment surface can be flat, or rectangular, curved, conical, spherical, elliptical, hemispherical, or circular.

In one embodiment, the temperature sensors (11) of the therapy device are thermocouples, eg, each thermocouple comprises a first junction and a second junction respectively. In one embodiment, the first junction of the thermocouple is located on the handle of the modification system or between the heat transfer plate and said handle. In another embodiment, the second junction of the thermocouple is located at the end, proximal end or center of the heat transfer sheet.

In one embodiment, the second junction of the thermocouple comprises a blunt end that contacts and measures the temperature of the superficial cells. Or the second junction of the thermocouple contains a probe that penetrates the surface cells to measure the temperature beneath the surface cells.

In one embodiment, the treatment tip further includes depth markings for sensing the depth of insertion into the vagina. In one embodiment, the depth markings are located on the treatment face of the tip end. For example, depth markings are located on a rectangular, arcuate, conical, spherical, hemispherical, elliptical or circular treatment surface, and in another embodiment, the depth markings comprise numbers. In one embodiment, the depth markings comprise raised lines, concave lines or numbers; in another embodiment, the depth markings are located on multiple sides of the treatment tip.

In another embodiment, the present invention provides a system for repairing vaginal tissue in a woman ('repair system'). The system includes the treatment head described above, the handle and an integrated controller, which may include a housing, a radio frequency generator and a cooling device inside the housing, and a manipulator of the prosthetic system.

Description of drawings

Figure 1 is a perspective view of an instrument for repairing female vaginal tissue. The instrument can cool the vaginal surface cells and simultaneously transmit energy to heat the tissue under the vaginal surface cells. The instrument includes a treatment head 1, a handle 2, a connecting part 3, and a heat transfer sheet 4.

Fig. 2 is a perspective view of another treatment device, the treatment head is connected with the handle, and the end of the treatment head has a spherical treatment surface.

Figure 3A shows a side perspective view of a cryogen spray pattern within a conical treatment surface; Figure 3B shows an interior and close-up view of the same spray pattern.

Fig. 4 shows a treatment device, which has a temperature sensor (11) for measuring the surface temperature of vaginal surface cells.

Figures 5A and 5B show another therapeutic device with a temperature sensor (11) for measuring the temperature under the vaginal superficial cells.

Figure 6A shows the depth markings on the conical treatment surface; Figure 6B shows the depth markings on the treatment head with the rectangular treatment surface (10); Figure 6C shows the bump depth on the treatment head with the rectangular treatment surface (10) mark.

Figures 7A and 7B show different angles of a complex of a prosthetic system.

specific implementation plan

Instruments for repairing vaginal tissue

In one embodiment, an apparatus for repairing female vaginal tissue includes a handle and a treatment head (see FIGS. 1-3 ), and the apparatus is used to repair target tissue beneath the superficial cells of the female vagina. The handle can be held by an operator such as a physician. The handle can be connected to other auxiliary systems, or as a stand-alone instrument. In one embodiment, the treatment head is detachable on the handle. For example, the treatment head can be quickly connected or disconnected from the handle.

In one embodiment, the instrument for repairing vaginal tissue may comprise a treatment head (1) connected to a handle (2) through a connecting portion (3), and the treatment surface at the end of the treatment head includes a heat transfer sheet (4) ( see picture 1).

treatment head

In one embodiment, the treatment head comprises a housing, a central portion and a treatment surface at the end of the treatment head, the treatment surface is covered by one or more heat transfer sheets, each heat transfer sheet includes an inner wall and a surface in contact with the surface cells. surface. The heat transfer sheet cools the superficial cells and at the same time transmits energy to heat the target tissue beneath the superficial cells. The treatment head housing forms an interior space extending to the end of the treatment device. The middle part of the treatment head allows the heat transfer sheet to extend forward from the handle. The length of the treatment device allows the treatment head to 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 device and a contact surface facing the outside of the treatment device capable of contacting vaginal surface cells. The inner wall of the heat transfer fin can be made of metals such as copper, gold, silver or aluminum. The surface cell interface can 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), aluminum oxide or other similar substances. In another embodiment, the heat transfer sheet is made of a mix of materials including, but not limited to, gold plated copper, copper polyimide, silicon/silicon nitride, or other similar substances.

In one embodiment, the heat transfer sheet can be a radio frequency electrode, a microwave transmitter or an ultrasonic transmitter. For example, an RF electrode is a capacitive electrode that makes contact with superficial cells. In another embodiment, the radiofrequency electrode can be monopolar or bipolar. In the monopolar mode, radiofrequency current is passed through the body tissue from a return electrode placed on another part of the patient's body, which may be formed in the form of a conductive pad. The tip of the therapy tip can have a pair of monopolar electrodes, a bipolar electrode, or multiple bipolar electrodes.

In one embodiment, the electrodes of the heat transfer sheet can cooperate with a programmable integrated memory chip EEROM (readable and erase-only memory, also known as EEPROM) installed in the treatment device. The chip can provide various information to the manipulator of the modification system, such as identification information or other operating or configuration parameters about the RF electrodes. The parameters may include the type and size of the electrodes, the number of times the heat transfer sheet has heated up, and the like.

treatment surface

In one embodiment, the treatment surface at the end of the treatment tip is flat, conical, spherical, hemispherical, circular or any other geometry suitable for the treatment surface where the heat transfer fins are located on the treatment surface (see Figure 1- 2). General practitioners in this technical field can freely design different sizes (such as small, medium and large) of treatment surfaces (conical, spherical, etc.) and heat transfer sheets to adapt to the differences in the structure of female reproductive organs.

Heat transfer sheets (or electrodes) can be arranged on the treatment surface in different forms (see Figure 1-2). For example, a heat transfer sheet can cover the entire treatment surface. In another embodiment, one or more portions of the treatment surface may not be covered by the heat transfer sheet. Ordinary practitioners in the technical field can freely set the size of the heat transfer sheet to meet the needs of treatment, and set the configuration of the treatment surface so that the treatment surface and the heat transfer sheet can properly cover the target tissue. In one embodiment, the heat transfer fins are divided into groups and through induction techniques, the operator can determine which group of heat transfer fins has achieved proper contact with body tissue to deliver radiant energy to these heat transfer fins.

In one embodiment, certain portions of the treatment surface are covered with insulating material rather than heat transfer sheets, and therefore, these portions of the treatment surface do not have electrodes or heat transfer sheets (see Figures 1-2). This allows the user to avoid treating certain areas of the vagina during treatment, thus improving the safety and effectiveness of the treatment.

In another embodiment, the heat transfer fins are spread over the entire treatment surface, but specific heat transfer fins can be turned on/off to avoid treating certain areas of the vagina.

In another embodiment, multiple heat transfer elements can be turned on/off in any order to treat the target tissue. For example, multiple heat transfer fins can be opened and closed clockwise or counterclockwise. In another embodiment, a user can remotely turn on and off specific heat transfer fins in any order. In another embodiment, the user can use a software program to record which heat transfer elements have been turned on and off, thereby identifying and separating untreated and treated areas.

cooling device

In one embodiment, the interior volume of the treatment head can accommodate a cooling system to cool the heat transfer fins. For example, the interior space contains a conduit to deliver refrigerant to a plurality of nozzles. Various refrigerants are known in the art, such as 1,1,1,2-tetrafluoroethane (R134A) which can be stored under high pressure. The nozzles are generally opposite the inner wall of the heat transfer fin. After the refrigerant is sprayed from the nozzle, it is sprinkled on the inner wall of the heat transfer fin, and the refrigerant cools the heat transfer fin during the process of changing from liquid to gas. Thus, the surface of the heat transfer sheet (surface cell interface) cools the surface cells of the target tissue.

One of ordinary skill in the art knows that any suitable refrigerant and internal cooling system can be used. In some embodiments, cooling can be done electrically (eg, via the Peltier effect or other similar effect). Therefore, in general, the cooling system of the treatment head may comprise a cooling chamber. The cooling chamber may include one or more nozzles for spraying or applying refrigerant. The refrigerant can be sprayed on the inner wall of the heat transfer fin in any form. For example, the spray pattern may be overlapping circles. In one embodiment, when the heat transfer fin is on the conical treatment surface, the nozzles may be opposite the heat transfer fin and the cryogen is sprayed out in a conical shape (see Figure 3).

handle

Generally, the handle is long enough to be held with both hands. The handle can be quite sturdy. In one embodiment, the handle is elongated and includes a gripping portion. The handle may also include one or more controls, such as buttons, scroll balls, dials, and the like. This control allows the operator to deliver energy to the heat transfer fins, spray refrigerant, or both. The handle may also include an indicator, and in one embodiment, the indicator may indicate whether the treatment device is connected; if the cryogen is depleted; or if the device can be turned on. In another embodiment, the indicator can show the temperature of the treatment device (eg, heat transfer sheet), and/or how long the device has been on. In some embodiments, the indicator includes one or more lights (such as light emitting diodes, etc.), color indicators (including colored lights), text indicators (such as a display screen or display), and the like. The handle usually matches the treatment head. In some embodiments, the treatment tip and handle can be designed to connect and detach quickly or easily.

In one embodiment, the treatment tip is a part designed to be used only once, while the handle is reusable. For example, the entire structure and parts of the treatment head are sterilized and individually packaged to maintain sterility until the package is opened and the treatment head is attached to the handle and ready for use.

temperature sensor

One factor that needs to be controlled during treatment is the temperature of the treatment site. This can be controlled by using a temperature sensor such as a thermocouple. Temperature sensors generally known to those skilled in the art can be used. For example, a thermocouple detects temperature by comparing the difference in temperature between two junctions, one of which is a reference junction and the other is placed at the target site.

In one embodiment, one junction of the thermocouple may be placed on the therapy electrode/heat transfer sheet. 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 causing damage to the tissue (see Figure 4). In another embodiment, to measure the temperature below the superficial cell surface, a thermocouple junction can be designed as a probe that penetrates the tissue surface and reaches a specific depth in the target tissue to measure temperature (see Figure 5).

In one embodiment, the thermocouple junctions in contact with the target tissue may be placed at the ends of one or more heat transfer fins, near the center of the heat transfer fins, or near the proximal end of the handle.

In another embodiment, more than one pair of temperature measuring hubs are placed on the heat transfer sheet in contact with the target tissue. This enables the measurement of relative temperatures or the monitoring of temperatures between heat transfer fins.

In one embodiment, a thermocouple reference junction not in contact with tissue may be placed between the heat transfer sheet and the handle, or on the handle.

The data obtained from the temperature measurement can be fed into the control unit and displayed, and/or used to generate an alarm if required. Temperature data can also be used to assess the effectiveness of therapy or to stop therapy when the target temperature has been reached or exceeded. Alarms and messages can be displayed graphically and/or audibly.

depth mark

In one embodiment, the tissue repair system described above is capable of treating vaginas of various shapes and depths. The depth of penetration of the treatment surface at the end of the treatment device into the vagina or other tissue can affect patient safety and/or treatment effectiveness. Therefore, having markings on the applicator enables the operator to quickly know how deep the treatment surface/appliance has penetrated into the vagina. The position of the mark depends on the setting of the therapy device itself.

In one embodiment, the markers can incorporate raised guide lines or other similar aids that can help the operator perceive depth either 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 tip and recessed on the other. Any of the marking designs described above can be used on one or more sides of the treatment tip to help the operator maintain a consistent depth when turning the treatment device intravaginally.

When the treatment surface at the end of the treatment device is conical (or spherical, circular, etc.), the depth mark can surround the treatment surface or cover the part of the treatment surface in an appropriate position (Figure 6A). helps.

In one embodiment, the depth markings may digitally indicate the depth of insertion of the treater (FIGS. 6A, 6B). Numerals may include numbers and units of measurement such as inches, millimeters or centimeters. These numbers can be imprinted on the treatment tip, flush with the surface of the treatment tip. In another embodiment, the numerals may be raised or recessed to provide a visual or tactile aid.

Numeral markings can also be printed on the treatment tip in a brightly contrasting color to the treatment tip color. For example, if the color of the treatment head is black, the marking can be white, or vice versa. The contrast of colors makes it easy to see the depth of the treatment.

In another embodiment, the numbers and markings can be staggered in different colors to indicate different insertion depths, for example using three different colors to indicate light, medium or dark.

In another embodiment, the numbers and markings can be staggered in two different colors as a sign of safety. For example, green can be used to show certain safe depths and red to show dangerous depths. Other contrasting colors can also be used.

To sum up, the marks on the treatment head can enable the operator to quickly judge the depth to which the tissue repair treatment head has penetrated into the target vaginal tissue. Markings and numbers are located on the treatment surface at the end of the treatment tip. In another embodiment, the markings are located a little back on the treatment tip. In another embodiment, markings can be placed at multiple locations on the treatment tip for added convenience.

electronic assistance system

The apparatus for repairing female vaginal tissue described above may be incorporated into a larger electronic system having, for example, an RF power supply capable of providing energy to a heat transfer sheet such as an RF electrode. The electronic system may also use multiplexers to measure current, voltage and temperature of thermal sensors connected to each RF electrode. The multiplexer can be controlled by a digital controller or a computer. When the controller is a data processor, such as a microprocessor in a computer, it may include a central processing unit via the system bus. The system may also have a keyboard, disk drive, or other non-volatile storage system, display, and other peripheral components. There may also be program memory and data memory to match the bus.

In one embodiment, the electronic assistance system may include an operator interface including operator controls and a display. The controller can cooperate with different types of imaging systems, for example, the imaging system can include ultrasound, thermal induction or full resistance monitors. In another embodiment, the current and voltage can then be used to calculate the total resistance. The electronic assistance system may also include a preliminary diagnostic program. Diagnostic procedures may use ultrasound or other means to determine the extent of treatment and may be performed before and after treatment.

In one embodiment, thermal energy sensors measure the voltage and current delivered to the treatment site; the output of the sensors is used by a controller to control the delivery of RF power, temperature and volume. The amount of charge and/or temperature can be set by the operator so as not to exceed a defined upper limit. The controller can maintain the specified standard under changing conditions. The delivered radio frequency energy controls the charge. A profile of the amount of electricity delivered as well as the scheduled energy to be delivered can be incorporated into the manipulator. Feedback control can be based on the monitoring of total resistance, temperature and other indicative signals, and can be sent from the controller or RF generator. Measurement of total resistance can be achieved by supplying less than therapeutic amounts of RF energy. Voltage and current are then measured to determine current delivery.

In one embodiment, the controller's circuitry, software, and feedback controls are capable of manipulating the operation of the above-described apparatus for modifying vaginal tissue, such as varying electrical power, fill factor, monopolar or bipolar energy delivery, flow and pressure, etc., and/or time of passage , temperature and/or total resistance to determine when the treatment process is complete. These procedural variables can be controlled and varied according to the temperature of the tissue, which can be derived from multiple locations on the surface of the RF electrodes, as measured by the ratio of total resistance to current across each RF electrode. Furthermore, the controller can provide multiplexing, monitor circuit continuity, and determine which RF electrodes are activated.

In one embodiment, the thermal sensor can be a thermistor with different thermal resistances according to different temperatures. An analog amplifier can be a conventional differential amplifier circuit used with thermistors and sensors. The output of the analog amplifier is connected to an analog-to-digital converter by an analog multiplexer. The output of the amplifier is a voltage representative of temperature. The output voltage of the digitized amplifier is sent to the microprocessor by the digital converter, and the microprocessor can calculate the temperature or total resistance of the tissue. General microprocessor or digital or analog computer can calculate total resistance or temperature. The microprocessor sequentially receives and stores the total resistance and temperature numbers. Each digital value received by the microprocessor represents a different temperature and total resistance.

The calculated temperature and total resistance value can be displayed on a display. Alternatively, instead of displaying the temperature or total resistance figures, the microprocessor can compare the calculated total resistance or temperature value to predetermined temperature and total resistance limits. When the value exceeds a predetermined temperature or total resistance value, the display will issue a warning, and the RF energy delivered to the electrode will be reduced or the energy will be sent to another electrode.

A system for repairing vaginal tissue

In one embodiment, a system for repairing vaginal tissue (abbreviated as 'repair system') may include a handle, a single-use (or re-use) treatment tip, a power supply, temperature sensors, a cooling system , and a controller. In one embodiment, the controller, power supply and cooling system can be integrated into a complex that can be fitted with a handle and treatment tip (see Figures 7A and 7B). For example, the complex 1500 includes a display 1501 and housing 1503 connected to the handle 1505 and treatment head 1507 by cables 1509 . The cable may include tubing to supply and recover cryogen, and the cable may also connect a source of RF energy to a sensor on the therapy device. The whole system is light and compact, easy to carry and use.

In one embodiment, the complex may include an opening through which cryogen may be inserted. For example, the cryogen may be pressurized canned 1521 cryogen. The canister may have screw threads or other means to secure the canister in the integrated manipulator, but the refrigerant may be kept sealed by any means of sealing. The amount of refrigerant can be measured by the controller, and the display can show how much refrigerant is left in the tank or modification system.

In one embodiment, the components of the integrated controller include a microprocessor (e.g., hardware, software, and/or firmware) used to control the prosthetic system's instruments, any outputs (e.g., a display, one or more speakers, etc.), RF power supply and cooling system. These components can be individually placed in the casing of the above-mentioned complex in a unitary manner.

The above repair system, especially the integrated controller, has a small total weight and occupied area, which makes the whole instrument easy to carry and store. For example, the entire system weighs less than 50 lbs.

In one embodiment, the controller may include a display capable of displaying information on steps, cryogens, treaters, handles, and other components. This information can be displayed on the front of the integrated controller or via acoustic signals. The display can also be used to display fault information (including error codes) for various system components (such as refrigerant status, skin contact, RF 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, and the like.

The prosthetic system may also include one or more controllers for controlling the instrumentation. For example, the system may include a controller for controlling the delivery of energy by the therapy device (eg, activation control), and may include one or more controllers for controlling the therapy program.

In one embodiment, the activation control (eg, a button) is on the handle. In another embodiment, the system may include a wired or wireless foot switch, or other activation control that is not on the handle. In one embodiment, the foot switch is connected to an integrated controller.

Claims (15)

1. therapeutic apparatus of repairing the vagina tissue, it is characterized in that, described therapeutic apparatus is made up for the treatment of head (1) and handle (2), treatment head is positioned at the top of handle and links together by being connected and fixed device (3) and handle, and therapeutic apparatus comprises one or more temperature inductors (11) that are used for meter confluent monolayer cells or the temperature below it.

2. according to the therapeutic apparatus of claim 1, it is characterized in that the end surface of described treatment head comprises one or more heat transfer sheet (4), described heat transfer sheet comprises an inwall and a surface that contacts with cells of superficial layer.

3. according to the therapeutic apparatus of claim 1, it is characterized in that the terminus inner of described treatment head contains a cooling chamber (5), cooling chamber comprises the cryogen carrier pipe, and carrier pipe comprises and a plurality ofly is used for spraying cryogen to the nozzle of heat transfer sheet inwall.

4. want 3 therapeutic apparatus according to right, it is characterized in that, described inner cooling chamber more comprises cryogen backflow road, thereby discharges the cryogen after using.

5. according to the therapeutic apparatus of claim 2, it is characterized in that the end surface shape of described treatment head is selected from that: Long is square, arc, taper shape, sphere, ellipse, hemispherical or circle.

6. according to the therapeutic apparatus of claim 1, it is characterized in that described induction apparatus is thermocouple, each thermocouple comprises first hinge and the 2nd Ge hinge.

7. according to the therapeutic apparatus of claim 6, it is characterized in that a described Ge hinge is on the handle or between heat transfer sheet and the described handle.

8. according to the therapeutic apparatus of claim 6, it is characterized in that described the 2nd Ge hinge is positioned at end, near-end or the center of heat transfer sheet.

9. according to the therapeutic apparatus of claim 6, it is characterized in that described the 2nd Ge hinge comprises a blunt end that contacts with cells of superficial layer and can meter confluent monolayer cells temperature.

10. according to the therapeutic apparatus of claim 6, it is characterized in that described the 2nd Ge hinge comprises a probe that can penetrate the temperature below cells of superficial layer and the meter confluent monolayer cells.

11. any Ge therapeutic apparatus according to claim 1-10 is characterized in that, described therapeutic apparatus more comprises the sounding mark that inserts the vagina degree of depth for perception.

12. the therapeutic apparatus according to claim 11 is characterized in that, described sounding mark is positioned on the terminal treatment face for the treatment of head.

13. any Ge therapeutic apparatus according to claim 11 is characterized in that, described sounding mark is positioned on a plurality of sides for the treatment of head.

14. any Ge therapeutic apparatus according to claim 11 is characterized in that described sounding mark comprises numeral.

15. any Ge therapeutic apparatus according to claim 11 is characterized in that described sounding mark comprises convex line, concave or numeral.

Images