Pelvic floor muscle group electrical stimulation equipment with customizable appearance and customizing method of pelvic floor muscle group electrical stimulation equipment

Abstract

The invention relates to the technical field of medical rehabilitation equipment, in particular to pelvic floor muscle group electrical stimulation equipment with a customizable appearance and a customizing method thereof.The pelvic floor muscle group electrical stimulation equipment comprises a treatment probe with the customizable appearance, and the treatment probe comprises a center shaft, a balloon body wrapping the center shaft and at least one flexible tensioning belt; one end of the flexible tensioning belt is anchored to the inner wall of the balloon body, the other end of the flexible tensioning belt penetrates through the outer wall of the center shaft to be connected with a locking ring arranged in the center shaft, the length of the flexible tensioning belt is determined by the rotating angle of the locking ring, and the locking ring can rotate when heated and cannot rotate after being cooled. According to the embodiment of the invention, the shape of the treatment probe can permanently reproduce the physiological contour of a user through one-time shaping and curing, so that the adaptation problem of a standardized probe is fundamentally solved, the wearing comfort and stability are greatly improved, the close and uniform contact between an electrode and pelvic floor muscle tissue is ensured, and the treatment effect is improved. And the current density distribution is uniform.

Description

Technical Field

[0001] This invention relates to the field of medical rehabilitation equipment technology, and in particular to a customizable pelvic floor muscle electrical stimulation device.

[0002] This invention also relates to a method for customizing pelvic floor muscle electrical stimulation devices. Background Technology

[0003] Pelvic floor muscle dysfunction, including stress urinary incontinence, pelvic organ prolapse, and chronic pelvic pain, is a common problem affecting the quality of life of many women. Pelvic floor muscle rehabilitation training is currently the mainstream non-surgical treatment method. Among them, rehabilitation training using endovenous therapy probes with electrical stimulation and biofeedback functions is a widely used technique in clinical and home settings.

[0004] However, existing pelvic floor muscle treatment probes typically employ standardized sizes and shapes. But each user's physiological structure (such as vaginal size, length, curvature, and internal morphology) exhibits significant individual differences. This makes it difficult for such standardized probes to achieve an ideal fit with all users' pelvic floor muscle tissue, leading to the following problems: Poor comfort: There are local pressure points or gaps between the probe and the tissue, which causes discomfort to the user during wearing and treatment, affecting treatment compliance.

[0005] Low treatment efficiency: The electrical stimulation electrodes cannot make close and uniform contact with the target muscle group, resulting in uneven current density distribution, which may produce a stinging sensation or "electric hot spots" and reduce the effectiveness of electrical stimulation therapy.

[0006] Biofeedback signal distortion: When performing Kegel exercises (active contraction of pelvic floor muscles), due to the gap between the probe and the cavity wall, the pressure generated by the user's muscle contraction cannot be accurately and sensitively captured by the pressure sensor built into the probe, resulting in inaccurate biofeedback data and inability to effectively assess and guide the user's training.

[0007] To address the fit issue, some solutions employ inflatable airbags, adjusting the inflation volume to suit different users. However, this simple inflatable structure tends to form a regular ellipsoid or cylinder when inflated, still failing to replicate the user's irregular internal cavity contour, resulting in limited fit.

[0008] Therefore, there is a need for a new type of pelvic floor muscle electrical stimulation device that can achieve a truly personalized fit while also being convenient to use, safe, and effective in treatment. Summary of the Invention

[0009] The present invention aims to overcome the shortcomings of the prior art and provide a customizable pelvic floor muscle electrical stimulation device and its customization method. It aims to enable the treatment probe to permanently match the physiological cavity contour of a specific user through a one-time shaping and curing process, thereby achieving optimal wearing comfort, electrical stimulation effectiveness and biofeedback accuracy.

[0010] To solve the above-mentioned technical problems, the present invention specifically provides the following technical solution: A customizable pelvic floor muscle electrical stimulation device, comprising: A treatment probe; A handheld controller integrated with the treatment probe; The treatment probe includes: A central axis extending longitudinally; A balloon-shaped body made of elastic material that is integrally molded and covers the outside of the central axis; At least two electrodes integrated on the outer surface of the balloon; and A shaping mechanism for pre-setting the three-dimensional shape of the balloon after inflation; The shaping mechanism includes: At least three flexible tensioning strips are evenly distributed around the central axis, with one end anchored to the inner wall of the balloon body and the other end passing through the outer wall of the central axis and extending into its interior. At least one locking ring is disposed inside the central shaft, and the other end of the flexible tension belt is wound around the locking ring; The locking ring is made of a material that is rigid glassy at room temperature and flexible and elastic above its glass transition temperature. It is used to adjust and lock the length of the flexible tension strip wound on it by heating, rotating and then cooling.

[0011] Furthermore, the flexible tensioning strip is anchored to one end of the inner wall of the balloon with an integrally formed anchor head, which is encased in the wall material of the balloon body during the injection molding process.

[0012] Furthermore, the flexible tension belt has an integrally formed plug-in block at one end inside the central shaft, and the outer ring of the locking ring has an inwardly recessed notch, and an inwardly extending plug-in groove is formed on the inner side of the notch, the plug-in groove being used to connect the plug-in block.

[0013] Furthermore, the locking ring is manufactured using an insert injection molding process and includes: A main body made of rigid engineering plastic that is electromagnetically inert to high-frequency magnetic fields; At least one metal insert made of ferromagnetic metal is pre-placed inside the main body as an insert, the metal insert being distributed in the outer ring area of ​​the main body, avoiding the insertion slot.

[0014] Furthermore, the main body of the locking ring is provided with a spline through hole at its center.

[0015] Furthermore, the handheld controller integrates: A pneumatic unit for inflating and deflating the balloon body, wherein the central shaft is located inside the handheld controller and one end is detachably connected to an air nozzle for connecting the pneumatic unit; Pressure sensing unit for real-time monitoring of the internal pressure of the balloon; A control unit for controlling the pneumatic unit to pump gas into the interior of the central shaft through the air nozzle and to output a treatment signal to the electrode, based on the signal from the pressure sensing unit.

[0016] Furthermore, the air nozzle is connected to the pneumatic unit via a three-way valve, with the remaining end of the three-way valve connected to the atmosphere.

[0017] A method for customizing a pelvic floor muscle electrical stimulation device includes the following steps: The three-dimensional shape data of the cavity of the user's treatment area is obtained, and the target length of each flexible tension belt is calculated based on the three-dimensional shape data, which is then converted into the angle that the corresponding locking ring needs to be adjusted. For each locking ring in the treatment probe, perform the following operations in sequence: Heating unlocking: The locking ring is locally heated to above its glass transition temperature, making it rotatable; Rotation adjustment: Drive the locking ring to rotate to adjust the length of the flexible tension strip wound on it until the preset target is reached; Cooling and locking: Stop heating to allow the locking ring to cool to room temperature and return to a rigid glassy state, thereby permanently locking its current rotation angle.

[0018] Furthermore, the outer ring of the locking ring is provided with a metal insert made of ferromagnetic metal. The heating unlocking step includes: using a high-frequency induction coil to generate an alternating magnetic field to heat the metal insert, so that the part of the locking ring near the metal insert softens.

[0019] Furthermore, the customization method is performed on a customization device, which includes: A high-frequency induction coil that can be fitted onto the outside of the treatment probe is used to generate the alternating magnetic field to perform the heating unlocking step; A probe that can extend into the interior of the central shaft, the head of the probe being provided with a rotary drive head for driving the locking ring to rotate; A linear driver and a rotary driver are connected to the end of the probe so that the probe can perform the rotation adjustment step.

[0020] Compared with the prior art, this application has the following advantages: The embodiments of the present invention enable the shape of the treatment probe to permanently replicate the user's physiological contour through one-time shaping and curing, fundamentally solving the adaptation problem of standardized probes, greatly improving the comfort and stability of wearing, and ensuring close and uniform contact between the electrode and the pelvic floor muscle tissue, resulting in a uniform current density distribution. Attached Figure Description

[0021] To more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are merely exemplary, and those skilled in the art can derive other embodiments based on the provided drawings without creative effort.

[0022] Figure 1 This is a top view of the usage state of an embodiment of the present invention; Figure 2 for Figure 1 A cross-sectional view along the AA direction; Figure 3 for Figure 1 A cross-sectional view along the BB direction; Figure 4 This is an assembly diagram of an embodiment of the present invention; Figure 5 This is an assembly diagram of the central shaft according to an embodiment of the present invention; Figure 6 This is a top view of the customized state according to an embodiment of the present invention; Figure 7 for Figure 6 A cross-sectional view along the CC direction; The labels in the diagram represent the following: 10-Treatment probe; 11-Central shaft; 111-Air nozzle; 12-Ball body; 13-Electrode; 14-Flexible tension belt; 141-Anchor head; 142-Plug block; 15-Locking ring; 151-Main body; 152-Spline through hole; 153-Metal insert; 154-Plug slot; 20 - Handheld controller; 21 - Control unit; 22 - Three-way valve; 31-High-frequency induction coil; 32-Probe; 33-Rotary drive head. Detailed Implementation

[0023] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0024] Please see Figures 1 to 5 The present invention provides a customizable pelvic floor muscle electrical stimulation device, which comprises a core treatment probe 10 and a portable handheld controller 20 integrated with the probe.

[0025] like Figure 2 and Figure 3 As shown, the treatment probe 10 is the core technology of this invention, and its precise design aims to achieve personalized matching with the user's physiological structure.

[0026] The skeleton of the treatment probe 10 is a central axis 11 extending longitudinally therein, which is manufactured by injection molding process from medical-grade liquid silicone rubber LSR or thermoplastic elastomer TPE, and has excellent biocompatibility, chemical stability and appropriate flexibility.

[0027] The central shaft 11 is hollow, with an internal installation space and operating channel. The operating channel can also be used as a gas channel. The part of the central shaft 11 located at the end of the handheld controller 20 is equipped with a detachable gas nozzle 111 for connecting to the gas circuit.

[0028] A balloon body 12 is wrapped around the outside of the central shaft 11. The balloon body 12 is made of highly elastic, airtight, biocompatible medical-grade silicone rubber.

[0029] At least two electrodes 13 are symmetrically integrated along the circumference of the outer surface of the balloon body 12. During the inflation and deflation of the balloon body 12, the electrodes 13 can move synchronously with the outer surface of the balloon body 12.

[0030] Inside the installation space of the central shaft 11, there is a shaping mechanism that connects to the inner surface of the balloon body 12. This shaping mechanism is made up of multiple flexible tension belts 14 and locking rings 15 working together, which allows the treatment probe 10 to be transformed from a standardized product into a personalized tool that is permanently customized for a specific user through a one-time curing process.

[0031] Please see Figure 3 The flexible tension belt 14 is the actuating element of the shaping mechanism and is made of a material with high tensile strength and low elongation, such as medical-grade polyester filament or Vickers fiber.

[0032] One end of the flexible tensioning belt 14 is anchored to the balloon body 12. To ensure the absolute reliability of the anchoring, each flexible tensioning belt 14 has an integrally formed anchor head 141, such as a "T" shape or a mushroom shape, at one end. During the injection molding process, the anchor head 141 is completely covered in the inner wall material of the balloon body 12, thereby reducing the risk of the anchor point tearing.

[0033] The other end of the flexible tensioning belt 14 passes through the through hole on the outer wall of the central shaft 11 and enters the interior of the central shaft 11. It is provided with an integrally formed plug block 142 for connecting to the plug groove 154 provided on the outer ring of the corresponding locking ring 15.

[0034] Please see Figure 3 and Figure 4 Inside the central shaft 11, at least one locking ring 15 is provided along its length. The locking ring 15 is precision manufactured by insert injection molding and its structure includes: Main body 151: Made of rigid engineering plastic such as polysulfone (PSU) that is electromagnetically inert to high-frequency magnetic fields, forming the overall frame of the locking ring. It has a spline through hole 152 in the center for reliable mechanical engagement and torque transmission with external adjustment tools.

[0035] Metal insert 153: Before injection molding, at least one metal insert 153 made of ferromagnetic metal such as medical grade 400 series stainless steel is pre-placed in the mold as an insert. These metal inserts 153 are distributed in the outer ring area of ​​the main body 151, avoiding the insertion groove 154, and are firmly covered and locked.

[0036] The outer ring of the locking ring 15 is provided with an inwardly recessed notch, and the insertion groove 154 is formed inside the notch. This notch structure allows the outer ring of the locking ring 15 to undergo elastic deformation after being heated and softened, which facilitates the winding and adjustment of the flexible tension belt 14.

[0037] The working principle of locking ring 15 is based on the phase transition of materials: At room temperature, the locking ring 15 is in a hard glassy state and cannot be rotated. When a part of it (the part near the metal insert 153) is heated above its glass transition temperature, it will transform into a soft, highly elastic state. At this time, the outer ring of the locking ring 15 can elastically deform toward the notch, thereby reducing the friction between the locking ring 15 and the central shaft 11, so that the locking ring 15 can be easily rotated by external force.

[0038] When no external force is applied, the elasticity of the metal insert 153 drives the outer ring of the locking ring 15 to abut against the inner wall of the central shaft 11. When the temperature of the locking ring 15 drops below the glass transition temperature, the locking ring 15 returns to a hard glassy state and cannot be rotated.

[0039] Regarding the handheld controller 20 and system operation: Please see Figure 1 and Figure 6 The daily use of this device is driven and managed by an integrated handheld controller 20, which integrates the following: Pneumatic unit: includes a miniature air pump (not shown in the figure), which is connected to the probe's nozzle 111 via a three-way valve 22. The remaining end of the three-way valve 22 is connected to the atmosphere and is used to control the inflation and rapid deflation of the balloon body 12.

[0040] Pressure sensing unit: A high-precision pressure sensor (not shown in the figure) is integrated in the air circuit to monitor the air pressure inside the balloon body 12 in real time. It can be used as a basis for safety interlocking and as a signal source for biofeedback.

[0041] Control Unit 21: A circuit board integrating a microcontroller, memory and communication module. As the brain of the device, it is responsible for executing all control logic, storing treatments and processing sensor data. Buttons are set on the circuit board, and the operating end of the buttons is located on the outside of the housing of the handheld controller 20.

[0042] Power unit (not shown): A rechargeable battery that powers the entire device.

[0043] The daily usage procedure for pelvic floor muscle electrical stimulation equipment is as follows: Preparation and wearing: The user inserts the personalized treatment probe 10 into the body.

[0044] Inflation and Fitting: The user operates the control unit 21 via a button, and the pneumatic unit inside the handheld controller 20 inflates the balloon body 12. Due to the preset length constraints of the multiple flexible tension belts 14 inside, the balloon body 12 automatically and repeatedly inflates to a customized shape that perfectly matches the user's body contour.

[0045] Treatment begins: During inflation, the pressure sensing unit continuously monitors the pressure. When the pressure reaches the preset value, the control unit 21 indicates that it is ready and unlocks the electrical stimulation function to begin the preset electrical stimulation treatment.

[0046] Biofeedback and data tracking: During treatment, the user actively contracts the pelvic floor muscles. The pressure exerted by the muscles on the probe 10 causes a momentary increase in the internal pressure of the balloon 12. This pressure change is accurately captured by the pressure sensing unit and recorded as a valid muscle contraction event by the control unit 21.

[0047] End and Cleaning: After treatment or by the user operating the control unit 21 via the button, the electrode 13 immediately stops electrical stimulation, the three-way valve 22 quickly releases air, and the user can easily remove the treatment probe 10 for cleaning.

[0048] Please see Figure 5 The method for customizing the treatment probe 10 includes the following steps: Step 1: Obtain the three-dimensional shape data of the cavity inside the user's treatment area: This can be achieved through various methods, such as scanning with three-dimensional intracavitary ultrasound or measuring with physical impression materials. The acquired data will generate a three-dimensional digital model of the user's cavity.

[0049] Step 2, Adjustment and Curing: This step is completed automatically on a customized device, which includes a high-frequency induction coil 31 that can be fitted onto the outside of the treatment probe 10, and a probe 32 that can be inserted into the central shaft 11. The head of the probe 32 is equipped with a rotary drive head 33.

[0050] The specific adjustment process is as follows: Calculation and positioning: A brand-new, custom-made treatment probe 10 is fixed in a fixture. Based on the three-dimensional digital model, the target length of each flexible tension belt 14 is calculated and converted into the required rotation angle of the corresponding locking ring 15. The probe 32 and the high-frequency induction coil 31 are synchronously moved to the position of the first locking ring 15 under the drive of the linear driver and the rotary driver. The rotary drive head 33 engages with the spline through hole 152 of the locking ring 15.

[0051] Heating unlocking: The high-frequency induction coil 31 is activated, and the alternating magnetic field generated by it penetrates the balloon body 12 and the central shaft 11 from the outside and focuses on the metal insert 153 inside the locking ring 15. It heats up instantly through induction heating, and the heat is conducted to the main body 151 of the locking ring, so that the outer ring area reaches above the glass transition temperature and softens, entering the rotatable "unlocked" state.

[0052] Rotation adjustment: The rotation drive head 33 of the probe 32 rotates, causing the unlocked locking ring 15 to rotate, thereby precisely adjusting the length of the flexible tension belt 14 wound on it until the calculated target angle is reached.

[0053] Cooling and locking: After adjustment, the high-frequency induction coil 31 is immediately de-energized, the heat source disappears, the locking ring 15 cools down rapidly, returns to a rigid glass state and is permanently locked at its current angle.

[0054] Shifting and repeating: The probe 32 and the high-frequency induction coil 31 move synchronously to the position of the next locking ring 15, repeating the above series of "heating-adjustment-cooling" actions until all locking rings are set.

[0055] Using this method, multiple flexible tension belts 14 distributed at different positions on the balloon body are set to different final lengths, thus "programming" in advance that when the balloon body 12 is inflated uniformly, its outer wall can form a unique three-dimensional shape under the common constraint of each flexible tension belt 14, which can accurately reproduce the physiological cavity contour of a specific user.

[0056] The above embodiments are merely exemplary embodiments of the present invention and are not intended to limit the present invention. The scope of protection of the present invention is defined by the claims. Those skilled in the art can make various modifications or equivalent substitutions to the present invention within its spirit and scope of protection, and such modifications or equivalent substitutions should also be considered as falling within the scope of protection of the embodiments of the present invention.

Claims

1. A customizable pelvic floor muscle electrical stimulation device, characterized in that, include: One treatment probe (10); A handheld controller (20) integrated with the treatment probe (10); The treatment probe (10) includes: A central axis extending longitudinally (11); A balloon body (12) made of elastic material that is integrally molded and covers the outside of the central axis (11); At least two electrodes (13) integrated on the outer surface of the balloon body (12); and A shaping mechanism for pre-setting the three-dimensional shape of the balloon body (12) after inflation; The shaping mechanism includes: At least three flexible tensioning strips (14) are evenly distributed around the central axis (11), one end of which is anchored to the inner wall of the balloon body (12), and the other end passes through the outer wall of the central axis (11) and extends into its interior. At least one locking ring (15) is disposed inside the central shaft (11), and the other end of the flexible tension belt (14) is wound around the locking ring (15); The locking ring (15) is made of a material that is rigid glassy at room temperature and flexible and elastic at temperatures above its glass transition temperature. It is used to adjust and lock the length of the flexible tension strip (14) wound on it by means of being heated, rotated and then cooled.

2. The pelvic floor muscle electrical stimulation device according to claim 1, characterized in that, The flexible tensioning strip (14) is anchored to one end of the inner wall of the balloon body (12) and has an integrally formed anchor head (141). The anchor head (141) is encased in the wall material of the balloon body (12) during the injection molding process.

3. The pelvic floor muscle electrical stimulation device according to claim 2, characterized in that, The flexible tension belt (14) is provided with an integrally formed plug block (142) at one end inside the central shaft (11). The outer ring of the locking ring (15) is provided with an inwardly recessed notch, and an inwardly extending plug groove (154) is formed on the inner side of the notch. The plug groove (154) is used to connect the plug block (142).

4. The pelvic floor muscle electrical stimulation device according to claim 3, characterized in that, The locking ring (15) is manufactured by insert injection molding and includes: A main body (151) is injection molded from a rigid engineering plastic that is electromagnetically inert to a high-frequency magnetic field. At least one metal insert (153) made of ferromagnetic metal is pre-placed inside the main body (151) as an insert, the metal insert (153) being distributed in the outer ring area of ​​the main body (151) away from the insertion slot (154).

5. The pelvic floor muscle electrical stimulation device according to claim 4, characterized in that, The locking ring (15) has a spline through hole (152) at the center of its main body (151).

6. The pelvic floor muscle electrical stimulation device according to claim 1, characterized in that, The handheld controller (20) integrates: A pneumatic unit for inflating and deflating the balloon body (12), wherein the central shaft (11) is located inside the handheld controller (20) and one end is detachably connected to an air nozzle (111) for connecting the pneumatic unit. Pressure sensing unit for real-time monitoring of the internal pressure of the balloon body (12); A control unit (21) for controlling the pneumatic unit to pump gas into the interior of the central shaft (11) through the air nozzle (111) and output a treatment signal to the electrode (13) based on the signal from the pressure sensing unit.

7. The pelvic floor muscle electrical stimulation device according to claim 6, characterized in that, The air nozzle (111) is connected to the pneumatic unit via a three-way valve (22), the remaining end of which is connected to the atmosphere.

8. A method for customizing a pelvic floor muscle electrical stimulation device according to any one of claims 1 to 7, characterized in that, The customization method includes the following steps: Obtain the three-dimensional shape data of the cavity of the user's treatment area, and calculate the target length of each flexible tension belt (14) based on the three-dimensional shape data, and convert it into the angle that the corresponding locking ring (15) needs to be adjusted. For each locking ring (15) in the treatment probe (10), the following operations are performed sequentially: Heating unlocking: The locking ring (15) is locally heated to above its glass transition temperature, so that it becomes rotatable; Rotation adjustment: Drive the locking ring (15) to rotate to adjust the length of the flexible tension belt (14) wound on it until the preset target is reached; Cooling lock: Stop heating and allow the locking ring (15) to cool to room temperature and return to a rigid glass state, thereby permanently locking its current rotation angle.

9. The customization method according to claim 8, characterized in that, The outer ring of the locking ring (15) is provided with a metal insert (153) made of ferromagnetic metal. The heating unlocking step includes: using a high-frequency induction coil (31) to generate an alternating magnetic field to heat the metal insert (153) so that the part of the locking ring (15) near the metal insert (153) softens.

10. The customization method according to claim 9, characterized in that, The customization method is performed on a customization device, which includes: A high-frequency induction coil (31) that can be fitted onto the outside of the treatment probe (10) is used to generate the alternating magnetic field to perform the heating unlocking step; A probe (32) that can extend into the interior of the central shaft (11), the head of the probe (32) being provided with a rotary drive head (33) for driving the locking ring (15) to rotate. A linear driver and a rotary driver are connected to the end of the probe (32) so that the probe (32) can perform the rotation adjustment step.

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