A customizable shape of the pelvic floor muscle group electric stimulation device and its customization method

Abstract

The present application relates to the technical field of medical rehabilitation equipment, and particularly relates to a pelvic floor muscle group electric stimulation device with a customizable shape and a customization method thereof. The pelvic floor muscle group electric stimulation device comprises a treatment probe with a customizable shape, the treatment probe comprises a central shaft and a balloon body wrapped outside the central shaft, and at least one flexible tension belt, one end of the flexible tension belt is anchored to the inner wall of the balloon body, the other end of the flexible tension belt passes through the outer wall of the central shaft and is connected to a locking ring arranged inside the central shaft, the length of the flexible tension belt is determined by the rotation angle of the locking ring, and the locking ring can rotate when heated and cannot rotate after cooling. The embodiments of the present application can permanently reproduce the physiological contour of the user by one-time shaping and solidification, fundamentally solve the fitting problem of the standardized probe, greatly improve the comfort and stability of wearing, and ensure the close and uniform contact of the electrode and the pelvic floor muscle tissue, so that the current density distribution is uniform.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical rehabilitation equipment, and in particular to a pelvic floor muscle group electrical stimulation device with customizable shape.

[0002] The present application also relates to a customization method of the pelvic floor muscle group electrical stimulation device. BACKGROUND

[0003] Pelvic floor dysfunction, including stress urinary incontinence, pelvic organ prolapse, chronic pelvic pain, etc., is a common problem affecting the quality of life of many women; pelvic floor rehabilitation training is the current mainstream non-surgical treatment method, among which the use of intracavitary treatment probes with electrical stimulation and biofeedback functions for rehabilitation training is a widely used technical means in clinical and home environments.

[0004] However, the pelvic floor treatment probes in the prior art are usually designed with standardized size and shape, but there are significant individual differences in the physiological structure of each user (such as the size, length, curvature and internal morphology of the vagina), and such standardized probes are difficult to achieve ideal fit with the pelvic floor muscle tissue of all users, resulting in the following problems:

[0005] Poor comfort: there are local compression points or gaps between the probe and the tissue, causing discomfort for the user during wearing and treatment, affecting the compliance of treatment.

[0006] Low treatment efficiency: the electrical stimulation electrodes cannot be in close and uniform contact with the target muscle group, resulting in uneven distribution of current density, which may cause a tingling sensation or "electric hot spots", and at the same time reduces the effectiveness of electrical stimulation treatment.

[0007] Biofeedback signal distortion: when performing Kegel exercises (active contraction of the 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 ineffective evaluation and guidance of the user's training.

[0008] To solve the fitting problem, some solutions use inflatable airbags to adapt to different users by adjusting the inflation amount; however, such simple inflatable structures tend to be regular ellipsoidal or cylindrical when inflated, and still cannot reproduce the irregular inner cavity profile of the user, with limited fitting effect.

[0009] Therefore, there is a need for a new type of pelvic floor muscle group electrical stimulation device that can achieve truly personalized fitting while taking into account the convenience, safety and effectiveness of use. SUMMARY

[0010] The present application aims to overcome the deficiencies of the prior art, and provides a customizable shape pelvic floor muscle group electrical stimulation device and a customization method thereof, which aims to enable the treatment probe to permanently match the physiological lumen profile of a specific user through a one-time shaping and solidification process, so as to achieve optimal wearing comfort, electrical stimulation effectiveness and biofeedback accuracy.

[0011] To solve the above technical problems, the present application specifically provides the following technical solutions:

[0012] A customizable shape pelvic floor muscle group electrical stimulation device, comprising:

[0013] a treatment probe;

[0014] a hand-held controller integrated with the treatment probe;

[0015] wherein the treatment probe comprises:

[0016] a central shaft extending along its longitudinal direction;

[0017] a balloon body made of elastic material integrally coated outside the central shaft;

[0018] at least two electrodes integrated on the outer surface of the balloon body; and

[0019] a shaping mechanism for presetting the three-dimensional shape of the balloon body after inflation;

[0020] the shaping mechanism comprises:

[0021] at least three flexible tensioning belts evenly distributed around the central shaft, one end of which is anchored to the inner wall of the balloon body, and the other end of which passes through the outer wall of the central shaft and extends to the inside thereof;

[0022] at least one locking ring arranged inside the central shaft, the other end of the flexible tensioning belt being wound around the locking ring;

[0023] the locking ring is made of a material that is in a rigid glass state at room temperature and in a flexible high-elastic state when the glass transition temperature is exceeded, so as to adjust and lock the length of the flexible tensioning belt wound thereon by being heated, rotated and then cooled.

[0024] Further, one end of the flexible tensioning belt anchored to the inner wall of the balloon body is provided with an integrally formed anchor head, which is coated in the wall material of the balloon body during injection molding.

[0025] Further, one end of the flexible tensioning belt arranged inside the central shaft is provided with an integrally formed plug-in block, the outer ring of the locking ring is provided with an inwardly recessed notch, the inner side of the notch is formed with an inwardly extending plug-in slot, and the plug-in slot is used to connect the plug-in block.

[0026] Further, the locking ring is made by insert injection molding process, which includes:

[0027] a main body part made of rigid engineering plastic which is electromagnetically inert to high-frequency magnetic field and is injection molded;

[0028] at least one metal insert made of ferromagnetic metal which is pre-arranged as an insert inside the main body part, and the metal insert is distributed in the outer ring area of the main body part away from the plug-in slot.

[0029] Further, the center of the main body part of the locking ring is provided with a spline through hole.

[0030] Further, the handheld controller integrates:

[0031] a pneumatic unit for inflating and deflating the balloon body, and one end of the central shaft inside the handheld controller is detachably connected with a gas nozzle for connecting the pneumatic unit;

[0032] a pressure sensing unit for monitoring the internal pressure of the balloon body in real time;

[0033] a control unit for controlling the pneumatic unit to pump gas into the inside of the central shaft through the gas nozzle and outputting a treatment signal to the electrode according to the signal of the pressure sensing unit.

[0034] Further, the gas nozzle connects the pneumatic unit through a three-way valve, and the remaining end of the three-way valve is connected to the atmosphere.

[0035] A customization method of a pelvic floor muscle group electrical stimulation device, comprising the following steps:

[0036] Obtaining three-dimensional shape data of the inner cavity of the user's treatment site, and calculating the target length of each flexible tensioning belt according to the three-dimensional shape data, and converting it into the angle required for adjusting the corresponding locking ring;

[0037] For each locking ring in the treatment probe, the following operations are sequentially performed:

[0038] Heating unlocking: locally heating the locking ring above its glass transition temperature, so that it changes to a rotatable state;

[0039] Rotary adjustment: driving the locking ring to rotate to adjust the length of the flexible tensioning belt wound thereon until the preset target is reached.

[0040] Cooling locking: stop heating, let the locking ring cool to room temperature and restore to rigid glass state, thereby permanently locking its current rotation angle.

[0041] Further, the outer ring region of the locking ring is provided with a metal insert made of ferromagnetic metal, and the heating unlocking step comprises: generating an alternating magnetic field by using a high-frequency induction coil to heat the metal insert so as to soften the part of the locking ring close to the metal insert.

[0042] Further, the customization method is completed on a customization device, and the customization device comprises:

[0043] a high-frequency induction coil which can be sleeved outside the treatment probe and is used for generating the alternating magnetic field to perform the heating unlocking step;

[0044] a probe which can be inserted into the inside of the central shaft, and the head of the probe is provided with a rotation driving head used for driving the rotation of the locking ring;

[0045] a linear driver and a rotation driver connected to the tail end of the probe, so that the probe can perform the rotation adjustment step.

[0046] Compared with the prior art, the present application has the following beneficial effects:

[0047] The embodiment of the present application can permanently reproduce the physiological contour of the user by one-time shaping and curing, fundamentally solves the fitting problem of the standardized probe, greatly improves the comfort and stability of wearing, and ensures the close and uniform contact between the electrode and the pelvic floor muscle tissue, so that the current density distribution is uniform. BRIEF DESCRIPTION OF DRAWINGS

[0048] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the embodiments or the prior art description will be briefly introduced below. Obviously, the drawings in the following description are only exemplary, and for those skilled in the art, other drawings can be obtained from the provided drawings without creative labor.

[0049] Figure 1 is a top view of the use state of the embodiment of the present application;

[0050] Figure 2 is a sectional view of the A-A direction of Figure 1

[0051] Figure 3 is a sectional view of the B-B direction of Figure 1 ​​

[0052] Figure 4 Assembly view of the embodiment of the present application;

[0053] Figure 5 Assembly view of the central shaft of the embodiment of the present application;

[0054] Figure 6 Top view of the customized state of the embodiment of the present application;

[0055] Figure 7 C-C direction sectional view of Figure 6

[0056] The reference numerals in the figures represent the following respectively:

[0057] 10 - treatment probe; 11 - central shaft; 111 - air nozzle; 12 - balloon body; 13 - electrode; 14 - flexible tension belt; 141 - anchoring head; 142 - insertion block; 15 - locking ring; 151 - main body; 152 - spline through hole; 153 - metal insert; 154 - insertion slot;

[0058] 20 - hand-held controller; 21 - control unit; 22 - three-way valve;

[0059] 31 - high-frequency induction coil; 32 - probe; 33 - rotary drive head. DETAILED DESCRIPTION

[0060] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work are within the protection scope of the present application.

[0061] Please refer to Figures 1 to 5 , the present application provides a customizable pelvic floor muscle group electrical stimulation device, which comprises a core treatment probe 10 and a portable hand-held controller 20 integrated with the probe.

[0062] As shown in Figure 2 and Figure 3 , the treatment probe 10 is the technical core of the present application, which is designed precisely to achieve personalized matching with the physiological structure of the user.

[0063] The skeleton of the treatment probe 10 is a central shaft 11 extending longitudinally, which is manufactured by injection molding process with medical-grade liquid silicone rubber (LSR) or thermoplastic elastomer (TPE), having excellent biocompatibility, chemical stability and appropriate flexibility.

[0064] ​The center shaft 11 is hollow, with an installation space and an operation channel inside, which can also be used as a gas channel. The end of the center shaft 11 is provided with a detachable air nozzle 111 for connecting the gas circuit.

[0065] The center shaft 11 is covered with a balloon body 12 made of high-elasticity, airtight, biocompatible medical-grade silicone rubber.

[0066] On the outer surface of the balloon body 12, at least two electrodes 13 are symmetrically integrated along the circumference. 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.

[0067] In the installation space inside the center shaft 11, a shaping mechanism is provided to connect the inner surface of the balloon body 12. The shaping mechanism is composed of multiple flexible tensioning bands 14 and locking rings 15, which can make the treatment probe 10 change from a standardized product to a personalized tool permanently customized for a specific user through one-time solidification.

[0068] Please refer to Figure 3 The flexible tensioning bands 14 are the execution elements of the shaping mechanism, which are made of materials with high tensile strength and low elongation, such as medical-grade polyester or Vicryl fibers.

[0069] One end of the flexible tensioning band 14 is anchored to the balloon body 12. To ensure the absolute reliability of anchoring, each flexible tensioning band 14 is provided with an integrally formed anchor head 141, such as a "T" type or a mushroom type. 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 tearing at the anchor point.

[0070] The other end of the flexible tensioning band 14 passes through the through hole on the outer wall of the center shaft 11, enters the inside of the center shaft 11, and is provided with an integrally formed plug-in block 142 for connecting the plug-in groove 154 provided on the outer ring of the corresponding locking ring 15.

[0071] Please refer to Figure 3 and Figure 4 Inside the center shaft 11, at least one locking ring 15 is provided along the length direction. The locking ring 15 is precisely made by insert molding process, and its structure includes:

[0072] The main body 151 is made of rigid engineering plastic such as polysulfone PSU, which is electromagnetically inert to high-frequency magnetic fields, and is one-time injection molded, constituting the overall framework of the locking ring. The center is provided with a spline through hole 152 for reliable mechanical engagement and torque transmission with the external adjustment tool.

[0073] Metal inserts 153: At least one metal insert 153 made of ferromagnetic metal such as medical-grade 400 series stainless steel is pre-installed in the mold as an insert before injection molding, which is distributed in the outer ring area of the main body 151 away from the insertion slot 154 and is firmly overlocked.

[0074] The outer ring of the locking ring 15 is provided with an inwardly recessed notch, and the insertion slot 154 is formed inside the notch. The notch structure allows the outer ring of the locking ring 15 to be elastically deformed after being heated and softened, facilitating the winding and adjustment of the flexible tension belt 14.

[0075] The working principle of the locking ring 15 is based on the phase transition of the material:

[0076] At room temperature, the locking ring 15 is in a hard glass state and cannot be rotated. When it is heated above its glass transition temperature, it will change to a soft and elastic state, and the outer ring of the locking ring 15 can be elastically deformed towards the notch, thereby reducing the friction between the locking ring 15 and the center shaft 11, so that the locking ring 15 can be easily rotated by external force.

[0077] When the external force is lost, the metal insert 153 itself drives the outer ring of the locking ring 15 to abut against the inner wall of the center shaft 11. When the temperature of the locking ring 15 drops below the glass transition temperature, the locking ring 15 returns to a hard glass state and cannot be rotated.

[0078] Regarding the handheld controller 20 and the system working mode:

[0079] Please refer to Figure 1 and Figure 6 The daily use of the device is driven and managed by an integrated handheld controller 20, which has the following functions:

[0080] Pneumatic unit: including a micro air pump (not shown in the figure), which is connected to the air nozzle 111 of the probe through a three-way valve 22, and the remaining end of the three-way valve 22 is connected to the atmosphere, which is used to control the inflation and rapid deflation of the balloon body 12.

[0081] Pressure sensing unit: a high-precision pressure sensor (not shown in the figure) integrated in the air circuit, which is used to monitor the air pressure inside the balloon body 12 in real time, which can be used as a safety interlock basis and a biological feedback signal source.

[0082] Control unit 21: a circuit board integrated with a microcontroller, memory and communication module, which serves as the brain of the device, responsible for executing all control logic, storing treatment programs and processing sensor data. The circuit board is provided with buttons, and the operation end of the buttons is located outside the shell of the handheld controller 20.

[0083] Power supply unit (not shown): a rechargeable battery, powering the whole device.

[0084] The daily use flow of the pelvic floor muscle electro-stimulation device is as follows:

[0085] Preparation and wearing: the user puts the treatment probe 10, which has been customized, into the body.

[0086] Inflation and fitting: the user controls the control unit 21 by button operation, and the pneumatic unit in the hand-held controller 20 inflates the balloon body 12. The balloon body 12 is automatically and repeatedly inflated to a customized shape that perfectly matches the user's body contour due to the constraint of the preset length of the multiple flexible tensioning belts 14 inside it.

[0087] Starting treatment: during the inflation process, the pressure sensing unit continuously monitors the pressure, and when the pressure reaches the preset value, the control unit 21 prompts that it is ready and unlocks the electro-stimulation function, starting to execute the preset electro-stimulation treatment course.

[0088] Biofeedback and data tracking: during the treatment process, the user actively contracts the pelvic floor muscles, and the pressure exerted by the muscles on the probe 10 causes a transient increase in the internal pressure of the balloon body 12. This pressure change is accurately captured by the pressure sensing unit and recorded as an effective muscle contraction event by the control unit 21.

[0089] End and cleaning: after the treatment ends or the user controls the control unit 21 by button operation, the electrodes 13 immediately stop electro-stimulation, and the three-way valve 22 quickly deflates, allowing the user to easily remove the treatment probe 10 and clean it.

[0090] Please refer to Figure 5 , the customization method of the treatment probe 10 includes the following steps:

[0091] Step one, obtain the three-dimensional shape data of the user's treatment site: achieved through various ways, such as using three-dimensional intracavity ultrasound for scanning, or using physical impression material for measurement, the obtained data will generate a three-dimensional digital model of the user's cavity.

[0092] Step two, adjustment and solidification: this step is automatically completed on the customization device, which includes a high-frequency induction coil 31 that can be fitted outside the treatment probe 10, and a probe 32 that can be inserted into the central shaft 11, the head of the probe 32 is provided with a rotary drive head 33.

[0093] The specific adjustment process is as follows:

[0094] Calculation and positioning: A brand new, to-be-customized treatment probe 10 is fixed in a fixture, the target length of each flexible tensioning belt 14 is calculated according to the three-dimensional digital model 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 driving of the linear driver and the rotary driver, and the rotary driving head 33 is engaged with the spline through hole 152 of the locking ring 15.

[0095] Heating unlocking: the high-frequency induction coil 31 is started, the alternating magnetic field generated thereby penetrates the balloon body 12 and the central shaft 11 from the outside, focuses on the metal insert 153 inside the locking ring 15, and makes it instantaneously heat up through induction heating, and the heat is conducted to the main body part 151 of the locking ring, so that the outer ring area thereof is softened above the glass transition temperature and enters the rotatable “unlocked” state.

[0096] Rotation adjustment: the rotary driving head 33 of the probe 32 is rotated to drive the unlocked locking ring 15 to rotate, so as to accurately adjust the length of the flexible tensioning belt 14 wound thereon until the calculated target angle is reached.

[0097] Cooling and locking: after adjustment, the high-frequency induction coil 31 is immediately powered off, the heat source disappears, the locking ring 15 cools rapidly and returns to the rigid glass state and is permanently locked at the current angle.

[0098] Shifting and repeating: the probe 32 and the high-frequency induction coil 31 are synchronously moved to the position of the next locking ring 15, and the above series of “heating-adjusting-cooling” actions are repeated until all the locking rings are set.

[0099] By this method, the multiple flexible tensioning belts 14 distributed at different positions of the balloon body are set to different final lengths, so as to be pre-programmed, when the balloon body 12 is uniformly inflated, the unique three-dimensional shape of the outer wall of the balloon body 12, which can accurately reproduce the specific user's physiological cavity contour, is formed under the joint constraint of the flexible tensioning belts 14.

[0100] The above embodiments are only exemplary embodiments of the present application and are not used to limit the present application, the protection scope of the present application is defined by the claims. Those skilled in the art can make various modifications or equivalent replacements to the present application within the spirit and protection scope of the present application, and such modifications or equivalent replacements are also regarded as falling within the protection scope of the embodiments of the present application.

Claims

1. A customizable profiled pelvic floor muscle electrical stimulation device, characterized by, The device comprises: a treatment probe (10); a hand-held controller (20) integrated with the treatment probe (10); wherein the treatment probe (10) comprises: a central shaft (11) extending along its longitudinal direction; a balloon body (12) made of elastic material integrally covering the outside of the central shaft (11); at least two electrodes (13) integrated on the outer surface of the balloon body (12); and a shaping mechanism for presetting the three-dimensional shape of the balloon body (12) after inflation; the shaping mechanism comprises: at least three flexible tensioning belts (14) evenly distributed around the central shaft (11), one end of which is anchored to the inner wall of the balloon body (12), and the other end of which passes through the outer wall of the central shaft (11) and extends into its interior; at least one locking ring (15) arranged in the interior of the central shaft (11), the other end of the flexible tensioning belt (14) being wound around the locking ring (15); the locking ring (15) is made of a material that is in a rigid glass state at room temperature and in a flexible high-elastic state above its glass transition temperature, so as to adjust and lock the length of the flexible tensioning belt (14) wound thereon by being heated, rotated and cooled.

2. The pelvic floor muscle electrical stimulation device according to claim 1, wherein one end of the flexible tensioning belt (14) anchored to the inner wall of the balloon body (12) is provided with an integrally formed anchor head (141), and the anchor head (141) is covered 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, wherein one end of the flexible tensioning belt (14) arranged in the interior of the central shaft (11) is provided with an integrally formed plug block (142), and the outer ring of the locking ring (15) is provided with an inwardly recessed notch, and the inner side of the notch is formed with an inwardly extending plug slot (154) for connecting the plug block (142).

4. The pelvic floor muscle electrical stimulation device according to claim 3, wherein the locking ring (15) is made by insert injection molding, which comprises: a main body part (151) made of a rigid engineering plastic that is electromagnetically inert to high-frequency magnetic fields; at least one metal insert (153) made of ferromagnetic metal, which is prearranged as an insert in the interior of the main body part (151), and the metal insert (153) is distributed in the outer ring area of the main body part (151) away from the plug slot (154).

5. The pelvic floor muscle electrical stimulation device according to claim 4, wherein the center of the main body part (151) of the locking ring (15) is provided with a spline through hole (152).

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

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

8. A customization method for the pelvic floor muscle electrical stimulation device according to any one of claims 1 to 7, wherein the customization method comprises the following steps: obtaining three-dimensional shape data of the inner cavity of the user's treatment site, and calculating the target length of each flexible tension belt (14) according to the three-dimensional shape data, and converting it into the angle required for adjusting the corresponding locking ring (15); for each locking ring (15) in the treatment probe (10), the following operations are sequentially performed: heating unlocking: locally heating the locking ring (15) above its glass transition temperature to make it change to a rotatable state; rotary adjustment: driving the locking ring (15) to rotate to adjust the length of the flexible tension belt (14) wound thereon until the preset target is reached; cooling and locking: stop heating, and cool the locking ring (15) to room temperature and restore it to a rigid glass state, thereby permanently locking its current rotation angle.

9. The customization method according to claim 8, wherein the outer ring area of the locking ring (15) is provided with a metal insert (153) made of ferromagnetic metal, and the heating unlocking step comprises: using a high-frequency induction coil (31) to generate an alternating magnetic field to heat the metal insert (153) to soften the part of the locking ring (15) close to the metal insert (153).

10. The customization method according to claim 9, wherein the customization method is completed on a customization device, and the customization device comprises: a high-frequency induction coil (31) that can be sleeved outside the treatment probe (10) and used to generate the alternating magnetic field to perform the heating unlocking step; a probe (32) that can be inserted into the inside of the central shaft (11), and the head of the probe (32) is provided with a rotary drive head (33) for driving the locking ring (15) to rotate; a linear drive and a rotary drive connected to the end of the probe (32) to enable the probe (32) to perform the rotary adjustment step.

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