Apparatus and method for detecting uterine endometrial peristaltic waves

Abstract

The application discloses a device and a use method for detecting endometrial peristaltic wave, which comprises a main stem, a branch stem, an electrode array and a drug sustained-release array, the main stem is provided with the branch stem, the main stem and the branch stem are both provided with the electrode array, and the main stem is further provided with the drug sustained-release array. The application belongs to the technical field of measuring devices, and aims to solve the problem of inaccurate measurement of endometrial peristaltic frequency in the prior art. The technical effect is that the device realizes the measurement of endometrial peristaltic wave and the treatment of endometrium through the arrangement of the electrode array and the drug sustained-release array.

Description

Technical Field

[0001] This invention relates to the field of measuring equipment technology, specifically to a device for detecting endometrial peristaltic waves, and also to a method of using the device for detecting endometrial peristaltic waves. Background Technology

[0002] The uterus is one of the most important reproductive organs in women, serving as the site of female reproductive activity. The uterus is a hollow organ located in the center of the pelvic cavity, lined with a mucous membrane called the endometrium. From puberty to menopause, the endometrium, influenced by ovarian hormones, periodically thickens and sheds to form menstruation. The uterus has a myometrium composed of numerous smooth muscle bundles and a small number of elastic fibers, mainly divided into three layers: the inner layer (muscle fibers arranged in a ring), the middle layer (muscle fibers arranged in a cross pattern), and the outer layer (muscle fibers arranged longitudinally). Due to the structural characteristics of the myometrium, its contractions exhibit two forms: one is a localized, intermittent contraction involving the entire myometrium, which can last for several minutes and is mainly used during childbirth to facilitate delivery, or during menstruation as a relatively low-intensity contraction to promote menstrual flow; the other is a fine, regular peristaltic contraction occurring in the myometrium adjacent to the endometrium, triggering endometrial peristalsis, or uterine peristalsis. Imaging studies can reveal regular, wave-like movements similar to intestinal peristalsis, known as endometrial peristalsis waves (EPW). These peristaltic movements are so subtle that they are imperceptible to the human body.

[0003] Endometrial peristaltic waves play a crucial role in regulating normal reproductive function and embryo implantation, such as sperm transport, embryo implantation, and maintaining pregnancy. Furthermore, in currently popular assisted reproductive technologies, endometrial peristaltic waves can affect endometrial receptivity, thereby impacting embryo implantation. Therefore, analyzing endometrial peristaltic waves and intervening in abnormalities is of great significance for improving clinical pregnancy rates.

[0004] The occurrence of endometrial peristaltic waves may be related to the regulation of secretion by the sympathetic / parasympathetic nervous system, estrogen, progesterone, prostaglandins, and oxytocin. The frequency, direction, and amplitude of endometrial peristaltic waves exhibit different characteristics at different stages as the follicle grows and ovulates. Generally, the direction of endometrial peristaltic waves is classified into five types: first, waves from the cervix to the fundus; second, waves from the fundus to the cervix; third, opposing waves emanating simultaneously from the fundus and cervix; fourth, random waves with uncertain direction; and fifth, no movement.

[0005] For example, during menstruation, reverse movement (peristaltic waves from the fundus to the cervix) is prevalent, facilitating the discharge of menstrual blood. During the follicular phase, as the follicle grows, the frequency, speed, and amplitude of forward movement (peristaltic waves from the cervix to the fundus) gradually increase, facilitating rapid sperm transport in the female reproductive tract and promoting fertilization, reaching its peak before ovulation. In the early luteal phase (early post-ovulation), opposing movements (opposing waves originating from both the cervix and fundus) appear, helping to prevent the embryo from being expelled from the cervix or fallopian tubes, thus promoting implantation. This movement also causes fluid flow within the uterine cavity, providing essential nutrients and oxygen to the embryo before implantation. In the late luteal phase (late post-ovulation), endometrial peristalsis decreases, providing a quiet environment for embryo implantation.

[0006] There are several possible causes of abnormal endometrial motility, and a comprehensive theoretical framework has not yet been established, with the specific mechanisms remaining unclear. For example, uterine lesions such as endometriosis, adenomyosis, uterine fibroids, and congenital uterine malformations can also cause abnormal endometrial motility. Abnormal endometrial motility may affect normal sperm transport or embryo implantation, thus causing infertility. Studies have also shown that endometrial motility waves have a significant impact on the pregnancy outcome of in-vitro fertilization (IVF) during assisted reproductive technology (ART). For instance, increased endometrial motility wave frequency may be one of the reasons affecting embryo implantation; studies have found a positive correlation between endometrial motility wave frequency and the number of implantation cycles in patients with repeated implantation failures. Furthermore, in infertile women with uterine fibroids, the endometrial motility wave frequency is higher than normal during the mid-luteal phase. One research theory suggests that fibroids can produce aromatase, which leads to increased estrogen production, thereby increasing the frequency of endometrial motility waves, resulting in abnormal endometrial motility waves and causing infertility or difficulty conceiving.

[0007] Therefore, in clinical practice, adding progesterone, phloroglucinol, and atosiban may effectively inhibit endometrial peristalsis, promoting embryo implantation, increasing embryo implantation and pregnancy rates, and reducing miscarriage rates, thereby improving the success rate of assisted reproductive treatment, especially for patients with recurrent implantation failure. Vaginal progesterone can significantly reduce the frequency of endometrial peristalsis. Reduced peristaltic wave frequency can improve endometrial receptivity during blastocyst transfer, thus facilitating embryo implantation. For patients with uterine lesions, problems can be detected early by examining endometrial peristaltic waves. Pre-treatment with medication or surgery before entering the assisted reproductive treatment cycle, or temporary suspension of the process and embryo freezing, can be recommended until the problem is resolved before transfer, thus ensuring the success rate of treatment, reducing the risk of failure, saving patient costs, and reducing patient suffering. For example, for women with uterine fibroids who are infertile, a myomectomy can reduce the frequency of endometrial peristaltic waves, thereby improving pregnancy rates.

[0008] Uterine contractions were initially assessed by measuring the pressure within the uterine cavity. For example, a miniature pressure sensor was placed inside the uterine cavity, or a pre-filled microcatheter was inserted into the uterine cavity and connected to an external pressure monitoring device to measure the pressure within the uterine cavity and assess uterine contractions.

[0009] Transvaginal ultrasound (EVA) can observe the frequency and direction of endometrial peristalsis, offering significant advantages in repeatability and operability, making it the most commonly used clinical detection method. By using a transvaginal ultrasound probe to record endometrial peristalsis for 3-5 minutes, and then using video processing software to accelerate playback of the recordings to analyze the frequency and direction of endometrial peristalsis (EPW), the biggest drawback of this method is the potential for subjectivity in the video analysis. This subjective error can be reduced by averaging the results of 2-3 video analysts. Developing automated detection and analysis equipment may lead to greater accuracy and holds promise for solving this problem in the future.

[0010] Another method for evaluating EPW is through magnetic resonance imaging (Cine-MRI). The direction and frequency of peristaltic waves can be observed in the sagittal and coronal planes. The advantage is that it allows observation of the entire uterus, including the endometrium and myometrium. The disadvantages are that it cannot detect the amplitude of the peristaltic waves, and it is expensive, time-consuming, and relatively complex to operate.

[0011] In addition, there is electromyography (EHG) signal monitoring technology. Muscle contraction is caused by spontaneous electrical activity at the cellular level in the form of action potentials. Electrodes can be placed on the surface of the pregnant woman's abdomen to detect the electrical activity of the pregnant uterus from the surface of the pregnant woman's body. It is mainly used to monitor uterine contractions. The target of monitoring is generally high-intensity uterine contractions involving the entire myometrium. These types of contractions are usually perceptible, such as the contractions that occur during labor. However, fine and weak endometrial peristalsis cannot be detected or identified.

[0012] In summary, many current methods for detecting endometrial peristaltic waves have various limitations and problems, hindering their widespread clinical application. For example:

[0013] Currently, methods for detecting intrauterine pressure or transvaginal ultrasound generally require a handheld design. The handle has a probe that can be inserted into the vagina or uterine cavity for measurement, and an external cable connects to a host unit, which may be a computer or a specialized control device. These devices are generally bulky, time-consuming, relatively complex to operate, and inconvenient to use.

[0014] Other technologies, such as Cine-MRI, use very expensive and bulky equipment, resulting in high operating costs. Hospitals and clinics typically only have one or a few units, which cannot meet the testing needs of many people.

[0015] Current devices based on uterine electromyography (EHG) signals are unable to detect or identify the delicate and weak peristaltic waves of the endometrium within the uterus.

[0016] The above-mentioned tests require significant patient cooperation during the measurement process, such as visiting a hospital or clinic for the examination; maintaining a certain posture and avoiding large movements during the examination; and the above tests can only provide a short-term (during measurement), single, "snapshot" examination. If updated test results are needed, the patient needs to visit the hospital or clinic again for a repeat visit.

[0017] Because of its "snapshot" nature, it is difficult to establish long-term historical information for patients, making it impossible to track long-term changes in the peristaltic waves of the uterine lining or to monitor the patient's treatment progress.

[0018] Currently, many methods for detecting endometrial peristaltic waves are based on visual information acquisition and analysis, which may involve a certain degree of subjectivity and human error.

[0019] The need to reuse the same examination equipment among different patients raises concerns about physiological contamination, thus placing higher demands on the disinfection of the equipment.

[0020] Some devices that require insertion into the vagina and uterus may cause discomfort or even harm to patients during use. For example, the procedure may involve dilating the vagina or cervix to the required size before inserting the probe. This process can potentially damage the vagina, cervix, endometrium, or other areas, causing discomfort or inflammation. Furthermore, the dilated state of the vagina or cervix during the examination can also cause discomfort. Summary of the Invention

[0021] Therefore, the present invention provides a device for detecting endometrial peristaltic waves to solve the above-mentioned problems in the prior art.

[0022] To achieve the above objectives, the present invention provides the following technical solution:

[0023] According to a first aspect of the present invention, an endometrial peristaltic wave detection device includes a main trunk, branches, an electrode array, and a drug sustained-release array. Branches are provided on the main trunk, and electrode arrays are provided on both the main trunk and the branches. A drug sustained-release array is also provided on the main trunk.

[0024] Furthermore, the electrode array includes measuring electrodes and reference electrodes, with branches on both sides of the main trunk, measuring electrodes on both surfaces of the main trunk and the branches, and a reference electrode at the end of the main trunk.

[0025] Furthermore, the electrode array also includes therapeutic electrodes, with therapeutic electrodes provided on both surfaces of the main trunk and both surfaces of the branches.

[0026] Furthermore, the drug sustained-release array includes multiple sustained-release units, all of which are disposed on the surface of the main body.

[0027] Furthermore, the drug sustained-release unit includes a switch and a drug storage unit, the switch being electrically connected to the drug storage unit, and both the drug sustained-release unit and the switch being disposed on the surface of the main body.

[0028] Furthermore, it also includes a protrusion, with a protrusion provided at one end of the main body, and a reference electrode disposed on the surface of the protrusion.

[0029] Furthermore, it also includes a collar, with a collar provided at the end of the protrusion that faces away from the main stem.

[0030] Furthermore, it also includes a tail wire, with a tail wire threaded onto the ferrule.

[0031] Furthermore, it also includes a pull cord and a kit, the kit being fitted onto the protrusion, one end of the pull cord being connected to the branch, and the other end of the pull cord passing through the kit and being slidable relative to the pull cord.

[0032] A second aspect of the present invention provides a method of using an endometrial peristaltic wave detection device, comprising the following steps:

[0033] Step S100: Load the device into the placer and compress and fold the branches;

[0034] Step S200: Place the device into the uterus using the placement device;

[0035] Step S300: Observe the detection signal output by the electrode array to determine the endometrial peristalsis.

[0036] Step S400: Confirm the treatment or recuperation method used on the patient;

[0037] Step S500: Perform sustained-release drug therapy and / or use therapeutic electrodes for bioelectric stimulation therapy on the patient;

[0038] Step S600, repeat steps S300 to S500;

[0039] Step S700: When the detection and treatment process is completed, remove the device.

[0040] This invention has the following advantages: The electrode array and drug-release array enable the measurement of endometrial peristaltic waves and the treatment of endometrial tissue. Furthermore, this device offers the following advantages: the technical solution of this invention enables the measurement and analysis of endometrial peristaltic waves within the uterus based on uterine electromyography signals (based on a sensor matrix). Unlike many commonly used detection methods and devices (such as transvaginal ultrasound and MRI), this method is more compact, easier to use, and provides the possibility for long-term, continuous monitoring.

[0041] First, this invention realizes a fully implantable intrauterine device that, after implantation, can continuously monitor and analyze endometrial peristaltic waves within the human body, without requiring the patient to remain in a hospital or clinic during the test. Furthermore, during the test, the patient does not need to maintain a specific posture or refrain from significant movements, and after implantation, the patient can resume normal daily activities.

[0042] Secondly, this invention enables a single implantation and continuous measurement mode, eliminating the need for frequent probe insertion and minimizing potential damage to the vagina, cervix, endometrium, or other areas. Furthermore, it avoids causing continuous discomfort to the patient during testing.

[0043] Third, based on the matrix electromyography sensor in the uterus, it is possible to sense and measure various parameters of endometrial peristaltic waves, such as frequency, direction, amplitude, distribution in the uterus, and propagation characteristics of peristaltic waves.

[0044] Fourth, by using the implantable endometrial peristaltic wave detection device of the present invention, based on the sensed and collected endometrial peristaltic wave parameter data, the user's reproductive health status can be assessed through corresponding algorithms to guide possible conditioning or assisted reproductive treatments.

[0045] Fifth, the equipment in this invention is for one person only and does not involve multiple people using it repeatedly, thus avoiding the problem of physiological contamination between multiple people and the problem of additional equipment disinfection.

[0046] Sixth, since the device in this invention does not require ultrasound units or MRI components, the cost can be significantly reduced. Due to the reduced cost, simple and convenient operation, and the elimination of personnel reuse, the device can be used at a lower cost and is more readily accepted by patients.

[0047] Seventh, the drug sustained-release module in this invention can achieve sustained drug release within the body, providing continuous conditioning and treatment for patients. Furthermore, it allows for continuous monitoring of treatment effects during the treatment process, truly achieving a closed loop of examination, treatment, and treatment effect tracking. Attached Figure Description

[0048] 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.

[0049] The structures, proportions, sizes, etc. illustrated in this specification are only for the purpose of assisting those skilled in the art in understanding and reading the content disclosed herein, and are not intended to limit the conditions under which the present invention can be implemented. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in the proportions, or adjustments to the size, without affecting the effects and objectives that the present invention can produce, should still fall within the scope of the technical content disclosed in the present invention.

[0050] Figure 1 This is a front view of a first structural schematic of an endometrial peristaltic wave detection device provided in some embodiments of the present invention.

[0051] Figure 2 This is a side view of a first structural schematic diagram of an endometrial peristaltic wave detection device provided in some embodiments of the present invention.

[0052] Figure 3 This is a front view of a second structural schematic diagram of an endometrial peristaltic wave detection device provided in some embodiments of the present invention.

[0053] Figure 4 This is a side view illustrating a second structural design of an endometrial peristaltic wave detection device provided in some embodiments of the present invention.

[0054] Figure 5 This is a schematic diagram of a third structure of an endometrial peristaltic wave detection device provided in some embodiments of the present invention.

[0055] Figure 6 This is a schematic diagram of the structure of a device for detecting endometrial peristaltic waves, provided in some embodiments of the present invention, disposed within a placement device.

[0056] Figure 7 The circuit diagram shows a device for detecting endometrial peristaltic waves, provided for some embodiments of the present invention.

[0057] Figure 8 This is a schematic diagram of an endometrial peristaltic wave detection device placed inside the uterus, as provided in some embodiments of the present invention.

[0058] Figure 9 This is a simulation diagram of the data matrix of a device for detecting endometrial peristaltic waves according to some embodiments of the present invention, showing the distribution of peristaltic waves at the first moment.

[0059] Figure 10 This is a simulation diagram of the data matrix of an endometrial peristaltic wave detection device provided in some embodiments of the present invention, showing the distribution of the peristaltic wave at the second moment.

[0060] Figure 11 The diagram shows the distribution of peristaltic waves at the third moment in a simulation schematic diagram of the data matrix of an endometrial peristaltic wave detection device provided in some embodiments of the present invention.

[0061] In the diagram: 1. Main trunk, 2. Branch trunk, 3. Measuring electrode, 4. Treatment electrode, 5. Protrusion, 6. Reference electrode, 7. Drug release array, 8. Loop, 9. Tail wire, 10. Main board, 11. Switch, 12. Drug storage unit, 13. Power supply, 14. Thin film layer, 15. Pull cord, 16. Placer, 17. Push rod, 18. Electrode array, 19. Multiplexer, 20. Signal conditioning device, 21. Filter, 22. Variable gain amplifier, 23. Analog-to-digital converter, 24. Power management module, 25. Wireless module, 26. Central processing unit, 27. Drug release drive unit, 28. Drug release control module, 29. Digital-to-analog converter. 30. Output signal modulation and conditioning module; 31. Analog signal drive module; 32. Multiplexer and state holder; 33. Kit; 34. First sub-branch; 35. Second sub-branch; 36. Third sub-branch; 37. Fourth sub-branch; 38. Fifth sub-branch. Detailed Implementation

[0062] The following specific embodiments illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. 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.

[0063] Example 1

[0064] like Figures 1 to 5As shown, an endometrial peristaltic wave detection device according to a first aspect embodiment of the present invention includes a main trunk 1, a branch trunk 2, an electrode array 18, and a drug sustained-release array 7. The branch trunk 2 is provided on the main trunk 1, and the electrode array 18 is provided on both the main trunk 1 and the branch trunk 2. The drug sustained-release array 7 is also provided on the main trunk 1.

[0065] In the above embodiments, it should be noted that the branch 2 includes a first sub-branch 34, a second sub-branch 35, a third sub-branch 36, a fourth sub-branch 37, and a fifth sub-branch 38. The first sub-branch 34, the second sub-branch 35, the third sub-branch 36, the fourth sub-branch 37, and the fifth sub-branch 38 are arranged sequentially from top to bottom on both sides of the main branch 1. The lengths of the first sub-branch 34, the second sub-branch 35, the third sub-branch 36, the fourth sub-branch 37, and the fifth sub-branch 38 decrease sequentially from top to bottom. The shape formed by the main branch 1 and the branch 2 is similar to that of a fishbone. In addition, the main branch 1 and the branch 2 are both made of flexible plastics such as polyethylene, polytetrafluoroethylene, or silicone rubber, which are soft, have a certain degree of elasticity and toughness, have good insulation and waterproof properties, and are of medical grade, that is, have good safety and biocompatibility.

[0066] Preferably, thin film layers 14 are provided on both sides of the main trunk 1, and electrode arrays 18 are provided on both sides of the thin film layers 14. The first sub-branch 34 and the second sub-branch 35, the second sub-branch 35 and the third sub-branch 36, the third sub-branch 36 and the fourth sub-branch 37, and the fourth sub-branch 37 and the fifth sub-branch 38 are all connected through the thin film layers 14.

[0067] The technical effect achieved by the above embodiments is that the setting of electrode array 18 and drug sustained-release array 7 enables the device to measure endometrial peristaltic waves and treat endometrium.

[0068] Optional, such as Figures 1 to 5 As shown, in some embodiments, the electrode array 18 includes a measuring electrode 3 and a reference electrode 6. Branches 2 are provided on both sides of the main trunk 1. Measuring electrodes 3 are provided on both surfaces of the main trunk 1 and on both surfaces of the branches 2. A reference electrode 6 is provided at the end of the main trunk 1.

[0069] In the above optional embodiments, it should be noted that when the device is placed inside the uterus, the reference electrode is located close to the cervix.

[0070] The advantages of the above optional embodiments are as follows: the cervix contains the least amount of smooth muscle tissue and is therefore considered to be the location with the most neutral bioelectric potential, making it the most suitable location as a reference bioelectric potential. The function of electromyography is realized by the cooperation of the reference electrode 6 and the measuring electrode 3.

[0071] Optional, such as Figures 1 to 5 As shown, in some embodiments, the electrode array 18 further includes a treatment electrode 4, and the treatment electrode 4 is provided on both surfaces of the main trunk 1 and both surfaces of the branch trunk 2.

[0072] The beneficial effect of the above optional embodiments is that the combination of the treatment electrode 4 and the reference electrode 6 through the setting of the treatment electrode 4 realizes the function of electromyography.

[0073] Optional, such as Figures 1 to 3 As shown, in some embodiments, the drug sustained-release array 7 includes a plurality of sustained-release units, all of which are disposed on the surface of the main body 1.

[0074] Optional, such as Figures 1 to 5 As shown, in some embodiments, the drug sustained-release unit includes a switch 11 and a drug storage unit 12, the switch 11 being electrically connected to the drug storage unit 12, and both the drug sustained-release unit and the switch 11 being disposed on the surface of the main body 1.

[0075] In the above optional embodiments, it should be noted that the drug storage unit 12 is provided with a sustained-release drug, and the switch 11 and the drug storage unit 12 are connected in a one-to-one correspondence.

[0076] Preferred, such as Figure 7 As shown, it also includes a motherboard 10 and a power supply device 13. The power supply device 13 is a battery or wireless charging module and charging coil, etc. Both the power supply device 13 and the motherboard 10 are located in the main body 1. The electrode array 18, switch 11 and power supply device 13 are all electrically connected to the motherboard 10. The motherboard 10 is provided with a circuit module, which includes a multiplexer 19, a signal conditioning device 20, a filter 21, a variable gain amplifier 22, an analog-to-digital converter 23, a power management module 24, a wireless module 25, a central processing unit 26, a drug sustained-release drive unit 27, a drug sustained-release control module 28, a digital-to-analog converter 29, an output signal modulation and conditioning module 30, an analog signal drive module 31 and a multiplexer and state holder 32. The beneficial effects of the above optional embodiments are: by setting the switch 11, the number of sustained-release units that are turned on or off can be controlled, thereby realizing the control of the drug sustained-release rate; in addition, by controlling the position of the sustained-release unit, drug sustained-release can be selectively performed at different positions.

[0077] Optional, such as Figures 1 to 5 As shown, in some embodiments, a protrusion 5 is also included, with a protrusion 5 provided at one end of the main body 1, and a reference electrode 6 disposed on the surface of the protrusion 5.

[0078] In the above optional embodiments, it should be noted that the protrusion 5 is made of flexible plastic.

[0079] Optional, such as Figures 1 to 5 As shown, in some embodiments, a collar 8 is also included, with the collar 8 provided at the end of the protrusion 5 facing away from the main stem 1.

[0080] In the above optional embodiments, it should be noted that the collar 8 is circular and also includes a placer 16. The placer 16 is provided with a push rod 17. The device is placed in the placer 16 and fixed in the uterus by the push rod 17. Specifically, when the device is implanted, the device to be implanted is placed in the placer 16. After the device enters the body, the push rod 17 releases the device and fixes it in the uterus.

[0081] The beneficial effect of the above optional embodiments is that the removal of the device after implantation is achieved by inserting a rubber rope or the like into the collar 8.

[0082] Optional, such as Figures 1 to 5 As shown, in some embodiments, a tail wire 9 is also included, and the tail wire 9 is threaded through the collar 8.

[0083] In the above optional embodiments, it should be noted that the tail thread 9 is a nylon thread or a rubber rope, etc.

[0084] The beneficial effect of the above optional embodiments is that the tail wire 9 facilitates the removal operation after the device is implanted.

[0085] Optional, such as Figures 1 to 5 As shown, in some embodiments, a pull cord 15 and a kit 33 are also included. The kit 33 is fitted onto the protrusion 5. One end of the pull cord 15 is connected to the branch 2, and the other end of the pull cord 15 passes through the kit 33 and is slidable relative to the pull cord 15.

[0086] In the above optional embodiments, it should be noted that there are multiple pull ropes 15, and the pull ropes 15 are connected to the end of the branch 2 away from the main branch 1; the kit 33 can be a sleeve or a rope, etc.; in addition, a groove is provided at the protrusion 5.

[0087] The advantages of the above optional embodiments are as follows: the combination of the pull rope 15 and the kit 33 allows the pull rope 15 to retract the branch 2 when the device needs to be removed after implantation in the uterus, further facilitating the removal of the device after implantation in the uterus; the kit 33, in conjunction with the groove at the protrusion 5, binds all the pull ropes 15 together, ensuring the pulling effect.

[0088] Example 2

[0089] A method of using an endometrial peristaltic wave detection device according to a second aspect embodiment of the present invention, using an endometrial peristaltic wave detection device according to a first aspect embodiment, includes the following steps:

[0090] Step S100: Load the device into the placer and compress and fold the branch 2;

[0091] Step S200: Place the device into the uterus using the placement device;

[0092] Step S300: Observe the detection signal output by electrode array 18 to determine the peristalsis of the endometrium;

[0093] Step S400: Confirm the treatment or recuperation method used on the patient;

[0094] Step S500: Perform sustained-release drug treatment on the patient and / or use the treatment electrode 4 for bioelectric stimulation treatment;

[0095] Step S600, repeat steps S300 to S500;

[0096] Step S700: When the detection and treatment process is completed, remove the device.

[0097] Example 3

[0098] like Figures 1 to 11 As shown, the third-party embodiments of the present invention include all the technical features of embodiments 1 and 2. Specifically, branch rods 2 are distributed on both sides of the main trunk 1. The materials of the main trunk 1 and the branch rods 2 are medical-grade soft plastics such as polyethylene, polytetrafluoroethylene, or silicone rubber, which are soft, have a certain degree of elasticity and toughness, and have good insulation and waterproof properties, i.e., good safety and biocompatibility. Electrode arrays 18 are distributed at the ends of the branch rods 2, i.e., at both ends and the middle part of the main trunk 1. Electrode arrays 18 are provided on both surfaces of the main trunk 1 and both surfaces of the branch rods 2, and the distribution is consistent. The electrode arrays 18 include measuring electrodes 3 and therapeutic electrodes 4. There is a protrusion 5 at the bottom of the main trunk 1. After being implanted into the uterus, the protrusion 5 will be located close to the cervix. On the protrusion 5, a reference electrode 6 is located towards the end to cooperate with the measuring electrode 3 and the therapeutic electrode 4 to realize the function of electromyography measurement and treatment. The reference electrode 6 is located near the cervix. The cervix contains the least amount of smooth muscle tissue and is therefore considered the most bioelectrically neutral location, making it the most suitable location for a reference bioelectric potential. A drug-release array 7 is designed on one side of the main stem 1. This array consists of numerous individually controllable release units, and the rate of drug release is controlled by adjusting the number of units that are turned on or off. Each unit comprises a drug release control mechanism, i.e., a switch 11, and a drug storage unit 12. A ring, i.e., a collar 8, is designed at the end of the protrusion 5 to secure the tail wire 9. The tail wire 9 can be a nylon thread used for device removal after implantation.

[0099] The main body internally encapsulates various electronic modules, including the motherboard 10, which implement various detection and control circuits. Multiple switches 11 are designed on the motherboard 10, each connected to a drug storage unit 12, enabling the control of starting or stopping the drug storage unit. The motherboard 10 is connected to all electrodes, including the reference electrode 6, various measuring electrodes 3, and treatment electrodes 4, via a flexible PCB or fine wires. The motherboard 10 and the connecting flexible PCB or fine wires are encapsulated in external material, with only the electrode portions exposed to the external environment. Furthermore, a power supply unit 13 provides the necessary energy to the motherboard 10. Depending on the application scenario, the power supply unit 13 can be a battery, a wireless charging module, or a charging coil, if required.

[0100] like Figure 5 As shown, a thin film layer 14 is designed between multiple branches 2 on both sides of the main trunk 1. The thin film layer 14 is a flexible thin film, and an electrode array 18 is arranged on the thin film layer 14.

[0101] This device can be implanted into the uterus in a similar manner to intrauterine device (IUD) implantation and will continue to function within the uterine cavity. Specifically, during implantation, a placement device 16, similar to that used with IUDs, is used for placement. Figure 6 As shown. When the device is loaded into the front end of the placer 16, the branches 2 on both sides of the main trunk 1 can be compressed and folded tightly against the side of the main trunk 1. The thin film layer 14 can also be folded together when the branches 2 are compressed and folded. Since the materials used for the branches 2 and the thin film layer 14 are soft and have a certain degree of toughness, they can protect the flexible PCB or fine wires inside from being torn or broken when folded, and the electrode array 18 will not be damaged. In addition, the flexible PCB or fine wires can also be serpentine bends, which can effectively disperse the force received when folded, thereby protecting them from damage. After being loaded into the front end of the placer 16, the position of the device is fixed by the push rod 17 inside the placer 16.

[0102] Once the device is released from the placer 16 and correctly placed into the uterus, the branch 2, freed from the restraint of the front end of the placer 16 and due to its own elasticity, will slowly open and return to its free shape. Its unique shape ensures the device remains securely and properly held within the uterine cavity. The electrode array 18 allows for the detection of endometrial peristaltic waves in different areas of the uterus.

[0103] Similarly, this device is removed using a method similar to that used for IUDs. The doctor or clinician will use a speculum to open the vagina, wipe away any fluid inside, and expose the cervix. After disinfecting the cervix, if necessary, cervical forceps can be used to clamp the anterior or posterior lip of the cervix to adjust the angle. Then, the tail string 9 is grasped with tweezers and carefully pulled to remove the device.

[0104] Furthermore, the electrode arrays 18 are all connected to multiple channels of the multiplexer in the main control circuit board, selecting a specific signal from multiple analog signals. The selected signal then enters the signal conditioning module for signal conditioning. The conditioning steps may include primary amplification of the analog signal, DC component extraction, and isolation. After conditioning, the analog signal enters a filter network for centralized filtering. This network can be configured to implement various combinations of different filters, such as low-pass, high-pass, band-pass, and notch filters. For example, the signal of peristaltic waves of the human uterine lining typically uses a filtering frequency band of 0.34Hz to 1Hz to avoid interference from signals generated by cardiopulmonary activity and interference introduced from the external environment. In actual system design, to ensure that more signal features and information are collected, a filtering frequency band of 0.05Hz to 5Hz can be used.

[0105] After conditioning and filtering, the analog signal is further amplified by a variable gain amplifier before entering the analog-to-digital converter (ADC), ensuring that the analog signal is better suited to the ADC's input range. The ADC then converts the analog signal into digital information and sends it to the central processing unit (CPU). The CPU can implement various data analysis and processing algorithms to achieve peristaltic wave detection. The raw data, processed data, and analysis results can all be wirelessly transmitted to a host computer or cloud server for storage or further analysis and processing.

[0106] If clinical experts confirm that treatment or conditioning is necessary for the patient, this device offers two treatment options: sustained-release drug therapy and bioelectric stimulation therapy via therapeutic electrodes. When sustained-release drug therapy is required, the central processing unit (CPU), based on a pre-set treatment plan confirmed by the clinical expert, selectively controls the sustained-release control module, driving the sustained-release control unit to open or close the drug storage unit. The drug storage unit can be pre-loaded with certain therapeutic drugs, such as progesterone, phloroglucinol, and atosiban. Controlling the number of open drug storage units allows for rate control of drug release. When bioelectric stimulation therapy is needed to intervene in endometrial peristalsis, the CPU, based on a pre-set treatment plan confirmed by the clinical expert, applies specific, pre-set electrical signal waveforms to certain therapeutic electrodes for intervention. Specifically, the CPU converts the digital data of the required electrical signal waveform into an analog signal via a digital-to-analog converter, then further optimizes the analog signal through modulation and conditioning before it enters the drive circuit. The drive circuit can provide a certain current output capability to achieve the therapeutic purpose. The signal from the drive circuit can be selectively applied to a specific treatment electrode by a multiplexer and state holder, thereby achieving treatment of a specific location within the uterus.

[0107] In addition, there is a power management module on the main control circuit board to provide stable power to various functional modules and to switch between multiple low-power modes.

[0108] Based on the aforementioned intrauterine matrix electromyography (EMG) sensor, EMG parameter data of endometrial peristaltic waves can be sensed and measured from each measuring electrode. By placing each data point into a data matrix according to the positional relationship of its electrodes, a planar distribution map of endometrial peristaltic waves within the uterus can be obtained. Since the electrode array is not a regular rectangular array, averaging the data in adjacent cells of the matrix can fill cells without electrodes, thus obtaining a complete digital matrix. Repeating this process with data from different time points yields multiple digital matrices. Arranging these matrices chronologically allows us to observe the distribution changes of intrauterine peristaltic waves, such as... Figure 9 , Figure 10 and Figure 11 The above is a simulated scenario.

[0109] Further analysis of the above data can reveal various parameters and properties of peristaltic waves, such as frequency, direction, amplitude, intrauterine distribution, propagation direction, propagation rate, source location, and type. For example, knowing the source location and propagation direction of the peristaltic waves allows for the identification of five types of endometrial peristaltic waves: first, CF (cervical to fundus wave); second, FC (fundus to cervix wave); third, OP (opposite waves originating simultaneously from the fundus and cervix); fourth, random waves with unpredictable direction (R); and fifth, no motion (N). By comparing the timing, frequency, and amplitude of different types of peristaltic waves with data from the literature at the same menstrual cycle stage, it is possible to determine whether the peristaltic waves at this stage are abnormal, which can serve as one of the assessment criteria for a patient's reproductive health.

[0110] Although the present invention has been described in detail above with general descriptions and specific embodiments, modifications or improvements can be made to it, which will be obvious to those skilled in the art. Therefore, all such modifications or improvements made without departing from the spirit of the present invention fall within the scope of protection claimed by the present invention.

[0111] The terms such as "upper," "lower," "left," "right," and "middle" used in this specification are merely for clarity of description and are not intended to limit the scope of the invention. Any changes or adjustments to their relative relationships, without substantially altering the technical content, should also be considered within the scope of the invention.

Claims

1. A device for detecting endometrial peristaltic waves, characterized in that, It includes a main trunk (1), a branch trunk (2), an electrode array (18), and a drug sustained-release array (7). The branch trunk (2) is provided on the main trunk (1). The electrode array (18) is provided on both the main trunk (1) and the branch trunk (2). The drug sustained-release array (7) is also provided on the main trunk (1). It also includes a motherboard and a power supply unit. The power supply unit is a battery or a wireless charging module and a charging coil. Both the power supply unit and the motherboard are located inside the main body. The electrode array, switches and the power supply unit are electrically connected to the motherboard. The motherboard is equipped with circuit modules, including a multiplexer, a signal conditioning device, a filter, a variable gain amplifier, an analog-to-digital converter, a power management module, a wireless module, a central processing unit, a drug release drive unit, a drug release control module, a digital-to-analog converter, an output signal modulation and conditioning module, an analog signal drive module, and a multiplexer and state holder. The electrode array (18) includes a measuring electrode (3) and a reference electrode (6). The branch (2) is provided on both sides of the main trunk (1). The measuring electrode (3) is provided on both surfaces of the main trunk (1). The measuring electrode (3) is provided on both surfaces of the branch (2). The reference electrode (6) is provided at the end of the main trunk (1). The device can sense and measure electromyographic parameters of endometrial peristaltic waves from each measuring electrode. By placing each data point into a data matrix according to the positional relationship of its electrodes, a planar distribution map of endometrial peristaltic waves in the uterus is obtained. By averaging the data of adjacent cells in the data matrix to fill cells without electrodes, a complete digital matrix is ​​obtained. By repeating the above processing on data from different times, multiple digital matrices are obtained. Finally, they are arranged in chronological order to obtain the distribution changes of peristaltic waves in the uterus.

2. The device for detecting endometrial peristaltic waves according to claim 1, characterized in that, The electrode array (18) also includes a treatment electrode (4), and the treatment electrode (4) is provided on both surfaces of the main trunk (1) and both surfaces of the branch trunk (2).

3. The device for detecting endometrial peristaltic waves according to claim 1, characterized in that, The drug sustained-release array (7) includes a plurality of sustained-release units, and the plurality of sustained-release units are disposed on the surface of the main body (1).

4. The device for detecting endometrial peristaltic waves according to claim 3, characterized in that, The sustained-release unit includes a switch (11) and a drug storage unit (12). The switch (11) is electrically connected to the drug storage unit (12). Both the sustained-release unit and the switch (11) are disposed on the surface of the main body (1).

5. The device for detecting endometrial peristaltic waves according to claim 1, characterized in that, It also includes a protrusion (5), one end of the main body (1) is provided with the protrusion (5), and the reference electrode (6) is provided on the surface of the protrusion (5).

6. The device for detecting endometrial peristaltic waves according to claim 5, characterized in that, It also includes a collar (8), which is provided at the end of the protrusion (5) away from the main stem (1).

7. The device for detecting endometrial peristaltic waves according to claim 6, characterized in that, It also includes a tail wire (9), and the tail wire (9) is threaded through the collar (8).

8. The device for detecting endometrial peristaltic waves according to claim 5, characterized in that, It also includes a pull cord (15) and a kit (33), the kit (33) being fitted onto the protrusion (5), one end of the pull cord (15) being connected to the branch (2), and the other end of the pull cord (15) passing through the kit (33) and being slidable relative to the kit (33) with respect to the pull cord (15).

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