CN113274028A - Device for detecting endometrial peristaltic waves and using method - Google Patents

Abstract

The invention discloses equipment for detecting endometrial wriggle waves and a using method thereof. The invention belongs to the technical field of measuring equipment, and aims to solve the problem that the measurement of the endometrial wriggling frequency is inaccurate in the prior art. The technical effects achieved are as follows: the device realizes the measurement of the endometrial peristaltic waves and the treatment of endometrium by the arrangement of the electrode array and the drug slow-release array.

Description

Device for detecting endometrial peristaltic waves and using method

Technical Field

The invention relates to the technical field of measuring equipment, in particular to equipment for detecting endometrial peristaltic waves and a using method of the equipment for detecting the endometrial peristaltic waves.

Background

The uterus is one of the important reproductive organs of women, and is an important place for reproductive and reproductive activities of women. The uterus is a cavity organ, located in the center of the pelvic cavity, and covered with mucosa, called endometrium. From puberty to menopause, the endometrium is affected by ovarian hormones, and the endometrium is periodically thickened and shed to form menses. The uterus has a myometrium layer composed of a large number of smooth muscle bundles and a small number of elastic fibers, and the myometrium layer is mainly divided into an inner layer (muscle fiber ring arrangement), a middle layer (muscle fiber cross arrangement) and an outer layer (muscle fiber longitudinal arrangement) 3 layers. Due to the structural characteristics of the myometrium, its contractions take two forms, one is a local accumulation involving the whole muscle layer, an occasional contraction that can last for a few minutes, mainly during delivery to promote the expulsion of the fetus, or during menstruation to promote the expulsion of the menses with a relatively low intensity of contractions; the other is the fine, regular peristaltic contractions that occur in the myometrium adjacent the endometrium, which induce Endometrial Peristalsis (otherwise known as uterine Peristalsis). A regular waveform movement similar to the intestinal Peristalsis, called Endometrial Peristalsis Wave (EPW), can be observed by imaging. The endometrial peristalsis is very slight and is not perceptible by the human body itself.

The waves of endometrial peristalsis play important roles in normal reproductive function regulation and embryo implantation, such as sperm transport, embryo implantation and maintenance of pregnancy. In addition, in the currently prevailing assisted reproduction techniques, waves of endometrial peristalsis affect endometrial receptivity and thus implantation of the embryo. Therefore, the method has important significance for analyzing the endometrial peristalsis waves and carrying out intervention treatment on abnormal conditions of the endometrial peristalsis waves and improving the clinical pregnancy rate.

The onset of endometrial peristaltic waves may be associated with secretory modulation of sympathetic/parasympathetic nerves, estrogens, progestins, prostaglandins, oxytocin, and the like. The frequency, direction and amplitude of the endometrial peristalsis waves present different characteristics at different periods along with the growth and ovulation of the follicles. The direction of the endometrial peristaltic waves is generally divided into 5 types: first, from cervix to fundus wave; second, from the fundus to the cervical wave; third, the opposite waves emitted from the uterine fundus and the cervix simultaneously; fourthly, random waves with uncertain directions; and fifthly, no movement.

For example, the menstrual period usually shows reverse movement (peristaltic wave from the uterine fundus to the cervix) to facilitate the discharge of menstrual blood; in the follicular stage, along with the growth of the follicle, the frequency, speed and amplitude of the positive movement (peristaltic wave from the cervix to the fundus) are gradually increased, which is beneficial to the rapid delivery of the sperms in the female reproductive tract, the fertilization and the peak before ovulation; the appearance of a phase shift (simultaneous wave of opposite direction from the cervix and fundus) in the early luteal phase (post-ovulatory phase) helps to prevent the embryo from exiting the cervix or fallopian tube, facilitating implantation of the embryo. Meanwhile, the movement mode can cause the liquid in the uterine cavity to flow, and provide necessary nutrition and oxygen for the embryo before implantation; at the late luteal phase (late post-ovulation) the endometrium peristalsis is less and less, providing a quiet environment for embryo implantation.

There are many kinds of abnormal uterine intimal peristalsis which may occur, and no complete theoretical system is established at present, and the specific mechanism is not clear at present. Such as uterine pathologies such as endometriosis, adenomyosis, uterine fibroids, congenital uterine malformations, etc., may also cause abnormal endometrial motility. Abnormal endometrial motility can affect the normal transport of sperm or embryo implantation, resulting in infertility. Further studies have shown that endometrium peristaltic waves during assisted reproductive procedures have a significant effect on pregnancy outcome of assisted pregnancy in test tube infants. For example, one of the reasons that the implantation of the embryo is influenced when the frequency of the endometrial peristalsis waves is increased, it is found that the frequency of the endometrial peristalsis waves of a patient with repeated implantation failure is positively correlated with the number of transplantation cycles, and for example, the frequency of the endometrial peristalsis waves of a female with uterine fibroids infertility is higher than the normal range in the middle luteal stage. One theory of research is that fibroids produce aromatase, which results in increased estrogen production, causing increased frequency of endometrial peristaltic waves, resulting in abnormal uterine wave peristaltic waves, resulting in infertility or infertility.

Therefore, in clinic, the addition of progesterone, phloroglucinol and atosiban can promote embryo implantation by effectively inhibiting endometrial peristalsis, increase embryo planting rate and pregnancy rate and reduce abortion rate, thereby improving the success rate of assisted reproductive therapy, and particularly having obvious effect on patients who have repeated implantation failure. The vaginal progesterone can obviously reduce the peristalsis frequency of endometrium, and the reduction of the peristalsis wave frequency can improve the receptivity of endometrium when blastocyst is transferred, thereby being beneficial to embryo implantation. For patients with uterine lesions, problems can be found early by checking the peristaltic waves of endometrium, medicine or operation pretreatment is carried out before entering an auxiliary reproductive treatment cycle or temporary flow suspension and embryo freezing are suggested, and transplantation is carried out after the problems are solved, so that the treatment success rate is ensured, the failure risk is reduced, the cost of the patients is saved, and the pain born by the patients is reduced. For example, for a female who has hysteromyoma but is not pregnant, the frequency of endometrial peristaltic waves can be reduced after the hysteromyoma is stripped in advance, so that the pregnancy rate is improved.

Uterine contractions were first evaluated by measuring the pressure within the uterine cavity. For example, a miniature pressure sensor is placed in a uterine cavity or a micro catheter for pre-flushing liquid is placed in the uterine cavity and connected with pressure detection equipment outside the body, so that the pressure in the uterine cavity is measured, and the contraction of the uterus is evaluated.

The vaginal ultrasound can observe the peristalsis frequency, direction and the like of endometrium, has obvious advantages in the aspects of repeatability and operability, and is the most commonly used detection method in clinic at present. The method has the biggest defects that a video analyst possibly has certain subjectivity, and the subjective error can be reduced by averaging the results of 2-3 video analysts, wherein the method comprises the steps of recording the creeping phenomenon of the endometrium for 3-5 min by using a vaginal ultrasonic probe, and accelerating the playing of videos by using video processing software to analyze the frequency and the direction of EPW. Development of automatic detection and analysis equipment may be more accurate and is expected to solve this problem in the future.

In addition EPW were evaluated by magnetic resonance imaging (Cine-MRI). The direction and frequency of the peristaltic wave can be observed from the sagittal and coronal planes, with the advantage of observing the contractions of the entire uterus, including the endometrium, the muscular layer, the disadvantage of not being able to detect the amplitude of the peristaltic wave, and with the expense, time-consuming and relatively complex operation.

There is also uterine myoelectricity (EHG) signal monitoring technology. The contraction of the muscles is triggered by electrical activity spontaneously generated at the cellular level in the form of action potentials, electrodes can be placed on the surface of the abdomen of a pregnant woman, and the electrical activity of the uterus of the pregnancy detected from the body surface of the pregnant woman is mainly used for monitoring uterine contractions. The goal of monitoring is generally the involvement of high-intensity uterine contractions of the whole muscle layer, which may be generally sensed, such as contractions that progress with labor, but are not detected or identified for fine, weak endometrial movements.

In summary, there are various limitations and problems in many current methods for detecting endometrial peristalsis waves, which make them not be well popularized and applied clinically, such as:

at present, methods based on detecting intrauterine pressure or transvaginal ultrasound generally need to adopt a handheld design, a probe is arranged at the front end of a handle and can penetrate into a vagina or a uterine cavity for measurement, a cable is connected to an external host, and the external host can be a computer or specially-made control equipment. The equipment for carrying out such tests is generally cumbersome, time consuming, relatively complex to operate and inconvenient to use.

Based on other types of technologies, such as a magnetic resonance imaging technology (Cine-MRI), the used equipment is very expensive and heavy, the use cost is very high, and a small number of 1 or several hospitals and clinics cannot meet the detection requirements of many people.

Currently available devices based on uterine myoelectric (EHG) signals cannot detect or identify fine and weak endometrial peristaltic waves in the uterus.

Testing in this manner requires a greater fit of the patient during the measurement, such as a visit to a hospital or clinic at the time of examination; a certain posture needs to be kept during the examination, and a large action cannot be performed; the above-mentioned detection can only be implemented in a short time (during measurement), single-time and "snapshot" examination, and if the examination result needs to be updated, the patient needs to go to the hospital and clinic again for repeated visit.

Formally, due to the 'snapshot' attribute, it is difficult to establish the long-term history information of the patient, and it is impossible to track the long-term change of the endometrial peristalsis wave of the patient or track the treatment condition of the patient.

At present, many methods for detecting endometrial peristalsis waves are based on visual information acquisition and analysis, and certain subjective types and human errors may exist.

The need to reuse the same examination apparatus between different patients presents a problem of physiological contamination between patients, and therefore a higher demand for sterilization of the apparatus.

For some devices that require vaginal and intrauterine testing, the use may cause discomfort to the patient and even some injury to the patient. For example, the vagina or cervix may be dilated to a desired size for testing, and the probe may be inserted, which may cause damage to the vagina or cervix, endometrium, or other location of the patient, causing discomfort or inflammation to the patient. In addition, the vagina or cervix may be kept in an expanded state during the examination, which may cause discomfort to the patient.

Disclosure of Invention

Therefore, the invention provides a device for detecting the endometrial peristaltic waves, which solves the problems in the prior art.

In order to achieve the above purpose, the invention provides the following technical scheme:

according to a first aspect of the invention, the device for detecting the endometrial wriggle waves comprises a main trunk, branches, an electrode array and a drug slow-release array, wherein the branches are arranged on the main trunk, the electrode array is arranged on the main trunk and the branches, and the drug slow-release array is arranged on the main trunk.

Further, the electrode array comprises a measuring electrode and a reference electrode, branch stems are arranged on two sides of the trunk, the measuring electrodes are arranged on two surfaces of the branch stems, and the reference electrode is arranged at the end of the trunk.

Furthermore, the electrode array also comprises treatment electrodes, and the two surfaces of the trunk and the two surfaces of the branches are provided with the treatment electrodes.

Furthermore, the drug sustained-release array comprises a plurality of sustained-release units which are all arranged on the surface of the trunk.

Furthermore, the medicine slow-release unit comprises a switch and a medicine storage unit, the switch is electrically connected with the medicine storage unit, and the medicine slow-release unit and the switch are both arranged on the surface of the trunk.

Further, still include the bulge, the one end of trunk is provided with the bulge, and the reference electrode sets up in the surface of bulge.

Further, still include the lantern ring, the bulge deviates from the one end of trunk and sets up the lantern ring.

Furthermore, the novel fiber-reinforced plastic sleeve also comprises a tail fiber, and the tail fiber is arranged on the sleeve ring in a penetrating way.

Furthermore, the telescopic type clothes hanger further comprises a pull rope and a sleeve piece, wherein the sleeve piece is sleeved on the protruding portion, one end of the pull rope is connected with the branch stem, and the other end of the pull rope penetrates through the sleeve piece and can slide relative to the sleeve piece.

In a second aspect of the invention, a method for using an apparatus for detecting endometrial peristalsis waves is provided, the apparatus for detecting endometrial peristalsis waves in the first aspect of the invention comprises the following steps:

s100, loading the equipment into a placer, and compressing and folding the branches;

step S200, using a placer to place the equipment into the uterus;

s300, observing a detection signal output by the electrode array, and judging the condition of endometrial peristalsis;

step S400, confirming the treatment or nursing mode adopted by the patient;

step S500, carrying out drug slow-release treatment on a patient and/or carrying out bioelectric stimulation treatment by using a treatment electrode;

step S600, repeating the steps S300 to S500;

and step S700, when the detection and treatment process is finished, taking out the equipment.

The invention has the following advantages: the device realizes the measurement of the endometrial peristaltic waves and the treatment of endometrium by arranging the electrode array and the drug slow-release array; in addition, the device has the following advantages that the technical scheme of the invention realizes a measuring and analyzing method of the uterine peristalsis wave based on the measurement of uterine myoelectric signals (based on a sensor matrix) in the uterus. Different from various detection methods and devices (such as transvaginal ultrasound, nuclear magnetic resonance devices and the like) which are commonly used at present, the device is smaller and more convenient to use, and provides possibility for long-term and continuous monitoring.

Firstly, the invention realizes the fully-implanted intrauterine device, can continuously monitor and analyze the endometrial peristalsis waves in a human body after being implanted, and does not need to stay in a hospital or clinic when a patient is detected. Meanwhile, during detection, the patient does not need to keep a certain posture and can not have larger actions, and after implantation is completed, the patient can recover to normal daily activities.

Secondly, the present invention achieves a one-time implantation, continuous measurement mode of operation without the need for frequent probe insertion, minimizing potential damage to the vagina, cervix, endometrium or other parts. In addition, the problem of continuous discomfort brought to the patient during detection can be avoided.

Thirdly, based on the intrauterine matrix type electromyography sensor, the sensor can sense and measure various parameter properties of the endometrial peristalsis wave, such as frequency, direction, amplitude, intrauterine distribution condition, peristalsis wave propagation characteristics and the like.

Fourthly, by using the implanted endometrial peristalsis wave detection device, the reproductive health condition of the user can be evaluated through a corresponding algorithm based on the sensed and collected multiple endometrial peristalsis wave parameter data, so as to guide possible conditioning or assisted reproductive treatment.

Fifth, the equipment of the invention is special for special persons, and the condition of repeated use by multiple persons does not exist, thereby avoiding the problems of physiological pollution among multiple persons and additional disinfection of the equipment.

Sixth, the apparatus of the present invention does not require an ultrasonic unit or an element for nuclear magnetic resonance, so that the cost can be greatly reduced. Because the equipment cost is reduced, the use method is simple and convenient, and the condition of personnel reuse does not exist, the use cost is lower, and the patient can accept the equipment more easily.

Seventh, the drug sustained release module of the present invention can achieve sustained drug release in vivo, and provide sustained conditioning and treatment for patients. In addition, the treatment effect can be continuously tracked while the treatment is carried out, and closed loops of examination, treatment and treatment effect tracking are really realized.

Drawings

In order 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 described below. It should be apparent that the drawings in the following description are merely exemplary, and that other embodiments can be derived from the drawings provided by those of ordinary skill in the art without inventive effort.

The structures, ratios, sizes, and the like shown in the present specification are only used for matching with the contents disclosed in the specification, so as to be understood and read by those skilled in the art, and are not used to limit the conditions that the present invention can be implemented, so that the present invention has no technical significance, and any structural modifications, changes in the ratio relationship, or adjustments of the sizes, without affecting the effects and the achievable by the present invention, should still fall within the range that the technical contents disclosed in the present invention can cover.

Fig. 1 is a front view of a schematic diagram of a first structure of an endometrial peristalsis wave detection device according to some embodiments of the present invention.

Fig. 2 is a side view of a first structural schematic diagram of an endometrial peristalsis wave detection device according to some embodiments of the present invention.

Fig. 3 is a front view of a second structural schematic diagram of an endometrial peristalsis wave detection device according to some embodiments of the present invention.

FIG. 4 is a side view of a second structural schematic of an endometrial peristalsis wave detection device according to some embodiments of the present invention.

Fig. 5 is a schematic diagram of a third structure of an apparatus for detecting endometrial peristalsis according to some embodiments of the present invention.

Fig. 6 is a schematic structural view of an endometrial peristalsis wave detection device arranged in an placer according to some embodiments of the present invention.

Fig. 7 is a schematic circuit diagram of an endometrial peristalsis wave detection device according to some embodiments of the present invention.

Figure 8 is a schematic view of a device for endometrial peristaltic wave detection placed within a uterus according to some embodiments of the present invention.

FIG. 9 is a graph showing a distribution of peristaltic waves at a first time in an analog representation of a data matrix of an apparatus for endometrial peristalsis detection according to some embodiments of the present invention.

FIG. 10 is a graph of a distribution of peristaltic waves at a second time in an analog representation of a data matrix of an apparatus for endometrial peristalsis detection according to some embodiments of the present invention.

FIG. 11 is a distribution diagram of peristaltic waves at a third time of an analog representation of a data matrix of an apparatus for endometrial peristalsis detection according to some embodiments of the present invention.

In the figure: 1. a main body, 2, a branch, 3, a measuring electrode, 4, a therapeutic electrode, 5, a bulge, 6, a reference electrode, 7, a drug slow-release array, 8, a lantern ring, 9, a tail, 10, a main board, 11, a switch, 12, a drug storage unit, 13, a power supply device, 14, a film layer, 15, a pull rope, 16, a placer, 17, a push rod, 18, an electrode array, 19, a multiplexer, 20, a signal conditioning device, 21, a filter, 22, a variable gain amplifier, 23, an analog-digital converter, 24, a power management module, 25, a wireless module, 26, a central processing unit, 27, a drug slow-release driving unit, 28, a drug slow-release control module, 29, a digital-analog converter, 30, an output signal modulation conditioning module, 31, an analog signal driving module, 32, a multiplexer and state keeper, 33 and a kit, 34. a first sub-branch, 35, a second sub-branch, 36, a third sub-branch, 37, a fourth sub-branch, 38 and a fifth sub-branch.

Detailed Description

The present invention is described in terms of particular embodiments, other advantages and features of the invention will become apparent to those skilled in the art from the following disclosure, and it is to be understood that the described embodiments are merely exemplary of the invention and that it is not intended to limit the invention to the particular embodiments disclosed. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1

As shown in fig. 1 to 5, an apparatus for detecting endometrial peristaltic waves in an embodiment of the first aspect of the present invention includes a main trunk 1, branches 2, an electrode array 18, and a drug sustained-release array 7, where the main trunk 1 is provided with the branches 2, the main trunk 1 and the branches 2 are both provided with the electrode array 18, and the main trunk 1 is further provided with the drug sustained-release array 7.

In the above embodiment, 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, two sides of the main trunk 1 are sequentially provided with 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 from top to bottom, and the length of the first sub-branch 34, the length of the second sub-branch 35, the length of the third sub-branch 36, the length of the fourth sub-branch 37, and the length of the fifth sub-branch 38 are sequentially reduced from top to bottom; the shape formed by the main trunk 1 and the branch trunk 2 is similar to the shape of a fishbone; in addition, the main trunk 1 and the branch trunk 2 are made of flexible plastics such as polyethylene, polytetrafluoroethylene or silicon rubber, are soft, have certain elasticity and toughness, have good insulating and waterproof properties, and are of a medical grade, namely have good safety and biocompatibility.

Preferably, the two sides of the trunk 1 are further provided with a thin film layer 14, the two surfaces of the thin film layer 14 are both provided with electrode arrays 18, and the first sub-branch 34 and the second sub-branch 35 are connected through the thin film layer 14, 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 connected through the thin film layer 35.

The technical effects achieved by the above embodiment are as follows: the device realizes the measurement of the uterine endometrium peristaltic wave and the treatment of the uterine endometrium by the arrangement of the electrode array 18 and the drug slow-release array 7.

Optionally, as shown in fig. 1 to 5, in some embodiments, the electrode array 18 includes a measuring electrode 3 and a reference electrode 6, the trunk 1 is provided with the branches 2 on both sides, the trunk 1 is provided with the measuring electrode 3 on both surfaces, the branches 2 are provided with the measuring electrode 3 on both surfaces, and the trunk 1 is provided with the reference electrode 6 at an end portion.

In the alternative embodiment described above, it should be noted that the reference electrode is positioned adjacent the cervix when the device is placed in the uterus.

The beneficial effects of the above alternative embodiment are: the cervical region contains the least smooth muscle tissue, and is therefore considered to be the most neutral position having the biopotential, and is the most suitable position for the reference biopotential, and the myoelectric measurement function is realized by the reference electrode 6 in cooperation with the measurement electrode 3.

Optionally, as shown in fig. 1 to 5, in some embodiments, the electrode array 18 further includes a treatment electrode 4, and the treatment electrodes 4 are disposed on both surfaces of the trunk 1 and both surfaces of the branch 2.

The beneficial effects of the above alternative embodiment are: the therapeutic electrode 4 and the reference electrode 6 are matched to realize the electromyographic therapy function through the arrangement of the therapeutic electrode 4.

Optionally, as shown in fig. 1 to fig. 3, in some embodiments, 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 trunk 1.

Optionally, as shown in fig. 1 to 5, in some embodiments, the drug 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, and both the drug sustained-release unit and the switch 11 are disposed on the surface of the trunk 1.

In the above alternative embodiment, it should be noted that the slow release drug is disposed in the drug storage unit 12, and the switches 11 are connected to the drug storage unit 12 in a one-to-one correspondence manner.

Preferably, as shown in fig. 7, the mobile phone further includes a main board 10 and a power supply device 13, where the power supply device 13 is a battery or a wireless charging module and a charging coil, the power supply device 13 and the main board 10 are both disposed in the main body 1, the electrode array 18, the switch 11 and the power supply device 13 are all electrically connected to the main board 10, and a circuit module is disposed on the main board 10, and the circuit module 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 slow-release driving unit 27, a drug slow-release control module 28, a digital-to-analog converter 29, an output signal modulation conditioning module 30, an analog signal driving module 31 and a multiplexer and state holder 32. The beneficial effects of the above alternative embodiment are: the quantity of the slow release units which are switched on or off is controlled by the arrangement of the switch 11, so that the slow and fast control of the slow release of the medicine is realized; in addition, the drug can be selectively released at different positions by controlling the opening position of the release unit.

Optionally, as shown in fig. 1 to 5, in some embodiments, the liquid crystal display further includes a protrusion 5, the protrusion 5 is disposed at one end of the stem 1, and the reference electrode 6 is disposed on a surface of the protrusion 5.

In the above alternative embodiment, it should be noted that the protrusion 5 is made of flexible plastic.

Optionally, as shown in fig. 1 to 5, in some embodiments, a collar 8 is further included, and the collar 8 is disposed at an end of the protrusion 5 facing away from the trunk 1.

In the above alternative embodiment, it should be noted that the collar 8 is a circular ring, and further comprises an placer 16, a push rod 17 is arranged in the placer 16, the device is placed in the placer 16, and the device is fixed in the uterus by the push rod 17; specifically, when the device is implanted, the implanted device is placed in the placer 16, and after the device has been introduced into the body, the device is released and secured in the uterus by the pusher 17.

The beneficial effects of the above alternative embodiment are: the extraction of the device after implantation is achieved by inserting a rubber rope or the like on the collar 8 through the arrangement of the collar 8.

Optionally, as shown in fig. 1 to 5, in some embodiments, the fiber optic cable further includes a tail fiber 9, and the tail fiber 9 is threaded through the collar 8.

In the above alternative embodiment, it should be noted that the tail fiber 9 is a nylon thread or a rubber rope.

The beneficial effects of the above alternative embodiment are: the device is convenient to take out after being implanted through the arrangement of the tail fiber 9.

Optionally, as shown in fig. 1 to 5, in some embodiments, the device further includes a pulling rope 15 and a sleeve 33, the sleeve 33 is sleeved on the protrusion 5, one end of the pulling rope 15 is connected to the stem 2, and the other end of the pulling rope 15 passes through the sleeve 33 and is slidable relative to the sleeve 33 relative to the pulling rope 15.

In the above alternative embodiment, it should be noted that there are a plurality of pulling ropes 15, and the pulling ropes 15 are connected to the end of the branch 2 away from the trunk 1; the sleeve 33 may be a sleeve or a rope; in addition, a groove is provided at the projection 5.

The beneficial effects of the above alternative embodiment are: through the matching arrangement of the pull rope 15 and the sleeve 33, when the device needs to be taken out after being implanted into the uterus, the pull rope 15 can fold the branch rod 2, so that the operation of taking out the device after being implanted into the uterus is further facilitated; all the pull cords 15 are tied together by the sleeve 33 cooperating with the groove at the protrusion 5, ensuring a pulling effect.

Example 2

The use method of the device for detecting the endometrial peristalsis waves in the second aspect of the invention uses the device for detecting the endometrial peristalsis waves in the first aspect of the invention, and comprises the following steps:

s100, loading the equipment into a placer, and compressing and folding the branch 2;

step S200, using a placer to place the equipment into the uterus;

step S300, observing a detection signal output by the electrode array 18, and judging the condition of endometrial peristalsis;

step S400, confirming the treatment or nursing mode adopted by the patient;

step S500, carrying out drug slow-release treatment on a patient and/or carrying out biological electrical stimulation treatment by using a treatment electrode 4;

step S600, repeating the steps S300 to S500;

and step S700, when the detection and treatment process is finished, taking out the equipment.

Example 3

As shown in fig. 1 to 11, a third convenient embodiment of the present invention includes all the technical features of embodiments 1 and 2, specifically, the branches 2 are distributed on both sides of the trunk 1, and the trunk 1 and the branches 2 are made of medical grade flexible plastics, such as polyethylene, polytetrafluoroethylene or silicone rubber, which are flexible, have certain elasticity and toughness, and have good insulating and waterproof properties, i.e., good safety and biocompatibility. Electrode arrays 18 are distributed at the tail ends of the branches 2, namely at the two ends and the middle part of the trunk 1, and the two surfaces of the trunk 1 and the two surfaces of the branches 2 are both provided with the electrode arrays 18 and are distributed uniformly. The electrode array 18 comprises a measuring electrode 3 and a treatment electrode 4 with a bulge 5 at the bottom of the trunk 1, which bulge 5 will be in a position closer to the ionic cervix after implantation in the uterus. On the projecting part 5, a reference electrode 6 is arranged at the position deviated to the tail end to match the measuring electrode 3 and the therapeutic electrode 4 to realize the electromyography and therapy functions. The position of the reference electrode 6 is located close to the cervix, which contains the least smooth muscle tissue and is therefore considered to be the most neutral position with biopotential, the position most suitable as the reference biopotential. The surface of one side of the main body 1 is provided with a drug slow release array 7, the drug slow release array 7 is composed of a plurality of slow release units which can be controlled independently, and the slow and fast of drug slow release is controlled by controlling the number of the slow release units which are switched on or switched off. Each unit consists of a drug release control mechanism, i.e. a switch 11, and a drug storage unit 12. At the end of the protrusion 5 a ring or collar 8 is designed for fixation of a tail wire 9, which may be a nylon thread 9 for removal of the device after implantation.

Various electronic modules are packaged in the main body, and compared with the main board 10, various detection circuits and control circuits are realized. A plurality of switches 11 are designed on the main board 10, and each switch 11 is connected with one drug storage unit 12, so that the operation of controlling the start or the turn-off of the drug storage unit is realized. The main board 10 is connected to all the electrodes, including the reference electrode 6, the respective measuring electrodes 3 and the therapy electrodes 4, by means of a flexible PCB or thin wire, while the main board 10 and the connecting portion of the flexible PCB or thin wire are encapsulated in an outer material, with only the electrode portions exposed to the external environment. Furthermore, there is the energy required by the power supply 13 to supply the motherboard 10. According to different usage scenarios, the power supply device 13 can be a battery or a wireless charging module and a charging coil, if necessary.

As shown in fig. 5, a thin film layer 14 is provided between a plurality of branches 2 on both sides of a trunk 1, the thin film layer 14 is a flexible thin film, and electrode arrays 18 are arranged on the thin film layer 14.

The implantation mode of the device can be implanted into the uterus of a human body in a similar mode of implanting the intrauterine device, and the device continuously works in the uterine cavity. Specifically, upon implantation, an applicator 16 similar to that used with a uterine contraceptive ring is used for placement, as shown in FIG. 6. When the device is loaded into the front of the presenter 16, the limbs 2 on either side of the spine 1 may be compressed to close against the spine 1. The film layer 14 may also be folded together when the stems 2 are compressed and collapsed. Since the materials used for the stem 2 and the film layer 14 are soft and flexible, the flexible PCB or the thin wires therein can be protected from being torn or broken when being folded, and the electrode array 18 is not damaged. In addition, the flexible PCB or the thin wire can also be a snake-shaped routing bending curve, and the acting force applied when the flexible PCB or the thin wire is folded can be effectively dispersed, so that the flexible PCB or the thin wire is protected from being damaged. 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.

When the device is released from the placer 16 and correctly placed in the uterus, the branch 2 will slowly expand and return to the free state due to the lack of restraint of the front end of the placer 16 and due to its own elasticity. By virtue of its particular shape, it is ensured that the device is held firmly and properly within the uterine cavity, and by virtue of the arrangement of the electrode array 18, the occurrence of endometrial peristaltic waves in different regions of the uterus can be detected.

Similarly, the device is also removed using a removal method similar to that of a uterine contraceptive ring. The doctor or the clinical specialist can open the vagina with the speculum, wipe off the accumulated fluid in the vagina and expose the cervix, after disinfecting the cervix, if necessary, the cervix can be clamped by cervical forceps to adjust the angle by clamping the front lip or the rear lip of the cervix, then the tail wire 9 is clamped by the forceps, and the tail wire is carefully pulled, so that the device is taken out.

In addition, the electrode arrays 18 are all connected to a plurality of channels of the multiplexer in the main control circuit board, a certain signal is selected from the plurality of analog signals, and then the selected signal enters the signal conditioning module for signal conditioning. The conditioning step may include analog signal primary amplification, dc component extraction and isolation, and the like. The conditioned analog signal enters a filter network for centralized filtering processing, and the filter network can be configured to realize the combination of various filters, such as low pass, high pass, band pass and notch. For example, the signal of the typical human endometrial peristalsis wave adopts a filtering frequency band of 0.34Hz to 1Hz, so as to avoid the interference from the signal generated by cardiopulmonary activity and the like and the interference induced in the external environment. In order to ensure that more signal characteristics and information are collected during actual system design, a filtering band of 0.05Hz to 5Hz may be used.

The conditioned and filtered signal can be further amplified by a first-stage variable gain amplifier before entering the analog-digital converter, so that the analog signal can be better suitable for the input range of the analog-digital converter. The analog-to-digital converter can convert the analog signal into digital information to be sent to the central processor. The central processing unit can realize the detection function of the peristaltic waves by realizing various data analysis and processing algorithms. The original data, the processed data and the analysis result can be sent to an upper computer through a wireless module, or a cloud server is used for storing or further analyzing and processing.

If the patient needs to be treated and nursed through the confirmation of clinical experts, the device provides two treatment possibilities, including drug slow-release treatment and bioelectric stimulation treatment through the treatment electrode. When the medicine slow-release treatment is needed, the central processing unit can be confirmed by clinical experts according to a preset treatment scheme, selectively controls the medicine slow-release control module and drives the medicine slow-release control unit, and then the opening or closing of the medicine storage unit is realized. The drug storage unit may be pre-loaded with certain therapeutic drugs, such as progesterone, phloroglucinol, atosiban, and the like. The rate control of the slow release of the medicine is realized by controlling the opening number of the medicine storage units. When bioelectric stimulation treatment is needed to intervene in the endometrial peristalsis waves, the central processing unit applies specific and preset electric signal waveforms to certain specific treatment electrodes according to preset treatment schemes and confirmed by clinical experts to perform intervention treatment. Specifically, the central processing unit converts the digital data of the desired electrical signal waveform into an analog signal through a digital-to-analog converter, further optimizes the analog signal by modulating and conditioning the output signal, and then enters the driving circuit. The drive circuit can provide certain current output capability so as to realize the purpose of treatment. The signals from the drive circuit may be multiplexed and the status keeper selectively applied to a particular treatment electrode to effect treatment at a particular location within the uterus.

In addition, a power management module is arranged on the main control circuit board to realize stable power supply of each functional module and switching of various low power consumption modes.

Based on the intrauterine matrix type electromyography sensor, electromyography parameter data of the measured endometrial peristalsis waves can be sensed from each measuring electrode, and a planar distribution diagram of the endometrial peristalsis waves in the uterus can be obtained by placing each datum into a data matrix according to the position relation of the electrode. Because the electrode array is not a regular rectangular array, the cells without the electrodes can be filled by averaging the data of the adjacent cells of the matrix, and a complete digital matrix is obtained. The above process is then repeated for data at different times to obtain a plurality of digital matrices, and if arranged in chronological order, the variation of the distribution of the intrauterine peristaltic waves can be obtained, as shown in a simulation of figures 9, 10 and 11.

Through further analysis of the data, various parameter properties of the peristaltic waves can be obtained, such as frequency, direction, amplitude, intrauterine distribution, propagation direction of the peristaltic waves, propagation speed of the peristaltic waves, source positions of the occurrence of the peristaltic waves, types of the peristaltic waves and the like. For example, when the source position and the propagation direction of the peristaltic wave are known, five types of the endometrial peristaltic waves can be matched: first, from cervix to fundus wave CF; second, from the fundus to the cervical wave FC; thirdly, opposite waves OP emitted from the uterine fundus and the cervix simultaneously; and fourthly, random waves R with uncertain directions. Fifth, no motion N. Then, according to the occurrence time, frequency, amplitude and the like of different types of peristaltic waves, the data in the same menstrual cycle stage in the literature can be compared, and whether the peristaltic waves in the stage are abnormal or not can be judged and known, so that the method can be used as one of the evaluation standards of the reproductive health state of the patient.

Although the invention has been described in detail above with reference to a general description and specific examples, it will be apparent to one skilled in the art that modifications or improvements may be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.

In the present specification, the terms "upper", "lower", "left", "right", "middle", and the like are used for clarity of description, and are not intended to limit the scope of the present invention, and changes or modifications in the relative relationship may be made without substantial changes in the technical content.

Claims (10)

1. The utility model provides an equipment that endometrium wriggling ripples detects, its characterized in that, includes trunk (1), branch trunk (2), electrode array (18) and medicine sustained release array (7), be provided with on trunk (1) branch trunk (2), trunk (1) reaches all be provided with on branch trunk (2) electrode array (18), still be provided with on trunk (1) medicine sustained release array (7).

2. An endometrium peristaltic wave detection device according to claim 1, wherein the electrode array (18) comprises a measuring electrode (3) and a reference electrode (6), the branches (2) are arranged on both sides of the trunk (1), the measuring electrode (3) is arranged on both surfaces of the branches (2), and the reference electrode (6) is arranged at the end of the trunk (1).

3. An endometrial wave detection device according to claim 2, characterized in that said electrode array (18) further comprises treatment electrodes (4), both surfaces of said stem (1) and both surfaces of said stem (2) being provided with said treatment electrodes (4).

4. An endometrial peristaltic wave detection device according to claim 1, characterized in that said drug release array (7) comprises a plurality of release units, and said plurality of release units are all arranged on the surface of said stem (1).

5. An endometrial peristaltic wave detection device according to claim 4, characterized in that said drug slow release unit comprises a switch (11) and a drug storage unit (12), said switch (11) is electrically connected with said drug storage unit (12), and both said drug slow release unit and said switch (11) are arranged on the surface of said main body (1).

6. An endometrial peristaltic wave detection device according to claim 2, characterized in that the device further comprises a protrusion (5), the protrusion (5) is arranged at one end of the stem (1), and the reference electrode (6) is arranged on the surface of the protrusion (5).

7. An endometrial wave detection device according to claim 6, characterized in that it further comprises a collar (8), said collar (8) being arranged at the end of the protrusion (5) facing away from the main stem (1).

8. An endometrium peristaltic wave detection device according to claim 7, further comprising a tail (9), wherein the tail (9) is threaded through the collar (8).

9. An endometrium peristaltic wave detection device according to claim 6, further comprising a pull rope (15) and a sleeve member (33), wherein the sleeve member (33) is sleeved on the protruding part (5), one end of the pull rope (15) is connected with the stem (2), and the other end of the pull rope (15) passes through the sleeve member (33) and is slidable relative to the pull rope (15) relative to the sleeve member (33).

10. Method of use of an apparatus for the detection of intrauterine peristaltic waves, using an apparatus for the measurement of intrauterine peristaltic waves according to claims 1 to 9, characterized in that it comprises the following steps:

s100, loading the equipment into a placer, and compressing and folding the branch stem (2);

step S200, using a placer to place the equipment into the uterus;

step S300, observing a detection signal output by the electrode array (18) and judging the condition of endometrial peristalsis;

step S400, confirming the treatment or nursing mode adopted by the patient;

step S500, carrying out drug slow-release treatment on a patient and/or carrying out bioelectric stimulation treatment by using a treatment electrode (4);

step S600, repeating the step S300 to the step S500;

and step S700, when the detection and treatment process is finished, taking out the equipment.

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