CN110786873A

CN110786873A - Device for detecting displacement and clinical characteristics of pelvic floor organ

Info

Publication number: CN110786873A
Application number: CN201911198603.6A
Authority: CN
Inventors: 李建民; 李根云; 李成成
Original assignee: Suzhou Youmai Medical Devices Co
Current assignee: Suzhou Youmai Medical Devices Co
Priority date: 2019-11-29
Filing date: 2019-11-29
Publication date: 2020-02-14

Abstract

The invention discloses a detection device for pelvic floor organ displacement and clinical characteristics, which comprises a pressure balloon capable of being inflated and deflated, a pressure reading instrument, a microprocessor and a display unit, wherein the pressure balloon is a flexible strip-shaped hollow elastic body, the strength of an air support meets the requirement of shape keeping, at least two detection balloon cavities are distributed in the pressure balloon, the inflation unit is connected with the pressure balloon to be controlled to inflate and deflate, and sub-channels of a pressure reading meter are connected into the detection balloon cavities and feed back the dynamic change of the pressure of the detection balloon cavities. The pressure size and the pressure change state of the corresponding position can be used as the evaluation basis of the normal anatomical position and clinical characteristics of the organ. The portable device can enter a human body to realize functions without damage, forms a local or integral pressure distribution model of an organ through pressure detection of controllable point positions, and then obtains a physical examination evaluation report or a medical judgment basis, and has the advantages of small pain, convenience in operation, high positioning precision, visual presentation of evaluation result data and the like.

Description

Device for detecting displacement and clinical characteristics of pelvic floor organ

Technical Field

The invention relates to a physiological evaluation device, in particular to a portable and easy-to-use device for evaluating and pathologically analyzing a urinary tract and other organs of a pelvic floor.

Background

Female Urinary Incontinence is a common disease in women, and the prevalence rate is close to 50% according to global statistics, wherein about half of the female Urinary Incontinence is Stress Incontinence (SUI). Stress incontinence means that when the bladder pressure is higher than the maximum urethral pressure, urine does not automatically overflow from the external orifice of the urethra under the state of no bladder detrusor contraction, and when the abdominal pressure suddenly increases, for example: laughing, sneezing, coughing, and the like. Postmenopausal populations are more susceptible to disease. The most causes of the diseases are birth injury during childbirth, postmenopausal estrogen level reduction, pelvic floor soft tissue relaxation and the like. SUI was beginning to be considered one of five major diseases affecting human health in the mid 90 s, called "social cancer". Especially in China, as the population further ages, SUI is more and more emphasized by people. The incidence of organ prolapse in the pelvic floor of middle-aged and elderly women is high, the development process and pathological cause of prolapse are not clear, and appropriate methods and devices for the systematic study of urinary incontinence and organ prolapse are urgently needed.

With the increasing of the daily life of people and the increasing crisis awareness of people, people pay more and more attention to periodic physical examination. The early pressure detection and detection of the pelvic floor organs such as bladder, vagina, uterus, rectum and the like so as to reliably care before the occurrence of pathological changes are effective means for prolonging the onset age. The prior art still has the defects of poor accuracy and repeatability in external manual finger-feel exploration or traumatic medical means for early detection and detection of the organs, and incapability of forming summarized data or a physiological state model which is easy to count and judge pathological disorder.

Disclosure of Invention

In view of the above-mentioned shortcomings in the prior art, the present invention aims to provide a device for detecting the displacement and clinical features of organs at the pelvic floor, so as to solve the problem of collecting physiological states of various organs at the pelvic floor in early physical examination.

The technical solution for achieving the above object of the present invention is a device for detecting pelvic floor organ displacement and clinical characteristics, characterized in that: the pressure sensing unit is at least a pressure balloon capable of inflating and deflating, the pressure balloon is a flexible strip-shaped hollow elastic body, the strength of an air support meets the requirement of keeping the shape of an implant and is attached to a detected organ, at least two detection balloon cavities are distributed on the pressure balloon, and the pressure reading instrument is connected into each detection balloon cavity through channels, is connected with a processor signal and feeds back pressure change. In particular, the detection device can be inserted into the body (e.g. in the vagina) for the purpose of detection corresponding to the anatomical site concerned, and after pressurization, the detection pockets on the sensing unit can be brought into close contact with the tissue surrounding them. In the detection process, the pressure of all the sensors is recorded along with the change of the body position of the patient, so that the three-dimensional change state of the detected organs, such as organs of the pelvic floor, is obtained. The clinical characteristics such as whether the organs around the vagina deviate from the normal anatomical position and the deviation degree can be detected through the pressure magnitude, the pressure change and the change process of the corresponding position.

Further, the device has a pressure balloon corresponding to the vagina, and the pressure balloon covers the cervix to the urethral opening in length.

Furthermore, the pressure balloon is provided with six detection sacs arranged in the length direction, wherein the first detection sac is suitable for being positioned at the cervix, the second detection sac and the third detection sac are suitable for being positioned at the bladder, and the fourth detection sac, the fifth detection sac and the sixth detection sac are suitable for being positioned at the urethra.

Further, the device is provided with a pressure balloon corresponding to the urinary tract and the rectum, the pressure balloon covers the vagina to the cervix in the length direction, and the pressure balloon is divided into a urinary bladder detection sac cavity and a rectal detection sac cavity through an axial diaphragm.

Furthermore, M sub-balloon cavities are formed in the urinary bladder detection balloon cavity in a partitioning mode along the length direction of the pressure balloon, N sub-balloon cavities are formed in the rectal detection balloon cavity in a partitioning mode along the length direction of the pressure balloon, and M, N are all natural numbers larger than 1.

Furthermore, the pressure balloon is provided with more than two split parts on the cross section perpendicular to the length direction, and the split parts extend along the length direction to form a detection balloon cavity.

Furthermore, the cross section of the pressure balloon perpendicular to the length direction is circular, the cross section is provided with six split parts which are uniformly split in the circumferential direction, and each split part is provided with more than two detection balloon cavities extending in the length direction.

Furthermore, eight split parts which are non-uniformly split in the circumferential direction are arranged on the cross section of the pressure balloon perpendicular to the length direction, and the split density of the split parts at the position close to the organ to be detected and the number of detection sac cavities arranged in an extending mode are larger than the same parameter configuration at the position far away from the organ to be detected.

Furthermore, the outer wall of the pressure balloon is provided with an X-ray visible positioning ring or mark, and the positioning ring or mark corresponds to the anatomical position of the organ to be detected.

Further, in the pressure sensing unit, the pressure balloon is provided with an integrally connected or detachably attached inflation tube.

Compared with the traditional medium for detection, the portable device provided by the invention has the outstanding substantive characteristics and remarkable progress: the portable device can enter a human body to realize functions without damage, forms a local or integral organ pressure distribution model through pressure detection of controllable point positions, then obtains a physical examination detection report or a medical judgment basis, and has the advantages of small pain, convenience in operation, high positioning precision, visual presentation of detection result data and the like.

Drawings

Fig. 1 is a schematic view of a preferred embodiment of the device of the present invention in use with a urinary tract.

FIG. 2 is a schematic diagram of another embodiment of a pressure bladder of the apparatus of the present invention.

Fig. 3 is a schematic structural view of another embodiment of a pressure bladder in the device of the present invention.

Detailed Description

The following detailed description of the embodiments of the present invention is provided in connection with the accompanying drawings for the purpose of understanding and controlling the technical solutions of the present invention, so as to define the protection scope of the present invention more clearly.

The designer of the invention carries out deep research aiming at the defects of the prior art that the early evaluation and detection of internal organs of the pelvic floor of a human body are still in the medical means of external force manual finger feeling exploration or traumatic property, the accuracy and the repeatability are poor, and the summarized data or physiological state model which is easy to count and judge pathological disorder can not be formed, summarizes the state and the physiological reaction of organ pathological changes, develops the idea to replace the operation of the traditional finger feeling exploration, and starts from the angle that the exploration result is visualized and digitalized, innovatively provides a portable device which is simple and easy to use and detects the displacement and the clinical characteristics of the pelvic floor organs, thereby solving the problem of early data acquisition of physical examination and pathological analysis.

From the outline characteristics of the technical scheme of the invention, the portable device for detecting the pelvic floor organ displacement and the clinical characteristics comprises a pressure sensing unit, a pressure reading instrument, a microprocessor and a display unit, wherein the pressure sensing unit is at least a pressure balloon which can be inflated and deflated, the pressure balloon is used as a main component for realizing evaluation and detection, the pressure balloon is a flexible strip-shaped hollow elastic body, the strength of an air support meets the requirement of a shape keeping insert body, and at least two detection balloon cavities are distributed in the pressure balloon. Firstly, the device has certain flexibility, and can not cause any damage to the inner wall of the channel when moving in the inner cavity of a human body; secondly, the inflatable bag has certain air supporting strength, and can be conveniently and easily pushed into a human body in an inner cavity filling state, and a pushing inlet is a non-operative wound; moreover, the design of a plurality of detection sacs enables the pressure acquisition to be distributed in a multi-point mode, so that the health state of internal organs in the pelvic floor can be mastered more accurately and comprehensively. As a necessary component, the inflation unit is connected with the pressure saccule for controlled inflation and deflation, when the inflation pressure reaches a certain value, the inlet and the outlet are closed, and then the pressure reading meter is connected into each detection saccule cavity in a channel manner and feeds back the pressure change. The inflation unit can be driven in an electric control mode or manually pressed by manpower, and the pressure increased by inflating the pressure balloon facing the pressure balloon is accurately controllable.

Of course, the pressure sensing unit is not limited to the pressure balloon, and other pressure electronic sensing devices, such as pressure-strain, electro-magnetic conversion sensors, etc., may be implemented.

In addition, the power supply, the circuit, the data collection and storage, the WiFi or Bluetooth devices and the microprocessor of the electronic equipment related to the vaginal pressure sensing can be placed in the middle of the 3D model of the vagina. The collected pressure signals can be transmitted into a signal collector carried by a patient or a mobile phone in real time through wireless communication, and the pressure detection device can be taken out intermittently and downloaded into a computer to perform 3D stress analysis on the surface of the vagina.

To more intuitively understand the functional implementation of the portable device of the present invention, reference is made to the state diagram of a preferred embodiment of the corresponding urinary tract application shown in fig. 1, which is described in detail below. As can be seen from the figure, the wire frame is a cross-sectional view of internal organs in the pelvic cavity 1 of the human body, and the wire frame includes the uterus 21, the bladder 22, and the urethra 23 for detecting the urinary tract. When physical examination is carried out, the female bladder and urethra are required to be judged whether to be in a normal anatomical position, the peripheral muscle relaxation degree of the female bladder and urethra and the clinical characteristics of stress urinary incontinence. Therefore, by detecting the applied pressure of the capsule cavity and the response degree of pressure change, detailed node pressure data can be acquired, so that reference evaluation is facilitated, clinical judgment is made, corresponding clinical treatment/prevention measures are made, and the like.

As shown in the figure, the pressure balloon 4 covers the cervix to the urethral opening in the longitudinal direction, and six detection lumens are arranged in the longitudinal direction. Specifically, wherein the first detection capsule 1 is adapted to be positioned at the cervix, the second detection capsule 42 and the third detection capsule 43 are adapted to be positioned at the bladder 22, and the fourth detection capsule 44, the fifth detection capsule 45 and the sixth detection capsule 46 are adapted to be positioned at the urethra 23. The manual inflation units 3 respectively inflate towards different detection sac cavities, so that the compressive strength of the bladder side wall and the peripheral muscles of the urethra on external pressure can be respectively positioned and grasped, and the compressive strength is fed back and presented to the pressure reading instrument 5 through a pressure data set. Therefore, the portable device realizes that the traditional empirical probing mode of the finger touch pressure is converted into a specific data result which can be obtained through an instrument, and becomes the basis for evaluation and pathological analysis of a follow-up doctor; the analysis of objective pressure data from the subjective experience is beneficial to forming more accurate diagnosis and treatment schemes by reference.

The pressure balloon is provided with six detection balloon cavities only in a preferable embodiment, and the application requirements of actual root detection objects can be increased and decreased in quantity and have a certain weight in distribution density.

As another embodiment, referring to fig. 1 and 2, the portable device has pressure balloons corresponding to the urinary tract and rectum. It can be seen from the illustration that the opposite side of the vagina and uterus 21 from bladder 22 is the rectum 24, and that such a pressure balloon as shown in figure 2 can be used when assessing and diagnosing prolapse of the uterus and rectum is desired. The pressure balloon covers the urethra to the cervix in the longitudinal direction, and the pressure balloon 4 is divided into a urethra-bladder detection sac 41a and a rectum detection sac 42a by an axial upper and lower diaphragm 49. When the pressure balloon 4 penetrates into the cervix through the vagina, the two detection balloon cavities are respectively pressurized and balanced through the inflation unit, and then the pressure data is read out and can be used for evaluation reference of the urinary tract and the rectum.

From the view of the length distribution of the pressure balloons, besides the detection of the prolapse of the uterus and the rectum, the physiological states of different positions of the rectum or different sections of the urinary tract can be further detected, and the two part detection balloons can be further provided with M, N sub-balloon cavities which are separated along the length direction, wherein M, N is a natural number which is more than 1. The number of the sub-capsule cavities arranged on the two parts can be the same or different, and the distribution density can be set dispersedly according to needs.

In addition to the two embodiments, the pressure balloon of the portable device can be further developed, namely, the portable device is used for probing into a body to acquire pressure data of the pressure balloon in all directions in the circumferential direction. For this purpose, the pressure balloon may be provided with two or more divided portions in a cross section perpendicular to the longitudinal direction, and the divided portions may extend in the longitudinal direction as a detection balloon cavity. Optional implementations include: the cross section of the pressure balloon perpendicular to the length direction is circular, six part parts which are uniformly divided in the circumferential direction are arranged on the cross section, more than two detection balloon cavities are arranged on each part in the length direction in an extending mode, namely at least 12 detection balloon cavities are distributed in the pressure balloon, and pressure data acquisition is carried out corresponding to different point positions respectively to form a detection result set. And (II) eight split parts which are non-uniformly split in the circumferential direction are arranged on the section of the pressure balloon perpendicular to the length direction, and the split density of the split parts at the position close to the organ to be detected and the number of detection sac cavities arranged in an extending mode are larger than the same parameter configuration at the position far away from the organ to be detected. The embodiment of the pressure balloon shown in fig. 3, when applied to the above-mentioned examination and evaluation of the urinary tract and rectum, wherein the divided

parts

42b, 43b, 44b with relatively concentrated dividing density are adjacent to the urethra 23, and more than six sub-balloon cavities may be respectively arranged in the length extension direction in order to increase the accuracy of urinary tract analysis; the other side divides the

split parts

46b, 47b with a slightly concentrated density to be adjacent to the rectum 24, and the number of the sub-sacculus cavities is arbitrarily defined and set. Since the other divided

parts

41b, 45b, 48b are relatively distant from the organ to be detected, and thus have no evaluation meaning in practical use, the division density is high and the length does not extend the number of sub-cystic spaces (but at least one detection cystic space remains). Through the subdivided detection capsule cavity and the pressure data acquisition of the sub-capsule cavity, an accurate 3D pressure distribution model under the background of the internal organs of the simulated pelvic floor can be obtained, so that doctors or physical examination personnel can make accurate detection more easily.

In addition, in order to further ensure the positioning precision of the pressure balloon embedded body of the portable device, the outer wall of the pressure balloon 4 is also distributed with positioning rings or marks which can be displayed by X rays, and the positioning rings or marks correspond to the anatomical position of the organ to be detected. After the pressure saccule is successfully inserted into the body and positioned, the conclusion of organ displacement detection can be obtained by judging the deviation of the positioning ring or the mark and the anatomical position where the organ theory should be located, and the clinical characteristics of the corresponding function of the current organ position can be obtained.

Because the pressure balloon has a multi-choice implementation structure and has the requirement of disposable use or the requirement of reuse after disinfection from the application point of view, the pressure balloon is preferably replaceable and assembled structure so as to realize quick replacement and assembly with the inflation unit as required and enhance the flexibility. Of course, if the inflation unit is a simple manual structure, the inflation unit can be integrally formed and connected with the pressure balloon, and the whole inflation unit can be used at one time.

Summarizing the general features and detailed description of embodiments of the portable device for detecting organ displacement and clinical features of the pelvic floor according to the invention, they have prominent substantive features and significant advancements compared to the media used in conventional such detection: the portable device can enter a human body to realize functions without damage, forms a local or integral organ pressure distribution model through pressure detection of controllable point positions, then obtains a physical examination detection report or a medical judgment basis, and has the advantages of small pain, convenience in operation, high positioning precision, visual presentation of detection result data and the like.

Claims

1. An apparatus for detecting pelvic floor organ displacement and clinical characteristics, comprising: the pressure sensing unit is at least a pressure balloon capable of inflating and deflating, the pressure balloon is a flexible strip-shaped hollow elastic body, the strength of an air support meets the requirement of keeping the shape of an implant and is attached to a detected organ, at least two detection balloon cavities are distributed on the pressure balloon, and the pressure reading instrument is connected into each detection balloon cavity through channels, is connected with a processor signal and feeds back pressure change.

2. The apparatus for detecting organ displacement and clinical features of the pelvic floor according to claim 1, wherein: the device has a pressure balloon corresponding to the vagina, and the pressure balloon covers the cervix to the vaginal opening in length.

3. The apparatus for detecting organ displacement and clinical features of the pelvic floor according to claim 2, wherein: the pressure sacculus is provided with six detection sacculus cavities which are arranged in the length direction, wherein the first detection sacculus cavity is matched and positioned at cervix, the second detection sacculus cavity and the third detection sacculus cavity are matched and positioned at bladder, and the fourth detection sacculus cavity, the fifth detection sacculus cavity and the sixth detection sacculus cavity are matched and positioned at urethra.

4. The apparatus for detecting organ displacement and clinical features of the pelvic floor according to claim 1, wherein: the device is provided with pressure balloons corresponding to a urinary tract and a rectum, the pressure balloons cover the vagina to the cervix along the length direction, and the pressure balloons are divided into a urinary bladder detection balloon cavity and a rectal detection balloon cavity through an upper diaphragm and a lower diaphragm along the axial direction.

5. The apparatus for detecting organ displacement and clinical features of the pelvic floor according to claim 4, wherein: the urethra and bladder detection sac cavity is provided with M sac cavities along the length direction of the pressure saccule in a separating manner, the rectum detection sac cavity is provided with N sac cavities along the length direction of the pressure saccule in a separating manner, and M, N are natural numbers larger than 1.

6. The apparatus for detecting organ displacement and clinical features of the pelvic floor according to claim 1, wherein: the pressure sacculus is provided with more than two split parts on the section perpendicular to the length direction, and the split parts extend along the length direction to form a detection sacculus cavity.

7. The apparatus for detecting organ displacement and clinical features of the pelvic floor according to claim 6, wherein: the cross section of the pressure balloon in the direction perpendicular to the length direction is circular, six split parts which are uniformly split in the circumferential direction are arranged on the cross section, and more than two detection balloon cavities are formed in the length direction of each split part in an extending mode.

8. The apparatus for detecting organ displacement and clinical features of the pelvic floor according to claim 6, wherein: eight split parts which are non-uniformly split in the circumferential direction are arranged on the cross section of the pressure balloon in the direction perpendicular to the length direction, and the split density of the split parts at the position close to an organ to be detected and the number of detection balloon cavities arranged in an extending mode are larger than the same parameter configuration at the position far away from the organ to be detected.

9. The apparatus for detecting organ displacement and clinical characteristics of the pelvic floor according to any one of claims 1 to 8, wherein: the outer wall of the pressure sacculus is provided with a positioning ring or a mark which can be displayed by X rays, and the positioning ring or the mark corresponds to the anatomical position of the organ to be detected.

10. The apparatus for detecting organ displacement and clinical features of the pelvic floor according to claim 1, wherein: in the pressure sensing unit, the pressure balloon is provided with an integrally connected or detachably connected inflation tube.