CN113143537A - Magnetic control device for treating female stress urinary incontinence - Google Patents
Magnetic control device for treating female stress urinary incontinence Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/028—Other inorganic materials not covered by A61L31/022 - A61L31/026
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/042—Polysaccharides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/145—Hydrogels or hydrocolloids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/009—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof magnetic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/06—Flowable or injectable implant compositions
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Abstract
A magnetic control device for treating female stress urinary incontinence comprises a permanent magnet and magnetic hydrogel, wherein the permanent magnet is fixed on the inner side of the lower end of the pubis, the magnetic hydrogel is positioned in the urethral vaginal septum of the horizontal plane where the permanent magnet is positioned and magnetically attracted with the permanent magnet, and the attraction force between the permanent magnet and the magnetic hydrogel meets the following requirements: when the urine is not excreted, the pressure is generated on the urethra to compensate the function of pelvic floor muscles, so that the urethra is closed; when urination is performed after urine accumulates in the bladder, the pressure of the urethra generated by the urination is overcome, so that the urethra is opened. The device applies pressure to the urethra according to the non-contact attraction principle of magnetic materials to prevent urine from overflowing under low pressure without influencing normal urination, and is expected to be used clinically after further animal experiment verification.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a magnetic control device for treating female stress urinary incontinence.
Background
Stress Urinary Incontinence (SUI) in women is a common disease affecting the health and quality of life of women, and is mainly manifested by involuntary urine leakage when the abdominal cavity pressure is increased due to coughing and sneezing of patients. According to research reports, the SUI incidence rate of foreign female population is up to 36.6%, the domestic adult female incidence rate is 18.9%, and the incidence rate of 50-59 years old female can be up to 28%, which becomes a serious medical burden. The female SUI is mainly caused by urethral closure disorder caused by defects or dysfunction of urinary control anatomical structures, and the pathological mechanisms of the female SUI comprise downward movement of the bladder neck and the proximal urethra, urethral mucosa sealing hypofunction, urethral intrinsic sphincter function reduction, nervous system dysfunction for controlling urinary tissues and the like. The mild and moderate SUI can be treated by non-operative methods such as pelvic muscle exercise, electrical stimulation, and biofeedback treatment (Yangjuan, Lidawn, Huijian, etc.. pelvic floor biofeedback electrical stimulation is used for clinical research on mild and moderate female stress urinary incontinence [ J ]. Ningxia journal of medicine, 2018,40(8): 708-.
The operation method obviously has great harm to the body and is difficult to completely cure. The non-operative method only aims at mild and moderate patients, the pelvic floor muscle exercise and biofeedback treatment method needs long-time participation of the patients, the internal functions are controlled by self-training, the effects are difficult to measure, the effect is extremely slow, the physiological and psychological functions of the patients are deeply depended on, the electric stimulation has obvious side effects on the patients, and the effect is not obvious.
Disclosure of Invention
In order to overcome the defects of the prior art, the invention aims to provide a magnetic control device for treating female stress urinary incontinence, which is based on the basic technical principle of magnetic surgery, combines the pathological basis of female stress urinary incontinence and the anatomical structure characteristics of female pelvic organs, adopts permanent magnet implantation and magnetic hydrogel injection to treat female stress urinary incontinence, applies pressure to urethra according to the principle of non-contact attraction of magnetic materials, prevents urine from overflowing under low pressure, does not influence normal urination, and is expected to be used clinically after further animal experiments verify.
In order to achieve the purpose, the invention adopts the technical scheme that:
a magnetic control device for treating female stress urinary incontinence comprises a permanent magnet 1 and a magnetic hydrogel 2, wherein the permanent magnet 1 is fixed on the inner side of the lower end of a pubis 3, the magnetic hydrogel 2 is positioned in a urethral vaginal septum 4 of a horizontal plane where the permanent magnet 1 is positioned and magnetically attracts the permanent magnet 1, and the attraction force between the permanent magnet 1 and the magnetic hydrogel 2 satisfies the following conditions: pressure-compensating pelvic floor muscle function on the urethra 5 during non-urination, so that the urethra 5 is closed; when urination is performed after the urine is accumulated in the bladder 6, the urethral pressure generated by the urination is overcome, so that the urethra 5 is opened.
The permanent magnet 1 is made of neodymium iron boron permanent magnet materials and is a cylinder with a counter bore structure in the center.
The magnetic hydrogel 2 is formed by the cross-linking reaction of sodium alginate-ferroferric oxide suspension and a cross-linking agent after being injected into a urethra vagina septum 4 through a coaxial double-channel injection device.
The sodium alginate-ferroferric oxide suspension is formed by uniformly mixing a sodium alginate solution with the mass concentration of 2-3% and ferroferric oxide particles with the particle size of 5-20 mu m according to the volume mass ratio of 1-3mL:1g, and the cross-linking agent is a calcium gluconate solution with the mass concentration of 1-10%.
The suction force between the permanent magnet 1 and the magnetic hydrogel 2 is 1N-1.5N, and when the urine volume in the bladder 6 reaches more than 300mL during urination, the urethral pressure caused by the suction force between the permanent magnet 1 and the magnetic hydrogel 2 is overcome.
Compared with the prior art, the invention has the beneficial effects that:
1. by utilizing the non-contact characteristic of the magnetic force, the magnetic attraction of the permanent magnet to the magnetic hydrogel is not interfered by surrounding organs and tissues, and the magnitude of the magnetic force between the permanent magnet and the magnetic hydrogel is only dependent on the magnetomechanical parameters of the permanent magnet and the quantity of the magnetic hydrogel, so that the adjustment is very convenient.
2. The closing and opening of the urethra are realized by precisely controlling the magnetic force. Accurate magnetic control can satisfy the patient and independently urinate, can exert pressure for the urethra again, avoids autonomic excessive urine.
3. In the prior magnetic surgery research, magnetic devices are mostly processed and prepared by permanent magnetic materials, but the invention adopts a scheme of combining permanent magnets and magnetic hydrogel, which is mainly based on the difference of application scenes. The front of female urethra is adjacent to pubis, and is bone structure, and the back is urethra vaginal septum, and belongs to soft tissue structure. The permanent magnet is fixed on the inner side of the lower end of the pubis, the hard structure characteristic is continuously kept, the magnetic hydrogel has the soft tissue characteristic, the magnetic hydrogel is placed in the urethral vaginal septum by an injection method, and the soft tissue characteristic of the urethral vaginal septum is continuously kept, so the physical characteristic of the basic tissue of an organism is kept to the maximum extent by the design.
Drawings
FIG. 1 is a schematic view of the operation principle of the magnetic control device for female urinary stress incontinence (non-urination state, magnetic hydrogel attracted by permanent magnet, urethra closed).
Fig. 2 is a schematic diagram of the working principle of the magnetic control device for female stress incontinence (urination state, urethra pressure overcoming the attraction between the magnetic hydrogel and the permanent magnet, urethra opening).
FIG. 3 is a graph showing the magnetic force-displacement curves between different amounts of sodium alginate-ferroferric oxide suspensions and permanent magnets, wherein (a) is a magnetic force curve between 1mL of magnetic suspension and the permanent magnet, (b) is a magnetic force curve between 2mL of magnetic suspension and the permanent magnet, and (c) is a magnetic force curve between 3mL of magnetic suspension and the permanent magnet.
Fig. 4 and 5 are schematic diagrams of in-vitro simulation experiments of the magnetic control device.
Detailed Description
The embodiments of the present invention will be described in detail below with reference to the drawings and examples.
As shown in fig. 1 and fig. 2, the magnetic control device for treating female stress urinary incontinence of the present invention mainly comprises two parts: a permanent magnet 1 and a magnetic hydrogel 2. The permanent magnet 1 is fixed on the inner side of the lower end of the pubic bone 3, and the magnetic hydrogel 2 is injected into the urethra vagina septum 4 on the horizontal plane of the permanent magnet 1 by means of an injection device. The principle is as follows: when the urinary incontinence is not in a urination state, the magnetic hydrogel 2 in the urethral vaginal septum 4 is attracted by the permanent magnet 1 on the inner side of the lower end of the pubis 3, certain pressure can be generated on the urethra 5, and the pressure can compensate part of the functions of pelvic floor muscles, so that the urethra 5 is closed, and the purpose of controlling urinary incontinence is achieved; when the urine in the bladder 6 is accumulated to a certain degree (generally above 300 mL), the pressure of the urethra of the patient rises when the patient urinates, the suction force between the magnetic hydrogel 2 and the permanent magnet 1 is overcome, the urethra 5 is opened, and the patient finishes the urination process. For ease of understanding, the uterus 7, vagina 8, rectovaginal septum 9 and rectum 10 are also shown.
In order to meet the design thought, the invention also carries out the following basic design:
1. the permanent magnet 1 is a cylindrical magnet with a counter bore structure on one surface, the diameter of the magnet is 12mm, the height of the magnet is 5mm, the center of the magnet is in the counter bore structure, and the counter bore structure is matched with a screw to be used, so that the magnet can be conveniently and firmly fixed on the inner side of the lower end of the pubis 3.
2. The magnetic hydrogel 2 is formed by the cross-linking reaction of sodium alginate-ferroferric oxide suspension and a calcium agent. When the magnetic hydrogel is used, the sodium alginate-ferroferric oxide suspension and the calcium agent are synchronously injected into the urethra and vagina septum 4 by using a coaxial double-channel injection device, and the sodium alginate-ferroferric oxide suspension and the calcium agent are subjected to a cross-linking reaction quickly after meeting to form the magnetic hydrogel 2. The magnetic hydrogel 2 has the characteristics of soft tissues and can ensure that the ferroferric oxide particles are not dispersed into the surrounding tissues.
Wherein the sodium alginate-ferroferric oxide suspension is formed by uniformly mixing a sodium alginate solution with the mass concentration of 2-3% and ferroferric oxide particles with the particle size of 5-20 mu m according to the volume mass ratio of 1-3mL:1g, and the cross-linking agent can be a calcium gluconate solution with the mass concentration of 1-10%.
3. In combination with human body structures of most people, the suction force between the permanent magnet 1 and the magnetic hydrogel 2 is generally in the range of 1N-1.5N, and the compensated pelvic floor muscle function is about 30-100 cmH2Magnetic attraction of O.
The magnetomechanical property test of the invention is as follows:
and (3) respectively testing the magnetic force-displacement curves between the magnetic hydrogel 2 and the permanent magnet 1 with different quantities by using an electronic material testing machine. The specific method is that 1mL, 2mL and 3mL sodium alginate-ferroferric oxide suspension are respectively filled into a 5mL EP tube and are fixed on a clamp of an electronic material testing machine (model UTM6020, Shenzhen Sansi longitudinal and transverse science and technology Co., Ltd.). Fixing the permanent magnet on the other clamp of the electronic material testing machine, testing the magnetic force between the permanent magnet and the sodium alginate-ferroferric oxide suspension at different distances by taking the distance between the permanent magnet and the clamp as a starting point, and drawing a magnetic force-displacement curve by taking the magnetic force as a vertical coordinate and the distance as a horizontal coordinate, as shown in (a), (b) and (c) in fig. 3. The change condition of the magnetic attraction formed by different amounts of sodium alginate-ferroferric oxide suspension and permanent magnets at different intervals can be known, so that the injection amount of the sodium alginate-ferroferric oxide suspension for the stress urinary incontinence patients with different degrees of severity can be clinically guided.
To verify the feasibility of the present invention, in vitro simulation experiments were performed as follows:
taking the bladder, urethra and vagina integral structure of the in vitro female experimental pig. The permanent magnet is properly fixed on the experiment table board. Injecting proper amount of sodium alginate-ferroferric oxide suspension and calcium agent into urethra and vagina septum by using a coaxial double-channel injection device. The whole specimen is vertically fixed above the bladder and with the urethral orifice facing downwards. Firstly, the bladder is in a vacuity state, and the magnetic hydrogel and the permanent magnet attract each other to make the urethra in a closed state; the normal saline is injected into the bladder through the bottom of the bladder, and the bladder pressure is shown when 60-80mL of normal saline is injected into the bladderAbout 45-60cmH2OmmHg, the pressure in the bladder is transmitted to the urethra, so that the magnetic hydrogel is separated from the permanent magnet, the urethra is opened, and the normal saline in the bladder is discharged through the urethra. When the pressure of the urethra disappears after the liquid in the bladder is discharged, the magnetic hydrogel is continuously attracted by the permanent magnet, and the urethra is closed. Fig. 4 and 5 show the comparison of the states of the isolated bladder storing liquid with the non-magnetic control device, and it can be seen that the isolated bladder cannot store liquid, and the urethra pressure compensation provided by the magnetic control device can enable the isolated bladder to store 80mL of liquid.
Claims (5)
1. The magnetic control device for treating female stress urinary incontinence is characterized by comprising a permanent magnet (1) and a magnetic hydrogel (2), wherein the permanent magnet (1) is fixed on the inner side of the lower end of a pubis (3), the magnetic hydrogel (2) is positioned in a urethral vaginal septum (4) of a horizontal plane where the permanent magnet (1) is positioned and magnetically attracts the permanent magnet (1), and the attraction force between the permanent magnet (1) and the magnetic hydrogel (2) meets the following requirements: pressure-compensating pelvic floor muscle function on the urethra (5) during non-urination, so that the urethra (5) is closed; when urination is performed after the urine is accumulated in the bladder (6), the urethral pressure generated by the urination is overcome, so that the urethra (5) is opened.
2. The magnetic control device for treating female stress urinary incontinence as claimed in claim 1, wherein said permanent magnet (1) is made of neodymium iron boron permanent magnet material and is a cylinder with a counterbore structure in the center.
3. The magnetic control device for treating female stress urinary incontinence as claimed in claim 1, wherein the magnetic hydrogel (2) is formed by a cross-linking reaction of sodium alginate-ferroferric oxide suspension and a cross-linking agent after being injected into the urethra-vagina septum (4) through a coaxial dual-channel injection device.
4. The magnetic control device for treating female stress urinary incontinence as claimed in claim 3, wherein the sodium alginate-ferroferric oxide suspension is formed by uniformly mixing a sodium alginate solution with a mass concentration of 2-3% and ferroferric oxide particles with a particle size of 5-20 μm according to a volume-mass ratio of 1-3mL:1g, and the cross-linking agent is a calcium gluconate solution with a mass concentration of 1-10%.
5. The magnetron device for the treatment of female stress urinary incontinence as claimed in claim 1, characterized in that the attraction force between the permanent magnet (1) and the magnetic hydrogel (2) is 1N-1.5N, and when the amount of urine in the bladder (6) reaches 300mL or more at the time of urination, the resulting urethral pressure overcomes the attraction force between the permanent magnet (1) and the magnetic hydrogel (2).
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CN108543165A (en) * | 2018-02-27 | 2018-09-18 | 宁波胜杰康生物科技有限公司 | A kind of muscular function auxiliary device based on carrier |
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US4751053A (en) * | 1984-10-23 | 1988-06-14 | Institut Pasteur | Magnetic device for removing magnetic gel balls from a medium to be analyzed and transferring them to an immunoenzymatic quantitative anaylsis medium |
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