CN113143537B - 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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- CN113143537B CN113143537B CN202110387755.1A CN202110387755A CN113143537B CN 113143537 B CN113143537 B CN 113143537B CN 202110387755 A CN202110387755 A CN 202110387755A CN 113143537 B CN113143537 B CN 113143537B
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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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- Health & Medical Sciences (AREA)
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- Oral & Maxillofacial Surgery (AREA)
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Abstract
The magnetic control device for treating female stress urinary incontinence comprises a permanent magnet and a magnetic hydrogel, wherein the permanent magnet is fixed on the inner side part of the lower end of a pubis, the magnetic hydrogel is positioned in the urethral vaginal septum of the horizontal plane where the permanent magnet is positioned and magnetically attracts the permanent magnet, and the attraction between the permanent magnet and the magnetic hydrogel is as follows: generating pressure to the urethra during non-urination to compensate for pelvic floor muscle function, such that the urethra is occluded; when urination occurs after urine accumulates in the bladder, the urethral pressure created by the urination is overcome, leaving the urethra open. The device is based on the basic technical principle of magnetic surgery, combines the pathological basis of female stress urinary incontinence and 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 non-contact attraction principle 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 experiment verification.
Description
Technical Field
The invention belongs to the technical field of medical appliances, and particularly relates to a magnetic control device for treating female stress urinary incontinence.
Background
Female stress urinary incontinence (stress urinary incontinence, SUI) is a common disease affecting female health and quality of life, and is mainly manifested by involuntary leakage of urine when the pressure in the abdominal cavity increases due to cough, sneeze, etc. of a patient. According to research reports, the incidence rate of SUI of foreign female population is up to 36.6%, the incidence rate of domestic adult female is 18.9%, and the incidence rate of female aged 50-59 can be up to 28%, so that the medical treatment burden is serious. The disease foundation of the female SUI is urethral occlusive disorder caused by defect or dysfunction of urine control anatomical structure, and the pathological mechanism comprises bladder neck and proximal urethral movement, urethral mucosa occlusion hypofunction, urethral intrinsic sphincter dysfunction, nervous system dysfunction of controlling urine control tissues and the like. Light and moderate SUI can be generally used by non-operative methods such as pelvic floor muscle exercise, electrical stimulation, biofeedback treatment (Yang Zhijuan, li Xiao, hu Huijuan, etc.. Clinical study of pelvic floor biological feedback stimulation treatment of light and moderate female stress urinary incontinence [ J ]. Ningxia medical journal 2018,40 (8): 708-710), and operative treatments for non-operative treatment poor in effect are available, including vaginal tension-free mid-urethra suspension surgery, pubic postbladder neck suspension surgery, etc. (department of gynaecology and obstetrics of China, department of science, pelvic floor, guide for female stress urinary incontinence diagnosis and treatment (2017) [ J ]. J. Gynaecology and obstetrics, 2017,52 (5): 289-293).
The surgical method obviously has great damage to the body and is difficult to radically cure. The non-operative method is only aimed at moderate and mild patients, the pelvic floor muscle exercise and biofeedback treatment method requires the patients to participate for a long time, the internal functions are controlled by self-training, the effect is 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 and combines the pathological basis of female stress urinary incontinence and anatomical structure characteristics of female pelvic organs, and adopts permanent magnet implantation and magnetic hydrogel injection to treat female stress urinary incontinence.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
the utility model provides a magnetic control device for treating female stress urinary incontinence, includes permanent magnet 1 and magnetism hydrogel 2, permanent magnet 1 is fixed in pubic bone 3 lower extreme medial part, magnetism hydrogel 2 is located the urethra vagina compartment 4 of permanent magnet 1 place horizontal plane and attracts mutually with permanent magnet 1 magnetism, and the suction between permanent magnet 1 and the magnetism hydrogel 2 satisfies: creating pressure compensating pelvic floor muscle function to the urethra 5 in the non-micturition state, such that the urethra 5 is occluded; when urination occurs after urine accumulates in the bladder 6, the urethral pressure created by the urination is overcome, leaving the urethra 5 open.
The permanent magnet 1 is processed by adopting a neodymium iron boron permanent magnet material and is a cylinder with a counter bore structure in the center.
The magnetic hydrogel 2 is formed by cross-linking reaction of sodium alginate-ferroferric oxide suspension and a cross-linking agent after the suspension and the cross-linking agent are injected into the urethra-vaginal septum 4 through a coaxial double-channel injection device.
The sodium alginate-ferroferric oxide suspension is formed by uniformly mixing 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 to 1g, and the cross-linking agent is 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 resulting urethral pressure overcomes the suction force between the permanent magnet 1 and the magnetic hydrogel 2.
Compared with the prior art, the invention has the beneficial effects that:
1. by utilizing the 'non-contact' characteristic of 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 only depends on the magnetomechanical parameter 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 utilizing the accurate control of the magnetic force. Accurate magnetic force control can not only satisfy the patient and independently urinate, can exert pressure for the urethra again, avoids involuntary urine overflow.
3. In the past magnetic surgery research, the magnetic device is mostly processed and prepared by permanent magnet materials, but the invention adopts a scheme of combining a permanent magnet and magnetic hydrogel, which is mainly based on the difference of application scenes. The female urethra is adjacent to pubis and is a bony structure, and the female urethra is at the rear, and the female urethra is at the vaginal septum, which belongs to a soft tissue structure. The permanent magnet is fixed on the inner side of the lower end of the pubis, the hard structural characteristic is kept continuously, the magnetic hydrogel has the soft tissue characteristic, and is placed in the urethral vaginal septum by an injection method, so that the soft tissue characteristic of the urethral vaginal septum is kept continuously, and the physical characteristics of basic tissues of a machine body are kept to the greatest extent by the design.
Drawings
Fig. 1 is a schematic diagram of the principle of operation of the magnetic control device for female stress urinary incontinence of the present invention (non-micturition state, magnetic hydrogel attracted by permanent magnet, urethra closed).
Fig. 2 is a schematic diagram of the operation principle of the magnetic control device for female stress urinary incontinence according to the present invention (urination state, urethra pressure overcomes 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 suspension and the permanent magnet, wherein (a) is a magnetic force curve between 1mL of the magnetic suspension and the permanent magnet, (b) is a magnetic force curve between 2mL of the magnetic suspension and the permanent magnet, and (c) is a magnetic force curve between 3mL of the 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
Embodiments of the present invention will be described in detail below with reference to the accompanying drawings and examples.
As shown in fig. 1 and 2, a magnetic control device for treating female stress urinary incontinence according to 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 urethral vaginal septum 4 at the level of the permanent magnet 1 by means of an injection device. The principle is as follows: in a non-urination state, the magnetic hydrogel 2 in the urethral vaginal septum 4 is attracted by the permanent magnet 1 at the inner side of the lower end of the pubic bone 3, so that a certain pressure can be generated on the urethra 5, and the pressure can compensate part of pelvic floor muscle functions, so that the urethra 5 is closed, and the aim of controlling urinary incontinence is fulfilled; when urine in the bladder 6 is accumulated to a certain degree (generally more than 300 mL), the pressure of the urethra 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, uterus 7, vagina 8, recto-vaginal 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 counter bore structure is arranged at the center of the magnet, and the counter bore structure is matched with a screw for use, so that the permanent magnet can be conveniently and firmly fixed on the inner side of the lower end of the pubic bone 3.
2. The magnetic hydrogel 2 is formed by the cross-linking reaction of sodium alginate-ferroferric oxide suspension and a calcium agent. When in use, the sodium alginate-ferroferric oxide suspension and the calcium agent are synchronously injected into the urethra-vagina septum 4 by using a coaxial double-channel injection device, and the two components are rapidly subjected to crosslinking reaction 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 surrounding tissues.
Wherein the sodium alginate-ferroferric oxide suspension is formed by uniformly mixing 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 to 1g, and the cross-linking agent can be calcium gluconate solution with the mass concentration of 1-10%.
3. In combination with the human body structure of most people, the suction force between the permanent magnet 1 and the magnetic hydrogel 2 is generally 1N-1.5N, and the compensating pelvic floor muscle function is approximately equivalent to 30-100 cmH 2 Magnetic attraction of O.
The invention performs the following magneto-mechanical property test:
the magnetic force-displacement curves between the magnetic hydrogel 2 and the permanent magnet 1 of different amounts were tested separately using an electronic material tester. The specific method is that 1mL, 2mL and 3mL of sodium alginate-ferroferric oxide suspension are respectively filled in a 5mL EP tube, and are fixed on a clamp of an electronic material tester (model UTM6020, shenzhen Sanzhen longitudinal and transverse science and technology Co., ltd.). The permanent magnet is fixed on the other clamp of the electronic material testing machine, the magnetic force between the permanent magnet and the sodium alginate-ferroferric oxide suspension is tested at different distances by taking the distance between the permanent magnet and the clamp as a starting point, the magnetic force is taken as an ordinate, and the magnetic force-displacement curve is drawn by taking the distance as an abscissa, and is shown in (a), (b) and (c) in figure 3. The change condition of magnetic attraction force formed by different amounts of sodium alginate-ferroferric oxide suspension and the permanent magnet at different intervals can be known, so that the injection quantity of sodium alginate-ferroferric oxide suspension of patients with stress urinary incontinence with different severity can be clinically guided.
In order to verify the feasibility of the invention, in vitro simulation experiments were performed as follows:
taking the integral structure of the bladder, urethra and vagina of the isolated female experimental pig. The permanent magnet is fixed on the experiment table surface. And injecting a proper amount of sodium alginate-ferroferric oxide suspension and a proper amount of calcium agent into the urethra-vaginal septum by using a coaxial double-channel injection device. The whole specimen is vertically fixed according to the position above the bladder and the urethral orifice downwards. Firstly, the bladder is in a null state, and the magnetic hydrogel is attracted with the permanent magnet to make the urethra in a closed state; through the bottom cannula of the bladder, the physiological saline is injected into the bladder, and when 60-80mL of physiological saline is injected into the bladder, the pressure of the bladder is about 45-60cmH 2 OmmHg, the intravesical pressure is transferred to the urethra, separating the magnetic hydrogel from the permanent magnet, opening the urethra and draining the intravesical normal saline 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. The comparison of the state of the liquid stored in the isolated bladder in the presence of the magnetic control device is shown in fig. 4 and 5, and it can be seen that the isolated bladder cannot store the liquid, and the urethral pressure compensation provided by the magnetic control device can enable the isolated bladder to store 80mL of liquid, obviously, the pressure is applied to the urethra based on the non-contact attraction principle of the magnetic material, so that the urine is prevented from overflowing under low pressure, normal urination is not influenced, and the urine control effect is good.
Claims (4)
1. A magnetic control device for treating female stress urinary incontinence, which is characterized by comprising a permanent magnet (1) and a magnetic hydrogel (2), wherein the permanent magnet (1) is fixed on the inner side part of the lower end of a pubic bone (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 between the permanent magnet (1) and the magnetic hydrogel (2) is as follows: generating pressure to the urethra (5) during non-urination to compensate for pelvic floor muscle function, such that the urethra (5) is occluded; when urination is performed after urine is accumulated in the bladder (6), the pressure of the urethra generated by urination is overcome, so that the urethra (5) is opened; wherein the magnetic hydrogel (2) is formed by a cross-linking reaction between sodium alginate-ferroferric oxide suspension and a cross-linking agent after the suspension and the cross-linking agent are injected into a urethra-vagina septum (4) through a coaxial double-channel injection device.
2. The magnetic control device for treating female stress urinary incontinence according to claim 1, wherein the permanent magnet (1) is made of neodymium iron boron permanent magnet material and is a cylinder with a countersink structure in the center.
3. The magnetic control device for treating female stress urinary incontinence according to claim 1, 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 μm according to the volume-mass ratio of 1-3mL to 1g, and the cross-linking agent is a calcium gluconate solution with the mass concentration of 1-10%.
4. The magnetic control device for treating female stress urinary incontinence according to claim 1, wherein the attractive 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 during urination, the resulting urethral pressure overcomes the attractive force between the permanent magnet (1) and the magnetic hydrogel (2).
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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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 |
| US4850963A (en) * | 1986-06-11 | 1989-07-25 | Utah Bioresearch, Inc. | Apparatus and methods for achieving urinary continence |
| CN105326590A (en) * | 2015-11-03 | 2016-02-17 | 广东工业大学 | Magnetic coupling resonance type electric heating evaporation steam-driven urethra valve |
| WO2019145616A1 (en) * | 2018-01-26 | 2019-08-01 | Patrick Sangouard | Artificial sphincter comprising a magnetic control system |
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| WO2002011696A2 (en) * | 2000-08-08 | 2002-02-14 | Ev & M | Active tissue augmentation materials and method |
| CN102727445A (en) * | 2012-07-14 | 2012-10-17 | 兰州大学第二医院 | Sophocarpidine pH/ magnetic dual-sensitive hydrogel globule and preparation method thereof |
| EP3288626A4 (en) * | 2015-04-27 | 2019-01-23 | Reflex Medical Inc. | Systems and mehtods for sympathetic cardiopulmonary neuromodulation |
| CN105175970B (en) * | 2015-08-10 | 2018-07-06 | 西安交通大学 | The preparation and application of high-strength tear-resistant magnetic hydrogel |
| CN106540372A (en) * | 2016-12-09 | 2017-03-29 | 广东工业大学 | The urethra valve that a kind of wireless power SMA drives |
| CN107998462B (en) * | 2017-11-10 | 2020-10-09 | 西安交通大学医学院第一附属医院 | Preparation method of magnetic gel for assisting endoscopic mucosal dissection surgery |
| CN108543165B (en) * | 2018-02-27 | 2021-06-18 | 宁波胜杰康生物科技有限公司 | Carrier-based muscle function auxiliary device |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| US4850963A (en) * | 1986-06-11 | 1989-07-25 | Utah Bioresearch, Inc. | Apparatus and methods for achieving urinary continence |
| CN105326590A (en) * | 2015-11-03 | 2016-02-17 | 广东工业大学 | Magnetic coupling resonance type electric heating evaporation steam-driven urethra valve |
| WO2019145616A1 (en) * | 2018-01-26 | 2019-08-01 | Patrick Sangouard | Artificial sphincter comprising a magnetic control system |
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