CN116785020A - Implantable wireless passive artificial urethral sphincter device and use method thereof - Google Patents
Implantable wireless passive artificial urethral sphincter device and use method thereof Download PDFInfo
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- CN116785020A CN116785020A CN202310577445.5A CN202310577445A CN116785020A CN 116785020 A CN116785020 A CN 116785020A CN 202310577445 A CN202310577445 A CN 202310577445A CN 116785020 A CN116785020 A CN 116785020A
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- gating
- storage bag
- urethra
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- 210000005070 sphincter Anatomy 0.000 title claims abstract description 41
- 238000000034 method Methods 0.000 title claims abstract description 12
- 210000003708 urethra Anatomy 0.000 claims abstract description 49
- 210000002700 urine Anatomy 0.000 claims abstract description 28
- 230000027939 micturition Effects 0.000 claims abstract description 23
- 238000001727 in vivo Methods 0.000 claims abstract description 15
- 238000000338 in vitro Methods 0.000 claims abstract description 11
- 230000002485 urinary effect Effects 0.000 claims description 24
- 230000005540 biological transmission Effects 0.000 claims description 3
- 239000011248 coating agent Substances 0.000 claims description 2
- 238000000576 coating method Methods 0.000 claims description 2
- 238000007920 subcutaneous administration Methods 0.000 claims description 2
- 230000000845 anti-microbial effect Effects 0.000 claims 1
- 239000004599 antimicrobial Substances 0.000 claims 1
- 230000000452 restraining effect Effects 0.000 claims 1
- 210000003437 trachea Anatomy 0.000 claims 1
- 230000035807 sensation Effects 0.000 abstract description 7
- 238000012423 maintenance Methods 0.000 abstract description 2
- 230000001939 inductive effect Effects 0.000 abstract 1
- 230000001276 controlling effect Effects 0.000 description 6
- 210000003491 skin Anatomy 0.000 description 6
- 239000002504 physiological saline solution Substances 0.000 description 5
- 230000008569 process Effects 0.000 description 4
- 230000001105 regulatory effect Effects 0.000 description 4
- 238000001356 surgical procedure Methods 0.000 description 4
- 230000008878 coupling Effects 0.000 description 3
- 238000010168 coupling process Methods 0.000 description 3
- 238000005859 coupling reaction Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 206010046543 Urinary incontinence Diseases 0.000 description 2
- 210000002615 epidermis Anatomy 0.000 description 2
- 208000028867 ischemia Diseases 0.000 description 2
- 230000017074 necrotic cell death Effects 0.000 description 2
- 238000012549 training Methods 0.000 description 2
- 208000033999 Device damage Diseases 0.000 description 1
- 238000007792 addition Methods 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000006996 mental state Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000003689 pubic bone Anatomy 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
Classifications
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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
- A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
- A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
- A61F2/004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable inflatable
Abstract
The invention discloses an implantable wireless passive artificial urethral sphincter device and a use method thereof, relating to the technical field of medical appliances, comprising the following steps: the device comprises an in-vivo receiving coil, a piezoelectric pump, a gating assembly, a limiting ring, an air storage bag, an in-vitro energy supply coil and an in-vitro energy supply circuit. The restriction ring is arranged around the urethra, and the piezoelectric pump, the air storage bag and the restriction ring are all connected with the gating component to form an airflow passage from the air storage bag, the gating component and the piezoelectric pump to the restriction ring through the gating component. The external energy supply coil and the internal receiving coil are used for wirelessly inducing energy to drive the piezoelectric pump to work, gas is filled into the limiting ring from the gas storage bag, and the limiting ring extrudes the urethra to realize urine storage; the gating component switches the air passage, air is put back into the air storage bag from the limiting ring, and the limiting ring loosens the urethra to realize urination. The device is wireless, has no built-in battery and built-in circuit, has little foreign body sensation, is convenient to operate, and can stably work for a long time without maintenance.
Description
Technical Field
The invention relates to the technical field of medical appliances, in particular to an implantable wireless passive artificial urethral sphincter device and a using method thereof.
Background
Urinary incontinence refers to involuntary leakage of urine through the urethra, which can occur at any age, with higher morbidity at older ages. Urinary incontinence can affect the daily life of a patient and even severely affect the mental state of a patient. The existing treatment schemes comprise urination training, bladder training, drug treatment, electrical stimulation treatment, surgical treatment and the like, wherein an artificial urinary sphincter device in the surgical treatment has become a main means of treatment, and the surgical treatment has high success rate and is suitable for elderly patients.
The existing artificial urethral sphincter device mainly surrounds the oversleeves around the urethra, controls the whole pressure through the liquid storage bag and the control pump, maintains balance, is used for simulating the urethral sphincter of a human body, extrudes or relaxes the urethra, and achieves the effect of urination or limiting urine leakage.
The most used product on the market today is AMS800 from boston science, consisting of three parts: the pressure regulating water bag is usually placed at the position behind pubis, and the switch pump is usually placed at the position which can be touched under the skin, so that manual operation is facilitated. The AMS800 system is filled with physiological saline, and the cuff is loosened or contracted by controlling the amount of physiological saline in the cuff, thereby opening or closing the urethra. When the patient needs to urinate, the physiological saline in the oversleeve is cleared by pressing the switch pump from the outer side of the skin for a plurality of times, so that the oversleeve is relaxed, and the bladder urine can flow out from the urethra. The sleeve can automatically fill a few minutes after the physiological saline is discharged, and the urethra is closed by re-pressing so as to recover the urine control state. However, AMS800 also has its own drawbacks: (1) The control of the switch pump and the drainage of the oversleeves need to be controlled manually, the drainage can be realized after a plurality of times of pressing, and the urethra is loosened to drain urine; (2) The time consuming water filling and draining is long, and if the patient has a need for urination, the whole process takes several minutes to complete from the beginning of pressing open Guan Beng to the full entry of physiological saline into the pressure regulating water bladder, which can cause unnecessary trouble to the patient.
Chinese patent application publication No. CN115252214a, an artificial urinary sphincter apparatus, discloses an implantable artificial urinary sphincter apparatus, which increases the speed of system operation by electrically driving a control pump, and maintains the use of the whole system for a while after charging an in-vivo control module by using an in-vivo storage battery and an in-vitro wireless charging transmitter. However, the device with the storage battery inside is implanted in the body, and the device has larger volume, so that foreign body sensation and uncomfortable feeling can be brought to the patient.
The Chinese patent application No. CN115105250A discloses a plugging artificial urethral sphincter device implanted in the urethra near the outlet of the bladder, the device monitors the urine volume in the bladder through a pressure sensor implanted in the bladder, when the urine volume exceeds a preset value, the plug is automatically opened to perform urination, the plug can be automatically closed after urination, meanwhile, the pressure sensor transmits signals to an external receiver to collect and record data, and the external controller can also set pressure preset value and other information. However, once the battery system used by the pressure sensor of the device runs out of power, surgery is required to replace part of the accessories, which increases the risk of infection of the patient and brings a lot of inconvenience to the patient.
Disclosure of Invention
In order to overcome the defects in the prior art, the invention aims to provide an implanted wireless passive artificial urethral sphincter device which is used for wireless transmission energy supply and has no built-in battery, the speed of inflation and deflation of a piezoelectric pump is high, the urination process can be accelerated, and the implanted wireless passive artificial urethral sphincter device is particularly suitable for a scene of long-time maintenance-free stable operation of an implanted medical instrument.
In order to achieve the above purpose, the invention adopts the following technical scheme:
an implantable wireless passive artificial urinary sphincter device, comprising: the device comprises an in-vivo receiving coil, a piezoelectric pump, a gating assembly, a limiting ring, an air storage bag, an in-vitro energy supply coil and an in-vitro energy supply circuit;
the piezoelectric pump, the air storage bag and the limiting ring are all connected with the gating assembly to form an airflow passage from the air storage bag, the gating assembly and the piezoelectric pump to the limiting ring through the gating assembly;
the external energy supply circuit controls the external energy supply coil, wirelessly transmits energy for the internal receiving coil, drives the piezoelectric pump to work, controls the inflation or deflation of the restriction ring through the cooperation of the gating component and the piezoelectric pump, and further controls the restriction ring to squeeze or loosen the urethra, thereby achieving the purpose of urine storage or urination.
Preferably, the restriction ring is arranged around the urethra, the middle of the restriction ring is used for passing through the urethra and controlling urination, and the restriction ring comprises an annular air pipe and a restriction shell; specific:
the annular air pipe is annularly attached to the inner wall of the limiting shell and is connected to the air flow passage and communicated with the gating component, and when the air is inflated or deflated, the annular air pipe can squeeze or loosen the urethra to control urine storage or urination;
the limiting shell is used for preventing the annular air tube from expanding outwards, so that the annular air tube can only expand inwards to squeeze the urethra after being inflated.
Preferably, the in-vivo receiving coil receives wireless energy of magnetic coupling resonance type of the in-vitro energy supply coil, the in-vitro energy supply coil and the in-vivo receiving coil are in a resonant circuit with the same frequency, and the energy received by the in-vivo receiving coil is used for driving the piezoelectric pump to work.
Preferably, the piezoelectric pump is provided with a piezoelectric pump air inlet and a piezoelectric pump air outlet, and the air flow passing through the piezoelectric pump is one-way output, namely the air can only flow in one way in the piezoelectric pump;
the principle of the piezoelectric pump is that an alternating current signal with resonant frequency is applied to the piezoelectric body, so that standing waves with high frequency and high amplitude are generated by the piezoelectric body, unidirectional constant-speed air passage pressurization and pulse-free unidirectional output of the piezoelectric pump are realized, and after the piezoelectric pump is driven, the annular air pipe of the restriction ring is inflated or deflated, so that the urethra is extruded or loosened, and the aim of controlling urine storage or urination is fulfilled.
Preferably, the gating assembly comprises a gating valve and a gating switch; specific:
one end of the gating valve is respectively connected with the air inlet of the piezoelectric pump and the air outlet of the piezoelectric pump, and the other end of the gating valve is respectively connected with the air storage bag and the limiting ring;
the gate valve is used for switching two gas path connection modes, one is an air inflation path for air flow passing through the air storage bag, the gate valve, the piezoelectric pump air inlet, the piezoelectric pump air outlet, the gate valve and the limiting ring, and the other is an air deflation path for air flow passing through the limiting ring, the gate valve, the piezoelectric pump air inlet, the piezoelectric pump air outlet, the gate valve and the air storage bag;
the gas in the gating valve can only circulate from one direction, so that no gas leakage is ensured when the gas path connection mode is switched;
the gating switch is used for controlling the gas path connection mode of the gating valve;
the gating switch is implanted in the body near the epidermis, the state of the gating valve is switched by pressing the gating switch through the epidermis outside the body, the selection of two gas path connection modes is realized, and only one mode can be selected at a time, namely, gas circulation is carried out from different passages when the gas is inflated or deflated.
Preferably, the pressure of the air storage bag is more than or equal to 6 kilopascals and less than or equal to 7 kilopascals, and the pressure in the interval can ensure that the annular air pipe has enough pressure to squeeze the urethra and prevent urine leakage, and meanwhile, the ischemia necrosis of the urethra caused by excessive pressure is avoided;
the gas storage bag is used for storing gas to maintain the air pressure balance of an air path formed by the annular air pipe, the gating valve, the piezoelectric pump and the gas storage bag in the limiting ring.
Preferably, the external energy supply coil is aligned with the internal receiving coil and the external energy supply coil in the process of transmitting energy to the internal receiving coil, so that the energy transmission efficiency is highest.
Preferably, the surfaces of the limiting ring and the air storage bag are coated with an antibacterial coating.
A method of using an implantable wireless passive artificial urinary sphincter device, comprising the steps of:
implanting the artificial urethral sphincter device into a human body, installing a restriction ring around the urethra, and placing an internal receiving coil and a gating assembly in a position which is subcutaneous close to the body surface and is easy to contact;
switching the gas circuit connection mode of the gating assembly, aligning the external energy supply coil with the internal receiving coil, then wirelessly driving the piezoelectric pump to work, controlling the inflation or deflation of the annular air pipe, extruding or loosening the urethra by the annular air pipe, and finally completing urine storage or urination; specific:
when urine is to be stored, the gating switch is pressed, the gating valve is switched into an air inflation channel, the external energy supply coil is close to the internal receiving coil, the wireless driving piezoelectric pump works, air is filled into the annular air tube of the limiting ring from the air storage bag, the annular air tube expands and extrudes the urethra, the gating valve has unidirectional conductivity, so that the air is not leaked when the air is filled, the air pressure of the annular air tube is maintained, and the state of extruding the urethra is kept, so that urine is not leaked;
when urination is to be performed, the gating switch is pressed again, the gating valve is switched to an air discharge air passage, the external energy supply coil is close to the internal receiving coil, the wireless driving piezoelectric pump works, air is put into the air storage bag from the annular air pipe of the limiting ring, and the annular air pipe discharges air and loosens the urethra, so that urine is discharged.
Preferably, the voltage provided by the external power supply circuit is changed, the power supply voltage of the internal receiving coil to the piezoelectric pump is controlled, the piezoelectric pump adjusts the gas flow rate according to the change of the voltage to obtain different pressures, and therefore the air pressure value in the restriction ring is adjusted, and the tightness of the restriction ring to the urethra restriction is adjusted.
Compared with the prior art, the invention has the beneficial effects that:
(1) The invention realizes wireless energy supply by adopting the matching of the internal receiving coil and the external energy supply coil, does not need an internal battery or an internal circuit, has small whole volume and simple structure, can reduce foreign body sensation of a patient, does not need to replace accessories during normal use, and is suitable for long-time maintenance-free stable operation of an implantable medical device;
(2) The piezoelectric pump used by the invention has the advantages of small volume, simple structure, reliability and stability, no moving parts, high air passage pressurization efficiency, higher speed of inflation or deflation, effective control and capability of avoiding the trouble caused by the labor and time consumption of manually operating and controlling the pump;
(3) According to the invention, aiming at the demands of users, the tightness of the restriction ring on the urethra restriction can be finally regulated by regulating the voltage provided by the external power supply circuit, so that the urethra restriction is more comfortable.
Drawings
Fig. 1 is a schematic view of an implantable wireless passive artificial urinary sphincter apparatus provided in an embodiment of the present invention;
figure 2 is a gating schematic of the gating assembly with the artificial urinary sphincter apparatus in a urine storage state;
figure 3 is a gating schematic view of the gating assembly with the artificial urinary sphincter apparatus in a urinated state;
fig. 4 is a schematic view of a confinement ring configuration in an implantable wireless passive artificial urinary sphincter device provided in an embodiment of the present invention;
figure 5 is a flow chart of urination control using an implantable wireless passive artificial urinary sphincter device provided by the present invention;
specific symbols in the drawings are:
A. an in vivo device; B. an extracorporeal device; 1. an in-vivo receiving coil; 2. a piezoelectric pump; 21. a piezoelectric pump air inlet; 22. the piezoelectric pump pumps out; 3. a gating assembly; 31. a gate valve; 32. a gating switch; 4. a confinement ring; 41. an annular air tube; 42. a limiting housing; 5. an air storage bag; 6. a urethra; 7. an external energy supply coil; 8. an external power supply circuit.
Detailed Description
The invention is further elucidated below in connection with the drawings and the examples. It should be understood that the embodiments described herein are illustrative of the invention and are not intended to limit the scope of the invention.
The invention is characterized in that: in order to solve the problems that the manual operation of the artificial urethral sphincter device in the prior art is inconvenient in time consumption, large in size and has foreign body sensation, and the built-in battery is required to be operated for replacing accessories, the implanted wireless passive artificial urethral sphincter device is provided, the effects of being convenient and rapid, reducing the foreign body sensation, and not requiring the operation for replacing accessories are achieved, and the device can be used for performing maintenance-free stable work for a long time.
Fig. 1 is a schematic view of an implantable wireless passive artificial urinary sphincter apparatus in accordance with an embodiment of the present invention. As shown in fig. 1, the implantable wireless passive artificial urinary sphincter device comprises an internal device a and an external device B, wherein the internal device a comprises an internal receiving coil 1, a piezoelectric pump 2, a gating component 3, a limiting ring 4 and a gas storage bag 5, and the external device B comprises an external energy supply coil 7 and an external energy supply circuit 8.
The piezoelectric pump 2, the air storage bag 5 and the limiting ring 4 are all connected with the gating assembly 3 to form an air flow passage from the air storage bag 5, the gating assembly 3 and the piezoelectric pump 2 to the limiting ring 4 through the gating assembly 3.
The external energy supply circuit 8 is connected with the external energy supply coil 7, the external energy supply coil 7 is aligned with the internal receiving coil 1, and the internal receiving coil 1 is used for transmitting energy in a magnetic coupling resonance type wireless energy supply mode to drive the piezoelectric pump 2 to work.
The piezoelectric pump 2 realizes unidirectional constant-speed air passage pressurization and pulse-free output by using standing waves with high frequency and high amplitude of the piezoelectric pump, namely, air flows in from the air inlet 21 of the piezoelectric pump and flows out from the air outlet 22 of the piezoelectric pump, so that reverse circulation cannot be realized.
The gating assembly 3 comprises a gating valve 31 and a gating switch 32; one end of the gate valve 31 is respectively connected with the piezoelectric pump air inlet 21 and the piezoelectric pump air outlet 22, and the other end is respectively connected with the air storage bag 5 and the annular air pipe 41 of the limiting ring 4; the gate valve 31 is used for switching two gas paths, one is an air inflation path for air to flow through the air storage bag 5, the gate valve 31, the piezoelectric pump air inlet 21, the piezoelectric pump air outlet 22, the gate valve 31 and the limiting ring 4, and the other is an air deflation path for air to flow through the limiting ring 4, the gate valve 31, the piezoelectric pump air inlet 21, the piezoelectric pump air outlet 22, the gate valve 31 and the air storage bag 5; the gate switch 32 is operated by pressing to switch the gas path connection mode of the gate valve 31, and selects the inflation or deflation gas path.
The gating component 3 and the piezoelectric pump 2 are matched to control the inflation or deflation of the restriction ring 4, so as to control the restriction ring 4 to squeeze or loosen the urethra 6, thereby achieving the purpose of urine storage or urination.
The gas storage bag 5 is connected with the gating valve 31 and is used for storing gas to maintain the air pressure balance of an air path formed by the annular air pipe 41, the gating valve 31, the piezoelectric pump 2 and the gas storage bag 5 in the limiting ring 4; the pressure of the air storage bag 5 is more than or equal to 6 kilopascals and less than or equal to 7 kilopascals, so as to prevent the symptoms of ischemia necrosis of the urethra 6 caused by excessive pressure and ensure that enough pressure can squeeze the urethra 6 to control urine storage.
The confinement rings 4 are arranged around the urethra 6; as shown in fig. 4, the annular air tube 41 of the restriction ring 4 is attached to the inner wall of the restriction housing 42, the annular air tube 41 is in air-path communication with the gating component 3, the restriction housing 42 wraps the annular air tube 41, and the annular air tube 41 can only expand to one side of the urethra 6 when inflated, so that the effect of squeezing the urethra 6 is achieved.
When the artificial urethral sphincter device is used, the internal device A of the artificial urethral sphincter device is implanted into a human body, the restriction ring 4 is installed around the urethra 6, the internal receiving coil 1 and the gating switch 32 are placed at a position which is close to the body surface under the skin and is easy to contact, the gating switch 32 is pressed, the mode of the gating valve 31 is switched according to the urine storage or urination requirement, the external energy supply coil 7 is close to the internal receiving coil 1 and aligned, the piezoelectric pump 2 is started, gas starts to flow, and the gas enters the annular air pipe 41 to extrude the urethra 6 to store urine, or the annular air pipe 41 discharges gas to loosen the urethra 6 to realize urination.
The piezoelectric pump 2 used in the invention has high air passage pressurizing efficiency, high inflation or discarding speed, time saving and labor saving; the device has small whole volume, no obvious foreign body sensation after being implanted into a patient, and comfortable use; the wireless energy supply mode is adopted, no battery assembly is arranged in the body, and the operation replacement is not needed when the device is normally used under the condition of no device damage, so that the device can stably work for a long time without maintenance.
Fig. 5 is a flow chart of urination control by using the implantable wireless passive artificial urinary sphincter apparatus provided by the present invention, specifically:
s51: an implant device. As shown in fig. 1, the in-vivo device a of the artificial urinary sphincter device provided by the present invention is implanted in a human body, the restriction ring 4 is installed around the urethra 6, and the in-vivo receiving coil 1 and the gating switch 32 are placed in a position close to the body surface under the skin to be easily contacted; the piezoelectric pump 2, the gas storage bag 5 and the limiting ring 4 are all connected with the gating component 3 to form an airflow passage from the gas storage bag 5, the gating component 3 and the piezoelectric pump 2 to the limiting ring 4 through the gating component 3; the external device B is connected with the external energy supply coil 7 and the external energy supply circuit 8, and is carried with the body.
S52: and (5) adjusting the air path. The air storage bag 5 is filled with air and controlled to be 6-7 kilopascals, all the components are connected and air tightness is checked, and the air pressure balance state of the whole air path system of the annular air pipe 41, the gate valve 31, the piezoelectric pump 2 and the air storage bag 5 in the limiting ring 4 is maintained.
S53: and (5) urine storage operation. When urine is to be stored, the gating switch 32 under the skin of the body surface is pressed first, and as shown in fig. 2, the gating valve 31 is switched to an air-charging path; the external energy supply coil 7 is close to the internal receiving coil 1, the internal receiving coil 1 receives the wireless energy supply of the external energy supply coil 7 in a magnetic coupling resonance mode, and the energy received by the internal receiving coil 1 drives the piezoelectric pump 2 to work; the piezoelectric pump 2 is started, gas sequentially passes through the gating valve 31, the piezoelectric pump 2 and the gating valve 31 from the gas storage bag 5, and finally is filled into the annular air pipe 41 of the limiting ring 4, after the annular air pipe 41 is inflated, the limiting shell 42 prevents the annular air pipe 41 from expanding outwards, and the annular air pipe 41 expands inwards to squeeze the urethra 6; the gate valve 31 has one-way conductivity, so that the air filled in is guaranteed not to leak, and the air pressure of the annular air tube 41 in the restriction ring 4 is maintained, and the state of pressing the urethra 6 is maintained, so that urine cannot leak.
S54: urination operation. When urination is to be performed, the gating switch 32 under the skin of the body surface is pressed again, and as shown in fig. 3, the gating valve 31 is switched to an air release path; the external energy supply coil 7 is close to the internal receiving coil 1, and the piezoelectric pump 2 is driven to work in a wireless mode; the piezoelectric pump 2 is started, gas sequentially passes through the gating valve 31, the piezoelectric pump 2 and the gating valve 31 from the annular air pipe 41 of the limiting ring 4, and finally is put back to the air storage bag 5, and the annular air pipe 41 in the limiting ring 4 is deflated and loosens the urethra 6, so that urine is discharged.
The patient can adjust the tightness of the restriction ring 4 around the urethra 6 by adjusting the voltage of the external power supply circuit 8.
After the first implantation, the patient only needs to perform the cycle of the steps S53 and S54 in the subsequent use process.
In summary, the implanted wireless passive artificial urethral sphincter device has higher inflation or deflation speed during working, effective control and time and labor saving during urine storage and urination operation; meanwhile, the invention is wireless and passive, has simple structure and small whole volume, reduces foreign body sensation and uncomfortable feeling of patients, and is suitable for long-time maintenance-free stable work; in addition, the use method provided by the invention can also control the voltage of the external power supply circuit 8 according to the requirement of a patient, so that the tightness limit of the restriction ring 4 on the urethra 6 is adjusted, and the patient is more comfortable.
Based on the invention, specific examples: the implanted wireless passive artificial urethral sphincter device is developed, the volume of the piezoelectric pump 2 is 19 x 2.4mm, the size of the gating component 3 is 10 x 2mm, the size of the limiting ring 4 is 30 x 20mm, the capacity of the air storage bag 5 is 15mL, the diameter of the urethra 6 passes through the hole to be 15mm, the resonance frequency 23kHz coil is used for wireless power supply, the piezoelectric pump 2 works, the air discharge or the air inflation is completed within 20 seconds, and experimental results prove that the device is feasible.
While the foregoing embodiments have been described in detail in connection with the embodiments of the invention, it should be understood that the foregoing embodiments are merely illustrative of the invention and are not intended to limit the invention, and any modifications, additions, substitutions and the like made within the principles of the invention are intended to be included within the scope of the invention.
Claims (10)
1. An implantable wireless passive artificial urinary sphincter apparatus, comprising: the device comprises an in-vivo receiving coil, a piezoelectric pump, a gating assembly, a limiting ring, an air storage bag, an in-vitro energy supply coil and an in-vitro energy supply circuit;
the piezoelectric pump, the air storage bag and the limiting ring are all connected with the gating assembly to form an airflow passage from the air storage bag, the gating assembly and the piezoelectric pump to the limiting ring through the gating assembly;
the external energy supply circuit controls the external energy supply coil, wirelessly transmits energy for the internal receiving coil, drives the piezoelectric pump to work, controls the inflation or deflation of the restriction ring through the cooperation of the gating component and the piezoelectric pump, and further controls the restriction ring to squeeze or loosen the urethra, thereby achieving the purpose of urine storage or urination.
2. The implantable wireless, passive artificial urinary sphincter device of claim 1, wherein said restriction ring is disposed around the urethra, comprising an annular trachea and a restriction housing;
the annular air pipe is attached to the inner wall of the limiting shell and connected into the air flow passage, and when the air is inflated or deflated, the annular air pipe extrudes or loosens the urethra;
the restraining housing is adapted to prevent outward expansion of the annular airway.
3. The implantable wireless passive artificial urinary sphincter apparatus of claim 1, wherein said in-vivo receiving coil receives wireless energy of the in-vitro energy supply coil in a magnetically coupled resonant mode, the in-vitro energy supply coil and the in-vivo receiving coil being in a resonant circuit at the same frequency, the energy received by the in-vivo receiving coil being used to drive the piezoelectric pump.
4. The implantable wireless passive artificial urinary sphincter apparatus of claim 1, wherein said piezoelectric pump has a piezoelectric pump inlet and a piezoelectric pump outlet, and wherein air flow through the piezoelectric pump is unidirectional.
5. The implantable wireless, passive artificial urinary sphincter device of claim 4, wherein said gating assembly comprises a gating valve and a gating switch;
one end of the gating valve is respectively connected with the air inlet of the piezoelectric pump and the air outlet of the piezoelectric pump, and the other end of the gating valve is respectively connected with the air storage bag and the limiting ring;
the gate valve is used for switching two gas path connection modes, one is an air inflation path for air flow passing through the air storage bag, the gate valve, the piezoelectric pump air inlet, the piezoelectric pump air outlet, the gate valve and the limiting ring, and the other is an air deflation path for air flow passing through the limiting ring, the gate valve, the piezoelectric pump air inlet, the piezoelectric pump air outlet, the gate valve and the air storage bag;
the gas in the gating valve can only flow from one direction;
the gating switch is used for controlling the gas path connection mode of the gating valve.
6. An implantable wireless passive artificial urinary sphincter apparatus according to any one of claims 1-5, wherein said balloon pressure is 6 kpa or greater and 7 kpa or less.
7. An implantable wireless passive artificial urinary sphincter device according to any one of claims 1-5, wherein said external power supply coil is aligned with the internal power supply coil during the power transmission to the internal power supply coil.
8. An implantable wireless passive artificial urinary sphincter device according to any one of claims 1-5, wherein said confinement ring, air reservoir surface is coated with an antimicrobial coating.
9. A method of using the implantable wireless passive artificial urinary sphincter device of any one of claims 1-8, comprising the steps of:
implanting the artificial urethral sphincter device into a human body, installing a restriction ring around the urethra, and placing an internal receiving coil and a gating assembly in a position which is subcutaneous close to the body surface and is easy to contact;
and switching the gas circuit connection mode of the gating assembly, aligning the external energy supply coil with the internal receiving coil, then wirelessly driving the piezoelectric pump to work, controlling the inflation or deflation of the annular air pipe, extruding or loosening the urethra by the annular air pipe, and finally completing urine storage or urination.
10. The method of using an implantable wireless passive artificial urinary sphincter apparatus of claim 9, wherein the pressure value within the restriction ring is adjusted by varying the voltage provided by the external power supply circuit to control the power supply voltage of the internal receiver coil to the piezoelectric pump to thereby adjust the tightness of the restriction ring to the urethral restriction.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310577445.5A CN116785020A (en) | 2023-05-22 | 2023-05-22 | Implantable wireless passive artificial urethral sphincter device and use method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310577445.5A CN116785020A (en) | 2023-05-22 | 2023-05-22 | Implantable wireless passive artificial urethral sphincter device and use method thereof |
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| Publication Number | Publication Date |
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| CN116785020A true CN116785020A (en) | 2023-09-22 |
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| CN202310577445.5A Pending CN116785020A (en) | 2023-05-22 | 2023-05-22 | Implantable wireless passive artificial urethral sphincter device and use method thereof |
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| Country | Link |
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| CN (1) | CN116785020A (en) |
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