A kind of for alleviating the medical device of female incontinence
Technical field
The invention belongs to medical instruments field, be specifically related to a kind of for alleviating the device of female incontinence.
Background technology
Female incontinence refers to that urine nonvoluntary spills, and urinary incontinence has brought the trouble of social and health aspect to patient.Urinary incontinence is non-lethal disease, and the mid-90 starts to be considered to one of five large diseases that affect the mankind.Female incontinence is because normal urine storage and to urinate be all not in tune at bladder pressure and urethra pressure.Too high or the urethral resistance of the bladder pressure of urine storage phase declines, and makes bladder can not produce pressure, thereby can not get the control of brain, so can not control by subjective consciousness, by urethra, discharges.Normal voiding needs the combined effect of brain, nerve, bladder, urethra, pelvic diaphragm muscle.Any reason causes the too high or urethral resistance of the bladder pressure of urine storage phase to decline, and all can cause urinary incontinence.
Female patients with urinary incontinence quantity is huge, accounts for the more than 20% of adult.Take community, Beijing sickness rate as 46.5% (94 people/202 people), and wherein more common with middle and aged women, along with the arrival of aging society, the problem of female incontinence is more outstanding, has a strong impact on patient's quality of life.The statistics of U.S. urology department medical association shows, has women over half to have the puzzlement of urinary incontinence, wherein has again nearly half female patients with urinary incontinence to affect quality of life.Generally patient's common paper urine pants or diaper are alleviated incontinence problems, although this method can be alleviated incontinence problems, dress diaper or diaper and can bring sense of discomfort to patient, especially in summer, in the situation of heat, can distribute the taste that is difficult to news.
In order to alleviate female incontinence, conventionally adopt embedded type pessary device or pessulum device, thereby by the effect of expanding, swelling anterior vaginal wall being exerted pressure or by the support arm retroaction application of force, urethra being provided pressure to reach to alleviate female incontinence.
Current pessary device, have that volume is large, have very strong sense of discomfort in patients with implantation body, affecting patient normally works and rests, due to pessary rigid design, can not arbitrarily change along with patient's vagina size, long-time use can produce pathological changes to patient's vagina, is unfavorable on the contrary alleviating patient's urinary incontinence.
Current pessulum device, although volume is little, with respect to pessary, patient's sense of discomfort obtains very large reduction.Pessulum is positioned on the musculus pubococcygeus meat of level, therefore support withstands the rear portion side of bladder conventionally, thereby for correcting the situation of urinary incontinence, but the length of pessulum is subject to the restriction of the width that the vagina of any female individual holds, and its two-dimensional structure, is easy to rotate, therefore pessulum when in use, especially in standing state, can not be held in place, tend to slide or come off.
Chinese patent application 201080032433.5 is improved with regard to the shortcoming of pessulum, pessulum site of action is transferred to and acted on mid-urethra by the trigone of bladder lower position directly over original bladder junction surface, thereby reach the effect of removing female incontinence.By Theoretical Proof, proved the effect that has better releasing female incontinence with respect to pessulum, we carry out the research of clinical effectiveness the embodiment enumerating according to this patent application, discovery is for pessulum, aspect the effect of releasing female incontinence, there iing fine effect, but can't remove very up hill and dale female incontinence, especially after strenuous exercise, patient generally feels uncomfortable.
Summary of the invention
The present invention improves prior art, and provide a kind of for alleviating the medical device of female incontinence, this device volume is little, strong to the adaptation of vagina shape, good stability, can not cause and slide and come off, and contact area very much not can cause that tissue local is downright bad, without complication, produces, and patient compliance is good.
We find by clinical research, and device of the present invention can act on trigone of urinary bladder and urethra top simultaneously, can not only effectively remove female incontinence, and patient compliance is good, without complication.
Device of the present invention is cranked arm by support arm, elasticity and fixed arm forms, support arm and elasticity are cranked arm and are formed Ω shape, the blind end of Ω is support arm, open two ends are that elasticity is cranked arm, two open ends that elasticity is cranked arm and fixed arm phase chain, the symmetrical rounded bendings mutually of two fixed arms, end is disjunct crotch shape, whole device is smooth and without the integrated symmetric structure of corner angle.
More detailed is described below: take support arm as starting point, lower 30 °~60 ° depression angles of horizontal alignment connect elastic device with the form of 1/2~3/4 round-formed arc surface (similar Ω type) from the off, elastic device is that spiralling elasticity is cranked arm, except one end link support arm, one end and fixed arm phase chain in addition, fixed arm is cranked arm link place for starting horizontal stretching gradually with elasticity, when stretching, article two, the fixed arm of symmetry is crooked to the other side each other mutually, and be finally each other the crotch shape that is not connected, fixed arm thickness in side-looking direction is narrowed down by wide gradually, by narrow, broadened gradually overlooking thickness in direction, crotch place is the terminal of this device grown form.
In support arm, there is a clasp at starting point place, the inside, and for fixed tractive one end, the other one end of pull rope does not fix.Pull rope length is pulled out as good to facilitate, and is generally 5cm~8cm.
In grown form of the present invention, support arm horizontal length accounts for 20%~35% of the horizontal total length of device, fixed arm horizontal length accounts for 60%~75% of the horizontal total length of device, the length of support arm and vagina supporting surface is the physiological feature that 0.1cm~5cm. considers all ages and classes women, the length of support arm and vagina supporting surface also can lengthen, its lengthening mode: take support arm top as starting point, gradient along support arm lengthens, and maximum support arm lengths is to 5cm.
This device is except basic feature, can also carry out auxiliary treatment with sub-arm, a kind of form of sub-arm wherein, be defined as sub-arm A, can be by above-mentioned support arm the inside top, starting point place be beginning, extend obliquely and an arc surface upwarping of final formation, the shape of arc surface can be a spoonful type, column type, heart type, ball-shaped.
The above-mentioned sub-arm A of the present invention horizontal length accounts for 20%~35% of the horizontal total length of device, and the length of sub-arm A is 0.1cm~5cm. under relaxed state completely, and sub-arm A and angle that support arm is are 0 °~25 °.
Another form of sub-arm, be defined as sub-arm B, also can be that link place of being cranked arm by above-mentioned support arm and elasticity is beginning, along elasticity crank arm and support arm overlook figure horizontal direction or the direction of level from beginning to support arm direction horizontal-extending, and the final shape forming similar in appearance to support arm, and the form of bifurcation making progress at an angle in support arm.
The above-mentioned sub-arm B of the present invention horizontal length accounts for 15%~25% of the horizontal total length of device, and sub-arm B horizontal length 0.1cm~2cm is under complete relaxed state, and sub-arm B and angle that support arm is are 0 °~25 °.
Can fixed tractive one end on above-mentioned sub-arm.
Overall structure of the present invention preferably selects the good polymeric material of the compatibility to form, and can be one or several compositions in Merlon, polyester, polyacrylamide, poly-perfluoro second propylene, polyfluorinated ethylene, polyformaldehyde, polymethyl methacrylate, polypropylene, politef, polytrifluorochloroethylene, polrvinyl chloride, polyurethane, nylon, siloxanes, carbon fiber, Merlon, polymethyl methacrylate, polystyrene, polyformaldehyde, polyvinyl alcohol, polyamide, polyacrylonitrile, ABS resin, metal material.
Pull rope material can be cotton thread or nylon wire etc.
For the pressure of relieving apparatus to vagina, can enclose resiliency material at apparatus surface, as medical substances such as silica gel, rubber, politef.
The using method of apparatus of the present invention: the invention belongs to medical disposable material, not reproducible use.Device of the present invention is packed in implantation device, and implantation device is inserted in vagina, after delivering to vagina middle part, device is released by the propeller of implantation device, after belting fixes, then implantation device is taken out, and by the loose hauling-out of rope being fixed on device.As long as drag rope when needs are changed, device hauled out together.
Accompanying drawing explanation
Fig. 1 is the front view (wherein 1-support arm, 2-elasticity is cranked arm, 3-fixed arm) of apparatus of the present invention
Fig. 2 is the top view (wherein 1-support arm, 2-elasticity is cranked arm, 3-fixed arm) of apparatus of the present invention
Fig. 3 is the axis figure (wherein 1-support arm, 2-elasticity is cranked arm, 3-fixed arm) of apparatus of the present invention
Fig. 4 is implantation device outside drawing (wherein 4-implantation device, 5-propeller)
Fig. 5 is the propeller propulsion mode exemplary view (wherein 6-vagina middle part, 7-propulsion mode) of implantation device
Fig. 6 is the king-size front view of apparatus of the present invention (wherein 8-extended type support arm, 2-elasticity is cranked arm, 3-fixed arm)
Fig. 7 is apparatus of the present invention front view with sub-arm A (wherein 1-support arm, 2-elasticity is cranked arm, 3-fixed arm, 9-sub-arm)
Fig. 8 is apparatus of the present invention top view with sub-arm A (wherein 1-support arm, 2-elasticity is cranked arm, 3-fixed arm, 9-sub-arm)
Fig. 9 is apparatus of the present invention axis figure with sub-arm A (wherein 1-support arm, 2-elasticity is cranked arm, 3-fixed arm, 9-sub-arm)
Figure 10 is apparatus of the present invention front view with sub-arm B (wherein 1-support arm, 2-elasticity is cranked arm, 3-fixed arm, 10-sub-arm)
Figure 11 is apparatus of the present invention top view with sub-arm B (wherein 1-support arm, 2-elasticity is cranked arm, 3-fixed arm, 10-sub-arm)
Figure 12 is apparatus of the present invention axis figure with sub-arm B (wherein 1-support arm, 2-elasticity is cranked arm, 3-fixed arm, 10-sub-arm)
The specific embodiment
Embodiment 1
As shown in Figure 1-Figure 3, this device comprise support arm 1, elasticity crank arm 2 and fixed arm 3. support arms and elasticity crank arm and form Ω shape, the blind end of Ω is support arm, open two ends are that elasticity is cranked arm, two open ends that elasticity is cranked arm and fixed arm phase chain, two fixed arm symmetrical rounded bendings mutually, end is disjunct crotch shape, whole device is smooth and without the integrated symmetric structure of corner angle, support arm 1 also can lengthen: take support arm top as starting point, gradient along support arm lengthens, and maximum support arm lengths can reach 5cm, as Fig. 6.
This device is by if the implantation device of Fig. 4 is according to as the mode of Fig. 5, device being implanted after vagina, and fixed arm 3 is fixed on this device between uterus fornix and vagina leading portion, and by the longitudinal tension force of self, expansion vaginal sidewall, can firmly fix.The end of fixed arm 3 is made flat and smooth circular-arc, and gradually to crank arm 2 direction thickening of elasticity, for can make implantation device better enter precalculated position, reduce vagina injured.Support arm 1 is by pressurizeing to anterior vaginal wall, reach simultaneously anterior urethra and trigone of urinary bladder are exerted pressure, be different from the mid-urethra of the trigone of urinary bladder of site of action and the site of action of patent 201080032433.5 of pessulum, we find to act on anterior urethra and trigone of urinary bladder simultaneously and exert pressure and can not only extraordinaryly alleviate or eliminate female incontinence, especially urinary incontinence strenuous exercise being caused, and patient's compliance is very good, except sexual life is had to impact, other can not affect substantially.
The present embodiment preparation method: the contour structures according to this example is made injection model, then politef is melted and inject injection machine, cooling rear taking-up model, is again to carry out sterilization after on clasp by traction cotton cord, finally packs and obtain this product.Can adhere to the compliance that the flexible well silica gel of one deck better increases patient at device and the contact surface of vagina in addition.
Clinical efficacy comparison according to the requirement of embodiment 1 to several urinary incontinence apparatus for correcting
Wherein, according to the shape requirement of Figure 18 of patent application 201080032433.5 and Figure 19, the urinary incontinence apparatus for correcting of preparing by injection molding material machine, is defined as device A, preparation material politef.And the embodiment of the present invention 1 material is also politef.
Clinical protocol:
Experimental subject: female old aged people urine incontinence 195 examples
The experimental subject age: 50~60 years old
Clinical manifestation is for firmly, urine independently flows out when cough, walking, clinical scale I level patient 78 examples wherein, and II level patient 89 examples, III level patient 28 examples, implant respectively pessulum, device A and the present invention and carry out clinical efficacy contrast in 24 hours.
Curative effect judgement: adopt Grouts-Blaivas scoring system in post-therapeutic evaluation surgical result standard, in Table 1.
Table 1 Grouts-Blaivas point system
Its 24 hours Clinical efficacy comparisons are in Table 2
Three groups of patients of table 2 implant 24 hours Clinical efficacy comparisons after pessulum, device A and the present invention
Adopt in addition quality of life questionnaire form, do the investigation of patient compliance, before 3 kinds of devices are used, within latter 1 month and 2 months, pay a return visit with using, the results are shown in Table 3
Table 3 is used Life For The Residents of Three Gorges Reservoir Before assessment
In the time of the use Life For The Residents of Three Gorges Reservoir Before assessment of carrying out table 3, use pessulum to find that 1 example infects cystitis, 1 routine nephritis in addition; In the time of operative installations A, find 3 routine cystitis, 1 routine hydronephrosis; When using apparatus of the present invention, do not find complication.
Conclusion: can find out from table 2 and table 3, device of the present invention is after implanting vagina, with respect to pessulum, device A, there is the effect of obvious alleviation urinary incontinence, although be not significantly improved aspect sexual life, but in the project of investigating at other, patient is had to good compliance, and produce without complication, there is fine clinical medicine use value.
Embodiment 2
Device with sub-arm A
As Figure 7-9, comprise sub-arm 9, support arm 1, elasticity and crank arm 2 and fixed arm 3.Wherein support arm 1, elasticity crank arm 2 with fixed arm 3 with in embodiment 1, about support arm 1, elasticity, crank arm 2 identical with the description of fixed arm 3.Difference is sub-arm 9, and sub-arm 9 is that the top, starting point place by above-mentioned support arm 1 interior the inside is beginning, extends obliquely and finally forms an arc surface upwarping, and in the present embodiment, the arc surface of Fig. 7~Fig. 9 be a spoonful type.
This device is by if the implantation device of Fig. 4 is according to as the mode of Fig. 5, device being implanted after vagina, and fixed arm 1 is fixed on this device between uterus fornix and vagina leading portion, and by the longitudinal tension force of self, expansion vaginal sidewall, can firmly fix.The end of fixed arm 3 is made flat and smooth circular-arc, and direction thickening laterally gradually, for can make implantation device better enter precalculated position, reduce vagina injured.Sub-arm 9, by anterior vaginal wall actuating pressure, is exerted pressure to trigone of urinary bladder thereby reach, and support arm 1, by anterior vaginal wall actuating pressure, is exerted pressure to anterior urethra thereby reach, thereby reaches the effect of alleviating or eliminate simultaneously female incontinence.To these two region pressurizations, the urinary incontinence especially strenuous exercise being caused, and also patient's compliance is very good, and except sexual life is had to impact, other can not affect substantially.
The present embodiment preparation method: the contour structures according to this example is made injection model, then polytrifluorochloroethylene is melted and inject injection machine, cooling rear taking-up model, is again to carry out sterilization after on clasp by traction cotton cord, this product is remembered in finally pack.Can adhere to the compliance that the flexible well rubber of one deck better increases patient at device and the contact surface of vagina in addition.
Embodiment 3
Device with sub-arm B
As shown in Figure 10-12, comprise sub-arm 10, support arm 1, elasticity crank arm 2 with fixed arm 3. wherein support arm 1, elasticity crank arm 2 with fixed arm 3 with in embodiment 1, about support arm 1, elasticity, crank arm 2 identical with the description of fixed arm 3.Difference is sub-arm 10, it is beginning that sub-arm 10 be take crank arm 2 link place of support arm 1 and elasticity, along elasticity crank arm and support arm overlook figure horizontal direction or the direction of level from beginning to support arm direction horizontal-extending, and the final shape (similar Ω type) forming similar in appearance to support arm 1, and the form of bifurcation making progress at an angle in support arm 1.
This device is by if the implantation device of Fig. 4 is according to as the mode of Fig. 5, device being implanted after vagina, and fixed arm 1 is fixed on this device between uterus fornix and vagina leading portion, and by the longitudinal tension force of self, expansion vaginal sidewall, can firmly fix.The end of fixed arm 1 is made flat and smooth circular-arc, and direction thickening laterally gradually, for can make implantation device better enter precalculated position, reduce vagina injured.Sub-arm 10, by anterior vaginal wall actuating pressure, is exerted pressure to trigone of urinary bladder thereby reach, and support arm 5, by anterior vaginal wall actuating pressure, is exerted pressure to anterior urethra thereby reach, thereby reaches the effect of alleviating or eliminate simultaneously female incontinence.To these two region pressurizations, the urinary incontinence especially strenuous exercise being caused, and also patient's compliance is very good, and except sexual life is had to impact, other can not affect substantially.
The present embodiment preparation method: the contour structures according to this example is made injection model, then by polyamidation and inject injection machine, cooling rear taking-up model, is again to carry out sterilization after on clasp by traction cotton cord, this product is remembered in finally pack.Can adhere to the compliance that the flexible well politef of one deck better increases patient at device and the contact surface of vagina in addition.
Embodiment 4
The present embodiment is the clinical data of part embodiment 2 and 3.
The device that adopts embodiment 2 and embodiment 3, material used is ABS resin, and prepares by injection machine.
Clinical protocol:
Experimental subject: female old aged people urine incontinence 115 examples
The experimental subject age: 48~57 years old
Clinical manifestation is for firmly, urine independently flows out when cough, walking, clinical scale I level patient 33 examples wherein, and II level patient 59 examples, III level patient 23 examples, implant respectively embodiment 2 and embodiment 3 and carry out clinical efficacy contrast in 24 hours.
Curative effect judgement: adopt Grouts-Blaivas scoring system in post-therapeutic evaluation surgical result standard, in Table 1.
Its 24 hours Clinical efficacy comparisons are in Table 4
Three groups of patients of table 4 implant 24 hours Clinical efficacy comparisons after pessulum, device A and the present invention
Adopt in addition quality of life questionnaire form, do the investigation of patient compliance, before two kinds of devices are used, within latter 1 month and 2 months, pay a return visit with using, the results are shown in Table 5.
The device of table 5:2 kind embodiment is used Life For The Residents of Three Gorges Reservoir Before assessment
In the time of the use Life For The Residents of Three Gorges Reservoir Before assessment of carrying out table 5, do not find complication in addition.
Conclusion: can find out from table 4 and table 5, the embodiment of the present invention 2 and 3 device are after implanting vagina, all there is the effect of obvious alleviation urinary incontinence, although be not significantly improved aspect sexual life, but in the project of investigating at other, patient is had to good compliance, and without complication, produce, there is fine clinical medicine use value.