CN1244783A - Urinary incontinence device - Google Patents

Abstract

A device (10) for managing uninary incontinence comprises a resilient body that engages the external genitalia and sealingly occludes the urethral meatus. In female embodiments, the body (12) fits between the labia minora (40) and the floor of the vulval vestibule (34), occuluding the meatus (38). An adhesive (22) on the body (12) sealingly engages with the meatus (38). In one female embodiment, the body has a base (14) with an adhesive layer (22) that seats against the vetsibule floor (34). A pair of flexible, lateral flaps (18) engage the labia minora (40). A layer of super-absorbent material (62) may be situated between the base (72) and the adhesive layer (92), and/or a layer of scrim material (90) may be so situated. The body (70) may have a longitudinal ridge (74) with a posterior edge (16) having a finger hole (76) to facilitate installation and removal. Several alternative female embodiments are also provided. In male embodiments, the device includes a resilient pad (122) with adhesive (128) on one surface. The pad (122) conforms and adhesively attaches to the penile glans (130), with the adhesive (128) sealingly occluding the meatus. Securing tabs (126) may be provided to adhere to the glans (130) or penile shaft (132).

Description

Urinary incontinence device

Background of invention

The present invention relates to be used to extenuate or the device or the utensil field of mitigation and the relevant difficult problem of people's urinary incontinence.More specifically say, the present invention relates to the movably outside occluder that a kind of human urethra uses.

Owing to disease, urinary incontinence injured or that other reason causes is a lot of people's of puzzlement a difficult problem.Serious incontinence cases usually needs operating intervention to treat, but patient only suffer from bladder regulatory function partial loss or patient be operation should not person's case in, need non-operative treatment.When the masculinity and femininity patient may all be the good object of non-operative treatment, this non-operative treatment mode is particularly suitable for suffering from the female patient of the sporadic loss of bladder regulatory function part, and the sporadic loss of said part is sometimes referred to as " stress incontinence " or " tonicity incontinence ".In fact, this repressive or tonicity incontinence is that the adult women urinates the most common reason of loss.

The non-operative treatment of urinary incontinence comprises the non-therapeutic processing, wherein allows the patient dress utensil or the device that is used for collecting or holding back the urine discharging near urethral orifice (" meatus ").This device is divided into two classes usually: (1) UCD and (2) absorption pad.

The urine gathering-device generally comprises receiving orifice or accepter, is used for holding back from the effusive urine of urethra; Retainer links to each other with accepter or hole, is used for fixing urethral orifice neighbouring accepter or hole; And be used for urine is transported to disposal with the device storage or the container etc. from accepter or hole.The device that is used for female patient of this common description has disclosed in following US patent: 3,512, and 185-Ellis; 3,661,155-Lindan; 4,412,511-Steer etc.; 4,457,314-Knowles; 4,484,917-Blackmon; 4,690,677-Erb; 4,822,347-MacDougall; With 4,846,819-Welch.Another kind of theme about the urine receiving device is a US patent 4,563, and disclosed among the 183-Barrodale etc. " women uses outer conduit " is comprising the conduit of one end insertion urethra.In a lot of this devices, retainer all is assembled into and is inserted between lip, and the anatomical structure by female external genital organs is retained in wherein.The device of Blackmon and MacDougall has also used the auxiliary reservation of binding agent.

The absorption pad class comprises various devices, mainly is that female patient uses, and this pad generally includes to be assembled into and can insert between lip and be retained in wherein absorbing material body by the anatomical structure of female external genital organs.This device generally is similar to menstruation sanitary towel (and in fact can play a part such).Following US patent disclosure can be considered to such device: 3,983,873-Hirschman; 4,595,392-Johnson etc.; 4,627,848-Lassen etc.; 4,673,403-Lassen etc.; 4,743,245-Lassen etc.; 4,804,380-Lassen etc.; With 4,846,824-Lassen etc.A kind of sanitary towel that is configured to keep and can be used to hold back and absorb between lip urine stream is disclosed in the BR patent 754,481.

Though said apparatus is useful to some application, there are a lot of shortcomings in they.For example, the urine gathering-device needs user to dress storage or the container that overflows easily or leak.And this device is more suitable in the user of suffering from the loss of chronic or serious bladder function, rather than only suffers from the patient of medium repressive or tonicity incontinence.Absorption pad expands easily and may be uncomfortable concerning some user, particularly when wet the time.What other defective can be noticed is the stink of urine gathering-device, and these are that people are undesirable.

The use of above-mentioned prior-art devices is based on the urine hypothesis that effusive urine can not or should not stop from urethra.This hypothesis may not be correct in the case of a lot of repressive or tonicity incontinences, and repressive or tonicity incontinence is instantaneous in essence.In this case, urethral orifice is carried out the restraining that outside obturation can provide abundant degree for a lot of patients, but this mode is not noticed by prior art (being most of at least).

Therefore, need a kind of mode that the device that urinary incontinence is effectively handled is provided by the outer obturation of urethral orifice; This device is easy to use and dress comfortable; And provide the safety of good closure to keep.

Summary of the invention

Generally speaking, the present invention is a kind of urethral orifice locking device that comprises projectile body, and said projectile body is assembled into engagement and sealing urethral orifice, and is meshed by the anatomical structure with external genitalia and is retained in therebetween.Say that more specifically with in the embodiment, projectile body is a pad a preferred women, this pad comprises the base of triangle basically or arrow shaped profile, and its profile is fit to the vestibule (front portion of vaginal pore) of sealing pudendum, inaccessible thus urethral orifice.The shape of the side of pad is fit to nympholabial inboard, and engagement is retained on the vestibule pad securely between pad and the labia, with urethral orifice sealing engagement.The face of the relative substrate of pad is equipped with central authorities and swells longitudinally, and when pad was placed in the vestibule, protuberance put between lip.One coil can be interted protuberance, and, perhaps can design a finger-hole and be convenient to identical purpose in the back of protuberance with removing of aid-device.

With in the embodiment, pad is piped basically shape in second preferred women of the present invention, and therefore lacks side or " wing " of first preferred women with embodiment.The end ratio that is somebody's turn to do the suitable vestibule of embodiment of " the no wing " is thought the user that " normally " is narrower.As first preferred women's embodiment, pad has sealed the end (front portion of vaginal pore) of vestibule, inaccessible thus urethral orifice.The shape of the tubular portion of pad is fit to nympholabial inboard, and engagement keeps on the vestibule pad securely between pad and the labia, with urethral orifice sealing engagement.The face of the relative substrate of pad is equipped with central authorities and swells longitudinally, and when pad was placed in the vestibule, protuberance put between lip, helps thus to insert and remove.

In above-mentioned two embodiments, the part with urethral orifice sealing engagement of pad applies with pressure-sensitive, hydrophilic hydrogel binding agent at least, so that be retained on the vestibule.Binding agent and resilience pad are deployed into simultaneously fills between near the lip of vestibule, reaches with the conformal of anatomical structure and complies with, and has strengthened the reservation of device.The advance capital for body can be the coating or suitable antibacterial or the antibacterial that infiltrated, to protect from infection.

With in the embodiment, pad comprises elastomeric bladder or the liquid capsule that is filled with softness, compliance, biocompatibility gel or liquid in the 3rd preferred women of the present invention, and keeps with reinforcement with the hydrophilic hydrogel binding agent coating of pressure-sensitive.Gel-filled liquid capsule launches between lip, complies with the anatomical structure of female external genital organs closely, and by the adhesive closure urethral orifice.

In the embodiment that a lot of male of being fit to use, the present invention includes that approach, a resilience absorption pad, its inner surface is coated with the hydrophilic hydrogel adhesive layer of pressure-sensitive.This pad is complied with the glans penis of penis, and sticks to movably on the penis by adhesive means, and binding agent has also sealed with obturation urethral orifice thus.With in the embodiment, spacer has oval-shaped basically middle body such male, wherein has the draw ring that extend a pair of side, and the end of each draw ring twines so that will fill up fixing on the throne around glans penis.With in the embodiment, spacer has a central enclosure portion another male, wherein has a plurality of draw rings that radially extend and fixes device.With in the embodiment, the structure of pad is for covering the common hemispherical cover of glans penis essential part the another one male.As women's embodiment, the male can be that coating or the medicinal compound that infiltrated are as antibacterial or antibacterial with the pad of embodiment.

Below will figure out the novel and useful device that processing incontinence provided by the invention is used.For example, device less, inconspicuous, be easy to use, dress comfortable.By allowing user effectively to keep urine, device of the present invention has avoided allowing in the above-mentioned prior art of enumerating the existing problem of device of urinating.Device of the present invention can be made into the most desirable each different users's of being fit to all size and shape.The manufacturing economy of device, and can be disposable product therefore.

The advantage of these and other will be realized from the following detailed description better.

The accompanying drawing summary

Fig. 1 is the perspective view of first preferred women of the present invention with the female incontinence device of embodiment.

Fig. 2 is the bottom plan view of Fig. 1 device;

Fig. 3 is the side view of Fig. 1 device;

Fig. 4 is the front view of Fig. 1 device;

Fig. 5 is the plane graph of Fig. 1 device, and display device is placed in the female external genital organs;

Fig. 6 is the sectional view of Fig. 5 along the 6-6 line;

Fig. 7 is the front view of first preferred women with first kind of improved form of device embodiment;

Fig. 8 is the perspective view of first preferred women with second kind of improved form of embodiment;

Fig. 9 is the sectional view of Fig. 8 along the 9-9 line;

Figure 10 is the sectional view identical with Fig. 9, shows the flexed portion of pad side;

Figure 11 is the sectional view of first preferred women with the third improved form of embodiment;

Figure 12, the sectional view identical with Figure 11 shows the flexed portion of filling up side;

Figure 13 is the perspective view of second preferred women of the present invention with embodiment;

Figure 14 is the sectional view of Figure 13 along the 14-14 line;

Figure 15 is the sectional view identical with Figure 14, shows the improved form of second preferred women with embodiment;

Figure 16 is the sectional view of female external genital organs, shows the vestibule of the structure that second preferred women complies with embodiment;

Figure 17 is the sectional view of first preferred women with the 4th kind of improved form of embodiment, and wherein pad comprises layer of super absorbent material;

Figure 18 is the sectional view identical with Figure 17, shows that apparatus of the present invention are placed in the female external genital organs;

Figure 19 is the sectional view identical with Figure 18, shows to have absorbed the superabsorbent material behind the moisture;

Figure 20 is the perspective view of first preferred women with the 5th kind of improved form of embodiment;

Figure 21 is the sectional view of Figure 20 21-21 along the line;

Figure 22 is the perspective view identical with Figure 20, and the finger that shows the people inserts the device of finger-hole;

Figure 23 is the sectional view identical with Figure 21, shows the six kind improved form of first preferred women with embodiment;

Figure 24 is the perspective view of the 3rd preferred women of the present invention with embodiment;

Figure 25 is the sectional view of Figure 24 25-25 along the line;

Figure 26 is the perspective view of first preferred male of the present invention with embodiment;

Figure 27 shows that Figure 26 embodiment sticks to the perspective view on the glans penis;

Figure 28 is the perspective view of second preferred male of the present invention with embodiment;

Figure 29 shows that Figure 28 embodiment sticks to the perspective view on the glans penis;

Figure 30 is the perspective view of the 3rd preferred male of the present invention with embodiment.

Detailed Description Of The Invention

The 1-4 with the aid of pictures of elder generation, accompanying drawing have shown the women urinary incontinence device 10 of first preferred women of the present invention with embodiment.Device comprises a device body or fills up 12, made by the resilient foams material of biocompatibility.A kind of material of suitable type is to start the foam that forms by toluene di-isocyanate(TDI) (TDI) or methylenediphenyl diisocyanates (MDI) through water for the prepolymer of raw material.This prepolymer is by W.R.Grace ﹠amp; Co.-Conn., (Lexington Massachusetts) (TDI) (MDI) sells with " HYPOLPLUS " with commodity " HYPOL " by name organic chemicals Division.

Perhaps, pad 12 can be by Biodegradable material such as cellulose or cotton fiber manufacturing.Can also use polyurethane foam, reach biological degradability by hydrolysis main chain weak bond such as amino.Other foamed materials such as polyolefin also can use, and by in main polymer chain, using weak bond such as starch to reach the hydrolysis biological degradability.

As shown in Figure 2, pad 12 comprises the substrate 14 with blunt arrow normal configuration.In first preferred embodiment of the present invention, substrate can be a concave surface slightly as shown in Figure 4.Perhaps, substrate 14 can be made as shown in Figure 7 convex surface slightly, so that those may find that this structure dresses more comfortable user.Substrate 14 has the rear end 16 of spill, and side 18 comes to a point mutually slightly gradually, extends to form circular front end 20.Therefore front end 20 is narrower than rear end 16.

The surface of pad is an adhesive surface, so that be retained at the end of vestibule.In this embodiment of the present invention, substrate is coated with adhesive phase 22, and this adhesive phase comprises pressure-sensitive, hydrophilic hydrogel adhesive material.(Minneapolis Minnesota) sells with the trade name of " PROMEON " this hydrogel adhesive by the PromeonDivision of Medtronic Inc..US patent 4,593 has the detailed description of this hydrogel composition among the 053-Jevne etc., its disclosure is incorporated in this as a reference.

Another kind of type shows that the binding agent of good result is polymethylacrylic acid 2-hydroxy methacrylate (PHEMA) and Polyethylene Glycol (PEG) mixture as plasticizer.The percentage composition of PHEMA can be that about 45%-is about 75%, and the respective range of PEG is about 55%-about 25%.Preferred compositions is about 53%-54%PHEMA and about 47%-46%PEG.The percentage composition of PHEMA is low more, and the viscosity of generation is big more, and the percentage composition of PHEMA is high more, produces high more durability.The molecular weight of PEG is about 400-about 1000, preferred 400.PHEMA is the mixture of low-molecular-weight PHEMA (Mw about 10,000-about 100,000) and high molecular PHEMA (Mw is greater than about 100,000) preferably.Low Mw PHEMA provides cohesive, and the globality of high Mw PHEMA improvement viscosity structure.The PHEMA mixture is low Mw PHEMA of about 10-50% and the high Mw PHEMA of about 90-50%, determines accurate mixture according to required concrete viscosity.

As mentioned above, preferred plasticizer is PEG, but can use other plasticizer such as propylene glycol, polypropylene glycol (PPG) or glycerol.

Made by TDI or MDI if fill up 12, then cushion material itself can reach viscosity by in foamy water start-up course TDI or 1: 1 weight ratio of MDI being mixed with about 0.25-0.50mol ammonium hydroxide.The material of gained has positively charged surface, thereby adheres to (as nympholabial vestibule and inner surface) on the electronegative mucoid surface.

Perhaps, pad can wholely be made with binding agent, as above-mentioned PHEMA/PEG mixture.

Side with respect to substrate 14 in the pad 12 comprises that central authorities reinforce protuberance 26 longitudinally, form the thick of pad 12.If adopting substrate is the routine understanding of pad 12 " bottoms ", then pad can be defined as and have and substrate facing surfaces 27, and this surface tilts from swelling any lateral edge 18 " downwards " of 26 both sides, reduces gradually Zi the thickness that swells to the edge thereby fill up.From another mode, pad can be defined as " top " or most advanced and sophisticated 28 that have from substrate 14 to protuberance 26 and be narrow cross sectional shape.The structure of gained is that lateral section (by the swelling 26 interceptings) formation that causes pad has fillet and the lateral similar leg-of-mutton shape of nick, as shown in Figure 6.Equally as shown in Figure 3, protuberance 26 has from filling up the leading edge 30 that 12 tip 28 forward end 20 " downwards " come to a point gradually.Thereby filling up 12 front end 20 compares thickness with rear end 16 and reduces basically.

Handle is housed on 10 or draw ring is favourable at device, it can be and pad 12 Unitarily molded being in the same place, or on connecting afterwards.In first embodiment preferred, handle is ring or encloses 32, preferably wears with line, and it interted pad 12 from the side.Though enclose 32 position is not crucial concerning its function, enclose 32 be preferably placed at protuberance 26 front ends 28 near, it will be described below function.

Fig. 5 and 6 has shown the incontinence device 10 that is placed in the female external genital organs.Device 10 is placed on the vestibule 34 that substrate 14 is located in pudendums 36 (front of vaginal pore 37), inaccessible thus urethral orifice 38.Adhesive surface is enough to seal the anti-arresting enursis of urethral orifice.The side 18 of pad and front end 20 plug are nympha 40 times.Engagement has strengthened and has filled up in 12 engagements that are retained in vestibule 34 between nympha and the inclined surface 27.The concave surface that fills up in 12 rear ends 16 allows the bigger surface area of nympha engagement, stays the space for vaginal pore 37 simultaneously.Protuberance 26 extends between lip, and encloses 32 and stretch out between the labium majus (not shown), helps hands to grab thereby expose, and removes device.

Pad 12 can be that various sizes are to adapt to the people of various kinds.The length of pad should and the anterior lip and the distance between the nympha junction of vaginal orifice nearly equal.The width of pad should most desirably be complied with the width of vestibule basically.The individual can adjust preliminary dimension and do best adaptation.In some cases, before the size of fixed pad, can get the model of pudendum relative section.

Adhesive layer 22 not only provides the sealing of the fluid-tight of urethral orifice, but also it is minimum to have reduced sliding into of device.Central uplift 26 provides rigidity, make the anti-distortion of pad and under the fluid pressure of urine the splitting of adhesive layer, strengthened the fluid-tight sealing of pad thus to urethral orifice.It is favourable that adhesive phase is expanded on the labia mating surface 27, has further strengthened the stability of device thus.

First preferred women's embodiment is the aforesaid incontinence device of structure according to the present invention, can make to stand at most at least about 100, preferably do not have the short time of obvious seepage to urinate flowing pressure to about 170 cm of water.The pressure of this scope causes the blank of nonvoluntary urine in repressive and the tonicity incontinence cases with generality, and 170 cm of water are that about maximum of typical adult women is born pressure.

Optionally, medicinally active compositions is provided for the foamed materials and/or the adhesive surface of pad.For example can use antibacterial or antibacterial, as silver oxide or silver azide.

First embodiment preferred is fit to much improve, so that can be more comfortable to some people.For example, Fig. 8,9 and 10 has shown a kind of improved device 50, and this device comprises except that vertical protuberance 54 thickness and fills up 52 uniformly basically.This improvement provides the side 56 than the easier bending of embodiment shown in Fig. 1-7.Shown in Figure 11 and 12, form longitudinal fluting 58 by each limit further bigger bendability can be provided on protuberance 54 both sides.

Another optionally can be provided with short projection 59, as Fig. 9 and 10 in substrate.The effect of projection 59 is localizers of urethral orifice, correctly the laying of aid-device.Projection 59 can also strengthen the obturation of urethral orifice.

First preferred women sees Figure 17,18 and 19 with the another kind improvement of embodiment.As shown in these figures, improved device 60 comprises a super-absorbert water wetted material layer 62, adjacent to the suprabasil adhesive phase 64 of pad.Hydrophilic layer 62 is the mixture of PHEMA/PEG binding agent and microsponge material such as carboxymethyl cellulose (CMC) preferably.Hydrophilic layer 62 is extracted moisture out and is absorbed moisture from adhesive phase 64, provide to postpone the service life that saturation has prolonged binding agent.As shown in figure 19, moisture absorption causes hydrophilic layer 62 to expand, closure that can intensifier.

Figure 20,21 and 22 has shown the another kind improvement of first preferred women with embodiment.In these figure, improved device 70 comprises that one has the whole vertically pad 72 of protuberance 74.There is a finger-hole 76 back of protuberance 74.Finger-hole 76 normally collapses flat, as shown in figure 20.As shown in figure 22, it opens the finger 78 of accepting user, helps to lay and remove.

In Figure 21, install 70 according to the show and have one and directly be coated in pad 72 suprabasil adhesive phase 80, as previously mentioned.Figure 23 has shown the another kind of characteristics that can be spiked into first preferred women with the further improvement of conduct in aforementioned any change scheme of embodiment.In this variation or improvement, in being coated in the suprabasil binding agent 92 of pad, wrap into a screen covering (scrim) layer 90.Screen covering layer 90 non-fabric sheet that is preferably thin, that can make the enhanced polyester of elastomeric material.In the present invention, screen covering layer 90 has increased the structural integrity of adhesive material, has strengthened the ruggedness of device thus.As shown in figure 23, before binding agent is solidified into semisolid, screen covering layer 90 is placed in the binding agent.Perhaps, can before the applying adhesive screen covering layer 90 be provided in the substrate of pad, the screen covering layer will be interlayer between the substrate of binding agent and pad this moment.

Notice more of the present invention may user vestibule at the bottom of relative narrower.Such anatomical structure is seen Figure 16, has wherein shown the simple sectional view of female external genital organs, and 94 have defined relative narrow space near urethral orifice 98 with nympha 96 at the bottom of the vestibule.Concerning such anatomical structure, above-mentioned first preferred women may be uncomfortable with embodiment, perhaps be not suitable for fully, so, for these user have been imagined second preferred women's embodiment shown in Figure 13,14 and 15.

According to second preferred women's embodiment of the present invention, the women comprises piped basically pad 102 with urinary incontinence device 100, and its whole basically outer surfaces are coated with the binding agent 104 of type as mentioned above.Pad 102 has a vertical protuberance 106, and it is applying adhesive not preferably, with the grasping element of helping lay and remove.Shown in Figure 13 and 14, tubular pad can have plurality of stepped serrations basically.Perhaps, as shown in figure 15, the pad 102a with similar round triangular-section may be more suitable for some user.

Figure 24 and 25 for example understands the 3rd preferred women's embodiment of the present invention.That urinary incontinence device 110 in this embodiment comprises is one thin, elastic container or capsule 112, and described capsule is made by polyurethane or similarly thin, elastic elastomeric material.To suitable biocompatible liquid or the gel 114 of capsule 112 fillings,, form compliance liquid capsule by pin then with the pinprick sealing.The raw material that filling liquid capsule is used is hydrogel preferably, is similar to above-mentioned hydrogel adhesive.Basically whole outer surfaces of liquid capsule are coated with the binding agent 116 as above-mentioned type.

In the use, will install 110 and be inserted under the nympha, so as the end of sealing vestibule, inaccessible urethral orifice.The liquid capsule is complied with the anatomical structure of female external genital organs, is full of between lip, and by the adhesive closure urethral orifice.Because the liquid capsule is obeyient so that can be used for various anatomical structures, reaches higher comfortableness.Be provided with on the device one not the draw ring 118 of the protuberance of applying adhesive be favourable, grasp by user and be convenient to lay and remove device 110.

Figure 26-30 understands that for example the present invention is fit to several embodiments that the male patient uses.According to the embodiment of Figure 26 and 27, the male comprises thin, a flexible resilience pad 122 with urinary incontinence device, and it can be made with any material of pad by women shown in above-mentioned Fig. 1-2 of being used to form 3.Pad 122 middle bodies 124 with ordinary elliptical, two ends are sheets 126 of a pair of sideways expansion.The inner surface that the hydrophilic hydrogel adhesive layer 128 of the useful pressure-sensitive of spacer provides, this adhesive phase can form in a manner described.Pad 122 is complied with the glans penis 130 of patient's penis 132, and by adhesive phase 128 it is kept thereon movably, and binding agent has also sealed with obturation the urethral orifice (not shown) thus.The middle body 124 engagement urethral orifices of ordinary elliptical, and play sealing and inaccessible function.Sideways expansion sheet 126 is wrapped in around the distal part of doing of penis 132, so as will to fill up 122 bonding firmly in position.

In the embodiment of Figure 27 and 28, the male comprises the pad 142 with central authorities sealing and inaccessible part 144 with urinary incontinence device, and wherein said middle body has the sheet 146 of a plurality of radial expansion, and pressure will install bonding firmly on glans penis 130.Equally, the inner surface of pad 142 is provided with the layer 148 of above-mentioned binding agent.

According to the embodiment of Figure 30, the male comprises pad 152 with urinary incontinence device, it be shaped as the common hemispherical cover of complying with and cover glans penis 130 essential parts.Equally, the inner surface of pad 152 is provided with the layer 154 of above-mentioned binding agent.In this embodiment, pad 152 has one and the middle body 154 of urethral orifice engagement, and and middle body 156 be one whole and from peripheral part of middle body 156 expansions, it sticks on the glans penis 130 movably by adhesive phase 154.

With embodiment, the male can apply or soak with pharmaceutically active compound with the pad of embodiment, as antibacterial or antibacterial as the women.As selection, this chemical compound also can add binding agent.

By above description, advantage of the present invention will readily appreciate.Incontinence device of the present invention provides effective processing to urinary incontinence, particularly to repressive and tonicity incontinence, and do not have the inconvenience and the uncomfortable problem of urine gathering-device and absorption pad in the prior art.The present invention uses easily and dresses comfortable.Be easy to molding and typing, the best body structure that effectively and cosily meets each user.Make simple and economically, can make disposable product.

Though described a lot of preferred embodiment of the present invention and evolutionary approach, should understand to persons skilled in the relevant art and still can have further improvement and variation.This variation and improvement should be considered to be in determined essence of the present invention of following claims and the protection domain.

Claims (20)

1. control the device of urinary incontinence by the urethral orifice of inaccessible patient's external genitalia, this device comprises: can with the resilience pad of patient's external genitalia engagement, this spacer has the surface that comprises bonding measure, said bonding measure is used for sealing and inaccessible urethral orifice.

2. the device of claim 1, wherein bonding measure comprise and are coated in the hydrophilic hydrogel jointing material of lip-deep pressure-sensitive.

3. the device of claim 1 wherein fills up basically by bonding measure and external genitalia maintenance engagement.

4. the device of claim 1 wherein fills up by the biocompatible foam material and makes.

5. the device of claim 4, wherein foamed materials is to be started through water by the prepolymer that is selected from toluene di-isocyanate(TDI) and methylenediphenyl diisocyanates to form.

6. the device of claim 5, wherein bonding measure is by forming at water start-up course prepolymer and ammonium hydroxide reaction.

7. the device of claim 2, wherein jointing material is the mixture of Polyethylene Glycol and polymethylacrylic acid 2-hydroxy methacrylate.

8. the device of claim 1, wherein bonding measure comprises pharmaceutically active compound.

9. the device of claim 1, wherein patient is the male, external genitalia comprises the penis with glans penis, thereby and pad comprise the inaccessible urethral orifice of the part that can comply with glans penis.

10. the device of claim 9, wherein pad comprises: and the middle body of urethral orifice engagement and from the retainer of middle body expansion, be used for pad firmly on penis.

11. the device of claim 10, wherein middle body is oval basically, and wherein retainer comprises a pair of sheet from middle body two ends sideways expansion.

12. the device of claim 10, wherein retainer comprises a plurality of sheets from the middle body radial expansion.

13. the device of claim 10, wherein pad comprises the cover of hemispherical basically with middle body, and wherein retainer comprises with the middle body integration and from peripheral part of the cover of middle body expansion.

14. control the device of urinary incontinence by the urethral orifice of inaccessible patient's male external genitalia, this device comprises: can with the resilience pad of patient's external genitalia engagement, this spacer has the surface that comprises bonding measure, is used for sealing and inaccessible urethral orifice.

15. the device of claim 14, wherein pad comprises: with the middle body of urethral orifice engagement and the retainer of expanding from middle body, be used for pad firmly on penis.

16. the device of claim 15, wherein middle body is oval basically, and wherein retainer comprises a pair of sheet from middle body two ends sideways expansion.

17. the device of claim 15, wherein retainer comprises a plurality of sheets from the middle body radial expansion.

18. the device of claim 15, wherein pad comprises the cover of hemispherical basically with middle body, and wherein retainer comprises with the middle body integration and from peripheral part of the cover of middle body expansion.

19. comprising, the device of claim 14, wherein bonding measure be coated in the hydrophilic hydrogel jointing material of lip-deep pressure-sensitive.

20. the device of claim 14, wherein pad is to be made by the biocompatible foam material, and said foamed materials is to be started through water by the prepolymer that is selected from toluene di-isocyanate(TDI) and methylenediphenyl diisocyanates to form.

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