CN104720956A - Fistulation pocket appliance - Google Patents

Abstract

A connecting assembly used for fastening an adhesive dry film to fistulation appliance equipment relates to capturing connection acting between the adhesive dry film and the fistulation appliance, and due to the capturing connection, relative capturing displacement between the whole adhesive dry film and the inlet hole diameter of the appliance is allowed so that the adhesive dry film can be driven to approach to an adaptive area from the side not next to the body. The connecting assembly further relates to fixed connection for fixing the adhesive dry film to an operation position.

Description

Ostomy pouch appliance

The application is the divisional application of Chinese patent patent application of application number 200980146185.4, November 30 2009 applying date, denomination of invention " ostomy pouch appliance ".

Technical field

The present invention relates to ostomy appliance, such as ostomy pouch.Especially, the present invention relates to so-called single type ostomy appliance, wherein shapeable viscosity human body adnexa is permanently attached to pocket.

Background technology

Generally by means of viscosity wafer, the ostomy appliance in modern times is attached to human body.The viscosity wafer the most often used is designed to have predetermined solid shape.Wearer cuts the central opening of viscosity wafer to mate his or her ostomy size and dimension, uses shears along the guide line cutting printed in advance on viscosity releasing piece for some standard size.

In so-called single type utensil, viscosity wafer is permanently attached to utensil, reaches the degree that viscosity wafer can not easily be separated when not damaging the risk of utensil.Intention uses single type utensil unit as a whole.Sometimes the complaint sent about single type utensil is the size always easily not adapting to the central opening in viscosity wafer for old, eyesight weaken or unskillful people, because utensil hinders from side close.

In so-called two-piece appliances, viscosity wafer forms the part by discharging the independent human body accessory assembly therefor connecting attachment.Two-piece appliances allows to be separated human body adnexa when not damaging from utensil, makes at least one continuation in parts be functionally available.Such as, human body adnexa can appropriate position still on human body, and installs and replace pocket and replace used pocket.Although two-piece appliances allows better close to adapt to wafer, the common complaint about two-piece appliances does not always easily make assembly alignment, especially for old, eyesight weaken or unskillful user.

U.S. Patent No. 6,840,924 single type or the two-piece type ostomy appliances describing the improvement comprising moldable adhesive (moldable adhesive), wherein, can be come manually to the self-defined cooperation moulding to provide stoma at least partially of adhesive plaster by wearer.This substitute mode self-defining ratio is carried out by providing better in the prospect that stoma coordinates along the cutting of standard size guide line is obtainable to wafer.Expect to realize good cooperation, to reduce stoma Dermal exposure in leaving ostomy stool.Stoma skin can be quite responsive, and easy inflammation or infection when being contacted by stool.Leave ostomy stool and can comprise Digestive system from human body, and this pseudo body fluid also may attack stoma skin, causes exfoliation.The effectiveness of adhesive plaster is also little by little reduced by stool contact.But ostomy have many different size and dimensions.As in U.S. Patent No. 6,840, in 924, the advantage of the moldable adhesive of instruction is that adhesive plaster can fashion into and closely mates ostomy accurate dimension and shape by user.

In U.S. Patent No. 6, the utensil of 840,924 is implemented as in the form of two-piece type ostomy appliance, and wearer can from both sides (comprising non-Body contact side) close to moldable adhesive when pocket is separated from human body adnexa.This can make wearer easily such as by being folded by adhesive plaster from non-Body contact side or rolling back and mould adhesive plaster.But, as shown in the pocket 20 in Fig. 1 of accompanying drawing, when being implemented as the single type utensil of conventional pattern, close to more limited.Wearer can only close to moldable adhesive 21 to mould from Body contact side 22 ostomy aperture, instead of from the relative non-Body contact side 23 covered by irremovable pocket 20.It is more difficult that this makes to mould adhesive plaster, and this means aperture shape and size may not as adhesive plaster can from both sides close to time so accurate.

WO2004/084777 and WO2006/035014 describes alternative single type ostomy pouch, and viscosity wafer is attached to pocket by two kinds of dissimilar attachments wherein using or arc fan-shaped with first and second of complementation jiaos to extend (its complete together extend around ostomy aperture).First jiao around ostomy aperture fan-shaped in, wafer is permanently immovably attached.Second jiao around aperture fan-shaped in, wafer is not attached at first or can be attached releasedly.Second jiao fan-shaped is said to be to allow pocket to be partially folded half-open wafer in the second fan-shaped finite region, allows the gap by producing between wafer and pocket close.This promotes cutting adhesive plaster close to being said to be, or coordinates independent containment member, or the removal of independent disposable interior pocket and cooperation.But this type of solution illustrates combined with single type utensil irremovable human body adnexa for the two-piece type behavior intrinsic incompatibility be associated with trial.Use this type of solution, first fan-shaped (wherein human body adnexa is irremovable) hinders close to human body adnexa, because pocket can not be folded in the region.Unless made the second fan-shaped anomaly large, otherwise still may be restricted the close of adhesive plaster generally, make old or unskillful people be difficult to use this utensil.In addition, at (i) the first and second fan-shaped some place met at the periphery in ostomy aperture, and/or (ii) is at the folding recess of used reinforcing ring or fold place (in view of in all these inevitable discontinuities in some place), may there is weakness in the sealing between panel and pocket.

The conventional single type pattern of Fig. 1 and the replacement described in WO2004/084777 and WO2006/035014 arrange another to manufacture restriction be the limit usually needing the size of pocket 20 to be defined as extending beyond in all sides adhesive plaster 21.This geometry is considered to be present in the single type pocket of current obtainable all large-scale production, and is the consequence of used manufacturing technology.Described technology requires usually after adhesive plaster 21 has been attached at its operating position around entrance hole diameter 27, and the space for the manufacture of equipment starts with the material close contact for pocket wall 24,25 to form girth seam 26 and to impress material.Pocket 20 projects significantly to entrance hole diameter 27 usually below to provide the main trapped volume of pocket 20, and therefore this geometry does not cause problem for the lower part of pocket.But, also need pocket 20 upwards to extend on adhesive plaster 22 and/or extend to the either side of adhesive plaster 22, causing not by the headroom 28 used.This type of headroom 28 is less desirable, because it can not be readily utilized as a part for the trapped volume of pocket, and it only increases the size of pocket 20 undesirably.

The invention provides the wonderful solution of these problems.

Summary of the invention

An aspect of of the present present invention provides the connecting device for viscosity wafer being fastened to ostomy appliance, and this connecting device comprises:

Viscosity wafer is connected with the restrained motion between utensil, it allows the relative shift between the entrance hole diameter of (i) whole viscosity wafer and (ii) utensil substantially, and this restrained motion is connected between (a) operating position and approximated position along relative shift described in restrained motion locus guiding; And

Be fixedly connected, it is for fixing viscosity wafer and utensil when being in operating position.

On operating position, viscosity wafer is superimposed on around the entrance hole diameter of utensil, and can being covered by utensil in non-side next to the skin by adaptation zone of viscosity wafer.Approximated position provides from non-side next to the skin can adaptation zone close.

This type of layout can by the alignment guidance of wafer and utensil to operating position, more easy for the people making this type of aim at for old, un-skill or eyesight weaken.Meanwhile, described restrained motion connects permission, and whole viscosity wafer is relative to the relative shift of entrance hole diameter substantially, and permission is close to make viscosity wafer adapt to ostomy size and/or the shape of user.Described restrained motion connects can comprise articulated link chain, the track of this hinged restriction restrained motion.

Of the present invention can be used for strengthening to viscosity wafer in this respect together with single type utensil close, avoids as problem that is integrally of the prior art or partly irremovable viscosity wafer simultaneously.Make whole viscosity wafer can allow the easier adaptation of wafer (no matter be by being formed ostomy aperture, cut or be shaped, or by coordinating the independent containment member at ostomy aperture place and/or be shaped) relative to the ability that relative shift is carried out in the entrance hole diameter of pocket.

Similarly, the easier aligning that can also be used for promoting member in this respect together with two-piece appliances of the present invention, and reduce indistinctively for make wafer be adapted to ostomy size and/or shape close to easness, be not reduced in the ability be positioned at by human body adnexa before being fixed on operating position relative to human body adnexa by utensil on human body yet.Restrained motion connects and is fixedly connected and can comprise and can discharge coupling part.

A second aspect of the present invention provides the single type utensil comprising and capture connection, described in capture connect to allow the mode of the entrance hole diameter of pocket and the relative shift substantially between whole viscosity wafer permanently viscosity wafer to be attached to utensil with capturing.

The described scope of capturing movement of capturing between connection restriction utensil and viscosity wafer.Capture moving range to comprise:

(i) overlap-add operation position, on this position, viscosity wafer is superimposed on around entrance hole diameter, and the adapted to part of viscosity wafer is covered in non-side next to the skin by utensil; And

(ii) non-superimposed position, it provides the close of the adapted to part from non-side next to the skin to viscosity wafer.

Described capture connection can be restrained motion as above connect to provide alignment guidance, or described in capture connect can be the tethers not limiting particular pilot track.In any one situation, it is more easily close that the use of capturing connection promotes the viscosity wafer of single type utensil, avoids the problem as the integrally or partly immovable viscosity wafer in this area simultaneously.Make whole viscosity wafer can allow to adapt to the easier adaptation (no matter be by being formed ostomy aperture, cut or be shaped, or by coordinating the independent containment member at ostomy aperture place and/or be shaped) of part relative to the ability that relative shift is carried out in the entrance hole diameter of pocket.Describedly capture the above-mentioned potential sealing problem that connection also makes it possible to avoid discontinuous place, at described discontinuous place, immovable and movably fan-shaped both directly and entrance hole diameter junction.

Describedly capture connection and also make it possible to use viscosity wafer, when it is on the operating position being in ostomy aperture, extend to always or even exceed the circumference of pocket.This type of geometry becomes and can easily realize, because capture the replacement position connecting and allow viscosity wafer to be positioned or to be displaced in pocket profile, to make it possible to perform circumference welding and coining manipulation around pocket profile.

In either side of the present invention, described ostomy appliance can be ostomy pouch, or some other fistulation equipment of such as ostomy port or controlled evacuator.

Term as used herein " be permanently attached " (or similar phrase) means each and to be so attached by force to such an extent as to they can not be separated when not destroying or damaging, itself and do not have to prevent from during optional equipment being again attached.

Although illustrated with claims the feature being considered to have special significance above, the rights protection to any novel feature described herein and/or shown in the drawings or thought can be sought, no matter whether highlighted thereon.

Accompanying drawing explanation

Fig. 1 is the side schematic sectional view of the exemplary single type ostomy pouch appliance of prior art.

Fig. 2 is the schematic cross sectional views of the first embodiment of the present invention illustrated on approximated position.

Fig. 3 is the schematic rear view of the first embodiment on approximated position.

Fig. 4 is the schematic cross sectional views of the first embodiment illustrated on operating position.

Fig. 5 is the schematic rear view of the first embodiment on operating position.

Fig. 6 is the schematic cross sectional views that the example utensil of the first embodiment being assembled to human body is shown.

Fig. 7 is the schematic cross sectional views of capturing the improved form of connection that the first embodiment is shown independently.

Fig. 8 is the schematic rear view of the second embodiment illustrated on approximated position.

Fig. 9 is the schematic cross sectional views of capturing connection of the second embodiment illustrated independently on its approximated position.

Figure 10 is the schematic rear view of the amendment of the second embodiment illustrated on operating position.

Figure 11 is the schematic rear view of the 3rd embodiment of the utensil illustrated on its approximated position.

Figure 12 is the schematic cross sectional views of the 3rd embodiment illustrated on its approximated position.

Figure 13 is the schematic rear view of the 4th embodiment of the utensil illustrated on its approximated position.

Figure 14 is the schematic cross sectional views of the 4th embodiment illustrated on its approximated position.

Figure 15 is the front schematic view of the 5th embodiment of coupling assembly.

Figure 16 is the schematic side elevation of the coupling assembly of Figure 15.

Figure 17 is the schematic rear view of the 6th embodiment of the ostomy appliance illustrated in its operative position.

Detailed description of the invention

With reference to figure 2 ~ 8, the first embodiment illustrates and comprises ostomy pouch 32 and be permanently attached to the single type ostomy appliance 30 of the viscosity wafer 34 of ostomy pouch 32.Ostomy pouch 32 can be any one in colostomy bag, regeneration of urethra art bag and ileum fistulation bag.

Ostomy pouch 32 generally includes rear wall 36 and antetheca 38.Front and rear wall 36,38 is made up of the flexible plastic film of usual impenetrable liquid and gas.Suitable film comprises the laminate of such as one or more layers ethane-acetic acid ethyenyl (EVA) and such as one or more layers gas-barrier material of poly-(vinylidene chloride) (PVDC) or poly-(vinylidene fluoride) (PVDF).Wall 36,38 is welded together around outer perimeter weld seam 40 each other.Rear wall 36 comprises ostomy or entrance hole diameter 42, and in use, by this, ostomy or entrance hole diameter 42 enters pocket 32 to ostomy effluent.Pocket 32 also comprises alternatively for deodorization and odor removal filter and the outlet (not shown) of discharging flatus.In addition or alternatively, pocket 32 is also included in the comfortable panel (not shown) on the outer surface of the one or both in wall 36,38 alternatively.

Viscosity wafer 34 comprises the skin-compatible adhesive plaster in use utensil being attached to stoma skin.Viscosity wafer 34 usually have in use face skin and contact skin side next to the skin 46 and in the face of rightabout non-side 48 next to the skin.At first can by such as silicone resin sheet or the releasing piece 50 of sheet being coated with silicones to protect side 46 next to the skin.Viscosity wafer 34 can be suitable for making it possible to ostomy aperture 52 be formed and/or is customized for the size and dimension that coupling is ostomy 60 (Fig. 6) of fistulation patient.The various technology adapted to for realizing this type of can be imagined.In one form, viscosity wafer 34 is shapeable or shapable type, and wherein, the 34a at least partially of adhesive plaster moulds by manual operation or is shaped.Viscosity wafer 34 can have the ostomy aperture 52 of preformed starting drive (starter), and around it, the inner rim region of viscosity wafer part 34a is shapeable or shapable.Alternatively, if do not provide starting drive ostomy aperture 52, then adhesive plaster can be allow user manually to produce suitable aperture 52 wherein and the type formed.Mouldability and/or formability make it possible to realize around ostomy 60 closely or the cooperation be close to.Snug fit is high expectations; so that (i) protection do the stoma skin 62 of fistulation patient can not owing to contacting and inflammation and exfoliation with the stool of flowing out from ostomy 60; and (ii) forms sealing; sealing hinders ostomy effluent to pollute the tacky surfaces of side 46 next to the skin, this otherwise the wear-out life of utensil 30 may be shortened.Viscosity wafer 34 can be such as in U.S. Patent No. 6,840, describe type in 924.This type of viscosity wafer 34 makes it possible to form while maintenance sheet form.Viscosity wafer 34 comprises laminar structure, and this laminar structure comprises (i) multiple carcass, and/or (ii) is by least one carcass of at least one deck plastic membranous layer reinforcing.As shown in Figure 3, around ostomy aperture 52, with rolling, self-defined shape and/or size can be expanded as in the ostomy aperture 52 in viscosity wafer 34 to back bending is bent by making viscosity wafer 34 on itself.Usually, viscosity wafer 34 on the side 48 non-next to the skin of viscosity wafer 34 to rollback move, and from non-side 48 next to the skin the most easily and perform exactly this operation.Alternatively, binding agent can be can flow or extrudable agglomerate type (not shown).Again, when close at least non-side 48 (preferably both sides 46,48) next to the skin the most easily and perform exactly this type of adapt to.

In replacement form, can be adapted to ostomy aperture 52 by the independent containment member (not shown) of fitting tight in inside, ostomy aperture 52 or self-defined.This type of containment member is also coupled to the side 48 non-next to the skin of viscosity wafer 34 best, thus does not interference with the adhesive interfacial between the viscosity wafer 34 on human body and side next to the skin 46.

It is close that the present embodiment promotes the side 48 non-next to the skin of viscosity wafer 34, because at first, viscosity wafer 34 is not immovably attached at around entrance hole diameter 42.Alternatively, utensil 30 also comprises the one or both in the following:

A () captures connection 54, viscosity wafer 34 is permanently attached to pocket 32 with capturing to allow the mode of the substantially whole entrance hole diameter 42 of (i) pocket 32 and (ii) relative shift substantially between whole viscosity wafer 34 by it;

B () is fixedly connected 56, viscosity wafer 34 is fixed on pocket 32 by it on the operating position when needed around entrance hole diameter 42.

Before the first use, capture connection 54 to allow capturing the relative shift in moving range between viscosity wafer 34 and pocket 32.Capture moving range to comprise:

(i) overlap-add operation position, on this position, viscosity wafer 34 is superimposed on around entrance hole diameter 42, and the adapted to part 34a of viscosity wafer 34 is covered by pocket 32 on non-side 48 next to the skin; And

(ii) approximated position, it is close that it provides from the adapted to part 34a of the 48 pairs of viscosity wafers 34 in non-side next to the skin.

This type of arranges the easy manipulation relative to each other allowing pocket 32 and viscosity wafer 34, close easily with what provide from the 48 pairs of viscosity wafers 34 in non-side next to the skin when there is no the obstruction of pocket 32.Preferably, user can from both sides 46,48 close.Therefore, user can easily be formed ostomy aperture 52 when not needing the sizable dexterity handling utensil 30 and/or is shaped and/or determines size.

In shown form, preferably realize capturing connection 54 in the mode connected along the restrained motion of predetermined movement locus or Route guiding relative shift.This type of restrained motion connect can at least one dimension or degree of freedom by the motion guidance between viscosity wafer 34 and/or pocket 32 to operating position.This make with such as wherein viscosity wafer 34 before fixing can substantially freely relative to utensil movement conventional two-piece appliances compared with more easily can aim at viscosity wafer 34 relative to pocket 32.

User can judge how to be assembled on health by utensil 30 best.In a technology, user substantially fully adapted to viscosity wafer 34 before utensil 30 is assembled to health.Made viscosity wafer 34 adapt on non-overlapping positions, viscosity wafer 34 was moved to its operating position (Figure 4 and 5) by user before utensil 30 is assembled to health.56 viscosity wafer 34 being fixed on appropriate location by being fixedly connected, then, with the pattern of conventional single type utensil, utensil 30 being assembled to health.

In many user's possibilities another technology preferred (shown in Fig. 6), before fixing in its operative position by viscosity wafer 34 relative to pocket 32, viscosity wafer 34 is assembled to human body 58.This technology allows user to be adapted on the spot in ostomy aperture 52 or adapts to around ostomy 60 further, from non-side 48 next to the skin close to viscosity wafer.The flexibility of pocket 32 can make pocket 32 easily to be folded up from whole viscosity wafer 34, and makes the side 48 non-next to the skin of viscosity wafer 34 be exposed to user.Once user is satisfied with the self-defined cooperation in ostomy aperture 52 to his or her ostomy 60, then user moves or launches pocket 32, enters operating position to make entrance hole diameter 42 relative to viscosity wafer 34 (being indicated by arrow 64).If achieve restrained motion to connect, then this connection is by motion guidance to operating position, helps user widely.Once on operating position, then pocket 32 connection 56 that is fixed is fixed relative to viscosity wafer 34.

Can imagine for realize (i) capture connection 54 and (ii) be fixedly connected 56 various modes.

Capture connection 54 can be flexible, flexible, rotatable, can pivotable, can distortion and/or stretchable at least one to allow relative shift.In replacement form, capturing connection 54 can be rigidity substantially, and provides relative shift by the flexibility of pocket 32 itself.

In the form shown in Fig. 1 ~ 7, capture connection 54 and comprise flexible and/or chain connection.Capture connection 54 and comprise flexible or knuckle joint 70 between the first attachment part 66, second attachment part 68 and two parts 66,68.Capture connection 54 to be made up of from one piece, and flexible tab 70 can be embodied as integral hinge, such as folding or flexible part or loose-joint butt or is weakened, thinning, perforation and/or any one region in ruling.Such as, capture connection 54 to be made up of single piece of plastic film.This film can be flexible, and is weakened to limit joint 70 alternatively, promotes that film bends at joint 70 place.

Alternatively, with reference to figure 7, the different parts that two parts 66,68 can be engaged by hinged component 70a or 70b.Hinged component 70a can be such as flexible material, such as fiber or flexible membrane.Alternatively, hinged component 70b can be linkage, may comprise rotating hinge.

In the form described in Fig. 1 ~ 7, joint 70 allows around an axis relative shift, and this axis extends abreast with the principal plane of viscosity wafer 34 and/or pocket 32 (when vertical) substantially.This advantage of arranging is when viscosity wafer 34 is shifted relative to entrance hole diameter 42, and the side 48 non-next to the skin of viscosity wafer 34 is automatically exposed and presents to user.Such as, with the relative shift of about 180 degree (Fig. 2,3,6 and 7), rear bag wall 36 presents the side 48 non-next to the skin in the face of user.This type of geometry provides the exception of the side 48 non-next to the skin to viscosity wafer 34 close easily, even when viscosity wafer 34 is permanently attached to pocket 32 as single type utensil.Therefore, user can from least non-side 48 next to the skin easily close to viscosity wafer 34 to allow the most accurate of ostomy aperture 52 and multi-functional adaptation.

First attachment part 66 is configured to such as passed through welding or be permanently attached to pocket 32 by strong adhesive.First attachment part 66 can be attached to any one in pocket wall 36,38 and/or seam 40.In shown form, the first attachment part 66 is attached to the rear wall 36 being adjacent to entrance hole diameter 42.The cardinal principle hollow shape (being preferably closed loop in shape) that first attachment part 66 comprises at least in part (and preferably complete) extends around entrance hole diameter 42.First attachment part 66 may be used for strengthening the pocket wall material around entrance hole diameter 42, to prevent from shrinking or stretching, and be provided for being fixedly connected 56 excellent surface.

Second attachment part 68 is configured to by such as by welding or being permanently attached to viscosity wafer 34 by strong binding agent effect (such as, between the adhesive plaster and the second attachment part 68 of viscosity wafer 34).In shown form, in the perimeter region 34b around inner perimeter region 34a, the second attachment part 68 is attached to viscosity wafer 34 on non-side 48 next to the skin.Second attachment part 68 can have any expectation form.As shown, the second attachment part 68 comprises at least in part (and preferably complete) in ostomy aperture 52 and/or the cardinal principle hollow shape (being preferably closed loop in shape) that can extend around adaptation zone 34a.

Capture connection 54 and can be similar to Eight characters shape, comprise and (directly contiguous or separation slightly) is set abreast and two closed-loop structure connected by joint 70.

First and second attachment part 66,68 have approximately identical size usually, namely have the inner and/or outer footpath of same size, thus are substantially back-to-backly engaged on operating position.Each attachment part can have respective contact pin (tab) 66a, 66b, and it is positioned as making contact pin 66a, 66b, and on operating position, registration ground is overlapping completely mutually substantially.Contact pin 66a, 66b allow the easy manipulation of capturing connection 54.

With reference to figure 8 and 9, the joint 70 of replacement be included in the plane of the plane being substantially parallel to pocket 32 (when vertical) and/or the principal plane being substantially parallel to viscosity wafer 34 allow between pocket 32 with viscosity wafer 34 relative to can the pivot 72 of pivotable movement.Pivot 72 can limit the pivot axis of the plane being essentially perpendicular to pocket 32 (when vertical) and/or the principal plane being essentially perpendicular to viscosity wafer 34.Pivot 72 can comprise pin, lug or rivet in the aperture in overlapping contact pin 66b, 68b of being received within the first and second attachment part 66,68.In shown form, the first and second attachment part 66,68 each be closed loop in shape.Pivot 72 allow the first and second attachment part 66,68 from substantially with one heart, the relation (corresponding to operating position) of superposition moves to the relation of non-concentric, non-superimposed substantially, allow away from entrance hole diameter 42 close to viscosity wafer 34.As seen from Figure 9, when capturing connection and rotating, there is not putting upside down of the position of side 46 next to the skin and non-side next to the skin 48.In any case, formed the plastic foil of the first and second attachment part 66,68 flexibility allow wafer 34 rotate away from during operating position easily close to non-side 48 next to the skin.

Figure 10 illustrates and to rotate to providing the additional amendment just coordinating second embodiment of (positive fit) during its operating position at viscosity wafer 34.The size of viscosity wafer 34 is confirmed as that its external diameter is slightly less than and is carried on the internal diameter of the adhesive plaster 84 that is fixedly connected in the first attachment part 66, viscosity wafer 34 can be nested at least in part and be fixedly connected in the aperture of adhesive plaster 84.This nested additional tactile information providing viscosity wafer 34 to be properly aligned at operating position place to user.Can also use together with the constructed of nested arrangements and other embodiment as herein described.

With reference to Figure 11 ~ 14, the connection 54 of capturing of replacement has the similar jackknife action with Fig. 1 ~ 7, except form instead of the closed loop shape for the first attachment part 66 being attached to pocket 32 with contact pin.Two kinds of different structures of contact pin can be imagined.In figs. 11 and 12, joint 70 is arranged on back in the part contact pin 76 of entrance hole diameter.In the mode identical with Fig. 1 ~ 7, joint 70 is unfolded on approximated position, and folded on themselves when entrance hole diameter 42 and viscosity wafer 23 are in operation, superposed positions.Joint 70 launches away from entrance hole diameter 42 is shifted along with viscosity wafer 34.

In the replacement of Figure 13 and 14 is arranged, joint 70 is arranged between contact pin 76 and entrance hole diameter 42 substantially.On approximated position, joint 70 is folded.In the operation, superposed positions of entrance hole diameter 42 and viscosity wafer 34, joint 70 is unfolded substantially.

When using contact pin 76, additional stiffener 80 can be provided around entrance hole diameter 42.Stiffener 80 can have contact pin 80a to help the manipulation of pocket 32.Stiffener 80 is made up of the material with the flexural modulus larger than the material of pocket wall 36,38, thus for fold protection pocket wall 36,38, and promote the excellent sealing around entrance hole diameter 42.

Be fixedly connected 56 can be viscosity or mechanical attachment.Being fixedly connected 56 can be permanent type, makes to be fixedly connected 56 to be not intended separated after tightening together at first (or again fastening).Alternatively, be fixedly connected 56 can be separable and can be again fastening type.This can allow care-giver or nurse temporarily to open pocket 32 away from viscosity wafer 34, to make it possible to while the original position of viscosity wafer 34 on health ostomy 60 checking, clean or apply medicine.

Be fixedly connected for 56 for realization, adhesive attachment is preferably current.Adhesive attachment provides the profile height lower than mechanical attachment usually.Adhesive attachment can use the skin-friendly adhesive plaster of viscosity wafer 34, or it can use different adhesive plasters.Adhesive attachment can be included in mutually cling when not being clamminess from adhesive film.

In a form (as shown in all embodiments), be fixedly connected 56 comprise be different from wafer 34 and by capture in the first and second attachment part 66,68 of connection 54 at least one carrying carcass 84.Any one of two attachment part 66,68 can carry this type of adhesive plaster, or in attachment part 66,68 one can be non-sticky touch-down zone.In the form shown in Fig. 2 ~ 14, the first attachment part 66 carries adhesive plaster 84 and by the second attachment part 68 to provide landing surface.But, can out of position as required by adhesive plaster.Protecting glue layer of cloth 84 can be carried out at first by silicones or the releasing piece 86 being coated with silicones.Releasing piece 86 can have usually spaced apart with the stripping contact pin 88 avoided confusion away from contact pin 66a, 80a angularly.Adhesive plaster 84 can have the identical type and/or thickness that are suitable for using in adhesive attachment two parts ostomy appliance, and therefore increases thickness or the profile height of utensil 30 indistinctively.

Figure 15 and 16 illustrates another example of capturing connection 54, wherein, carries adhesive plaster 84 by the first and second attachment part 66,68 on its respective surface relative when being on operating position.These figure also illustrate the example arrangement of viscosity wafer 34, comprise be provided by above-mentioned U.S. Patent No. 6,840,924 with explaining similar shapeable characteristic flexible sheets 34d be separated carcass 34c, 34e.

In another form, be fixedly connected 56 parts being included in the tacky surfaces of the viscosity wafer 34 on non-side next to the skin 48.

In the above-described embodiments, the size of viscosity wafer 34 and position are confirmed as making it be positioned at the inside of the welding circumference 40 of pocket 32 substantially.But, another feature of the present invention is that it can provide single type utensil 30, wherein, viscosity wafer 34 can (such as, as shown in figure 17) extend to when viscosity wafer 34 is in operating condition or even exceed the girth seam 40 of pocket 32.This type of design is possible, allows viscosity wafer 34 to be displaced to a position during manufacture because capture connection 54, and in this position, viscosity wafer 34 is not in the position realizing girth seam 40.This makes normal welding equipment position close to girth seam 40 when not hindered by wafer 34.This amendment can with as herein described any capture to be connected and/or to be fixedly connected use in combination.

Same principle as discussed above can be applied to be separated or the two-piece appliances of " suit " form supply and/or single type utensil.In case of a two-piece appliance, be fixedly connected 56 can be that the conventional two-piece type of viscosity or mechanical interference/interlock types connects.First attachment part 66 of capturing connection 54 preferably can aim at and before fixing the parts of two-piece appliances fixing (such as, releasedly) to pocket.

By further detailed example, above-mentioned principle is described now:

example 1

Utensil 30 be formed into comprise for the pocket 32 of collection material, material pass therethrough enter pocket 32 entrance hole diameter 42, the viscosity wafer 34 on the surface of collecting will be realized for pocket is attached to and will be used for viscosity wafer 34 to be connected to the coupling components 54,56 of pocket 32.

Form pocket 32 by taking advantage of about 10 inches of long oval perimeters to be welded together by two of film panels around about 5 inches wide, one in panel has opening, at this opening part, and the material inlet ports bag 32 that collect.The flexible closed cell's foam with about 0.006 inch thickness be made up of the polyethylene vinyl acetate being coated with palyacrylate binder in side is cut into and is similar to two adjacent rings of numeral " 8 " (Fig. 8) or the single shape of circle.Connect a circle (representing the first attachment part 66) be thermally welded to pocket face plate without coated side, make circle at its whole circumference around entrance hole diameter 42.

Comprise and have by United States Patent (USP) 4,551, the hydrocolloid adhesive plaster of viscosity wafer 34 of any one formula described in the example 15 ~ 25 in 490 is shaped as the viscosity wafer 34 of about 0.010 inch, and it has the internal diameter of about 10mm and is approximately equal to the external diameter of external diameter of the second circle of connection foam of digital 8 shapes.Hydrocolloid viscosity wafer 34 is protected by cated releasing piece 50 in side.The opposite side of hydrocolloid viscosity wafer 34 be adhered to connect foam without the second circle (representing the second attachment part 68) in coated side.The internal diameter of hydrocolloid viscosity wafer 34 is less than the internal diameter of the second attachment part 68 that it is attached to, and protects the hydrocolloid adhesive plaster connected in internal diameter with the second release liner 82.

In order to prepare use, remove in two release liners 82,86 any one or the two.When hydrocolloid adhesive plaster is exposed at present, such as, is that coupling is collected surface and improves the efficient material collection of pocket 32 manually by the size adjusting in ostomy aperture 52, makes it adapt to as required so that the performance be improved.

Two circles of the connection of numeral 8 shapes are folded together along the axis at its adjacent (at 70 places) place now, make the coating binding agent of each circle surface contact another, and viscosity wafer 34 and pocket 32 are coupled together now.Viscosity wafer 34 is now via the whole circumference of this connection indirect abutment entrance hole diameter 42.Any residue release liner 82,86 is removed from hydrocolloid viscosity wafer 34 and viscosity wafer 34 is adhered to surface for material collection, such as, be attached to the skin 62 for single type utensil around ostomy 60 with moldable adhesive.

example 2

Use and there is about 0.002 inch thickness and be shaped as being linked together by the pocket 32 and viscosity wafer 34 with those similar structures described in above example 1 from adhesive film of numeral 8.Circle the area that adjoins be little compared with the gross area of circle.A circle (representing the first attachment part 66) is thermally welded to pocket face plate, and weld seam Perfect Ring is around entrance hole diameter 42.Hydrocolloid viscosity wafer 34 is shaped as the circular discs of about 0.080 inch, and it has the approximately equalised external diameter of external diameter with the second circle of connecting film (representing the second attachment part 68).Hydrocolloid viscosity wafer 34 is adhered to the second circle in the side of the connecting film contrary with the side being soldered to pocket panel.Viscosity wafer 34 is suitable for as used described in example 1.Two circles that the film of numeral 8 shapes connects are twisted now and are folded together along the axis near its adjoiner, make the Free Surface of each circle contact and automatically adhere to each other, in the mode preventing collected material from being overflowed by coupling components, pocket 32 is connected to attachment adhesive plaster.Can describe as in above example 1 and use pocket 32 to carry out collection material.

example 3

Use there is about 0.010 inch thickness and be shaped as numeral 8 plastic of poly vinyl acetate sheet flat in essence the pocket 32 and hydrocolloid viscosity wafer 34 with those similar structures described in above example 1 is linked together.Abutment points between circle is heated and pressurizes to reduce its thickness and produce hinge 70 to promote folding or distortion.With contact adhesive, a circle (representing the first attachment part 66) is adhered to pocket face plate, this circle is around entrance hole diameter 42.Hydrocolloid viscosity wafer 34 is shaped as the circular discs of about 0.040 inch, and it has the external diameter equal with the external diameter of the second circle of digital 8 plates (representing the second connector part 68).Hydrocolloid viscosity wafer 34 is adhered to described connection and is suitable for as used described in example 1.Two circles that the sheet of digital 8 shapes connects are folded to produce contact between circle by present use hinge 70.Pocket 32 collection material can be used by removing release liner 82,86 from hydrocolloid viscosity wafer 34 and be attached to surface (being such as attached to the skin 62 around ostomy 60).

example 4

Use have about 0.030 inch gross thickness and be shaped as numeral 8 plastic polyethylene connect the pocket 32 and hydrocolloid viscosity wafer 34 with those similar structures described in above example 1 is linked together.The circumference of each circle is flat in essence, and comprises such as, by seal member, the edge raised and the recessed groove that can be formed by the respective surfaces of mechanically interlocking when flocking together.Use routing tool to reduce the thickness of the neighboring region (at 70 places) between circle, produce hinge to promote folding or distortion.Circle (representing the first attachment part 66) is flat in essence and is thermally welded to pocket face plate, and this circle is around entrance hole diameter 42.The nonwoven fabric of coating binding agent is attached to the outer perimeter of this circle in the position of the circumference being soldered to pocket wall 36,38 close to circle.Binding agent is subject to the protection of release liner 82,86 and is applied to the side being close to the fabric connected.

Hydrocolloid adhesive plaster is shaped as the viscosity wafer 34 of about 0.040 inch, and it has the approximately equalised external diameter of external diameter of the second circle (representing the second attachment part) connected with digital 8 plastics.Hydrocolloid viscosity wafer 34 is being adhered to the second circle with the side of the identical connection being soldered to pocket wall 36,38.In this case, plastics connection is shaped as by making it stretch away from entrance hole diameter 42 when connecting and being in its final structure to plastic components imparting convex shape and promotes the adhesion to sunk surface.The hydrocolloid viscosity wafer 34 being adhered to the male portion of connection has this convex shape.

Hydrocolloid viscosity wafer 34 is adhered to described connection and is suitable for as used described in example 1.Two circles that the sheet of digital 8 shapes connects are folded the contact promoted between circle by present use hinge 70.Such as, inserted the corresponding recessed groove of the opposite side connected by the raising edges of the side that will connect, this is connected and fixed in its final orientation with interlocking mechanism's (representing that machinery is fixedly connected 56) now.Pocket 32 collection material can be used by removing release liner from hydrocolloid viscosity wafer 34 and be attached to surface (being such as attached to the skin 62 around ostomy 60).Make now pocket 32 be optionally further secured surface, this surface by by coating binding agent fabric adhere to be attached hydrocolloid viscosity wafer 34 same surface on complete collection.

example 5

The connector of two discrete ring-type attachment part 66,68 is used to be linked together comprising with the pocket 32 of those similar structures described in above example 1 and the utensil 30 of hydrocolloid viscosity wafer 34, described two discrete ring-type attachment part 66,68 are attached together by use rivet 72, and attachment part 66,68 freely can be rotated to substantially concentric final position from non-concentric position at least in part.Rotated by this, make it cross over communicating surface and adjoin and aim at pocket entrance hole diameter 42.A ring (representing the first attachment part 66) of this connection is attached to pocket 32 on relative with communicating surface surface, and another ring of this connection (representing the second attachment part 68) is attached to hydrocolloid viscosity wafer 34 on the surface at another relative with communicating surface.Connection adhesive plaster in one or two communicating surface or gasket material remain on connecting on its final position and the material helped collected by maintenance.

example 6

Use rivet 74 to be linked together by the utensil 30 comprised with the pocket 32 of those similar structures described in above example 5, hydrocolloid viscosity wafer 34 and coupling components, this coupling components freely can be rotated to substantially concentric final position from non-concentric position at least in part.Rotated by this, make it cross over communicating surface and adjoin and aim at entrance hole diameter 42.A ring (representing the first attachment part 66) of this connection is attached to pocket 32 on relative with communicating surface surface, and another ring of this connection (representing the second attachment part 68) is attached to hydrocolloid viscosity wafer 34 on the surface at another relative with communicating surface.In this example, the diameter of pocket coupling ring is designed to be larger than the diameter of hydrocolloid viscosity wafer coupling ring, makes the external diameter of the latter be engaged in the former inside diameter completely.When rotating to its final structure, hydrocolloid viscosity wafer coupling ring is inserted in pocket adhesive attachment ring with substantially coplanar structure, and result is that hydrocolloid viscosity wafer 34 is attached to collection surface and is attached to two coupling rings at opposite side in side.

example 7

Use the connection be made up of flexible closed cell's foam with about 0.006 inch thickness to be linked together comprising with the pocket 32 of those similar structures described in above example 1 and the utensil 30 of hydrocolloid viscosity wafer 34, described flexible closed cell's foam is made up of the plastic of poly vinyl acetate being coated with palyacrylate binder in side.Palyacrylate binder is protected before the use with release liner 82,86.Connect and be cut into single annular shape, it is attached to the pocket wall 36,38 with entrance hole diameter 42 by the contact pin region 76 extended via the external diameter radially from coupling ring between coupling ring and entrance hole diameter 42.What connect is adhered to hydrocolloid viscosity wafer 34 without coated side.Then as adapted to viscosity wafer 34 described in example 1.Then cross over contact pin 76 by connection folding, make exposed palyacrylate binder be attached to pocket 32 and at its whole circumference around entrance hole diameter 42.Any residue release liner 82,86 is removed from hydrocolloid viscosity wafer 34 and viscosity wafer 34 is adhered to surface for material collection, such as, be attached to the skin 62 for single type utensil around ostomy 60 with moldable adhesive.

Alternatively, the contact pin part 76 of connection can in the relative formation entrance hole diameter, side 42 of coupling ring.In this case, deflect by making contact pin 76 and realize the adaptation of hydrocolloid viscosity wafer 34, so that it is close easily to obtain arbitrary surface of hydrocolloid viscosity wafer 34.Once adapt to hydrocolloid viscosity wafer 34, then the surface being coated with palyacrylate binder connected is adhered to pocket 32 around entrance hole diameter 42.

Alternately, can be strengthened region around entrance hole diameter 42 by whole circumference viscosity wafer 34 being attached at entrance hole diameter 42 to contribute to operation, this strengthening part has the flexural modulus exceeding bag surface panel material.

example 8

Comprise and to comprise with the pocket 32 of those similar structures described in above example 1 and the utensil 30 of hydrocolloid viscosity wafer 34 by there is the minimum thickness of about 0.002 inch and connecting of being shaped as that other sheet of the flexible membrane of numeral 8, foam, non-woven or flexible material forms.This is connected in the pressure sensitive adhesive coating that side is coated with at least 0.001 inch protected with release liner 82,86 before the use.

Circle the area that adjoins be little compared with the gross area of circle.A circle (representing the first attachment part 66) is thermally welded to pocket wall 36,38, and weld seam Perfect Ring is around entrance hole diameter 42.Hydrocolloid viscosity wafer 34 is shaped as the circular discs of about 0.050 inch, and it has and the external diameter of the second circle connected and the approximately equalised external diameter of internal diameter and internal diameter.Hydrocolloid viscosity wafer 34 is adhered to the second circle in the side of the connector relative with the side being soldered to pocket wall 36,38.Adhesive plaster is suitable for as used described in example 1 together with connection, and advantage is that the hydrocolloid viscosity wafer 34 in the face of pocket 32 inside is protected, now further from the impact of the collection material in the region of its coupled covering.Two circles of the connection of numeral 8 shapes are twisted now and are folded together along the axis near its adjoiner, the Free Surface of each circle is contacted with each other, in the mode preventing collected material from being overflowed by coupling components, pocket 32 is connected to viscosity wafer 34.Collection material can be carried out by use pocket 32 as described in above example 1.

example 9

Use and stop that the utensil 30 comprised with the pocket 32 of those described in the figure 7 similar structures, hydrocolloid viscosity wafer 34 and coupling components is linked together by the self-adhering material of ostomy effluent.By thermal weld around entrance hole diameter 42 whole circumference without coated side attachment foam ring, this foam ring is coated with silicone coatings, and it has the probe being less than the power of 50 grams measured by said method.The non-pressure-sensitive adhesive tab formed by about 0.010 inch and by the polyester sheet of plastic of poly vinyl acetate or flexible thickness cuts into contact pin ring and is thermally welded to the pocket wall 36,38 with entrance hole diameter 42.Then as adapted to viscosity wafer 34 described in example 1.The side of contact pin ring is adhered to hydrocolloid viscosity wafer 34 and opposite side is contacted with silicone coatings.Any remaining release liner 82,86 is removed from hydrocolloid viscosity wafer 34 and viscosity wafer 34 is adhered to surface for material collection, such as, be attached to the skin 62 for single type utensil around ostomy 60 with moldable adhesive.

Will be appreciated that and can realize many amendments, improvement and equivalent in claimed scope of the present invention.

Claims (23)

1. one kind for being fastened to the fistulation coupling assembly of ostomy appliance by viscosity wafer, described ostomy appliance has entrance hole diameter, and what described viscosity wafer comprised the side next to the skin of the skin for contacting user, the non-next to the skin side relative with described side next to the skin and can be adapted to be engaged in stoma can adaptation zone, and described connection comprises:

Described viscosity wafer is connected with the restrained motion between described ostomy appliance, it allows (i) relative shift substantially between whole described viscosity wafer and the entrance hole diameter of (ii) described ostomy appliance, described restrained motion to be connected to around entrance hole diameter that (a) wherein said viscosity wafer is superimposed on described ostomy appliance and described viscosity wafer can the operating position that covered by described ostomy appliance in described non-side next to the skin of adaptation zone, (b) between approximated position along relative shift described in described restrained motion path or locus guiding, described viscosity wafer is shifted about 180 degree from the entrance hole diameter of pocket in this approximated position, for provide from described non-side next to the skin close to described can adaptation zone, and

Be fixedly connected, it is for fixing described viscosity wafer and described ostomy appliance when being in described operating position.

2. fistulation coupling assembly as claimed in claim 1, wherein, described restrained motion connection permanently joins described viscosity wafer to described ostomy appliance.

3. fistulation coupling assembly as claimed in claim 1, wherein, described restrained motion connect comprise for being attached to pocket the first attachment part, for being attached to the active joint part between the second attachment part of described viscosity wafer and first and second attachment part described.

4. fistulation coupling assembly as claimed in claim 3, wherein, at least one in described first and second attachment part has closed loop shape.

5. fistulation coupling assembly as claimed in claim 3, wherein, described first and second attachment part and described active joint part are integrally formed as single-piece.

6. fistulation coupling assembly as claimed in claim 3, wherein, described first and second attachment part are connected to the discrete item of described connector portions office actively.

7. fistulation coupling assembly as claimed in claim 3, wherein, described first and second attachment part are made up of plastic foil.

8. fistulation coupling assembly as claimed in claim 1, wherein, described restrained motion connects the motion track limited around axis, and described axis is selected from: the plane being substantially parallel to described wafer; Or be essentially perpendicular to the plane of described wafer.

9. fistulation coupling assembly as claimed in claim 1, wherein, described in be fixedly connected and be selected from: mechanical attachment, adhesive attachment.

10. fistulation coupling assembly as claimed in claim 1, wherein, described in be fixedly connected be connected with restrained motion at least partially in aggregates at least partially.

11. fistulation coupling assemblies as claimed in claim 1, wherein, it is single equipment that described fistulation connects.

12. 1 kinds of ostomy appliances, comprising:

Appliance device, its have for the ostomy entrance hole diameter be communicated with;

Viscosity wafer, it for being arranged on stoma on human body, and what described viscosity wafer comprised the side next to the skin of the skin for contacting user, the non-next to the skin side relative with described side next to the skin and can be adapted to be engaged in stoma can adaptation zone; And coupling assembly, it is for being connected to described appliance device by described viscosity wafer, and described coupling assembly comprises:

Described viscosity wafer is connected with the restrained motion between described utensil, it allows (i) relative shift substantially between whole described viscosity wafer and the entrance hole diameter of (ii) described utensil, described restrained motion to be connected to around entrance hole diameter that (a) wherein said viscosity wafer is superimposed on described utensil and described viscosity wafer can the operating position that covered by described utensil in described non-side next to the skin of adaptation zone, (b) between approximated position along relative shift described in restrained motion locus guiding, described viscosity wafer is shifted about 180 degree from the entrance hole diameter of pocket in this approximated position, for provide from described non-side next to the skin close to described can adaptation zone, and

Be fixedly connected, it is for fixing described viscosity wafer and described utensil when being in described operating position.

13. ostomy appliances as claimed in claim 12, wherein, described utensil is selected from: single type utensil, and wherein, described viscosity wafer is permanently attached to described appliance device by described coupling assembly; Two-piece appliances, wherein, described viscosity wafer is attached to described appliance device by described coupling assembly releasedly.

14. 1 kinds of single type ostomy appliances, comprising:

Appliance device, its have for the ostomy entrance hole diameter be communicated with;

Viscosity wafer, it for being arranged on stoma on human body, and what described viscosity wafer comprised the side next to the skin of the skin for contacting user, the non-next to the skin side relative with described side next to the skin and can be adapted to be engaged in stoma can adaptation zone; And capture connection, it permanently joins described viscosity wafer to described pocket with capturing to allow the mode of the entrance hole diameter of pocket and the relative shift substantially between whole described viscosity wafer, describedly capture the scope of capturing movement connecting and limit between described pocket and described viscosity wafer, described in capture moving range and comprise:

(i) overlap-add operation position, on described overlap-add operation position, described viscosity wafer is superimposed on around described entrance hole diameter, and the adapted to part of described viscosity wafer is covered by described utensil on described non-side next to the skin; And

(ii) approximated position, described viscosity wafer in this approximated position from about 180 degree of the entrance hole diameter of pocket displacement, for provide from described non-side next to the skin close to described viscosity wafer can adaptation zone.

15. single type ostomy appliances as claimed in claim 14, wherein, described in capture connect be for guiding the restrained motion of the relative shift between described viscosity wafer and described entrance hole diameter to connect.

16. single type ostomy appliances as claimed in claim 14, wherein, the active joint part connecting and comprise between the first attachment part being attached to described pocket, the second attachment part being attached to described viscosity wafer and first and second attachment part described is captured.

17. single type ostomy appliances as claimed in claim 16, wherein, at least one in described first and second attachment part has closed loop shape.

18. single type ostomy appliances as claimed in claim 16, wherein, described first and second attachment part and described blank area are integrally formed as single-piece.

19. single type ostomy appliances as claimed in claim 16, wherein, described first and second attachment part are connected to the discrete item of described connector portions office actively.

20. single type ostomy appliances as claimed in claim 16, wherein, described first and second attachment part are made up of plastic foil.

21. single type ostomy appliances as claimed in claim 14, wherein, described in be fixedly connected and be selected from: mechanical attachment, adhesive attachment.

22. single type ostomy appliances as claimed in claim 14, wherein, described in be fixedly connected be connected with described restrained motion at least partially in aggregates at least partially.

23. 1 kinds of methods, comprising:

A () provides ostomy appliance, it comprises:

Appliance device, its have for the ostomy entrance hole diameter be communicated with;

Viscosity wafer, it for being arranged on stoma on human body, and what described viscosity wafer comprised the side next to the skin of the skin for contacting user, the non-next to the skin side relative with described side next to the skin and can be adapted to be engaged in stoma can adaptation zone;

Capture connection, it joins described viscosity wafer to described pocket with capturing to allow the mode of the entrance hole diameter of pocket and the relative shift substantially between whole described viscosity wafer, described capture to connect to limit capture moving range between described pocket and described viscosity wafer, described moving range of capturing comprises: (i) overlap-add operation position, on described overlap-add operation position, described viscosity wafer is superimposed on around described entrance hole diameter, and the adapted to part of described viscosity wafer is covered by described utensil in described non-side next to the skin; And (ii) approximated position, described viscosity wafer in this approximated position from about 180 degree of the entrance hole diameter of pocket displacement, for provide from described non-side next to the skin close to described viscosity wafer can adaptation zone; With

Be fixedly connected, it is for fixing described viscosity wafer when being in described operating position relative to described entrance hole diameter;

Wherein, described method also comprises:

B (), when described viscosity wafer is in described approximated position relative to described entrance hole diameter, at least described non-side next to the skin close to described viscosity wafer can be suitable for applicable ostomy by adaptation zone with what make described viscosity wafer;

C described viscosity wafer is moved to described operating position relative to described entrance hole diameter by (); And

D described viscosity wafer is fixed on described operating position by means of described being fixedly connected by ().