DK178401B1

DK178401B1 - An ostomy bag

Info

Publication number: DK178401B1
Application number: DKPA201400443A
Authority: DK
Inventors: Kurt Malmbak Kjeldsen
Original assignee: Kmk Aps
Priority date: 2014-08-08
Filing date: 2014-08-08
Publication date: 2016-02-01
Also published as: WO2016019963A3; WO2016019963A2

Abstract

Stomipose omfattende en indsætningsdel og en opsamlingspose, hvor indsætningsdelen omfatter en første ring og en anden ring samt et plastisk deformerbart mellemstykke. Første ring kan placeres på indersiden af bugvæggen og har en diameter større end stomiåbningen, men ikke så stor, at den vil udøve et ubehageligt pres på indersiden af tarmen. Anden ring kan placeres på ydersiden af bugvæggen og har en diameter større end tarmens udkravning. Længden af mellemstykket er kortere end bugvæggens profil imellem den første ring og den anden ring, så mellemstykket er plastisk deformeret, når det er monteret. Opsamlingsposen udgør en forlængelse af indsætningsdelen.An ostomy bag comprising an insert member and a collection bag, wherein the insert member comprises a first ring and a second ring as well as a plastic deformable spacer. The first ring can be placed on the inside of the abdominal wall and has a diameter greater than the ostomy opening, but not so large that it will exert an uncomfortable pressure on the inside of the intestine. The second ring can be placed on the outside of the abdominal wall and has a diameter greater than the intestinal collapse. The length of the spacer is shorter than the profile of the abdominal wall between the first ring and the second ring, so that the spacer is plastically deformed when mounted. The collection bag constitutes an extension of the insert portion.

Description

StomiposeAn ostomy bag

Opfindelsen vedrører en fleksibel stomipose til opsamling af fæces fra stomiopererede patienter.The invention relates to a flexible ostomy bag for the collection of faeces from stoma-operated patients.

Baggrund for opfindelsenBACKGROUND OF THE INVENTION

Ved Colo- og lleostomi bortskæres den syge del af henholdsvis tyk- og tyndtarmen. Forbindelsen til anus lukkes, og mundingen på resten af tarmen føres ud gennem et hul i bugvæggen, hvor tarmenden syes fast til det ydre epitel. Grundet fraværet af ringmusklen vil fæces herefter passivt flyde ud af kroppen.In Colo- and lleostomy, the diseased part of the colon and small intestine are cut off, respectively. The connection to the anus is closed and the mouth of the remainder of the intestine is led out through a hole in the abdominal wall where the intestine ends are stitched to the outer epithelium. Due to the absence of the ring muscle, the stool will then passively flow out of the body.

For at afhjælpe dette er der på markedet talrige stomiposer. De er af forskellige udformninger, og fælles for dem er, at de består af flere dele, og indkapsler den udflydende fæces ved klæbning af posen på det ydre epitel. De fleste af disse tilgængelige løsninger fungerer efter en vis uddannelse og indøvning for så vidt udmærket. Men dels skal den individuelle tilpasning ske med saks og sammensætningen af delene foretages meget omhyggeligt, og dels kan limen til fastgørelsen ofte give uønskede hudreaktioner efter længere tids brug.To remedy this, there are numerous ostomy bags on the market. They are of different shapes, and common to them is that they are made up of several parts, and encapsulate the flowing stool by adhering the bag to the outer epithelium. Most of these available solutions work after some training and practice so far. But partly the individual adjustment has to be done with scissors and the composition of the parts is done very carefully, and partly the glue to the attachment can often cause unwanted skin reactions after prolonged use.

US 2011/0092929 angår en stomaforlænger, der indbefatter en første ende til indføring i en stomiåbning, beregnet til at aflede stomal udstrømmende materiale ind i stomaforlængeren, før det udstrømmende materiale forlader stomaen. Plus en anden ende, som dækker den resterende ydre del af stomaen, der udgør en udledningsudgang for stomal udstrømmende materiale. Samt endelig en rørformet del koblet mellem den første og anden ende til at føre stomal udstrømmende materiale gennem stomaforlængeren, hvor længden af den rørformede del er justerbar for at tillade tilpasning af stomaforlængeren til den individuelle persons stoma.US 2011/0092929 relates to an ostomy extender which includes a first end for insertion into an ostomy opening intended to divert ostomy effluent material into the ostomy extender before the effluent exits the ostomy. Plus another end, which covers the remaining outer portion of the stoma, constituting a discharge outlet for ostomy-flowing material. As well as finally a tubular portion coupled between the first and second ends to pass ostomy outflow material through the stoma extender, the length of the tubular portion being adjustable to allow adaptation of the stoma extender to the individual's stoma.

Ulempen ved stomaforlængeren er, at den skal bruges i samspil med flere dele, heriblandt en plade, der klistres på det ydre epitel. En yderligere ulempe ved stomaforlængeren er, at den fastholdes ved at udvide tarmen.The disadvantage of the stoma extender is that it must be used in conjunction with several parts, including a plate that is glued to the outer epithelium. A further disadvantage of the stoma extender is that it is retained by expanding the bowel.

WO 2012/016575 angår en stomaprotese bestående af et stift mellemstykke samt en indvendig ringe indopereret i bugvæggen, og en udvendig ring skruet på mellemstykket. Den indvendige og udvendige ring fastholder protesen med et pres omkring bugvæggen. På stomaprotesen kan sættes en opsamlingspose og et låg.WO 2012/016575 relates to a stoma prosthesis consisting of a rigid spacer as well as an inner ring inserted into the abdominal wall, and an outer ring screwed onto the spacer. The inner and outer ring retains the prosthesis with pressure around the abdominal wall. A collection bag and a lid can be placed on the stoma prosthesis.

Ulempen for patienten ved stomaprotesen er det stive mellemstykke som vil være svær at skjule på den måde, mellemstykket stikker ud af bugvæggen, og som kan være svær at ignorere ved bevægelse af maveregionen, da mellemstykket ikke er deformerbar.The disadvantage for the patient of the stoma prosthesis is the rigid spacer which will be difficult to conceal in the way the spacer protrudes from the abdominal wall and which may be difficult to ignore when moving the abdominal region as the spacer is not deformable.

Stomiposen ifølge nærværende opfindelse er en fuldt integreret pose, der indkapsler og opsamler fæces uden brug af lim, og som kun består af én del, der udgør et billigt engangsprodukt. Stomiposen påsættes med én hånd og uden brug af spejl, saks m.v. Integreringen af posen med monteringsenheden sikrer imod forekomsten af læk af fæces, der kan generer huden rundt om stomiåbningen. Herudover opnås fastholdelse af stomiposen med et pres omkring bugvæggen, som er mindre sårbar overfor pres end tarmvæggen. Et billigt og let anvendeligt engangsprodukt som dette vil f.eks. være velegnet til stomapatienter i fattige lande.The ostomy bag of the present invention is a fully integrated bag that encapsulates and collects faeces without the use of glue, and which consists of only one portion which constitutes a cheap disposable product. The ostomy bag is applied with one hand and without the use of a mirror, scissors, etc. The integration of the bag with the mounting unit ensures the appearance of faecal leaks that can irritate the skin around the ostomy opening. In addition, retention of the ostomy bag is achieved with pressure around the abdominal wall, which is less vulnerable to pressure than the intestinal wall. A cheap and easily usable disposable product such as this will e.g. be suitable for stoma patients in poor countries.

Beskrivelse af opfindelsenDescription of the Invention

Stomiposen omfatter en indsætningsdel og en opsamlingspose, hvor indsætningsdelen omfatter en første ring og en anden ring samt et plastisk deformerbart mellemstykke. Første ring kan placeres på indersiden af bugvæggen og har en diameter større end stomiåbningen, men ikke så stor, at den vil udøve et ubehageligt pres på indersiden af tarmen. Anden ring kan placeres på ydersiden af bugvæggen og har en diameter større end stomiåbningen. Normalt vil den anden ring ligeledes være større end tarmens udkravning. Længden af mellemstykket er kortere end bugvæggens profil imellem den første ring og den anden ring, så mellemstykket er plastisk deformeret, når det er monteret. Opsamlingsposen udgør en forlængelse af indsætningsdelen.The ostomy bag comprises an insert portion and a collection bag, the insert portion comprising a first ring and a second ring as well as a plastic deformable spacer. The first ring can be placed on the inside of the abdominal wall and has a diameter greater than the ostomy opening, but not so large that it will exert an uncomfortable pressure on the inside of the intestine. The second ring can be placed on the outside of the abdominal wall and has a diameter larger than the ostomy opening. Normally, the second ring will also be larger than the bowel outcrop. The length of the spacer is shorter than the profile of the abdominal wall between the first ring and the second ring, so that the spacer is plastically deformed when mounted. The collection bag constitutes an extension of the insert portion.

Stomiposen holdes derved på plads af den plastiske spænding af mellemstykket imellem første ring og anden ring. Herved undgås anvendelsen af plader limet på huden eller udspilning af tarmen, som begge dele kan være til stor gene for brugeren.The ostomy bag is thereby held in place by the plastic tension of the adapter between the first ring and the second ring. This avoids the use of sheets glued to the skin or play out of the bowel, both of which can be a major nuisance to the user.

I en foretrukken udførelsesform er mellemstykket enten cylindrisk eller keglestubformet, når det udstrækkes mellem den første ring og den anden ring i ikke-monteret tilstand.In a preferred embodiment, the spacer is either cylindrical or cone-shaped when extended between the first ring and the second ring in the non-assembled state.

Opsamlingsposen er lavet af samme materiale som mellemstykket.The collection bag is made of the same material as the spacer.

Opsamlingsposen kan omfatte et afgasningsemne bestående af et afgasningsfilter med bl.a. aktivt kul.The collection bag may comprise a degassing blank consisting of a degassing filter with, inter alia, active fun.

Opsamlingsposen kan i en anden udførelsesform omfatte et afgasningsemne bestående af en afgasningsventil, der er forsynet med et filter med bl.a. aktivt kul.In another embodiment, the collection bag may comprise a degassing item consisting of a degassing valve which is provided with a filter including a. active fun.

Alt eller dele af materialet i stomiposen kan være bionedbrydeligt. Dette gør at hele stomiposen med indhold kan bortskaffes i toilettet.All or part of the material in the ostomy bag may be biodegradable. This allows the entire ostomy bag with contents to be disposed of in the toilet.

Afstanden mellem den første ring og den anden ring kan varieres ved, at den anden ring holdes i position af et antal cirkulært eller delvist cirkulært placerede ribber, som stikker ud fra den indvendige overflade i den ydre ende af mellemstykket. Det er derved muligt for brugeren at finjustere indsætningsdelens pres omkring bugvæggen, når f.eks. et større pres kunne være ønskeligt under forskellige fysiske aktiviteter, som f.eks. løb og dans, eller et mindre pres kunne være ønskeligt, hvis brugeren i en periode har taget på i vægt og bugvæggens tykkelse derved er øget.The distance between the first ring and the second ring can be varied by holding the second ring in position by a plurality of circular or partially circularly positioned ribs protruding from the inner surface at the outer end of the spacer. It is thus possible for the user to fine-tune the pressure of the insertion part around the abdominal wall, when e.g. greater pressure could be desirable during various physical activities, such as running and dancing, or less pressure could be desirable if the user has gained weight for a period and the thickness of the abdominal wall is thereby increased.

I en yderligere udførelsesform har den anden ring en diameter på 80-150 mm, fortrinsvist 110-150 mm. Diameteren af den anden ring er derved væsentligt større end stomiåbningen.In a further embodiment, the second ring has a diameter of 80-150 mm, preferably 110-150 mm. The diameter of the second ring is thereby substantially larger than the ostomy opening.

I denne udførelsesform kan mellemstykket være opdelt i to dele, en indre del og en ydre del, hvor den ydre del af mellemstykket består af et materiale, der er mindre elastisk end den indre del.In this embodiment, the spacer may be divided into two portions, an inner portion and an outer portion, the outer portion of the spacer consisting of a material less resilient than the inner portion.

Fordelen ved denne udførelsesform er, at den øgede diameter af den anden ring og den øgede stivhed af den ydre del af mellemstykket støtter vævet omkring stomaåbningen, og derved mindsker sandsynligheden for, at patienten får brok omkring stomien.The advantage of this embodiment is that the increased diameter of the second ring and the increased stiffness of the outer portion support the tissue around the stoma opening, thereby reducing the likelihood of the patient getting hernia around the stoma.

Opfindelsen vedrører ligeledes en stomiprop omfattende en indsætningsdel, hvor indsætningsdelen omfatter en første ring og en anden ring, et plastisk deformerbart mellemstykke samt mindst et afgasningsfilter. Første ring kan placeres på indersiden af bugvæggen og har en diameter større end stomiåbningen. Anden ring kan placeres på ydersiden af bugvæggen og har en diameter større end stomiåbningen. Længden af mellemstykket er kortere end bugvæggens profil imellem den første ring og den anden ring, så mellemstykket er plastisk deformeret, når det er monteret. Afgasningsfiltret aflukker enten den første ring eller den anden ring.The invention also relates to an ostomy plug comprising an insert member, wherein the insert member comprises a first ring and a second ring, a plastic deformable intermediate member and at least one degassing filter. The first ring can be placed on the inside of the abdominal wall and has a diameter larger than the ostomy opening. The second ring can be placed on the outside of the abdominal wall and has a diameter larger than the ostomy opening. The length of the spacer is shorter than the profile of the abdominal wall between the first ring and the second ring, so that the spacer is plastically deformed when mounted. The degassing filter closes either the first ring or the second ring.

Stomiproppen holdes derved på plads af den plastiske spænding på mellemstykket imellem første ring og anden ring.The ostomy plug is thereby held in place by the plastic tension on the adapter between the first ring and the second ring.

Både den første ring og den anden ring kan være aflukket af et afgasningsfilter, således at stomiproppen omfatter to afgasningsfiltre, hvor den første ring er aflukket af et afgasningsfilter og den anden ring er aflukket af et andet afgasningsfilter. Dette kan give brugeren en ekstra sikring mod lugtgener.Both the first ring and the second ring can be closed by a degassing filter, so that the ostomy plug comprises two degassing filters, the first ring being closed by a degassing filter and the second ring being closed by a second degassing filter. This can give the user extra protection against odor nuisance.

Alt eller dele af materialet i stomiproppen kan være bionedbrydeligt. DefinitionerAll or part of the material in the ostomy plug may be biodegradable. definitions

Elastisk: En reversibel deformation (dvs. ændring af form) af et materiale under påvirkning af en ydre kraft, hvor der med "reversibel" menes at materialet vender tilbage til sin oprindelige form efter deformationen.Elastic: A reversible deformation (ie change of shape) of a material under the influence of an external force, where "reversible" means that the material returns to its original shape after the deformation.

Cirkulær: En mere eller mindre cirkelformet ring eller kreds, der kan være enten afbrudt eller uafbrudt.Circular: A more or less circular ring or circle that can be either disconnected or uninterrupted.

Kort beskrivelse af figurerBrief description of figures

Figur 1 viser stomiposen i ikke monteret tilstand.Figure 1 shows the ostomy bag in the non-fitted condition.

Figur 2 viser et tværsnit af stomiposen i monteret tilstand. Der er dog ikke taget tværsnit af den første ring og den anden ring.Figure 2 shows a cross section of the ostomy bag in the mounted condition. However, no cross sections of the first ring and the second ring have been taken.

Figur 3 viser et tværsnit ved stomiposens ydre montageflade.Figure 3 shows a cross section at the outer mounting surface of the ostomy bag.

Figur 4a viser et tværsnit på langs af mellemstykket, der viser en udførelsesform af ribberne.Figure 4a shows a longitudinal cross-section of the spacer showing an embodiment of the ribs.

Figur 4b viser et tværsnit på tværs af mellemstykket, der viser en udførelsesform af ribberne uden monteret ring.Figure 4b shows a cross-sectional cross-section showing an embodiment of the ribs without mounted ring.

Figur 4c viser et tværsnit på tværs af mellemstykket, der viser en udførelsesform af ribberne med monteret ring.Figure 4c shows a cross-sectional cross-section showing an embodiment of the mounted ring ribs.

Figur 5 viser et tværsnit af afgasningsfilteret.Figure 5 shows a cross section of the degassing filter.

Figur 6 viser en udførelsesform af et indsætningsværktøj.Figure 6 shows one embodiment of an insertion tool.

Figur 7 viser en udførelsesform, hvor posen er erstattet af et afgasningsfilter således, at den kan fungere som en stomiprop.Figure 7 shows an embodiment in which the bag is replaced by a degassing filter so that it can act as an ostomy plug.

Figur 8 viser en udførelsesform af stomiposen, hvor den ydre ring er væsentligt større end stomiåbningen og et todelt mellemstykke.Figure 8 shows an embodiment of the ostomy bag, wherein the outer ring is substantially larger than the ostomy opening and a two-piece spacer.

Detaljeret beskrivelseDetailed description

Som vist på figur 1 er stomiposen ifølge den foretrukne udførelsesform en simpel og enkel konstruktion bestående af en indsætningsdel 1 og i forlængelse af denne en opsamlingspose 2. Indsætningsdelen 1 består af en første ring 3 og en anden ring 4, som begge er fleksible og omsluttet og forbundne af et mellemstykke 5 af tyndt fleksibelt og elastiskt materiale. Dette materiale fortsætter ud over den anden ring 4 og danner opsamlingsposen 2 til opsamling af fæces. Stomiposen er derved en enhed, der hverken skal limes på huden, eller samles med andre dele for at fungere.As shown in Figure 1, the ostomy bag according to the preferred embodiment is a simple and simple construction consisting of an insert part 1 and, by extension, a collection bag 2. The insert part 1 consists of a first ring 3 and a second ring 4, both of which are flexible and enclosed. and connected by an intermediate piece 5 of thin flexible and elastic material. This material continues beyond the second ring 4 and forms the collection bag 2 for the collection of faeces. The ostomy bag is thus a device that must neither be glued to the skin nor joined with other parts to function.

Den første 3 og anden 4 ring er ikke nødvendigvis cirkulære i ringens eget tværsnit. Det kan lige så vel være ovalt eller have en anden passende form.The first 3 and second 4 rings are not necessarily circular in their own cross-section. It may as well be oval or have another suitable shape.

Den første ring 3 er en elastisk ring med en diameter lidt større end stomiåbningen 23 i bugvæggen 20, f.eks. 30 mm. Samtidig må diameteren af den første ring 3 ikke være så stor, at den yder et ubehageligt pres på tarmvæggen 25. Selve ringens stivhed og tykkelse er afpasset således, at den sammenklemt nemt kan indføres i stomiåbningen 23 og ind på indersiden af bugvæggen 21. Dette uden hjælp af spejl, saks, lim eller andre hjælpemidler. Materialevalg og tykkelse kan varieres, indtil tilpas elasticitet og pres opnås. Tykkelsen af den første ring 3 kan f.eks. være 1-3 mm.The first ring 3 is an elastic ring having a diameter slightly larger than the ostomy opening 23 in the abdominal wall 20, e.g. 30 mm. At the same time, the diameter of the first ring 3 must not be so large as to provide uncomfortable pressure on the intestinal wall 25. The rigidity and thickness of the ring itself are adapted so that it can be easily inserted into the ostomy opening 23 and into the inside of the abdominal wall 21. This without the help of a mirror, scissors, glue or other aids. Material selection and thickness can be varied until appropriate elasticity and pressure are achieved. The thickness of the first ring 3 may e.g. be 1-3 mm.

Ring 3 og hele stomiposen udtages ligeledes let ved at trække skævt i den anden ring 4 og mellemstykket 5. Evt. efter at have drejet ring 4 et par gange for at lukke af for fæces.Ring 3 and the entire ostomy bag are also easily removed by pulling obliquely in the other ring 4 and the intermediate piece 5. If necessary. after turning ring 4 a few times to shut off the stool.

Som vist på figur 2 forbinder mellemstykket 5 den første ring 3 og den anden ring 4 og er lavet af et tyndt og elastisk materiale. Materialevalg og tykkelse kan varieres, indtil tilpas elasticitet og pres opnås. Et foretrukket materiale kunne være polymeren kendt under navnet Latex. Mellemstykkets længde afhænger af den individuelle bugvæg 20, og er normalt kortere end bugvæggens tykkelse, hvorved den første ring 3 og den anden ring 4 trækkes mod hinanden og slutter tæt mod henholdsvis indersiden 22 og ydersiden 21 af bugvæggen 20. Det er således den plastiske spænding af mellemstykket 5 imellem de to ringe 3, 4 der holder hele stomiposen på plads.As shown in Figure 2, the intermediate piece 5 connects the first ring 3 and the second ring 4 and is made of a thin and elastic material. Material selection and thickness can be varied until appropriate elasticity and pressure are achieved. A preferred material could be the polymer known by the name of latex. The length of the intermediate piece depends on the individual abdominal wall 20, and is usually shorter than the thickness of the abdominal wall, whereby the first ring 3 and the second ring 4 are pulled towards one another and end tightly against the inside 22 and the outer 21 respectively of the abdominal wall 20. It is thus the plastic tension. of the spacer 5 between the two rings 3, 4 holding the entire ostomy bag in place.

Den første ring 3 er svejst, rullet eller på anden måde sat fast til enden af mellemstykket 5. Indvendig er mellemstykket 5 ved den anden ring 4 forsynet med en cirkulært eller delvist cirkulært placeret ribbe 7, der fastholder den ellers løse ring 4 i den ønskede position. At en ribbe er delvist cirkulær betyder, at ribben 7 kan udgøre en afbrudt eller uafbrudt cirkel på indersiden af mellemstykket 5. Ribben 7 kan være udformet som en række modhager vendt mod den første ring 3. I en anden udførelsesform kan ribben 7 erstattes af en ring, af samme materiale som den første 3 og anden 4 ring, der er svejst, rullet eller på anden måde sat fast på indersiden af mellemstykket 5.The first ring 3 is welded, rolled or otherwise fixed to the end of the spacer 5. Internally, the spacer 5 at the second ring 4 is provided with a circular or partially circular rib 7 which retains the otherwise loose ring 4 in the desired position. The fact that a rib is partially circular means that the rib 7 may form a discontinuous or continuous circle on the inside of the spacer 5. The rib 7 may be formed as a series of barbs facing the first ring 3. In a second embodiment, the rib 7 may be replaced by a rib. ring, of the same material as the first 3 and second 4 rings which are welded, rolled or otherwise affixed to the inside of the spacer 5.

Den anden ring 4 er en elastisk ring med en diameter noget større end tarmens udkravning 24 på ydersiden af bugvæggen 22, f.eks. 50-70 mm. Den anden ring 4 kan være lavet af samme materiale som den første ring 3. Selve den anden rings 4 tykkelse er normalt større end den første rings 3, f.eks. 3-6 mm. Ringen er normalt ved levering placeret i ribben 7 i mellemstykket 5. Mellemstykket 5 kan være forsynet med flere rækker af ribber 7, hvorved afstanden mellem den første ring 3 og den anden ring 4 kan reguleres, efter indførelse af den første ring 3, ved at flytte den anden ring 4 til en af de andre ribber 7. Det er derved muligt at finjustere længden af mellemstykket til optimal pasform i forhold til tykkelsen af bugvæggen 20 på den enkelte bruger.The second ring 4 is an elastic ring having a diameter somewhat larger than the casing 24 of the intestine on the outside of the abdominal wall 22, e.g. 50-70 mm. The second ring 4 may be made of the same material as the first ring 3. The thickness of the second ring 4 itself is usually greater than the first ring 3, e.g. 3-6 mm. The ring is normally delivered at the rib 7 in the spacer 5. The spacer 5 may be provided with several rows of ribs 7, whereby the distance between the first ring 3 and the second ring 4 can be adjusted, after insertion of the first ring 3, by moving the second ring 4 to one of the other ribs 7. It is thereby possible to fine-tune the length of the spacer for optimal fit to the thickness of the abdominal wall 20 of the individual user.

Som vist på figur 3 er den anden ring 4 større end tarmens udkravning 24. Det er derved kun mellemstykket 5, som er lavet af et mere fleksibelt og blødere materiale end ringen 4, der kommer i berøring med tarmens udkravning 24. Dette er en fordel, da tarmens udkravning 24 kan være meget følsom.As shown in Figure 3, the second ring 4 is larger than the bowel collar 24. Thus, only the intermediate piece 5, which is made of a more flexible and softer material than the ring 4, comes into contact with the bowel collar 24. This is an advantage since intestinal collapse 24 can be very sensitive.

På figur 4a, 4b og 4c vises en udførelsesform, hvor ribberne 7 er udformet som et antal modhager 7, der sidder med afstand til hinanden i en cirkel på indersiden af mellemstykket 5. Figur 4a og 4c viser ligeledes den anden rings 4 placering i en af ribberne 7. Meningen hermed er, at når stomiposen er monteret og den anden ring 4 er placeret i en af ribberne 7, vil den anden ring 4 ikke kunne falde tilbage på en ribbe 7 tættere på opsamlingsposen 2.Figures 4a, 4b and 4c show an embodiment in which the ribs 7 are designed as a number of barbs 7 spaced apart in a circle on the inside of the spacer 5. Figures 4a and 4c also show the location of the second ring 4 in a of the ribs 7. This means that when the ostomy bag is mounted and the second ring 4 is placed in one of the ribs 7, the second ring 4 will not be able to fall back on a rib 7 closer to the collection bag 2.

Opsamlingsposen 2 er lavet i samme materiale som mellemstykket 5. Opsamlingsposen 2 kan øverst være forsynet med en åbning på ca. 20x40 mm dækket af et afgasningsemne 6, der tillader tarmluft at forlade opsamlingsposen 2 uden at tillade væske at trække igennem, samt fjerner den ubehagelige lugt fra tarmluften. Afgasningsemnet 6 kan være et afgasningsfilter 8 eller en afgasningsventil forsynet med et afgasningsfilter 8.The collection bag 2 is made of the same material as the intermediate piece 5. The collection bag 2 can be provided at the top with an opening of approx. 20x40 mm covered by a degassing blank 6 which allows intestinal air to exit the collection bag 2 without allowing liquid to pass through, and removes the unpleasant odor from the intestinal air. The degassing item 6 may be a degassing filter 8 or a degassing valve provided with a degassing filter 8.

Et afgasningsfilter er normalt opbygget af flere lag, hvor hvert lag har samme eller forskellig funktion, på figur 5 er vist et afgasningsfilter 8 udført i tre lag. De tre lag omfatter et inderste lag 9 bestående af et grovfilter 9 mod fæces. Dette kunne f.eks. være et lag nylonsvamp eller et andet skummateriale. Dernæst et midterste lag 10 velegnet til adsorption af urenheder fra væsker og luftarter som f.eks. aktivt kul 10 og sidst en membran 11 af et vandtæt, men åndbart materiale. Et foretrukket materiale kunne være en af polymererne kendt under navnet Gore-Tex og SympaTex.A degassing filter is usually made up of several layers, each layer having the same or different function, in Figure 5 a degassing filter 8 is made in three layers. The three layers comprise an inner layer 9 consisting of a stool coarse filter 9. This could, for example. be a layer of nylon sponge or other foam material. Next, a middle layer 10 suitable for adsorption of impurities from liquids and gases, e.g. activated charcoal 10 and lastly a membrane 11 of a waterproof but breathable material. A preferred material could be one of the polymers known by the name of Gore-Tex and SympaTex.

At indsætningsdelen 1 og opsamlingsposen 2 er lavet ud i ét forhindrer, at fæces kommer i kontakt med den afskårne ende af tarmen 25 og huden på ydersiden af bugvæggen 22, når stomiposen er monteret. Stomiposen vil derved være velegnet i tilfælde, hvor det ikke er muligt, eller af andre grunde ikke vil være en fordel, at lave en udkravning 24 af tarmen 25 på patienten. Det kunne f.eks. være nødvendigt at bibeholde så meget funktionel tarm som muligt. Eller man kunne være interesseret i at undgå den følsomme udkravning.The insertion portion 1 and the collection bag 2 are integral preventing faeces from contacting the cut end of the bowel 25 and the skin on the outside of the abdominal wall 22 when the ostomy bag is mounted. The ostomy bag will thereby be suitable in cases where it is not possible, or for other reasons, not advantageous to make a claim 24 of the bowel 25 on the patient. It could, for example. be required to maintain as much functional bowel as possible. Or you could be interested in avoiding the delicate crowding.

Til stomiposen kan der med fordel være et låg 30 med en flade opbygget som, eller med samme egenskaber som afgasningsfilteret 8 i afgasningsventilen 6. Efter indføring af den første ring 3 og evt. justering af den anden ring 4 skubbes opsamlingsposen 2 ind i indsætningsdelen 1 eller blot sammen og låget 30 klikkes på den anden ring 4.Advantageously, for the ostomy bag there may be a lid 30 having a surface constructed as, or having the same properties as, the degassing filter 8 in the degassing valve 6. After insertion of the first ring 3 and possibly To adjust the second ring 4, the collecting bag 2 is pushed into the insert part 1 or simply together and the lid 30 is clicked on the second ring 4.

Ved at påklikke låget 30 kan stomiposen hurtigt laves om til en fuldstændig aflukning af fæces. I tilfælde af, at låget 30 skulle falde af den anden ring 4 vil opsamlingsposen 2 folde sig ud og fungere normalt. Dette uden risiko for læk af fæces eller lugtgener.Clicking on the lid 30 can quickly transform the ostomy bag into a complete stool closure. In case the lid 30 should fall off the second ring 4, the collecting bag 2 will unfold and function normally. This without the risk of leaking faeces or odors.

Et indsætningsværktøj 12 kan ligeledes være et supplement til stomiposen. Som vist på figur 6 kunne indsætningsværktøjet 12 være en 10-20 cm lang pind 12 med et U-formet fastholdelsesemne i den ene ende, som er indrettet til at sættes på den første ring 3. Et let træk i mellemstykket 5 vil deformere den første ring 3 og holde kontakt med pindens 12 greb i den første ring 3, der så kan føres ind i stomaen 23. Når ring 3, ved hjælp af pinden 12, er ført godt og vel ind på indersiden af bugvæggen 21, trækkes pinden 12 tilbage, ringen 3 retter sig cirkulært ud, og et lige træk i den anden ring 4 får den første ring 3 til at lægge an mod indersiden af bugvæggen 21. Efter fuldstændig udtrækning af pinden 12 placeres ring 4 i den rette ribbe 7 til sikring af tætheden.An insertion tool 12 may also be an adjunct to the ostomy bag. As shown in Figure 6, the insertion tool 12 could be a 10-20 cm long pin 12 with a U-shaped retaining member at one end arranged to be attached to the first ring 3. A slight pull in the intermediate piece 5 will deform the first ring 3 and keeping in contact with the grip of the pin 12 in the first ring 3, which can then be inserted into the stoma 23. When ring 3, by means of the stick 12, is inserted firmly on the inside of the abdominal wall 21, the pin 12 is retracted , the ring 3 extends circularly, and a straight pull in the second ring 4 causes the first ring 3 to abut against the inside of the abdominal wall 21. After complete removal of the pin 12, ring 4 is placed in the proper rib 7 to ensure the tightness .

I en yderligere fordelagtig udførelsesform er opsamlingsposen 2 fjernet fra stomiposen, således at stomiposen i stedet kommer til at fungere som en stomiprop 40. Stomiproppen 40 består af indsætningsdelen 1, og en første ring 3 og en anden ring 4, som begge er fleksible og omsluttet og forbundne af et mellemstykke 5 af tyndt fleksibelt materiale. Indgangen til indsætningsdelen 1 igennem den første ring 3 er aflukket med et afgasningsfilter 8, der kunne være magen til eller med samme egenskaber som afgasningsfilteret 8 i afgasningsventilen 6. På den anden ring 4 kan der efter montering placeres et låg 30 som beskrevet ovenfor. Indgangen til indsætningsdelen 1 igennem den anden ring 4 kan ligeledes være aflukket med et afgasningsfilter 8, der ligeledes kunne være magen til eller med samme egenskaber som afgasningsfilteret 8 i afgasningsventilen 6. At have to afgasningsfiltre 8, et hhv. på den første ring 3 og den anden ring 4, sørger for at fæces holdes tilbage, samtidig men at tarmluften kan passere. Fordelen ved dette er, at patienten kan undgå at føle sig oppustet kort efter, at proppen er monteret. Det føromtalte låg 30 kan også monteres på den anden ring 4, hvis indgangen til indsætningsdelen 1 igennem den anden ring 4 er aflukket med et afgasningsfilter 8. Dette kunne være relevant i perioder, hvor patienten ønsker ekstra sikring mod lugtgener.In a further advantageous embodiment, the collection bag 2 is removed from the ostomy bag so that the ostomy bag will instead function as an ostomy socket 40. The ostomy socket 40 consists of the insert part 1 and a first ring 3 and a second ring 4, both of which are flexible and enclosed. and connected by an intermediate piece 5 of thin flexible material. The entrance to the insert part 1 through the first ring 3 is closed with a degassing filter 8 which could be similar to or with the same characteristics as the degassing filter 8 in the degassing valve 6. On the second ring 4, a lid 30 can be placed as described above. The entrance to the insert part 1 through the second ring 4 may also be closed with a degassing filter 8 which may also be similar to or having the same characteristics as the degassing filter 8 in the degassing valve 6. Having two degassing filters 8, one and one respectively. on the first ring 3 and the second ring 4, the stool is retained at the same time but the intestinal air can pass. The advantage of this is that the patient can avoid feeling bloated soon after the plug is fitted. The aforementioned lid 30 may also be mounted on the second ring 4 if the entrance to the insert part 1 through the second ring 4 is sealed with a degassing filter 8. This could be relevant in periods when the patient wants extra protection against odor nuisance.

I en yderligere fordelagtig udførelsesform har den anden ring 4 en diameter meget større end stomiåbningen 23 i bugvæggen 20, f.eks. 80-150 mm fortrinsvist 110-150 mm. Mellemstykket 5 er i denne udførelsesform opdelt i to dele, en indre del 51 og en ydre del 52. Den indre del 51, er den del af mellemstykket 5 som sidder inde i stomiåbningen 23 og som dækker tarmens udkravning 24, hvis der er en udkravning. Den ydre del 52, er den del af mellemstykket 5 som ligger langs ydersiden af bugvæggen 22. Den ydre del 52 af mellemstykket 5 består af et materiale stivere end det, den indre del 51 består af. Ved stivere, menes et mindre fleksibelt og elastisk materiale. Den øgede stivhed kan opnås ved at bruge et andet stivere materiale, end der er brugt til den indre del 51. De to dele 51, 52 af forskelligt materiale kan være svejst sammen. Eller materialet i den ydre del 52 kan være stivere pga. en øget materialetykkelse. Fordelen ved denne udførelsesform er, at den øgede diameter af den anden ring 4 og den øgede stivhed af den ydre del 52 af mellemstykket 5 støtter vævet omkring stomaåbningen 23, og derved mindsker sandsynligheden for, at patienten får brok omkring stomien.In a further advantageous embodiment, the second ring 4 has a diameter much larger than the ostomy opening 23 in the abdominal wall 20, e.g. 80-150 mm, preferably 110-150 mm. In this embodiment, the spacer 5 is divided into two parts, an inner portion 51 and an outer portion 52. The inner portion 51 is the portion of the spacer 5 which is located within the ostomy opening 23 and which covers the bowel collar 24 if there is a collar . The outer portion 52 is that portion of the spacer 5 which lies along the outside of the abdominal wall 22. The outer portion 52 of the spacer 5 consists of a material stiffer than that of the inner portion 51. By stiffeners is meant a less flexible and resilient material. The increased stiffness can be achieved by using a stiffer material than that used for the inner part 51. The two parts 51, 52 of different material may be welded together. Or, the material in the outer portion 52 may be stiffer due to an increased material thickness. The advantage of this embodiment is that the increased diameter of the second ring 4 and the increased stiffness of the outer portion 52 of the spacer 5 support the tissue around the stoma aperture 23, thereby reducing the likelihood of the patient getting hernia around the stoma.

Claims

An ostomy bag comprising an insert (1) and a collection bag (2), wherein the insert (1) comprises a first ring (3) and a second ring (4) as well as a plastic deformable spacer (5), - first ring (3) ) can be placed on the inside of the abdominal wall (20) and has a diameter greater than the ostomy opening (23), - the second ring (4) can be placed on the outside of the abdominal wall (21) and has a diameter greater than the ostomy opening (23), - the length of the spacer (5) is shorter than the profile of the abdominal wall (20) between the first ring (3) and the second ring (4), so that the spacer (5) is plastically deformed when mounted, - the bag (2) constitutes an extension of the insert part (1).

An ostomy bag according to claim 1, characterized in that the ostomy bag is held in place by the plastic tension on the intermediate piece (5) between the first ring (3) and the second ring (4).

An ostomy bag according to one or more of the preceding claims, characterized in that the spacer (5) is either cylindrical or cone-shaped when extended between the first ring (3) and the second ring (4) in the non-mounted state.

An ostomy bag according to one or more of the preceding claims, characterized in that the collection bag (2) is made of the same material as the adapter (5) ·

An ostomy bag according to one or more of the preceding claims, characterized in that the collecting bag (2) comprises a degassing blank (6) consisting of a degassing filter (8) with activated charcoal (10).

An ostomy bag according to one or more of the preceding claims, characterized in that the collecting bag (2) comprises a degassing element (6) consisting of a degassing valve provided with an active carbon filter (8).

An ostomy bag according to one or more of the preceding claims, characterized in that all or part of the material in the ostomy bag is biodegradable.

An ostomy bag according to one or more of the preceding claims, characterized in that the distance between the first ring (3) and the second ring (4) can be varied by holding the second ring (4) in position by a number of circular or partially circularly arranged ribs (7) protruding from the inner surface at the outer end of the intermediate piece (5).

An ostomy bag according to one or more of the preceding claims, characterized in that the second ring (4) has a diameter of 80-150 mm, preferably 110-150 mm.

An ostomy bag according to one or more of the preceding claims, characterized in that the intermediate part (5) is divided into two parts, an inner part (51) and an outer part (52), wherein the outer part (52) of the intermediate part ( 5) consists of a material which is less elastic than the inner part (51).

An ostomy plug comprising an insert member (1), wherein the insert member (1) comprises a first ring (3) and a second ring (4), a plastic deformable spacer (5) and a degassing filter (8), - first ring (3) ) can be placed on the inside of the abdominal wall (20) and has a diameter greater than the ostomy opening (23), - the second ring (4) can be placed on the outside of the abdominal wall (21) and has a diameter greater than the ostomy opening (23), - the length of the spacer (5) is shorter than the profile of the abdominal wall (20) between the first ring (3) and the second ring (4), so that the spacer (5) is plastically deformed when mounted, - the degassing filter (8) closes either the first ring (3) or the other ring (4).

An ostomy plug according to claim 11, characterized in that the ostomy plug is held in place by the plastic tension on the intermediate piece (5) between the first ring (3) and the second ring (4).

An ostomy stopper according to claim 11 or 12, characterized in that the spacer (5) is either cylindrical or cone-shaped when extended between the first ring (3) and the second ring (4) in the non-mounted state.

An ostomy plug according to one or more of claims 11-13, characterized in that the ostomy plug comprises two degassing filters where the first ring (3) is closed by a degassing filter (8) and the second ring (4) is closed by a second degassing filter. (8).

An ostomy plug according to one or more of claims 11 to 14, characterized in that all or part of the material in the ostomy plug is biodegradable.