CA1108958A - Venting device for stomas and other body openings - Google Patents
Venting device for stomas and other body openingsInfo
- Publication number
- CA1108958A CA1108958A CA269,102A CA269102A CA1108958A CA 1108958 A CA1108958 A CA 1108958A CA 269102 A CA269102 A CA 269102A CA 1108958 A CA1108958 A CA 1108958A
- Authority
- CA
- Canada
- Prior art keywords
- filter
- gas
- filter body
- cover
- stoma
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/441—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices having venting or deodorant means, e.g. filters ; having antiseptic means, e.g. bacterial barriers
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- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Nursing (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
Abstract
ABSTRACT OF THE DISCLOSURE
The invention concerns a device for venting stomas and other discharge openings for metabolic products from the human body, the venting device being adapted to be placed in close direct or indirect relationship to the human body and stoma or other body opening, the venting device having a dimension perpendicular to the human body less than at least one dimension parallel to the body, the venting device con-taining an odor-removing filter material between gas- and liquid-tight walls with delimited passage for gaseous sub-stances, the odor-removing filter material being passed by gases by a path longer than the dimension of the filter perpen-dicular to the body.
The invention concerns a device for venting stomas and other discharge openings for metabolic products from the human body, the venting device being adapted to be placed in close direct or indirect relationship to the human body and stoma or other body opening, the venting device having a dimension perpendicular to the human body less than at least one dimension parallel to the body, the venting device con-taining an odor-removing filter material between gas- and liquid-tight walls with delimited passage for gaseous sub-stances, the odor-removing filter material being passed by gases by a path longer than the dimension of the filter perpen-dicular to the body.
Description
''3~
Field of the invention~
.
This invention relates to improvernents in the post surgical ostomy devices used for preventing the escape of gaseous, liquid, and solid wastematerials from the stoma of ostomy patients or from anus with insufficient will control of the anus closing ring muscle.
More specifically, the invention relates to devices for venting stomas and other discharge openings for metabolic products from the human body.
A surgical procedure such as colostomy, ileostomy or ureteromy comprises the formation of an opening, or stoma, in the wall of the intestine or urethra so as to form a channel to the outer world through the body wall and skin of the patient. The stoma provides a means of communicatlon between the intestine or urethra and the external world so as to permit the excretion of excretions such as fecal material or urineO As the excretion cannot be controlled by the will in the same manner as excretions from the normal body openings, it is necessary for the patient to wear some sealing device which may comprise a collecting device. Actually, it is quite common for ostomy patients to wear some form of a 'stoma bag' or 'stoma pouch' for the rest of their life.
The most widely form for collecting receptacle - 30 is a bag or pouch made of film or foil of a transparent polymer material, affixed to the
Field of the invention~
.
This invention relates to improvernents in the post surgical ostomy devices used for preventing the escape of gaseous, liquid, and solid wastematerials from the stoma of ostomy patients or from anus with insufficient will control of the anus closing ring muscle.
More specifically, the invention relates to devices for venting stomas and other discharge openings for metabolic products from the human body.
A surgical procedure such as colostomy, ileostomy or ureteromy comprises the formation of an opening, or stoma, in the wall of the intestine or urethra so as to form a channel to the outer world through the body wall and skin of the patient. The stoma provides a means of communicatlon between the intestine or urethra and the external world so as to permit the excretion of excretions such as fecal material or urineO As the excretion cannot be controlled by the will in the same manner as excretions from the normal body openings, it is necessary for the patient to wear some sealing device which may comprise a collecting device. Actually, it is quite common for ostomy patients to wear some form of a 'stoma bag' or 'stoma pouch' for the rest of their life.
The most widely form for collecting receptacle - 30 is a bag or pouch made of film or foil of a transparent polymer material, affixed to the
- 2 ~
rJ 4~ ~
abdomen of -the patien-t by rneans of a double-sided adhesive disc with a central opening registering with the stoma; the stoma may be slightly projectiny from the abdomen and passed through the central opening of the adhesive disc. In another embodiment a flange made of relatively stiff material such as a suitable polymer is secured to the back panel of the pouch, for instance by heat sealing; and a sealing gasket isaffixed between the flange and the skin of the patier.t, whereby the pouch is held in position by means of a belt attached to the flange.
Fecal material is collected more or less constantly in the pouch and after a period, usually several hours, the pouch is discarded and replaced by another. The length of the period during which any given pouch may be used is strongly influenced, however, by the rate of production of flatus, i.e.
of instestinal gases.
Several factors such as kind of food eaten, type of microflora and psychic condition affect the production rate and the composition of the intestinal gases. Over a 12 hours - period the amount ~ay vary between 50 and 1000 ml or even more. Generally the volume of ; flatus and intes-tinal gas passed via rectal tube ranges from about 400 to about 1200 ml per day. The commonly held belief that certain
rJ 4~ ~
abdomen of -the patien-t by rneans of a double-sided adhesive disc with a central opening registering with the stoma; the stoma may be slightly projectiny from the abdomen and passed through the central opening of the adhesive disc. In another embodiment a flange made of relatively stiff material such as a suitable polymer is secured to the back panel of the pouch, for instance by heat sealing; and a sealing gasket isaffixed between the flange and the skin of the patier.t, whereby the pouch is held in position by means of a belt attached to the flange.
Fecal material is collected more or less constantly in the pouch and after a period, usually several hours, the pouch is discarded and replaced by another. The length of the period during which any given pouch may be used is strongly influenced, however, by the rate of production of flatus, i.e.
of instestinal gases.
Several factors such as kind of food eaten, type of microflora and psychic condition affect the production rate and the composition of the intestinal gases. Over a 12 hours - period the amount ~ay vary between 50 and 1000 ml or even more. Generally the volume of ; flatus and intes-tinal gas passed via rectal tube ranges from about 400 to about 1200 ml per day. The commonly held belief that certain
- 3 -'~ .
,: , foods produce flatulence has heen well documented.
Ingestion of beans, fpr instance, may increase the mean flatus excretion ra-te from 15 ml to 176 ml per hr. The rate over shorter periods of time may show wide variations, and it is particurlarly the flatus released at high rate which is difficult to deodorize and also most likely to createproblems for the patient.
Thus, the variations 1n amounts and composition of flatus in themselves give great problems.
The composition of the intestinal gas depends in part upon the site in the gastro-intestinal tract from which it is obtained. Stomach gas usually has a composltion relatively similar to that of atmospheric air, for example 78% N2, 17% 2' 3% CO2. ~latus in general contains less than 2% oxygen with the remainder of the gas consisting of varying proportions of nitrogen, carbon dioxide, hydrogen, methane and trace components. Keizo Kodama and Yoshiaki Miura in J.Japan Soc. Food Nutrition 2, pages 149-152 (1949) give the following composition: CO2 13-34%, CH4 19-26%, H2 20~27%, N2 17-48%. The odoriferous gases include indole, skatole, volatile amines, and hydrogen sulfide, and represent normally less than 1~ of flatus.
Of these gases hydroyen sulfide is by far the major component and presents the worst problem since lt is readily detected by the nose in concentrations as low as 1 part in 100 million.
X - 4 _ The gases enter 'che drainage pouch and expand it which gives rise to both practical and psychic problems ~or the patient. It has been practice to teach him to vent the gases from the pouch by puncturiny the upper part of the pouch with a needle and after the exit of the gases seal the puncture anew with adhesive tape. However, because of the obnoxious nature of some of the yases and the frequency with wich i~ is necessary to vent the pouch, this solution is quite unsatisfactory and may give rise to embarrassing situations.
Therefore, it is known to provide the pouch with some sort of filter to allow escape of gases.
Another manner of sealing the stoma of ostomy patients is to close it by a so-called stoma-cap, which is afixed to the body in much the same manner as the drainage pouch. A third and more important is to close the stoma by a plug or a stopper-like device inserted into the stoma and maintained in position by a flange or cover plate the inner face of which is in contact with the skin of the abdomen around the stoma. Such stopper may be maintained in po~ition hy magnetic foxce, small permanent magnets being sewn into the body of the patient around the stoma by a surgical operation. There is no drainage pouch, but the fecal material is ramoved from time to time by irrigation, e.g.
every two days, after removal of the plug and subsequenk re-insertion of it. To prevent pressure-build up behlnd the plug (or behind the stoma cap), we have suggested to provide it with a venting opening covered with several layers of non-woven textile containing active carbon. In practice the gases are not, however, made non-odorous by the passage through this filter, possibly 10- because the path passed by the gasses through the filter is very short. Accordingly, this device may also give rise to em~arrassing situations.
Background of the invention As will be understood it is known in the three forms of sealing devices for stomas to insert a filter at some suitable spot of the path o the gases. Several such filters are known. Thus, a preferred embodiment of a filter known from US Patent Specification No.
3,759,260 comprises a disc of matted fibres and activated granulax carbon having one suxface overlying the inner side of the ven-t aperture of the pouch and an area surroundiny the aperture~ and an impervious cover over the opposite surface of the disc, whereby the gases to be vented pass radially through the disc from the perphery to the vent aperture placed centrally relative the filter.
This does not function quite satisfactory, .
~ - 6 -which is believed to be due to the short path passed by the gaSes and, perhaps most important, a tendency to a channelling e~fect to-be discussed later in this text.
A filter for venting gases from stoma pouches is described in Danish pa-tent specifi-cation No. 130,277, h;aving a priority rom US patent application Serial No. 290,149 of 18th September, 1972. The preferred embodiment of this comprises a square disc of matted fibres and activated carbon in granular form.
One surface is covered with a gas-tight material with a central venting aperture, whereas the other surface of the disc is covered with another cover of gas-tight material with several apertures displaced relative the centre, whereby the gases to be exhausted pass through an oblique, partly radial path trough the filter~ A similar filter is disclosed in Danish patent specification No. 133,080, having priority from US patent application Serial No. 401,337 of 27th September, 1973.
In this , one of the impervious covers has a central venting aperture and the opposite cover several venting apertures evenly distribu-ted over the area of the filter dlsc.
The prior art filter devices described are similar in that they all comprise a flat disc of matted fibres and activated granular carbon, said disc having the two opposite faces covered with impervious materials with apertures so that the gases to be exhausted are forced to pass in a more or less radial direction through the filter, i~e. by a path longer than the Lhickness of the disc.
The purpose of this is to make more effective use of the capacity oE the activated carbon for absorbing the odorous constituents of the intestine gases. However, in practice the known filter assemblies do not function as intended and the useful lifetime of filters are not satisfactory whereby despite of the use of filters there may arise embarrassing situations; also frequent removals and re-placements of the filters are needed and the active carbon present is not utilized full, which means an extra financial burden.
It is believed that one reason for the unsatisfactory function of the known filters described is that a considerable 'channelling' takes place during the passage of the gases. The filter disc is made of comparatively stiff material. The gas-tight covers are made of thin films or foils of plasti~ with no special precautions to ensure a stable, gas-tight contact with the surfaces of the filter disc. As a result, the path axial~y through the filter and then along a channel between the filter disc and ~ the cover to the vent aperture or apertures (or vice versa, first along a channel between the filter disc and cover and then axially through the filter) will offer much less resistance than the path r~diall~ or obliquely through the filter disc and there20re will be preferably followed.
Another reason for the unsatisfactory Eunction of the knowndevices must be sought in the irregular production and composition of the intesti.nal waste gases. If the absolute amount of odoriferous substances to remove were rather constant over the hours of the day, the filter material, for instance active carbon, cGuld be provided in an amount corresponding to the xate of odoriferous gases and the geometry of the placing of the active carbon would be relatively unimportant. As, however, amounts and compositi.on vary very much, a regulax utilisation of the entire mass of active carbon i.5 impossible and the geometry of the device becom~s more important.
Obiect of the invention It is an object of the invention to overcome the disadvantages involved in the channeling effect existing in known filters for venting devices f.or stoma seals such as stoma bags, stoma caps and stoma plugs, so as to ensure that the gases do not pas.s unpurified through the venting device via nor~absorbing pa~ts thereof. Particularly, is it an object of the invention to prov.ide the filter in a forrn so as to give optimal _ g _ . ~ ', . . . .
' ', ' ' ~ :
utilisation of the active filter material therein, i.e. of the odor-rernoving substances whereby the geometric construction of the filter will ensure that an amount of filter material not greater than hitherto used will be able to remove odoriferous gases from the intestine gases even in periods with maximum production of such gases with maximum contents of malodorous components. It is a further lo object of the invention to provide a filter or venting device which will be equally well adaptable to stoma pouches or bags, to stoma caps and to stoma plugs or stoppers and which can be manufactured as a releasable member that can be uséd for a prolonged period of tirne and be.transferred from one stoma pouch, cap or pl.ug to another.
An important o~ject of the invention is to provide a venting device including filter which will be cheap and easy to make from materials readily available. One important further object of the invention is to provide a filtering and venting device of the type in question, which is reliable and will permit the escape of no obnoxious gases from the stoma or from a mal-func~tioniny anus, the gases vented being free from a.ll malodorous components.
; A further object is to provide a filtering and venting device of the type concerned which will avoid the condensation ,.......... ......
of water vapours within the filter whereby its usefu:L lifetime may be prolonged~
STATEMENT OF THE INVENTION
The invention concerns a device for ventiny discharge openings from the human body, comprising in combination: -a flat, platelet-like filter body of an odor-absorbing filter material; a first cover adhesively bonded at one of its surfaces substantially in the entirety thereof to one flat surface of the filter body, the cover being made of a liquid and gas-impervious sheet material and having substantially -the - same shape and size as the filter body; a second cover adhesively bonded at one of its surfaces substan-tially in the entirety thereof to the other flat surface of the filter body, the second cover being made of a liquid- and gas-impervious sheet material and having substantially the same outer shape and size as the filter body; the second cover is provided with a substantially centrally placed opening defining a gas inlet to the filter body; the edge of the filter body constitutes a gas outle-t from -the filter body and is uncovered.
In one preferred form of the device made in accordance with the present invention, the filter body has a substantially central opening aligned with the central opening in the second cover so as to admit gas entrance to the filter body via the inner edge formed at the central opening thereof.
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:;~ ,' .
., - 11 -.
DETAILED DESCRIPTION OF THE D:RAWINGS.
The venting devic~ according to the invention will now be described mo~e in detail with reference to the drawinys, it being un~erstood that drawings only serve at illustrating the various principles involved as represented by the various embodiments shown, and must not be construed as a limitation of the invention.
In the drawing, Fig. 1 is a cross section through the torso of a person wearing a stoma pouch provided with one embodiment ~f the venting device according to the invention, fig. 2 a part sec~ion through a person with a stoma bag with another ernbodiment of the venting device according to the invention, fig~ 3 a part sec~ion through a third emhodiment of a venting device according to the invention, fig. 4 a section through a person and his stoma, a plug inserted into the~stoma and provided with a venting device according to the invention, fig. 5 part of fig. 4 in larger scale, figO 6 a cross section through part of ernbodiment of the venting device according to the invention, fig. 7 a cross section through part of a still further embod~nent of the venting device according to the in~ention, fig. 8 a cross section through a plug for a stoma~
incorporating a venting device according to the in-vention, fig. 9 a longitudinal section of a stlll further , .
embodiment of a ventlng device according to the invention, fig. 10 a cross sectiorl through the embodiment of fig~ g, .
, :
Fig. 11 a longitudinal sec-tion through still another embodiment of the venting device according to the invention, Fig. 12 a cross-section through the embodiment of Fig. 11, Fig. 13 a flat view of part of a stoma bay provided with a venting device according to the invention, and Fig. 14 a cross-section through the bay and venting device of Fig. 13.
Figs. 1-7 for reasons of clarity are shown as slightly exploded views. In reality there will be no space between, e.g., objects 1, 3~ ~ and 5.
As shown in Fig. 1, a stoma bay or pouch 6 is fastened to the torso 1 of a person having a stoma 2, for ~` instance made by a surgical operation. A venting device according to the invention is situated between the skin of the patient and the bag. The venting device comprises a ring-- shaped, gas-tight disc 3 of an adhesive polymer composition.
The disc has a central hole fitting more or less closely around the outer opening of the stoma. One side of disc 3 adheres to the skin of the person and thereby acts as a means or part of the means for carrying the stoma bag. The other side of disc adheres to a ring~shaped filter element 4 comprising an odor-removing material~ Filter element 4 has a radial width a number of times its thickness (in the embodiment shown about 20 times its thickness) and may for instance consist of a ; commercial filter paper impregnated with activa-ted carbon.
In a preferred embodiment, the ring-shaped filter element is made of an open-celled, elastic cellular polymer foam impregnated with or containiny activated carbon. On the ~o other flat surface of filter element 4 a further ring-shaped, gas-tight disc of an adhesive polymer composition ~.~
is affixed; it bonds together filter element 4 and stoma bag 6 the inlet opening of which is aligned with central openings in adhesive rings 3 and 5 and filter element 4 as well as stoma 2 when situated in operative place. In use, liquids and solids from stoma 2 can enter bay 6 via the openings in ring-shaped elements 3, 4, and 5.
Intestine gases or gases evolved by the liquids and solids can escape via the venting device; the~ enter the ring-shaped filter element through the inner periphery, pass radially through the filter element and leave through the outer periphery. As ring-shaped discs 3 and 5 are adhesive, there is ensured gas-tight contac-t between them and the filter element, as well as gas-tight contact to the skin of person 1 and to bag 6. Accordingly, the gases can onl~ escape through the filter element; as this filter element contains an odor-removing filter material, and as its dimensions ensure a long path for the gases through this filter material, it will effectively ensure the removal of malodorous components of the gases whereby only innocuous gases actually leave the device.
In fig. 1, the filtering element is situated between the bag and the skin of the person. It might be placed at the outer side of the bag 6, away from the patient~s body. Thereby suitable means would be provided to affix the bag direct to the body with its inlet aligning the stoma; the opposite side of the bag would have an opening aligning with the cerltral hole irl the filter element 4, the latter being affixed to the bag. The outer face of the filter eLement would be in gas-tight contact with an entire disc of a gas-tight material e.g. a gas tight plastic film, covering both the ring-shaped filter element and the central opening thereof.
' , However, the position shown in fig. 1 ls the most advantageous because it has been found tha-t although the intestine gases are saturated ~ith water vapour, no condensation of water -vapour occurs inside the filter element. Such condensation is difficult to avoid in a filter placed at the outer, cooler surface of the stoma bag and would, when formed, seriously interfere with the function of the filter.
Although no special means are provided to prevent liquid collected in the stoma bag from entering the filter element, it has surprisingly been found that the latter remains dry and active for long periods.
Nevertheless~ if the material collected in the bag contains large amounts of water, or other special conditions exist, it may be advantageous to use the embodiment shown in fig. 2. Here, again, 1 is the torso of a person with a stoma 2. Again, an inner ring-shaped adhesive disc 3/ a r~ng-shaped filter disc 4 and an outer ring-shaped adhesive disc 5 form a connection betwe~n torso 1 and bag 6, the connection being gas-tight except ; for the possibillty of gases escaping through the odor-removing filter material from inner edge to outer edge of the disc. Here, however~ the inner edge of filter element 4 is covered by a film 7 of a gas-permeable hydrophobic material (e.g. the material sold by E i. du Pont de Nemours and Company under the registered trade mark "Tyvec")~ The "Tyvec" 7 is secured by yluelng or welding to the inner part of the adhesive rings 3 and 5.
As actually shown, the stoma bag 6 ln ig. 2 is adapted to be ~ecured to the fllter assembiy 3, 4, 5, 7 via flange 14. S~ch flange 1~ may be used to ensure greated freedom of movement of ~he stoma bag. It may also ~r~J / ~
be used when the stoma bag is fastened to the torso by means of a belt~ The embodiment of venting device shown in fig. ~ may well be carried out without this flange 14~
. It will be understood that in use there is no space between torso 1 and ring 3, between rings 3 and 4, or between rings 4 and 5, or between ring 5 and either bag 6 (fig. 1) or flanye 14 ~fig. 2). A similar observation will apply to the othe~ figures.
Fig. 3 shows a cross section of another embodiment of a filter for use under conditions of large amount of water in the bag, or other special conditions. Reference numerals 3, 4 and 5 have the same meanings as in fig. 1 and 2 and 8 is an inner riny of a gas-permeable hydrophobic material such as "Tyvec" (trademark) or of an open-celled h,vdrophobic foam plastic.
Fig. 4 is a cross section in the torso 1 of a patient with a stoma 2 closed by a so-called magnetic - plug 11. By a surgical operation a permanent magnet in the form of a riny enclosed in a suitable plastic material 12 has been placed around stoma 2. This ring attracts and holds the plug 11 which contains another magnet or set of magnets (not shown). By the attractive forces between the magnet(s) in 12 and 11, a cover plate 10, which is part of plug llp is pressed against a gasket 9 which prevents leakage from the stoma. With this type of closure for the stoma the build up o pressure ~rom intestine gas collected in the stoma is a particularly severe problem. The gas pressure lifts the plug away from the gasket even if the yasket is adhesive, and leakage results. For this type of stoma closure our invention is particularly useful.
Fig. 5 shows a detailed half cross-section of , .. ... .. . . .
¢~
gasket 9 which is made according to our invention and comprises a filter allowing the intestine gases to leave the stoma without ~scharging malodorous gases to the free. A ring-shaped inner disc 3 of gas-impervious material is adapted to bé held in gas-tight contact with the skin under the influence of the magnetic forces. Ring 3 is in gas-tight contact with a ring-shaped filter disc
,: , foods produce flatulence has heen well documented.
Ingestion of beans, fpr instance, may increase the mean flatus excretion ra-te from 15 ml to 176 ml per hr. The rate over shorter periods of time may show wide variations, and it is particurlarly the flatus released at high rate which is difficult to deodorize and also most likely to createproblems for the patient.
Thus, the variations 1n amounts and composition of flatus in themselves give great problems.
The composition of the intestinal gas depends in part upon the site in the gastro-intestinal tract from which it is obtained. Stomach gas usually has a composltion relatively similar to that of atmospheric air, for example 78% N2, 17% 2' 3% CO2. ~latus in general contains less than 2% oxygen with the remainder of the gas consisting of varying proportions of nitrogen, carbon dioxide, hydrogen, methane and trace components. Keizo Kodama and Yoshiaki Miura in J.Japan Soc. Food Nutrition 2, pages 149-152 (1949) give the following composition: CO2 13-34%, CH4 19-26%, H2 20~27%, N2 17-48%. The odoriferous gases include indole, skatole, volatile amines, and hydrogen sulfide, and represent normally less than 1~ of flatus.
Of these gases hydroyen sulfide is by far the major component and presents the worst problem since lt is readily detected by the nose in concentrations as low as 1 part in 100 million.
X - 4 _ The gases enter 'che drainage pouch and expand it which gives rise to both practical and psychic problems ~or the patient. It has been practice to teach him to vent the gases from the pouch by puncturiny the upper part of the pouch with a needle and after the exit of the gases seal the puncture anew with adhesive tape. However, because of the obnoxious nature of some of the yases and the frequency with wich i~ is necessary to vent the pouch, this solution is quite unsatisfactory and may give rise to embarrassing situations.
Therefore, it is known to provide the pouch with some sort of filter to allow escape of gases.
Another manner of sealing the stoma of ostomy patients is to close it by a so-called stoma-cap, which is afixed to the body in much the same manner as the drainage pouch. A third and more important is to close the stoma by a plug or a stopper-like device inserted into the stoma and maintained in position by a flange or cover plate the inner face of which is in contact with the skin of the abdomen around the stoma. Such stopper may be maintained in po~ition hy magnetic foxce, small permanent magnets being sewn into the body of the patient around the stoma by a surgical operation. There is no drainage pouch, but the fecal material is ramoved from time to time by irrigation, e.g.
every two days, after removal of the plug and subsequenk re-insertion of it. To prevent pressure-build up behlnd the plug (or behind the stoma cap), we have suggested to provide it with a venting opening covered with several layers of non-woven textile containing active carbon. In practice the gases are not, however, made non-odorous by the passage through this filter, possibly 10- because the path passed by the gasses through the filter is very short. Accordingly, this device may also give rise to em~arrassing situations.
Background of the invention As will be understood it is known in the three forms of sealing devices for stomas to insert a filter at some suitable spot of the path o the gases. Several such filters are known. Thus, a preferred embodiment of a filter known from US Patent Specification No.
3,759,260 comprises a disc of matted fibres and activated granulax carbon having one suxface overlying the inner side of the ven-t aperture of the pouch and an area surroundiny the aperture~ and an impervious cover over the opposite surface of the disc, whereby the gases to be vented pass radially through the disc from the perphery to the vent aperture placed centrally relative the filter.
This does not function quite satisfactory, .
~ - 6 -which is believed to be due to the short path passed by the gaSes and, perhaps most important, a tendency to a channelling e~fect to-be discussed later in this text.
A filter for venting gases from stoma pouches is described in Danish pa-tent specifi-cation No. 130,277, h;aving a priority rom US patent application Serial No. 290,149 of 18th September, 1972. The preferred embodiment of this comprises a square disc of matted fibres and activated carbon in granular form.
One surface is covered with a gas-tight material with a central venting aperture, whereas the other surface of the disc is covered with another cover of gas-tight material with several apertures displaced relative the centre, whereby the gases to be exhausted pass through an oblique, partly radial path trough the filter~ A similar filter is disclosed in Danish patent specification No. 133,080, having priority from US patent application Serial No. 401,337 of 27th September, 1973.
In this , one of the impervious covers has a central venting aperture and the opposite cover several venting apertures evenly distribu-ted over the area of the filter dlsc.
The prior art filter devices described are similar in that they all comprise a flat disc of matted fibres and activated granular carbon, said disc having the two opposite faces covered with impervious materials with apertures so that the gases to be exhausted are forced to pass in a more or less radial direction through the filter, i~e. by a path longer than the Lhickness of the disc.
The purpose of this is to make more effective use of the capacity oE the activated carbon for absorbing the odorous constituents of the intestine gases. However, in practice the known filter assemblies do not function as intended and the useful lifetime of filters are not satisfactory whereby despite of the use of filters there may arise embarrassing situations; also frequent removals and re-placements of the filters are needed and the active carbon present is not utilized full, which means an extra financial burden.
It is believed that one reason for the unsatisfactory function of the known filters described is that a considerable 'channelling' takes place during the passage of the gases. The filter disc is made of comparatively stiff material. The gas-tight covers are made of thin films or foils of plasti~ with no special precautions to ensure a stable, gas-tight contact with the surfaces of the filter disc. As a result, the path axial~y through the filter and then along a channel between the filter disc and ~ the cover to the vent aperture or apertures (or vice versa, first along a channel between the filter disc and cover and then axially through the filter) will offer much less resistance than the path r~diall~ or obliquely through the filter disc and there20re will be preferably followed.
Another reason for the unsatisfactory Eunction of the knowndevices must be sought in the irregular production and composition of the intesti.nal waste gases. If the absolute amount of odoriferous substances to remove were rather constant over the hours of the day, the filter material, for instance active carbon, cGuld be provided in an amount corresponding to the xate of odoriferous gases and the geometry of the placing of the active carbon would be relatively unimportant. As, however, amounts and compositi.on vary very much, a regulax utilisation of the entire mass of active carbon i.5 impossible and the geometry of the device becom~s more important.
Obiect of the invention It is an object of the invention to overcome the disadvantages involved in the channeling effect existing in known filters for venting devices f.or stoma seals such as stoma bags, stoma caps and stoma plugs, so as to ensure that the gases do not pas.s unpurified through the venting device via nor~absorbing pa~ts thereof. Particularly, is it an object of the invention to prov.ide the filter in a forrn so as to give optimal _ g _ . ~ ', . . . .
' ', ' ' ~ :
utilisation of the active filter material therein, i.e. of the odor-rernoving substances whereby the geometric construction of the filter will ensure that an amount of filter material not greater than hitherto used will be able to remove odoriferous gases from the intestine gases even in periods with maximum production of such gases with maximum contents of malodorous components. It is a further lo object of the invention to provide a filter or venting device which will be equally well adaptable to stoma pouches or bags, to stoma caps and to stoma plugs or stoppers and which can be manufactured as a releasable member that can be uséd for a prolonged period of tirne and be.transferred from one stoma pouch, cap or pl.ug to another.
An important o~ject of the invention is to provide a venting device including filter which will be cheap and easy to make from materials readily available. One important further object of the invention is to provide a filtering and venting device of the type in question, which is reliable and will permit the escape of no obnoxious gases from the stoma or from a mal-func~tioniny anus, the gases vented being free from a.ll malodorous components.
; A further object is to provide a filtering and venting device of the type concerned which will avoid the condensation ,.......... ......
of water vapours within the filter whereby its usefu:L lifetime may be prolonged~
STATEMENT OF THE INVENTION
The invention concerns a device for ventiny discharge openings from the human body, comprising in combination: -a flat, platelet-like filter body of an odor-absorbing filter material; a first cover adhesively bonded at one of its surfaces substantially in the entirety thereof to one flat surface of the filter body, the cover being made of a liquid and gas-impervious sheet material and having substantially -the - same shape and size as the filter body; a second cover adhesively bonded at one of its surfaces substan-tially in the entirety thereof to the other flat surface of the filter body, the second cover being made of a liquid- and gas-impervious sheet material and having substantially the same outer shape and size as the filter body; the second cover is provided with a substantially centrally placed opening defining a gas inlet to the filter body; the edge of the filter body constitutes a gas outle-t from -the filter body and is uncovered.
In one preferred form of the device made in accordance with the present invention, the filter body has a substantially central opening aligned with the central opening in the second cover so as to admit gas entrance to the filter body via the inner edge formed at the central opening thereof.
.
:;~ ,' .
., - 11 -.
DETAILED DESCRIPTION OF THE D:RAWINGS.
The venting devic~ according to the invention will now be described mo~e in detail with reference to the drawinys, it being un~erstood that drawings only serve at illustrating the various principles involved as represented by the various embodiments shown, and must not be construed as a limitation of the invention.
In the drawing, Fig. 1 is a cross section through the torso of a person wearing a stoma pouch provided with one embodiment ~f the venting device according to the invention, fig. 2 a part sec~ion through a person with a stoma bag with another ernbodiment of the venting device according to the invention, fig~ 3 a part sec~ion through a third emhodiment of a venting device according to the invention, fig. 4 a section through a person and his stoma, a plug inserted into the~stoma and provided with a venting device according to the invention, fig. 5 part of fig. 4 in larger scale, figO 6 a cross section through part of ernbodiment of the venting device according to the invention, fig. 7 a cross section through part of a still further embod~nent of the venting device according to the in~ention, fig. 8 a cross section through a plug for a stoma~
incorporating a venting device according to the in-vention, fig. 9 a longitudinal section of a stlll further , .
embodiment of a ventlng device according to the invention, fig. 10 a cross sectiorl through the embodiment of fig~ g, .
, :
Fig. 11 a longitudinal sec-tion through still another embodiment of the venting device according to the invention, Fig. 12 a cross-section through the embodiment of Fig. 11, Fig. 13 a flat view of part of a stoma bay provided with a venting device according to the invention, and Fig. 14 a cross-section through the bay and venting device of Fig. 13.
Figs. 1-7 for reasons of clarity are shown as slightly exploded views. In reality there will be no space between, e.g., objects 1, 3~ ~ and 5.
As shown in Fig. 1, a stoma bay or pouch 6 is fastened to the torso 1 of a person having a stoma 2, for ~` instance made by a surgical operation. A venting device according to the invention is situated between the skin of the patient and the bag. The venting device comprises a ring-- shaped, gas-tight disc 3 of an adhesive polymer composition.
The disc has a central hole fitting more or less closely around the outer opening of the stoma. One side of disc 3 adheres to the skin of the person and thereby acts as a means or part of the means for carrying the stoma bag. The other side of disc adheres to a ring~shaped filter element 4 comprising an odor-removing material~ Filter element 4 has a radial width a number of times its thickness (in the embodiment shown about 20 times its thickness) and may for instance consist of a ; commercial filter paper impregnated with activa-ted carbon.
In a preferred embodiment, the ring-shaped filter element is made of an open-celled, elastic cellular polymer foam impregnated with or containiny activated carbon. On the ~o other flat surface of filter element 4 a further ring-shaped, gas-tight disc of an adhesive polymer composition ~.~
is affixed; it bonds together filter element 4 and stoma bag 6 the inlet opening of which is aligned with central openings in adhesive rings 3 and 5 and filter element 4 as well as stoma 2 when situated in operative place. In use, liquids and solids from stoma 2 can enter bay 6 via the openings in ring-shaped elements 3, 4, and 5.
Intestine gases or gases evolved by the liquids and solids can escape via the venting device; the~ enter the ring-shaped filter element through the inner periphery, pass radially through the filter element and leave through the outer periphery. As ring-shaped discs 3 and 5 are adhesive, there is ensured gas-tight contac-t between them and the filter element, as well as gas-tight contact to the skin of person 1 and to bag 6. Accordingly, the gases can onl~ escape through the filter element; as this filter element contains an odor-removing filter material, and as its dimensions ensure a long path for the gases through this filter material, it will effectively ensure the removal of malodorous components of the gases whereby only innocuous gases actually leave the device.
In fig. 1, the filtering element is situated between the bag and the skin of the person. It might be placed at the outer side of the bag 6, away from the patient~s body. Thereby suitable means would be provided to affix the bag direct to the body with its inlet aligning the stoma; the opposite side of the bag would have an opening aligning with the cerltral hole irl the filter element 4, the latter being affixed to the bag. The outer face of the filter eLement would be in gas-tight contact with an entire disc of a gas-tight material e.g. a gas tight plastic film, covering both the ring-shaped filter element and the central opening thereof.
' , However, the position shown in fig. 1 ls the most advantageous because it has been found tha-t although the intestine gases are saturated ~ith water vapour, no condensation of water -vapour occurs inside the filter element. Such condensation is difficult to avoid in a filter placed at the outer, cooler surface of the stoma bag and would, when formed, seriously interfere with the function of the filter.
Although no special means are provided to prevent liquid collected in the stoma bag from entering the filter element, it has surprisingly been found that the latter remains dry and active for long periods.
Nevertheless~ if the material collected in the bag contains large amounts of water, or other special conditions exist, it may be advantageous to use the embodiment shown in fig. 2. Here, again, 1 is the torso of a person with a stoma 2. Again, an inner ring-shaped adhesive disc 3/ a r~ng-shaped filter disc 4 and an outer ring-shaped adhesive disc 5 form a connection betwe~n torso 1 and bag 6, the connection being gas-tight except ; for the possibillty of gases escaping through the odor-removing filter material from inner edge to outer edge of the disc. Here, however~ the inner edge of filter element 4 is covered by a film 7 of a gas-permeable hydrophobic material (e.g. the material sold by E i. du Pont de Nemours and Company under the registered trade mark "Tyvec")~ The "Tyvec" 7 is secured by yluelng or welding to the inner part of the adhesive rings 3 and 5.
As actually shown, the stoma bag 6 ln ig. 2 is adapted to be ~ecured to the fllter assembiy 3, 4, 5, 7 via flange 14. S~ch flange 1~ may be used to ensure greated freedom of movement of ~he stoma bag. It may also ~r~J / ~
be used when the stoma bag is fastened to the torso by means of a belt~ The embodiment of venting device shown in fig. ~ may well be carried out without this flange 14~
. It will be understood that in use there is no space between torso 1 and ring 3, between rings 3 and 4, or between rings 4 and 5, or between ring 5 and either bag 6 (fig. 1) or flanye 14 ~fig. 2). A similar observation will apply to the othe~ figures.
Fig. 3 shows a cross section of another embodiment of a filter for use under conditions of large amount of water in the bag, or other special conditions. Reference numerals 3, 4 and 5 have the same meanings as in fig. 1 and 2 and 8 is an inner riny of a gas-permeable hydrophobic material such as "Tyvec" (trademark) or of an open-celled h,vdrophobic foam plastic.
Fig. 4 is a cross section in the torso 1 of a patient with a stoma 2 closed by a so-called magnetic - plug 11. By a surgical operation a permanent magnet in the form of a riny enclosed in a suitable plastic material 12 has been placed around stoma 2. This ring attracts and holds the plug 11 which contains another magnet or set of magnets (not shown). By the attractive forces between the magnet(s) in 12 and 11, a cover plate 10, which is part of plug llp is pressed against a gasket 9 which prevents leakage from the stoma. With this type of closure for the stoma the build up o pressure ~rom intestine gas collected in the stoma is a particularly severe problem. The gas pressure lifts the plug away from the gasket even if the yasket is adhesive, and leakage results. For this type of stoma closure our invention is particularly useful.
Fig. 5 shows a detailed half cross-section of , .. ... .. . . .
¢~
gasket 9 which is made according to our invention and comprises a filter allowing the intestine gases to leave the stoma without ~scharging malodorous gases to the free. A ring-shaped inner disc 3 of gas-impervious material is adapted to bé held in gas-tight contact with the skin under the influence of the magnetic forces. Ring 3 is in gas-tight contact with a ring-shaped filter disc
4, e.g. of similar const~uction as disc used in connection with figs. 1 and 2, and thus again in gas-tight contact with an outer gas-impervious disc 13 which is made of adhesive material or provided with an adhesive on both sidesO
The radial width of yasket 9 is at least 5 times the thickness of filter ring 4. Disc 13 is not absolutely necessary as cover plate 10 may itself act as the gas-impervious cover. It is, however, an advantage to use the adhesive disc 13 which positions and keeps the filtre disc in place when the plug is opened and closed for removal of faecal material.
Ring 3 may be a so~t flexible gasket and if desired may also be adhesive to obtain maximum security against leakage.
Fig. 6 shows a cross-section of another gasket suitable for use with the magnetic plug 10, 11. Reference numerals 3, 4, and 13 hav~ the same meaning as in fig. 5.
Reference 7 is a ring of ';Tyvec" (trademark) which extends over the inner edge of the filter disc 4. This disc oE
"Tyvec" (trademark) or other hydrophobic gas-permeable - material must have an outer diameter smaller than the filter disc; the radial distance from its outer periphery to the outer periphery of the filter ring must be at least 5 times the thickness of the filter discs. It goes without saying that there must be gas-tight contact must be gas-tight contact between filter ring 4 and ring 3 where the "Tyvec" (trademark) ring 7 is not pxe~ent.
Fig. 7 shows a cross-section of another filtre assembly suitable for use both with a magnetic plug and a stoma bag. Here one of the gas-impervious covers (3) has a larger central opening than filtre ele~ent 4, thereby increasing the effective area through which the gas may enter the interior of the filtre element. Again, the three rings must be in gas-tight contact with each other and the radial width of the cover ring (3) having the larger central opening must be at least 5 times the thickness of the filter ring.
If desired the filter element may be impregnated partly or wholly with a hydrophobiny agent such as a fluorpolymer or a silicone.
It is also understood that if desired the filtre need not be symmetric with respect to dimensions or other properties around the stoma, but may for instance be gas-impervious around a fraction of the stoma periphery.
Fig. 8 shows a section of a plug 11 somewhat like that shown in fig. 4. It is held in the stoma 2 of a patient 1 by magnetic means placed partially as a strong permanent magnet ring 12 situated under the skin of the patient around the stoma, partially placed in the plug which contains several strong magnets rnoulded into a co~non housing o~ a suitable plastic 10~ Be-tween the plug and the skin, iOe. at the inner surPace of a Plange-like extension or cover plate 10, there is a sealin~ gasket 9 o~
.
a soft material. In the plug proper there is a longi-tudinal channel extending from the inner end of the plug to the top or flange 10 which is integral with the plug proper.
In this top ther~ is a cavity or rece3s in which there is ~; .
inserted a venting device in 'che ~orm of a capsule 17.
Expediently there is a pl~te 13 of erro-magnetic m~terial moulded into the base of the venting device; this will ensure that the venting ~evice is held in place by the strong magnets inside th~ plug and ye-t allow easy replacement when exhausted. The venting device 17 may also be held in place by a self adhesive coating a by a - snap lock.
Figs. 9-10 show a very convenient venting device for use as device 17 in ~he plug shown in fig~ 8.
Here 21 is a flat cylindrical box or capsule having a hole 22 in the bottom ~hrough which the intestine gas may enter the interior o~ the box, e.g. via the channel in plug 11. The hole is ~overed with a relatively coarse filter 23 which prevents the intrusion of solid material from the stoma and the escape of absorbing media from the ; box. The box has a dividing member or partition 24 moulded to the bottom thereof an~ extending up to covering lid 25 and forming a spiral path from the entry hole 22 to the exit hole 26 in the lid. ~7 is a so~t material which provides a gas tight seal between the dividing member and the lid thereby forcing the intestine gas to follow the long spiral pa~h. The interior of the box is filled with one of the odor-removing materials 28 described.
29 is a self--adhesive rnaterial which allows the patient to affix the filtering d~vice to the stoma seal or stoma bag and may replace plate 18~ The length of the spirally coiled channel is at least 5 times the square root of its cros~ sectional area !
In ~igs~ 9-10 the ~ntry opening 22 for the gases is placed near the periphery and the exit hole 26 .~ centrally; ackually, the opposite positions is more .~ 5~
suitable when using this form of a venting device in a plug as shown in fiy. 8 whereas the positions actually shown are convenient when using such form of venting device in connection with a stoma bag.
Another embodiment of a venting device according to the invention and suitable especially for a stoma bag is shown in figs. 11 and 12. Again, the venting devices consists of a flat box or capsule (which in this embodiment is preferably rectangular or even square) having an entry opening 22 for intestine gases in the bottom and an exit opening 26 for purified (deodorized) intestine gases in the top or lid. The box is filled with an odox~
removing filter material 28 and this is effectively in the form of a long channel (at least 5 times its smallest dimension) formed by the aid of several vertical partitions each extending from upper or lower side wall o~ the box to a position near the opposite wall so as to form a zig-zay or wavy channel. The vertical orientation of the partitions is preferred (it is observed in this connection that "vertical" refers to the position in use when the patient is sitting, standing or going; the "bottom" and "lid" refers to the larger surfaces of the box; the "bottom" in use is nearest the skin and the "lid" turned away therefrom). The advantage of the vertical ori~ntation of the partitions is that gravity will drag the filter material 28, if it i5 granular, towards the lower parts of the box and completely ensure filling of the channels an counteract channeling.
Filter material 28 is held in gas-tight contact with lid 25 by soft material 27. Self-adhesive material 29 permits the box to be affixed to a stoma bag.
It is preferred that the channel through ~Jhich .
$
the gases must pass is filled with filter material 28, from the side and not from one end, especially if it is granular.
In the preferred embodiment this is obtained by n~king the housing of the filtering device in two parts, one comprising the bottomj the outer walls, and the dividing members forming ~he channel, and the other being in the form of a lid which closes the channels.
Filling material is poured into the open box, and excess material is removed by a doctor blade before the lld is put on. This methad of filling is - par-ticularly in the case of complicated patterns - much simpler and more efficient than any other method.
It has been found that by making the filter in the form of a flat container which is used with the flat dimension parallel to the skin of the patient, the deodoriæing filling material remains dry and active over a long period of timeO This is in contrast to other designs where condensation of water vapour takes place, and the condensed water rapidly reduces the effectiveness of the filter. A possible explanation may be that the design according to the invention ensures maximum contac~
with the patient's skin and gives substantially body temperature in all parts of the filter.
In a preferred embodiment the filtering device is affixed to the upper part of a stoma bag.
An embodiment especially preferred for use with certain stoma bags is shown in fig. 13 and fig. 14. Here 31 is a flat plastic ~ilm which is part of a stoma bag.
In the upper part there is a venting device 32 comprising a carrier impregnated with the odor-removing filter material, and comprising a flexible member 33 which may ~ 2]
be in the fo~n of a flat strip as shown in fig. 13 or in another suitable form, for instane in the form of a core placed in the center of the filter. The filter is closed by a profiled or grooved sheet of plastic film 34 placed on top of bag 31 and sealed to it preferably under slight compression of the flexible member. This compression of the flexible mem~er will assure that in use the filter is pressed against the walls whereby channeling (- the passage of gases in voids along the walls in insufficient contact with the filter) is effectively prevented. The groove may, for instance, have the shape shown in fig. 14.
A filter of the same general shape as that shown in fig. 13 and fig. 14 may also be made by heat sealing the two films forming the external walls but leaving the top end unsealed. A filtering material is then filled into the parallel channels, to ease the filling these may for example ~e kept open by applying a slight vacuum to the external walls. After the channels are filled they are closed and interconnected by heat-sealing of the top.
Exam~le 1 A stoma bag made from polyvinylidene chl~ride and having a flange on the r~ar side was fitted with a filter element of the general construction shown in fig. 2 The active fi]-ter element (~ was made from 3 mm thick opencelled polyurethane foam of density 17 kg/m3 impregnated with a slurry of activated carbon powder in a binder compxising an ethylene-vinylacetate polymer dispersion. The impregnated polyurethane foarn had a density of 48 kg/m and contained 37% b.w. of activated carbon.
The ring-shaped gas-tight discs (3) and (5) were made from a double sided self~adhesive polymer composition which adhered firmly to the filter element (4) and this prevented channeling.
The stoma bag wastested on a male patient having severe problems with large volumes of intestine gas. The bag was used over 28 hours and during this time the intestine gas was released continously and was completely free of odor.
When using a stoma bag with a filter device according to USP 3,759.260 the patient complained that the venting device was not able to deodorise the intestine gas as fast as it was produced and he had to change back to a venting device according to the invention.
Example 2 A patient having a stoma closed by a magnetic plug as shown in fig~ 4 complains o~ leakage around the plug. Various gasket materials and known gaskets constructions are tried, but the seal is never tight for more than a short period, after which time faecal rnaterial starts toleak out. The magnetic plug is now fitted with a filter device oE a .
.J~ .
construction as shown in fig. 7. The actlve filter elernent is made from an opencelled flexible polyurethane foam impregnated with activa-ted carbon. The overall densi,ty is 60 kg/m3 and the filter contains 29% b.w. of carbon.
The outer gas-tight disc (13) is made from a double-sided self-adhesive polymer composition and the inner yas-tight disc is made from a sealing material comprising about 50%
of a viscous polyisobutylene matrix and about 50% of a hydrophilic powdery filter comprising gelatin, sodium carboxy-methyl cellulose and powdery pectin . The outer diameter of the filter device is 60 millimeters and the diameter of the central hole in ring (4) and adhesive disc ~13) is 10 mm and in the inner cover (3) the hole diameter is 14 mm.
With this filter device the plug remains tight for 82 hours. The intestine gas is completely deodorized and lS vented as fast as it is produced and there is no leakage of feacal material. ~he plug is opened three times during this period and faecal material is removed by irrigation of the intestine. When the plug is reinserted the seal is still perfect.
Example 3.
In an investigation at the University Clinic at Erlangen, Germany, nine stoma patients, who all had severe problems with leakage of obnoxious material around their magnetic stoma plugs when using known gaskets were given venting devices according to the invention. With a venting device as shown in fig. 7, eight of the nine patients became free of problems, i.e., the intestine gas was removed in a controlled manner through the filter and there was no problem with leakage or odour.
In a slmliar investigation made by Dr. H. Feustel at - 24 ~
,~
the University Clinic at Giessen, Gerrnany, nine out of ten patients were relieved of problems with their stoma.
Example 4 A magnetic stoma plug was fitted with a venting device of the construction shown in fig. 6. The filter elernent (4) was made from filter paper impregnat0d with active carbon.
The outer gas-impervious disc t13) was made from a styrene-isoprene-styrene rubbex sheet, and the inner disc (3) was made from sealing material comprising a viscous polyisobutylene matrix wi~h a hydrophili filter comprising a blend of starch~ gelatin and pectin. The gas~tiyht contac-t between disc (13) and the fil~er element (4) was obtained by the magnetic forces holdiny the plug in place in the stoma. This plug was tested on a patient who had never been free of leakage and odours from his stoma. With the new venting device he had no problems with leakage and the intestine gas leaving the filter element was completely free of odour. After 29 hours the plug was removed. The filter element was still active 9 but the inner gas-impervious disc (3) had swollen so much from intestine fluids that the passage between the inner rim of the disc and the plug (11 in fig. 4) was blocked. The function of this v~nting device could ba further improved hy incr~asing the diameter of the central hole of disc (3~ as shown in fig. 7. The ratio between thickness of filter element and radial path from the centxal hole to the outer rim wa~ in this experiment 1.40.
. .
_ ample 5 In order to investig~te the in1uence of the physical . , ~.~
.. . . ..
, :, , , . , :
dimensions upon the performance of the active filter element the following experiment was made.
A flexible open-celled polyurethane foam was cut into sheets of a thickness of 3 mm. The sheets were impregnated with active carbon in a binder comprising a vinyl copolymer dispersion. The dried sheets contained 28% b.w. of carbon and had a density of 55 kg/m .
- Rectangular discs were cut from a sheet. The area of the discs were in all cases 4,5 cm and the lenyth and width lQ were as shown in table 1. These discs were each covered with adhesive gas impervious tape on top, bottom and the two sides, whereas the remaining two sides were sealed to small plastic tubes to allow the passage of gas through the inlet tube into the disc through its lengthwise direction, and then out through the exit tube. The inlet tube could be connected to a gas tank filled with a test gas at atmospheric pressure. The exit tube could be connected to a detector tube containing a plumbous salt and calibrated to show the amount of H2S in the gas passing the tube. The other end of the detector tube was connected to a calibrated suction pump which could pump precisely known volumes of test gas from the gas tank, through the filter el ment and the detector tube. The test gas consisted of a blend oi 80~ nitrogen and about 20% methane with 25 p.p.m. N2S added. During the experiment any H2S not being absorbed by the filter element would react with the plumbous salt in the detector tube from which a direct reading of the amount could be obtained.
Since in practice the stoma patients have the greatest pro~lems when large volumes of intestine gas is suddenly re-leased the gas rates were varied to find the filter dimensions most effective at the high gas rates corresponding to this situation.
- 2~ _ .
Table 1. DiMensions of Filter Elements Filter No. Length Width Thickness Length mm mm mm Thickness _ ~
1 322.4 22.4 0.1 2 _ 10_ _ 15 1.1 _1 :
4 ~ 30 15 10 -_ 1~ 3 15 Table 2. Efficiency of Filter Elements versus Flow Rate _ Rate ~lf/mian. 10 20 50 100 200 : Filter Total Effi- Effi- Effi- Effi- Effi-No. vol. ml. cieney eieney eieney eieney ciency % % % ~ %
: 100 9890 77 60 20 20~ 25 -: : 1 300 9784 66 47 27 400 30 .
_ _ ' ", 2 300 9992 78 59 42 ~. :
.......
3 300 100g8 84 70 50 _ . 4 300 100100 93 83 60 . 500 10099 89 72 52 . _ : 100 100100 100 100 86 ~00 100100 90 77 55 ~ 500 10099 _ 90 72 55 .' :
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The results of the experiment are shown in table 2.
It will be seen that filter No. 1, where the gas passes perpendicularly to the plane of the filter element is the least efficient. Even at the lowest gas flo~ rate 100% efficiency is never reached and as the flow rate increases the efficiency drops rapidly. ~Efficiency is the percentaye of H2S
absorbed by the filter).
The filters Nos. 3, 4j and 5 are all highly efficient at the lower flow rates even after a total of 500 ml of test gas has passed the filter elements. At higher flow rates the filters drop off in efficiency, but even at a rate of 100 ml/min filters Nos. 4 and 5 retain an efficiency of 83% after the first 300 ml of test gas and 72 % after 500 ml.
Filter No. 2 is, although clearly better than No. 1, never 100% efficient and is more sensitive to an increase in flow rate and volume than filters 3, 4, and 5.
It is thus seen that in order to combine efficiency at high flow rates with large total capacity the venting device should be designed with a gas path through the filter element which is considerably longer (at least 5 times) than the sma~estdimension of the filter element.
Example 6 A test gas comprising nitrogen, methane, hydrogen , carbondioxide and 25 p.p.m. H2S was passed into a commercial stoma cap manufactured by 'iHollister Incorporated" and basicly described in Danish Patent Specification No. 133080.
The gases leaving the exit hole in the venting device were passed through a detector tube and the total amount of ~l2S
passing the venting device was measured. After 400 ml of .
"': . ' ': ' ' ' "
test gas had passsed a re~ding of 5 was obtained. After 600 ml the reading had incx~ased to 15 and th~ experiment was stopped. In a similar stoma cap the fil-ter element was brought into gas-tight contact with enclosing gas-tight plastic foils by the use of an adhesive, so that the gas had to pass from the rim 'co the venting hole through the filter element and channeling waseffectively prevented.
Test gas was now passed through the venting device. After 400 ml the reading was zero. After 600 ml the reading was 7.5 and the experiment was stopped.
Example 7 A stoma bag made from two rectangular sheets of plastic foil sealed around the edges is fitted with a venting device consisting of flat filter element measuring 15 x 30 x 3 mm made from elted cellulosic fibers and containing finely granulated active carbon. The filter element is placed into a small pockat made by sealing of a 22 x 40 mm sheet of a similar plastic foil onto one of the sheets forming the stoma bag. An entry hole and an exit hole i5 made in the two sheets enclosing the filter element so that the gas to be vented is forced to pass through the length of the filter element.
In anothex stoma bag of a similax construction a gas-tight contact between the filter element and the enclosing walls is obtain d by means of an adhesive.
The capacity and efficiency o~ the two v~nting devices is compared by passing a test gas containing H2S through them. The results are shown in table 3.
, ~-~ æ~ ' ;; '! -- ,A~ --. .
Table 3 Vol~ ~n 1 Efficiency of Test without gas-tight contact with yas-tight contact Gas 50 ml/min100 ml/min 50 ml/min100 ml/min . , 200 l00 90 100 96 300 93 66 95 8~
500 66 52 _ 89 72 The results clearly show that efficiency can be considerably improved by bringing the filter element into gas-tight contact with the enclosing walls.
Example 8 In another experiment the venting device described in the above example was fitted onto a stoma bag by an self-adhesive disc ((29) in fig. 10)~ so that intestine gases collected in the bag could be vented through the venting device into the a~nosphere~ In use the stoma bag would collect the solid and liquid faecal material produced in the intestine while the intestine gas was deodorized and released through the venting device. After a period of the normally 5~10 hours the bag with the collected material would be removed and discharged, while the venting device was transferred onto a new bag, which was placed over -the stoma. After three weeks o continous use in this manner the venting device still performed satisfactory and the patient had no problems with odours.
Exa~
A venting device as shown in fig. 9 and 10 is fitted .` ,. . -- A--~ --3~
into a magnetic plug as shown in fig. 8. The venting device comprises a flat cylindrical box or capsule moulded from a thermoplastic polymer and having the following dimensions in millimeters: outer diameter: 23, inner diameter. 19.2, height of inner compartment: 4.0, length of path from inlet hole (22) to outlet hole (26): 100.
(Note that in this example the entryhole is placed in the bot~om at the center, while th exit hole is placed in the lid(25) near the periphery). Average width of ~piral path:
approximately 3 mm. The capsule is filled with granular activated carbon and a substantially gas-tight seal is formed between the walls of the capsule and the act~vated carbon by the use of a flexible material (27) which in this case is a flexible cellular polyurethane.
The magnetic plug with the venting device is tested for a week on a patient complaining of large volumes of odorous intestine gas. The filter element gave excellent performance and the patient had no problems with ordours during the entire test period.
.
;~
The radial width of yasket 9 is at least 5 times the thickness of filter ring 4. Disc 13 is not absolutely necessary as cover plate 10 may itself act as the gas-impervious cover. It is, however, an advantage to use the adhesive disc 13 which positions and keeps the filtre disc in place when the plug is opened and closed for removal of faecal material.
Ring 3 may be a so~t flexible gasket and if desired may also be adhesive to obtain maximum security against leakage.
Fig. 6 shows a cross-section of another gasket suitable for use with the magnetic plug 10, 11. Reference numerals 3, 4, and 13 hav~ the same meaning as in fig. 5.
Reference 7 is a ring of ';Tyvec" (trademark) which extends over the inner edge of the filter disc 4. This disc oE
"Tyvec" (trademark) or other hydrophobic gas-permeable - material must have an outer diameter smaller than the filter disc; the radial distance from its outer periphery to the outer periphery of the filter ring must be at least 5 times the thickness of the filter discs. It goes without saying that there must be gas-tight contact must be gas-tight contact between filter ring 4 and ring 3 where the "Tyvec" (trademark) ring 7 is not pxe~ent.
Fig. 7 shows a cross-section of another filtre assembly suitable for use both with a magnetic plug and a stoma bag. Here one of the gas-impervious covers (3) has a larger central opening than filtre ele~ent 4, thereby increasing the effective area through which the gas may enter the interior of the filtre element. Again, the three rings must be in gas-tight contact with each other and the radial width of the cover ring (3) having the larger central opening must be at least 5 times the thickness of the filter ring.
If desired the filter element may be impregnated partly or wholly with a hydrophobiny agent such as a fluorpolymer or a silicone.
It is also understood that if desired the filtre need not be symmetric with respect to dimensions or other properties around the stoma, but may for instance be gas-impervious around a fraction of the stoma periphery.
Fig. 8 shows a section of a plug 11 somewhat like that shown in fig. 4. It is held in the stoma 2 of a patient 1 by magnetic means placed partially as a strong permanent magnet ring 12 situated under the skin of the patient around the stoma, partially placed in the plug which contains several strong magnets rnoulded into a co~non housing o~ a suitable plastic 10~ Be-tween the plug and the skin, iOe. at the inner surPace of a Plange-like extension or cover plate 10, there is a sealin~ gasket 9 o~
.
a soft material. In the plug proper there is a longi-tudinal channel extending from the inner end of the plug to the top or flange 10 which is integral with the plug proper.
In this top ther~ is a cavity or rece3s in which there is ~; .
inserted a venting device in 'che ~orm of a capsule 17.
Expediently there is a pl~te 13 of erro-magnetic m~terial moulded into the base of the venting device; this will ensure that the venting ~evice is held in place by the strong magnets inside th~ plug and ye-t allow easy replacement when exhausted. The venting device 17 may also be held in place by a self adhesive coating a by a - snap lock.
Figs. 9-10 show a very convenient venting device for use as device 17 in ~he plug shown in fig~ 8.
Here 21 is a flat cylindrical box or capsule having a hole 22 in the bottom ~hrough which the intestine gas may enter the interior o~ the box, e.g. via the channel in plug 11. The hole is ~overed with a relatively coarse filter 23 which prevents the intrusion of solid material from the stoma and the escape of absorbing media from the ; box. The box has a dividing member or partition 24 moulded to the bottom thereof an~ extending up to covering lid 25 and forming a spiral path from the entry hole 22 to the exit hole 26 in the lid. ~7 is a so~t material which provides a gas tight seal between the dividing member and the lid thereby forcing the intestine gas to follow the long spiral pa~h. The interior of the box is filled with one of the odor-removing materials 28 described.
29 is a self--adhesive rnaterial which allows the patient to affix the filtering d~vice to the stoma seal or stoma bag and may replace plate 18~ The length of the spirally coiled channel is at least 5 times the square root of its cros~ sectional area !
In ~igs~ 9-10 the ~ntry opening 22 for the gases is placed near the periphery and the exit hole 26 .~ centrally; ackually, the opposite positions is more .~ 5~
suitable when using this form of a venting device in a plug as shown in fiy. 8 whereas the positions actually shown are convenient when using such form of venting device in connection with a stoma bag.
Another embodiment of a venting device according to the invention and suitable especially for a stoma bag is shown in figs. 11 and 12. Again, the venting devices consists of a flat box or capsule (which in this embodiment is preferably rectangular or even square) having an entry opening 22 for intestine gases in the bottom and an exit opening 26 for purified (deodorized) intestine gases in the top or lid. The box is filled with an odox~
removing filter material 28 and this is effectively in the form of a long channel (at least 5 times its smallest dimension) formed by the aid of several vertical partitions each extending from upper or lower side wall o~ the box to a position near the opposite wall so as to form a zig-zay or wavy channel. The vertical orientation of the partitions is preferred (it is observed in this connection that "vertical" refers to the position in use when the patient is sitting, standing or going; the "bottom" and "lid" refers to the larger surfaces of the box; the "bottom" in use is nearest the skin and the "lid" turned away therefrom). The advantage of the vertical ori~ntation of the partitions is that gravity will drag the filter material 28, if it i5 granular, towards the lower parts of the box and completely ensure filling of the channels an counteract channeling.
Filter material 28 is held in gas-tight contact with lid 25 by soft material 27. Self-adhesive material 29 permits the box to be affixed to a stoma bag.
It is preferred that the channel through ~Jhich .
$
the gases must pass is filled with filter material 28, from the side and not from one end, especially if it is granular.
In the preferred embodiment this is obtained by n~king the housing of the filtering device in two parts, one comprising the bottomj the outer walls, and the dividing members forming ~he channel, and the other being in the form of a lid which closes the channels.
Filling material is poured into the open box, and excess material is removed by a doctor blade before the lld is put on. This methad of filling is - par-ticularly in the case of complicated patterns - much simpler and more efficient than any other method.
It has been found that by making the filter in the form of a flat container which is used with the flat dimension parallel to the skin of the patient, the deodoriæing filling material remains dry and active over a long period of timeO This is in contrast to other designs where condensation of water vapour takes place, and the condensed water rapidly reduces the effectiveness of the filter. A possible explanation may be that the design according to the invention ensures maximum contac~
with the patient's skin and gives substantially body temperature in all parts of the filter.
In a preferred embodiment the filtering device is affixed to the upper part of a stoma bag.
An embodiment especially preferred for use with certain stoma bags is shown in fig. 13 and fig. 14. Here 31 is a flat plastic ~ilm which is part of a stoma bag.
In the upper part there is a venting device 32 comprising a carrier impregnated with the odor-removing filter material, and comprising a flexible member 33 which may ~ 2]
be in the fo~n of a flat strip as shown in fig. 13 or in another suitable form, for instane in the form of a core placed in the center of the filter. The filter is closed by a profiled or grooved sheet of plastic film 34 placed on top of bag 31 and sealed to it preferably under slight compression of the flexible member. This compression of the flexible mem~er will assure that in use the filter is pressed against the walls whereby channeling (- the passage of gases in voids along the walls in insufficient contact with the filter) is effectively prevented. The groove may, for instance, have the shape shown in fig. 14.
A filter of the same general shape as that shown in fig. 13 and fig. 14 may also be made by heat sealing the two films forming the external walls but leaving the top end unsealed. A filtering material is then filled into the parallel channels, to ease the filling these may for example ~e kept open by applying a slight vacuum to the external walls. After the channels are filled they are closed and interconnected by heat-sealing of the top.
Exam~le 1 A stoma bag made from polyvinylidene chl~ride and having a flange on the r~ar side was fitted with a filter element of the general construction shown in fig. 2 The active fi]-ter element (~ was made from 3 mm thick opencelled polyurethane foam of density 17 kg/m3 impregnated with a slurry of activated carbon powder in a binder compxising an ethylene-vinylacetate polymer dispersion. The impregnated polyurethane foarn had a density of 48 kg/m and contained 37% b.w. of activated carbon.
The ring-shaped gas-tight discs (3) and (5) were made from a double sided self~adhesive polymer composition which adhered firmly to the filter element (4) and this prevented channeling.
The stoma bag wastested on a male patient having severe problems with large volumes of intestine gas. The bag was used over 28 hours and during this time the intestine gas was released continously and was completely free of odor.
When using a stoma bag with a filter device according to USP 3,759.260 the patient complained that the venting device was not able to deodorise the intestine gas as fast as it was produced and he had to change back to a venting device according to the invention.
Example 2 A patient having a stoma closed by a magnetic plug as shown in fig~ 4 complains o~ leakage around the plug. Various gasket materials and known gaskets constructions are tried, but the seal is never tight for more than a short period, after which time faecal rnaterial starts toleak out. The magnetic plug is now fitted with a filter device oE a .
.J~ .
construction as shown in fig. 7. The actlve filter elernent is made from an opencelled flexible polyurethane foam impregnated with activa-ted carbon. The overall densi,ty is 60 kg/m3 and the filter contains 29% b.w. of carbon.
The outer gas-tight disc (13) is made from a double-sided self-adhesive polymer composition and the inner yas-tight disc is made from a sealing material comprising about 50%
of a viscous polyisobutylene matrix and about 50% of a hydrophilic powdery filter comprising gelatin, sodium carboxy-methyl cellulose and powdery pectin . The outer diameter of the filter device is 60 millimeters and the diameter of the central hole in ring (4) and adhesive disc ~13) is 10 mm and in the inner cover (3) the hole diameter is 14 mm.
With this filter device the plug remains tight for 82 hours. The intestine gas is completely deodorized and lS vented as fast as it is produced and there is no leakage of feacal material. ~he plug is opened three times during this period and faecal material is removed by irrigation of the intestine. When the plug is reinserted the seal is still perfect.
Example 3.
In an investigation at the University Clinic at Erlangen, Germany, nine stoma patients, who all had severe problems with leakage of obnoxious material around their magnetic stoma plugs when using known gaskets were given venting devices according to the invention. With a venting device as shown in fig. 7, eight of the nine patients became free of problems, i.e., the intestine gas was removed in a controlled manner through the filter and there was no problem with leakage or odour.
In a slmliar investigation made by Dr. H. Feustel at - 24 ~
,~
the University Clinic at Giessen, Gerrnany, nine out of ten patients were relieved of problems with their stoma.
Example 4 A magnetic stoma plug was fitted with a venting device of the construction shown in fig. 6. The filter elernent (4) was made from filter paper impregnat0d with active carbon.
The outer gas-impervious disc t13) was made from a styrene-isoprene-styrene rubbex sheet, and the inner disc (3) was made from sealing material comprising a viscous polyisobutylene matrix wi~h a hydrophili filter comprising a blend of starch~ gelatin and pectin. The gas~tiyht contac-t between disc (13) and the fil~er element (4) was obtained by the magnetic forces holdiny the plug in place in the stoma. This plug was tested on a patient who had never been free of leakage and odours from his stoma. With the new venting device he had no problems with leakage and the intestine gas leaving the filter element was completely free of odour. After 29 hours the plug was removed. The filter element was still active 9 but the inner gas-impervious disc (3) had swollen so much from intestine fluids that the passage between the inner rim of the disc and the plug (11 in fig. 4) was blocked. The function of this v~nting device could ba further improved hy incr~asing the diameter of the central hole of disc (3~ as shown in fig. 7. The ratio between thickness of filter element and radial path from the centxal hole to the outer rim wa~ in this experiment 1.40.
. .
_ ample 5 In order to investig~te the in1uence of the physical . , ~.~
.. . . ..
, :, , , . , :
dimensions upon the performance of the active filter element the following experiment was made.
A flexible open-celled polyurethane foam was cut into sheets of a thickness of 3 mm. The sheets were impregnated with active carbon in a binder comprising a vinyl copolymer dispersion. The dried sheets contained 28% b.w. of carbon and had a density of 55 kg/m .
- Rectangular discs were cut from a sheet. The area of the discs were in all cases 4,5 cm and the lenyth and width lQ were as shown in table 1. These discs were each covered with adhesive gas impervious tape on top, bottom and the two sides, whereas the remaining two sides were sealed to small plastic tubes to allow the passage of gas through the inlet tube into the disc through its lengthwise direction, and then out through the exit tube. The inlet tube could be connected to a gas tank filled with a test gas at atmospheric pressure. The exit tube could be connected to a detector tube containing a plumbous salt and calibrated to show the amount of H2S in the gas passing the tube. The other end of the detector tube was connected to a calibrated suction pump which could pump precisely known volumes of test gas from the gas tank, through the filter el ment and the detector tube. The test gas consisted of a blend oi 80~ nitrogen and about 20% methane with 25 p.p.m. N2S added. During the experiment any H2S not being absorbed by the filter element would react with the plumbous salt in the detector tube from which a direct reading of the amount could be obtained.
Since in practice the stoma patients have the greatest pro~lems when large volumes of intestine gas is suddenly re-leased the gas rates were varied to find the filter dimensions most effective at the high gas rates corresponding to this situation.
- 2~ _ .
Table 1. DiMensions of Filter Elements Filter No. Length Width Thickness Length mm mm mm Thickness _ ~
1 322.4 22.4 0.1 2 _ 10_ _ 15 1.1 _1 :
4 ~ 30 15 10 -_ 1~ 3 15 Table 2. Efficiency of Filter Elements versus Flow Rate _ Rate ~lf/mian. 10 20 50 100 200 : Filter Total Effi- Effi- Effi- Effi- Effi-No. vol. ml. cieney eieney eieney eieney ciency % % % ~ %
: 100 9890 77 60 20 20~ 25 -: : 1 300 9784 66 47 27 400 30 .
_ _ ' ", 2 300 9992 78 59 42 ~. :
.......
3 300 100g8 84 70 50 _ . 4 300 100100 93 83 60 . 500 10099 89 72 52 . _ : 100 100100 100 100 86 ~00 100100 90 77 55 ~ 500 10099 _ 90 72 55 .' :
-~
`. '~
~'~ .
.. ~ ' ' ., ~ ' ' , .
~3~
The results of the experiment are shown in table 2.
It will be seen that filter No. 1, where the gas passes perpendicularly to the plane of the filter element is the least efficient. Even at the lowest gas flo~ rate 100% efficiency is never reached and as the flow rate increases the efficiency drops rapidly. ~Efficiency is the percentaye of H2S
absorbed by the filter).
The filters Nos. 3, 4j and 5 are all highly efficient at the lower flow rates even after a total of 500 ml of test gas has passed the filter elements. At higher flow rates the filters drop off in efficiency, but even at a rate of 100 ml/min filters Nos. 4 and 5 retain an efficiency of 83% after the first 300 ml of test gas and 72 % after 500 ml.
Filter No. 2 is, although clearly better than No. 1, never 100% efficient and is more sensitive to an increase in flow rate and volume than filters 3, 4, and 5.
It is thus seen that in order to combine efficiency at high flow rates with large total capacity the venting device should be designed with a gas path through the filter element which is considerably longer (at least 5 times) than the sma~estdimension of the filter element.
Example 6 A test gas comprising nitrogen, methane, hydrogen , carbondioxide and 25 p.p.m. H2S was passed into a commercial stoma cap manufactured by 'iHollister Incorporated" and basicly described in Danish Patent Specification No. 133080.
The gases leaving the exit hole in the venting device were passed through a detector tube and the total amount of ~l2S
passing the venting device was measured. After 400 ml of .
"': . ' ': ' ' ' "
test gas had passsed a re~ding of 5 was obtained. After 600 ml the reading had incx~ased to 15 and th~ experiment was stopped. In a similar stoma cap the fil-ter element was brought into gas-tight contact with enclosing gas-tight plastic foils by the use of an adhesive, so that the gas had to pass from the rim 'co the venting hole through the filter element and channeling waseffectively prevented.
Test gas was now passed through the venting device. After 400 ml the reading was zero. After 600 ml the reading was 7.5 and the experiment was stopped.
Example 7 A stoma bag made from two rectangular sheets of plastic foil sealed around the edges is fitted with a venting device consisting of flat filter element measuring 15 x 30 x 3 mm made from elted cellulosic fibers and containing finely granulated active carbon. The filter element is placed into a small pockat made by sealing of a 22 x 40 mm sheet of a similar plastic foil onto one of the sheets forming the stoma bag. An entry hole and an exit hole i5 made in the two sheets enclosing the filter element so that the gas to be vented is forced to pass through the length of the filter element.
In anothex stoma bag of a similax construction a gas-tight contact between the filter element and the enclosing walls is obtain d by means of an adhesive.
The capacity and efficiency o~ the two v~nting devices is compared by passing a test gas containing H2S through them. The results are shown in table 3.
, ~-~ æ~ ' ;; '! -- ,A~ --. .
Table 3 Vol~ ~n 1 Efficiency of Test without gas-tight contact with yas-tight contact Gas 50 ml/min100 ml/min 50 ml/min100 ml/min . , 200 l00 90 100 96 300 93 66 95 8~
500 66 52 _ 89 72 The results clearly show that efficiency can be considerably improved by bringing the filter element into gas-tight contact with the enclosing walls.
Example 8 In another experiment the venting device described in the above example was fitted onto a stoma bag by an self-adhesive disc ((29) in fig. 10)~ so that intestine gases collected in the bag could be vented through the venting device into the a~nosphere~ In use the stoma bag would collect the solid and liquid faecal material produced in the intestine while the intestine gas was deodorized and released through the venting device. After a period of the normally 5~10 hours the bag with the collected material would be removed and discharged, while the venting device was transferred onto a new bag, which was placed over -the stoma. After three weeks o continous use in this manner the venting device still performed satisfactory and the patient had no problems with odours.
Exa~
A venting device as shown in fig. 9 and 10 is fitted .` ,. . -- A--~ --3~
into a magnetic plug as shown in fig. 8. The venting device comprises a flat cylindrical box or capsule moulded from a thermoplastic polymer and having the following dimensions in millimeters: outer diameter: 23, inner diameter. 19.2, height of inner compartment: 4.0, length of path from inlet hole (22) to outlet hole (26): 100.
(Note that in this example the entryhole is placed in the bot~om at the center, while th exit hole is placed in the lid(25) near the periphery). Average width of ~piral path:
approximately 3 mm. The capsule is filled with granular activated carbon and a substantially gas-tight seal is formed between the walls of the capsule and the act~vated carbon by the use of a flexible material (27) which in this case is a flexible cellular polyurethane.
The magnetic plug with the venting device is tested for a week on a patient complaining of large volumes of odorous intestine gas. The filter element gave excellent performance and the patient had no problems with ordours during the entire test period.
.
;~
Claims (5)
1. A device for venting discharge openings from the human body, comprising in combination a flat, platelet-like filter body of an odor-absorbing filter material, a first cover adhesively bonded at one of its surfaces substantially in the entirety thereof to one flat surface of the filter body, said cover made of a liquid- and gas-im-pervious sheet material and having substantially the same shape and size as the filter body, a second cover adhesively bonded at one of its surfaces substantially in the entirety thereof to the other flat surface of the filter body, said second cover made of a liquid-and gas-impervious sheet material and having substantially the same outer shape and size as the filter body, said second cover provided with a substantially centrally placed opening defining a gas inlet to the filter body, the edge of the filter body constituting a gas outlet from the filter body and being uncovered.
2. A device as claimed in Claim 1, wherein the filter body has a substantially central opening aligned with the central opening in the second cover so as to admit gas entrance to the filter body via the inner edge formed at the central opening thereof.
3. A device as claimed in Claim 1, wherein the second cover is integral with an ostomy pouch adapted to collect fecal material from the discharge opening, the filter body and first cover being positioned on the exterior side of the pouch, the central opening in the second cover constituting in combi-nation with the filter body a gas outlet from the pouch, an inlet for fecal material into the pouch being positioned at a distance from the filter.
4. A device as claimed in Claim 1, wherein the second cover is adhesively secured to an ostomy pouch adapted to collect fecal material from the discharge opening, the filter body and first cover being positioned on the exterior side of the pouch, the central opening in the second cover constituting with the filter body a gas outlet from the pouch, an inlet for fecal material into the pouch being positioned at a distance from the filter.
5. A device as claimed in Claim 1, wherein the odor-absorbing filter material is prepared from an open-celled, elastic, cellular matrix which has been impregnated with a dispersion of active carbon in a binder.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB29376A GB1571382A (en) | 1976-01-06 | 1976-01-06 | Venting device for stomas and other body openings |
| GB293/76 | 1976-01-06 | ||
| GB23796/76 | 1976-06-09 | ||
| GB2379676 | 1976-06-09 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1108958A true CA1108958A (en) | 1981-09-15 |
Family
ID=26235824
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA269,102A Expired CA1108958A (en) | 1976-01-06 | 1977-01-04 | Venting device for stomas and other body openings |
Country Status (18)
| Country | Link |
|---|---|
| JP (1) | JPS52109793A (en) |
| AT (1) | AT369979B (en) |
| AU (1) | AU510236B2 (en) |
| BR (1) | BR7700061A (en) |
| CA (1) | CA1108958A (en) |
| CH (1) | CH613113A5 (en) |
| DD (1) | DD129160A5 (en) |
| DE (1) | DE2700372C2 (en) |
| DK (1) | DK141392B3 (en) |
| FI (1) | FI70373C (en) |
| FR (2) | FR2337545A1 (en) |
| IE (1) | IE44244B1 (en) |
| IT (1) | IT1202405B (en) |
| LU (1) | LU76527A1 (en) |
| NL (1) | NL7700097A (en) |
| NO (1) | NO139029C (en) |
| NZ (1) | NZ183023A (en) |
| SU (1) | SU1347861A3 (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7470263B2 (en) | 2004-03-01 | 2008-12-30 | Coloplast A/S | Ostomy system |
| US7722586B2 (en) | 2003-03-17 | 2010-05-25 | Coloplast A/S | Ostomy appliance |
| US7819850B2 (en) | 2004-03-01 | 2010-10-26 | Coloplast A/S | Ostomy appliance and a compacted bag |
| US8105298B2 (en) | 2004-03-01 | 2012-01-31 | Coloplast A/S | Ostomy appliance |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2417291A1 (en) * | 1978-02-21 | 1979-09-14 | Biotrol Sa Lab | ARTIFICIAL ANUS BLOCKING DEVICE |
| DE3013255A1 (en) * | 1980-04-03 | 1981-10-08 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V., 8000 München | METHOD AND MEANS FOR ADSORPTION AND CATALYTIC DISASSEMBLY OF SMELLING SMALL GASES |
| FR2479682A1 (en) * | 1980-04-04 | 1981-10-09 | Biotrol Sa Lab | NOISE ATTENUATING DEVICE EMITTED BY AN ARTIFICIAL ANUS |
| DE3304311C2 (en) * | 1983-02-09 | 1985-01-03 | Sorbexx GmbH Gesellschaft für Adsorptionstechnik und Verbundstoffe, 8586 Gefrees | Device for venting colostomy bags |
| US4490145A (en) * | 1983-06-27 | 1984-12-25 | E. R. Squibb & Sons, Inc. | Ostomy pouch with deodorizing filter |
| JPS6095080U (en) * | 1983-12-05 | 1985-06-28 | 池田物産株式会社 | carpet |
| EP0345381A3 (en) * | 1988-06-07 | 1991-04-10 | The Clorox Company | Liquid filter |
| DE19537289A1 (en) * | 1995-10-06 | 1996-03-21 | Heiner Dipl Ing Goerich | Cover for anus which consists of body plate with adhesive foil |
| DE19845488A1 (en) * | 1998-10-02 | 2000-04-06 | Lasota Iris | Process for maintaining clean air, especially in hospital rooms, comprises giving people active carbon clothing inserts for removal of bowel smells |
| DE19930620A1 (en) * | 1999-07-02 | 2001-01-04 | Sandler Helmut Helsa Werke | Ostomy filter |
| DE20308266U1 (en) * | 2003-01-16 | 2003-08-07 | For Life Produktions- und Vertriebsgesellschaft für Heil- und Hilfsmittel mbH, 12459 Berlin | A filter assembly |
| EP1722730B1 (en) | 2004-03-01 | 2008-12-03 | Coloplast A/S | Ostomy System |
| DE102009048607A1 (en) * | 2009-09-30 | 2011-04-07 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. | Seal for fluid containing chamber |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3519708A (en) * | 1966-11-21 | 1970-07-07 | Dow Chemical Co | Method of forming selectively permeable bodies from flexible polyurethane foam |
| GB1363644A (en) * | 1971-08-18 | 1974-08-14 | Caldwell C E J | Colostomy and like devices |
| US3759260A (en) * | 1971-09-20 | 1973-09-18 | Hollister Inc | Post surgical drainage collection pouch |
| US3804091A (en) * | 1972-09-18 | 1974-04-16 | Hollister Inc | Ostomy appliance |
| US3952727A (en) * | 1973-09-27 | 1976-04-27 | Hollister Incorporated | Vent device for ostomy appliance |
| CA1030032A (en) * | 1973-09-27 | 1978-04-25 | Hollister Incorporated | Vent device for astomy appliance |
| CA1053109A (en) * | 1973-12-20 | 1979-04-24 | Gerhard R. Hennig | Magnetic attachment means for stoma rings |
-
1977
- 1977-01-03 DK DK000977AA patent/DK141392B3/en active
- 1977-01-04 NO NO770013A patent/NO139029C/en unknown
- 1977-01-04 CA CA269,102A patent/CA1108958A/en not_active Expired
- 1977-01-04 IE IE6/77A patent/IE44244B1/en not_active IP Right Cessation
- 1977-01-05 LU LU76527A patent/LU76527A1/xx unknown
- 1977-01-05 FI FI770028A patent/FI70373C/en not_active IP Right Cessation
- 1977-01-05 IT IT67014/77A patent/IT1202405B/en active
- 1977-01-05 FR FR7700132A patent/FR2337545A1/en active Granted
- 1977-01-05 AU AU21067/77A patent/AU510236B2/en not_active Expired
- 1977-01-06 DD DD7700196842A patent/DD129160A5/en unknown
- 1977-01-06 JP JP72077A patent/JPS52109793A/en active Granted
- 1977-01-06 CH CH14877A patent/CH613113A5/en not_active IP Right Cessation
- 1977-01-06 SU SU772438152A patent/SU1347861A3/en active
- 1977-01-06 BR BR7700061A patent/BR7700061A/en unknown
- 1977-01-06 NZ NZ183023A patent/NZ183023A/en unknown
- 1977-01-06 NL NL7700097A patent/NL7700097A/en active Search and Examination
- 1977-01-07 DE DE2700372A patent/DE2700372C2/en not_active Expired
- 1977-01-07 AT AT0005977A patent/AT369979B/en not_active IP Right Cessation
-
1979
- 1979-11-20 FR FR7928594A patent/FR2476481A1/en active Granted
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7722586B2 (en) | 2003-03-17 | 2010-05-25 | Coloplast A/S | Ostomy appliance |
| US7470263B2 (en) | 2004-03-01 | 2008-12-30 | Coloplast A/S | Ostomy system |
| US7819850B2 (en) | 2004-03-01 | 2010-10-26 | Coloplast A/S | Ostomy appliance and a compacted bag |
| US8105298B2 (en) | 2004-03-01 | 2012-01-31 | Coloplast A/S | Ostomy appliance |
Also Published As
| Publication number | Publication date |
|---|---|
| NO139029C (en) | 1978-12-27 |
| FR2337545A1 (en) | 1977-08-05 |
| ATA5977A (en) | 1982-07-15 |
| DK141392C (en) | 1980-09-08 |
| AU2106777A (en) | 1978-07-13 |
| BR7700061A (en) | 1977-09-06 |
| FR2476481A1 (en) | 1981-08-28 |
| AT369979B (en) | 1983-02-25 |
| AU510236B2 (en) | 1980-06-19 |
| DD129160A5 (en) | 1978-01-04 |
| SU1347861A3 (en) | 1987-10-23 |
| FI770028A (en) | 1977-07-07 |
| NZ183023A (en) | 1980-02-21 |
| FI70373B (en) | 1986-03-27 |
| DK141392B3 (en) | 1995-11-06 |
| LU76527A1 (en) | 1977-06-17 |
| DK977A (en) | 1977-07-07 |
| DE2700372A1 (en) | 1977-07-14 |
| NO770013L (en) | 1977-07-07 |
| NL7700097A (en) | 1977-07-08 |
| CH613113A5 (en) | 1979-09-14 |
| NO139029B (en) | 1978-09-18 |
| IE44244B1 (en) | 1981-09-23 |
| DE2700372C2 (en) | 1983-02-17 |
| IT1202405B (en) | 1989-02-09 |
| IE44244L (en) | 1977-07-06 |
| FR2476481B1 (en) | 1984-02-17 |
| FR2337545B1 (en) | 1980-11-21 |
| DK141392B (en) | 1980-03-10 |
| FI70373C (en) | 1986-09-19 |
| JPS52109793A (en) | 1977-09-14 |
| JPS5646430B2 (en) | 1981-11-02 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry |