CA1197747A - Fecal incontinence device - Google Patents
Fecal incontinence deviceInfo
- Publication number
- CA1197747A CA1197747A CA000476590A CA476590A CA1197747A CA 1197747 A CA1197747 A CA 1197747A CA 000476590 A CA000476590 A CA 000476590A CA 476590 A CA476590 A CA 476590A CA 1197747 A CA1197747 A CA 1197747A
- Authority
- CA
- Canada
- Prior art keywords
- bag
- ring
- collector
- attachment
- panels
- 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
Links
Abstract
FECAL INCONTINENCE DEVICE
Abstract A fecal incontinence device in the form of an elongated collection bag having an attachment ring about an opening at one end of the bag. The ring is formed of a soft, pliable, and stretchable closed-cell thermoplastic foam, and the bag is formed from a single sheet or film of thermoplastic material that, following its attachment to the ring, is folded to provide a pair of side panels extending at right angles to the plane of the ring such panels then being heat sealed to each other along their margins to define the finished bag. The foam attachment ring has its surface coated with a pressure-sensitive adhesive, and its inner and outer margins are non-concentric to define a relatively narrow perineal attachment zone. A plurality of release sheet sections cover the adhesive coating of the ring and are sequentially removable to facilitate effective attachment of the ring to a patient. The bag is also provided with a protected gas vent and a self-closing passage for the insertion of a thermometer or other medical instrument.
Abstract A fecal incontinence device in the form of an elongated collection bag having an attachment ring about an opening at one end of the bag. The ring is formed of a soft, pliable, and stretchable closed-cell thermoplastic foam, and the bag is formed from a single sheet or film of thermoplastic material that, following its attachment to the ring, is folded to provide a pair of side panels extending at right angles to the plane of the ring such panels then being heat sealed to each other along their margins to define the finished bag. The foam attachment ring has its surface coated with a pressure-sensitive adhesive, and its inner and outer margins are non-concentric to define a relatively narrow perineal attachment zone. A plurality of release sheet sections cover the adhesive coating of the ring and are sequentially removable to facilitate effective attachment of the ring to a patient. The bag is also provided with a protected gas vent and a self-closing passage for the insertion of a thermometer or other medical instrument.
Description
7~
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This application is a division of serial number 423,333, filed March 10, 1983.
Background and Summaxy While collection bags for incontinent patients are known in the art, such devices have no~ been free of seriou - shortcomings~ One major problem concerns the formation of an effective external seal about the rectum, various types of adhesive rings have been di~closed but no singl~ design is known for its ease of application and remo~al, freedom from leakag~ and unintentional d~tachment, and adaptabilit~, conformabllity, and comfort in use. Patents 3,577,9~9 and
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This application is a division of serial number 423,333, filed March 10, 1983.
Background and Summaxy While collection bags for incontinent patients are known in the art, such devices have no~ been free of seriou - shortcomings~ One major problem concerns the formation of an effective external seal about the rectum, various types of adhesive rings have been di~closed but no singl~ design is known for its ease of application and remo~al, freedom from leakag~ and unintentional d~tachment, and adaptabilit~, conformabllity, and comfort in use. Patents 3,577,9~9 and
2,491,799 disclose collection bags which are strapped to patients. The manipulation of such straps during attachment and detachment/ and the need to move or repositio~ a patient : during such operations, complicates ~he use of such devices and increases patient inconvenience and discomfort~ Devices with adhesive~coated att~chment rings, such as disclosed in
3,577,989, 3,734,096, 3,522,807; 3,952,336, and 3~29~,626 are also difficult to af~ix, at le~st if an effec~ive seal is to be formed, because of the varying contours, and the stretchability, contractability, and softnessJ of the perianal surfaces. Making adequate sealing contact is only one problem;
maintaining such contact is another. If the adhesive used to xetain such colle5tors is aggres5ive enough to 2revent accidental detachment, such collec~ors may be relatively dificult to remove without causing patie~t discomfort.
Conversely, if a less aggressi~e adhesive is used ko ~acilitate in~entional removal, ~he posslbilities of acciden~al de~achmen~
are incxeased~ In addition, con~entional bags are frequently dimensioned and shaped to have inadequate collection capacity or, i of sufflcien~ ~ize, to become twisted and kinked in use, or become wrapped about the leg of a bedridden .patient, thereby increasing patient discom~ort and the likelihood of accidental detachment.
~l~
It is therefore an object of this invention to provide an improved fecal collector which i~ accommodated comfoxtably between ~he legs of a bedridden patient, has relatively large capacity when considered in terms of its length and collapsed dimensions, and has a highly effec~ive attachment ring that is relatively easy to secure in place and, because of its configuration, conformabilityr and stretchability, is more likely to remaln adhered throughout its intended period of use without causing pain or discomfor~
when intentional removal is under~aken. Another object is to provide a fecal collec or having an adhesive-coated attachment ring that is extendable and contractable, thereby reducing shear forces on the adhe.~ive during body movements and producing more uniform distribution of forces on the attachment ring and bag, all with the result that a more affective ~ealing engagement may be achieved while at the same time utilizing an adhesive thatisnotunacceptably aggressive. Other features of the bag, such as the location of the attachment riny and its ang~lar relationship to the rest of the bag, the provision of a protected vent to prevent gas buildup, and the pleated construction of the bag, all contribute, along with the extensibility and flexibility of the attachment ring, in preventing concentration of forces in the areas of adhesive attachment that might result in unintended detachment or leakage of the appliance~
The adhesive-coated attachment ring is formed of a soft, pliable, and stretchable closed-cell thermoplastic foam. In an undeformed state, the ring is generally flat and circ~lar in outline with inner and outer margins that are non-concentric. The adhesive-coated surface has four conc~ntrically-arranged portions, namely, a perineal surface portion intended to seal against the perineal area, a coccygeal surface portion, and a pair of relatively large lateral surface portions. All four portions are covered by individually-removable release sheet sections. Sequential removal of such sheets or sheet sections to dispose the respective adhesive-coated surface por~ions, starting with the p~rineal por~ion, ~hen ~he coccygeal portion, and finally the lateral portions, greatly facilitates complete and effective adhesive attachment of the ring to a patient.
The bag is formed from a single shee~ of odor-barrier film folded upon itself with the folded panels then heat-sealed to each other along their free edges. The a~tachment xing, or at least a liner for that ring, may be heat sealed to the sheet prior to the sealing of the edges of the side panels to form the finished bag. The capacity of the enlongated bag i5 significantly increased, without increasing the total length of the bag, by pleati~g at least one of the slde panels prior ~o the final marginal heat sealing operation~
The bag includes bo~h a vent for the escape o gases and a passage for the insertion of a thermometer or other instrument into the interior of the bag and into direct contact with a patient. It has been found that the passage and vent may be easily and effe~ti~ely formed hy providing each side panel o the bag with a flap or tab portion, then folding such flap portions reversely inwardly into con~iguous relation to form a pair of adjacent pocke~s when the panels are finally heat sealed together and, just before the heat sealing operation, inserting a resilient foam paa into at least one o the pockets. The self~closing passagP leading into the interiox of the fini~hed bag extends between the '1 -contiguous infolded flaps of the pockets. The vent for the escape o gases takes the form of one or more pinhol~s formed in the wall of a pocket containing the foam pad.
Other features, objects, and advantages of the invention will become apparent rom the specification and drawings.
Drawings ~ igure 1 is a perspective view of a fecal collector embodying the invention.
Figure 2 is a perspective view of the collector showing (in solid lines) the relationship between the side panels of the bag prior to marginal heat sealing and ( in broken lines) the relationship between the bag material .~ and the attachment ring at the time such parts are joined together .
Figure 3 is an enlarged fragmentary sectional view taken alon~ line 3-3 of Figure 1.
~igure 4 is a side elevational vlew of the collec~or.
Figure 5 .is a sectiona~ view taken along line 5-5 of Figure 4.
:
Figure 6 i5 aa~ enlarged fragmentary sect:ional view take~ alor~g lin~ 6-6 of Figure 4.
.
i~ Figure 7 is an enlargi3d sectional view taken along ~'~
line 7-7 of Figure 4.
Figure B as a sectional viaw similar to Figure 7 but illustrating use of the p~ssage for the ins~3rtio~ of a thermometer .
~ 5 --'~' Figuxe 9 is an exploded fragmentary perspective view of the attachment ring and release sheets ~howing the ralationship between 5uch el men~s.
Figures 10-12 are a serles of simplified arld omewhat schematic views illustrating ~he sequence of ~teps for properly securing the attachment ring ~o a patien~.
Det a i 1 ed De scr ipt i on Referring to the drawings, the numeral 10 ger~erally d~signates a fecal collector in the form of a collectioII bag 10 11 ha~ing an attachment ring 12. In the preferred em~odimer~
depicted, the bag is formed essentially fxom a single sheet o~ odor-barrler thexmopla~tic f ilm folded alor~g ttertical midline 13 to provide a pair of contiguous side panels 14 and 15 ~Figure 2 ) O The panels are heat sealed together along their upper, lower~ and distal edges lla, llb, and llCt respectively~ Just prior to such heat sealing, one or both o~ the panels may be pleated or olded along generally vertical lines, as shown at 16, to increase the capacity of the bag without adding o its length.
It will be noted Prom Figure 2 that each of the lower edges llb of the side panels i5 contoured to def in~ a depending tab or fïap 17, 18. Prior to heat sealing of the pan~ls, the flaps 17 and 18 ar~ folded upwardly and inwardly to defin~ pockets 17a and 18a, respectively. A foam pad 19 is inserted into one (or both) or~ the pockets 18a and, durin~
a f inal heat sealing operation, the pan~ls and f laps ar~ heat sealed together along spaced paxallel lines 20 and 21 to d~fine a normally-closed passage 22 (Figures 6-8) between the opposed f lap5 17 and 1 8 of the Ee~pective paneis . Venting rneans, in the form of or~e or mor~ pinholes 2 3, are formed in ~ 6 ~
~he wall o~ the pocket 18a that xetains the resilient foam pad 19. The pad performs ~he functions of restraining the outflow of liquids and solids through vent 23 without at the same time preventing the escape of gases, and of exerting a : ge~tle orce against flap 18 to maintain passage 22 in closed condition when not in use (Figures 6, 7). To the extent that the excretory contents of the bag may enter and expand pockets 17a and 18a, the walls of pascage 22 tend to be sealed even more tightly in use~ ~owever, should access to the rec~al area beeome lo necessary for purposes of insertinq a thermometer T or other medical instrument, such a procedure may be carried out without de~ac~ing the collector from the patient simply by inserting the instrument through passage 22 (Figure 8) and into contact with the wearer.
The attachment xing 12 is formed essentially of soft, flexible, and stretchable closed-cell thermoplastic foam having normal planar opposite surfaces 26 and 27 (Figure 3) and pre-ferably having generally circular out~r and inner ~argins, respectively. A closed-cell foam of polyethylene ha~ing a thick ; 20 ness within the general range of 2 to 10 millimeters (preferably about 3 millimeters) has been found particularly effective, other thermoplastic foam materials such as polyurethane, or other suitable plastic sheet materials having the described propertie~
of such foams (i~e., softness, pliability, stretchability, and contractability) migh~ be usedO
`. Surface 26 of foam ring 12 is coated with a layer of pressure-sensitive and water-resistant medically-approved adhesive. The tacky adhesive coating is in turn covered by removable release sheets as will be described in detall hereinater, The inner mar~in 29 of the foam xing 12 define~
a generally circular aperture 30 that is substantially the same size~ and is directly aligned with, opening 31 in one end of the elongated plastic bag 11~ The bag and ring may bP permanently secured together along the inner margin of the ring in any suitable manner~ Since the bag and ring are both formed of thermoplastic material, the two may be heat sealed together along the inne~ margin of the ring. However, to a~oid deformation of the foam that might occur during heat sealing, ik is believed preferable ta adhesively secure the ~ag to the ring as indicated in Figure 3. Such adhesive attachment is facilitated i a thermoplastic annular liner 32 o is first heat sealed to the bag along a heat seal zone 32a extending about opening 31. Thereafter, the ou~er surface of the annular liner is adhesively bonded to the foam ring 12.
While the inner and outer margins 29 and 28 of the foam attachment ring 12 are preferably circular, they are not concentric. Specifically, inner margin 29 is displaced upwardly as ~iewed in Figures 1 and 9, or anteriorly in relation to a patient wearing the collection device. The adhesive-covered face 26 of the ring therefore has surface portions of different sizes or areas disposed about aperture 30 Four such portions are depicted in ~igure 9 as demareated by vertical phantom lines along face 26. A relatively small perineal zone or portion 26a is located at the upper margin of the ring, such portion having a maximum radial width subs~antially less than the minimum radial width of the diametrically-disposed coccygeal portion or zone 26b. A
pair o lateral portions or zones 26c extend between the perineal and lower coccygeal por~ions 26a and 26b and, as depicted in ~igure 9, have circum~erential or angular dimensions sub-stantially greater than either of the perineal and coccygeal portions.
~77~7 ~ removahle protec~ive coverirlg 3~ extends over the adh~sive-coated surface of the foam xing 12. The coveril~g may he foxmed of paper, suitably coated with a relea e layer to permit the covering to be peeled away from the adhPsive ~oating of the rin~. A polyethylene coating on th@ paper, to which a silicone coating is applied O has been fotlnd efective, but other coat.ing materials such as waxes may be used. As illustrated in Figure 9, the covering has an overall ~hape and size conformirag with surface 26 of foam ring 12 and 0 i5 composed of our individually removable sectio~s or portions, namely, a perineal section 34a csvering perineal portiosl 26a of the ring, a coccygeal section 34b over ring E~ortion 25b, and a pair of la~eral sect ion~ 34c over portions 26c o:f ~he foam ring. In the embodiment depicted in the drawings, such sec:tions of the release sheet or covering 34 are defined by lines of perforation 35 that coincide with the phantorn lirles shown on ring 12 in ~igure 9, and the sheet 34 is readily torn along those li~les of perfora~is~ to permit indi~7idual and sequerlti~l removal of sections 34a-3~c; however, it is to be 20 understood that instead of having perforation line~ 35 detachably connecting the several sections of the release sheet, those sec~ions may be ::ompletely separated from each other so that no tearing apart is required at the time of sequential removal.
The individually-removable s~ctions 34a~34c o~
the release sheet, and the particular areas or zones of the adhesive-coated ring sur~ace 26 which they cover, gr~akly facilitate e~ective attachment o the foam ring to a patientO
In such an attachment proc~dure, the perineal section 34a is ~irst r~moved to expose the a~he~iv~-coated pe~ineal ~ur~ace portion 26a of th~ ring, and that portion is pressed into ~ ~ ~ ~a ~
: firm contac~ with thq perineal. area 40 of patien~ P as : somewha~ ~chematically depic~ed in Figure 10~ During adhesive attachment of the perineal portion 26a of the ring to the perin~um cf the patien~, by pressure applied iA
the direction of arrow 41, the pliable ring 12 becomes deformed or wedged between the patient's buttocks 42. The coccygeal sheet section 34b is then stripped from ~he ring (alternatively, it may have been xemoved from the ring at the time that perineal sectlon 34a was removed) and the o exposed adhesive-covered surfaoe of csccygeal ring por~ion 26b is pressed into contact with the patient's coccygeal area (Figure 11). It is only after the perineal a~d coccygaal `. portions 26a and 26b are firmly secured to the patient, with th~ ring folded between the buttocks as shown in Figure 11, that one of the lateral sections 34c is removed to permit on~ of the side portions 26c of the ring to become adhesively sealed to the patient. The proceduxe is then repeated by ;~ removing the other lateral section 34c of the release sheet and pressing the other adhesive-covered portion 2Sc of the ring into sealing contact with the patient (Figur~ 12). The collection device is thus compLetely and adhesively sealed to the patient in the perianal area.
The collection bag may be ormed of any suitable thermoplastic film or ilm laminate. ~or example~ 1exible walls of ~he bag may be formed o a polyolefin f.ilm lamina~ed : with an appropriate gas barrier film. A particulaxly suitable commercial material compri~es low density polyethylen~
coextru~ed with a coextensive layer or core of polyvinylidene chloride, but any of a wide variety of other materials may be employed.
- lU -While in the foregoing I ha~re disclosed an embodiment o the invention in considerable detail :or purposes of illustration, it will be undç~rstood by those skilled in the art that many o:~ these details may b2 varied without departing from the ~pirit and scope of the in~ention.
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maintaining such contact is another. If the adhesive used to xetain such colle5tors is aggres5ive enough to 2revent accidental detachment, such collec~ors may be relatively dificult to remove without causing patie~t discomfort.
Conversely, if a less aggressi~e adhesive is used ko ~acilitate in~entional removal, ~he posslbilities of acciden~al de~achmen~
are incxeased~ In addition, con~entional bags are frequently dimensioned and shaped to have inadequate collection capacity or, i of sufflcien~ ~ize, to become twisted and kinked in use, or become wrapped about the leg of a bedridden .patient, thereby increasing patient discom~ort and the likelihood of accidental detachment.
~l~
It is therefore an object of this invention to provide an improved fecal collector which i~ accommodated comfoxtably between ~he legs of a bedridden patient, has relatively large capacity when considered in terms of its length and collapsed dimensions, and has a highly effec~ive attachment ring that is relatively easy to secure in place and, because of its configuration, conformabilityr and stretchability, is more likely to remaln adhered throughout its intended period of use without causing pain or discomfor~
when intentional removal is under~aken. Another object is to provide a fecal collec or having an adhesive-coated attachment ring that is extendable and contractable, thereby reducing shear forces on the adhe.~ive during body movements and producing more uniform distribution of forces on the attachment ring and bag, all with the result that a more affective ~ealing engagement may be achieved while at the same time utilizing an adhesive thatisnotunacceptably aggressive. Other features of the bag, such as the location of the attachment riny and its ang~lar relationship to the rest of the bag, the provision of a protected vent to prevent gas buildup, and the pleated construction of the bag, all contribute, along with the extensibility and flexibility of the attachment ring, in preventing concentration of forces in the areas of adhesive attachment that might result in unintended detachment or leakage of the appliance~
The adhesive-coated attachment ring is formed of a soft, pliable, and stretchable closed-cell thermoplastic foam. In an undeformed state, the ring is generally flat and circ~lar in outline with inner and outer margins that are non-concentric. The adhesive-coated surface has four conc~ntrically-arranged portions, namely, a perineal surface portion intended to seal against the perineal area, a coccygeal surface portion, and a pair of relatively large lateral surface portions. All four portions are covered by individually-removable release sheet sections. Sequential removal of such sheets or sheet sections to dispose the respective adhesive-coated surface por~ions, starting with the p~rineal por~ion, ~hen ~he coccygeal portion, and finally the lateral portions, greatly facilitates complete and effective adhesive attachment of the ring to a patient.
The bag is formed from a single shee~ of odor-barrier film folded upon itself with the folded panels then heat-sealed to each other along their free edges. The a~tachment xing, or at least a liner for that ring, may be heat sealed to the sheet prior to the sealing of the edges of the side panels to form the finished bag. The capacity of the enlongated bag i5 significantly increased, without increasing the total length of the bag, by pleati~g at least one of the slde panels prior ~o the final marginal heat sealing operation~
The bag includes bo~h a vent for the escape o gases and a passage for the insertion of a thermometer or other instrument into the interior of the bag and into direct contact with a patient. It has been found that the passage and vent may be easily and effe~ti~ely formed hy providing each side panel o the bag with a flap or tab portion, then folding such flap portions reversely inwardly into con~iguous relation to form a pair of adjacent pocke~s when the panels are finally heat sealed together and, just before the heat sealing operation, inserting a resilient foam paa into at least one o the pockets. The self~closing passagP leading into the interiox of the fini~hed bag extends between the '1 -contiguous infolded flaps of the pockets. The vent for the escape o gases takes the form of one or more pinhol~s formed in the wall of a pocket containing the foam pad.
Other features, objects, and advantages of the invention will become apparent rom the specification and drawings.
Drawings ~ igure 1 is a perspective view of a fecal collector embodying the invention.
Figure 2 is a perspective view of the collector showing (in solid lines) the relationship between the side panels of the bag prior to marginal heat sealing and ( in broken lines) the relationship between the bag material .~ and the attachment ring at the time such parts are joined together .
Figure 3 is an enlarged fragmentary sectional view taken alon~ line 3-3 of Figure 1.
~igure 4 is a side elevational vlew of the collec~or.
Figure 5 .is a sectiona~ view taken along line 5-5 of Figure 4.
:
Figure 6 i5 aa~ enlarged fragmentary sect:ional view take~ alor~g lin~ 6-6 of Figure 4.
.
i~ Figure 7 is an enlargi3d sectional view taken along ~'~
line 7-7 of Figure 4.
Figure B as a sectional viaw similar to Figure 7 but illustrating use of the p~ssage for the ins~3rtio~ of a thermometer .
~ 5 --'~' Figuxe 9 is an exploded fragmentary perspective view of the attachment ring and release sheets ~howing the ralationship between 5uch el men~s.
Figures 10-12 are a serles of simplified arld omewhat schematic views illustrating ~he sequence of ~teps for properly securing the attachment ring ~o a patien~.
Det a i 1 ed De scr ipt i on Referring to the drawings, the numeral 10 ger~erally d~signates a fecal collector in the form of a collectioII bag 10 11 ha~ing an attachment ring 12. In the preferred em~odimer~
depicted, the bag is formed essentially fxom a single sheet o~ odor-barrler thexmopla~tic f ilm folded alor~g ttertical midline 13 to provide a pair of contiguous side panels 14 and 15 ~Figure 2 ) O The panels are heat sealed together along their upper, lower~ and distal edges lla, llb, and llCt respectively~ Just prior to such heat sealing, one or both o~ the panels may be pleated or olded along generally vertical lines, as shown at 16, to increase the capacity of the bag without adding o its length.
It will be noted Prom Figure 2 that each of the lower edges llb of the side panels i5 contoured to def in~ a depending tab or fïap 17, 18. Prior to heat sealing of the pan~ls, the flaps 17 and 18 ar~ folded upwardly and inwardly to defin~ pockets 17a and 18a, respectively. A foam pad 19 is inserted into one (or both) or~ the pockets 18a and, durin~
a f inal heat sealing operation, the pan~ls and f laps ar~ heat sealed together along spaced paxallel lines 20 and 21 to d~fine a normally-closed passage 22 (Figures 6-8) between the opposed f lap5 17 and 1 8 of the Ee~pective paneis . Venting rneans, in the form of or~e or mor~ pinholes 2 3, are formed in ~ 6 ~
~he wall o~ the pocket 18a that xetains the resilient foam pad 19. The pad performs ~he functions of restraining the outflow of liquids and solids through vent 23 without at the same time preventing the escape of gases, and of exerting a : ge~tle orce against flap 18 to maintain passage 22 in closed condition when not in use (Figures 6, 7). To the extent that the excretory contents of the bag may enter and expand pockets 17a and 18a, the walls of pascage 22 tend to be sealed even more tightly in use~ ~owever, should access to the rec~al area beeome lo necessary for purposes of insertinq a thermometer T or other medical instrument, such a procedure may be carried out without de~ac~ing the collector from the patient simply by inserting the instrument through passage 22 (Figure 8) and into contact with the wearer.
The attachment xing 12 is formed essentially of soft, flexible, and stretchable closed-cell thermoplastic foam having normal planar opposite surfaces 26 and 27 (Figure 3) and pre-ferably having generally circular out~r and inner ~argins, respectively. A closed-cell foam of polyethylene ha~ing a thick ; 20 ness within the general range of 2 to 10 millimeters (preferably about 3 millimeters) has been found particularly effective, other thermoplastic foam materials such as polyurethane, or other suitable plastic sheet materials having the described propertie~
of such foams (i~e., softness, pliability, stretchability, and contractability) migh~ be usedO
`. Surface 26 of foam ring 12 is coated with a layer of pressure-sensitive and water-resistant medically-approved adhesive. The tacky adhesive coating is in turn covered by removable release sheets as will be described in detall hereinater, The inner mar~in 29 of the foam xing 12 define~
a generally circular aperture 30 that is substantially the same size~ and is directly aligned with, opening 31 in one end of the elongated plastic bag 11~ The bag and ring may bP permanently secured together along the inner margin of the ring in any suitable manner~ Since the bag and ring are both formed of thermoplastic material, the two may be heat sealed together along the inne~ margin of the ring. However, to a~oid deformation of the foam that might occur during heat sealing, ik is believed preferable ta adhesively secure the ~ag to the ring as indicated in Figure 3. Such adhesive attachment is facilitated i a thermoplastic annular liner 32 o is first heat sealed to the bag along a heat seal zone 32a extending about opening 31. Thereafter, the ou~er surface of the annular liner is adhesively bonded to the foam ring 12.
While the inner and outer margins 29 and 28 of the foam attachment ring 12 are preferably circular, they are not concentric. Specifically, inner margin 29 is displaced upwardly as ~iewed in Figures 1 and 9, or anteriorly in relation to a patient wearing the collection device. The adhesive-covered face 26 of the ring therefore has surface portions of different sizes or areas disposed about aperture 30 Four such portions are depicted in ~igure 9 as demareated by vertical phantom lines along face 26. A relatively small perineal zone or portion 26a is located at the upper margin of the ring, such portion having a maximum radial width subs~antially less than the minimum radial width of the diametrically-disposed coccygeal portion or zone 26b. A
pair o lateral portions or zones 26c extend between the perineal and lower coccygeal por~ions 26a and 26b and, as depicted in ~igure 9, have circum~erential or angular dimensions sub-stantially greater than either of the perineal and coccygeal portions.
~77~7 ~ removahle protec~ive coverirlg 3~ extends over the adh~sive-coated surface of the foam xing 12. The coveril~g may he foxmed of paper, suitably coated with a relea e layer to permit the covering to be peeled away from the adhPsive ~oating of the rin~. A polyethylene coating on th@ paper, to which a silicone coating is applied O has been fotlnd efective, but other coat.ing materials such as waxes may be used. As illustrated in Figure 9, the covering has an overall ~hape and size conformirag with surface 26 of foam ring 12 and 0 i5 composed of our individually removable sectio~s or portions, namely, a perineal section 34a csvering perineal portiosl 26a of the ring, a coccygeal section 34b over ring E~ortion 25b, and a pair of la~eral sect ion~ 34c over portions 26c o:f ~he foam ring. In the embodiment depicted in the drawings, such sec:tions of the release sheet or covering 34 are defined by lines of perforation 35 that coincide with the phantorn lirles shown on ring 12 in ~igure 9, and the sheet 34 is readily torn along those li~les of perfora~is~ to permit indi~7idual and sequerlti~l removal of sections 34a-3~c; however, it is to be 20 understood that instead of having perforation line~ 35 detachably connecting the several sections of the release sheet, those sec~ions may be ::ompletely separated from each other so that no tearing apart is required at the time of sequential removal.
The individually-removable s~ctions 34a~34c o~
the release sheet, and the particular areas or zones of the adhesive-coated ring sur~ace 26 which they cover, gr~akly facilitate e~ective attachment o the foam ring to a patientO
In such an attachment proc~dure, the perineal section 34a is ~irst r~moved to expose the a~he~iv~-coated pe~ineal ~ur~ace portion 26a of th~ ring, and that portion is pressed into ~ ~ ~ ~a ~
: firm contac~ with thq perineal. area 40 of patien~ P as : somewha~ ~chematically depic~ed in Figure 10~ During adhesive attachment of the perineal portion 26a of the ring to the perin~um cf the patien~, by pressure applied iA
the direction of arrow 41, the pliable ring 12 becomes deformed or wedged between the patient's buttocks 42. The coccygeal sheet section 34b is then stripped from ~he ring (alternatively, it may have been xemoved from the ring at the time that perineal sectlon 34a was removed) and the o exposed adhesive-covered surfaoe of csccygeal ring por~ion 26b is pressed into contact with the patient's coccygeal area (Figure 11). It is only after the perineal a~d coccygaal `. portions 26a and 26b are firmly secured to the patient, with th~ ring folded between the buttocks as shown in Figure 11, that one of the lateral sections 34c is removed to permit on~ of the side portions 26c of the ring to become adhesively sealed to the patient. The proceduxe is then repeated by ;~ removing the other lateral section 34c of the release sheet and pressing the other adhesive-covered portion 2Sc of the ring into sealing contact with the patient (Figur~ 12). The collection device is thus compLetely and adhesively sealed to the patient in the perianal area.
The collection bag may be ormed of any suitable thermoplastic film or ilm laminate. ~or example~ 1exible walls of ~he bag may be formed o a polyolefin f.ilm lamina~ed : with an appropriate gas barrier film. A particulaxly suitable commercial material compri~es low density polyethylen~
coextru~ed with a coextensive layer or core of polyvinylidene chloride, but any of a wide variety of other materials may be employed.
- lU -While in the foregoing I ha~re disclosed an embodiment o the invention in considerable detail :or purposes of illustration, it will be undç~rstood by those skilled in the art that many o:~ these details may b2 varied without departing from the ~pirit and scope of the in~ention.
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Claims (7)
OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A fecal collector comprising a pair of panels of thermoplastic sheet material joined at their margins to define a bag having an opening at one end thereof; a ring of soft, pliable, stretchable and contractable closed-cell thermoplastic film secured to said bag about said opening;
said bag being provided with a vent opening along a marginal portion thereof; and a foam pad secured to an interior wall portion of said bag adjacent said vent opening.
said bag being provided with a vent opening along a marginal portion thereof; and a foam pad secured to an interior wall portion of said bag adjacent said vent opening.
2. The collector of Claim 1 in which said vent opening is provided in a longitudinal marginal portion of said bag adjacent to said opening of said bag.
3. The collector of Claim 1 in which said marginal portion with said vent opening comprises a flap portion of one of said panels reversely folded to define a pocket facing inwardly into the interior of said bag; said vent opening being located at the folded end of said pocket and said foam pad being disposed within said pocket.
4. The collector of Claim 3 in which said other of said panels also has a reversely-folded flap portion; said reversely-folded flap portions of the respective panels normally engaging each other but being separable to form a passage for the insertion of a medical instrument into the interior of said bag.
5. The collector of Claim 4 in which said foam pad normally urges said first-mentioned flap portion into passage-sealing engagement with said second-mentioned flap portion.
6. The collector of Claim 1 in which said thermoplastic sheet material of said bag is gas impermeable to serve as an odor barrier.
7. The collector of Claims 1, 3 or 4 in which said bag has a distal end opposite from said one end with at least one of said panels pleated along fold lines adjacent to but spaced from said distal end for increasing the volumetric capacity of said bag.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US06/358,690 US4445898A (en) | 1982-03-16 | 1982-03-16 | Fecal incontinence device with separable release sheets |
| CA000423333A CA1190823A (en) | 1982-03-16 | 1983-03-10 | Fecal incontinence device |
| US358,690 | 1989-05-30 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000423333A Division CA1190823A (en) | 1982-03-16 | 1983-03-10 | Fecal incontinence device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1197747A true CA1197747A (en) | 1985-12-10 |
Family
ID=25669964
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000476590A Expired CA1197747A (en) | 1982-03-16 | 1985-03-14 | Fecal incontinence device |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1197747A (en) |
-
1985
- 1985-03-14 CA CA000476590A patent/CA1197747A/en not_active Expired
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEC | Expiry (correction) | ||
| MKEX | Expiry |