WO2014110645A1 - An ostomy bag and disposable ostomy bag liner apparatus therefor - Google Patents

An ostomy bag and disposable ostomy bag liner apparatus therefor Download PDF

Info

Publication number
WO2014110645A1
WO2014110645A1 PCT/CA2013/000051 CA2013000051W WO2014110645A1 WO 2014110645 A1 WO2014110645 A1 WO 2014110645A1 CA 2013000051 W CA2013000051 W CA 2013000051W WO 2014110645 A1 WO2014110645 A1 WO 2014110645A1
Authority
WO
WIPO (PCT)
Prior art keywords
bag
ostomy
ostomy bag
portions
flange
Prior art date
Application number
PCT/CA2013/000051
Other languages
French (fr)
Inventor
Douglas H. WOLRICH
Mark D. WOLRICH
Original Assignee
Colo-Majic Enterprises Ltd.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Colo-Majic Enterprises Ltd. filed Critical Colo-Majic Enterprises Ltd.
Priority to PCT/CA2013/000051 priority Critical patent/WO2014110645A1/en
Publication of WO2014110645A1 publication Critical patent/WO2014110645A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445Colostomy, ileostomy or urethrostomy devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445Colostomy, ileostomy or urethrostomy devices
    • A61F5/448Means for attaching bag to seal ring

Definitions

  • This invention relates to ostomy bags and ostomy bag liner apparatus.
  • Liners for ostomy bags permit users to reduce their costs of ostomy supplies because fewer, more expensive ostomy bags are employed while lower cost liners are discarded and replaced with new ones.
  • Persons such as the elderly who may have problems with dexterity can often have difficulty installing and removing liners of the types known to date, due to limited ostomy bag designs and limited liner designs.
  • some liners have top margins that are uneven and therefore difficult to engage between the flange on the ostomy bag and the flange on the user by a person of limited dexterity.
  • the shapes of some liners can cause a certain crumpling of the liner which can create constrictions that impede the flow of waste material into the liner.
  • a disposable ostomy bag liner apparatus employs first and second sheet portions of film material. Each sheet has first and second side edge portions a bottom edge portion and a top edge portion. The top edge portions are disposed generally flat against each other and define a top portion having an open top edge. The first side edge portions are secured together to form a first side edge, the second side edge portions are secured together to form a second side edge and the bottom edge portions are secured together to form a bottom edge.
  • the first, second, top and bottom edges define a water-tight bag having an opening between the top edge portions.
  • the first and second side edges and each have a narrowed connector area, extending from a side of the top edge defining a connector portion of the apparatus and a curved body- defining area, between the narrowed connector area, and a side of the bottom edge for defining a body portion of the apparatus.
  • the top edge includes open first and second straight edges extending parallel to a longitudinal axis of the bag and an open curved top edge extending between the first and second straight edges, to define first and second flange portions, in the first and second sheet portions, respectively, for connecting the bag to an ostomy bag coupling of an ostomy bag.
  • the open curved top edge may have a radius of about 11cm to about 14cm.
  • the open first and second straight edges may have a length of between about 0.7 cm to about 2.5 cm.
  • the first and second straight edges may be are spaced apart by about 3cm to about 18cm.
  • the narrowed connector area may include third and fourth straight edges, on opposite sides of the bag.
  • the third and fourth straight edges may be disposed between about 45 degrees and about 90 degrees to the longitudinal axis of the bag and may extend from the first and second open straight edges, respectively and may terminate in fifth and sixth straight edges, respectively.
  • the fifth and sixth straight edges are spaced apart and are disposed generally parallel to the longitudinal axis.
  • the third and fourth straight edges may have respective lengths of about 0.5 cm to about 2 cm and the fifth and sixth straight edges may have respective lengths of about 0.4cm to about 0.7cm.
  • the fifth and sixth straight edges may be spaced apart by about 2.5cm to about 13.5cm.
  • Each of the curved body-defining areas may include a continuous curved region, extending between its associated narrowed connector area, and the bottom edge.
  • the continuous curved regions may extend outwardly away from the longitudinal axis of the respective narrowed connector areas, and then curve inwardly toward the longitudinal axis before terminating at the bottom edge.
  • the continuous curved regions may extend symmetrically, in respective arcs of varying radius.
  • the first side edge portions may be heat-sealed together and the second side edge portions may be heat sealed together.
  • the bottom edge portions may be heat sealed together.
  • the first and second sheet portions may be mirror-image symmetrically shaped halves of a unitary solid sheet of film folded in half to align the top edge portions, the first side edge portions, and the second side edge portions, respectively, and to form a fold line in the unitary solid sheet such that the fold line acts as the bottom edge.
  • the apparatus may further include first and second angularly disposed partitions, in the body portion adjacent the first and second side edges, respectively to define a chute area between the partitions and first and second gas receiving areas, between the first side edge and the first partition and between the second side edge and the second partition respectively.
  • the first and second partitions may include first and second weld lines welding the first and second sheet portions together along the first and second weld lines respectively.
  • the apparatus may further include openings, in the first and second gas receiving areas for releasing gas received in the first and second gas receiving areas.
  • the first and second sheet portions may be formed of a biodegradable polyester film having a thickness of between about 0.015mm to about 0.040mm.
  • an ostomy system including the ostomy bag liner apparatus described above and further including a disposable ostomy bag having an interior portion and a bag flange for cooperating with a mating flange secured to a user's body and surrounding an ostomy of the user.
  • the bag flange may have a generally circular opening that is generally aligned with the ostomy when the bag flange is secured to the mating flange and the connector portion of the disposable ostomy bag may be held within the generally circular opening in the bag flange such that the body portion of the disposable ostomy bag liner apparatus is disposed in the interior portion of the ostomy bag and the top portion of the disposable ostomy bag disposed outside of the ostomy bag.
  • the bag flange is coupled with the mating flange such that the top portion of the disposable ostomy bag is located between the bag flange and the mating flange to secure the disposable ostomy bag liner apparatus to the ostomy bag in a position to receive intestinal waste from the user's ostomy between the first and second top edge portions such that the intestinal waste is received inside the body portion of the disposable ostomy bag liner apparatus.
  • the opening in the flange on the ostomy bag may have a diameter and the fifth and sixth straight edges may be spaced apart by a distance between about 80% of the diameter and 120% of the diameter.
  • the curved body-defining areas of the first and second side edges may cause the body portion of the disposable ostomy bag apparatus to have a shape that generally follows a shape of an interior of the ostomy bag.
  • the ostomy bag may be formed of an air-permeable material.
  • Figure 1 is a schematic representation of an ostomy bag having an ostomy bag liner according to a first embodiment of the invention.
  • Figure 2 is a perspective view of a front side of the ostomy bag shown in
  • Figure 3 is a perspective view of a rear side of the ostomy bag shown in
  • Figure 4 is a top plan view of an ostomy bag liner in accordance with an embodiment of the invention.
  • Figure 5 is a fragmented cross-sectional view of the ostomy bag apparatus shown in Figure 1 shown with flange portions of the ostomy bag liner captured between a flange on the ostomy bag and a flange on the user.
  • Figure 6 is a perspective view of the liner shown with first and second flanges therof, spread apart, to define an opening for receiving intestinal waste.
  • Figure 7 is a top plan view of a sheet of material cut into a particular form that facilitates manufacture of an ostomy bag liner apparatus according to another embodiment of the invention.
  • Figure 8 is a top plan view of an ostomy bag liner apparatus according to another embodiment of the invention. DETAILED DESCRIPTION
  • an ostomy system according to a first embodiment of the invention is shown generally at 10.
  • the ostomy system 10 includes an ostomy bag 12 that may be formed of an air permeable material, for example, having a bag flange 14 operably configured to cooperate with a mating flange 16 secured to a user's body and surrounding an ostomy 18 of the user.
  • the bag flange 14 has a generally circular opening 20 that is generally aligned with the ostomy 8 when the bag flange 14 is secured to the mating flange 16.
  • the ostomy bag 12 is shown in greater detail and has an elongated curved shape formed by first and second sheets 22 and 24 of sheet material secured together around a perimeter edge 26 to define an interior portion of the bag between the first and second sheets 22 and 24. Access to the interior portion is provided through an opening in the first sheet 22 about which the bag flange 14 is coaxially positioned.
  • the first sheet 22 defines a broad front face 28 and the second sheet 24 defines a rear facing broad face 30 as shown in Figure 3.
  • the rear face has a slit or opening 32 that divides the second sheet 24 into first and second sheet portions 34 and 36.
  • the first sheet portion 34 has a flap 38 that extends over at least a portion of the second sheet 24.
  • An inside face 40 of the flap 38 is covered with a first portion of a hook and loop type fastener and a corresponding portion 42 of the second sheet 24 is covered with a second complementary portion of a hook and loop fastener such that when the flap is positioned as shown in Figure 3 the first and second portions of the hook and loop fastener overlap and are thereby secured together.
  • the use of the hook and loop fastener portions allows the user to simply slide their fingers through the flap 38 and the second sheet portion 24 to release the opposite portions of the hook and loop fastener to allow a user access to the interior portion of the bag 12.
  • FIG. 1 A suitable disposable ostomy bag liner apparatus for this purpose is shown generally at 50 in Figure 4.
  • the disposable ostomy bag liner apparatus comprises first and second sheet portions 52, 54 of biodegradable polyester film material such as for example, a sheet comprised of about 85% to about 95% BASF Ecovio® F Film C2331 and about 15% to about 5% BASF Ecoflex® C Blend Film 200 available from BASF of Germany.
  • the sheet may have a thickness of between about 0.015mm to about 0.040mm, for example.
  • Each of the first and second sheet portions 52 and 54 has a respective first side edge portion
  • the top edge portions 62 are disposed generally flat against each other and define a top portion 64 having an open top 66.
  • the first side edge portions 56 are secured together to form a first side edge 70 and the second side edge portions 58 are secured together to form a second side edge 72.
  • the bottom edge portions 60 are secured together to form a bottom edge 74.
  • the first side edge portions 56, the second side edge portions 58 and the bottom edge portions 60 are secured together such as by heat welding, or adhesive for example.
  • a double seal provided by a double weld line may be used in this area.
  • the first, second and bottom edges 70, 72 and 74 define a water tight bag having an opening 78 between the top edge portions 62.
  • the first and second side edges 70 and 72 each have a narrowed connector area 80, 82 extending from a side from the top edge portion 12 defining a connector portion 84 of the apparatus.
  • the first and second side edges 70 and 72 each have a curved body-defining area 86 and 88 respectively between their corresponding narrowed connector area 80 and 82 and a respective side of the bottom edge 74.
  • the curved body-defining areas 86 and 88 define a body portion 90 of the apparatus.
  • the top edge 66 includes open first and second straight edges 92 and 94 extending parallel to a longitudinal axis 96 of the apparatus 50.
  • the top edge 66 also includes a curved open top edge curve 98 extending between the first and second straight edges 92, 94 to define first and second flange portions 100 and 102 in the first and second sheet portions 52 and 54 respectively for connecting the bag to the ostomy bag flange 14 of the ostomy bag shown in Figures 1 - 3.
  • the open first and second straight edges 92 and 94 may have a length of between about 7mm to about 25mm.
  • the first and second straight edges may be spaced apart by about 10cm to about 18cm.
  • the open curved top edge 98 may have a radius of about 11cm to about 14cm.
  • the narrowed connector areas 80 and 82 include third and fourth straight edges 104, 106 on opposite sides of the bag.
  • the third and fourth straight edges 104 and 106 are disposed generally at right angles to the longitudinal axis 96 and extend from the first and second open straight edges 92 and 94 respectively to terminate in fifth and sixth straight edges 108 and 110 respectively.
  • the third and fourth straight edges may be disposed at other angles such as, for example, between about 45 degrees and 90 degress to the longitudinal axis.
  • the third and fourth straight edges 104 and 106 of each of the first and second sheets are respectively joined together with respective single weld lines or adhesive and have respective lengths of between about 0.5cm to about 2cm.
  • the fifth and sixth straight edges 108 and 110 are respectively joined together with respective single weld lines or adhesive and are spaced apart and are disposed generally parallel to the longitudinal axis 96.
  • the fifth and sixth straight edges 108 and 110 each generally have lengths of between about 0.4cm to about 0.7cm.
  • the opening 20 in the first sheet 22 has a diameter which depends upon the size of the ostomy bag 12.
  • Ostomy bags may be provided in various sizes to suit the needs of users, from children to large adults. Therefore, the opening 20 about which the flange 14 extends can vary in size and diameter over a significant range. Consequently, in the disposable liner apparatus 50, the fifth and sixth straight edges 108 and 110 may be spaced apart anywhere from about 2.5cm to about 13.5cm depending on the diameter of the opening of the ostomy bag with which the liner apparatus 50 is to be used. Generally, it is desirable that the spacing between the fifth and sixth edges 108 and 110 be between about 80% to about 120% of the diameter of the opening 20 shown in Figure 2.
  • Each of the curved body defining areas 86 and 88 includes a continuous curved region 120, 122 respectively extending between its associated narrowed connector areas 80, 82 and the bottom edge 74.
  • These continuous curved regions 120 and 122 generally extend outwardly away from the longitudinal axis 96 beginning at the respective narrowed connector area 80 and 82 and then at about half their length they start to curve inwardly toward the longitudinal axis 96 to terminate at their respective sides of the bottom edge 74.
  • these continuous curved regions 120 and 122 extend symmetrically in respective arcs of varying radius such that the body has a widening then narrowing profile.
  • first side edge 70 extends to include the third straight edge 108 and the continuous curved region 120.
  • the second side edge 72 extended to include the fourth straight edge 10 and the second continuous curved region 122.
  • the first and second side edges 70 and 72 are completely sealed.
  • the opened curved top edge 98 extending between the first and second straight edges 92 and 94 is not sealed and the first and second straight edges 92 and 94 of the first sheet are not joined to corresponding edges of the second sheet.
  • the apparatus 50 has first and second angularly disposed partitions 121 and 123 formed by heat sealing together or adhesively securing together the first and second sheets 52 and 54 in converging line segments angled inwardly from respective fifth and sixth straight portions 108 and 110 toward the longitudinal axis 96 to define a chute area 124 therebetween.
  • the partitions 121 and 123 also define first and second gas receiving areas 126 and 128 between the first side edge 70 and the first partition 121 and between the second partition 123 and second side edge 72 respectively. Small pinholes such as shown at 130 and 132 may be punctured in the first and/or second sheets 52 and 54 in the gas receiving area 126 and 128 to permit the escape of small amounts of gas that may accumulate in these areas.
  • the mating flange 16 on the user is shown to have a connector ring portion 150 having an annular male protrusion 152 extending about an opening 154 in the mating flange 16 through which the stoma 18 extends.
  • the flange 14 on the ostomy bag 12 has a complimentary receptacle 156 for receiving and holding the annular male protrusion 152 to secure the bag apparatus 12 to the mating flange 16 on the user.
  • the first and second flange portions 100 and 102 of the liner shown in Figure 4 are spread across respective portions of the flange 14 such that the flange portions 100 and 102 of the liner are captured between the annular male protrusion 152 and receptacle 156 in the respective mating flange 16 and bag flange 14.
  • This provides for easy positioning of the flange portions 100 and 102 over the bag flange and the non-sealed first and second straight edges 92 and 94 help facilitate spreading of the flange portions 100 and 102 so that they can generally lie in a plane generally parallel to a plane of the body 90 of the bag 50 when the body 90 of the disposable ostomy bag liner 50 is in the ostomy bag 12 (not shown in Figure 6).
  • the disposable liner apparatus 50 may be placed into or removed from the ostomy bag 12 through the opening provided by the flap 38 shown in Figure 3.
  • a user can open the flap 38 and insert a disposable ostomy bag liner such as shown in Figure 4 and then, from the inside the ostomy bag, push the first and second flange portion 100 and 102 though the opening 20 shown in Figure 2 and then spread the flanges 100 and 102 such as shown in Figure 6 such that they cover the female annular receptacle 156 in the flange 14 as shown in Figure 5.
  • the annular male member portion 52 of the mating flange 16 on the user can be received in the female receptacle 156, with the flanges 100 and 102 received therebetween, thereby firmly securing the disposable ostomy bag liner 50 in the ostomy bag 12 at the same time the ostomy bag 12 is secured to the patient through the cooperation of the flanges 14 and 16.
  • a disposable ostomy bag having the features of the bag described in connection with Figure 4 can be made by stamping a sheet of biodegradable polyester film, which for example, may be comprised of about 85% to about 95% BASF Ecovio® F Film C2331 and about 5% to about 5% BASF Ecoflex® C Blend Film 1200 having a thickness of between about 0.015mm to about 0.040mm to define sheet portions 160 and 162 that are mirror-image, symmetrically shaped halves of a unitary solid sheet of film.
  • the film is then folded in half along a fold line 164 to align edges 92, 98, 104, 108 and 70 of the first half 160 with correspondingly numbered edges of the second half 162 and to align edges 94, 106, 110 and 72 of the first half 160 with correspondingly numbered edges of the second half 162.
  • edges 70 are heat sealed together
  • edges 72 are heat sealed together
  • edges 108 are heat sealed together
  • edges 110 are heat sealed together.
  • the heat seal is not required along the fold line 164 because the fold line becomes the bottom edge 74 of the liner apparatus 50 and inherently acts as an integral water-tight joint in the bag.
  • a disposable ostomy bag apparatus according to an alternative embodiment of the invention is shown generally at 170.
  • the apparatus of this embodiment has the same top edges 92, 94, 98 and third, fourth, fifth and sixth straight edges 104, 106, 108 and 110, but has more accentuated first and second side edges 172 and 174.
  • These first and second accentuated side edges 172 and 174 extend outwardly by a distance 176 of respective planes 178 and 180 in which the first and second straight edges 92 and 94 lie, respectively to form an accentuated body portion 182.
  • the apparatus this has a body resembling a "jug”.
  • body portions 90 and 182 in each embodiment depecited in Figures 4-8 extend outwardly from the fifth and sixth straight portions 108 and 110 in order to maximize the volumetric capacity of the liner apparatus by occupying as much of the interior of the ostomy bag as possible.

Abstract

A disposable ostomy bag liner apparatus employs first and second sheet portions of film material. Each sheet has first and second side edge portions a bottom edge portion and a top edge portion. The top edge portions are disposed generally flat against each other and define a top portion having an open top edge. The first side edge portions are secured together to form a first side edge, the second side edge portions are secured together to form a second side edge and the bottom edge portions are secured together to form a bottom edge. The first, second, top and bottom edges define a water-tight bag having an opening between the top edge portions. The first and second side edges and each have a narrowed connector area, extending from a side of the top edge defining a connector portion of the apparatus and a curved body-defining area, between the narrowed connector area, and a side of the bottom edge for defining a body portion of the apparatus. The top edge includes open first and second straight edges extending parallel to a longitudinal axis of the bag and an open curved top edge extending between the first and second straight edges, to define first and second flange portions, in the first and second sheet portions, respectively, for connecting the bag to an ostomy bag coupling of an ostomy bag.

Description

AN OSTOMY BAG AND DISPOSABLE OSTOMY BAG LINER
APPARATUS THEREFOR
BACKGROUND OF THE INVENTION
1. Field of Invention
This invention relates to ostomy bags and ostomy bag liner apparatus.
2. Description of Related Art
Liners for ostomy bags permit users to reduce their costs of ostomy supplies because fewer, more expensive ostomy bags are employed while lower cost liners are discarded and replaced with new ones. Persons such as the elderly who may have problems with dexterity can often have difficulty installing and removing liners of the types known to date, due to limited ostomy bag designs and limited liner designs. For example some liners have top margins that are uneven and therefore difficult to engage between the flange on the ostomy bag and the flange on the user by a person of limited dexterity. In addition, the shapes of some liners can cause a certain crumpling of the liner which can create constrictions that impede the flow of waste material into the liner. There problems are considered by the new ostomy bag liner and ostomy bag proposed herein.
SUMMARY OF THE INVENTION
In accordance with one aspect of the invention, there is provided a disposable ostomy bag liner apparatus employs first and second sheet portions of film material. Each sheet has first and second side edge portions a bottom edge portion and a top edge portion. The top edge portions are disposed generally flat against each other and define a top portion having an open top edge. The first side edge portions are secured together to form a first side edge, the second side edge portions are secured together to form a second side edge and the bottom edge portions are secured together to form a bottom edge.
The first, second, top and bottom edges define a water-tight bag having an opening between the top edge portions. The first and second side edges and each have a narrowed connector area, extending from a side of the top edge defining a connector portion of the apparatus and a curved body- defining area, between the narrowed connector area, and a side of the bottom edge for defining a body portion of the apparatus. The top edge includes open first and second straight edges extending parallel to a longitudinal axis of the bag and an open curved top edge extending between the first and second straight edges, to define first and second flange portions, in the first and second sheet portions, respectively, for connecting the bag to an ostomy bag coupling of an ostomy bag. The open curved top edge may have a radius of about 11cm to about 14cm.
The open first and second straight edges may have a length of between about 0.7 cm to about 2.5 cm. The first and second straight edges may be are spaced apart by about 3cm to about 18cm.
The narrowed connector area may include third and fourth straight edges, on opposite sides of the bag. The third and fourth straight edges may be disposed between about 45 degrees and about 90 degrees to the longitudinal axis of the bag and may extend from the first and second open straight edges, respectively and may terminate in fifth and sixth straight edges, respectively. The fifth and sixth straight edges are spaced apart and are disposed generally parallel to the longitudinal axis.
The third and fourth straight edges may have respective lengths of about 0.5 cm to about 2 cm and the fifth and sixth straight edges may have respective lengths of about 0.4cm to about 0.7cm. The fifth and sixth straight edges may be spaced apart by about 2.5cm to about 13.5cm. Each of the curved body-defining areas may include a continuous curved region, extending between its associated narrowed connector area, and the bottom edge.
The continuous curved regions may extend outwardly away from the longitudinal axis of the respective narrowed connector areas, and then curve inwardly toward the longitudinal axis before terminating at the bottom edge.
The continuous curved regions may extend symmetrically, in respective arcs of varying radius.
The first side edge portions may be heat-sealed together and the second side edge portions may be heat sealed together. The bottom edge portions may be heat sealed together.
The first and second sheet portions may be mirror-image symmetrically shaped halves of a unitary solid sheet of film folded in half to align the top edge portions, the first side edge portions, and the second side edge portions, respectively, and to form a fold line in the unitary solid sheet such that the fold line acts as the bottom edge.
The apparatus may further include first and second angularly disposed partitions, in the body portion adjacent the first and second side edges, respectively to define a chute area between the partitions and first and second gas receiving areas, between the first side edge and the first partition and between the second side edge and the second partition respectively.
The first and second partitions may include first and second weld lines welding the first and second sheet portions together along the first and second weld lines respectively. The apparatus may further include openings, in the first and second gas receiving areas for releasing gas received in the first and second gas receiving areas. The first and second sheet portions may be formed of a biodegradable polyester film having a thickness of between about 0.015mm to about 0.040mm.
In accordance with another aspect of the invention there is provided an ostomy system including the ostomy bag liner apparatus described above and further including a disposable ostomy bag having an interior portion and a bag flange for cooperating with a mating flange secured to a user's body and surrounding an ostomy of the user. The bag flange may have a generally circular opening that is generally aligned with the ostomy when the bag flange is secured to the mating flange and the connector portion of the disposable ostomy bag may be held within the generally circular opening in the bag flange such that the body portion of the disposable ostomy bag liner apparatus is disposed in the interior portion of the ostomy bag and the top portion of the disposable ostomy bag disposed outside of the ostomy bag.
The bag flange is coupled with the mating flange such that the top portion of the disposable ostomy bag is located between the bag flange and the mating flange to secure the disposable ostomy bag liner apparatus to the ostomy bag in a position to receive intestinal waste from the user's ostomy between the first and second top edge portions such that the intestinal waste is received inside the body portion of the disposable ostomy bag liner apparatus.
The opening in the flange on the ostomy bag may have a diameter and the fifth and sixth straight edges may be spaced apart by a distance between about 80% of the diameter and 120% of the diameter. The curved body-defining areas of the first and second side edges may cause the body portion of the disposable ostomy bag apparatus to have a shape that generally follows a shape of an interior of the ostomy bag. The ostomy bag may be formed of an air-permeable material.
Other aspects and features of the present invention will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS
In drawings which illustrate embodiments of the invention,
Figure 1 is a schematic representation of an ostomy bag having an ostomy bag liner according to a first embodiment of the invention.
Figure 2 is a perspective view of a front side of the ostomy bag shown in
Figure 1.
Figure 3 is a perspective view of a rear side of the ostomy bag shown in
Figures 1 and 2.
Figure 4 is a top plan view of an ostomy bag liner in accordance with an embodiment of the invention.
Figure 5 is a fragmented cross-sectional view of the ostomy bag apparatus shown in Figure 1 shown with flange portions of the ostomy bag liner captured between a flange on the ostomy bag and a flange on the user.
Figure 6 is a perspective view of the liner shown with first and second flanges therof, spread apart, to define an opening for receiving intestinal waste.
Figure 7 is a top plan view of a sheet of material cut into a particular form that facilitates manufacture of an ostomy bag liner apparatus according to another embodiment of the invention.
Figure 8 is a top plan view of an ostomy bag liner apparatus according to another embodiment of the invention. DETAILED DESCRIPTION
Referring to Figure 1 , an ostomy system according to a first embodiment of the invention is shown generally at 10. The ostomy system 10 includes an ostomy bag 12 that may be formed of an air permeable material, for example, having a bag flange 14 operably configured to cooperate with a mating flange 16 secured to a user's body and surrounding an ostomy 18 of the user. The bag flange 14 has a generally circular opening 20 that is generally aligned with the ostomy 8 when the bag flange 14 is secured to the mating flange 16.
Referring to Figure 2, the ostomy bag 12 is shown in greater detail and has an elongated curved shape formed by first and second sheets 22 and 24 of sheet material secured together around a perimeter edge 26 to define an interior portion of the bag between the first and second sheets 22 and 24. Access to the interior portion is provided through an opening in the first sheet 22 about which the bag flange 14 is coaxially positioned. The first sheet 22 defines a broad front face 28 and the second sheet 24 defines a rear facing broad face 30 as shown in Figure 3. The rear face has a slit or opening 32 that divides the second sheet 24 into first and second sheet portions 34 and 36. The first sheet portion 34 has a flap 38 that extends over at least a portion of the second sheet 24. An inside face 40 of the flap 38 is covered with a first portion of a hook and loop type fastener and a corresponding portion 42 of the second sheet 24 is covered with a second complementary portion of a hook and loop fastener such that when the flap is positioned as shown in Figure 3 the first and second portions of the hook and loop fastener overlap and are thereby secured together. The use of the hook and loop fastener portions allows the user to simply slide their fingers through the flap 38 and the second sheet portion 24 to release the opposite portions of the hook and loop fastener to allow a user access to the interior portion of the bag 12.
Referring to Figures 1 , 2, and 3, the user opens the flap 38 to access the interior of the bag 12 to position a disposable ostomy bag liner apparatus 50 in the interior portion. A suitable disposable ostomy bag liner apparatus for this purpose is shown generally at 50 in Figure 4.
Referring to Figure 4, the disposable ostomy bag liner apparatus comprises first and second sheet portions 52, 54 of biodegradable polyester film material such as for example, a sheet comprised of about 85% to about 95% BASF Ecovio® F Film C2331 and about 15% to about 5% BASF Ecoflex® C Blend Film 200 available from BASF of Germany. The sheet may have a thickness of between about 0.015mm to about 0.040mm, for example. Each of the first and second sheet portions 52 and 54 has a respective first side edge portion
56, a second side edge portion 58 a bottom edge portion 60 and a top edge portion 62. The top edge portions 62 are disposed generally flat against each other and define a top portion 64 having an open top 66. The first side edge portions 56 are secured together to form a first side edge 70 and the second side edge portions 58 are secured together to form a second side edge 72.
The bottom edge portions 60 are secured together to form a bottom edge 74. The first side edge portions 56, the second side edge portions 58 and the bottom edge portions 60 are secured together such as by heat welding, or adhesive for example. A double seal provided by a double weld line may be used in this area. The first, second and bottom edges 70, 72 and 74 define a water tight bag having an opening 78 between the top edge portions 62.
The first and second side edges 70 and 72 each have a narrowed connector area 80, 82 extending from a side from the top edge portion 12 defining a connector portion 84 of the apparatus. In addition, the first and second side edges 70 and 72 each have a curved body-defining area 86 and 88 respectively between their corresponding narrowed connector area 80 and 82 and a respective side of the bottom edge 74. The curved body-defining areas 86 and 88 define a body portion 90 of the apparatus.
The top edge 66 includes open first and second straight edges 92 and 94 extending parallel to a longitudinal axis 96 of the apparatus 50. The top edge 66 also includes a curved open top edge curve 98 extending between the first and second straight edges 92, 94 to define first and second flange portions 100 and 102 in the first and second sheet portions 52 and 54 respectively for connecting the bag to the ostomy bag flange 14 of the ostomy bag shown in Figures 1 - 3. The open first and second straight edges 92 and 94 may have a length of between about 7mm to about 25mm. The first and second straight edges may be spaced apart by about 10cm to about 18cm. The open curved top edge 98 may have a radius of about 11cm to about 14cm.
The narrowed connector areas 80 and 82 include third and fourth straight edges 104, 106 on opposite sides of the bag. In the embodiment shown, the third and fourth straight edges 104 and 106 are disposed generally at right angles to the longitudinal axis 96 and extend from the first and second open straight edges 92 and 94 respectively to terminate in fifth and sixth straight edges 108 and 110 respectively. Alternatively, the third and fourth straight edges may be disposed at other angles such as, for example, between about 45 degrees and 90 degress to the longitudinal axis.
The third and fourth straight edges 104 and 106 of each of the first and second sheets are respectively joined together with respective single weld lines or adhesive and have respective lengths of between about 0.5cm to about 2cm. The fifth and sixth straight edges 108 and 110 are respectively joined together with respective single weld lines or adhesive and are spaced apart and are disposed generally parallel to the longitudinal axis 96. The fifth and sixth straight edges 108 and 110 each generally have lengths of between about 0.4cm to about 0.7cm.
Referring back to Figure 2, the opening 20 in the first sheet 22 has a diameter which depends upon the size of the ostomy bag 12. Ostomy bags may be provided in various sizes to suit the needs of users, from children to large adults. Therefore, the opening 20 about which the flange 14 extends can vary in size and diameter over a significant range. Consequently, in the disposable liner apparatus 50, the fifth and sixth straight edges 108 and 110 may be spaced apart anywhere from about 2.5cm to about 13.5cm depending on the diameter of the opening of the ostomy bag with which the liner apparatus 50 is to be used. Generally, it is desirable that the spacing between the fifth and sixth edges 108 and 110 be between about 80% to about 120% of the diameter of the opening 20 shown in Figure 2.
Each of the curved body defining areas 86 and 88 includes a continuous curved region 120, 122 respectively extending between its associated narrowed connector areas 80, 82 and the bottom edge 74. These continuous curved regions 120 and 122 generally extend outwardly away from the longitudinal axis 96 beginning at the respective narrowed connector area 80 and 82 and then at about half their length they start to curve inwardly toward the longitudinal axis 96 to terminate at their respective sides of the bottom edge 74. Generally these continuous curved regions 120 and 122 extend symmetrically in respective arcs of varying radius such that the body has a widening then narrowing profile.
Of particular importance, it should be noted that the first side edge 70 extends to include the third straight edge 108 and the continuous curved region 120. The second side edge 72 extended to include the fourth straight edge 10 and the second continuous curved region 122. Thus, the first and second side edges 70 and 72 are completely sealed. At the same time, the opened curved top edge 98 extending between the first and second straight edges 92 and 94 is not sealed and the first and second straight edges 92 and 94 of the first sheet are not joined to corresponding edges of the second sheet. These unjoined edges define the first and second flange portions 100 and 102 in an area above the third and fourth straight edges 104 and 106 and these flange portions 100 and 102 are spreadable from each other to define a relatively large-mouth opening that provides access to the interior of the apparatus 50. In the embodiment shown, the apparatus 50 has first and second angularly disposed partitions 121 and 123 formed by heat sealing together or adhesively securing together the first and second sheets 52 and 54 in converging line segments angled inwardly from respective fifth and sixth straight portions 108 and 110 toward the longitudinal axis 96 to define a chute area 124 therebetween. Waste material, from the stoma 18 depicted in Figure 1, is received in the opening 78 at the top portion 64 of the apparatus 50 is thus deflected by these partitions 121 and 123 into an interior portion of the apparatus 50. The partitions 121 and 123 also define first and second gas receiving areas 126 and 128 between the first side edge 70 and the first partition 121 and between the second partition 123 and second side edge 72 respectively. Small pinholes such as shown at 130 and 132 may be punctured in the first and/or second sheets 52 and 54 in the gas receiving area 126 and 128 to permit the escape of small amounts of gas that may accumulate in these areas.
Referring to Figure 5, the mating flange 16 on the user is shown to have a connector ring portion 150 having an annular male protrusion 152 extending about an opening 154 in the mating flange 16 through which the stoma 18 extends.
The flange 14 on the ostomy bag 12 has a complimentary receptacle 156 for receiving and holding the annular male protrusion 152 to secure the bag apparatus 12 to the mating flange 16 on the user. Before securing the bag flange 14 to the mating flange 16, the first and second flange portions 100 and 102 of the liner shown in Figure 4 are spread across respective portions of the flange 14 such that the flange portions 100 and 102 of the liner are captured between the annular male protrusion 152 and receptacle 156 in the respective mating flange 16 and bag flange 14. This positions the connector portion 84 in an area immediately adjacent the annular flange 14 such that the chute portion 124 is positioned adjacent the stoma 18, and the body portion 90 is held in a interior portion 28 of the bag 12. Referring to Figure 6, it will be appreciated that by providing the curved flange portions 100 and 102, a generally circular or generally elliptical form is established by the top edge portions 62 of each of the first and second sheets 52 and 54 respectively, which causes the curved flange portions 100 and 102 to extend relatively evenly about the bag flange 14. This provides for easy positioning of the flange portions 100 and 102 over the bag flange and the non-sealed first and second straight edges 92 and 94 help facilitate spreading of the flange portions 100 and 102 so that they can generally lie in a plane generally parallel to a plane of the body 90 of the bag 50 when the body 90 of the disposable ostomy bag liner 50 is in the ostomy bag 12 (not shown in Figure 6).
Referring back to Figures 1 and 3, it will be appreciated that when the flanges 14 and 16 are separated to remove the bag 12 from the patient the disposable liner apparatus 50 may be placed into or removed from the ostomy bag 12 through the opening provided by the flap 38 shown in Figure 3. Thus, a user can open the flap 38 and insert a disposable ostomy bag liner such as shown in Figure 4 and then, from the inside the ostomy bag, push the first and second flange portion 100 and 102 though the opening 20 shown in Figure 2 and then spread the flanges 100 and 102 such as shown in Figure 6 such that they cover the female annular receptacle 156 in the flange 14 as shown in Figure 5. Then the annular male member portion 52 of the mating flange 16 on the user can be received in the female receptacle 156, with the flanges 100 and 102 received therebetween, thereby firmly securing the disposable ostomy bag liner 50 in the ostomy bag 12 at the same time the ostomy bag 12 is secured to the patient through the cooperation of the flanges 14 and 16.
Referring to Figure 7, in alternative embodiment, a disposable ostomy bag having the features of the bag described in connection with Figure 4 can be made by stamping a sheet of biodegradable polyester film, which for example, may be comprised of about 85% to about 95% BASF Ecovio® F Film C2331 and about 5% to about 5% BASF Ecoflex® C Blend Film 1200 having a thickness of between about 0.015mm to about 0.040mm to define sheet portions 160 and 162 that are mirror-image, symmetrically shaped halves of a unitary solid sheet of film. The film is then folded in half along a fold line 164 to align edges 92, 98, 104, 108 and 70 of the first half 160 with correspondingly numbered edges of the second half 162 and to align edges 94, 106, 110 and 72 of the first half 160 with correspondingly numbered edges of the second half 162. Then, edges 70 are heat sealed together, edges 72 are heat sealed together, edges 108 are heat sealed together and edges 110 are heat sealed together. The heat seal is not required along the fold line 164 because the fold line becomes the bottom edge 74 of the liner apparatus 50 and inherently acts as an integral water-tight joint in the bag.
Referring to Figure 8, a disposable ostomy bag apparatus according to an alternative embodiment of the invention is shown generally at 170. The apparatus of this embodiment has the same top edges 92, 94, 98 and third, fourth, fifth and sixth straight edges 104, 106, 108 and 110, but has more accentuated first and second side edges 172 and 174. These first and second accentuated side edges 172 and 174 extend outwardly by a distance 176 of respective planes 178 and 180 in which the first and second straight edges 92 and 94 lie, respectively to form an accentuated body portion 182.
The apparatus this has a body resembling a "jug".
It will be appreciated that the body portions 90 and 182 in each embodiment depecited in Figures 4-8 extend outwardly from the fifth and sixth straight portions 108 and 110 in order to maximize the volumetric capacity of the liner apparatus by occupying as much of the interior of the ostomy bag as possible.
While specific embodiments of the invention have been described and illustrated, such embodiments should be considered illustrative of the invention only and not as limiting the invention as construed in accordance with the accompanying claims.

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
A disposable ostomy bag liner apparatus comprising: first and second sheet portions of film material each having first and second side edge portions a bottom edge portion and a top edge portion, said top edge portions being disposed generally flat against each other and defining a top portion having an open top edge, said first side edge portions being secured together to form a first side edge, said second side edge portions being secured together to form a second side edge and said bottom edge portions being secured together to form a bottom edge, whereby said first, second, top and bottom edges define a water-tight bag having an opening between said top edge portions; said first and second side edges each having: a narrowed connector area, extending from a side of said top edge defining a connector portion of the apparatus; and a curved body-defining area, between said narrowed connector area, and a side of said bottom edge for defining a body portion of the apparatus; said top edge including open first and second straight edges, extending parallel to a longitudinal axis of the bag and an open curved top edge extending between said first and second straight edges, to define first and second flange portions, in the first and second sheet portions, respectively, for connecting the bag to an ostomy bag coupling of an ostomy bag.
The apparatus of claim 1 wherein said open curved top edge has a radius of about 11cm to about 14cm.
The apparatus of claim 2 wherein said open first and second straight edges, have a length of between about 0.7 cm to about 2.5 cm.
The apparatus of claim 2 wherein said first and second straight edges, are spaced apart by about 3cm to about 18cm.
The apparatus of claim 4 wherein said narrowed connector area, includes third and fourth straight edges, on opposite sides of the bag, said third and fourth straight edges being disposed between about 45 degrees and about 90 degrees to the longitudinal axis of the bag and extending from said first and second open straight edges, respectively and terminating in fifth and sixth straight edges, respectively, said fifth and sixth straight edges being spaced apart and disposed generally parallel to said longitudinal axis.
The apparatus of claim 5 wherein said third and fourth straight edges, have respective lengths of about 0.5 cm to about 2 cm and said fifth and sixth straight edges, have respective lengths of about 0.4cm to about 0.7cm.
The apparatus of claim 6 wherein said fifth and sixth straight edges, are spaced apart by about 2.5cm to about 13.5cm.
The apparatus of claim 7 wherein each of said curved body-defining areas, includes a continuous curved region, extending between its associated narrowed connector area, and said bottom edge.
9. The apparatus of claim 8 wherein said continuous curved regions, extend outwardly away from the longitudinal axis of the respective narrowed connector areas, and then curve inwardly toward said longitudinal axis before terminating at said bottom edge.
10. The apparatus of claim 9 wherein said continuous curved regions, extend symmetrically, in respective arcs of varying radius.
11. The apparatus of claim 10 wherein said first side edge portions are heat-sealed together and wherein said second side edge portions are heat sealed together.
12. The apparatus of claim 11 wherein said bottom edge portions are heat sealed together.
13. The apparatus of claim 11 wherein said first and second sheet portions and are mirror-image symmetrically shaped halves of a unitary solid sheet of film folded in half to align said top edge portions, said first side edge portions, and said second side edge portions, respectively, and to form a fold line in said unitary solid sheet such that said fold line acts as said bottom edge.
14. The apparatus of claim 13 further comprising first and second angularly disposed partitions, in the body portion adjacent the first and second side edges, respectively to define a chute area between said partitions and first and second gas receiving areas, between the first side edge and the first partition and between the second side edge and the second partition respectively. 15. The apparatus of claim 14 wherein said first and second partitions, include first and second weld lines, welding said first and second sheet portions, together along said first and second weld lines respectively. The apparatus of claim 15 further comprising openings, in said first and second gas receiving areas, for releasing gas received in said first and second gas receiving areas.
The apparatus of claim 16 wherein said first and second sheet portions are formed of biodegradable polyester film having a thickness of between about 0.015mm to about 0.040mm.
An ostomy system comprising the ostomy bag liner apparatus of any one of claims 5-17 and further comprising a disposable ostomy bag having an interior portion and a bag flange for cooperating with a mating flange secured to a user's body and surrounding an ostomy of the user, said bag flange having a generally circular opening that is generally aligned with the ostomy when the bag flange is secured to the mating flange, wherein said connector portion of said disposable ostomy bag is held within said generally circular opening in said bag flange such that said body portion of the disposable ostomy bag liner apparatus is disposed in said interior portion of said ostomy bag and said top portion of said disposable ostomy bag disposed outside of said ostomy bag.
The ostomy system of claim 18 wherein said bag flange is coupled with said mating flange such that said top portion of said disposable ostomy bag is located between said bag flange and said mating flange to secure said disposable ostomy bag liner apparatus to said ostomy bag in a position to receive intestinal waste from the user's ostomy between said first and second top edge portions such that said intestinal waste is received inside the body portion of the disposable ostomy bag liner apparatus.
The ostomy system of claim 9 wherein said opening in said flange on said ostomy bag has a diameter and wherein said fifth and sixth straight edges are spaced apart by a distance between about 80% of said diameter and 120% of said diameter.
The ostomy system of claim 20 wherein said curved body-defining areas of said first and second side edges cause said body portion of said disposable ostomy bag apparatus to have a shape that generally follows a shape of an interior of the ostomy bag.
22. The ostomy system of claim 21 wherein said ostomy bag is formed of an air-permeable material.
PCT/CA2013/000051 2013-01-17 2013-01-17 An ostomy bag and disposable ostomy bag liner apparatus therefor WO2014110645A1 (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016146136A1 (en) * 2015-03-18 2016-09-22 Multi-Lock Aps Ostomy device
CN108245309A (en) * 2016-12-29 2018-07-06 光正龙 A kind of ostomy bag of multilayer sack

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US2634727A (en) * 1949-04-11 1953-04-14 Medical Specialty Company Inc Colostomy appliance
US4816027A (en) * 1987-09-03 1989-03-28 Gilchrist Richard J Disposable ostomy bag liner
US5423782A (en) * 1994-06-17 1995-06-13 Wolrich; Douglas H. Disposable ostomy bag liner
US5785695A (en) * 1995-11-10 1998-07-28 Alcare Co., Ltd. Body wastes receiving appliance
WO2012019271A1 (en) * 2010-08-12 2012-02-16 Colo-Majic Enterprises Ltd. Ostomy pouch apparatus with closable opening

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Publication number Priority date Publication date Assignee Title
US2634727A (en) * 1949-04-11 1953-04-14 Medical Specialty Company Inc Colostomy appliance
US4816027A (en) * 1987-09-03 1989-03-28 Gilchrist Richard J Disposable ostomy bag liner
US5423782A (en) * 1994-06-17 1995-06-13 Wolrich; Douglas H. Disposable ostomy bag liner
US5785695A (en) * 1995-11-10 1998-07-28 Alcare Co., Ltd. Body wastes receiving appliance
WO2012019271A1 (en) * 2010-08-12 2012-02-16 Colo-Majic Enterprises Ltd. Ostomy pouch apparatus with closable opening

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016146136A1 (en) * 2015-03-18 2016-09-22 Multi-Lock Aps Ostomy device
US11083617B2 (en) 2015-03-18 2021-08-10 Multi-Lock Aps Ostomy device
CN108245309A (en) * 2016-12-29 2018-07-06 光正龙 A kind of ostomy bag of multilayer sack

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