WO2015132779A1 - Poche de stomie destinée à diriger des sorties de stomie, et ses moyens - Google Patents

Poche de stomie destinée à diriger des sorties de stomie, et ses moyens Download PDF

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Publication number
WO2015132779A1
WO2015132779A1 PCT/IL2015/050214 IL2015050214W WO2015132779A1 WO 2015132779 A1 WO2015132779 A1 WO 2015132779A1 IL 2015050214 W IL2015050214 W IL 2015050214W WO 2015132779 A1 WO2015132779 A1 WO 2015132779A1
Authority
WO
WIPO (PCT)
Prior art keywords
ostomy
pouch
sleeve
opening
diameter
Prior art date
Application number
PCT/IL2015/050214
Other languages
English (en)
Inventor
Eitan YEVZORI
Original Assignee
Yevzori Eitan
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 Yevzori Eitan filed Critical Yevzori Eitan
Publication of WO2015132779A1 publication Critical patent/WO2015132779A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A61F2005/4483—Convex pressure ring

Definitions

  • the present invention pertains to an ostomy collecting pouch comprising a flexible sleeve for directing patient's stoma output stool and further securing and providing a fluid-tight seal with ostomy skin barrier.
  • a consequence is, in many cases, that the patient is left with an ostomy such as a colostomy, an ileostomy or an ostomy in the abdominal wall for the discharge of the effluents or waste products of the body, which are conveyed through the colon, the ileum or the ureter.
  • the discharge of visceral contents including intestinal gases cannot be regulated at will, and for that purpose the opening may be closed with a closure means, e.g. a tampon or a magnetic closure, or the patient will have to rely on an appliance to collect the material emerging from such opening in the form of a receiving pouch which is later emptied and/or discarded at suitable times.
  • Ostomy appliances are well known. Such appliances may be two-piece or one- piece appliances. In both types of appliances, an adhesive wafer is attached to the wearer's skin. In case of a one-piece appliance, a receiving member or pouch is attached directly to the patient's skin adhesively. In case of a two-piece appliance, the adhesive wafer or barrier forms part of a body side member and a receiving bag is attached releasable to the body side ostomy member for receiving output from the stoma.
  • a stoma is a permanent surgically-made opening that protrudes through a user's skin from the inside of an organ to the outside, generally through the abdominal wall to the exterior, through which the waste material is discharged.
  • a stoma operation is performed to treat serious, often life threatening, diseases and medical conditions such as bowel or bladder cancer, inflammatory bowel disease (ulcerative colitis or Crohn's Disease), diverticulitis, congenital abnormalities or injury.
  • diseases and medical conditions such as bowel or bladder cancer, inflammatory bowel disease (ulcerative colitis or Crohn's Disease), diverticulitis, congenital abnormalities or injury.
  • An opening in one of the sidewalls is adapted to receive a stoma of a patient, from which waste material exits a patient and is collected in the pouch.
  • Ostomy appliances such as ostomy pouches, are used to receive body waste material by people who have had such surgeries.
  • Conventional collection units include a one-piece or two-piece system.
  • Both kinds consist from a skin barrier and a collection pouch.
  • One-piece units consist of a skin barrier and a pouch joined together. Two-piece systems allow the individual to change pouches while leaving the barrier attached to the skin. These do not require changing the entire unit, including skin barrier, when only the collection pouch is changed while the skin barrier stays intact.
  • the whole appliance including the adhesive skin barrier securing the appliance to the skin is normally removed and replaced by a fresh appliance.
  • the skin barrier is left in place up to several days, and only the collection pouch is replaced.
  • a permanent ostomy is made, and the downstream part of the intestines is removed, but where the prognosis is in favor, a temporary ostomy is made and the downstream part is kept intact.
  • loop-ostomies are made, with an afferent leg carrying visceral content to the ostomy and an efferent leg leading into the downstream part of the intestines from the site of the ostomy, in the same place on the abdominal wall, and thus- the visceral content's normal flow is interrupted at this point - often corresponding to the small intestine - but with further anal continuity via the efferent leg of the ostomy.
  • an ostomy pouch for directing stool from a stoma having an external diameter (ED-S), comprising: a sleeve having an arcing spring diaphragmlike structure, the sleeve comprising:
  • a middle arcuate flexible elastic portion connecting the first and second openings; at least a portion of the middle arcuate flexible elastic body, in proximity to the first opening is introduced into an skin barrier; wherein Dl is greater than ED-S such that the portion is fixedly secured to the ostomy skin barrier in a tight-fit fluid-occlusive manner.
  • the sleeve is preferably of a polymer selected from a group consisting of polypropylene, polytan, polyamide, nylon, polyarylate and a combination thereof.
  • step of attaching the collection pouch to the skin barrier further comprising the step of securely fixing the portion in a tight-fit fluid occlusive manner to the ostomy skin barrier by means of placing and adjusting the first opening having a first diameter Dl, which is greater than ED-S.
  • Fig. 1 is an isometric view of a flexible sleeve having an arcing spring diaphragm-like structure, of the present invention
  • Fig. 2 is a cross section view of the collecting pouch comprising a flexible sleeve before interconnecting with a skin barrier, of the present invention.
  • Fig. 3 is a cross section view of the collecting pouch comprising a flexible sleeve after interconnecting to a skin barrier, of the present invention.
  • the present invention provides an ostomy appliance configured to prevent the accumulation of stoma output into the area between a skin barrier and a collection pouch when an ostomy pouch is introduced, placed, and being replaced.
  • the ostomy pouch of the present invention provides a unified two-piece system of a collecting pouch integrated with a sleeve having an arcing spring diaphragm-like structure.
  • the sleeve is configured as an extension part of the collecting pouch having a conical, arcing, convex, domed, rounded, curved or spherical base shape.
  • the sleeve is a build-in part of the pouch.
  • the sleeve is configured as a funnel-like in order to receive a stoma, to guide and direct stoma stool flow and further preventing accumulation in-between the area of the skin barrier, the stoma and the collecting pouch.
  • the sleeve of the present invention is of outmost importance since it provides the patient a tolerable existence by sparing them the time-consuming procedure of cleansing the filthy surface of the remaining skin barrier and further preventing infections and further inflammations in the stoma area.
  • the sleeve is configured as an integrated connector to the pouch rim thereby, fixedly securing the pouch to the skin barrier and further overlapping the stoma in a fluid occlusive, tight-fit manner preventing accumulation of the ostomy stool in-between the surface of the skin barrier and the pouch.
  • the term "sleeve” refers herein to an elastic and flexible extension having an arcing spring diaphragm-like structure, comprising a first opening portion having a first diameter for connecting to the ostomy skin barrier, a second opening portion having a second diameter; and a middle arcuate flexible elastic portion connecting the first and second opening portions.
  • the sleeve may have a structure selected from the group consisting of conical shape, arcing shape, convex shape, domed shape, rounded shape, curved shape, spherical base shape, cylindrical elastically deformable shape and a combination thereof.
  • the sleeve is with a first opening interconnected to an internal surface of a pouch rimby means of shape and size to seamlessly overlap a stoma, whilst the second opening receives a user's stoma such that the ostomy pouch comprising the sleeve guides and directs the stoma stool and further prevents accumulation into the area between a skin barrier and the collection mounting pouch.
  • the second opening is with a diameter greater than patient stoma's diameter by about 2 to about 4mm, therefore, the pouch comprising the sleeve does not come in touch with the stoma.
  • the sleeve may be composed from the same material of the pouch, the skin barrier or from another semi-rigid or flexible material, which is biocompatible.
  • the term "about X” or “approximately X” or “substantially X” usually refers to a range 25% less than to 25% more than of X (X + 25%), at times X + 20%, X + 15% and preferably X + 10.
  • Fig. 1 illustrates a sleeve configured by means of shape and size to seamlessly interconnect a pouch thereby forming a one unit collecting pouch.
  • the sleeve demonstrated is an elastic and flexible sleeve having an arcing spring diaphragm-like structure, comprising: a first opening portion (1) having a first diameter Dl for connecting to the ostomy skin barrier, a second opening (2) portion having a second diameter D2 and a middle arcuate flexible elastic body (4) connecting the first and second opening portions. At least a portion of the middle arcuate flexible elastic body, in proximity to the first opening, is introduced into an ostomy skin barrier.
  • the first opening portion is characterized by a stretchable elastic annular sealing film-like region configured to contact and seal the skin barrier in an occlusive and elastic fit and second opening portion is contiguous with the pouch.
  • the conical sleeve comprises a first opening (1) and a second opening (2) for seamlessly overlapping a pouch (3) forming a one integrated unit.
  • the sleeve is elastic and thin in thickness such that easy to be applied upon a subject's stoma without force or creating pressure around the stoma.
  • Dl is greater than said ED-S such that the portion of the middle arcuate flexible elastic body is fixedly secured to said ostomy skin barrier in a tight-fit fluid-occlusive manner.
  • the sleeve further comprises an annulus portion which is a ring-shaped portion bounded by two concentric circles.
  • the flexible elastic area of the annulus is the difference in the areas of the larger circle of radius R and the smaller one of radius r:
  • the annulus portion of the sleeve provides a surface area allowing the sleeve to be affixed to the skin barrier and further providing sealing in a tight- fit manner.
  • Table 1 presents the stoma diameter relative to the diameter of the first opening of the sleeve of the present invention:
  • the pouch comprising a sleeve elastically deformable to provide a fluid-tight seal with an ostomy skin barrier.
  • the sleeve may be manufactured from a material selected from the group consisting of polymer, latex, spandex, natural and synthetic rubber materials, cardboard or paper and any combination thereof.
  • the sleeve is preferably made of a polymer selected from the group consisting of polypropylene, polytan, polyamide, nylon, polyarylate and a combination thereof.
  • additional materials may be used to provide the sleeve having elasticity and flexibility characteristics.
  • the sleeve is with a tendency to return to its original shape after being deformed resulting from the stretching of polymer chains when forces are applied.
  • the elasticity of the sleeve is characterized by stress-strain relation.
  • the amount of elasticity of the sleeve can further be determined by modulus material parameter which measures the amount of force per unit area (stress) needed to achieve a given amount of deformation.
  • An elastic modulus has the form
  • the sleeve is with a low modulus indicating that the material can be deform.
  • the sleeve is further with elastic limit.
  • the pouch comprising the sleeve having a conical shape may be manufactured as a one-piece component using a molding process.
  • a molding process any other appropriate forming process may be used.
  • the sleeve may be integrated and incorporated with the pouch rim, which can be permanently affixed to the pouch by means of a thermal-, HF- ultrasonic welding technique, adhesive material, molding, fusion, pasting, gluing, welding or any known technique.
  • FIG. 2 illustrates cross section of an ostomy pouch (10) for directing stool from a stoma having an external diameter (ED-S) (13), comprising: an elastic and flexible sleeve having an arcing spring diaphragm-like structure, comprising: a first opening portion having a first diameter for connecting to the ostomy skin barrier, a second opening portion having a second diameter and, a middle arcuate flexible elastic portion connecting the first and second opening portions. Furthermore, at least the first opening portion is characterized by a stretchable elastic annular sealing film-like region configured to contact and seal the skin barrier in an occlusive and elastic fit and second opening portion is contiguous with the pouch.
  • the pouch (10) comprising an elastic sleeve (12) configured by means of shape and size as one single unit for guiding patient's stoma (13) output stool directly to the collection pouch and further to protect the area (11) in between the skin barrier (14) and further prevent any leakage or infection around and in-between the skin barrier and the pouch.
  • the pouch (10) comprising the elastic sleeve 12 is presented before joining and connecting the pouch comprising the sleeve to the skin barrier (14).
  • the flexible sleeve is configured to extent the pouch rim thereby, the sleeve is provided as an extension portion of the pouch wall.
  • the sleeve is integrally combined with the pouch rim such that the external diameter of the flexible sleeve does not come in touch with the stoma of an individual.
  • the pouch comprising the flexible sleeve is designed with a thin annular-like to contact and affixed directly to the skin barrier.
  • the sleeve middle arcuate flexible elastic portion is further with the advantage that the contact surface is flat and flexible.
  • the flexible sleeve having an arcing spring diaphragm-like structure provides sealing means, which extends around the second opening for sealing the pouch to the skin of a wearer as part of the pouch.
  • FIG. 3 illustrates a cross section of an ostomy pouch (10) comprising an elastic and flexible sleeve having an arcing spring diaphragm-like structure, comprising: a first opening portion having a first diameter for connecting to the ostomy skin barrier, a second opening portion having a second diameter and, a middle arcuate flexible elastic portion connecting the first and second opening portions. Furthermore, at least the first opening portion is characterized by a stretchable elastic annular sealing film-like region configured to contact and seal the skin barrier in an occlusive and elastic fit and second opening portion is contiguous with the pouch.
  • the flexible sleeve is configured by means of shape and size to seamlessly overlap a stoma output (13).
  • the flexible sleeve (12) joint together with the pouch is further configured to direct and guide patient's stoma (13) output stool to the collection pouch and further provides a sealing manner which secures the area (11) in between the pouch, the stoma and the skin barrier.
  • the pouch comprising the sleeve presented in Fig. 3 is after accommodating and connecting to a skin barrier (14). Furthermore the sleeve may be contiguous with a conventional pouch having locking clips 15 and skin barrier having the same which can be manually disengaged by the user.
  • the present invention further provides a method of directing ostomy stool from a stoma having an external diameter (ED-S), comprising steps of: providing ostomy pouch for directing stool from a stoma having an external diameter (ED-S),comprising: an elastic and flexible sleeve having an arcing spring diaphragm-like structure, comprising: a first opening portion having a first diameter for connecting to the ostomy skin barrier, a second opening portion having a second diameter contiguous with the pouch, a middle arcuate flexible elastic portion connecting the first and second opening portions.
  • ED-S external diameter
  • the method further comprising the step of attaching the collection pouch to the skin barrier.
  • the method further comprising the steps of placing and adjusting the first opening portion having a stretchable elastic annular sealing film-like region configured to contact and seal the skin barrier in an occlusive and elastic fit.
  • the method further comprising step of providing a sleeve with a first opening for preventing any contact of the pouch with the stoma and further accumulation of the ostomy stool in- between the surface of the skin barrier, the stoma and the pouch.
  • the method of the present invention further comprises the step of fixedly securing the pouch extension to the skin barrier via the extension in a fluid occlusive, tight-fit manner.

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

La présente invention concerne une poche de stomie destinée à diriger les selles d'une stomie ayant un diamètre externe (ED-S), comprenant : une structure du type diaphragme à ressort en arc, le diaphragme comprenant : une première ouverture ayant un premier diamètre Dl, une seconde ouverture ayant un second diamètre D2 et un corps élastique souple arqué central reliant les première et seconde ouvertures ; au moins une partie dudit corps élastique souple arqué central, à proximité de ladite première ouverture, est introduite dans une barrière cutanée de stomie. Dl est supérieur à ED-S de telle sorte que la partie du corps élastique souple arqué central est fermement fixée à la barrière cutanée de stomie par occlusion à ajustement serré imperméable aux fluides.
PCT/IL2015/050214 2014-03-05 2015-02-25 Poche de stomie destinée à diriger des sorties de stomie, et ses moyens WO2015132779A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL231334A IL231334A0 (en) 2014-03-05 2014-03-05 A stoma device containing an open-ended conduit for transporting stoma secretions
IL231334 2014-03-05

Publications (1)

Publication Number Publication Date
WO2015132779A1 true WO2015132779A1 (fr) 2015-09-11

Family

ID=51221227

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2015/050214 WO2015132779A1 (fr) 2014-03-05 2015-02-25 Poche de stomie destinée à diriger des sorties de stomie, et ses moyens

Country Status (2)

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IL (1) IL231334A0 (fr)
WO (1) WO2015132779A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11918508B1 (en) 2022-09-01 2024-03-05 Hollister Incorporated Ostomy appliance for providing customized and localized convex support

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5000748A (en) * 1986-01-02 1991-03-19 Marlen Manufacturing & Development Company Ostomy drainage receptacle
US5607413A (en) * 1996-03-12 1997-03-04 Dansac A/S Convex ostomy faceplate with floating flange and finger recess
US5618276A (en) * 1996-02-14 1997-04-08 Hollister Incorporated Ostomy appliance with convex pressure ring
GB2476680A (en) * 2010-01-05 2011-07-06 Pelican Healthcare Ltd Ostomy mounting with attachment points

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5000748A (en) * 1986-01-02 1991-03-19 Marlen Manufacturing & Development Company Ostomy drainage receptacle
US5618276A (en) * 1996-02-14 1997-04-08 Hollister Incorporated Ostomy appliance with convex pressure ring
US5607413A (en) * 1996-03-12 1997-03-04 Dansac A/S Convex ostomy faceplate with floating flange and finger recess
GB2476680A (en) * 2010-01-05 2011-07-06 Pelican Healthcare Ltd Ostomy mounting with attachment points

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11918508B1 (en) 2022-09-01 2024-03-05 Hollister Incorporated Ostomy appliance for providing customized and localized convex support

Also Published As

Publication number Publication date
IL231334A0 (en) 2014-06-30

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