WO2015132779A1

WO2015132779A1 - An ostomy pouch for directing stoma outputs and means thereof

Info

Publication number: WO2015132779A1
Application number: PCT/IL2015/050214
Authority: WO
Inventors: Eitan YEVZORI
Original assignee: Yevzori Eitan
Priority date: 2014-03-05
Filing date: 2015-02-25
Publication date: 2015-09-11
Also published as: IL231334A0

Abstract

The present invention provides an ostomy pouch for directing stool from a stoma having an external diameter (ED-S), comprising: an arcing spring diaphragm-like structure, the diaphragm comprising: a first opening having a first diameter Dl, a second opening having a second diameter D2 and a middle arcuate flexible elastic body connecting the first and the second openings; at least a portion of said middle arcuate flexible elastic body, in proximity to said first opening, is introduced into an ostomy skin barrier. Dl is greater than said ED-S such that the portion of the middle arcuate flexible elastic body is fixedly secured to the ostomy skin barrier in a tight-fit fluid-occlusive manner.

Description

AN OSTOMY POUCH FOR DIRECTING STOMA OUTPUTS AND MEANS

THEREOF

FIELD OF THE INVENTION

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.

BACKGROUND OF THE INVENTION

In connection with surgery for a number of diseases in the gastro-intestinal tract 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. One consequence thereof is that the patient will lack the ability to control the discharge of urine, fecal material, liquid and/or gases. 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. When using one-piece appliances, the whole appliance, including the adhesive skin barrier securing the appliance to the skin is normally removed and replaced by a fresh appliance. When using two-piece appliances, the skin barrier is left in place up to several days, and only the collection pouch is replaced. In the treatment of some diseases, 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. In a number of these cases 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. In other patients a double-ostomy is made which is analogue to the loop-ostomy, but the two parts of the intestine end in stomas placed on the abdominal wall separated with a distance between them. In the process of changing a conventional pouch in a two-piece system the patient has to clean the accumulation of bowel contents on the surface of the skin barrier. Thus arises the need to invent an appliance which eases the changing process and provides a sanitary and convenient solution.

There is therefore, a long-felt and unmet need to provide an ostomy pouch which will accelerate the pouch- replacement process in a convenient and secured manner, and further easier and non-repulsive manner.

SUMMARY OF THE INVENTION

It is one object of the invention to disclose 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. a first opening having a first diameter D 1 ;

b. a second opening having a second diameter D2; and,

c. 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.

It is another object of the present invention to provide the ostomy pouch as defined in any of the above, wherein the first opening is greater than the ED-S by about 2mm to about 4 mm. It is another object of the present invention to provide the ostomy pouch as defined in any of the above, wherein the first diameter is in the range of about 30mm to about 37mm such that the first opening seamlessly overlap the stoma in a fluid occlusive, tight-fit manner thus, the diameter first opening does not come in touch with the stoma.

It is another object of the present invention to provide the ostomy pouch as defined in any of the above, wherein the sleeve structure is selected from the group consisting of conical, arcing, convex, domed, rounded, curved, spherical, cylindrical, torus and a combination thereof.

It is another object of the present invention to provide the ostomy pouch as defined in any of the above, wherein at least one portion of the sleeve is composed of a material selected from the group consisting of polymer, latex, spandex, rubber, cardboard paper and any combination thereof.

It is another object of the present invention to provide the ostomy pouch as defined in any of the above, wherein the sleeve is preferably of a polymer selected from a group consisting of polypropylene, polytan, polyamide, nylon, polyarylate and a combination thereof.

It is another object of the present invention to provide the ostomy pouch as defined in any of the above, wherein at least one portion of the sleeve is of a material selected from a group consisting of flexible, semi-flexible, semi-rigid and a combination thereof. It is another object of the present invention to provide the ostomy pouch as defined in any of the above, wherein the second diameter is in the range of about 45 to about 55 mm.

It is another object of the invention to disclose a method of directing ostomy stool from a stoma having an external diameter (ED-S), comprising steps of:

a. providing ostomy pouch for directing stool from a stoma having an external diameter (ED-S), comprising: a sleeve having an arcing spring diaphragm-like structure, the sleeve comprising:

i. a first opening having a first diameter D 1 ; f

ii. a second opening having a second diameter D2; and

iii. a middle arcuate flexible elastic body connecting the first and second openings; and

b. introducing the at least portion of the middle arcuate flexible elastic body into the ostomy skin barrier;

c. attaching the collection pouch to the skin barrier;

wherein the 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.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be implemented in practice, a plurality of embodiments is adapted to now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which

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; and,

Fig. 3is a cross section view of the collecting pouch comprising a flexible sleeve after interconnecting to a skin barrier, of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description is provided, to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, are adapted to remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide an ostomy mounting pouch comprising a sleeve configured to contact and seal a conventional ostomy skin barrier in a faster, more convenient, reliable, and easier manner.

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.

In another embodiment of the present invention, 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.

In another embodiment of the present invention, 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. In accordance of the present invention, 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.

As used herein 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.

Reference is now made to Fig. 1, which 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. 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 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.

Furthermore, 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.

In another embodiment of the present invention, 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:

— ¾ i , ?! T ^™ ?j I_, h. ^{■■■■■■■} T I .

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 below presents the stoma diameter relative to the diameter of the first opening of the sleeve of the present invention:

Table 1

55mm

35

40 55mm

In another embodiment 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.

In another embodiment of the present invention, 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

Where stress is the force causing the deformation divided by the area to which the force is applied and strain is the ratio of the change in some length parameter caused by the deformation to the original value of the length parameter. The sleeve is with a low modulus indicating that the material can be deform. The sleeve is further with elastic limit.

In another embodiment of the present invention, the pouch comprising the sleeve having a conical shape may be manufactured as a one-piece component using a molding process. However, 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.

Reference is now made to Fig. 2, which 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.

In another embodiment of the present invention, the pouch comprising the flexible sleeve is designed with a thin annular-like to contact and affixed directly to the skin barrier.

Furthermore, the sleeve middle arcuate flexible elastic portion is further with the advantage that the contact surface is flat and flexible.

In another embodiment of the present invention, 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.

Reference is now made to Fig. 3, which 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.

The method further comprising the step of attaching the collection pouch to the skin barrier. In another embodiment of the present invention, 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.

The features disclosed in the foregoing description, or the following claims, or the accompanying drawings, expressed in their specific forms or in terms of a means for performing the disclosed function, or a method or process for attaining the disclosed result, as appropriate, may, separately, or in any combination of such features, be utilized for realizing the invention in diverse forms thereof.

Claims

1. An ostomy pouch for directing stool from a stoma having an external diameter (ED- S),comprising: a sleeve having an arcing spring diaphragm-like structure, said sleeve comprising:

a. a first opening having a first diameter D 1 ;

b. a second opening having a second diameter D2; and,

c. a middle arcuate flexible elastic body connecting said first and said second openings; at least a portion of said middle arcuate flexible elastic body, in proximity to said first opening, is introduced into an ostomy skin barrier;

wherein said Dl is greater than said ED-S such that said portion of said middle arcuate flexible elastic body is fixedly secured to said ostomy skin barrier in a tight-fit fluid- occlusive manner .

2. The ostomy pouch of claim 1, wherein said first opening is greater than said ED-S by about 2mm to about 4 mm.

3. The ostomy pouch of claim 1, wherein said first diameter is in the range of about 30mm to about 37mm such that said first opening seamlessly overlap said stoma in a fluid occlusive, tight-fit manner thus, said diameter first opening does not come in touch with said stoma.

4. The ostomy pouch of claim 1, wherein said sleeve structure is selected from the group consisting of conical, arcing, convex, domed, rounded, curved, spherical, cylindrical, torus and a combination thereof.

5. The ostomy pouch of claim 1, wherein at least one portion of said sleeve is composed of a material selected from the group consisting of polymer, latex, spandex, rubber, cardboard paper and any combination thereof.

6. The ostomy pouch of claim 1, wherein said sleeve is preferably of a polymer selected from a group consisting of polypropylene, polytan, polyamide, nylon, polyarylate and a combination thereof.

7. The ostomy pouch of claiml, wherein at least one portion of said sleeve is of a material selected from a group consisting of flexible, semi-flexible, semi-rigid and a combination thereof.

8. The ostomy pouch of claim 1, wherein said second diameter is in the range of about 45 to about 55 mm. A method of directing ostomy stool from a stoma having an external diameter (ED-S), comprising steps of:

a. providing ostomy pouch for directing stool from a stoma having an external diameter (ED-S),comprising: a sleeve having an arcing spring diaphragm-like structure, said sleeve comprising:

i. a first opening having a first diameter D 1 ;

ii. a second opening having a second diameter D2; and

iii. a middle arcuate flexible elastic body connecting said first and second openings;

b. introducing said at least portion of said middle arcuate flexible elastic into said ostomy skin barrier;

c. attaching said collection pouch to said skin barrier;

wherein said step of attaching said collection pouch to said skin barrier further comprising step of securely fixing said portion in a tight-fit fluid occlusive manner to said ostomy skin barrier by means of placing and adjusting said first opening having a first diameter Dl, which is greater than ED-S.