US3898990A - Ostomy seal and method of making the same - Google Patents

Ostomy seal and method of making the same Download PDF

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Publication number
US3898990A
US3898990A US32832473A US3898990A US 3898990 A US3898990 A US 3898990A US 32832473 A US32832473 A US 32832473A US 3898990 A US3898990 A US 3898990A
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seal
ring
sheet
face
material
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John L Nolan
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Hollister Inc
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Hollister Inc
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    • 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
    • A61F5/443Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type, e.g. gels, starches, karaya gums

Abstract

A nonirritating seal to be used in conjunction with an ostomy bag for patients who have undergone operations such as colostomies and ileostomies, wherein the seal is provided with a flexible backing material such as a polyethylene film to enable the seal to retain its shape and also permitting the seal to have an interference fit with a plastic retaining ring carrying the ostomy bag. The seal is made by a novel method which includes placing in a rigid mold an upper and lower sheet of thin flexible plastic material and injecting the seal material into the mold between the sheets so that upon removal one flexible sheet becomes a backing for supporting the seal while the other forms a ''''peel-off'''' type of cover for the face of the seal which can be removed immediately before applying the same against the skin of a patient.

Description

United States Patent [191 Nolan 1 Aug. 12, 1975 1 OSTOMY SEAL AND METHOD OF MAKING THE SAME [75] Inventor: John L. Nolan, Glenview, Ill.

[73] Assignee: Hollister Incorporated, Chicago, Ill.

[22] Filed: Jan. 31, 1973 [21] Appl. No.: 328,324

Primary ExaminerAldrich F. Medbery Attorney, Agent, or Firm--Wegner, Stellman, McCord, Wiles & Wood [5 7] ABSTRACT A nonirritating seal to be used in conjunction with an ostomy bag for patients who have undergone operations such as colostomies and ileostomies, wherein the seal is provided with a flexible backing material such as a polyethylene film to enable the seal to retain its shape and also permitting the seal to have an interference fit with a plastic retaining ring carrying the ostomy bag. The seal is made by a novel method which includes placing in a rigid mold an upper and lower sheet of thin flexible plastic material and injecting the seal material into the mold between the sheets so that upon removal one flexible sheet becomes a backing for supporting the seal while the other forms a peeloff type of cover for the face of the seal which can be removed immediately before applying the same against the skin of a patient.

2 Claims, 9 Drawing Figures FATE-HEB AUB 1 21975 ill/5 225111111111.

x J l OSTOMY SEAL AND METHOD OF MAKING THE SAME BACKGROUND OF THE INVENTION Major operations of the ostomy type, namely, colostomies and ileostomies, are becoming more commonly performed principally to remove malignant or diseased tissue, thereby prolonging the lift of the patient and in many cases effecting a complete cure of the malignant or diseased condition. In such operations, a section of the intestine is removed and an opening is made in the abdominal wall of the patient so that waste material accumulating in the intestine may be discharged through a discharge opening called a stoma. The waste material is directed into a container, usually in the form of a flexible plastic bag, from which it may be emptied periodically. It is necessary that a liquidproof seal be maintained between the patients skin and a relatively stiff plastic retaining member which supports the bag, and which in turn is supported by a belt or other means on the patient, thereby to prevent leakage of the waste material onto the skin of the patient surrounding the stoma or even therebeyond. In addition to the odor which would result from such leakage, irritation of the skin of the patient surrounding the stoma is extremely likely under circumstances of leakage, and in ileostomy cases where the discharge is from the small intestine digestive liquids are still very active and can actually digest the skin of the patient if they come in contact therewith. Accordingly, there has been developed a soft, oleaginous seal containing karaya holding the bag in position, have exhibited tendencies to lose their shape by flattening out with a consequent impairment in their sealing capabilities and also with a reduction in the useful life of the seal. Furthermore, when karaya seals are stored for any period of time, the seals near the bottom of a stack of seals will occasionally become deformed due to the weight of the overlying material. In such cases the deformed seals may be unusable, or at least unsalable.

BRIEF SUMMARY OF THE INVENTION According to the present invention, a karaya seal which may be made in accordance with the teachings of said US. Pat. No. 3,302,647 is provided with a substantially nonstretchable backing. In its simple version, the backing may take the form of a sheet of flexible plastic material such as polyethylene. The backing, although made of flexible material, aids the karaya ring in holding its shape and thus inhibits the spreading or other deformation of the seal during actual use and also during transit and storage. In its preferred form, the back of the karaya ring is formed with a groove or other engaging portion, again covered by the film of flexible plastic material, with the groove forming an interference fit with a complementary receiving portion on the retainer forming a part of an ostomy bag. In accordance with the invention, the karaya ring may be formed by providing a mold having a contoured surface (to form the above-mentioned groove in the ring). A sheet of polyethylene is laid in the mold and heated somewhat so as to conform to the shape thereof, a second sheet of polyethylene is laid over the first, and a backing plate provided to close the upper face of the mold. Karaya ring forming material is then injected into.

the mold between the two sheets of plastic material.

Before removal from the mold, and in some cases before filling the form, the two sheets are heat sealed together around the inner and outer peripheries of the karaya ring, with the face sheet forming the aforementioned backing material and with the second sheet forming a removable covering for the front face of the seal, that is the face that is pressed against the skin of the patient.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an elevational view showing an ostomy bag in place on the body of a patient; 1

FIG. 2 is an enlarged view of the upper portion of FIG. 7 is an elevational view of the karaya ring and flexible sheets after the same have been withdrawn from the mold;

FIG. 8 is a view like FIG. 7 showing the peel off feature of the invention; and

FIG. 9 is a sectional view through a portion of an ostomy bag including the karaya ring of the present invention, showing the same in place on the body of a patient.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings, there is shown in FIGS. 1 and 2 an ostomy bag including a retainer 10 provided with a pair of integral projections 1 1 to which a belt 12 may be secured for holding the ostomy appliance in place on the body of a patient. The retainer 10 is provided with an annular seal-receiving portion 13 for receiving and retaining an annular seal of oleaginous material, preferably including karaya, said seal being indicated as 14. The seal is backed by a flexible plastic sheet 15 of substantially non-stretchable material, such as polyethylene, and covers the back portion of the seal including an engaging portion 16 formed in the seal, which engaging portion is complementary to the seal-receiving portion 13 to provide therebetween an interference fit for holding the sealing ring in place on the retaining member. An ostomy bag 17 of flexible soft plastic material is secured to the retainer 10 and is provided with a suitable opening surrounding the circular opening formed in the retainer.

From the foregoing it can be seen that the ostomy appliance, including the bag 17 and attached retainer 10, can be supplied with karaya seals simply by pressing the seal into position on the retainer so that the engaging portion 16 of the seal engages the seal-receiving portion 13 on the retainer. This interference fit helps hold the karaya seal in position while the patient is wearing the appliance. When so positioned, and even though the backing sheet 15 is of soft plastic film material, the seal is capable of maintaining its shape and hence its sealing ability under conditions of stress arising from use and heat. If desired, adhesive may be used to hold the karaya seal even more firmly to the retainer.

The preferred method of forming the seal of the present invention comprises an annular mold having an annular cavity 21 formed therein. The mold is made of stiff material, for example metal, and into the mold there is laid a sheet of flexible plastic material 15 which has a portion 15a bridging the center of the mold. For this purpose the mold or the sheet may be heated to enable the latter more closely to conform to the shape of the mold. A covering sheet 22 of similar plastic material is then laid over the mold 20 and a backing plate 23 placed thereon to complete the mold. A plastic tab 30 is heat-sealed to covering sheet 22. Sheet 15 and covering sheet 22 are heat-sealed together at 28 and 29 as shown in FIG. 6 after sheet 15 has been formed to confonn to the annular cavity 21 in the mold 20. Oleaginous material to form the sealing ring is then injected by perforating the covering sheet 22 or through opening 24 formed therein, by means of an injector nozzle 25. As clearly seen from the drawings, the karaya seal material when injected conforms to the shape of the mold and is completely enclosed between the covering sheet 22 and the sheet 15, where it sets and becomes firm. The effect of heat sealing is akin to die cutting the material as the excess portion can readily be removed, including the bridging portion 15a and the portion 27 which extends beyond the outer extremity of the karaya ring. Since the heat sealing operation acts something like die cutting, the annular remaining portion of the covering sheet 22 may be stripped off as illustrated in FIG. 8 simply by pulling on the free end 31 of the tab 30. This latter operation, of course, occurs after the seal has been pressed or glued into position on the retainer, as illustrated in FIG. 3, and before applying the same to the skin of the patient as illustrated in 'FIG. 9.

I claim:

1. A seal adapted to be used in combination with an ostomy bag secured to a retainer with said retainer having an opening therein to surround the stoma of an ostomy patient, there being an annular contoured locating element formed around the periphery of said opening, said seal comprising a ring of gelatinous material, said ring having an annular portion on one face thereof shaped complementary to said annular contoured locating element, a sheet of flexible substantially nonstretchable material covering said face of said ring, a second sheet of flexible substantially non-stretchable material covering the other face of said ring, said sheets being heat sealed together around the inner and outer peripheries of said ring, and a pull tab having one end free and having its other end heat sealed to said second sheet whereby said second sheet may be removed from the ring by pulling on said tab.

2. A seal adapted to be used in combination with an ostomy bag secured to a retainer with said retainer having an opening therein to surround the stoma of an ostomy patient, there being an annular rib formed around the periphery of said opening, said seal comprising a ring of gelatinous material containing karaya, said ring having an annular groove on one face thereof complementary to said annular rib, a sheet of flexible substantially non-stretchable material covering said face of said ring, a second sheet of flexible substantially nonstretchable material covering the other face of said ring, said sheets being heat sealed together around the inner and outer peripheries of said ring, and a pull tab having one end free and having its other end heat sealed to said second sheet whereby said second sheet may be removed from the ring by pulling on said tab.

Claims (2)

1. A seal adapted to be used in combination with an ostomy bag secured to a retainer with said retainer having an opening therein to surround the stoma of an ostomy patient, there being an annular contoured locating element formed around the periphery of said opening, said seal comprising a ring of gelatinous material, said ring having an annular portion on one face thereof shaped complementary to said annular contoured locating element, a sheet of flexible substantially non-stretchable material covering said face of said ring, a second sheet of flexible substantially non-stretchable material covering the other face of said ring, said sheets being heat sealed together around the inner and outer peripheries of said ring, and a pull tab having one end free and having its other end heat sealed to said second sheet whereby said second sheet may be removed from the ring by pulling on said tab.
2. A seal adapted to be used in combination with an ostomy bag secured to a retainer with said retainer having an opening therein to surround the stoma of an ostomy patient, there being an annular rib formed around the periphery of said opening, said seal comprising a ring of gelatinous material containing karaya, said ring having an annular groove on one face thereof complementary to said annular rib, a sheet of flexible substantially non-stretchable material covering said face of said ring, a second sheet of flexible substantially non-stretchable material covering the other face of said ring, said sheets being heat sealed together around the inner and outer peripheries of said ring, and a pull tab having one end Free and having its other end heat sealed to said second sheet whereby said second sheet may be removed from the ring by pulling on said tab.
US3898990A 1973-01-31 1973-01-31 Ostomy seal and method of making the same Expired - Lifetime US3898990A (en)

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Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4078567A (en) * 1976-03-03 1978-03-14 Marlen Manufacturing And Development Co. Ileostomy pouch and mounting arrangement therefor
US4095599A (en) * 1976-02-18 1978-06-20 Laboratoires Biotrol Societe Anonyme Device for collecting body excretions and method of using same
US4319571A (en) * 1979-03-01 1982-03-16 General Motors Corporation Ostomy appliance
US4326521A (en) * 1976-11-11 1982-04-27 Marsan Arthur E Appliance for the treatment of colostomy and the like
US4573984A (en) * 1982-12-11 1986-03-04 Benzies George Y Waste retaining receptacles for patients with colostomies and ileostomies
US4786285A (en) * 1986-12-18 1988-11-22 Hollister Incorporated Ostomy appliance and coupling ring assembly therefor
US5004464A (en) * 1989-08-28 1991-04-02 E.R. Squibb & Sons Convex adapter for ostomy device
EP0503029A1 (en) * 1990-10-01 1992-09-16 Jensen Ole R Wound dressing having a countoured adhesive layer.
US5496296A (en) * 1994-06-06 1996-03-05 Dansac A/S Ostomy appliance with extrudable gasket
WO1998055057A1 (en) * 1997-06-04 1998-12-10 Coloplast A/S An ostomy appliance
US6569134B1 (en) * 2000-06-14 2003-05-27 Hollister Incorporated Reformable convex adapter for ostomy appliance and method of use
US20040026821A1 (en) * 2001-06-16 2004-02-12 Joon-Suk Chae Method of manufacturing an abdominal belt and mould
US6740067B2 (en) 2000-06-14 2004-05-25 Hollister Incorporated Reformable convex adapter for ostomy appliance
US7540861B1 (en) 2005-02-28 2009-06-02 Voto Albert J Wafer retaining belt for a colostomy bag
US20090148661A1 (en) * 2006-05-24 2009-06-11 Esben Stroebech Layered adhesive construction useful for attaching a collecting bag or collecting device to the perianal area
US20100114044A1 (en) * 2007-04-09 2010-05-06 Cramer Kathryn E Adhesive body fitment for ostomy appliane
US20100324511A1 (en) * 2009-06-17 2010-12-23 Hollister Incorporated Ostomy faceplate having moldable adhesive wafer with diminishing surface undulations
US20110118684A1 (en) * 2008-07-16 2011-05-19 Convatec Technologies Inc. Adhesive ostomy coupling
US20130035654A1 (en) * 2011-08-03 2013-02-07 Hollister Incorporated Ostomy appliance with integrated belt tabs
US20170181885A1 (en) * 2014-05-08 2017-06-29 Nu-Hope Laboratories, Inc. Ostomy pouch support kit, system and method

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2746456A (en) * 1955-01-31 1956-05-22 Camillis Amilcare De Colostomy devices
US2914068A (en) * 1958-02-11 1959-11-24 Elmer C Schacht Colostomy device
US3351061A (en) * 1965-03-08 1967-11-07 Hollister Inc Drainage pouch for post-surgical use
US3520301A (en) * 1966-05-12 1970-07-14 Leonard Fenton Stomatic appliance
US3612053A (en) * 1969-06-23 1971-10-12 Minnesota Mining & Mfg Ostomy sealing washer
US3667469A (en) * 1969-12-15 1972-06-06 Arthur E Marsan Post-surgical drainage pouch
US3712304A (en) * 1970-11-17 1973-01-23 A Marsan Starch seal and appliance for ostomy
US3713445A (en) * 1971-01-27 1973-01-30 A Marsan Sealing ring or pad for a post surgical drainage pouch

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2746456A (en) * 1955-01-31 1956-05-22 Camillis Amilcare De Colostomy devices
US2914068A (en) * 1958-02-11 1959-11-24 Elmer C Schacht Colostomy device
US3351061A (en) * 1965-03-08 1967-11-07 Hollister Inc Drainage pouch for post-surgical use
US3520301A (en) * 1966-05-12 1970-07-14 Leonard Fenton Stomatic appliance
US3612053A (en) * 1969-06-23 1971-10-12 Minnesota Mining & Mfg Ostomy sealing washer
US3667469A (en) * 1969-12-15 1972-06-06 Arthur E Marsan Post-surgical drainage pouch
US3712304A (en) * 1970-11-17 1973-01-23 A Marsan Starch seal and appliance for ostomy
US3713445A (en) * 1971-01-27 1973-01-30 A Marsan Sealing ring or pad for a post surgical drainage pouch

Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4095599A (en) * 1976-02-18 1978-06-20 Laboratoires Biotrol Societe Anonyme Device for collecting body excretions and method of using same
US4078567A (en) * 1976-03-03 1978-03-14 Marlen Manufacturing And Development Co. Ileostomy pouch and mounting arrangement therefor
US4326521A (en) * 1976-11-11 1982-04-27 Marsan Arthur E Appliance for the treatment of colostomy and the like
US4319571A (en) * 1979-03-01 1982-03-16 General Motors Corporation Ostomy appliance
US4573984A (en) * 1982-12-11 1986-03-04 Benzies George Y Waste retaining receptacles for patients with colostomies and ileostomies
US4786285A (en) * 1986-12-18 1988-11-22 Hollister Incorporated Ostomy appliance and coupling ring assembly therefor
US5004464A (en) * 1989-08-28 1991-04-02 E.R. Squibb & Sons Convex adapter for ostomy device
EP0503029A1 (en) * 1990-10-01 1992-09-16 Jensen Ole R Wound dressing having a countoured adhesive layer.
EP0503029A4 (en) * 1990-10-01 1993-04-28 Ole Roger Jensen Wound dressing having a countoured adhesive layer
US5496296A (en) * 1994-06-06 1996-03-05 Dansac A/S Ostomy appliance with extrudable gasket
WO1998055057A1 (en) * 1997-06-04 1998-12-10 Coloplast A/S An ostomy appliance
US6569134B1 (en) * 2000-06-14 2003-05-27 Hollister Incorporated Reformable convex adapter for ostomy appliance and method of use
US6740067B2 (en) 2000-06-14 2004-05-25 Hollister Incorporated Reformable convex adapter for ostomy appliance
US20040026821A1 (en) * 2001-06-16 2004-02-12 Joon-Suk Chae Method of manufacturing an abdominal belt and mould
US7540861B1 (en) 2005-02-28 2009-06-02 Voto Albert J Wafer retaining belt for a colostomy bag
US20090148661A1 (en) * 2006-05-24 2009-06-11 Esben Stroebech Layered adhesive construction useful for attaching a collecting bag or collecting device to the perianal area
US7862878B2 (en) * 2006-05-24 2011-01-04 Coloplast A/S Layered adhesive construction useful for attaching a collecting bag or collecting device to the perianal area
US20100114044A1 (en) * 2007-04-09 2010-05-06 Cramer Kathryn E Adhesive body fitment for ostomy appliane
US20110118684A1 (en) * 2008-07-16 2011-05-19 Convatec Technologies Inc. Adhesive ostomy coupling
US20100324511A1 (en) * 2009-06-17 2010-12-23 Hollister Incorporated Ostomy faceplate having moldable adhesive wafer with diminishing surface undulations
US8211073B2 (en) * 2009-06-17 2012-07-03 Hollister Incorporated Ostomy faceplate having moldable adhesive wafer with diminishing surface undulations
US20130035654A1 (en) * 2011-08-03 2013-02-07 Hollister Incorporated Ostomy appliance with integrated belt tabs
US8945076B2 (en) * 2011-08-03 2015-02-03 Hollister Incorporated Ostomy appliance with integrated belt tabs
US20170181885A1 (en) * 2014-05-08 2017-06-29 Nu-Hope Laboratories, Inc. Ostomy pouch support kit, system and method

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