US3762412A - Drainage bag holder shield and method - Google Patents

Abstract

Reusable drainage bag holder shields are disclosed which have a novel generally oval-shaped configuration and are made of flexible molded materials which are resistant to body secretions and will not deform after extended body contact or cleaning to provide a highly effective support for a removable-type drainage bag and afford improved wearer comfort.

Description

United States Patent [191 Frank 1 Oct. 2, 1973 1 DRAINAGE BAG HOLDER SHIELD AND METHOD [76] Inventor: Mathilda C. Frank, 1800 E. 84th Ave., Denver, Colo. 80229 [22] Filed: May 20, 1971 [21] Appl. No.: 145,386

[52] US. Cl. 128/283 [51] Int. Cl. A6lf 5/44 [58] Field of Search 128/283 [56] References Cited UNITED STATES PATENTS 2,524,750 10/1950 Bellinger 128/283 3,074,404

1/1963 Robinson 128/283 3,373,745 3/1968 Benfield et a1 128/283 3,528,420 9/1970 Nielsen 128/283 3,557,790 1/1971 Hauser 128/283 3,618,606 11/1971 Brown et a1. 128/283 Primary Examiner-Charles F. Rosenbaum Attorney-Reilly & Lewis [57] ABSTRACT Reusable drainage bag holder shields are disclosed which have a novel generally oval-shaped configuration and are made of flexible molded materials which are resistant to body secretions and will not deform after extended body contact or cleaning to provide a highly effective support for a removable-type drainage bag and afford improved wearer comfort.

9 Claims, 6 Drawing Figures PATENTED 21973 3 762,412

.11 llll lllllhlllLd 'IIIIA 28 INVENTOR M QTH J LDA c. FRANK Jul L'aHY-A TORNEYS DRAINAGE BAG HOLDER SHIELD AND METHOD BACKGROUND OF THE INVENTION 1. Field This invention in general relates to medical appliances and more particularly tonovel and improved bag holder shields for supporting drainage bags applied to a patient following certain surgical procedures.

2. Description of the Prior Art Following certain surgical procedures it is necessary to mount a disposable drainage bag on the body of a patient to receive draining body fluids via the stoma which extends through the outer wall of the abdomen. Appliances of this type may also be used for fistulas and all body drainage due to injuries or tumors. It is also highly desirable to provide an effective. airtight seal between the body and the bag holder shield and between the stoma and the bag holder shield to prevent the release of undesirable odors. The portion of the shield which engages the skin and stoma can cause great discomfort if it does not flex properly. At the same time a degree of rigidity is required to support the depending bag. For some patients such as those which are obese a greater degree of rigidity is required to hold the bag. For other patients a greater degree of softness is required. A number of approaches have heretofore been used to secure a drainage bag to the body of a patient and many attempts have been made to minimize the discomfort to the wearer and provide ease of removal and replacement of both the shield and bag. In the past a wide variety of structural configurations and materials have been attempted for making up the bag holder shield but as yet they have not been entirely satisfactory for all patients. Accordingly, it is an object of this invention to provide novel and improved bag holder shields which overcome many of the above-mentioned deficiencies in the prior art to make them suitable for a wider range of surgical appliances and patients.

Another object of this invention is to provide novel and improved bag holder shields having an improved configuration and made of molded flexible materials which afford improved results in wearer comfort, do not irritate the skin, prevent injury to the stoma or other drainage tube of the wearer, and are highly effective in supporting of a drainage bag.

Yet another object of this invention is to provide a novel bag holder shield which is resistant to weak acids found in body secretions, resistant to oils and will not swell ordeform after extended body contact or cleaning with hydrocarbon solvents or the like.

Still another object of this invention is to provide a novel bag holder shield which is readily secured on the skin of the patient and may be removed and replaced so that it may be reused many times.

SUMMARY OF THE INVENTION In accordance with the present invention in the preferred embodiments shown there is provided a bag holder shield of a symmetrically balanced, generally oval-shaped configuration made of a relatively soft, compression-molded thermoplastic resin which has a sufficient degree of rigidity to enable use by more obese patients; and in another form there is provided a shield of a similar configuration made of a relatively soft, transfer-molded thermosetting elastomeric material which is suitable for more average patients and has a greater degree of softness. Each of these shields are in the form of an integral member made entirely of the same flexible molded material throughout having a relatively thin flat base section with a smooth flat undersurface adapted to be placed over and secured to the skin and conform to the contour of the wearers body. The base section includes a generally circular central portion and tapered end portions. The integral member is made to be symmetrical about both the major and minor axes of the oval shape and terminates in generally rounded outer edges. A central flange section projects outwardly from the central portion of the base section and is arranged concentrically thereof to provide an area of greatest thickness outwardly around the center of the integral member. The flange section has a concave peripheral edge and a dished outer face which progressively decreases in cross section toward the center. The center portion is formed by a relatively thin section in which an opening may be cut to size to receive the stoma for each particular patient or formed with a small opening which may be cut to a larger size. The outer end portions of the body are provided with loops through which the ends of a support belt extend and are secured to provide support for the shield on the wearer.

Other objects, advantages and capabilities of the present invention will become more apparent as the description proceeds taken in conjunction with the accompanying drawings in which:

FIG. 1 is a top plan view of one form of bag holder shield embodying features of the present invention;

FIG. 2 is an end elevation view of the bag holder shield shown in FIG. 1;

FIG. 3 is a vertical sectional view of the bag holder shield taken along lines 3-3 of FIG.'1 and further illustrated as secured to a patient and having a drainage bag affixed thereto and shown as having a stoma of the body extending therethrough;

FIG. 4 is a top plan view of another form of bag holder shield embodying features of the present invention;

FIG. 5 is an end elevation view of the shield shown in FIG. 4; and

FIG. 6 is a side elevation view of the shield shown in FIG. 4.

DESCRIPTION OF PREFERRED EMBODIMENTS Referring now to the drawings, in FIGS. 1-3 there is shown one form of bag holder shield made as an integral member 11 entirely of a compression-molded, thermoplastic resin described in more detail hereinafter. The shield is generally oval-shaped and includes a relatively thin, flat base section 12 and a smooth flat undersurface 12a adapted to be placed over the body of the wearer and conform to the curvature thereof. The base section 12 includes a generally circular, wider central portion 12b and a pair of outwardly converging ear-like narrower end portions which terminate in generally rounded outer edges 13. The shield is constructed to be symmetrical about both the major and minor axes of the oval shape. The shield also includes a central flanged section 15 projecting outwardly from the base section and arranged concentrically with the center thereof to provide a bag-supporting annulus of maximum thickness surrounding and outwardly spaced from the center of the member. The flanged section annulus has an overhanging lip portion 15a and a concave peripheral edge 15b and is also shaped with a straight flat outer portion 15c parallel to the bottom surface 12a, an inwardly extending dished outer portion 15d which converges toward the center of the member and terminates in a flat, central portion 16 of minimum thickness. The shield member also has an inwardly extending step 17 in the undersurface between the center and outer edge of the body which further reduces the thickness of the central portion 16.

In the use of the shield a hole is cut ofa desired diameter for a particular patient in the central portion 16 through which a stoma 18 from the wearers body is passed to discharge body fluids into the supported bag 27. The stoma is a portion of the bowel brought through an outer wall of the abdomen by the surgeon. The bag holder shield and associated bag or pouch 27 act as an external collecting device to collect urine or feces. The shield is also used for fistulas and all body drains due to injuries or tumors. A U-shaped portion 19 is provided with an outer surface of each end portion to provide a loop which the ends of a support belt may extend to further secure the shield to the body of the patient.

The shield 11 is molded as a one-piece integral unit or body made of arelatively soft thermoplastic resin which affords a highly desirable degree of flexibility to conform to the contour of the body and prevent injury to the stoma, adequate-rigidity and sufficient softness for maximum comfort to the wearer. The shield flexes at the ends so as to be readily removed and reused and the annulus is sufficiently thick to afford an adequate support for the depending drainage bag. The central portion 16 can be cut to the desired size to fit the stoma of each individual patient.

The typical physical properties of the shield shown in FIGS. l-3 are in the range of about:

Durometer3244 Shore A, (38 Shore A nominal) Tensile-1440 psi-l 575 psi Elongation-540-660% Tensile Modulus 0.02 X 10 psi 0.12 X psi The above values are taken using the ASTM Standard No. 638.

As represented in FIG. 3, the above-described shield may be attached to the skin 20 of a patient by first making a center aperture in portion 16 through which the stoma 18 will extend and of a size so that the walls defining the aperture engage the sides of the stoma. A

layer of medicament such as karaya powder represented at 21 is applied directly to the skin 20 and a liquid seal coating is applied over the medicament which dries to form a flexible film base 22. A coat of rubberbase adhesive is then applied to the base 22 to form an adhesive layer 23. The undersurface of the shield 11 is precoated with the liquid seal coating to form a layer 24. The details of the liquid seal coating and the procedure to secure the shield to the body are described in more detail in a copending application entitled FLEXI- BLE FILM-FORMING LIQUID AND METHOD FOR APPLYING SURGICAL APPLIANCES.

An alternative form of bag holder shield shown in FIGS. 4-6 is also formed as an integral or one-piece member 31 but this form is made entirely of a thermosetting elastomeric, non-plastic, transfer-molded flexible material. The shield includes a relatively thin, flat, flexible base section 32 with a smooth flat undersurface 32a to be placed over the body of the patient and conform to the curvature thereof. The base section includes a generally circular central portion 32b and a pair of outwardly converging narrower ear-like end portions 32c on each side of the central portion and terminate in generally rounded outer edges 33. The shield is generally oval-shaped and symmetrically balanced about both the major and minor axes thereof. The shield also includes a central flanged section 35 projecting forwardly and outwardly from the base section and arranged concentric to the center thereof to provide a bag-supporting annulus of maximum thickness surrounding and outwardly spaced from the center thereof. The flanged section has an overhanging lip 35a and an outer concave peripheral edge 35b adapted to receive the end of the bag together with a flat outer section parallel to the undersurface and a dished outer portion 350 which inwardly converges toward the center of the body and terminates in a flat portion 35d of minimum thickness surrounding a central opening 36. The central opening is small enough so that it may be cut to the required stoma size. A U-shaped portion 39 is provided on the outer surface of each end portion to form a loop through which the ends of the support belt extend to further support the shield on the body of a wearer.

The bag holder shield 31 is secured to the patients body in the same manner as that above described in FIGS. 1-3. The shield of this arrangement is molded as a one-piece integral body of a material somewhat softer and less rigid than that of FIGS. 1 through 3 and affords use more by patients that are not obese and require less rigidity and greater softness. The material used for this shield is a homogeneous blend of: (1) A polymer or polymers such as a blend of Nitrile Rubber and Polyvinyl Chloride (PVC). This blend is well suited because ofits resistance to weak acids found in body secretions. It is also very resistant to oils and will not swell or deform after extended body contact or cleaning with hydrocarbon solvents. (2) Inert fillers such as Barium Sulfate and Silica which are added to control the hardness; and (3) Organic Accelerators and sulfur used to control the time and temperature of the molding.

The typical physical properties of the shield shown in FIGS. 4-6 are in the range of about:

Durometer-7O Shore A Tensile-l360 psi-1660 psi Elongation540660% Modulus-775 psi-865 psi The material which exhibits these characteristics and found suitable for this configuration is presently being made by the US. Industrial Chemicals and identified under code UE-636. The above described materials so far as known have not heretofore been used to provide a bag-supporting shield on the body of a patient and are therefore believed to constitute a new use thereof.

Although the present invention has been described with a certain degree of particularity, it is understood that the present disclosure has been made by way of example and tha changes in details of structure may be made without departing from the spirit thereof.

What is claimed is:

l. A drainage bag holder shield adapted to be positioned on the body of a wearer and pass a drainage tube therethrough, said shield comprising an integral member composed of a flexible relatively soft material resistant to weak acids found in body secretions, resistant to oils and which will not deform after extended body contact, said member having a thin flat base section and a relatively thick, upstanding flange section diverging outwardly from the base section on the side opposite to that side of the base adapted to contact the body of the wearer, said flange section defining an outwardly divergent'support annulus terminating in an outer peripheral lip portion adapted to engage the open end of a drainage bag, the outer face of said flange section being concave in cross-section and said flange section progressively decreasing in thickness toward the center thereof, the center thereof substantially corresponding in thickness to that of said base section and provided with a hole to receive a drainage tube passing from the body of the wearer,

2. A drainage bag holder shield as set forth in claim 1 wherein said material forming the integral member is a thermoplastic resin.

3. A drainage bag holder shield as set forth in claim 1 wherein said material forming the integral member is a thermosetting elastomeric material exhibiting a relatively high degree of softness and flexibility.

4. A drainage bag holder as set forth in claim 3 wherein said material includes a blend of nitrile rubber and polyvinyl chloride.

5. A drainage bag holder shield as set forth in'claim 1 wherein the integral member is made of a material having a durometer reading in the range of 60-70 Shore A, a tensile strength in the range of 1360 psi- 1660 psi, an elongation in the range of 54 O 660 percent and a modulus in the range of775 psi865 psi.

6. A drainage bag holder shield as set forth in claim 1 wherein the integral member is made of a material having a durometer reading in the range of 32-44 Shore A, a tensile strength in the range of 1440 psi-b 1575 psi, an elongation in the range of 540-660 percent and a tensile modulus in the range of 0.02 X psi 0.12 X10 psi.

7. A drainage bag holder shield adapted to be positioned over the body of a wearer thereof comprising an integral member composed of a flexible, relatively soft, molded material resistant to weak acids found in body secretions, which is resistant to oils and will not swell or deform after extended body contact, said member having a relatively thin, generally oval-shaped base section with a smooth flat undersurface adapted to be placed over the body of the wearer and conform to the curvature thereof, said base section having a central portion and a pair of outwardly disposed ear-like end portions, a generally circular flange section diverging outwardly from the center of said base section and arranged concentrically with the center thereof to provide a centrally disposed, generally dish-shaped support annulus surrounding the center of the base section, said flange section terminating in an outer peripheral lip and a peripheral groove under the lip adapted to receive an open end of a drainage bag, and the center of the member spaced outwardly of the plane of said base section to form a recessed portion thereunder with a central opening therein sized to receive and flexibly embrace a drainage tube from the body of the wearer,

said outer end portions having means through which the ends of a support belt extend to further support the shield on the wearer.

8. A drainage bag holder shield adapted to be positioned over the body of a wearer thereof comprising a generally oval-shaped, relatively thin flexible base section provided with a smooth flat undersurface adapted to be placed over the body of the wearer and conform,

to the curvature thereof, said base section having a central portion and a pair of outwardly converging ear-like end portions, each said end portion terminating in a generally rounded outer edge, a relatively thick, inflexible central flange section diverging outwardly from said central portion and arranged concentrically with the center of said base section to define a centrally disposed support annulus of maximum thickness surrounding and outwardly spaced from the center thereof, said flange section having an outer peripheral lip and a peripheral groove surface under the lip adapted to receive an open end of a drainage bag, the outer face of said flange section being concave in crosssection and said flange section progressively decreasing in thickness toward the center thereof, the center thereof substantially corresponding in thickness to that of said base section and provided with a hole to receive a drainage tube from the body of the wearer, said outer end portions having means for receiving the ends of a support belt to support the shield on the body of the wearer.

9. A drainage bag holder shield adapted to be positioned over the body of a wearer thereof comprising a generally oval shaped, relatively thin flexible base section provided with a smooth flat undersurface adapted to be placed over the body of the wearer and conform to the curvature thereof, said base section having a central portion and a pair of outwardly converging ear-like end portions, each said end portion terminating in a generally rounded outer edge, a relatively thick, inflexible central flange section diverging outwardly from said central portion and arranged concentrically with the center of said base section to define a centrally disposed support annulus of maximum thickness surrounding and outwardly spaced from the center thereof, said flange section having an outer peripheral lip and a peripheral groove surface under the lip adapted to receive an open end of a drainage bag, said flange section progressively decreasing in thickness to that of said base section, said central portion spaced outwardly of the plane of said base section to form a recessed portion thereunder with a central opening through said central portion sized to receive and embrace a drainage tube from the body of the wearer, said outer end portions having generally inverted U-shaped members secured thereto for receiving the ends of a support belt in order to support the shield on the body of the wearer.

22 3 I UNITED STATES PATENT OFF-ICE v CERTIFICATE OF CORRECTION Patent No.3,762,412 Dated 2 October 1973 Inventor(s) Mathilda C. Frank It is certified 'that error appears in the above-identified parent and that said Letters Patent are hereby corrected as shown below:

In the Technical Disclosure:

Column 3, line 20, after "loop" insert through Column 4, line 57, cancel "tha" and substitute that-r- In the Claims:

Claim 6, line 132, cancel "psi-b" and substitute, psi- Sirzned and sealed this l th day of June 19714.. I

(SEAL) Attest:

EDWARD MRLETCHER,JR. C. MARSHALL DANN Attestin Officer Commissioner of Patents

Claims (9)

1. A drainage bag holder shield adapted to be positioned on the body of a wearer and pass a drainage tube therethrough, said shield comprising an integral member composed of a flexible relatively soft material resistant to weak acids found in body secretions, resistant to oils and which will not deform after extended body contact, said member having a thin flat base section and a relatively thick, upstanding flange section diverging outwardly from the base section on the side opposite to that side of the base adapted to contact the body of the wearer, said flange section defining an outwardly divergent support annulus terminating in an outer peripheral lip portion adapted to engage the open end of a drainage bag, the outer face of said flange section being concave in cross-section and said flange section progressively decreasing in thickness toward the center thereof, the center thereof substantially corresponding in thickness to that of said base section and provided with a hole to receive a drainage tube passing from the body of the wearer.

2. A drainage bag holder shield as set forth in claim 1 wherein said material forming the integral member is a thermoplastic resin.

3. A drainage bag holder shield as set forth in claim 1 wherein said material forming the integral member is a thermosetting elastomeric material exhibiting a relatively high degree of softness and flexibility.

4. A drainage bag holder as set forth in claim 3 wherein said material includes a blend of nitrile rubber and polyvinyl chloride.

5. A drainage bag holder shield as set forth in claim 1 wherein the integral member is made of a material having a durometer reading in the range of 60-70 Shore A, a tensile strength in the range of 1360 psi-1660 psi, An elongation in the range of 540-660 percent and a modulus in the range of 775 psi-865 psi.

6. A drainage bag holder shield as set forth in claim 1 wherein the integral member is made of a material having a durometer reading in the range of 32-44 Shore A, a tensile strength in the range of 1440 psi-b 1575 psi, an elongation in the range of 540-660 percent and a tensile modulus in the range of 0.02 X 105 psi - 0.12 X 105 psi.

7. A drainage bag holder shield adapted to be positioned over the body of a wearer thereof comprising an integral member composed of a flexible, relatively soft, molded material resistant to weak acids found in body secretions, which is resistant to oils and will not swell or deform after extended body contact, said member having a relatively thin, generally oval-shaped base section with a smooth flat undersurface adapted to be placed over the body of the wearer and conform to the curvature thereof, said base section having a central portion and a pair of outwardly disposed ear-like end portions, a generally circular flange section diverging outwardly from the center of said base section and arranged concentrically with the center thereof to provide a centrally disposed, generally dish-shaped support annulus surrounding the center of the base section, said flange section terminating in an outer peripheral lip and a peripheral groove under the lip adapted to receive an open end of a drainage bag, and the center of the member spaced outwardly of the plane of said base section to form a recessed portion thereunder with a central opening therein sized to receive and flexibly embrace a drainage tube from the body of the wearer, said outer end portions having means through which the ends of a support belt extend to further support the shield on the wearer.

8. A drainage bag holder shield adapted to be positioned over the body of a wearer thereof comprising a generally oval-shaped, relatively thin flexible base section provided with a smooth flat undersurface adapted to be placed over the body of the wearer and conform to the curvature thereof, said base section having a central portion and a pair of outwardly converging ear-like end portions, each said end portion terminating in a generally rounded outer edge, a relatively thick, inflexible central flange section diverging outwardly from said central portion and arranged concentrically with the center of said base section to define a centrally disposed support annulus of maximum thickness surrounding and outwardly spaced from the center thereof, said flange section having an outer peripheral lip and a peripheral groove surface under the lip adapted to receive an open end of a drainage bag, the outer face of said flange section being concave in cross-section and said flange section progressively decreasing in thickness toward the center thereof, the center thereof substantially corresponding in thickness to that of said base section and provided with a hole to receive a drainage tube from the body of the wearer, said outer end portions having means for receiving the ends of a support belt to support the shield on the body of the wearer.

9. A drainage bag holder shield adapted to be positioned over the body of a wearer thereof comprising a generally oval shaped, relatively thin flexible base section provided with a smooth flat undersurface adapted to be placed over the body of the wearer and conform to the curvature thereof, said base section having a central portion and a pair of outwardly converging ear-like end portions, each said end portion terminating in a generally rounded outer edge, a relatively thick, inflexible central flange section diverging outwardly from said central portion and arranged concentrically with the center of said base section to define a centrally disposed support annulus of maximum thickness surrounding and outwardly spaced from the center thereof, said flange section having an outer peripheral lip and a periPheral groove surface under the lip adapted to receive an open end of a drainage bag, said flange section progressively decreasing in thickness to that of said base section, said central portion spaced outwardly of the plane of said base section to form a recessed portion thereunder with a central opening through said central portion sized to receive and embrace a drainage tube from the body of the wearer, said outer end portions having generally inverted U-shaped members secured thereto for receiving the ends of a support belt in order to support the shield on the body of the wearer.

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