US 3302647 A
Description (OCR text may contain errors)
A. E. MARSAN 3,302,647
SEALING PAD FOR A POST-SURGICAL DRAINAGE POUCH Feb. 7, 1967 Filed March 5, 1964 smart? Fatented Feb. 7, i967 lire - ICAL This invention relates to surgical devices and more particularly to a sealing means for use with a drainage pouch.
This invention is concerned with an improved sealing means for use with surgical drainage pouches. Certain abdominal surgery, such as those known as a colostomy, ileostomy, ureter-ostomy and the like result in an opening in the abdominal wall which permits drainage from the interior of the abdominal cavity. The patient cannot control the drainage and therefore drainage appliances in the form of a pouch or bag, such as those disclosed in the aforementioned patents, are used to contain the drainage.
Often the body drainage contains fluids which irritate and which are harmful to the external body tissues. To heal the excoriated skin, various methods have been used including salves, ointments and powders. One well known healing means is karaya powder. Previously, this was usually applied *by moistenin-g the skin with water and sprinkling the karaya thereon to build up a protective layer over the irritated skin. Rubber cement was then applied over the karaya layer as well as to the opening in the drainage pouch. The pouch then was pressed against the rubber cement coated karaya surface in an attempt to form a liquid-tight seal. This procedure usually took a great deal of time and skill and many times the seal was not adequate to prevent leakage and skin irritation.
It is therefore a general object of this invention to provide a new and improved sealing means for use with a surgical drainage pouch.
It is a primary object of this invention to provide a new pre-formed sealing pad of medicinal compounds for use with a post-surgical drainage pouch.
It is another object of this invention to provide a new pre-formed elastic gasket of medicinal compounds for forming a leakproof seal with a post-surgical drainage pouch.
It is a more specific object of this invention to provide a new and improved pre-forrned gasket of a karaya base which may be used with a post-surgical drainage pouch to form a medicinal liquid-tight seal therewith.
Other objects, features and advantages of the present invention will be apparent from the following description of the preferred embodiment illustrated in the accompanying drawings, in which:
FIGURE 1 is a fragmentary View of the abdominal section of the human torso showing a post-surgical drainage pouch in use;
FIGURE 2 is a fragmentary enlarged view of the surgical pouch shown in FIGURE 1;
FIGURE 3 is a ection view taken along the line 3-3 of FIGURE 2;
FIGURE 4 is a section view taken along the line 4-4 of FIGURE 2;
FIGURE 5 is a section view taken along the line 5-5 of FIGURE 2;
FIGURE 6 is a fragmentary section view of a drainage pouch similar to that shown in FIGURE 2 but being provided with a smaller opening therein;
FIGURE 7 is a section view taken along the line 77 of FIGURE 6; and
FIGURE 8 is a section view taken along the line 8-8 of FIGURE 6.
While I have shown and described certain embodiments of my invention, it is to :be understood that it is capable of many modifications. Changes, therefore, in the construction and arrangement may be made without departing from the spirit and scope of my invention as set out in the appended claims.
Referring now to the drawings, in FIGURE 1 there is shown a post-surgical drainage pouch or bag 10 secured to the torso 12 by means of a belt 14. The bag 10 is provided with a retainer portion 15 and is sealed to the torso with the aid of the medicinal sealing pad or gasket 16 of this invention.
The drainage pouch It is provided with a back and front panel 13 and 19, respectively, and is sealed about the edges thereof, such as at the top and bottom Zlla and 2%, respectively, and the two sides 29c and Ztld. The pouch is preferably made of a well known sheet-like plastic waterproof. material. A centrally disposed stoma opening 22 is provided in the back panel 18 near the top of the pouch.
The retainer portion 15 is of relatively stiff, hard material and is secured to the back panel 18 of the pouch 10 in the opening 22 by suitable means, such as heat sealing or the like. The retainer is similarly provided with an opening 23 in registry with the opening 22. Two laterally projecting ears 24 and 25 are provided with notches, such as 26 and 27, respectively, which receive locking pins 28 and 29 secured to the ends of the belt 14 for removably fastening the pouch to the belt. The belt may be made of elastic material to facilitate fastening of the retainer and securement of the drainage back to the body 12.
FIGURES 6-8 illustrate a bag having a smaller stoma opening 22a and a smaller retainer means 16a used to secure the bag. Retaining means 15a is similarly secured within the hole 22a as well as at portions 21 behind the laterally projecting ears 24a and 25a by suitable means, such as heat sealing. The cars 24a and 2512 are similarly provided with notches 26a and 27a, respectively, to receive pins 28 and 29 at the ends of the belt '14 to secure the pouch to the belt.
The medicinal sealing pad or gasket 16 of this invention is a semisolid gelatinous, fiat, donut-shaped ring having an external arcuate periphery 32. and a centrally disposed internal opening 33 of a size to be telescoped on a protruding stoma 36 and adapted for registration with the openings 22 and 23 to permit drainage of. fluid from the body cavity through the stoma to the pouch. Preferably, the outer diameter of the pad 16 is slightly larger than the drainage opening of the pouch, and the inner diameter is slightly smaller than the pouch and the retaining means.
The pad is formed of a mixture of a nonevaporative oleaginous liquid carrier and a healing powder miscible with the carrier which forms a gel when mixed in sufiicient quantity with the carrier. In the preferred embodiment, karaya powder, a well known healing powder, is mixed with glycerol. A suitable mixture of karaya and glycerol may be at least 33% karaya to 67% glycerol and as much as 50% karaya and as much as 50% glycerol. The more glycerol used, the softer or less solid the ring formed. With the addition of heat in the order of 200300 F. the gel time is shortened.
Karaya and glycerol gel is relatively viscous so that in forming the sealing ring of this invention an open face dished mold with a centrally upstanding boss can be used. Preferably, the inside of the mold (that portion which will contact the mixture) is precoated with a suitable wax or oil, such as parafiin in a hexane solution. After the application, the hexane will evaporate leaving the parafiin base. The mixture may be poured into the coated mold and is allowed to stand and solidify into a relatively stifi, semisolid, tacky ring which contains elastic and resilient properties. After the mixture has gelled, an adhesive, such as well known pressure sensitive adhesives made from a base of vinyl ethyl ethers may be applied to one face of the ring to promote attachment of the face of the ring to a drainage bag or similar appliance. The other face of the ring is sufiiciently tacky so that when it is placed about the stoma and against the body of the patient, the body heat will increase the tackiness of the face of the ring which contacts the body to form a very effective seal with the patients skin. Perspiration from the body of a patient or water from the stoma discharge which contacts the karaya ring 'Wlll increase the tackiness of the ring and further promote the seal with the patients skin.
\Vith particular reference to FIGURES 3 and 4, the stoma 36 which protrudes from the :body of the patient is generally one of the intestinal organs and therefore basically of hollow tubular configuration. One characteristic of the stoma, such as the small and large intestine, is that it will expand and contract relative to its diameter. Thus, it is the usual practice to leave at least a A radial clearance between the perimeter of the stoma and the inner periphery of the opening in the drainage pouch. It is to be noted that the sealing ring of this invention, however, is snugly telescoped about the periphery of the stoma. This ring is, though semisolid, still relatively resilient and elastic so that it can be physically manipulated by the patient or attendant to work the inner diameter of the ring so that it may obtain a precise fit with the outer diameter of the stoma. Body heat tends to soften the ring permitting it to expand and contract with the expansions and contractions of the stoma. Thus, an absolutely snug fit is secured effectively sealing stoma drainage from the skin of a patient and promoting the healing process.
It is to be understood that the sealing ring is not limited in use to bags having a retaining ring portion 15, such as shown in the drawings. The ring may be adhered to any bag having a relatively stiff portion about the bag opening, whether the stiffness be attributable to the bag material or a bag component in that area. Moreover, it may be desirable in some instances to secure the ring to the bag prior to telescoping the ring and the bag about the stoma. It is even further possible for the bag and the ring to come prepacked as a unit with the open face mold in which the ring is prepared serving as the outer cover for that face of the ring which is to be placed against the skin of a patient until such time as the bag and ring are intended for use. With the belt 14 properly securing the drainage pouch to the body of a patient, a very effective seal is created by the sealing ring 16 between the drainage bag and the body of a patient which permits the drainage of fluid from the stoma without the fluid coming into contact with exposed areas of the skin.
After a few hours of wearing, the pad may absorb a great deal of water from the drainage and lose some of its elasticity and its leakproof qualities. The useful life of the pad may be extended by watenproofing those surfaces which do not contact the skin. Waterproofing may be accomplished by using well known rubber solutions, synthetic elastomers in solution, various resinous emulsions, organosols or plastisols.
One such. suitable waterproof coating may be made by coating an aluminum open face mold with plastisol, having 40% dibutylphthalate, to a thickness of about .020 and then curing the coated mold at about 250 F. for approximately two minutes. After the mold is allowed to cool to room temperature, a mixture of karaya and glycerine may be poured in 1 3 mold, and the mold and the contents again heated to 250 F. for approximately two minutes to hasten gelation. After the mold and the contents again cool to ambient temperature, they may be stripped from the mold and the sealing pad produced thereby may be worn for as much as a week without replacement.
A well known base, such as aluminum hydroxide, could be added to the karaya glycerin mixture to neutralize acid present in the drainage. Antibacterial compounds could be added to the karaya and glycerine mixture to destroy bacteria in the body discharge which might seep between the sealing pad and the skin.
Thus this invention provides a pre-molded surgical sealing ring or gasket having a definitive shape and consisting of a healing powder mixed in an oleaginous nonevaporative material which combine to form a semisolid gel. The ring is somewhat tacky so that when it is placed between the skin of a patient and the opening of a postsurgical drainage pouch, a liquid-tight seal will be formed. There is no guess work or hit or miss speculation as to the reliability of the seal. The former guess Work practice of forming the sealing ring on the skin of a patient by mixing a healing powder and rubber cement and pressing the surgical pouch against the mixture is eliminated. Instead, the sealing ring of this invention is pre-molded, ready for use and reliable in every application.
1. For use with a post-surgical drainage pouch adapted to receive drainage from the stoma of a patient, a semisolid gelatinous sealing ring comprising an oleaginous nonexaporative vehicle having a healing powder therein of a sufiicient quantity to produce a semisolid gel, said ring having a central opening of a size to receive the stoma of a patient, said ring adapted to be telescoped on the stoma between the skin of a patient and the drainage pouch to form a seal therebetween.
2. For use with a post-surgical drainage pouch adapted to receive drainage from the stoma of a patient, a semisolid gelatinous sealing ring comprising a nonevaporative, liquid, oleaginous carrier mixed with a miscible healing powder in sufiicient quantity to form a ring-like molded gel with the carrier, said ring having a central opening for telescoping on the stoma between the skin of a patient and the pouch to form a seal therebetween.
3. The sealing ring of claim 2 wherein one side is provided with a plastic coating.
4. The sealing ring of claim 3 wherein the plastic coating comprises a plastisol having a plasticizer of 40% dibutylphthalate.
5. For use with a post-surgical drainage pouch adapted to receive drainage from the stoma of a patient, a sealing ring comprising a mixture of at least a minor part of karaya powder and at least an equal part of glycerol, said ring having a central opening of a size to receive the stoma, said ring adapted to be telescoped on the stoma between the skin of the patient and the drainage pouch to form a seal therebetween.
6. The ring of claim 5 wherein one side is coated with a plastic coating.
References Cited by the Examiner UNITED STATES PATENTS 2,896,625 7/1959 Austin 128283 3,029,187 4/ 1962 Steinhardt 322 X 3,077,192 2/1963 Berger 128-283 RICHARD A. GAUDET, Primary Examiner,
L. W, TRAPP, Assistant Examinerr