KR900004993B1 - Ostomy applicance coupling with viscoelastic liner - Google Patents

Abstract

A coupling for an ostomy appliance, comprising a first ring (13a) formed of flexible plastics material defining an axiallyextending opening therethrough for receiving a patient's stoma, the first ring also having a generally radially-facing annular channel for receiving and detachably engaging an annular flange (31) of a second coupling ring (13b) adapted to mate with the first ring, and a deformable liner (29) of viscoelastic polymeric material securely and sealingly bonded to the first ring within the channel for making direct, shape- conforming, fluid-tight sealing contact with the flange when the first and second ring are coupled together.

Description

Opening Instrument Coupling with Viscoelastic Liner

1 is a perspective view of an opening surgery instrument equipped with the coupling ring assembly of the present invention shown in a separated state to explain the opening surgery bag and the face plate.

2 is a partially enlarged schematic sectional view showing the relationship of each component when a ring is connected.

3 is another partially enlarged cross-sectional view of a face plate on which a viscoelastic sealing liner is formed.

4 is an enlarged cross-sectional view similar to FIG. 3 but showing deformation of the liner when the ring flange of the vesicle is received in the channel.

5 is a partial cross-sectional view showing a change in liner shape or viscous flow when the force exerted by the coupling ring flange is removed.

* Explanation of symbols for main parts of the drawings

10: aperture surgery instrument 11: face plate

12: bag, vesicle 13: ring assembly

13a: faceplate ring 13b: vesicle ring

14 outlet 18 seat

19: attachment ring 23: web

25: body 26: neck

28: Rim 29: Liner

30: body portion 32: rib

33: recess

The present invention relates to a coupling ring assembly for an open surgical instrument having an annular channel which is generally radially contacted so that one of the rings is detachably connected and received with the latch flange of the other of the rings. It has a variable liner of viscoelastic material fixed therein. In a preferred embodiment, the liner also has a pressure sensitive adhesive.

U. S. Patent No. 4,610, 676 discloses a coupling ring structure of an open surgery instrument consisting of a pair of relatively flat rings formed of polyethylene or a relatively flexible, deformable plastic material. One of the rings has a tubular neck of a restricted shaft that ends with an annular rim, the shape of which defines the generally outwardly facing channel that receives the annular collar or flange of the other ring when the two are joined together. The contact between the two rings in the channel allows for a seal to effectively prevent fluid leakage between the parts. Such a seal is retained in spite of the bending or bending that the ring is likely to use in use because of the second contact area which essentially latches outward from the sealed area.

The coupling ring assembly according to the foregoing patent, the coupling ring assembly for all other recent surgical instruments, facilitates the exchange of the open surgical vesicles, while the adhesive face plate is located on the user's body. Thus, for several days, many vesicles will be connected and detached from the single faceplate coupling ring. In each case where this connection / disengagement takes place, there is a risk that the sealing surface of the ring is scratched, scratched or damaged by the nail. Scratches, such as scratches that are so small that they are not easily observed by the naked eye, provide sufficient leakage path when the rings are joined together. This problem is a problem due to the fact that it is often worn by older or weaker patients who lack the minimum skills necessary to easily connect and detach the ring and cannot operate the ring without damaging the sealing surface.

An important aspect of the present invention is to find that fixing the viscoelastic polymer liner in the radially facing channel of one of the rings can virtually eliminate the leakage problem and provide other important benefits. In particular, advantageous results are obtained because the deformable viscoelastic liner controls pressure sensitive adhesive properties. Whether tacky or not, the elastomeric liner deforms according to the inconsistent force exerted by the other coupling ring when it is placed in the channel. Any gap between the two rings where leakage or fluid bypass can occur can be effectively eliminated. The adhesive elastic liner can adjust itself to light dimensional deformations that may exist between successive vesicle rings, giving the user the confidence that a single faceplate ring can be successfully connected to multiple vesicle rings without the risk of leakage. The viscoelastic elastic liner is also tacky, which not only prevents leakage but also increases the certainty of the connection between the two rings. The bonding force between the liner and the channel is greater than the adhesion between the liner and the flange of the other ring, requiring the liner to be in the channel when the other ring is removed. This can be done by forming a liner of hot melt adhesive and sending the molten adhesive into the channel where it solidifies or cures. The adhesion between the liner and the flange of the other ring can be controlled by selecting the proper organization or surface treatment for the ring so that its surface is smaller than the affinity of the channel provided with the ring.

The liner also exhibits cohesiveness, which provides a coupling ring assembly that requires greater force for disassembly than assembly. The user will find that the ring can be easily slipped together since it is connected. The substantially greater force needed to separate them gives stability to the possibility of sudden separation of parts.

Other features, advantages and objects of the invention will be apparent from the description and the accompanying drawings.

Reference numeral 10 generally denotes a face plate 11 and an open surgical instrument in which a bag or a vesicle is formed. A two piece coupling ring assembly 13 is formed for removably connecting the face plate and the vesicle, one of which is the face plate ring 13a and the other is the vesicle ring 13b.

The vesicles and faceplates vary considerably in size, shape, and configuration, all of which are well known in the art, and the coupling assembly 13 is not limited to being used only for the specific vesicle and faceplate configurations described in the drawings. For example, the vesicle 12 has an outlet formed at its lower end, which outlet is closed by a suitable clamp device (not shown), such as that set forth in Patent 3,523,534. However, if necessary, the vesicles may not be drained, in which case the outlet 14 will be omitted. Typically, the vesicles 12 are flattened into two sheets or walls 12a, 12b, which are flexible thermoplastic films that are designed flat and heat sealed along their periphery as indicated by (15) in FIG. consist of.

In the particular form shown in the figure, the face plate 11 is generally constructed in accordance with the technique of patent 4,213,458, which has been referred to in order to provide the technique in a detailed configuration. The face plate 11 is made of a highly flexible cloth or parchment paper formed of a material having a fine hole that can penetrate gas but is waterproof. Various materials having such properties are known and can be used. In any case, the faceplate can be easily deformed so that it easily matches the body contour and movement, and when removing the padded sheet 18, a microporous pressure-coated cloth 17 is placed in the patient's surrounding area. It will be coated on its back or back with a pressure sensitive medical adhesive that can be fixed to the skin.

The attachment ring or collar 19 is fixed to the front of the microporous fabric 17 by heat sealing or other suitable means. The attachment ring may also be heat sealed or rigidly fixed directly or indirectly to the ring 13a of the coupling ring assembly 13. In the structure shown in the figures, such a connection is made of a thin, flexible, elastic thermoplastic web between the faceplate ring 13a and the attachment ring 19 of the faceplate 11 as shown in US Pat. No. 4,419,100. 23) is indirect to the extent that is placed. In particular, the inner edge of the annular web 23 is heat sealed at the face plate 11 at 20, and its outer edge is heat sealed at 24 at the face plate ring 13a. The web creates a floating relationship between the faceplate ring 13a and the faceplate 11, increases the suitability of the faceplate to the user's body without resistance from the connecting ring, and generally allows limited movement of the faceplate ring in the axial direction with respect to the faceplate. do. Such limited movement allows the user to easily insert and attach his finger between the ring 13a and the face plate 11 in order to easily detach and attach the connecting ring without any inconvenience. The web is formed of a material that may be heat sealed and that is rough, durable and can act as a fluid and directional wall. Although vinylidene chloride, named Saraney of Midland Dow Chemical Co., Ltd., has been found to be suitable for low density polyethylene protruding jointly with layers or nuclei in the same range, other materials with similar properties may be used and may be used.

The structural relationship between the coupling ring assembly, in particular the faceplate ring 13a and the vesicle ring 13b, is evident in FIGS. 2 and 4. The ring 13a forms a tubular neck 25 integrated with the annular body 25. At its outer limit, the body portion 25 of the plate is provided with an annular latch shoulder 27, which is shown continuously but disconnected or broken along its periphery if necessary.

The neck portion 26 of the ring 13a is inclined in the forward axial direction from the body portion 25 of the plate and forms an annular and outward radial projection 28 at its front or distal end. The rim, neck and body all together define an annular channel 26a facing radially. In the outer radially facing channel there is a liner or layer 29 of sticky and elastic polymer sealant.

The liner 29 can be easily deformed and exhibits the conditions shown in FIG. 3 without being obstructed. In that condition it actually provides a uniform coating or layer along the base of the channel 26a. Since the liner is fixedly coupled to the neck portion 26 of the coupling ring 13a, it is not freely removed from the channel. However, the shape that is thought to be in the channel can be changed as shown in FIGS. 2 and 4.

The cohesive elastic liner can be formed of any variable material that has combined properties such as deformability, resilience, tack, and flow. Low hardness thermoplastic elastomers such as silicone rubber, polyurethane, or polybutene / polyisoprene may be used and may be applied from a dispersion or solvent system, or applied by mechanical transfer or other suitable technique. Ideally, the viscoelastic liner is formed in place as it is placed in the channel in a molten state. For that purpose, the melting temperature of the sealant liner material should no longer exceed the melting temperature of the thermoplastic material forming the ring 13a when the melt liner solidifies. It can be seen that the melt sealant makes the surface of the ring slightly softer instantaneously to increase the bonding force between the ring and the sealing liner. In its application, the liner material may generally be described as "hot melt sealant." Such hot melt sealants are well known and are usually composed of thermoplastic elastomers mixed with polyethylene or ethylene copolymers and in many cases with latent agents such as terpenoids or polyisobutylene.

In addition to being recoverable thermoplastic, deformable, and elastic, an effective result is that the tacky elastic sealant also has the property of being sensitive to pressure. Again, hot melt adhesives having such properties are known and some of them can be used for this purpose. For example, one such substance is described in Minnesota, St. Available as HM 6515 from Paul H. B. Fuller.

Others are designated 34-2881 by National Starch & Chemical Corporation, Bridgewater, New Jersey, and 8416 by the Swift Adhesives Division, Reichhold Chemicals, Chicago, Illinois. While these adhesive properties can contribute to enhancing a more effective seal between the connecting rings, a function presumably achieved by the deformability of the sealant, they allow for a more robust connection between the parts. The hot melt material is melted and placed in channel 26a to form a liner having a thickness in the range of about 0.01 to 0.05 inches.

A vesicle coupling ring 13b is provided in the body portion 30 extending in a plane perpendicular to the central axis of the ring. The conical collar or flange 31 is generally inclined axially at the inner edge of the body 30. The general inclination direction of the flange is the same as the inclination direction of the neck portion (26). An annular projection 31a is provided on the inner surface of the flange, the projection defining the minimum inner diameter of the flange to seal sealingly with the liner 29 along the outer surface 26 of the ring 13b. At the distal or free end, as shown in FIGS. 2 and 4, the flange is provided with an axial contact annular ridge 31b perpendicular to the rim 28 when the parts are assembled.

Along the outer periphery, the body portion 30 protrudes in the axial direction inward in the opposite direction to the outer periphery of the flange 31, and separates the shoulder of the faceplate ring 13a along the rest of the body portion 30. It engages with an annular latch rib 32 which defines a recess 33 facing outwardly in order to be accepted and supported. Ribs 32 are provided with a rounded surface to facilitate latching and disengaging the two rings as shown in FIG.

When the deformable sealant liner 29 is pushed out, the connection rings 13a and 13b are similar to those described in US Pat. No. 4,610,676 and are referred to for more details on the features, functions and advantages of this ring structure. Will be. While the rings 13a and 13b represent particularly effective connection ring devices for using the sealing liner 29, the ring structure can be modified in many ways. The liner 29 is thus pressure sensitive, and it is possible to omit the rib 32 and its outer clasp completely. Alternatively, the surface abutting while defining the recess 33 radially inward is also located side by side with the adhesive elastic sealing material to change the outer clasp area into the clasp / sealed area.

Important characteristics of the sealing liner 29 are shown in FIGS. 3-5. In the unobstructed state, the thickness of the adhesive elastic liner is generally constant (FIG. 3), but is easily deformed by forced contact by the flange 31, in particular the protrusion 31a. This forced contact causes the viscoelastic material to flow or move circumferentially, radially and axially so that no gap exists between the liner 29 and the flange 31. The sealing liner or layer 29 and the rings 13a and 13b are balanced so that several liners are replaced when the parts are joined. When the parts are separated, the memory properties of the viscoelastic material are at least partially returned to their original state in the direction of the arrow 35. As a result, the vesicle ring 13b can be repeatedly connected to the faceplate ring 13 and then dropped, and the viscoelastic liner can be flexibly combined with the vesicle ring in each case and form a watertight seal with it. The liner here is pressure sensitive and the rings 13a and 13b are much more flexible to match changes in the body without the risk of sudden separation. Thus, the elastic, flexible coupling rings formed from low density polyethylene are platter shaped so that they do not protrude from the surface of the patient's body. Not only does this construction make the product less recognizable, but the low profile also makes the ring easily matched to changes in body movement, which makes the patient more comfortable and reduces the likelihood of the adhesive faceplate falling from the skin. .

In addition, the use of a pressure sensitive adhesive hot melt seal liner allows for a tighter waterproof connection between other types of medical couplings, such as intravenous set couplings, and the force required to separate the parts requires assembly. It is necessary to make a connection that is larger than the force and prevents fluid (liquid and gas) leakage.

In the foregoing, embodiments of the present invention have been described in more detail to give an understanding. It will be understood by those skilled in the art that many of these items can be changed without departing from the spirit and scope of the invention.

Claims (10)

To accept and fall off the annular flange 31 of the second coupling ring 13b made of a flexible plastic material having an axially extending hole to receive the patient's globules and mating with the first ring 13a. A first ring forming an annular channel 26a radially in contact with each other; When the first and second rings are connected together, it is made of an adhesive and elastic polymer material that is tightly sealed to the first ring in the channel to make direct contact with the flange while preventing the fluid leakage. A coupling for an open surgical instrument comprising a variable liner (29). The coupling of claim 1 wherein the viscoelastic material is a hot melt sealant. The coupling of claim 2 wherein the sealant has a pressure sensitive adhesiveness. 4. A coupling according to claim 3, wherein the bond strength between the sealant and the first ring exceeds the bond strength to the second ring. The coupling of claim 1, wherein the annular channel is generally radially outwardly facing. Coupling according to claim 5, characterized in that the adhesive face plate (11) is fixed to the first ring and the first ring for adhesive attachment to the skin of the patient around the small hole. 6. The coupling of claim 5 wherein the thickness of the unstressed adhesive elastic liner is in the range of 0.010 to 0.050 inches. The coupling of claim 1, wherein the first ring is formed of low density polyethylene and the viscoelastic liner is comprised of a pressure sensitive hot melt adhesive. The coupling according to claim 8, wherein the bonding strength between the hot melt adhesive and the first ring exceeds the adhesive strength of the hot melt adhesive and the second ring. 10. The method of claim 9, wherein a pressure sensitive hot melt adhesive is applied to the first ring in the channel at a sufficient temperature to soften the surface of the first ring in contact with the adhesive so that the liner and the first ring are firmly fixed to each other. Characterized by a coupling.

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