JPH0528145B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION Field of the Invention This invention relates to gastrointestinal stoma devices, and more particularly to gastrointestinal stoma devices having a three-part connecting ring assembly.

PRIOR ART U.S. Pat. No. 4,610,676 describes a gastrointestinal stoma device provided with an interlocking ring assembly consisting of a pair of flat rings of polyethylene or other relatively soft and flexible plastic material. There is. Both rings are removably connected together to an outer locking portion in which the radially deformable peripheral rim of one ring receives the outer edge of the other ring. A watertight seal is formed somewhere within the flesh annular seal portion where the flexible lip or flange of one ring is pressed radially inwardly against the tubular neck of the other ring.

The concept of forming a water-tight seal, i.e. a liquid- and gas-tight seal, between connecting rings of a gastrointestinal prosthesis device by means of a radially deformable sealing lip or rim that abuts inwardly or outwardly against an annular sealing surface is known, for example, in the United States. Patent No. 3528420, No. 4610677
No. 4,460,363, etc.

One feature of the invention is that a radially deformable rib or rim is advantageously provided for locking together a pair of connecting rings and is essential as a means of achieving the effect of forming a watertight seal between the members. It is to acknowledge that less is required. One reason is that such ribs can become scratched, deformed or otherwise damaged during use, with the result that any slight imperfection can result in leakage. Another problem, one which increases the difficulty and expense of manufacturing, is that the thermoplastic material from which the connecting ring is formed shrinks somewhat unpredictably as it cools to room temperature during manufacturing. Shrinkage rates of 1% or more are not uncommon for injection molding of such plastic materials. Since such a ring is relatively flat, it will experience greater contraction in the radial direction than in the axial direction. If the member relied upon to achieve a watertight seal of the final connecting ring assembly must have a radially deformable sealing lip and sealingly engage the radially oriented surface, shrinkage will result in substantial fabrication. It is a variable cause of the problem.

Another feature of the invention is that if the locking action is provided by a radially deformable lip or flange or other locking device and the sealing action is provided by an axially compressible device. This difficulty can be avoided if the sealing devices are separated from each other. Due to the relatively low axial shrinkage during production, great uniformity and reliability of the sealing action can thus be achieved. The sealing effect is further enhanced by the use of a soft compressible sealing ring between the locking rings of the assembly, the sealing rings being axially engaged by both locking rings. In a preferred embodiment of the invention, a resilient sealing ring is secured to one of the locking rings during manufacture and is axially engaged by one or more annular ribs of the other locking ring. The resilient sealing ring is in axial compression when the members are coupled together, so that the sealing ring forces the outer annular lip and shoulder of the locking member, i.e., the locking ring, into tighter engagement. Restoration forces are applied in opposite axial directions.

In one of the described types of members, the deformable sealing ring can be joined by the user to the locking ring of the face plate and is capable of engaging both locking rings when the locking rings are axially pressed together. It is therefore a separate member that is forcefully engaged. The second member is the same except that during manufacture the sealing ring is secured to one of the locking rings. In both such embodiments, the sealing ring has a smaller inner diameter than both locking rings and provides a soft, deformable surface for contacting the patient's prosthesis. In a third embodiment, the sealing ring is held within an annular groove of one of the locking rings and is engaged by an annular rib of the other locking ring when the parts are coupled together. In a fourth embodiment, the sealing ring is similarly maintained within one groove of the locking ring, but projects from the groove for axial sealing engagement with the other locking ring. In all embodiments of the invention, the seal ring can be any number of soft, impermeable, elastic materials. Elastomeric materials can be used, as well as common skin barrier materials that have the advantage of low elasticity and surface adhesion. Adhesive materials with pressure sensitive adhesive properties, such as hot melt adhesives, can be suitably used. Materials with adhesive properties are used not only to enhance the sealing effect, but also to enhance the sealing effect of the members, i.e. the adhesive properties supplement the locking action of the locking ring and require a greater force to separate the rings than the force required to join them together. It is suitable for

Other features, objects, and advantages of the invention will become apparent from the detailed description below.

Embodiment FIG. 1 shows a collection bag 11, a face plate 12, and a first locking ring 1 attached to the collection bag 11.
3 and a second locking ring 14 joined to the face plate 12
1 shows a gastrointestinal prosthesis device 10 consisting essentially of a connecting ring device consisting of a flexible sealing ring 15 and a soft elastic sealing ring 15. It is understood that the collection bag 11 and face plate 12 can vary considerably in size, shape and configuration, as is well known to those skilled in the art, and that the coupling ring arrangement is not limited in use to the particular collection bag and face plate configuration shown in the drawings. Should. For example, bag 11
is shown having an outlet 16 at its lower end adapted to be closed by a suitable fastening device (not shown), one of which is described in U.S. Pat. No. 3,523,534; The collection bag 11 can then be rendered non-drainable, in which case the outlet 16 is omitted. Generally, the collection bag 11 is constructed to be relatively flat and consists of two sheets of flexible thermoplastic film that are heat sealed together along their outer edges, as shown at 17 in FIG. That is, it is made up of walls 11a and 11b.

The particular form of collection bag 11 shown in the drawings is generally constructed in accordance with that disclosed in U.S. Pat. No. 4,213,458, to which reference may be made for construction details. Faceplate 12 has a highly flexible patch or panel 18 made of a microporous material that is breathable and waterproof. A variety of materials with such properties are well known and can be used.
The faceplate 12 should be highly flexible, so it can easily conform to the shape and movement of the body, and be coated on the back or rear side with a medical grade pressure sensitive adhesive, so that it does not need a backing. The sheet 19 can be peeled off and the microporous adhesive coated patch or panel 18 can be adhered to the patient's skin at the orifice margin.

A mounting ring or collar 20 may be secured to the front surface of the microporous panel 18 by heat sealing or other suitable means. The attachment ring or collar 20 must be capable of being heat-sealed or similarly fixedly bonded to the second locking ring 14, either directly or indirectly. In the configuration shown in the drawings, such a connection is such that a web 21 of thin, flexible, elastic thermoplastic material connects the locking ring 14 and the collar 20 of the faceplate 12 as described in U.S. Pat. No. 4,419,100. It is secondary to the extent that it is inserted between. In particular, the inner edge of the annular web 21 is attached to the face plate 12 at 22
The outer edge is heat sealed with a locking ring 14.
Heat sealed at 23. The web 21 is raised in a floating state between the locking ring 14 and the faceplate 12, allowing the faceplate 12 to suitably fit the wearer's body without resistance from the locking rings 13, 14, and approximately axially centered with respect to the faceplate 12. generally allowing limited movement of the connecting ring device in the direction. Such limited movement allows the user's fingers to be inserted between the connecting ring device and the faceplate 12 to facilitate installation and removal of the connecting ring device without causing discomfort. Web 21 should be made of a strong, durable material that can be heat sealed and act as a liquid and odor barrier. Low-density polyethylene formed as a layer or core of polyvinylidene chloride, sold under the trade name Saranex by the Dow Chemical Company of Midland, Michigan, is suitable for Web 21, but other similar properties may be used. It is also possible to use materials that have some properties.

The connecting ring device, in particular the locking ring 13 and sealing ring 15 of the collection bag 11 and the locking ring 1 of the face plate.
The related structure between 4 and 4 is clearly shown in FIGS. 2 and 3. The two locking rings 13, 14 have opposing wall portions 13a, 14a which are substantially planar and are located along a plane perpendicular to the axis of the connecting ring arrangement. When the locking rings are connected as shown in FIG. 2, an annular gap or chamber 25 is formed between the locking rings. A soft, deformable sealing ring 15 is provided within the chamber 25 in sealing contact with the opposing wall portions 13a, 14a. The opening 26 in the sealing ring 15 is aligned with the opening 27 in the locking ring 14 and the hole 28 in the face plate 12 (FIG. 3). An axially extending neck 15a of the sealing ring 15 extends through an opening 27 in the locking ring 14, and an annular enlargement 15b at the end of the neck 15a retains the locking ring 14 and the sealing ring 15 and the web 21. It has a dual effect of pressing the face plate 12 toward the face plate 12 (FIG. 2). Since the web 21 is normally in a flat state, such deformation may occur in the web 21.
and sealing ring 15, and forming an effective seal between web 21 and sealing ring 15.

In the embodiment shown in FIGS. 1 to 3, the sealing ring 15 is not glued or fixed to either of the locking rings 13, 14, but has a protrusion of the neck 15a and an annular enlargement 15b at the end of the neck 15. Therefore, it is clear that there is a mechanical connection between the locking ring 14 and the sealing ring 15. To ensure a watertight seal between the wall portion 14a of the locking ring 14 and the flat surface 15c of the sealing ring 15, one or more annular ribs 29 are integrated along the surface of the wall portion 14a facing the sealing ring 15. can be formed into
Similarly, one or more annular ribs 30 can be provided on the surface of the wall portion 13a of the locking ring 13 opposite the plane 15b of the sealing ring 15. These annular ribs 29, 30 are attached to the resilient sealing ring 1 when the parts are assembled as shown in FIG.
A portion of the material of the deformable seal ring 15 press-fitted into the seal ring 15 is forced away, creating a concentrated sealing area of relatively high force to ensure a watertight seal between the parts. Such a force acts essentially axially on the sealing ring 15, i.e. on the opposite wall sections 13a, 14a of the locking rings 13, 14, in particular on the annular ribs 29, 30 of these wall sections. It will be appreciated that the sealing ring 15 is placed in axial compression.

The locking device securing the parts together includes a radially deformable annular lip 31 of locking ring 13 which is fitted around an annular peripheral shoulder 32 of locking ring 14.
It takes the form of Figure 3 shows the members of the connecting ring device in a removed state, and shows the locking ring 1.
It will be apparent that the annular lip 31 must be pulled radially outwardly so that the peripheral shoulders 32 mate when 3, 14 are pressed toward each other. When the locking rings 13, 14 are fully connected, the enlarged rim 31a of the annular lip 31 engages the annular shoulder 32, pulling the annular lip 31 outwardly and bending the shoulder 32. Separation of the locking rings 13, 14 is prevented until a sufficiently large force is applied to release them. Since seal ring 15 is in axial compression when the parts are assembled, the restoring force exerted by seal ring 15 forces locking rings 13, 14 in opposing axial directions to firmly lock them together. Make a locking engagement. However, the strong mechanical lock is the lock ring 1.
3 and 14 during which the sealing action imposed to prevent leakage of fluids such as liquids or gases is achieved by deformable sealing ring 15 and locking ring 1
It should be noted that this is achieved within the locking part by a tight and strong axial contact between the 3, 14 opposing wall sections 13a, 14a.

FIG. 4 is similar to FIGS. 1 to 3 except that the annular rib 29 is omitted from the locking ring 14' and the sealing ring 15 is secured when the wall portion 14a' of the locking ring 14 is constructed. This is the same as the embodiment.
Typically, such attachments are in adhesive configurations based on either the formation of an adhesive layer between opposing surfaces or the adhesive properties of the seal ring composition. If an adhesive layer is used, it can be a medical grade acrylic latex composition or any other suitable pressure sensitive adhesive composition. Furthermore, depending on the composition of the parts, locking rings 13, 14 may be used, for example heat seals.
Other means can be used to permanently affix them together.

Seal ring 15 can be made from a soft, deformable, elastic, impermeable material. Durometer elastomers such as silicone rubber, polyurethane, polybutylene/polyisoprene can be used. Also, elastic closed cell homes of polyurethane, polyethylene or other polymeric materials can be used. Particularly advantageous results can be achieved if, in addition to being deformable and elastically recoverable, the sealing ring has pressure-sensitive adhesive properties. Hot melt adhesives having such characteristics are known, and various adhesives can be used for this purpose. For example, one such material is available as HM6515 from H.B. Fuller, St. Paul, Minn. Other materials include New Jersey;
34-2881, available from National Starch and Chemical Co., Bridgewater, and 84116, available from Swift Adhesive Division, Raycord Chemical Co., Chicago, Illinois. Other deformable sealing materials with adhesive properties include skin barrier materials commonly used in gastrointestinal stoma devices. Karaya glycerin formulations, mixtures of polyacrylamide resins and other polyols, mixtures of elastomers and hydrocolloids can be used.
Reference may be made to US Pat. Nos. 4,477,325 and 4,496,357 for a review of conventional skin barrier compositions and a description of alternative compositions with particular advantages that may be used here.

Locking rings 13, 14 are preferably constructed from low density polyethylene, although other suitable thermoplastic materials having similar characteristics of flexibility and strength may be used.

Figures 5 and 6 show another embodiment having a face plate 112 and a collection bag 111 that can be made the same as previously described. Accordingly, the faceplate 112 includes a microporous patch or panel 118 with a pressure sensitive adhesive surface covered by a peelable sheet 119, which patch or panel 118 is connected to a mounting ring 120. The locking ring 114 is connected to the locking ring 114 by a web 121. The collection bag 110 has walls 111a, 111b of thermoplastic film, and the wall 111a facing the patient is provided with an opening 111c for a gastrointestinal ostomy. The first locking ring 113 is fixed to the bag wall 111a around the gastrointestinal stoma opening 111c, and the second locking ring 11
4 is connected to the web 121 of the face plate 112. 2
A soft and deformable sealing ring 115 is inserted between the two locking rings 113, 114. The three rings together constitute the connecting ring system of the gastrointestinal stoma device 110.

As in the previous embodiment, the locking ring 11
3, 114 have opposing wall portions 113a, 114a which together form a chamber 125 when the locking rings 113, 114 are locked together.
Seal ring 115 is completely contained within chamber 125. The wall portion 113a of the locking ring 113 has at least one annular rib 130 which is pressed against the generally planar surface of the sealing ring 115 when the parts are coupled together as shown in FIGS. The operation is the same as previously described, in particular the sealing ring 115 is used to close the two locking rings 113, 114 when the locking rings 113, 114 are pressed together into the fully connected state shown in FIG. axially compressed between.

The locking ring 114 for the face plate has a wall portion 114a as well as a pair of concentric side wall extensions 114b, each wall extension 114b being connected to the sealing ring 11.
5 has an annular shoulder 132 facing away from the groove 114c (FIG. 6). These annular shoulders 132 engage the radially deformable flange or lip 131 of the bag's locking ring 113 when the locking rings 113, 114 are locked together.

Locking rings 113, 114 and seal ring 11
The material of 5 can be the same material as described for the previous embodiment. Although sealing ring 115 can be provided as a separate member that is fitted into chamber 125 by the user, sealing ring 115 is preferably placed or formed within groove 114c of locking ring 114 during manufacture. . Seal ring 115 has groove 114
It will be appreciated that the groove 114c does not protrude from the groove 114c and can therefore be easily constructed by pouring a molten or liquid sealant material into the groove 114c and allowing it to then cure, in whole or in part, to the condition shown in FIG. It will be.

Figures 7 and 8 show another embodiment which is the same as the previous embodiment except for the structure of the connecting ring device. The seal ring 215 has an annular shape with a circular cross section in an undeformed state (FIG. 8). This seal ring 215 is received within the groove 214b of the faceplate locking ring 214. Face plate locking ring 21
4 and the locking ring 213 of the bag are the locking ring 21
3, 214 have opposing walls 214a, 213a that place the seal ring 215 in axial compression when they are coupled together. Furthermore, the locking ring 214 of the face plate includes the locking rings 213, 214.
radially deformable lip or flange 231 of locking ring 213 when the two are locked together.
It has an annular shoulder 232 engaged by. The material of the locking rings 213, 214 can be the same as described for the other embodiments. Seal ring 2
15 can be provided as a separate member to fit within groove 214b during use, and sealing ring 215 and locking ring 214 are preferably provided to the user in a pre-assembled condition as shown in FIG. be done.

In all embodiments described, a locking ring 14, 114, 214 with an outwardly facing shoulder 32, 132, 232 is attached to the face plate or connecting web 2.
1, 121, 221, so that the lip or flange 3 is deformable in the outward radial direction.
Locking ring 13,1 with 1,131,231
13,213 are attached to bags 11,111,211. Although such a configuration is preferred, it is understood that the position of each of the locking rings can be reversed if desired, and that most if not all of the benefits and advantages of the invention can be provided in the reversed configuration. should be understood.

Although several embodiments of the invention have been described for purposes of illustration and description, those skilled in the art will recognize that many of these details may be changed without departing from the spirit and scope of the invention.

[Brief explanation of the drawing]

FIG. 1 is an exploded perspective view of a gastrointestinal prosthesis device embodying the present invention, showing the collecting bag, the adhesive face plate, and the connecting ring supported by each member separated, and FIG. An enlarged longitudinal sectional view showing the face plate, the bag and the connecting ring device, FIG. 3 a longitudinal sectional view showing the components of FIG. 2 in a separated state, and FIG. 4 showing a seal secured to one of the locking rings. a longitudinal sectional view of a modified structure similar to the embodiment of FIGS. 1 to 3 with a ring;
FIG. 5 is a schematic longitudinal cross-sectional view of yet another embodiment shown in an assembled state, FIG. 6 is a longitudinal cross-sectional view similar to FIG. 5 showing members in a removed state, and FIG. 7 is another embodiment. FIG. 8 is a schematic longitudinal sectional view showing the member of FIG. 7 in an assembled state, and FIG. 8 is a schematic longitudinal sectional view showing the member of FIG. 7 in an exploded state. In the figure, 10,110: gastrointestinal artificial hole device,
11, 111, 112: bag, 13, 14, 11
3,114,213,214: Locking ring, 1
5,115,215: Seal ring, 16: Outlet, 18,118: Panel, 19,119: Backing sheet, 20,120: Color, 21,12
1: Web, 25,125: Room, 29,30,1
30: Rib, 31,131,231: Lip.

Claims (1)

[Scope of Claims] 1. A collection bag having an opening for a gastrointestinal artificial hole, an adhesive face plate having a hole that can be aligned with the opening for a gastrointestinal artificial hole,
A coupling device removably couples the bag and face plate together, the coupling device including a first locking ring secured to the bag around the gastrointestinal stoma opening, and a second locking ring connected to the face plate around the hole. locking rings, the first and second locking rings being constructed from a flexible plastic material, one locking ring having an annular shoulder and the other locking ring having both locking rings. have radially deformable lips for radially locking engagement with the shoulders when the radially deformable lips are axially pressed together; The radially inwardly projecting locking rim has a radially inwardly projecting locking rim that extends in the axial direction of both locking rings without radially outward deformation of the lip when the locking rings are coupled together. extending behind the shoulder to prevent separation, both locking rings having axially coincident openings therethrough and forming an annular chamber when the locking rings are coupled together. spaced apart opposing wall portions disposed within the annular chamber in sealing engagement with the opposing wall portions of both locking rings and in axial compression when the locking rings are coupled together; A gastrointestinal prosthesis device having a sealing ring of soft and deformable elastic material. 2. The gastrointestinal prosthesis device according to claim 1, wherein the sealing ring is fixed to the wall portion of one of the locking rings. 3. The gastrointestinal prosthesis device according to claim 2, wherein the sealing ring is fixed to the wall portion of the second locking ring. 4. The gastrointestinal prosthesis device according to claim 3, wherein the wall portion of the first locking ring is provided with an annular rib. 5. The gastrointestinal prosthesis device according to any one of claims 1, 2, 3, and 4, wherein the sealing ring is made of a material having pressure-sensitive adhesive properties. 6. The sealing ring is made from a hot melt adhesive that is adhered to the second locking ring, and the adhesive strength between the hot melt adhesive and the second locking ring is the adhesive strength of the first locking ring to the first locking ring. The gastrointestinal prosthesis device according to claim 5, which exceeds the scope of claim 5.