MXPA98000516A - Coupling of orifi - Google Patents

Abstract

The present invention relates to a coupling for a medical device characterized in that it comprises: first and second coupling members adapted to surround a body opening, a resilient split fastener ring, mounted on the first coupling member, the first and second members of coupling are releasably secured together to the fastener ring, the fastener ring is adjusted to the second coupling member substantially continuously around the periphery of the second coupling member so as to secure together the coupling members, the fastener ring releases the second coupling member when external forces are applied to expand the coupling ring

Description

ORIFICE COUPLING Field of the Invention This invention relates to an orifice coupling. The invention is particularly suitable for use in the field of ostomy, but is not limited exclusively to this field.

Ostomy couplings are used to connect and disconnect a bag to receive a stomal discharge to and from a medical-grade adhesive pad or base that is applied to the peristomal area of the wearer's skin.

Description of the Prior Art Many ostomy coupling designs are known. In particular, EP-A-0737459 discloses said coupling in which the first and second coupling members are held together by a flexible and elastic split fastener ring. A plurality of tabs symmetrically placed on each end of the clamping ring, project through openings in an edge of the first coupling member to retain the captive clamping ring in the first coupling member, the tips of the tabs are engageable REF: 26717 with the second coupling member through the openings for securing the coupling members together. The tabs can generally be withdrawn radially outwardly by movement of the clamping ring to allow separation of the two coupling members. This is achieved by applying an external force to the ends of the partition ring, to deform the limbs and thereby expand the ring.

BRIEF DESCRIPTION OF THE INVENTION In contrast to the prior art, the present invention provides in a first aspect, a coupling in which first and second coupling members surrounding an orifice are secured together by an elastic split fastener ring, captive in the First coupling member, the split fastener ring is configured to engage the second coupling member substantially continuously around the periphery of the second coupling member, and to release the fit with the second coupling member, when an external force is applied to the ends of the split bra to expand the ring.

With such an arrangement, the fastener ring can be adjusted to the second coupling member over a much larger area than in the prior art, and can therefore provide a more positive fit.

The fastener ring does not need to be adjusted with the second coupling member at each single point around the periphery. In a preferred embodiment, the fastener ring includes a continuous region of first fit at one end, and a second continuous coupling ring at the second end, which together in use, leave a small region of circumferential periphery of this coupling member not adjusted .. The unadjusted region is at the pivot point or "hinge" of the fastener ring, which is diametrically opposite to the "division" in the ring and is the region where no, or only little, radial movement occurs when it deforms the ring.

In a second aspect, the invention provides a coupling in which the first and second coupling members surrounding an orifice are secured together by an elastic split fastener ring on a first coupling means and which is adjustable with the second coupling member. , the first coupling member comprises retaining means extending radially out of the splitter ring to retain the splitter ring in the first member, the retaining means permit expansion of the splitter ring when an external force is applied to the ends of the ring divider, to release the fit with the second coupling member and allowing the coupling members to separate.

With said arrangement, the retaining means for retaining the dividing ring on the first coupling member can retain the ring radially outside the ring. In other words, the retaining means do not have to interpose between the dividing ring and the peripheral surface of the second coupling member. This can provide a larger area of adjustment between the dividing ring and the second coupling member. Advantageously (although not essential in this respect), the dividing ring may be configured to adjust the second coupling member substantially continuously around the periphery of the second coupling member.

In the preferred embodiment, the retaining means of the splitting ring on the first coupling means comprises * one or more retaining projections.

In a further aspect, the invention provides a coupling in which first and second coupling members surrounding an orifice are secured, together with an elastic split fastener ring, which is integral with the first of the coupling members and is captive in the same, the ring being deformable in use, by applying a force to the ends of the dividing fastening ring, to allow the coupling members to be separated.

In a closely related aspect, the invention provides a method for the production of a coupling member for use in a coupling according to the third aspect, the method comprising integrally molding a coupling member and a longitudinally dividing fastening ring and attached to the coupling member. coupling member by a flexible weft, and by folding the weft to overcome the split fastener ring on the coupling member.

Said method provides a convenient technique for producing a coupling member with a positioned split fastener ring, and can provide a quicker and easier assembly than molding the coupling member and the fastener member separately. Preferably, the fastening member is retained in its bent operating state by one or more protrusions projecting from the coupling member. A further preferred feature is that the flexible weave joining the fastener ring and the coupling member is diametrically opposite to the "splitting" or crossing region of the fastener ring.

As defined herein, the term "dividing ring" is intended to cover any ring or partial ring member that functions in use as a ring with two limbs that can be moved separately and / or towards the other end to expand and / or contract the ring .

Preferably, the coupling (in some aspect) is an ostomy coupling. One of the first and second coupling members would then form a body-side coupling member, and the other would form a bag-side coupling member.

An embodiment of the invention is now described by way of example only, with reference to the accompanying drawings in which: Figure 1 is a detailed view showing the components of the coupling; Figure 2 is a plan view of the integral coupling member and the clamping ring before assembly; Figure 3 is a vertical section through the coupling in the assembled condition; Figure 4 is a schematic partial view of a mold for forming the first coupling member; and Figure 5 is a partial schematic view of a detail of the divided ring.

Detailed Description of the Invention The illustrated and preferred ostomy coupling comprises first and second coupling members 10 and 20, and a split fastener ring 30. In this embodiment, the first coupling member 10 is for placement in the body of a person and has a flange 11 from which a cylindrical wall 12 surrounding the stomal orifice is projected. The flange 11 is placed on a medical grade adhesive pad 15 (Fig. 3) which is preferably a thin film of polymeric material such as polyethylene and a layer of adhesive located on the back surface of a base. Said adhesive layer is preferably formed of a homogeneous mixture of one or more elastomeric or viscous pressure sensitive materials having intermittently dispersed therein, one or more water soluble or inflatable hydrocolloid gums, and may also include one or more thermoplastic elastomers. and / or one or more inflatable adhesive strengthening agents.

With reference to Figures 1 and 3, the second coupling member is very similar to the conventional ostomy coupling member on the side of the bag, and comprises a cylindrical wall 21 and a flange extending radially outwardly 22. To the surface 22a of the flange 22, an ostomy bag 24 is placed in some appropriate manner, for example, by means of an adhesive. The cylindrical wall 21 is dimensioned to fit closely around the wall 12 of the first coupling member. An elastic seal tape 23 is integral with the cylindrical wall 21 and extends in contact with the wall 12 of the first coupling member 10 when the coupling is assembled. The function of the seal tape 23 (Fig. 3) is to prevent leakage and accommodate any minor variations of tolerance that may have appeared in the molding operation by which the coupling members 10 and are manufactured.

Outside the seal tape 23, the outer periphery of the cylindrical wall 21 is formed with an adjustment profile for engagement fit with the fastening ring 30. The adjustment profile includes a radially sloping guide on the surface 24, and a annular butt joint surface 25.

In this embodiment, the fastener ring 30 is formed integrally with the first coupling member 10 and is joined thereto by an articulated web 3I. Adjacent to the frame 31, the fastener ring is formed with a slit 32 which provides a point of flexure around which the ends of the split ring can be deformed. As best seen in Figure 2, the fastener ring includes two limbs 33 and 34, which extend in opposite directions from the slit 32, and intersect with each other in the "divided" region 35, diametrically opposite the slit 32. Region 35 corresponds to the "split" in the ring, which allows the extremities to deform to expand and contract the ring, Extremities 33 and 34 end after crossing with finger projections 36 and 37, respectively, which allows the ring to expand by pressing the finger that pushes the projecting ends 36 and 37 toward each other.

As best seen in Figures 1 and 3, each limb 33 and 34 consists of a radially flat portion 38 on which a radially outer edge 39 depends. The radially inner edge of the flat portion 38 is formed with an adjustment profile generally triangular having a guide surface with slope 41, and an abutting engagement surface 42, for adjusting the second coupling member.

In this embodiment, the dividing ring 30 is integrally molded with the first coupling member as a shape with figure of eight. This provides a convenient way to reduce the counting of the individual part of the coupling, and can also simplify the assembly process. Before the coupling can be used, it is necessary to fold the fastening ring 30 into its operative position in which it surrounds the cylindrical wall 12 of the first coupling member (as illustrated in Figs 1 and 3). The dividing ring 30 is retained in its operative position by a number of "L" shaped retention protrusions 13 (four projections in this embodiment) projecting from the flange 11. Initially, in order to adjust the split ring under the projections 13, it is necessary to move the finger-shaped projections 36 and 37 of the ring, horizontally remote from one another, in order to reduce the diameter of the ring. Once the ring has passed under the projections, the finger projections 36 and 37 can be released to allow the split ring 30 to expand back to its usual size.

With the split ring 30 in its operative position, the coupling can be assembled as the second coupling member 20 advances over the first coupling member (Fig. 3). The guide on the surface 24 of the second coupling member 20 is progressively supported against the guide of the surface 41 of the split ring 30, for pushing the ends 33 and 34 of the split ring separately and allowing the adjustment profile of the second member of coupling 20 moves after the coupling profile of the split ring 10. From there, the split ring 30 jumps back to its original position (Fig. 3) and the butt joint surface 42 of the split ring 30, fits behind the abutting surface 25 of the second coupling member 20, whereby the second coupling member 20 is engaged in position. The second connector member 20 thus forms a sharp break that fits against the first coupling member 10 without the need for the user to manipulate the split ring by itself.

To release the coupling, the user presses projections 36 and 37 of the split ring towards each other, to move the limbs 33 and 34 separately, and thus expand the split ring 30. This action changes the abutting surface 42 of the split ring 30 laterally out of the abutment surface 25 of the second coupling member 20, and thus it allows the second coupling member 20 to be separated from the first coupling member 10. It will be appreciated that the degree of movement of the clamping ring at the ends 33 and 34 is larger adjacent to the crossing (region 35) and, progressively becomes plus • small towards the bending point 32. The size of the abutting surface 42 of the clamping ring, reflects this by being radially larger (i.e., it projects radially inward further) adjacent to the crossover (and therefore it needs a greater movement to disengage the abutting surface 25 from the second coupling member), and becomes progressively radially smaller towards the bending point 32 (such that less movement is required to disengage the abutment surface 25). ).

As can be seen in figures 1 and 2, the flange 11 has openings 14 which are coextensive with the projections 13. The openings 14 do not have a function in use of the coupling, but instead, are a consequence of the shape of the parts of molding used to mold the flange 11 with the integral protrusions 13. Typically, the molding portions to form the protrusions 13, will be as illustrated in Figure 4. In this drawing, the numeral 40 details an upper part of the mold with a recess 52, the number 54 details a lower part of the mold with a projection 56. The space 58 between the parts of the mold, defines the molded shape of the coupling member. It will be appreciated that an opening in the flange under the projection allows the molding portions (and in particular the projection 56 below the projection) to be separated by a simple movement in the direction indicated by the arrow 60. Of course, if desired , the flange 11 can be molded without the openings 14, but a more complicated mold would then be required (for example, with a part that "can be rotated from under the projection 13 when the mold is to be opened).

When the fastener ring 30 is molded, it may be found convenient to mold the ends 33 and 34 with a thin connecting weft 62 at the crossing 35, as illustrated in Figure 5. The closed spacing of the ends 33 and 34 means that there is little space for a molding part to fit between the extremities in the crossing, without causing the extremities to mold severely outside of their correct planes. After molding, the web 62 would not need to be separated, before the fastener ring 30 was bent into its operative position. Of course, if it is desired to mold the limbs 33 and 34 without a frame 62, then the mold may include a thin tongue which, under use, would fit between the extremities. However, said thin molding part may be vulnerable to damage during the manufacturing process, and repair would then be costly.

Although the split ring 30 is integrally molded with the first coupling member in the above embodiment, it will be appreciated that this is not essential. In an alternative embodiment, the fastener ring 30 could be molded separately, and fit the first coupling member in a manner similar to that described above.

It will also be appreciated that the invention, particularly as described in the preferred embodiments, can provide a coupling that is simple to use and manufacture, but that can achieve a positive fit between the coupling portions over a large portion of the circumferential periphery of the invention. the coupling members.

In one aspect, the projections extending radially out of the split ring do not obstruct or otherwise interfere with the radially inner fit surface of the split ring. This provides an extremely convenient (but not necessarily the only) way to increase the available adjustment areas around the periphery of the coupling members. The split ring and / or removable coupling member may have substantially continuous adjusting or sealing surfaces around the periphery, or may have discrete tabs.

In another embodiment, the substantially continuous adjustment between the "partition ring and the second coupling member around the periphery of the second coupling member, can provide an excellent positive adjustment, and can prevent unintentional release of the coupling. the coupling is nonetheless, as easy to release manually as other links in this field.

In a further aspect, the molding of the clamping ring integrally with the first coupling member provides a convenient way of reducing the individual count of the parts and simplifying the assembly.

While aspects of the invention that are believed to be of particular importance have been emphasized in the description and claims, the applicant claims protection for any novel feature or combination of features described or illustrated in the drawings, regardless of the emphasis placed on the same.

With reference to this date, the best method known by the applicant to carry out the present invention is the conventional one for the manufacture of the objects to which it refers.

Having described the invention as above, property is claimed as contained in the following

Claims (15)

1. A coupling for a medical device characterized in that it comprises: first and second coupling members adapted to surround a body opening; an elastic split fastener ring, mounted on the first coupling member, the first and second coupling members releasably secured together to the fastening ring, the fastening ring engaging the second coupling member substantially continuously around the periphery of the coupling member. second coupling member so as to secure together the coupling members, the fastener ring releases the second coupling member when external forces are applied to expand the coupling ring.

2. The coupling according to claim 1, characterized in that the split fastener ring includes a first and second ends, each of the ends has a continuous adjustment portion for continuously contacting the periphery of the second coupling member.

3. The coupling according to claim 1, characterized in that each of the extremities includes a terminal portion close to the terminal and divided portions that overlap one with the other.

4. The coupling according to claim 3, characterized in that the end portions include finger-shaped projections.

5. The coupling according to claim 1, characterized in that the split fastener ring is retained or the first coupling mimembro and the first coupling include a retaining means for retaining the fastener ring divided therein.

6. The coupling according to claim 1, characterized in that the first coupling member and the clamping ring are integral.

7. A coupling for a medical device characterized in that it comprises: first and second coupling members adapted to surround a body opening; a resilient split fastener ring retained on the first coupling member, the first and second coupling members releasably secured together with the fastener ring, the first coupling member includes retaining means for retaining the fastener ring therein; retaining means allow the expansion of the clamping ring when an external force is applied to the clamping ring, the clamping ring expands to release the second coupling member and allow the coupling members to be separated.

8. The coupling in accordance with the claim 7, characterized in that the retaining means include at least one retaining projection projecting from the first coupling member.

9. The coupling in accordance with the claim 8, characterized in that the first coupling member includes a respective opening associated with each retaining projection.

10. The coupling according to claim 7, characterized in that the first coupling member and the clamping ring are integral.

11. The coupling in accordance with the claim 10, characterized in that the clamping ring is joined to the first coupling member by a flexible web.

12. The coupling in accordance with the claim 11, characterized in that the flexible web has a joint that allows the clamping ring to be bent over the first coupling member.

13. The coupling according to claim 7, characterized in that at least one of the clamping ring and the second coupling member have a tipped surface to facilitate the adjustment of the clamping ring with the second coupling member.

14. The coupling according to claim 7, characterized in that the first coupling member is placed on a medical grade adhesive pad.

15. The coupling according to claim 7, characterized in that the coupling is an ostomy coupling. . with orm a with claim 15, characterized in that the first coupling member is a body-side coupling member and the second coupling member is a bag-side coupling member.