MXPA96002141A - Auto-alineamie ostomy device - Google Patents

Abstract

The present invention relates to an ostomy device characterized in that it comprises a first part in the form of a waste collection bag and a second part in the form of an adhesive front plate, coupling rings mounted respectively in the first part and the second part for releasably attaching or joining said parts, and means for aligning the coupled coupling thereof, the aligned means include hook means associated with one of the parts of the hook engaging means associated with the other parts of the parts, the hook coupling means have a tongue with an opening defined at least in part by a laterally extending element.

Description

OSTOMY DEVICE OF SELF-ALIGNMENT Field of the Invention The present invention relates to ostomy devices of the type including a faceplate adapted to be adhesively attached to the skin surrounding the stoma or orifice and a waste collection bag mounted spaced apart therein and more particularly to a device that includes means for facilitating the alignment of the bag or bladder and the faceplate.

Background of the Invention Some surgical procedures known as colostomy, ileostomy and urostomy cause an opening in the abdominal wall, called a stoma, that allows waste to be discharged from inside a body cavity. Since the patient has no control over the discharge of waste or excrement, it is often necessary for patients who have to undergo these surgical procedures, use an ostomy device to protect the stoma and collect the material REF: 22604 when it is Discharged. For years, ostomy devices of a variety of different types and constructions have been used. Various materials and adhesives have been developed to increase their usefulness and wear. The basic device includes a waste collection container connected to a faceplate coated with adhesive which serves to mount the container or receptacle to the body. The receptacle typically includes first and second thin film walls, which are sealed by hot welding or the same along the periphery to form the outline of a sack or bag. A faceplate with adhesive backing is designed to secure the pouch to the skin surrounding the stoma. The faceplate and pouch have openings adapted to align the stoma. Recent improvements have extended the period during which the faceplate can be used, to be longer than normally required by a bag to fill its capacity with the waste material. However, with respect to new users, in particular, it will be necessary to frequently remove the device to provide access to the skin surrounding the stoma and stoma by itself. The removal of the frontal plate allows the observation and verification of the condition of the skin surrounding the stoma and, if necessary, the treatment thereof. Therefore, it is suggested from the improvements in the materials and adhesives of the front plate, to frequently remove the device, due to the cleaning of the bag and verification for the treatment of the skin that surrounds the stoma, and the stoma , may be required. However, frequent removal of the skin's frontal plate should be avoided. The skin surrounding the stoma is often extremely sensitive and may include an incision with scarring or scar tissue. Frequent removal of a faceplate with adhesive backing can lead to irritation and skin flaking. A popular solution to this problem is to provide an ostomy device in which the bag is detachably attached to the faceplate. In this so-called "two-piece" device, the face plate can remain fixed to the skin for a prolonged period of time, but the bag can be removed for observation and treatment of the stoma and replaced when necessary. The two-piece device requires a means for releasably attaching the bag to the faceplate. A particularly successful structure takes the form of a pair of semi-rigid or rigid plastic or plastic parts resembling a ring or annular, one in the form of a flange or rib extending axially and the other in the form of a channel in the which the flange or rib can be received in a removable form and coupled or frictionally engaged. When the faceplate is mounted to the skin, the parts of the ostomy device are assembled by first aligning the plastic rings. Then a force is applied to the outer portion of the bag, on the coupling rings, in a direction towards the body, along the axis of the rings, to close the rings at once. An extremely successful commercial coupling ring structure is described in U.S. Patent No. 4,460,363 to Steer et al. This patent discloses a pair of coupling rings, one of which includes an axially extended rib or flange comprising an edge or flange extending radially outwardly and an inwardly extending fillet or sealing tape, which is extremely resilient or flexible. The other coupling ring includes a channel formed by spaced relatively rigid walls. One of the walls has a projection extending radially inward which cooperates with the edge or flange extending radially outwardly in the flange or rib to hold the flange within the channel. The sealing band or band is deviated or deformed by channel walls, when the ridge or rib is received. The offset sealing or sealing tape applies a force on the flange or rib in the direction of the edge to hold the flange securely within the channel. To attach the rings, precise alignment of the rings is required. Users with manual dexterity problems may encounter this difficulty. In addition, the rings may be difficult for the user to see, either because he himself has poor eyesight or is obese, which makes alignment a problem. The present invention overcomes these difficulties by providing a gravimetric, simple self-aligning mechanism. In general, the mechanism includes a connecting element or hook having a flat upper surface which is received in an opening defined by a laterally elongated element in the bag, such that the bag can hang from the hook. As soon as the front plate is in place in the user and the user is in a vertical position such that the front plate is in a substantially vertical plane, the flat upper surface of the hook and the elongated element in the bag cooperate to cause the bag tilts you to a position where the center line of the bag ring is substantially vertical. While the connecting element or hook is located at the top and along the center line of the coupling ring of the front plate, gravity could cause the rings to be aligned, without any manipulation by the user. Once aligned, the rings can be coupled in the conventional manner, without difficulty. Another problem with two-piece ostomy devices is that the coupling rings can be accidentally separated by vigorous movements of the user. Such a separation could normally cause the bag to fall away from the faceplate, a result that should be avoided. The hook in the present invention can act as an auxiliary fastening mechanism to prevent separation, for even greater safety. U.S. Patent No. 4,846,820 issued July 11, 1989, by Ole R. Jensen, and entitled "Ostomy Device" teaches interem-brague or auxiliary internal clutch parts, which act along the coupling rings for prevent accidental separation, and help in the support or fixation of the bag. However, it is not taught how these parts are formed or placed, to facilitate the alignment of the coupling rings. In addition, they are not provided with a fastening mechanism.

Description of the invention It is therefore a first object of the invention to provide an ostomy device with a simple self-aligning mechanism. Another object of the present invention is to provide an ostomy device wherein the self-aligning mechanism includes a secondary means for securing the bag to the faceplate, for additional security against accidental separation. According to the present invention, an ostomy device is provided, which includes a first part in the form of a collection bag and a second part in the form of an adhesive face plate. Coupling rings are mounted respectively on the bag and on the front plate to detachably connect the parts. Means are provided for aligning the coupling rings to facilitate coupling or engagement thereof. The alignment means includes hook means mounted on one of the parts and hook coupling means mounted on the other part. The hook means include a substantially flatter upper surface. The coupling or engagement means of the hook includes an opening defined, in part, by a laterally extending member. The element is adapted to be coupled by the upper surface of the hook means. Preferably, the engagement means of the hook comprises a projection extending from the coupling ring of the bag. The projection or tongue includes a recess which is arched in the configuration. Means are provided in the hook means for holding the element. The securing means may include a notch or recess in the hook means. To this and such other objects that may appear later, the present invention relates to a self-aligning ostomy device as described in detail in the following specification and referenced in the appended claims, taken in conjunction with the drawings that the accompany, where numerical similarities refer to like parts and in which: Figure 1 is an exploded isometric view of a first preferred embodiment of the ostomy device of the present invention; Figure 2 is a plan view of the device; Figure 3 is an enlarged cross-sectional view of the coupling rings after connection or coupling; Figure 4 is a view similar to Figure 3, showing the coupling rings prior to connection or coupling; Figure 5 is a side cross-sectional view showing a second hook shape; Figure 6 is a side cross-sectional view of a third form of the hook or hook element; Figure 7 is an exploded isometric partial view of a second preferred embodiment of the present invention; and Figure 8 is a side, cross-sectional view of a third preferred embodiment of the present invention. As seen in the drawings, the device of the present invention includes an adhesive backing faceplate, generally designated A, and a waste collection bag, generally designated B. Faceplate A and bag B which are illustrated, are essentially as described in U.S. Patent No. 4,400,363 to Steer et al. Bag B is made of two sheets of flexible, thin film. The film is manufactured from materials that have the properties of being impervious to moisture, impervious to odor and are capable of being thermosealed or welded on impulse. Suitable materials include polyethylene, copolymers of polyethylene and ethylene vinyl acetate, copolymers of polyethylene acetate, copolymers of vinyl chloride and polyvinylidene chloride and laminates thereof. The walls of the bags are preferably approximately 0.0051 to 0.0102 cm (2 to 4 mils) thick. The walls are sealed around its periphery to provide a waste receptacle. The end of the bag can be closed or opened, when desired. A wall of the bag is provided with a coupling ring 12 in the form of a channel or annular groove, of rigid plastic, which is welded or otherwise fixed to its exterior. The interior of the ring 12 defines the stoma that receives the opening 14 in the bag. The ring 12 is designed to be received in a second coupling ring 16 which is welded to the side of the bag 18 of the faceplate A. The coupling rings 12 and 16 interlock with sealing to removably fix the boJL sa B to the faceplate A. The side of the bag 18 of the faceplate A is formed by a thin film of polymeric material 20 to which the base 21 resembles an enhancement of the coupling ring 16, is fixed. On the body side 22 of the faceplate A is a layer 23 of adhesive suitable for use on human skin, and capable of supporting the weight of the device. The adhesive layer 23 is covered by a sheet of release paper (not shown) prior to use. In normal use, the opening 24 in the front plate A is designed to be fixed by hand to the stoma by the user. This is done by enlarging the opening to fit or fix it comfortably around the stoma. The faceplate is then affixed to the patient's body such that the adhesive layer 23 on the body side 22 adheres to the skin surrounding the stoma and the stoma is interposed through the enlarged opening 24. When the faceplate A is at its place securely, the bag B is mounted thereto by the proper coupling or coupling of the coupling rings 12 and 16. As best seen in Figures 3 and 4, the coupling ring 16 includes a straight annular wall 28 with projections 30 and 32 designed to fit hermetically with the channel 34 of the coupling ring 12, which is fixed to the outer surface of the wall 10 of the bag A. It should be appreciated that the particular configuration of the rings of Coupling is not part of the present invention and could not be considered a limitation thereof. The adhesive layer 23 of the faceplate A, may be formed of any pressure sensitive adhesive, suitable for use in human skin and capable of supporting the weight of the application or ostomy device. Preferably the adhesive consists of an elastomeric substance such as polyisobutylene containing one or more hydrocolloids, as taught by Chen in U.S. Patent No. 3,339,546? by Chen et al., in U.S. Patent No. 4,192,785; by Pawelchak in U.S. Patent No. 4,393,080, or the same could additionally include a styrene-type block copolymer as taught by Doyle et al. in U.S. Patent No. 4,551,490. The Host or Disk adhesive will preferably be from about 0.0508 to 0.1778 cm (20 to 70 mils) thick. The present invention involves the addition of the self-aligning means consisting of a hook 36 placed on the faceplate A, either extending from the base 21 of the coupling ring 16 of the faceplate (Figures 1-7) or from the annular wall 28 of the coupling ring 16 (FIG. 8), and a engaging portion of the hook in the shape of a tab 38, which extends from the coupling ring 12 of the bag.

The tongue 38 extends axially from the top of the ring 12, along the vertical axis of the ring. It has a generally arched opening 40 defined in part by an elongated element 42 extending laterally. It is located such that it is bisected by the vertical center line of the coupling ring 12 of the bag. The central portion of the lower surface of the element 42 has the substantially planar portion extending in a direction generally perpendicular to the vertical center line of the coupling ring 12. The hook or latch member 36 has a flat upper surface 35. The It is located along the vertical centerline of the faceplate. As seen in Figures 3 and 4, when the latching element 36 is received in the opening 40 of the tongue 38 such that the lower surface of the element 42 remains on the flat upper surface 35 of the element 36, the bag B It will oscillate freely until the gravity and the contours of the casing or joint surfaces cause the alignment of the coupling rings. This could occur while the faceplate is in the vertical position and the element 36 and the tongue 38 are located above and along the vertical center lines of the coupling rings. Once the coupling rings are aligned in this manner, they can be closed at the same time, as illustrated in Figure 4. Figures 1-4 illustrate a hook or hook member 36 with a straight portion 44 made of substantially flexible plastic material. The portion 44 is provided with an outer surface 46 inclined to facilitate insertion into the opening 40. The inner surface 48 of the portion 44 is generally flat and parallel to the surface of the base 21. Figure 5 illustrates another form of hook 36 wherein the straight portion 44 is a little elongated and is provided with a notch or recess 50 in which the element 42 is retained with friction. The resilience or flexibility of the material of which the portion 44 is composed will tend to accommodate the element 42 within the cavity 50. Figure 6 still illustrates another form of flexible portion 44, again elongated, with a cavity 50. However, in this form, the mouth or hole of the cavity 50 is provided with parts that extend in opposite form, 52, 54 which will monitor the "fixing" element 42 in the cavity or ca 50, when the same is received in this . In this way, the accidental separation of the bag B from the front plate A will be very small. Figure 7 illustrates another preferred embodiment wherein the opening 40 in the tongue 38 is provided with a straight vertical extending portion 60. The portion 60 is formed and sized to more closely receive the engaging member 36. Figure 8 shows another preferred embodiment of the present invention. In this embodiment, the latching element 36 extends from the outer wall 28 of the ring 16, instead of the base 21. More specifically, the element 36 extends from the wall 28 to a point on this immediately adjacent to where the rim or edge of the ring 12 is located, when the ring 12 is received in the ring 16. It should now be appreciated that the present invention relates to a self-aligning mechanism for a two-piece ostomy device in the form of a hook and a hook coupling tongue. When these parts are conveniently formed and located, and the hook engaging or engaging means are received in the hook, the bag will swing to a position where the coupling rings are aligned to facilitate engagement of the bag to the faceplate. In one embodiment, the hook is provided with a simple mechanism for interlocking the engagement tongue of the hook to provide additional security against accidental separation or detachment of the front plate bag. Although only a limited number of preferred modalities have been described for purposes of illustration, it is obvious that many modifications and variations could be made. It is intended to cover all of these variations and modifications that are within the scope of the present invention as defined by the following claims: It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which refers to the manufacture of the objects to which it refers.

Having described the invention as above, the content of the following is claimed as property 15 20 25

Claims (14)

1. An ostomy device characterized in that it comprises a first part in the shape of a bowl. Said waste collection and a second part in the form of an adhesive faceplate, coupling rings mounted respectively on the first part and the second part to detachably join or join said parts and means to align said ani-lys coupling to facilitate the coupling of the same.

2. The device according to claim 1, characterized in that the aligning means comprise hook means associated with one of the hook coupling parts and means associated with the other of such parts.

3. The device according to claim 1, characterized in that the means for coupling or engaging the hook are mounted on the first part and the hook means are mounted on the second part.

4. The device according to claim 1, characterized in that the coupling or engagement means of the hook comprises a tongue with an opening defined, in part, by a laterally extending element.

5. The device according to claim 4, characterized in that they also comprise substantially flatter means in the hook means to cooperate with said element.

6. The device according to claim 5, characterized in that they also comprise a notch or hollow in the hook means for receiving said element.

7. The device according to claim 6, characterized in that the means of the hook comprise a straight portion and wherein the notch or hollow is located in the straight portion.

8. The device according to claim 5, characterized in that it also comprises means in said means of the hook to interlock or fix said element.

9. The device according to claim 1 characterized in that the means of the hook extend from the coupling ring mounted in the first part.

10. An ostomy device characterized in that it comprises a collection bag, an adhesive faceplate, coupling rings mounted on said bag and said faceplate, respectively, for releasably connecting the bag and the faceplate, each of which Coupling rings have a vertical centerline, hook means mounted on the faceplate along the vertical centerline of the faceplate engagement ring and comprising a surface with a substantially planar portion extending in a direction substantially perpendicular to the vertical center line of the coupling ring of the front plate and means for engaging or joining the connecting or hook means mounted on the bag along the center line of the coupling ring of the bag and which it comprises a laterally extending element with a portion substantially perpendicular to the vertical center line of the ring d e coupling of the bag.

11. The device according to claim 10, characterized in that the means for engaging or joining the hook means comprise an arched opening, defined, in part, by said element.

12. The device according to claim 11, characterized in that the hook means comprise a notch or slot for engaging or joining said element.

13. The device according to claim 12, characterized in that the hook means comprise means for fixing or interlacing said element.

14. The device according to claim 10, characterized in that the connection or hook means comprise a straight portion with a notch or hollow adapted to frictionally engage said element.