ADHESIVE POUCH DRESSING
TECHNICAL FIELD
The objective of the present invention is related to adhesive dressings.
BACKGROUND ART
The flat adhesive sheet is commonly used as barrier protection of objects and structures. More specifically in medical field, its application in wounds, catheters fixation and so on is well documented and practised. However, on protruding bodily organs or structures, such as ears, chin, fingers, toes, and penis, and medical devices attached onto body surfaces, such as central venous catheter, a two dimensional, or flat, adhesive sheet cannot provide satisfactory barrier protection. We need a non-adhesive pouch, or bag, in addition to the flat adhesive sheet in such situations. There are in the market ostomy bags (such as USD909572S, USD618791 S1 , USD753820S1 , USD460550S1 and USD607559S1) and wound pouches (such as USD303575S) with a configuration of a non-adhesive pouch welded to a flat adhesive sheet. They are generally made of thick and non-breathable materials, which allow easy handling in the process of manufacture, with a design based on sealing two or more flat sheets of polymer to form a bag with adhesive layer on the skin-facing surface, which in turn has a hole that communicates with wound, stoma, or orifice to enable passage of exudates and excreta into the pouch or bag. However, as wound heals better with a breathable barrier that allows gaseous exchange, thick and non-breathable materials that can cause wound maceration are not conducive for comfort and wound healing. Furthermore, in such a design, the pouch runs parallel to the skin surface rather than perpendicular to it, thereby precluding its application on protruding objects and structures such as those mentioned above.
SUMMARY OF THE INVENTION
The objective of the present invention is to provide an adhesive pouch dressing comprising a non-adhesive pouch with its open end welded substantially perpendicular to a hole in a flat adhesive sheet. It also provides a novel method of perpendicularly welding a non-adhesive pouch to a piece of adhesive sheet. The invention thus overcomes the problems of covering a protruding object or structure as mentioned above, be it on living or nonliving things.
In a preferred embodiment, both the non-adhesive pouch and the adhesive sheet are thin, soft and flexible, either translucent or transparent polymeric elastic films. Most preferably, the material is a high moisture vapor permeable, or breathable, film. The pouch is manufactured separately, either by welding two layers of non-adhesive sheets together like a bag or by dip moulding like a rubber glove or condom. The adhesive sheet is preferably in a four-layer surgical dressing configuration, in the order of a semi- rigid backing sheet, soft dressing sheet, adhesive coating (together with dressing sheet to be termed “adhesive sheet” for easier reference, since the two are inseparable in this patent filing) and releasing sheet, with a hole cutting through the four layers. A rim of either the backing sheet or the releasing sheet next to the hole is cut and removed to expose the underlying pouch so that it can be welded directly onto the adhesive sheet, by using either physical (such as heat or ultrasonic welding) or chemical means (such as adhesive). At deployment of the pouch dressing onto an intended surface, the releasing sheet is peeled off to stick the adhesive sheet onto the surface. This is followed by removing the semi-rigid backing sheet to leave only the soft and breathable pouch and adhesive sheet on the skin surface. An example for use is as a male condom, wherein the pouch functions as condom and the flat sheet adheres to the skin at the base of the penis. The non-adhesive pouch may be turned inside out to be used as female condom by having the pouch lining the vagina and the adhesive sheet covering the vulvae and perinium. By adding a luminal connector to the pouch, the pouch dressing can function as an external urinary catheter, where a urine bag can be attached to the connector. The pouch can be also used as a collector or reservoir of bodily discharges or wound exudates, with optional resealable connectors for drainage or irrigation. To prevent the connector from twisting and tearing the flexible pouch, a thicker or less flexible adhesive strap can be affixed onto the connector and adhered to the exterior of the pouch. Alternatively, a sponge or foam like material can be inserted inside the pouch for this purpose.
It is another objective of the present invention to provide a better pouch dressing that prevents bodily discharges or exudates from striking through, and more resistant to be pulled off. This is achieved by welding the pouch’s open edges substantially away from the hole in the adhesive sheet. The resultant product will then have an adhesive portion both inside and outside the pouch, giving the pouch a better grip on the skin in resisting detachment. To go a step further, the inner dressing sheet may have a rim of semirigid backing sheet to prevent the inner adhesive portion from rolling up to prevent striking through. To provide reinforcement of the welding seam, an extra adhesive strip may be applied, preferably circumferentially, onto the joint between the pouch and the adhesive sheet after the adhesive pouch dressing is dully applied onto the surface. This is important especially when the seam between the pouch and adhesive sheet is not strong due to the ultrathin nature of the latter or when the materials used for the pouch and the adhesive sheet are different, leading to weaking of the seam.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 shows a cross-sectional schematic view of a non-adhesive pouch 1 with an intra- pouch adhesive sheet 2b adhering 3 to a surface 10.
Figure 1 b shows a cross-sectional schematic view of a non-adhesive pouch 1 with an extra-pouch adhesive sheet 2a adhering 3 to a surface 10.
Figure 1c shows a cross-sectional schematic view of a non-adhesive pouch 1 with both intra-pouch 2b and extra-pouch adhesive 2a sheets adhering 3 to a surface 10.
Figure 2 is a perspective view of a non-adhesive pouch 1.
Figure 3a is a top perspective view of a four-layer-with-a-hole configuration of an adhesive sheet 2 with backing sheet 5 on top. The inner rim of the backing sheet 5 by the hole is removed to expose the underlying adhesive sheet 2.
Figure 3b is the view of a four-layer-with-a-hole configuration of an adhesive sheet 2 as shown in Figure 3a wherein the device has been turned upside down. Here the top layer is releasing sheet 4.
Figure 4 is a top perspective view of a four-layer configuration of an adhesive sheet 2. A rim of backing sheet 5 is removed, but its inner most rim 5b by the hole 6 is spared.
Figure 5 is a top perspective view of another four-layer-with-a-hole configuration of adhesive sheet 2 wherein the top layer is the releasing sheet 4 with its inner rim removed to expose the adhesive layer 3 of the adhesive sheet 2.
Figures 6a to 6d show a preferred process in manufacturing the present invention.
Figure 6a shows a welding device 11, a four-layer-with-a-hole adhesive sheet configuration as shown in Figures 3a, 3b, 4 and 5, a non-adhesive pouch 1 and a cushioning pipe 12 duly aligned for welding.
Figure 6b The pouch 1 is placed inside the cushioning pipe 12 with its open end 1z of the pouch 1 inverted over the upper edge 12a of the pipe 12 to prepare the area between 1x and 1y for welding.
Figure 6c Coinciding with the exposed rim 2 or 3 of the adhesive sheet 2, the welding device 11 is pressing onto the adhesive sheet configuration and the pouch area between 1x and 1y beneath.
Figure 6d Disengaging the welding device 11 and the pipe 12 releases the present invention.
Figure 7a shows a perspective view of a preferred embodiment of the present invention (an inverted device image of Figure 6d), noting the welding seam 1s (area between 1x and 1y of Figure 6b) and the inverted portion 1r (area between 1y and 1z of Figure 6b) of the pouch 1, which can be removed with an appropriate means.
Figure 7b shows a cross-sectional schematic view of the embodiment as shown in Figure 7a.
Figure 7c shows the embodiment as shown in Figure 7b duly applied on a surface 10, with the backing sheet 5a and releasing sheet 4 removed.
Figure 8a shows a cross-section of another embodiment, wherein the innermost rim of backing sheet 5b has been retained (ref. Figure 4).
Figure 8b shows a cross-sectional view of the embodiment as in Figure 8a applied on a surface 10. Figure 9 show a cross-section of yet another embodiment wherein the adhesive sheet 2b is only found in the confines of pouch 1 (ref Figure 1a).
Figure 10a shows a perspective view of an adhesive pouch dressing wherein there is attached a luminal connector 20 with adhesive straps 22 and its corresponding releasing sheet 4 protected adhesive 3.
Figure 10b shows a perspective view of the embodiment as in Figure 10a duly applied on a surface 10 wherein the backing sheet 5 is removed and the straps 22 are affixed 3 to the pouch 1 and the adhesive sheet 2.
Figure 11a shows a combined perspective and cross-sectional view of an embodiment as in Figure 7a where in an adhesive strip 32 is circumferentially affixed to the joint between the pouch 1 and the adhesive sheet 2, applied on a surface 10.
Figure 11 b shows a cross-sectional view of the configuration of the embodiment as in Figure 11a.
Figures 12a to 12d show another preferred manufacturing process of the present invention.
Figure 12a shows a welding means 11 with a centrally located probe 13.
Figure 12b shows a pouch 1 completely capped 1c over a cushioning pipe 12.
Figure 12c shows the welding device 11 with its probe 13 pushing the closed end of the pouch 1c into the pipe 12 through a hole 6 in an adhesive sheet while simultaneously welding the adhesive film 2 to the inverted rim 1r of the pouch 1.
Figure 12d shows the resultant adhesive pouch dressing comprising a non-adhesive pouch 1 welded 1s to a four layer configurated adhesive sheet 2, 3, 4, 5 with a hole 6.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
According to the preferred embodiment of the present invention, the adhesive pouch dressing (Figure 7a) comprises two components: a non-adhesive pouch 1 (Figure 2) and a flat adhesive sheet 2 (Figure 3a) with a hole 6 in it. The two components are welded 1s substantially perpendicular to one another by aligning the open end 1z of the pouch 1 to coincide with the hole 6 to create the pouch dressing (Figures 6a to 6d, Figures 12a to 12d). The adhesive sheet 2 is typically in a surgical dressing’s configuration of four layers (the backing sheet 5, dressing sheet 2, adhesive layer 3 and releasing sheet 4) for stability and easy handling. A rim of either backing sheet 5 (Figures 3a and 3b) or releasing sheet 4 (Figure 5) adjacent to the hole 6 is removed to expose the underlying adhesive sheet 2. The welding is achieved through inserting the pouch 1 into a cushioning pipe 12 and flipping the open end 1z of the pouch 1 over the upper opening 12 of the pipe 12 (Figures 6a and 6b), placing and aligning the said adhesive sheet assembly ( 2, 3, 4, 5, 6) on top, followed by welding of the pouch 1 and adhesive sheet 2 together using an appropriate means (11), such as ultrasound or heat welding (Figures 6c and 6d). The pouch 1 and adhesive sheet 2 are then irreversibly welded 1s together into a single piece (Figures 7a and 7b). The welding can also be achieved (Figures 12a to 12d) by capping a pouch 1 over a cushioning pipe 12 (Figure 12b), and the pouch’s closed end 1c is pushed into the pipe 12 by an appropriate means, such as a probe 13, with the pouch open edge 1z still being kept at the brim of the pipe 12 for welding (Figure 12c) as mentioned above. The two approaches are the same, except that in the former the pouch is flipped inside out while the latter outside in for welding. Due to the inevitable folds or wrinkles that are created with such flipping around, it is to be emphasized that welding, whether by heat, ultrasound, or other means, up to the extent of melting both components together is a must in order to achieve a leak proof seam. At deployment, the releasing sheet 4 is removed to stick the adhesive sheet 2 on a designated surface 10, followed by removal of backing sheet 4. What are then left on the surface are the flexible pouch 1 and the flat adhesive sheet 2 (Figure 7c). There may be cut lines on both backing sheet 5c and releasing sheet 4c to ease the respective sheet’s removal from the adhesive sheet 2.
In another preferred embodiment, an inner rim of adhesive sheet 2b adjacent to the hole 6 is created in the confines of the pouch 1 (Figures 1 b, 1c, 7b, 7c, 8a, 8b, 9) by welding the pouch’s open edge 1z further away from the hole 6. The advantage of such a wider inner rim 2b is to enable the pouch 1 to hold a higher intra-pouch 8 pressure. One can easily understand from studying the Figures 1 a, 1 b and 1 c to realize that the configuration of having both intra-pouch 2b and extra-pouch’s 2a adhesive sheet (Figure 1c) is most resistant to be pulled off from the underlying surface 10. To further prevent striking through of exudates, a rim of harder and less flexible backing sheet 5b (Figures 4, 8a, and 8b) can be retained on the adhesive rim 2b.
In another preferred embodiment (Figure 9), the inner adhesive rim 2b, with the optional inner backing rim 5b (Figure 9), is the only anchoring means for the non-adhesive pouch 1. This configuration may be useful when the adhering surface 10 is limited, such as interdigital space between the fingers when the pouch 1 is capped onto a finger.
In another preferred embodiment, the distal end of the pouch 1 can be opened or be attached to a luminal connector 20, which in turn can be resealable with a plug or be connected to a bag, for drainage of discharges. To prevent the pouch 1 from being twisted or tom by the connector 20, less flexible or thicker adhesive straps 22 can be affixed to the exteriors of the luminal connector 20 and the pouch 1 (Figures 10a and 10b). There may be more than one such connectors 20 to allow concurrent irrigation from one connector and drainage from the other.
One or more adhesive strips can also be attached to reinforce the strength of the seam 1s (Figures 11a and 11 b) when needed. It can be in a circular adhesive strip 32 that is adhered 33 onto the seam 1s circumferentially after the pouch/adhesive sheet combo is deployed on the surface 10 with the backing sheet 5 removed.
In the case of using the present invention as a male condom, a small receptacle at the tip of the pouch 1 can be created. The receptacle can also be opened and used to house a standalone luminal connector 20, affixed by welding or binding means to create the above drainage function, especially as a condom catheter. Adhesive straps 22 can also be attached to stabilize the connector 2 on the pouch 1.
It is to be emphasized that the hole 6 on the adhesive sheet 2 and the corresponding welding seams 1s can be of other shapes other than the typical circular shape as shown here. Likewise, the adhesive sheet 2 can be of various sizes and shapes. Furthermore, there is an option where the hole 6 is not created during manufacture, instead the user can cut out an appropriate hole in a shape and size according to his/her requirements before using the present invention. In the case of having one or more drainage connectors on the pouch, the length of the pouch can be elongated, emulating a tube, so that the hard connectors and their corresponding counterpart is away from the vicinity of the body to avoid pressure points on the skin. Additional cushioning means, such as foam, can be inserted inside the pouch to prevent kinking or, in the case of negative pressure wound therapy, complete collapse of the pouch when in use.