Drainage catheter

Abstract

A novel drainage catheter comprising an ultrathin and collapsible adhesive pouch, a drainage connector and external adhesive straps for draining urine or other bodily discharges. The straps are for stabilizing the connector to prevent it from twisting and tearing the pouch. The pouch can be replaced by one or two adhesive films to enable it to be used on both protruding and non-protruding surfaces, including penis of various sizes and states, on female's genitalia, exudating wounds and other skin surfaces. An optional suction means with pressure distribution cushion is also disclosed. There may be multiple resealable connectors for concurrent irrigation and drainage.

Description

[0001] DRAINAGE CATHETER

[0002] TECHNICAL FIELD

[0003] The present invention is related to external urinary catheters. It is also about drainage means of other bodily discharges or wound exudates.

[0004] BACKGROUND ART

[0005] The external urinary catheters are important medical devices for bed ridden or incontinent patients as unlike indwelling urinary catheters, they are non-invasive. For man, they are also known as condom catheters. They typically comprise an adhesive pouch, or condom, and a non-adhesive tubular connector at the distal tip, for which a urine bag can be attached. To anchor condom catheter on human body, there are a variety of adhesive pouches that adhere to the glans (US 7896857 B2, DE60126822T2, FI75731 C), the shaft (US 4475910) or the base of the penis (Qivi male external urine management device by Consure Medical) according to their respective designs. However, as the size of penis varies individually, made worse by alteration of sizes in various physiological states and slidable foreskin, there is inevitably a distal loose segment of the pouch that is prompt to kinking and twisting, resulting in obstruction to urine flow. Therefore, regardless of the designs, the pouch, especially at the distal part where it is joined to the connector, must be thick or semi-rigid (except Qivi product mentioned above which requires cumbersome wall suction) to prevent such kinking and twisting. Unfortunately, due to such occlusive (or non-breathable) and rigid (or non-collapsible) characteristics, moisture is inevitably and constantly caught inside the pouch, thereby predisposing the confined penis to irritation and maceration. Because of these, finding the correct size and shape of external urinary catheter to avoid leakage, twisting and strangulation has always been challenging.

[0006] In the case of female external urinary catheters, there has also not been a truly satisfactory solution for anchoring them properly. To date, this has typically involved the application of an adhesive bag (US11207206B2), an adhesive silicon cup (Kitty Kath female external catheter), or a porous cushion (Purewick female external catheter) placed at the i ntroitus, typically with the use of suction means. However, the uneven and sensitive peri-urethral structures are not ideal for adhesive application of an occlusive and non- breathable device, and it may not be comfortable to be on constant suction as humans do not urinate constantly.

[0007] The management of profuse bodily discharges such as wound exudates to a large extend is not dissimilar to urinary management. Its approach is to cover a wound surface with a breathable dressing and to prevent striking through of the dressing by either using absorbing pads or suction. The principal is basic: striking through will not happen provided the pressure under the dressing is lower than the adhesive strength of the dressing on the skin, i.e., there is a way for the discharges to be absorbed or drained before the pressure builds up. However, excessive discharges can make both methods expensive, such as frequent changing of pads, and inconvenient, such as suction mounted on the wall.

[0008] SUMMARY OF THE INVENTION

[0009] The objective of the present invention is to provide a novel ultra-thin, breathable, collapsible, and stretchable drainage catheter for the external management of profuse bodily discharges such as urine and wound exudates in both man and woman so that there is constant dryness inside the catheter. Furthermore, it can be transparent for better monitoring of the underlying tissues, and one-size for all for better economic management. There is also a mechanism to prevent kinking and twisting of the connector on the pouch as well as a suction mechanism that is activated by the presence of moisture and heightened pressure.

[0010] In a preferred embodiment, the drainage catheter comprises three components, namely an ultra-thin pouch, a connector, and adhesive straps. The pouch may be partially or fully coated with adhesive on its inner surface. The distal tip of the pouch is attached with the connector which in turn has semi-rigid adhesive straps extending from it. The pouch is to be capped on protruding organs such as penis while the straps are applied onto the exterior of pouch to prevent twisting and tearing of the thin and flexible pouch by the connector and the attached urine bag. It must be stressed that the adhesive straps must stick not just onto the loose pouch area (non-adhesive part) but also onto the adhered pouch area (adhesive part) on the skin surface to serve its functions.

[0011] To make the pouch free size to accommodate all penile size and shapes, including retracted penis, and to be used on female introitus and other flat surfaces, another preferred embodiment is provided. It comprises an adhesive coated ultrathin film folded or welded in a double layer configuration with the connector and the adhesive strap attached to the fold or the seam. On a protruding organ such as glans penis and penile shaft the two adhesive films are approximated to stick onto the organ circumferentially at the centre and onto themselves at the sides. To avoid the adhesive film sticking onto the sensitive and fragile glans and to create a non-adhesive portion of the pouch from the films, the distal portion of the films may be adhesive free. On a non-protruding penile base, female introitus or other flat surfaces, the adhesive films can be partially or fully spread out to be applied on the skin or wound surface. Adhesive straps are then applied onto the exterior of the adhered films to keep the connector in place. The connector may be placed at either the distal tip or the proximal base of the pouch / films depending on the direction of flow of the discharges. For example, the latter may provide a better urine flow if the patient is in a recumbent position and the pouch / films are to adhere to the base of penis or vulvae. There may also be multiple connectors on the pouch to allow irrigation from one connector and drainage from the other.

[0012] In another preferred embodiment, the connector is partially or completely inside the confines of the pouch / films and the adhesive straps are attached to the connector outside the films. The whole assembly can be put together using adhesive, welding, or binding means. Furthermore, to prevent the glans from being traumatised by the relatively hard connector, a soft external rubbery ring can be placed both internally and / or externally as a cushion.

[0013] In addition to the above designs, a moisture or pressure sensor can be attached to the connector, the pouch, or the adhesive straps, so that the sensor can trigger a suction machine when discharges, such as urine, or pressure are detected inside the pouch.

[0014] To make the ultrathin adhesive film easier to handle, its non-adhesive face can be supported by semi-right backing films which are to be removed after the former is applied.

[0015] In a simplified deployment embodiment, straps can be pre-attached onto or built into the ultrathin pouch / films during manufacture.

[0016] BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 shows a perspective view of a preferred embodiment, a drainage catheter comprising a pouch 1 (in a rolled-up state 1x) with an attached luminal connector 2, which has adhesive 4 straps 3 extending form it.

[0018] Figure 1a shows a perspective view of the deployed drainage catheter with the pouch 1 unrolled onto penis 10 and the adhesive strap 3 affixed 4 to the exterior of the pouch 1.

[0019] Figure 2 shows a cross-sectional view of another preferred embodiment wherein the drainage catheter is an assembly of more parts.

[0020] Figure 2a shows a perspective view of the embodiment shown in Figure 2 wherein the pouch 1 is made up of two adhesive films 1a joined at a fold or seam 1s. The films may have non-adhesive regions 1b around the connector 8 (Figure2).

[0021] Figure 3 shows standalone adhesive straps 3 used for preventing twisting and tearing of the pouch / films 1 by the connecter 8.

[0022] Figure 3a shows multiple adhesive straps 3 joined together in a cross shape with a hole 3h in the centre.

[0023] Figure 4 shows a cross-sectional view of the embodiment in Figure 2 being deployed on penis 10, note the adhesive straps 3 stick 4 all the way to the proximal adhesive part 1a of the films. Figure 4a shows a perspective view of Figure 4, wherein the adhesive films 1a circumscribe the penis 10 in the centre while folding and sticking onto each other 4b at the sides.

[0024] Figure 5 shows a perspective view of Figure 4a wherein the pouch / films 1 cover glans penis 11 only.

[0025] Figure 6 shows a perspective view of Figure 4a wherein the pouch / films 1 cover the entire penis and its base 13.

[0026] Figure 7 shows another embodiment based on Figures 1 and 4, wherein the connector 1 or 8 is located not at the distal tip of the pouch / films 1 but proximally 1c near the adhesive film 1a with the adhesive straps 3 circumscribing the exterior of adhesive film 1a to anchor the connector 8.

[0027] Figure 8 shows another embodiment based on Figures 6 and 7, wherein the connector 8 is located proximally 1c near the adhesive film 1a. The adhesive straps 3 stick onto both the non-adhesive film 1b and adhesive film 1a to anchor the connector 8.

[0028] Figure 9 shows the back perspective view of another embodiment wherein the luminal connector 2 is partially embedded inside the adhesive film 1a1 and 1a2. The embedded proximal portion 2f has a flat or funnel shape rim to encircle the urethral orifice.

[0029] Figure 9a shows the front perspective view of the embodiment as in Figure 9.

[0030] Figure 9b shows the front perspective view of the embodiment as in Figure 9 wherein it is deployed onto penis 10 with the adhesive film, 1a1 anteriorly and 1a2 posteriorly, wrapped around the penis 10, the proximal embedded portion 2f of the connector 2 capped over the urethral orifice and the adhesive strap 3 applied 4 onto the external surface of the film (1a1 and 1A2).

[0031] DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0032] It is to reemphasize that the objectives of the present invention of a drainage catheter is that the entire dressing, pouch, or film that is in immediate contact with the skin or wound surface is ultrathin, collapsible, and breathable. There is a luminal connector for draining bodily discharges collected in the pouch / film on both protruding and non-protruding surfaces. The fragile pouch / films are prevented from being tom or twisted by the connector by the fixating semi-rigid adhesive straps.

[0033] Accordingly, a preferred embodiment is a drainage catheter (Figures 1 and 1 a) comprising a pouch 1 , a connector 2 and adhesive straps 3. To attach the device on protruding organs such as penis, the pouch maybe precoated with adhesive 4 or be rolled onto the penis pre-treated with a double adhesive tape or an adhesive coating. The distal part and / or the tip 22 of the pouch 1 is affixed with the connector 2 and its lumen 2h either by welding or adhesive or binding means. The strap 3 is adhesive coated 4 and covered with releasing sheet 5. The straps 3 can either be in one piece with the connector 1 (Figures 1 and 1a) or be standalone attachments (Figures 3 and 3a). To better stabilize the connector 1 at deployment, there may be one or multiple adhesive straps 3 (Figure 3a). In the case of external urinary catheter, because the adhesive pouch 1 can move according to foreskin mobility and the state of erection of penis, it can be loose and prompt to twisting. The application of thicker and more rigid adhesive strap 3 on the exterior of the pouch 1 serves to prevent such twisting from happening. Besides, the sturdier straps 3 also prevents the connector 2 from tearing the thin adhesive pouch 1 when undue pulling occurs.

[0034] In another preferred embodiment (Figures 2 and 2a), the present invention is an assembly of different components to accommodate the difficulties faced by handling the ultrathin adhesive film and its application on structurally challenging surfaces such as the dynamic male and uneven female urethral orifices. The pouch 1 is now in a configuration of two films, consisting of 1a, the adhesive part, and 1b, the non-adhesive part, joined at the top 1s, with the adhesive surfaces 4 and their corresponding releasing sheets 5 facing downward and inward. A semi-rigid backing sheet (not shown here) is usually present on non-adhesive face of the adhesive films 1a, as seen in a transparent surgical wound dressing (such as Opsite or Tegaderm), for easier handling of the film 1. A novel standalone connector 8 is attached to the films 1 by wrapping the films 1b over it and secured in placed by a binding 8e, adhesive or welding means. The connector 8 may have ridges 8a on it to offer a better grip during its connection to a drainage bag. An external cushioning ring 9 may be placed at the distal end of the film 1 proximal to the connector 2 to prevent the more rigid connector 2 from rubbing and traumatising the underlying soft tissues. The adhesive straps 3 adhere and wrap onto the films 1 that cover the connector 2 and onto the films 1a that are adhered to the underlying tissues (Figures 4 and 4a) to stabilize the connector 8. The straps 3 have a hole 3h that coincides with the connector’s lumen 8b for the drainage bag’s attachment. At deployment, the double films 1 (Figure 2a) are approximated and applied onto penis 10 with the releasing sheets 6 and 6a peeled off to expose the underlying adhesive layer 4 for both films 1a to adhere to the penis 10 centrally and to themselves 4b on both sides (Figures 4 and 4a). In this way, regardless of the size of the penis 10, a complete adhesive seal on the penile shaft 10 is assured. This is followed by the removal of the releasing sheets 5, 5a to adhere the adhesive straps 3 onto the external surface of the applied films 1a, 1b. A drainage bag is then duly attached to the connector’s lumen 8b through the hole 3h on the straps 3.

[0035] The connector 2 and the adhesive straps 3 may be united to be a standalone device (Figure 1) to act as an accessary on other waterproof dressings. An adhesive means can be used here to attach the two devices onto a padded dressing that has a hole created on it for the drainage of discharges.

[0036] In another preferred embodiment as seen in Figures 1 and 1a, the pouch 1 is completely replaced by the double films 1a, 1b configuration as seen in Figures 1 and 2a, but the connector 2 and the adhesive straps 3 remain in one integral piece.

[0037] The adhesive films 1a can be trimmed and the non-adhesive films 1b reduced so that they only cover glans penis 11 or smaller protruding organs (Figure 5). For the usage in retracted penis, female genitalia or other flat skin surfaces, the films 1a can be spread out partially or fully to cover the surfaces (Figure 6). The double film configuration of the present invention thus provides for improved versatility in managing urine or other discharges on both protruding and non-protruding surfaces.

[0038] As discussed above, there may be an optional pressure and / or moisture sensor inside the pouch 1 to trigger a suction mechanism when urine or other discharges flow through. Such configuration can be useful since in normal setting the fluid needs to build up enough pressure inside the pouch before it can push the column of air inside the tubing that leads to drainage bag to get the fluid flowing. It is often during this undue pressure build up that striking through of the adhesion of the pouch 1 occurs, leading to dislodgement of the drainage catheter. By immediate removal of the pressure build up with a suction means, the striking through can thus be minimized. To this end, a soft and porous cushion, or pad, may also be installed inside the pouch 1 to allow better distribution of the suction pressure within the pouch 1.

[0039] In another preferred embodiment (Figure 7), to minimise twisting and kinking of the connector 2, 8 on the pouch / films 1, the connector 2, 8 can be placed nearer or adjacent to 1c the adhesive area 1b of the pouch / films 1, instead of at the loose distal tip of the pouch / films 1b (Figures 4 and 4a). In this way, the discharges or urine will be collected in the pouch 1b before overflowing or being sucked into the connector to be drained (Figure 7). The same can be applied to the double film configuration on non-protruding surface 13 (Figure 8). This is especially practical for incumbent incontinent patients as the urine or other discharges will readily gravitate towards the connector 2, 8 at the base 1c to be drained. The external strap 3 can be applied to further secure the connector 2,8 in place to prevent accidental twisting or tearing of the flimsy pouch 1.

[0040] Another preferred embodiment is a combination of those in Figures 6 and 8, wherein there are more than one connector on the pouch / films 1 to provide for irrigating and cleansing of tissues, especially dirty wounds, without removal of the pouch / films 1. While one connector 2,8 is connected to irrigating solution, the other is connected to a drainage bag or suction tube, thus provides for cost saving from changing the dressing and contaminating the surrounding areas by the contents of the pouch / films 1. The connectors 2,8 may thereof be resealable with plugs for instilling therapeutic or healing agents to enhance recovery.

[0041] Figures 9, 9a and 9b disclose yet another preferred embodiment wherein the connector 2 is partially inside the pouch / films 1. In a preferred embodiment, the connector 2 has a proximal circumferentially protruding rim 2f, which can be flat or in a shape of a funnel, that is held inside the pouch / film 1 by adhesive, binding or welding means as disclosed above. Both the pouch / film 1 and the connector 2 are again stabilized and kept in place by the external adhesive strap 3 on the penis 10. When a single adhesive film 1a is used (Figure 9 and 9a), it is preferable that at folding it at the connector 2, the two opposing sides of the adhesive film 1a1 and 1a2 are of different dimensions. This is to provide a neat and wrinkle free deployment of the drainage catheter on a protruding structure such as penis by having the bigger side 1a2 wrapping over the smaller side 1a1 from both side edges after the smaller side of the film 1a1 has been deployed onto penis 10 (Figure 9b). The adhesive strap 3 is then applied to further secure the connector 2 on the film 1a (Figure 9b). Again, all the previous disclosures on the drainage means, such as having a non-adhesive area 1b around the proximal portion of the connector 2f to avoid adhesive from getting in contact with the sensitive glans penis, are applicable on this embodiment.

[0042] The above disclosures thus cover the various installation positions of the connector 2, which can be completely outside (Figures 1 and 1a), completely inside (Figures 2 to 8) or partially inside (Figures 9 to 9b) the pouch / film 1, and the different shapes of the luminal connectors 2,8 that are obvious to the person skilled in the art.

Claims

AMENDED CLAIMS received by the International Bureau on 17 August 2025 (17.08.2025)1. A drainage catheter comprising: a. an ultrathin pouch, wherein there may be an adhesive coating on the inner surface of the whole or proximal part of the pouch, which is to be donned onto a protruding body structure; b. a luminal connector at the distant part of the pouch; and c. at least one semi-rigid or thicker adhesive strap extending from the connector onto the exterior surface of the pouch that is or to be deployed onto the protruding body structure.

2. The drainage catheter of Claim 1 , wherein the pouch comprises an adhesive film, which is folded into two opposing films or manufactured by welding two films into one.

3. The drainage catheter of Claim 2, wherein the film or films around the connector are adhesive free.

4. The drainage catheter of any one of claims 1 to 3, wherein the connector is standalone and is held in place on the pouch / films by a securing means, such as adhesive, welding, or binding means, or being held inside the pouch / films.

5. The drainage catheter of any one of claims 1 to 3, wherein the adhesive straps are standalone and have a hole that coincide with the connector's lumen.

6. The drainage catheter of any one of claims 1 to 3, wherein the connector and the adhesive straps are united to be attached as a drainage accessary on other adhesive dressings.

7. The drainage catheter of any one of claims 1 to 3, wherein there is an external cushioning ring at the distal end of the pouch / films.

8. The drainage catheter of any one of claims 1 to 3, wherein the pouch / films are attached with a moisture and / or pressure sensor for activating a suction pump that works through an optional soft and porous cushion, or pad, held inside the pouch / films.

9. The drainage catheter of any one of claims 1 to 3, wherein the connector is situated at the proximal end of the pouch / films and may be resealable.

10. The drainage catheter of any one of claims 1 to 3, where in there are multiple luminal connectors.[0001][0002]STATEMENT UNDER ARTICLE 19 (1)[0003]I would like to submit that neither D1 , D2, nor D3 expressly discloses a twisting preventing feature on their embodiments, let alone “the application of thicker and more rigid adhesive strap 3 on the exterior of the pouch 1” (Page 6, lines 17 and 18). I wish to emphasize that “the sturdier straps 3” (Page 6, Line 18) is a single most important inventive step that prevents the inevitable “distal loose segment of the pouch that is prompt to kinking and twisting, resulting in obstruction to urine flow” (Page 1 , Lines 17 and 18), a unique problem encountered during its deployment on the highly slidable skin of penis. It is to be noted that ultrathin, breathable and transparent (Page 2, Lines 18 to 22) film is a novel material for drainage device such as in the case of external urinary catheter. To incorporate a thick external strap onto such a flimsy pouch / film and connector involves complex manufacture and application processes that cannot be obvious to the person skill in the art.

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