WO2025202808A1 - Cathéter de drainage - Google Patents

Cathéter de drainage

Info

Publication number
WO2025202808A1
WO2025202808A1 PCT/IB2025/052507 IB2025052507W WO2025202808A1 WO 2025202808 A1 WO2025202808 A1 WO 2025202808A1 IB 2025052507 W IB2025052507 W IB 2025052507W WO 2025202808 A1 WO2025202808 A1 WO 2025202808A1
Authority
WO
WIPO (PCT)
Prior art keywords
pouch
adhesive
connector
films
straps
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2025/052507
Other languages
English (en)
Inventor
John Ing Ching TANG
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2025202808A1 publication Critical patent/WO2025202808A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/69—Drainage containers not being adapted for subjection to vacuum, e.g. bags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/4404—Details or parts
    • A61F5/4405—Valves or valve arrangements specially adapted therefor ; Fluid inlets or outlets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/443—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type seals, e.g. gels, starches, karaya gums
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/451—Genital or anal receptacles
    • A61F5/453—Genital or anal receptacles for collecting urine or other discharge from male member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/451—Genital or anal receptacles
    • A61F5/455—Genital or anal receptacles for collecting urine or discharge from female member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/87—Details of the aspiration tip, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/16—Male reproductive, genital organs
    • A61M2210/167—Penis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings

Definitions

  • the external urinary catheters are important medical devices for bed ridden or incontinent patients as unlike indwelling urinary catheters, they are non-invasive.
  • condom catheters 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the two adhesive films are approximated to stick onto the organ circumferentially at the centre and onto themselves at the sides.
  • the distal portion of the films may be adhesive free.
  • 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.
  • 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.
  • Figure 2 shows a cross-sectional view of another preferred embodiment wherein the drainage catheter is an assembly of more parts.
  • Figure 3 shows standalone adhesive straps 3 used for preventing twisting and tearing of the pouch/films 1 by the connecter 8.
  • 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.
  • 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.
  • a preferred embodiment is a drainage catheter ( Figures 1 and 1 a) comprising a pouch 1 , a connector 2 and adhesive straps 3.
  • 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).
  • the connector 1 there may be one or multiple adhesive straps 3 (Figure 3a).
  • 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.
  • 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.
  • 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).
  • 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.
  • 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).
  • 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.
  • a 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.
  • 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.
  • 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.
  • FIG. 6 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.
  • Figures 9, 9a and 9b disclose yet another preferred embodiment wherein the connector 2 is partially inside the pouch/ films 1.
  • 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.
  • a single adhesive film 1a is used ( Figure 9 and 9a)

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nursing (AREA)
  • Epidemiology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Reproductive Health (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

L'invention concerne un nouveau cathéter de drainage comprenant une poche adhésive ultramince et pliable, un raccord de drainage et des sangles adhésives externes pour drainer l'urine ou d'autres décharges corporelles. Les sangles sont destinées à stabiliser le connecteur pour l'empêcher de tordre et de déchirer la poche. La poche peut être remplacée par un ou deux films adhésifs pour permettre son utilisation à la fois sur des surfaces en saillie et non en saillie, notamment un pénis de diverses tailles et états, sur les organes génitaux de la femme, les plaies exsudatives et d'autres surfaces cutanées. L'invention concerne également un moyen d'aspiration facultatif doté d'un coussin de répartition de pression. Il peut y avoir de multiples connecteurs refermables destinés à une irrigation et un drainage simultanés.
PCT/IB2025/052507 2024-03-24 2025-03-09 Cathéter de drainage Pending WO2025202808A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
MYPI2024001790 2024-03-24
MYPI2024001790 2024-03-24

Publications (1)

Publication Number Publication Date
WO2025202808A1 true WO2025202808A1 (fr) 2025-10-02

Family

ID=97216819

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2025/052507 Pending WO2025202808A1 (fr) 2024-03-24 2025-03-09 Cathéter de drainage

Country Status (1)

Country Link
WO (1) WO2025202808A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2126483A (en) * 1982-09-14 1984-03-28 William Ralph Coleman Ivens A penial urine ducting device
US20120029451A1 (en) * 2010-07-30 2012-02-02 Conway Anthony J Male external urinary incontinence device
US20200054480A1 (en) * 2017-05-02 2020-02-20 John Ing Ching TANG Condom with wrapping adhesive flanges
US10603204B2 (en) * 2014-12-24 2020-03-31 Tilla Care Ltd. Device and method for external urinary incontinence treatment for men
CN111467116A (zh) * 2020-04-30 2020-07-31 中南大学湘雅医院 一种男性导尿装置

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2126483A (en) * 1982-09-14 1984-03-28 William Ralph Coleman Ivens A penial urine ducting device
US20120029451A1 (en) * 2010-07-30 2012-02-02 Conway Anthony J Male external urinary incontinence device
US10603204B2 (en) * 2014-12-24 2020-03-31 Tilla Care Ltd. Device and method for external urinary incontinence treatment for men
US20200054480A1 (en) * 2017-05-02 2020-02-20 John Ing Ching TANG Condom with wrapping adhesive flanges
CN111467116A (zh) * 2020-04-30 2020-07-31 中南大学湘雅医院 一种男性导尿装置

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