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WO2025149888A1 - Système implantable pour gestion de stomie - Google Patents

Système implantable pour gestion de stomie

Info

Publication number
WO2025149888A1
WO2025149888A1 PCT/IB2025/050140 IB2025050140W WO2025149888A1 WO 2025149888 A1 WO2025149888 A1 WO 2025149888A1 IB 2025050140 W IB2025050140 W IB 2025050140W WO 2025149888 A1 WO2025149888 A1 WO 2025149888A1
Authority
WO
WIPO (PCT)
Prior art keywords
stoma
tube
flange
bowel
skin
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/IB2025/050140
Other languages
English (en)
Inventor
Gayatri Muley
Zeenal Punamiya
Girish Bakhshi
Ajay Bhandarwar
Venkatesh Gadi
Chinmay Nikharge
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 WO2025149888A1 publication Critical patent/WO2025149888A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • 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
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A61F2005/4455—Implantable

Definitions

  • Another objective of the present invention is to eliminate the need for adhesives to reduce skin complications such as irritation, dermatitis, and maceration.
  • Another objective is to include a sunrays pattern of the tube; the surgeon will incorporate the implant while forming the stoma intraoperatively with a new SOP to include the implant
  • Another objective of the present invention is to offer a universal Tube flange system adaptable for both intraoperative and postoperative use with a few modifications in the tube.
  • An aspect of the present disclosure is to provide an implantable stoma management system comprising a (perforated tube) Tube (both perforated and sunrays pattern), flanges with locking ridges, and a reusable stoma bag.
  • Figure 2 displays lateral and lower view of the device wherein the skin-colored pad is a dummy of the skin.
  • the lateral view highlights the layers of the skin and how the implant is put over the stoma intraoperatively.
  • the lower view highlights the sunray pattern of the device.
  • FIG. 3 displays 3D Models of the device (intraoperative and post-operative)
  • the above two diagrams are the 3D models of the stoma device that would be used intraoperatively and post-operative ly.
  • the devices used for both phases (Intra-op and post-op) have the same concept (comprising of the cylindrical tube, and a flange to which a stoma bag would be attached).
  • the post-operative stoma device will be a tube with multiple holes, whereas the intra-operative device will be of sunrays pattern.
  • the approximate dimensions for both designs are mentioned in the figures above have not yet frozen the exact dimensions, but it would be +/- 0.5 cms.
  • Stoma Management System may be defined as a combination of components designed to manage (Fecal) waste excretion in patients with surgically created stomas, ensuring comfort, hygiene, and functional reliability.
  • Ostomy may be defined as a surgical procedure to create an artificial opening (stoma) in the body for the discharge of (fecal)waste.
  • Common types include colostomy and ileostomy.
  • Medical-Grade Materials may be defined as Materials certified for use in medical applications due to their biocompatibility, durability, and resistance to degradation. Examples include silicone, polyurethane, and ethylene-vinyl alcohol (EVOH).
  • Non-Absorbable Sutures may be defined as Stitches made from materials like nylon or prolene, which do not degrade over time and provide permanent fixation in medical applications.
  • Perforations may be defined as small holes distributed along the length and circumference of the implant tube, designed to facilitate the passage of (fecal) waste, during bowel contractions, into the Inside of the tube.
  • Flange may be defined as a flat, circular component attached to the tube, providing a surface for secure attachment to the abdominal wall using sutures.
  • Peristalsis may be defined as a rhythmic contraction and relaxation of bowel muscles, aiding in the natural movement of contents through the digestive system.
  • Stoma Bag may be defined as a reusable or disposable pouch attached to the flange, designed to collect (fecal) waste excreted from the stoma.
  • Adhesive-Free Design may be defined as a feature that eliminates the need for sticky materials to attach components to the skin, thereby reducing skin-related complications.
  • Skin Maceration may be defined as a condition where the skin becomes overly moist, often caused by leakage or prolonged exposure to adhesives, leading to breakdown of skin barrier and irritation, thus making it prone to infections.
  • Surgical Modification may be defined as Adjustments made during a surgical procedure to accommodate new implants or improve the outcomes of traditional techniques.
  • Patient Comfort may be defined as the ease and convenience experienced by patients using the stoma management system, encompassing aspects like reduced irritation, better hygiene, and user-friendly design.
  • Quality of Life may be defined as a measure of a patient’s overall well-being, including physical, psychological, and social aspects, often impacted by health conditions and their management.
  • the present invention discloses an implantable system for managing stomas, comprising: a tube configured with modifications for intraoperative and postoperative purposes, wherein the tube is cylindrical and comprises multiple holes along its length and circumference to facilitate the passage of stools from outside to the inside of the Lumen of tube due to peristalsis of the bowel wall outside the tube; wherein the tube is configured for intraoperative use with a sunrays pattern, enabling the bowel to be snugly accommodated and easily pulled through the tube during the procedure; flanges attached to the tube, each flange comprising locking ridges for securing a stoma bag; non-absorbable sutures, for securing the bowel mucosa to the flange throughout its circumference and fixing the flange to the underlying skin in a circumferential manner, thereby eliminating contact between the mucosa and the abdominal skin; a stoma bag removably attachable to the flanges using a click-lock mechanism; wherein the
  • the tube and flanges are made of medical-grade silicone, polyurethane, polyvinyl chloride (PVC), or ethylene-vinyl alcohol (EVOH).
  • PVC polyvinyl chloride
  • EVOH ethylene-vinyl alcohol
  • the locking ridges on the flange provide a secure and leakproof connection with the stoma bag to prevent stool leakage and ensure hygiene.
  • the Stoma system ensures that no adhesive between the skin and flange is used, thereby minimizing the risk of dermatitis and peristomal skin complications.
  • the system is tailored for pediatric, adult, and geriatric patients with no limitations concerning specific pathologies or diseases.
  • the flange includes inner ridges configured to interface with the rectus sheath or subcutaneous tissue for enhanced stability and attachment.
  • the postoperative flange is designed with extensions to accommodate variations in bowel wall thickness and ensure a secure fit.
  • the click-lock mechanism allows for effortless attachment and removal of the stoma bag without requiring specialized tools or training.
  • the present invention provides a kit comprising said implantable system and an instruction manual thereof.
  • the tube is cylindrical with sunrays pattern and configured to slide over the bowel wall to rest comfortably with the positioned against the abdominal wall and a postoperative modification.
  • the cylindrical tube includes multiple holes slid inside the bowel, i. e already formed stoma, wherein the holes ensure the return of stools collected in between the bowel mucosa and the outer wall of the tube, facilitated by bowel peristalsis.
  • the tube is cylindrical with sunrays pattern and configured to slide over the bowel wall to rest comfortably with the flange positioned against the abdominal wall and a postoperative modification wherein the cylindrical tube includes multiple holes slid inside the bowel, i. e already formed stoma, the holes ensure the return of stools collected in between the bowel mucosa and the outer wall of the tube, facilitated by bowel peristalsis.
  • the flange design prevents direct contact between stool and the skin, thereby reducing odors and enhancing the patient's social and psychological comfort.
  • the system is adaptable for use in intraoperative and postoperative scenarios, catering to both newly created and pre-existing stomas.
  • the tube designed for insertion into the bowel, features multiple holes along its length and circumference to facilitate the movement of stools into the lumen during bowel contractions.
  • the flanges sit on the stoma as well as the skin, and are secured circumferentially to underlying Mucosa of the stoma and the surrounding skin using nonabsorbable sutures circumferentially, creating a leak-proof barrier and eliminating the need for adhesives.
  • the tube features a sunrays pattern, is designed to be inserted in the patient’s stoma site on the abdomen such that the flanges rest on the skin.
  • the sunrays tube is slid over the bowel into the surrounding subcutaneous tissue, until the flange rest flat on the skin.
  • the flange will be sutured to the skin using a non-absorbable suture material.
  • the stoma is then matured onto the flange (i.e bowel mucosa is sutured to the flange with non-absorbable suture material), instead of on the skin directly.
  • the tube is first inserted inside the stoma site on the abdominal wall until the flange rests on the skin, the Bowel in then brought out through the inside of the tube, to form the stoma, such that the bowel mucosa is secured to the flange using non-absorbable sutures circumferentially, ensuring no contact between the bowel and abdominal skin.
  • the flange is also fixed to the abdominal skin using non absorbable suture material. This eliminates the use of adhesives, reducing peristomal skin complications.
  • the tube featuring multiple perforations along its length and circumference. is inserted into an already existing stoma such that the flange rests on the mucosa of the stoma and onto the surrounding skin. These perforations enable stools outside the tube to be pushed into its lumen during natural bowel contractions (peristalsis).
  • the underlying mucosal of the formed stoma is fixed to the flange using non absorbable suture material.
  • the flange is then fixed to the skin using non absorbable suture materials in a circumferential manner similar to the intra-operative use.
  • the stoma bag attaches securely to the flanges using a click-lock mechanism, ensuring ease of handling and reusability.
  • This system is versatile, being equally effective in intraoperative and postoperative settings, making it suitable for newly formed and preexisting stomas.
  • the components are constructed from durable, biocompatible materials, ensuring patient safety and cost-effectiveness.
  • the system reduces the frequency of clinic visits due to its durable design and ease of maintenance.
  • the ergonomic design of the flange ensures minimal strain on surrounding tissues, improving overall comfort for the patient.
  • the device is suitable for patients undergoing cancer treatments, abdominal Koch's disease, or inflammatory bowel disease.
  • the flange can be customized to patient-specific dimensions and anatomical variations to enhance fit and function.
  • the tube includes visual markers to aid surgeons in proper placement and alignment during implantation.
  • the intraoperative procedure involves securing the bowel to the rectus muscle with non-absorbable sutures before sliding the tube and flange into position.
  • this invention offers a technological solution to the challenges of stoma management. By combining simplicity, adaptability, and physiological integration, it significantly improves patient comfort, reduces complications, and enhances overall quality of life.
  • Example 1 Details of implantable system of Stoma
  • the Stoma system disclosed herein is a two-piece system, with a fixed Implant and a removable, reusable stoma bag (Figure 1).
  • the appliance will have the following parts - i. Tube-flange Implant with a locking ridge and ii. Stoma Bag
  • This invention presents the Intraoperative Implant with the Cylindrical tube will have a sunrays pattern and a Postoperative Implant wherein the Tube will be cylinder with multiple holes along the entire length and circumference. Surgeons may require a training session to be able to use the implant, with the following SOPs ( Figure 2).
  • Example 3 Intraoperative modification of the surgical technique, to incorporate Prosthesis.
  • Example 4 Postoperative SOPS for insertion of implant.
  • Adhesive-Free Design By eliminating adhesives, the invention prevents common peristomal skin complications such as irritation, dermatitis, and maceration. Adhesives can be sticky, causing discomfort and trapping waste, leading to hygiene issues. This design avoids such drawbacks. Also, adhesive-free attachment reduces the risk of infections and allows the skin to breathe, promoting better healing around the stoma.
  • Enhanced Stool Management The multiple holes in the tube facilitate the movement of stools from outside to inside the lumen during bowel contractions, leveraging the natural process of peristalsis. Also, the design prevents the buildup of Fecal waste in between the tube and the bowel mucosa.
  • Ease of Handling The reusable stoma bag attaches easily to the flange using a clicklock system, ensuring secure attachment and simplifying handling for patients and caregivers as the system is designed for ease of use, reducing the need for extensive training or frequent professional assistance.

Landscapes

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

Abstract

L'invention concerne un système de gestion de stomie complète qui améliore les résultats pour les patients et répond aux limitations actuelles. Le système comporte un tube, des brides avec des nervures de verrouillage, et un sac de stomie réutilisable. Le tube s'adapte pour une utilisation peropératoire et postopératoire ; la version peropératoire utilise un motif d'éventail pour faciliter l'évacuation des selles, tandis que la version postopératoire, insérée dans une stomie formée, comprend des perforations pour rediriger des selles par l'intermédiaire de contractions intestinales, assurant ainsi l'hygiène. Les brides sont fixées de manière circonférentielle à la muqueuse intestinale et à la peau à l'aide de sutures non résorbables, ce qui permet d'éliminer le recours à des adhésifs et de réduire les complications cutanées. La conception de bride plate supporte la fixation à la peau abdominale, la muqueuse intestinale étant suturée à la bride pour une stomie sécurisée. Le sac de stomie réutilisable se fixe par l'intermédiaire d'un mécanisme de verrouillage par encliquetage pour plus de commodité. Construit à partir de matériaux durables et biocompatibles, le système prévient les fuites, atténue les problèmes cutanés et améliore la gestion des selles, ce qui améliore considérablement le confort du patient, sa qualité de vie et les résultats des soins de santé.
PCT/IB2025/050140 2024-01-08 2025-01-07 Système implantable pour gestion de stomie Pending WO2025149888A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202421001398 2024-01-08
IN202421001398 2024-01-08

Publications (1)

Publication Number Publication Date
WO2025149888A1 true WO2025149888A1 (fr) 2025-07-17

Family

ID=96386472

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2025/050140 Pending WO2025149888A1 (fr) 2024-01-08 2025-01-07 Système implantable pour gestion de stomie

Country Status (1)

Country Link
WO (1) WO2025149888A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6485476B1 (en) * 1998-02-25 2002-11-26 Zassi Medical Evolutions, Inc. Continent ostomy port
WO2011007355A2 (fr) * 2009-07-14 2011-01-20 Stimatix Gi Ltd. Dispositif de confinement pour stomie
US20200390590A1 (en) * 2017-10-09 2020-12-17 The Insides Company Limited Nutrient recycling device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6485476B1 (en) * 1998-02-25 2002-11-26 Zassi Medical Evolutions, Inc. Continent ostomy port
WO2011007355A2 (fr) * 2009-07-14 2011-01-20 Stimatix Gi Ltd. Dispositif de confinement pour stomie
US20200390590A1 (en) * 2017-10-09 2020-12-17 The Insides Company Limited Nutrient recycling device

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