Implantable system for stoma management

Abstract

The invention introduces a comprehensive stoma management system that enhances patient outcomes and addresses current limitations. It features a tube, flanges with locking ridges, and a reusable stoma bag. The tube adapts for intraoperative and postoperative use; its intraoperative version employs a sunrays pattern for smooth bowel accommodation, while the postoperative version, inserted into a formed stoma, includes perforations to redirect stools via bowel contractions, ensuring hygiene. The flanges are circumferentially secured to the bowel mucosa and skin using non-absorbable sutures, eliminating adhesives and reducing skin complications. The flat flange design supports attachment to the abdominal skin, with the bowel mucosa sutured to the flange for a secure stoma. The reusable stoma bag attaches via a click-lock mechanism for convenience. Constructed from durable, biocompatible materials, the system prevents leakage, minimizes skin issues, and enhances stool management, significantly improving patient comfort, quality of life, and healthcare outcomes.

Description

IMPLANTABLE SYSTEM FOR STOMA MANAGEMENTFIELD OF THE INVENTION

[0001] The present disclosure relates to the field of medical devices, specifically to systems and methods for managing stomas in patients who have undergone colostomy, ileostomy, or similar surgical procedures. The invention focuses on improving (fecal) waste management, patient comfort, and quality of life through a simplified, adhesive-free, and physiologically adaptive system.BACKGROUND OF THE INVENTION

[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0003] Stoma management has been an essential area of focus in medical practice, especially for patients undergoing ostomy surgeries like colostomies and ileostomies. These procedures involve creating an artificial opening (stoma) to allow (Fecal) waste to exit the body, often necessitated by conditions such as colorectal cancer, inflammatory bowel disease, or trauma. While existing stoma management technologies aim to improve patient outcomes, they face several inherent limitations that compromise effectiveness, patient comfort, and quality of life.

[0004] Various prior art solutions have been explored, including prosthetic implants, stoma rings, and adhesive-based ostomy bags. A detailed examination of existing patents and nonpatent literature highlights key technological advancements and their shortcomings. For example, WO2023099864A1 introduces a prosthetic sphincter apparatus equipped with a controllable valve and an implantable component surgically attached to the body. Although it provides an innovative mechanism for waste control, it fails to address stool redirection using natural bowel movements like peristalsis. Moreover, its complex structure and lack of adaptability limit its utility for diverse patient needs.

[0005] Similarly, WO2022174288A1 discloses a stoma implant assembly with a base and apertures designed to alleviate issues such as leakage and skin irritation. However, this solution lacks a detailed surgical technique for integrating the implant and does not offer features to leverage bowel contractions for stool management. This omission leads toinefficiencies in waste collection, particularly in managing stool accumulation around the implant.

[0006] Another example, US20190240061A1, describes an implantable stoma ring with an inner ring and a lip seal. This device is biocompatible and can be securely fixated, yet it focuses primarily on sealing the stoma rather than on the critical aspect of waste redirection or efficient integration during surgery. Similarly, US4338937A Iproposes a mechanical continent ileostomy or colostomy with a flexible flange and stopper mechanism. While it provides mechanical sealing to prevent leakage, it lacks emphasis on optimizing the natural physiological processes like bowel peristalsis.

[0007] Few non-patent literatures also discuss an artificial sphincter-type intestinal valve designed to eliminate the need for collection bags and improve patient quality of life. Despite its innovative approach to voluntary containment, the device is complex and does not integrate features to enhance stool redirection or simplify surgical techniques.

[0008] Despite these advancements, existing stoma management solutions face significant challenges. Adhesive-based ostomy bags, while widely used, often lead to skin complications such as irritation, dermatitis, and maceration. Leakage of stools remains a persistent problem, exacerbating discomfort, hygiene issues, and the risk of infections. These complications not only affect physical well-being but also lead to psychosocial challenges, including social stigma, anxiety, and reduced quality of life.

[0009] Another critical issue is the inefficiency in managing stool movement. Current solutions do not leverage natural bowel contractions to facilitate stool redirection, leading to accumulation around the implant and necessitating frequent manual intervention. Furthermore, the high cost and frequent replacement of many systems impose a significant financial burden on patients, reducing accessibility and long-term usability.

[0010] Given these limitations, there is an urgent need for a stoma management solution that addresses these challenges comprehensively. An ideal solution would include a simplified implant design that minimizes surgical complexity while ensuring secure attachment without the use of adhesives. The system should integrate features like multiple perforations in the tube, allowing natural bowel contractions to redirect stools into the lumen effectively.

[0011] Moreover, such a solution should be adaptable for both intraoperative and postoperative scenarios, catering to patients with new and pre-existing stomas. Durability, cost-effectiveness, and ease of use are also essential to ensure long-term sustainability and improved patient outcomes. By addressing these critical gaps, a comprehensive stomamanagement system can significantly enhance patient comfort, reduce complications, and improve the overall quality of life.OBJECTS OF THE INVENTION

[0012] The primary objective of the invention is to to address the challenges associated with existing stoma management systems.

[0013] Another objective of the present invention is to eliminate the need for adhesives to reduce skin complications such as irritation, dermatitis, and maceration.

[0014] Another objective of the present invention is to provide a simplified implant prototype that facilitates secure attachment using non-absorbable sutures.

[0015] 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

[0016] Another objective of the present invention is to enhance stool management through a tube with multiple perforations that leverage natural bowel contractions for (fecal) waste redirection in patients already living with a formed stoma, i.e. Post operatively.

[0017] 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.

[0018] Another objective of the present invention is to improve durability, cost-effectiveness, and ease of handling to reduce the financial and psychological burden on patients.SUMMARY OF THE INVENTION

[0019] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description section. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0020] 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.

[0021] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments.FIGURES OF THE INVENTION

[0022] Figure 1 displays lateral view of the device and the structures and layers of skin involved.

[0023] 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.

[0024] Figure 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). However, 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.DETAILED DESCRIPTION OF THE INVENTION

[0025] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0026] Unless the context requires otherwise, throughout the specification which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”

[0027] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. It should also be noted that the term “or” is generally employed in its sense including “and / or” unless the content clearly dictates otherwise.

[0028] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description are approximations that can vary depending upon the desiredproperties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable.

[0029] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it is individually recited herein.

[0030] All processes described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0031] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[0032] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus, if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.

[0033] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.

[0034] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimedindividually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description that follows, and the embodiments described herein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.

[0035] It should also be appreciated that the present invention can be implemented in numerous ways, including as a system, a method or a device. In this specification, these implementations, or any other form that the invention may take, may be referred to as processes. In general, the order of the steps of the disclosed processes may be altered within the scope of the invention.

[0036] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.Definitions

[0037] For the purpose of the present invention, 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.

[0038] For the purpose of the present invention, 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.

[0039] For the purpose of the present invention, Colostomy may be defined as a surgical procedure where a portion of the large intestine is diverted to an artificial opening in the abdominal wall.

[0040] For the purpose of the present invention, Ileostomy may be defined as a surgical procedure where the end of the small intestine is brought through an artificial opening in the abdominal wall.

[0041] For the purpose of the present invention, Peristomal Skin may be defined as the skin surrounding the stoma, often prone to irritation and damage from leakage or adhesives.

[0042] For the purpose of the present invention, Click-Lock Mechanism may be defined as a secure attachment system used for connecting components like stoma bags to flanges, enabling easy handling and secure sealing.

[0043] For the purpose of the present invention, Leakage Prevention may be defined as a design aspect focused on preventing the escape of (Fecal)waste materials from the stoma system, onto the surrounding skin and clothes of the patient, ensuring hygiene and patient comfort.

[0044] For the purpose of the present invention, 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).

[0045] For the purpose of the present invention, Biocompatibility may be defined as the ability of a material to perform its intended function in a biological environment without causing adverse effects.

[0046] For the purpose of the present invention, 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.

[0047] For the purpose of the present invention, Intraoperative Procedure may be defined as a surgical process performed during the creation of a stoma, focusing on the precise placement and fixation of components like the tube and flanges.

[0048] For the purpose of the present invention, Postoperative Procedure may be defined as Techniques applied after the surgical creation of a stoma, often for patients with pre-existing stomas, to ensure continued functionality and comfort.

[0049] For the purpose of the present invention, Lumen may be defined as the hollow interior of a tubular structure, such as the implant tube, where (fecal) waste is directed for collection.

[0050] For the purpose of the present invention, 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.

[0051] For the purpose of the present invention, Bowel Mucosa may be defined as the innermost lining of the bowel, responsible for absorbing nutrients and water.

[0052] For the purpose of the present invention, 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.

[0053] For the purpose of the present invention, Peristalsis may be defined as a rhythmic contraction and relaxation of bowel muscles, aiding in the natural movement of contents through the digestive system.

[0054] For the purpose of the present invention, Stoma Bag may be defined as a reusable or disposable pouch attached to the flange, designed to collect (fecal) waste excreted from the stoma.

[0055] For the purpose of the present invention, 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.

[0056] For the purpose of the present invention, 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.

[0057] For the purpose of the present invention, Surgical Modification may be defined as Adjustments made during a surgical procedure to accommodate new implants or improve the outcomes of traditional techniques.

[0058] For the purpose of the present invention, 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.

[0059] For the purpose of the present invention, Durability may be defined as the ability of a component to withstand long-term use without degradation, ensuring reliability and costefficiency.

[0060] For the purpose of the present invention, Quality of Life (QoL) 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.

[0061] These definitions provide clarity on the various technical terms and concepts used in the detailed description of the invention.

[0062] In an embodiment, the present invention provides an implantable stoma management system comprising a (perforated tube) Tube (both perforated and sunrays pattern), flanges with locking ridges, and a reusable stoma bag.

[0063] In an embodiment, 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 modification of the surgical technique involves securing the mucosa of the bowel with non-absorbable suture materials to the flange throughout the circumference and then securing the flange to the underlying skin in a circumferential manner using nonabsorbable suture materials.

[0064] In another embodiment, the tube and flanges are made of medical-grade silicone, polyurethane, polyvinyl chloride (PVC), or ethylene-vinyl alcohol (EVOH).

[0065] In another embodiment, the non-absorbable materials are selected from PDS, prolene, nylon or a combination thereof,

[0066] In another embodiment, the locking ridges on the flange provide a secure and leakproof connection with the stoma bag to prevent stool leakage and ensure hygiene.

[0067] In another embodiment, the Stoma system ensures that no adhesive between the skin and flange is used, thereby minimizing the risk of dermatitis and peristomal skin complications.

[0068] In another embodiment, the system is tailored for pediatric, adult, and geriatric patients with no limitations concerning specific pathologies or diseases.

[0069] In another embodiment, the flange includes inner ridges configured to interface with the rectus sheath or subcutaneous tissue for enhanced stability and attachment.

[0070] In another embodiment, the postoperative flange is designed with extensions to accommodate variations in bowel wall thickness and ensure a secure fit.

[0071] In another embodiment, the click-lock mechanism allows for effortless attachment and removal of the stoma bag without requiring specialized tools or training.

[0072] In another embodiment, the present invention provides a kit comprising said implantable system and an instruction manual thereof.

[0073] In another embodiment, 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.

[0074] In another embodiment, the stoma bag is reusable and attaches to the flanges via a click-lock mechanism for easy handling and cost efficiency.

[0075] In another embodiment, the flanges are designed to provide ergonomic support and distribute tension evenly across the attachment area to enhance durability and patient comfort, and to prevent peristomal skin complications by creating a physical barrier between the bowel mucosa and the abdominal skin.

[0076] In another embodiment, 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.

[0077] In another embodiment, the flange design prevents direct contact between stool and the skin, thereby reducing odors and enhancing the patient's social and psychological comfort.

[0078] In another embodiment, the system is adaptable for use in intraoperative and postoperative scenarios, catering to both newly created and pre-existing stomas. In patients with 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.

[0079] Accordingly, in patients undergoing the stoma surgery, the tube, features a sunrays pattern, is designed to be inserted in the patient’s stoma site on the abdomen such that theflanges rest on the skin. Once the bowel is sutured to the rectus muscle as in the Standard operating procedure and brought out to form the stoma, 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.

[0080] Hence, the present disclosure focuses on the proposed stoma management system addresses significant limitations in existing technologies. It comprises a medical-grade tube, flanges, and a reusable stoma bag.

[0081] During intraoperative procedures, 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.

[0082] During the post operative use, 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.

[0083] 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.

[0084] In an embodiment, the system reduces the frequency of clinic visits due to its durable design and ease of maintenance.

[0085] In another embodiment, the ergonomic flange and tube are configured to create a secure seal to further prevent leakage.

[0086] In another embodiment, the ergonomic flange and tube are configured to create a secure seal to further prevent leakage.

[0087] In another embodiment, the tube’s holes enable any particulate fecal matter outside the tube to effectively drain inside the tube because of the surrounding bowel wall’s peristaltic action, thereby preventing large accumulation of fecal matter in between the outer part of the tube and mucosal of bowel wall

[0088] In another embodiment, the tube’s sunrays pattern, allow for easy passage of bowel inside the tube's lumen, while allowing serosa of the bowel to be in contact with surrounding fat.

[0089] In another embodiment, the ergonomic design of the flange ensures minimal strain on surrounding tissues, improving overall comfort for the patient.

[0090] In another embodiment, the device is suitable for patients undergoing cancer treatments, abdominal Koch's disease, or inflammatory bowel disease.

[0091] In an exemplary embodiment, the flange can be customized to patient-specific dimensions and anatomical variations to enhance fit and function.

[0092] In an exemplary embodiment, the tube includes visual markers to aid surgeons in proper placement and alignment during implantation.

[0093] In another embodiment, the intraoperative procedure involves securing the bowel to the rectus muscle with non-absorbable sutures before sliding the tube and flange into position.

[0094] In another embodiment, the device is applicable for both ileostomies and colostomies, including end, loop, double-barrel, and spectacle stoma types.

[0095] In another embodiment, the flange provides ergonomic compatibility with the patient's anatomy to reduce the risk of pressure points or irritation.

[0096] Accordingly, this invention offers a groundbreaking 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.

[0097] While the foregoing describes various embodiments of the disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.EXAMPLES

[0098] The present invention is further explained in the form of following examples. However, it is to be understood that the following examples are merely illustrative and are not to be taken as limitations upon the scope of the invention.Example 1 : Details of implantable system of Stoma

[0099] 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 BagExample 2: Implants of the system

[0100] 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.

[0101] The surgery was proceeded in the usual steps, upto the point where the bowel was hitched to the rectus muscle using non absorbable sutures. After this step the technique was modified as follows- Slide over the tube flange Implant over the bowel, until the flange rests comfortably over the skin, and the bowel is over the flange. Once in place, secure the mucosa of the bowel, with non-absorbable suture materials to the flange throughout the circumference, and then secure the flange with the underlying skin in a circumferential manner using non absorbable suture material. Thus, there will be no contact whatsoever between the mucosa of the bowel and the skin of the abdominal wall, and since the flange is sutured, there is no use of adhesive and thus no cause for peristomal skin complications. Once matured the bag can simply be fit using a click lock mechanism, the bag will be reusable and easy to handle (Figure 3).Example 4: Postoperative SOPS for insertion of implant.

[0102] For patients who are already living with stomas, similar tube flange Implant with Holes can be used. Here, the tube of the prosthesis will be slid inside the bowel wall, and the flange will be covering the mucosa of the bowel wall and extend upto the abdominal wall. The flange is then fixed to the abdominal wall using non absorbable suture materials, in a circumferential manner (Figure 3).ADVANTAGES OF THE INVENTION

[0103] The proposed implantable system for stoma management provides numerous advantages, addressing critical limitations of existing technologies while enhancing patient outcomes. Below is a detailed explanation of these benefits:

[0104] 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.

[0105] Secure and Leak-Proof Mechanism: The use of non-absorbable sutures ensures a secure and tight connection between the bowel mucosa, flange, and underlying skin. The system’s design, including the locking ridges, minimizes the risk of stool leakage, which is a major concern with existing stoma management systems.

[0106] 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.

[0107] Universal Adaptability: The system is suitable for both new stomas created during surgery and existing stomas in postoperative patients, making it versatile and can be used for colostomies, ileostomies, and other ostomy types across different age groups and medical conditions.

[0108] 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.

[0109] Cost-Effectiveness: The stoma bag is durable and reusable, significantly reducing long-term costs for patients compared to disposable systems. Nevertheless, by minimizing complications like infections and dermatitis, the system lowers the need for medical interventions and associated expenses.

[0110] Improved Durability and Longevity: Constructed from biocompatible and durable materials like silicone and polyurethane, the system ensures reliability and long-lasting performance. The use of non-absorbable sutures offers a permanent and stable attachment, reducing the need for frequent adjustments or replacements.

[0111] Patient Comfort and Quality of Life: By preventing leaks and reducing skin complications, the system alleviates anxiety, social stigma, and psychological distress commonly associated with stoma management wherein secure and lightweight design enhances freedom of movement and reduces discomfort during daily activities. Also, the leak-proof system and efficient stool management improve hygiene, contributing to a better overall experience.

[0112] Simplified Surgical Integration: The intraoperative surgical modification is straightforward and avoids complex procedures, reducing operating time and improving outcomes. The system integrates seamlessly with existing surgical protocols while offering enhancements to traditional methods.

[0113] Environmentally Friendly: The reuse of components, especially the stoma bag, contributes to reduced medical waste compared to disposable systems. Further, the cost- effective and durable nature of the system makes it accessible to a wider range of patients, including those in low-resource settings.

Claims

We Claim:

1. 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 modification of the surgical technique involves securing the mucosa of the bowel with non-absorbable suture materials to the flange throughout the circumference and then securing the flange to the underlying skin in a circumferential manner using non-absorbable suture materials.

2. The implantable system as claimed in claim 1, wherein the tube and flanges are made of medical -grade silicone, polyurethane, polyvinyl chloride (PVC), or ethylene-vinyl alcohol (EVOH).

3. The implantable system as claimed in claim 1, wherein the non-absorbable materials are selected from PDS, prolene, nylon or a combination thereof,4. The implantable system as claimed in claim 1, wherein the locking ridges on the flange provide a secure and leak-proof connection with the stoma bag to prevent stool leakage and ensure hygiene.

5. The implantable system as claimed in claim 1, wherein the Stoma system ensures that no adhesive between the skin and flange is used, thereby minimizing the risk of dermatitis and peristomal skin complications.

6. The implantable system as claimed in claim 1, wherein the system is tailored for pediatric, adult, and geriatric patients with no limitations concerning specific pathologies or diseases.

7. The implantable system as claimed in claim 1, wherein the flange includes inner ridges configured to interface with the rectus sheath or subcutaneous tissue for enhanced stability and attachment.

8. The implantable system as claimed in claim 1, wherein the postoperative flange is designed with extensions to accommodate variations in bowel wall thickness and ensure a secure fit.

9. The implantable system as claimed in claim 1, wherein the click-lock mechanism allows for effortless attachment and removal of the stoma bag without requiring specialized tools or training.

10. A kit comprising said implantable system and an instruction manual thereof.

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