WO2025248140A1

WO2025248140A1 - Transcutaneous ostomy implant

Info

Publication number: WO2025248140A1
Application number: PCT/EP2025/065188
Authority: WO
Inventors: Manish CHAND; William Rutan; Graeme Smith; Mats Erik KINDAHL CARDELL
Original assignee: Ostomycure AS
Current assignee: Ostomycure AS
Priority date: 2024-05-31
Filing date: 2025-06-02
Publication date: 2025-12-04
Anticipated expiration: 2026-11-30

Abstract

The invention regards a transcutaneous ostomy implant comprising: a first part configured for implantation into a patient; a second part connected to the first part; and an opening extending from the first part to the second part, the opening having a central axis, and wherein the opening is adapted to accommodate a part of a body duct; wherein the transcutaneous ostomy implant is adapted for a secure and efficient implantation.

Description

Transcutaneous ostomy implant

The present disclosure relates to a transcutaneous ostomy implant and methods of manufacturing such implant, and methods of processing such implant.

Background

Ileostomy and colostomy are common surgical procedures necessitated by conditions such as malignancy or chronic bowel inflammation. An ileostomy involves the removal of the colon and rectum, whereas a colostomy involves only the removal of the rectum. Similarly, an abdominal urostomy is performed when the urinary bladder must be removed due to conditions like bladder cancer. These procedures involve creating an opening in the abdominal wall that extends to the outside of the patient.

Ostomy is a generic term encompassing any surgical procedure where a stoma is created. The stoma, in most cases, has to be connected to a bag for the collection of bodily waste. However, instead of a conventional ileostomy, it is possible to create a reservoir known as a "Kock pouch" from the distal part of the ileum. The pouch is formed in such a way that a nipple valve is created which serves to close the reservoir while allowing it to be drained intermittently by means of a catheter. Although this continent ileostomy (Cl) was formerly an attractive alternative to conventional ileostomy, it is now rarely used due to the complexity of the procedure and the high potential for complications, most of them related to dysfunction of the continence nipple valve.

The ileopouch anal anastomosis (I PAA) is currently the gold standard worldwide for patients requiring such surgeries. However, like the Kock's pouch, this operation carries significant risks, and failures are common, often leading to pouch excision and loss of bowel. Conversion of a failed I PAA to a continent ileostomy (Cl) would be preferable, yet the complexity and unreliability of the technique deter many surgeons. Similarly, converting a malfunctioning orthotopic neobladder or Bricker urostomy would be desirable.

The surgical implantation of ostomy implants is a complex procedure that is critical for the long-term success of the transcutaneous ostomy implant. Proper healing of the stoma and integration of the transcutaneous ostomy implant with the surrounding tissues are crucial. If the initial surgery does not go as planned, the success rate of the transcutaneous ostomy implant can significantly drop. One common issue is ensuring that the ileum remains fixed in place while the tissue grows into the transcutaneous ostomy implant. Traditionally, this has been achieved by temporarily suturing the ileum to the abdominal wall, which provides the necessary stabilization, allowing the tissue to integrate effectively with the transcutaneous ostomy implant. Once healing is complete, the part of the ileum that protrudes outside the transcutaneous ostomy implant dries out and can be removed, leaving a secure connection between the ileum and the transcutaneous ostomy implant.

There are various ways in which the bowel segment can be secured or fixated. One conventional method is a surgical procedure referred to as a "Turnbull." During this procedure, on a conventional stoma, the efferent part of the intestine is wrung inside out and attached to the skin surrounding the stoma. However, after this procedure, the stoma often retracts at skin level, leaving a space and resulting in leakage. Additionally, it is not possible to perform a conventional Turnbull with an implant because this would completely cover and hide the transcutaneous ostomy implant. This would prevent the use of a stabilizer device (to hold the transcutaneous ostomy implant in position) during healing and hinder monitoring the healing and ingrowth of the transcutaneous ostomy implant. Bodily waste could become trapped under the Turnbull and around the transcutaneous ostomy implant, potentially causing infection and making it difficult to clean and remove such waste.

To address some of the shortcomings in conventional ostomy procedures, the applicant previously developed an external adaptor for securing a bowel segment outside the patient's body following ostomy formation, as disclosed in

WO 2014/140344. This adaptor was designed to facilitate a modified Turnbull-like fixation by providing an external anchoring interface for the bowel.

However, despite such advancements, current methods still present challenges in achieving consistently stable and anatomically integrated implantation. Surgical outcomes can be compromised by implant micromotion, leakage, improper tissue approximation, or healing complications. In particular, the risk of implant instability during the early postoperative period remains a critical limitation.

Accordingly, there remains a need for improved implant systems that enable secure and efficient implantation, promote reliable tissue integration, and minimize dependence on external fixation techniques. The present disclosure addresses this need by providing a transcutaneous ostomy implant with integrated structural features configured to enhance surgical control, fixation stability, and long-term healing.

Summary

Conventional methods for implanting transcutaneous ostomy implants often rely on external fixation devices or sutures, which can be difficult to manage and may not provide reliable long-term results. These traditional approaches can lead to complications such as improper healing, skin soiling, infections, and the need for revision surgeries due to implant displacement or instability. They may also result in prolonged surgical times, increased patient discomfort, and elevated healthcare costs.

The present disclosure addresses one or more of these challenges by providing an improved transcutaneous ostomy implant designed to enable secure and efficient implantation. The present disclosure includes structural and functional features that, individually or in combination, may contribute to effects such as improved tissue integration, reliable positioning of the body duct, simplified surgical handling, and reduced reliance on external fixation. These enhancements may help reduce postoperative complications and improve patient outcomes in ostomy procedures.

Therefore, in a first aspect, the present disclosure relates to a transcutaneous ostomy implant comprising:

• a first part configured for implantation into a patient;

• a second part connected to the first part; and

• an opening extending through at least a portion of the first part and the second part, the opening defining a central axis and being adapted to accommodate at least a segment of a body duct.

Preferably the implant is configured for secure and efficient implantation.

The implant facilitates a more reliable and efficient implantation process, which may promote integration with surrounding tissues and reduce the risk of adverse effects such as micromotion, leakage, or infection. As described in further detail below, these and other advantageous effects may be achieved through various structural and functional features disclosed herein, which may be used individually or in combination and may be regarded as corresponding special technical features. In some embodiments of the present disclosure, an inner part of the ostomy implant may comprise one or more inwardly protruding engaging elements extending into the opening. The engaging elements can be arranged for securing the body duct during implantation in a position wherein the body duct extends through at least a part of the opening.

The engaging elements may serve to retain the body duct in a fixed position relative to the implant, reducing the risk of displacement or retraction during healing. By maintaining alignment between the body duct and the implant, the engaging elements can promote consistent tissue contact and improve the conditions for tissue ingrowth and integration. The resulting stability may help minimize irritation or inflammation caused by unintended movement of the body duct during the early post-operative period.

In some embodiments, the engaging elements may reduce or eliminate the need for additional fixation means, such as external sutures or stabilizers. This can simplify the surgical procedure, reduce operation time, and lower the risk of complications associated with external fixation.

In a further embodiment of the present disclosure, the second part comprises one or more fastening elements for securing the body duct, for example during tissue integration. The fastening elements may be located on an inner part of the second part and protrude radially inwardly into the opening.

The fastening elements may for example comprise or consist of one or more loop structures arranged for accommodating a suturing thread, such as wherein the fastening elements are integral to the second part.

Thereby, the fastening elements can allow for a more secure and reliable attachment of the body duct to the implant. The fastening elements may be provided as dedicated structures, such as loop structures, that can accommodate suturing threads. The fastening elements can facilitate a stable and fixed positioning of the body duct during and after the implantation procedure. This can ensure that the body duct remains securely attached to the implant, and help reduce the risk of dislodgement or movement that could compromise the healing process. The fastening means, e.g. the loop structures, can for example accommodate suturing threads and is particularly beneficial as it allows for a more controlled and precise method of securing the body duct. This method may ensure that the body duct is tightly and evenly attached to the implant, promote better tissue integration and reduce the likelihood of leakage or other complications. The fastening elements can help maintain the correct positioning of the body duct, to ensure that it remains aligned within the implant and reducing the risk of misalignment that could lead to discomfort or other issues for the patient.

Additionally, as the second part comprises the fastening elements, the surgical procedure can be simplified significantly. Surgeons can use the loop structures to easily and effectively secure the body duct without the need for additional external fixation devices or complex techniques. This can streamline the implantation process, reduces surgical time, and lower the risk of complications associated with more complex attachment methods.

The integral design of the fastening elements can also enhance the durability and stability of the implant. By being an inherent part of the second part of the implant, the fastening elements can be less likely to become dislodged or damaged over time, for example due to patient movement during the healing process. This can further contribute to the long-term success of the implantation, as the secure attachment of the body duct is maintained throughout the healing process and beyond.

In a further embodiment of the present disclosure, the transcutaneous ostomy implant comprises a plurality of inner suture anchors distributed around the opening, such as around an outer part of the transcutaneous ostomy implant. The inner suture anchors may be arranged for accommodating a circular purse string suture around the transcutaneous ostomy implant, in order to tighten the surrounding skin towards the transcutaneous ostomy implant. Additionally, the first part comprises a plurality of connecting elements, in a plane perpendicular to the central axis, connecting the first part with the second part, and wherein said connecting elements comprise the inner suture anchors and optionally one or more support columns.

These inner suture anchors provide a reliable and efficient method for securing the surrounding skin tightly against the implant. This promotes better tissue integration and healing by minimizing gaps and reducing the risk of infection or leakage. The suture anchors may be used to form a circular purse string suture, allowing for a uniform and consistent tension around the implant, ensuring that the skin is drawn securely towards it.

In this way, the implant can remain stable and securely fixed in place, reducing the likelihood of movement or displacement that could compromise the healing process. The tight and secure attachment of the skin also helps to create a better seal around the implant, preventing bodily fluids from leaking and reducing the risk of soiling and infection.

The transcutaneous ostomy implant may comprise a plurality of connecting elements, which include the inner suture anchors and optionally one or more support columns. These connecting elements provide a robust and stable connection between the first and second parts of the implant, ensuring that the implant remains securely in place during and after the implantation procedure, the openings between the individual connecting elements allows for ingrowth of tissue and thereby further promotes a strong integration of the implant.

In one embodiment of the present disclosure, the transcutaneous ostomy implant comprises one or more visual indicators arranged to assist in surgical implantation of the implant. The visual indicators may be provided as color zones, surface markings, contrast patterns or textured regions. The visual indicators can offer clear and intuitive guidance to the surgeon during the implantation process, ensuring that the implant is positioned correctly and at the appropriate depth. This precise placement of the implant can be crucial for optimal skin and subdermal tissue integration and long-term implant stability.

Further, visual indicators can help distinguish between different parts of the implant, such as interior and exterior sections, which is particularly useful in complex surgical environments. By highlighting key components like suture anchors, fastening elements, and engaging elements, these indicators make it easier for the surgeon to navigate the implant and perform the procedure more efficiently.

The use of visual indicators also reduces the likelihood of errors during surgery. For instance, color-coding can prevent the accidental misplacement of sutures or other fixation devices, thereby enhancing the overall accuracy of the implantation. This can lead to a reduction in post-surgical complications, such as infections or the need for reoperations, ultimately improving patient outcomes. In one embodiment of the present disclosure, the first part of the transcutaneous ostomy implant comprises an anchoring flange that extends outwardly from a region around the central axis of the opening, e.g. radially outwardly, wherein the stiffness of this anchoring flange varies across different regions of the anchoring flange.

One advantage of having a flange with variable stiffness is the ability to compress it for insertion through a smaller surgical incision. This feature is particularly important as a smaller incision minimizes tissue damage, reduces the risk of infection, and promotes faster and less complicated healing. Once the flange has been inserted through the incision, it can expand to provide a large surface area that offers substantial support to the implant. This ensures that the implant remains securely in place during the critical initial healing period, before the body tissue has fully integrated with the implant.

Thus, the role of the anchoring flange in maintaining the position of the implant may be particularly important during the initial healing phase. Before the tissue has grown into the implant’s mesh structures, the flange provides necessary mechanical support. This reduces the reliance on external fixation devices or additional sutures, which can be less reliable and more cumbersome for both the surgeon and the patient.

The flexible nature of the flange can also allow it to conform to the unique contours and movements of the patient’s body, providing continuous support without causing discomfort or irritation. This adaptability is particularly beneficial because it accommodates the anatomical differences between patients, allowing the flange to follow the natural curvature of the body. In contrast, a stiff flange with a specific radius of curvature may not fit all body types effectively, potentially causing discomfort and reducing the effectiveness of the tissue integration.

Moreover, a larger surface area of an expanded flexible flange can enhance tissue integration by providing more space for tissue ingrowth. This can lead to a more secure and stable implant, as the surrounding tissue can grow into the mesh structures of the flange, anchoring it firmly in place. This can be a significant improvement over smaller or rigid flanges, which offer less surface area for tissue integration and may not adapt as well to the body's natural shape.

The variable stiffness of the flange also means that it can offer adequate support where needed while being flexible enough to accommodate body movements. This reduces the likelihood of implant displacement, which is a common issue with rigid implants. Additionally, the large surface area of the expanded flange can help distribute mechanical loads evenly, acting to prevent localized pressure points that could lead to tissue damage or necrosis.

In a further embodiment of the present disclosure, the first part comprises an anchoring flange extending outwardly, e.g. radially outwardly, from a region around the central axis of the opening, wherein at least a part of the anchoring flange is resorbable.

After the healing process, which typically takes a few weeks, the function of the anchoring flange can be limited. A permanent flange could even become a nuisance to the patient, potentially hindering movement and causing general discomfort. The resorbable flange, by dissolving naturally, alleviates this issue, ensuring that the implant does not interfere with the patient’s daily activities or comfort after the initial healing period.

The resorbable flange can be designed to degrade at a controlled rate, which can be tailored to match the specific healing requirements of the patient. This adaptability can ensure that the flange provides sufficient support for as long as needed while avoiding any long-term presence that could interfere with bodily functions or cause adverse reactions. The controlled degradation may also allow the implant to adapt to the natural changes in the patient's body over time, maintaining its effectiveness and comfort.

In a further aspect, the present disclosure relates to a method of manufacturing a transcutaneous ostomy implant. The implant may be arranged as disclosed elsewhere herein. The method may comprise using at least one process, such as assembly, additive manufacturing and/or machining to manufacture at least part of the transcutaneous ostomy implant.

In yet a further aspect, the present disclosure relates to a method for processing a transcutaneous ostomy implant comprising:

• providing the transcutaneous ostomy implant;

• applying one or more visual indicators to the transcutaneous ostomy implant for guiding implantation of the transcutaneous ostomy implant.

Description of the drawings

In the following, embodiment and examples will be described in greater detail with reference to the accompanying drawings: Fig. 1 is a schematic side view of an embodiment of a transcutaneous ostomy implant;

Fig. 2 is a schematic top view of the transcutaneous ostomy implant of Fig. 1;

Fig. 3 is a sectional view along line A-A in Fig. 1, illustrating internal structures of the implant;

Fig. 4A is a sectional view along line B-B in Fig. 2, further detailing internal structures of the implant;

Fig. 4B is a similar sectional view to Fig. 4A, illustrating a variation of the implant comprising a downward-curved anchoring flange with a rounded terminal edge;

Fig. 5 is a perspective view of the transcutaneous ostomy implant;

Fig. 6 is a perspective view of an embodiment of a lid for use with the ostomy implant;

Fig. 7 is a schematic illustration of an emptying device for use with the ostomy implant;

Fig. 8 is a flowchart illustrating a method for processing a transcutaneous ostomy implant;

Fig. 9 is a flowchart illustrating a method for manufacturing a transcutaneous ostomy implant.

Detailed description

In a first aspect, the present disclosure relates to an implant, preferably a surgical implant, preferably an ostomy implant, such as a transcutaneous ostomy implant, which in some contexts may also be referred to as a percutaneous ostomy implant.

The implant may be suitable for use in connection with various types of stomas, including, but not limited to, ileostomies, colostomies, and urostomies.

The present disclosure concerns the design, manufacture, and use of these implants to improve the reliability and success rate of ostomy procedures. This includes features that enhance tissue integration, minimize the risk of infection, and facilitate easier and more secure implantation. The implants described herein may be adapted for temporary and/or permanent use, and may be configured to accommodate different body ducts, such as sections of the intestine (e.g., the ileum or colon) or the urethra. Furthermore, the present disclosure encompasses methods for manufacturing these implants using various techniques including additive manufacturing, molding, machining, and assembly methods. It further encompasses implant processing techniques to integrate visual indicators and other functional features that assist surgical implantation and support long-term implant performance.

By addressing technical issues related to tissue integration, patient comfort, and surgical application, the present disclosure aims to support improved outcomes for patients undergoing ostomy procedures. This includes reducing the likelihood of complications, enhancing the healing process, and providing a stable and reliable interface between the body and the implant. More broadly, the features disclosed herein are directed toward enabling secure and efficient implantation of transcutaneous ostomy implants, both during surgery and throughout post-operative healing.

The ostomy implant may comprise a first part. Typically, the first part is configured for implantation into a patient, such as partly or fully. Thus, in some examples the first part is adapted to be partly implanted into the patient, such that at least a part of the first part protrude outside of the patient. The implant may further comprise a second part, that is arranged to be connected to the first part. The second part can, in specific examples, be connected to the first part. The second part may be configured for at least partly protrude outside of the patient, following implantation. As such, a part of the second part may be arranged for being implanted into a patient. Alternatively, the second part may be arranged to be positioned outside of the patient following implantation.

In one embodiment, the transcutaneous ostomy implant may be arranged such that, when implanted, at least a portion of the second part protrudes outside of the patient’s body. The externally accessible part of the second part may be used as an attachment interface for various accessories, such as collection bags, sealing lids, or protective covers, thereby enhancing the functional versatility of the implant system in clinical use.

The implant comprises an opening extending through at least a portion of the first part and the second part. The opening can define a central axis and may be adapted to accommodate at least a part of a body duct, such as an intestinal, colon, or urinary segment. In this way, the opening may allow the duct to pass through the implant from inside the body to the exterior. In some examples the opening extends continuously from an interior end of the first part to an exterior end of the second part. The shape of the opening may be cylindrical, conical, or another geometry, but typically defines a central axis for alignment and interaction with internal features such as engaging and fastening elements.

Engaging elements

In one embodiment of the present disclosure the implant comprises one or more engaging elements that protrude inwardly from an inner part of the implant. For example, an inner part of the second part may comprise the engaging elements. However, alternatively or additionally, the first part may comprise the engaging elements. Thus, an inner part of the first part and/or the second part may comprise the engaging elements. The engaging elements may be arranged so that they extend, for example radially or at an angle, into the opening, for example towards the central axis. The engaging elements may be arranged to engage the body duct, such as to provide contact against the duct wall, which may assist in maintaining the duct in position and/or promote a healing response. The engaging elements can enhance the stability and integration of the implant within the body. By providing internal mechanical engagement, the engaging elements contribute to secure and efficient implantation of the implant, supporting stable positioning, improved tissue integration, and better surgical outcomes.

The engaging elements may extend from a surface in a direction perpendicular to that surface, or at a slanted angle, for example directed radially inwardly and toward the exterior end of the implant. The specific orientation may be selected to optimize performance, for instance to promote controlled friction or mechanical resistance that can help prevent displacement of the body duct. Some arrangements may allow the engaging elements to exert a retaining function, whether by direct contact pressure, angled orientation, or spatial distribution around the opening. In such a configuration the engaging element may also be referred to as retaining elements.

The geometry of the engaging elements may be adapted to promote tissue integration, for instance by provoking a mild inflammatory response at the surface of the duct through localized irritation or contact. This may stimulate biological ingrowth into or around the implant, such as into an adjacent mesh structure, including, for example, a three-dimensional porous scaffold, thereby enhancing the integration between tissue and implant. The engaging elements may have a variety of shapes and sizes, which may be selected based on intended function and anatomical compatibility. They may be formed as part of a surface or structure of the implant, and may comprise features such as tapered tips, surface roughness, or textured contours. The design may be configured to promote sufficient engagement with the tissue while minimizing risk of damage. In certain implementations, the material, flexibility, and surface treatment of the engaging elements may be adapted to further influence the mechanical interaction with the body duct and the biological response that follows.

By inducing a controlled inflammatory response, the engaging elements may encourage the body’s natural healing processes to secure the implant more effectively. This can support the formation of a resilient tissue-implant interface, reducing the likelihood of infection and improving the overall success rate of the implantation procedure.

In one embodiment of the present disclosure, the engaging elements can be, additionally or alternatively, be arranged to retain the body duct. For example the engaging elements may be angled toward an exterior part of the implant, such as in a direction extending from the inner surface of the implant toward the exterior end. This may be referred to herein as an upward direction. Thus, in some examples, the engaging elements may protrude radially inwardly and simultaneously at an angle with respect to the central axis, as illustrated in Figs. 3-4.

Such an arrangement can assist in maintaining the body duct, for example a section of the intestine or the urethra, in a stable position within the implant. The engaging elements may provide a mechanical anchoring effect, preventing the duct from retracting or slipping out of place. This feature can be particularly important for the early postoperative phase, where tissue ingrowth is ongoing, and is also relevant for ensuring the long-term stability of the implant. Examples of suitable configurations may include hook-like structures or angled projections directed inwardly and upwardly within the implant lumen. In this configuration, the engaging elements may also be referred to as retaining elements.

The engaging elements may thereby be arranged to engage the wall of the body duct, for example by contacting and/or partially embedding into the surface tissue, thereby helping to prevent the body duct from retracting. In this way, the engaging elements may function as mechanical anchors. The engaging elements may have different geometries suited to their functional purpose. In some examples, they may be pointed or narrowed at the tip to enhance tissue contact. The narrowing may be gradual (e.g. tapered) or more abrupt (e.g. conical or spiked). In other examples, the elements may be blunt, hook-shaped, or barbed, depending on the level of engagement desired. The tip of each engaging element may be located at or near its radially innermost point, such as directed toward the central axis or angled upward toward the exterior part of the implant.

In one embodiment of the present disclosure, the engaging elements are pointed structures. The tip of each engaging element may be located at the radially innermost part, e.g. towards the central axis of the opening. This pointed design allows the elements to better penetrate the tissue of the body duct, which can help in securing the duct and promoting a controlled inflammatory response to aid in healing.

The engaging elements may be arranged to provoke a localized biological or inflammatory response by lightly irritating or scraping the surface of the body duct, for instance through contact with intestinal mucosa or urethral lining. This localized irritation can support tissue regeneration and promote ingrowth, for example into a mesh structure surrounding the implant.

Alternatively or additionally, the engaging elements may be configured to mechanically retain the body duct, helping to prevent slippage, retraction, or axial displacement. This is particularly important during early healing, when tissue anchoring is incomplete.

In one embodiment, the engaging elements are configured to ensure that the body duct remains in a position extending through at least a portion of the opening. The engaging elements may act in combination with other features of the implant, such as fastening elements, inner suture anchors, and/or sealing lid, to ensure functional positioning of the body duct and long-term integration between the duct and the implant. The length, shape, and spacing of the engaging elements may be selected depending on the application, for example based on the type of duct (e.g. ileum or urethra), the expected implantation time, and the desired mechanical or biological effect.

In one embodiment of the present disclosure, the implant comprises one or more engaging elements that protrude inwardly from an inner part of the implant. For example, the engaging elements may extend from an inner part of the second part, or alternatively or additionally from the first part. The engaging elements may protrude toward the central axis of the opening, and may be arranged to engage the body duct. The elements may extend generally radially inwardly, and may optionally be oriented at an angle with respect to the central axis or to the surface from which they extend, thereby adopting a slanted configuration. This slanted arrangement may result in the elements extending inwardly and upwardly, for example toward an exterior end of the implant. The angle of extension may be less than 90°, such as 85°, 70°, 60°, 45°, 30°, or 10°, depending on the application and desired interaction with the body duct.

In one embodiment of the present disclosure, an inner part of the implant, such as a surface of the first part and/or the second part, comprises a mesh structure. The mesh structure may for example be a three-dimensional mesh, which may be a three- dimensional structure adapted for tissue ingrowth, for example as disclosed in applicant’s previous application WO 2014/140344. The engaging elements may be arranged to extend from the mesh structure, e.g. radially inwardly and/or upwardly.

The orientation and length of the engaging elements may be measured from the surface from which they extend, and the radial projection may be shorter than the actual element length in cases where the elements are slanted.

In one embodiment of the present disclosure, the engaging elements extend radially inwardly by less than 3 mm, such as less than 2 mm. The term “radially inwardly” refers to the direction from the surface of the implant — such as from an inner surface of the first or second part — toward the central axis of the opening. In cases where the engaging elements extend perpendicular to the central axis, this radial inward distance may correspond to the total length of the elements. However, where the engaging elements are slanted, the radial projection is shorter than the actual length of the element. That is, the radial distance describes the orthogonal component of the extension toward the axis, whereas the total or slanted length follows the axis of the element itself. Thus the total length may be considered the length from a base to a tip of each engaging element.

In some embodiments, the engaging elements extend radially inwardly in the range of 0.1 mm to 3 mm, such as from 0.3 mm to 2.5 mm, or from 0.5 mm to 1 mm, such as around 0.8 mm. These dimensions may be selected to provide mechanical interaction with the body duct while reducing the risk of excessive irritation or damage. In a further embodiment, the engaging elements have a total length — i.e., a slanted or directional length — that is greater than or equal to their radial inward projection. This length may be less than 3 mm, such as less than 2 mm, for example around 1.25 mm. In other examples, the slanted length may be in the range from 0.1 mm to 3 mm, such as from 0.5 mm to 2.5 mm, or from 0.8 mm to 2 mm, such as around 1.3 mm. The slanted configuration can allow the engaging elements to achieve a combined function of duct retention and inflammatory stimulation, while avoiding excessive tissue penetration.

The measurement of these dimensions may be taken from the base surface from which the engaging elements protrude — such as from the mesh structure or inner wall — to the tip of the engaging element. The tip may be located at a radially innermost point or angled toward an exterior portion of the implant. The geometry and size of the engaging elements are thus selected to balance secure mechanical retention and safe interaction with the body duct, without full perforation.

Fastening elements

In one embodiment of the present disclosure, the implant comprises one or more fastening elements for securing the body duct. For example, the second part may comprise said fastening elements. The fastening elements may be structures arranged for accommodating a suturing thread. For example, the fastening elements may have a curved shape, such as a loop-shape, which may be shaped to accommodate the suturing thread. The fastening elements may be arranged to provide additional stability and security to the body duct, ensuring it remains properly positioned within the implant, in particular during the initial healing stage. The fastening elements address several shortcomings in the prior art, where external fixation devices or external sutures are commonly used. These traditional methods can be less reliable, more difficult to manage, and may cause discomfort or complications for the patient. By being integrated into the implant, the fastening elements support secure and efficient implantation by enabling precise and stable fixation of the duct without the need for external devices, thereby improving surgical accuracy and reducing post-operative risks.

In one embodiment of the present disclosure, the fastening elements are arranged to retain the body duct at or near its terminal end. This positioning ensures that the body duct is secured as close as possible to its natural exit point from the implant, minimizing the risk of retraction or misalignment. By anchoring the duct at or near its end, the fastening elements help preserve anatomical integrity, support proper functioning of the ostomy, and may contribute to more consistent healing and integration with the implant. This arrangement also reduces the need for trimming or repositioning the duct during or after surgery.

In one embodiment of the present disclosure, the fastening elements are loop structures arranged for accommodating a suturing thread. This design allows for the easy and secure attachment of sutures, facilitating the surgical procedure and ensuring a stable fixation of the body duct.

In one embodiment of the present disclosure, the fastening elements are provided at or in proximity to an end region of the second part, such as an exterior end of the second part and/or the exterior end of the implant. This positioning allows the fastening elements to secure the body duct effectively at or near the point where it exits the implant, which can enhance the mechanical stability of the attachment. In this region, the implant may also be configured to support the application of a sealing lid, such as a lid of the type disclosed in the applicant’s patent application WO 2023/203250. For example, the exterior region of the implant may define a flat or substantially planar annular surface that facilitates sealing engagement with the lid. Importantly, the placement of the fastening elements may be configured such that they do not obstruct the sealing function of the lid. In some arrangements, the fastening elements may be recessed, flush with, or slightly spaced from the outermost end of the implant. This structural layout enables simultaneous use of the fastening elements for duct fixation and the lid for sealing during the healing phase. The ability to close the implant with a lid immediately after implantation can contribute to a controlled healing environment by maintaining temperature, moisture, and hygienic conditions, thereby promoting tissue integration and reducing the risk of post-operative complications.

In one embodiment of the present disclosure, the fastening elements are arranged along an inner region of the second part, for example on an inner surface thereof. The fastening elements may protrude into the opening, allowing the body duct to be positioned in an anatomically favorable position for healing and integration. By securing the body duct directly within the implant, the need for external fixation devices or subsequent resection of protruding duct segments is avoided, simplifying postoperative care. In some embodiments, the fastening elements are integral to the second part, improving reliability and minimizing the risk of mechanical failure or detachment.

In some embodiments, the fastening elements may be arranged at or near the end of the second part, such as the exterior end of the implant. For example, the fastening elements may be positioned substantially flush with the exterior surface, or they may be spaced axially from the end by a small distance, such as at least 0.05 mm or 0.1 mm, or within a range of 0.05 mm to 10 mm. This flexibility allows the implant to accommodate various sealing solutions, including lids that require a continuous flat annular surface and those that can engage with raised or contoured end geometries. By providing structural separation or surface clearance where needed, or placing the fastening elements flush when appropriate, the implant can facilitate both effective duct fixation and compatibility with different lid types used during or after the healing period.

In one embodiment, the fastening elements are arranged in a plane that is substantially perpendicular to the central axis of the opening. This facilitates symmetrical distribution of the securing forces around the body duct, which may reduce stress concentrations and enhance fixation. These fastening elements may be distributed circumferentially, for example at regular angular intervals or irregularly based on the desired fixation profile. In one embodiment, the transcutaneous ostomy implant comprises a plurality of fastening elements, such as at least 3, 4, 5, 6, 7, 8, 9, or 10, or more than 10. Multiple fastening elements enhance the mechanical stability of the implant and help ensure the duct is held firmly in position.

Each fastening element may extend from its supporting surface in a specific direction, depending on the desired orientation of the suture. In some examples, the elements extend in a plane perpendicular to the central axis of the opening, such that a suture may pass in an axial direction. In other cases, the fastening elements may extend in a direction parallel to the axis of the opening, so the suture passes through in a radial or tangential direction. Oblique angles combining axial and radial/tangential components are also possible. This geometric flexibility allows tailoring for different suture approaches and lid compatibility.

In one embodiment, the fastening elements are loop-shaped, defining a through-hole with an inner diameter of at least 1 mm, such as at least 1.25 mm or 1.5 mm, sufficient for receiving suture material or surgical tools. Alternatively, the fastening elements may be partial loops, arms, hooks, or pins that support suturing without requiring the suture to pass through a complete aperture. Such variations may simplify surgical handling and reduce material use. Rounded edges or cross-sections of the fastening elements can further minimize damage to tissue and reduce wear on suturing material.

In one embodiment of the present disclosure, the fastening elements are arranged to retain the body duct at or near its terminal end. This configuration helps prevent retraction of the duct into the body and supports its functional alignment within the implant. In some cases, the fastening elements may be configured to be temporary, for example resorbable or deformable after healing, enabling them to serve their purpose without remaining permanently in place.

In one embodiment of the present disclosure, the fastening elements extend at an angle with respect to the central axis of the opening. The angle may range from 0° to 90°, depending on the desired interaction between the suture and the implant geometry. For example, in one embodiment, the fastening elements extend at an angle of 0°, meaning they are oriented perpendicular to the central axis — i.e. , radially relative to the opening. This arrangement can facilitate straightforward linear securement of the body duct and can be beneficial in minimizing lateral displacement while ensuring stable fixation. Thus, the fastening elements may be inclines at an angle from 0° to 90° relative to the central axis.

In other embodiments, the fastening elements extend at an angle greater than 0°, such as 30° or 45°, relative to the central axis. Such configurations may offer improved accessibility during suturing, while enhancing the mechanical grip of the fastening mechanism. Angled fastening elements may also contribute to distributing stress more uniformly along the tissue interface, reducing the risk of local irritation or trauma and thereby promoting improved healing outcomes. An angle of 90°, i.e., a configuration where the fastening elements are aligned parallel to the central axis, may further reduce interference with the passage of stomal output and contribute to unobstructed flow.

It should be noted that the fastening elements may be distributed around the opening, such as in a plane that is substantially perpendicular to the central axis. However, the direction in which each fastening element extends need not align with the plane in which the fastening elements are arranged. For instance, loop structures may be arranged around the opening in a perpendicular plane but individually extend in a radial direction or at an oblique angle relative to the central axis. In one embodiment of the present disclosure, one or more of the fastening elements are temporary fastening elements. These may be configured to be removed or rendered non-obstructive after the initial healing period. For example, the fastening elements may be fabricated from a resorbable material that gradually degrades in the body, such as polylactic acid (PLA), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) (PLGA), or magnesium alloys. Alternatively, the fastening elements may be mechanically detachable, such as configured to break off from the implant via an applied tool, manual manipulation, or due to structural weakening over time. In some examples, the fastening elements may deform or collapse under a specific mechanical load or physiological condition, effectively removing their obstructive presence. These features allow the fastening elements to provide the required stabilization of the body duct during early healing, while avoiding long-term interference with the function of the implant, the application of closure devices such as a lid, or with patient comfort.

Inner suture anchors

In one embodiment of the present disclosure, the transcutaneous ostomy implant comprises a plurality of inner suture anchors. The inner suture anchors may be arranged at or near any structural portion of the implant. For instance, in certain configurations, the inner suture anchors may be circumferentially distributed around an outer portion of the implant body, such as along an external surface or interface zone of the transcutaneous ostomy implant. This positioning may be selected to correspond with anatomical features or to facilitate surgical access and fixation.

The inner suture anchors may be configured to provide secure attachment points for surgical sutures or equivalent fastening means. By enabling the fixation of surrounding tissue directly to the implant structure, the anchors may help maintain stable tissueimplant contact. This promotes localized pressure and alignment that may enhance tissue integration, reduce micromotion, and facilitate the formation of a biological seal or ingrowth layer, thereby supporting more effective healing and long-term stability of the implant. Through these effects, the inner suture anchors contribute directly to secure and efficient implantation of the implant by enhancing fixation reliability, simplifying surgical handling, and reducing post-operative complications.

In one embodiment, the implant may comprise a first part that includes a plurality of connecting elements configured to extend toward and physically couple the first part to the second part of the implant. These connecting elements may form an integrated load-bearing network that preserves the structural coherence of the implant across internal and external sections. Such a configuration may be advantageous in withstanding physiological mechanical forces during and after implantation, including those resulting from bodily movement, internal organ pressure, or routine handling.

In certain embodiments, one or more of the inner suture anchors may be formed integrally with the connecting elements. This integration may simplify the overall architecture of the implant, potentially reducing the number of distinct components required during manufacturing, and may enhance performance by ensuring precise relative positioning between structural and fixation features. Additionally, by embedding the anchors within load-bearing elements, the implant may avoid localized stress concentrations and ensure reliable tissue anchorage without compromising strength or flexibility.

In a further embodiment, the connecting elements may comprise both inner suture anchors and structural support columns. The support columns may be configured to contribute to radial or axial reinforcement of the implant body, or to stabilize particular implant regions. The combination of suture anchors and support columns may provide a synergistic effect, offering both mechanical support and surgical fixation functionality. Such a configuration may facilitate controlled deformation, resist displacement, and help achieve more predictable post-surgical outcomes.

In certain embodiments, the inner suture anchors may comprise a rounded profile or curvature. For example, the rounding may be present on one or more connecting elements that serve as inner suture anchors, such as at the junction between the first and second parts of the implant. The rounded geometry may provide a smooth contour that minimizes sharp edges or abrupt transitions, thereby reducing the risk of localized tissue irritation or damage. Additionally, the rounded surface may facilitate atraumatic passage and secure placement of sutures, which can be particularly advantageous when securing inflamed, delicate, or regenerating tissue.

In one embodiment, each inner suture anchor may extend, at least in part, within a radial plane, the plane being defined as extending outward from the central axis of the opening of the implant. Such a radial orientation may contribute to a uniform distribution of tensile forces when sutures are applied, thereby reducing the risk of localized tearing, asymmetric loading, or uneven compression around the implant. Aligning the anchors in this manner may also correspond with typical anatomical force vectors encountered during surgical implantation.

In some configurations, each inner suture anchor may additionally be positioned, at least partly, within the same radial plane. This positional alignment may improve surgical access to the anchors and allow for more predictable suture placement and tension distribution. Together, these features may enhance the mechanical reliability and positional stability of the implant during and after implantation, particularly under dynamic physiological conditions.

In one embodiment, the inner suture anchors may be distributed around an outer portion of the transcutaneous ostomy implant, such as at or near a plane that is substantially perpendicular to the central axis of the implant's opening. This circumferential distribution may allow the anchors to provide uniform support and securement of surrounding tissue, potentially reducing the risk of asymmetric loading, displacement, or rotation of the implant. By providing multiple fixation points evenly spaced around the implant body, this configuration may also facilitate consistent integration with adjacent tissue structures.

In certain embodiments, the inner suture anchors may be specifically arranged or shaped to accommodate a suture thread and/or a suture needle. This configuration may simplify the surgical fixation process and allow the implant to be secured using standard surgical instruments and techniques. For instance, the anchors may define apertures, hooks, eyelets, or recesses that are dimensioned to receive or retain the surgical suture components. The ability to accommodate both suture threads and suture needles may offer procedural flexibility, supporting both manual and automated or guided surgical placement methods.

In a further embodiment, the inner suture anchors may comprise a rounded contour, for example at a portion of the structure exposed to the suture path. The rounding may define an internal curvature that forms a recessed space or loop. This curvature may result in the formation of a free space on the interior side of the rounding, configured for receiving and securing the suture. The geometry of this free space may prevent unintentional displacement of the suture and reduce the likelihood of abrasion or cutting into surrounding tissue. In this way, the rounded anchor structure may improve both patient comfort and the mechanical reliability of the fixation. In some embodiments, the free space defined by the curvature of the inner suture anchors may have a diameter of at least 1 mm, such as at least 1.2 mm, or at least 1.5 mm. These dimensions may be selected to accommodate standard suture thread gauges and needle sizes used in surgical practice. The defined range ensures compatibility with commonly available surgical materials, while also supporting adequate clearance for manipulation during implantation. The sizing may strike a balance between providing reliable engagement and minimizing bulk or rigidity that could otherwise interfere with tissue integration.

In one embodiment, the inner suture anchors may be arranged such that they are suitable for receiving a circular purse string suture, placed circumferentially around the transcutaneous ostomy implant. A purse string configuration may be particularly effective for drawing the surrounding skin or tissue inward toward the implant, thereby forming a snug seal and increasing implant stability. This method of fixation may also distribute tension uniformly around the implant interface, which can be advantageous in promoting even tissue healing and reducing the risk of localized strain or necrosis.

In some embodiments, the inner suture anchors are arranged at a position, such that when implanted, they are located beneath the skin surface, such as within or adjacent to the subcutaneous tissue layer or dermis. This subdermal positioning enables the application of a circular purse string suture that passes through soft tissue located below the epidermis. When the suture is drawn tight, the surrounding tissue is pulled inwardly toward the implant, promoting circumferential contact between the tissue and the implant surface. This close approximation of tissue to implant may enhance biological integration by reducing dead space, improving mechanical stability, and minimizing micromotion. Furthermore, by anchoring the implant securely within the subcutaneous environment, this arrangement may reduce the risk of upward displacement or extrusion during the healing process. The purse string configuration can also facilitate uniform tensioning around the implant’s perimeter, thereby distributing load evenly and potentially reducing focal stress or ischemia in the surrounding tissue.

In certain embodiments, the connecting elements of the implant, including those that function as or comprise inner suture anchors, may have a thickness (e.g., a cross- sectional diameter) in the range of from 0.1 mm to 0.5 mm. This dimension may be selected to provide sufficient mechanical strength for both structural support and secure suture retention, while remaining minimally invasive and reducing the implant’s overall profile. The choice of thickness may also help avoid excessive rigidity, which could compromise flexibility or contribute to tissue irritation. As such, the geometry of the connecting elements may be tailored to optimize both functional integration and surgical handling.

In certain embodiments, the transcutaneous ostomy implant may comprise a plurality of outer suture anchors arranged at a radial position outward of the inner suture anchors. These outer suture anchors may function as supplemental fixation points, enhancing the overall mechanical stability of the implant and reducing the risk of displacement, tilting, or rotation under physiological loading conditions. By providing an additional set of tissue engagement structures, the outer suture anchors may contribute to more uniform distribution of tensile forces across the implant-tissue interface. This distribution may support both reliable initial fixation and improved long-term biological integration.

In some embodiments, each outer suture anchor may be arranged in a radial plane that also includes a corresponding inner suture anchor, wherein the radial plane extends outwardly from the central axis of the opening of the implant. This configuration may enable coordinated or paired placement of sutures through both inner and outer anchors along the same anatomical vector. By aligning these anchors within shared radial planes, the implant may facilitate controlled and balanced fixation across multiple tissue layers, improving both ease of implantation and force distribution. Such radial alignment may also support the use of symmetrical or circular suturing patterns, which can contribute to consistent tensioning and improved healing outcomes.

In one embodiment, the first part of the transcutaneous ostomy implant may comprise an anchoring flange extending radially outward from a region surrounding the central axis of the opening. In such configurations, the outer suture anchors may be positioned on a surface of the anchoring flange or integrated into its structure. The anchoring flange may serve as a support platform, providing a broad area of contact with surrounding tissue to enhance mechanical stability. The placement of outer suture anchors along the anchoring flange may facilitate secure tissue fixation, reduce the risk of implant migration — particularly in anatomically mobile regions — and promote uniform force distribution. This configuration may also enable circular or multi-point suturing techniques, supporting even tensioning and consistent healing responses in the surrounding tissue.

However, in alternative embodiments, the implant may be configured without an anchoring flange and/or without a radially extending component. For instance, the implant may be designed for use in anatomical locations where a low-profile interface or reduced radial footprint is desirable. Such variations may be beneficial in minimizing surgical intrusion or in accommodating space-limited implant sites, while still maintaining sufficient fixation through other anchoring features.

In another embodiment, the first part of the implant may comprise an anchoring flange that extends outwardly from the region surrounding the central axis of the opening, and wherein the stiffness of the flange varies across different radial zones. This gradation in stiffness may be achieved through variations in material composition, structural geometry, or manufacturing parameters. The resulting design may allow the flange to conform more closely to the natural curvature and compliance of the patient’s tissue layers, thereby minimizing the risk of localized pressure points or mechanical mismatch. In particular, areas of lower stiffness near the outer edge may provide cushioning and flexibility, while inner zones of higher stiffness may offer robust support at the implant interface. Such variable stiffness may enhance patient comfort, reduce long-term irritation, and promote stable integration of the implant with adjacent biological structures.

As used herein, a “plane perpendicular to the central axis of the opening” refers to a cross-sectional plane that intersects the implant at a fixed depth and extends radially outward from the central axis. This orientation enables circumferential distribution of features such as suture anchors, and supports uniform load distribution during tissue fixation.

Outer suture anchors

In one embodiment, the present disclosure relates to a transcutaneous ostomy implant comprising a plurality of outer suture anchors positioned within a curved peripheral portion of an anchoring flange. The curved peripheral portion is configured to conform to the curvature of a patient’s abdominal wall, thereby promoting secure anatomical fit, minimizing localized pressure, and enhancing patient comfort. By providing dedicated suture attachment points in this curved region, the implant enables effective peripheral fixation while maintaining anatomical compatibility.

By integrating suture anchors into a curved peripheral portion of the anchoring flange, the implant enables stable peripheral fixation that complements the natural anatomical contours of the abdominal wall. This configuration supports improved tissue contact, distributes mechanical loads more evenly, and reduces micromotion at the skin interface. These features collectively contribute to the secure and efficient implantation of the transcutaneous ostomy implant, enhancing healing conditions and reducing reliance on external fixation techniques.

In some embodiments, the anchoring flange has a relatively large outer diameter to provide an expanded surface area for tissue engagement and implant stability. The ability to use such larger flanges is supported by the presence of outer suture anchors positioned within the curved peripheral portion of the flange, which enable secure fixation even near the periphery without compromising anatomical conformity or patient comfort.

The ability to use larger anchoring flanges, made possible by the integration of outer suture anchors in the curved peripheral portion, addresses important challenges in prior art implants. Conventional systems often rely on smaller flanges due to difficulties in achieving reliable fixation at the periphery without increasing surgical complexity or causing skin irritation. By enabling secure peripheral fixation in a zone that conforms to the body’s curvature and avoids pressure points, the disclosed configuration supports broader tissue engagement, improved distribution of mechanical loads, and enhanced implant stability. These features contribute directly to the overarching goal of the present disclosure, a transcutaneous ostomy implant that enables secure and efficient implantation, reduces reliance on external fixation techniques, and improves long-term tissue integration.

The outer diameter of the flange may be, for example, at least 40 mm, such as at least 60 mm, 80 mm, or 100 mm, depending on the application and patient anatomy. Prefearbly the outer diameter is at least 100 mm, or yet more preferably at least 150 mm. In certain embodiments, the outer diameter is within a range of 50 mm to 200 mm, such as 60 mm to 180 mm, or more specifically 70 mm to 160 mm. The terminal edge portion — typically extending 1 mm to 10 mm inward from the outermost boundary — remains free of suture anchors to allow atraumatic skin contact, while the outer anchors are positioned inboard of this region to enable stable peripheral fixation.

Larger flange diameters may be especially advantageous for securing the implant in locations subject to anatomical movement, or where broader tissue distribution helps reduce micromotion, pressure concentration, or pull-through. The structural and functional features disclosed herein are particularly suited to supporting such larger- diameter implants without sacrificing fixation reliability or surgical ease.

In certain embodiments, the curved peripheral portion of the flange includes a reduced- stiffness material region, allowing it to flex in response to surgical manipulation or patient movement. The compliant nature of this region allows the flange to remain in intimate contact with the surrounding tissue throughout dynamic physiological conditions. Despite this flexibility, the outer suture anchors within this region provide mechanically stable fixation points, ensuring that secure attachment can be achieved without excessive stress on the surrounding tissue or on the implant itself.

In particular, while it is generally advantageous to place suture anchors as far radially outward as possible to maximize fixation area and mechanical leverage, the outermost terminal edge of the flange may be designed with a rounded or curved profile to reduce sharp transitions and minimize contact pressure against the skin. Accordingly, the outer suture anchors are preferably positioned within the curved peripheral portion, but inward of the terminal rounded edge. This arrangement allows the anchors to be located in a structurally robust region suitable for reliable suturing, while preserving a smooth, atraumatic edge at the skin-contacting periphery of the flange.

Each outer suture anchor may include a defined aperture adapted to accommodate standard surgical suture threads, for example with an internal diameter of at least 1 mm, such as at least 1.2 mm or at least 1.5 mm. The suture-contacting surfaces may exhibit a smooth finish or be coated with a biocompatible low-friction layer, reducing the risk of thread fraying, tearing, or abrasion during and after implantation. In some embodiments, the entire exposed contour of the anchor structure is smooth and rounded, promoting atraumatic suture engagement and enhanced mechanical durability.

In some embodiments, the anchoring flange comprises a rounded terminal edge region that is free of suture anchors and configured to ensure atraumatic contact with the skin. This terminal region may extend 1 mm to 10 mm inward along the surface contour of the flange from its outermost boundary. The outer suture anchors are positioned just inward of this region, in a part of the flange that is suitable for surgical suturing to subcutaneous tissue. This arrangement supports secure peripheral fixation while maintaining comfort at the skin interface.

In further embodiments, the outer suture anchors are radially aligned with inner suture anchors located closer to the implant’s central axis. This alignment may facilitate a coordinated circular purse-string suture path, enabling the surgeon to draw skin or soft tissue inward evenly around the implant. Such paired fixation geometry supports balanced loading, minimizes implant tilting or asymmetry, and may contribute to enhanced tissue integration and sealing.

The combination of a curved, flexible peripheral flange with structurally reinforced, optimally positioned outer suture anchors enables the implant to achieve a broad area of stable fixation. This arrangement supports the use of larger-diameter flanges, which would otherwise be difficult to secure effectively without compromising anatomical conformity or patient comfort. By addressing these mechanical and anatomical challenges in an integrated design, the disclosed implant improves both surgical handling and post-operative outcomes.

Visual indicators

In one embodiment, the present disclosure relates to an implant comprising one or more visual indicators arranged to assist in the surgical implantation of the implant. These visual indicators may serve to guide the surgeon during placement, alignment, orientation, and fixation of the implant within the patient. Such guidance may be particularly valuable for improving procedural consistency, reducing surgical complexity, and minimizing the risk of incorrect positioning. By providing intuitive intraoperative guidance, the visual indicators contribute directly to secure and efficient implantation.

The implant may be of any type where precision in placement is important. For example, in certain embodiments, the implant may be a transcutaneous ostomy implant, wherein accurate positioning is critical to avoid complications such as leakage, tissue trauma, or mechanical malfunction. In other embodiments, the implant may be a neurostimulator, orthopedic anchor, cranial plate, cochlear implant, dental fixture, or another surgically implanted device, where visual indicators can assist in aligning the implant with anatomical landmarks or ensuring that a desired insertion depth or rotational orientation is achieved.

In all such contexts, the inclusion of visual indicators may contribute directly to enhanced clinical outcomes, more predictable biological integration, and improved long-term device performance. These improvements result from more accurate placement and fixation, which are essential elements of secure and efficient implantation.

The visual indicators may be configured to perform one or more implantation-related functions. For example, in certain embodiments, they may be associated with a specific surgical task, such as indicating the correct insertion depth, identifying a boundary between structural regions, or marking the position of features requiring surgical interaction, such as engaging elements, fastening elements, inner suture anchors, or an anchoring flange. In some configurations, visual indicators may serve as anatomical references, aligning the implant with specific tissue layers or predefined surgical margins. In each case, the visual indicators facilitate correct execution of critical surgical steps, supporting the implant's accurate positioning and secure fixation.

The terms “guiding implantation” and “assist in the surgical implantation” of the implant as used herein is to be interpreted broadly and may refer to any visual cue that supports correct positioning or handling of the implant. This may include, without limitation, marking the intended depth of implantation, indicating which part of the implant should remain external, distinguishing between interior and exterior regions, highlighting the relative orientation of components, identifying functional zones requiring engagement with sutures or other fixation means, or identifying other functional component of the implant.

In one embodiment, the visual indicators may comprise color zones, surface markings, contrast patterns, and/or textured regions. These indicators may be applied to the surface of the implant, or may be integrated into the implant’s material or coating. By introducing visible differences between implant regions, such indicators may facilitate rapid identification and reduce reliance on prior training or experience, which may be particularly useful for less familiar surgical teams or in time-sensitive procedures. In some embodiments, different parts of the implant may be associated with different visual indicators. For instance, internal structural regions intended to be placed within the body may be marked using one visual scheme, while the external parts may use another. Such differentiation may make it easier for the surgeon to verify the correct orientation and seating of the implant during and after insertion. The indicators may also be used to demarcate functionally distinct zones, such as the interface between the inner part of the implant and the external access portion. Thus, each type of visual indicator can be associated with a distinct implantation function, such as indicating an insertion depth, identifying a structural interface, marking an anatomical reference, or distinguishing a specific component of the implant, including a suture anchor, a fastening element, or an anchoring flange.

In certain embodiments, the visual indicators may highlight interfaces between adjacent or functionally distinct structural regions of the implant. For example, they may mark the boundary between the second part, which is configured to protrude externally, and the first part, which is configured for subcutaneous placement. This may assist in correctly aligning an anchoring flange or locating key fixation features relative to anatomical reference points.

In further embodiments, the visual indicators may be configured to indicate a target implantation depth. This may correspond to a specific anatomical depth at which the implant is intended to be seated, such as a level where an anchoring flange aligns with a predefined tissue plane. Providing such depth references may help ensure consistent implantation geometry across different patients or surgical environments, and may reduce the likelihood of under-insertion or over-penetration.

The visual indicators may be designed to remain visible under common surgical lighting conditions, which may include bright overhead illumination, shadowing, and the presence of bodily fluids. In some embodiments, the indicators may be constructed from or coated with biocompatible materials selected to retain their visual properties over time, including after exposure to moisture, tissue contact, or sterilization processes.

In one embodiment, the visual indicators may form part of the surface texture, finish, or coating of the implant. For example, textured regions may reflect or scatter light differently, or may incorporate micro-patterns that create a visual cue through physical or optical contrast. Alternatively, the indicators may be formed by a controlled surface modification process, such as an electrochemical surface treatment.

In particular embodiments, the visual indicators may be created by an electrochemical surface modification process, such as anodizing. This process may alter the oxide layer of the implant material, thereby generating visible interference colors without introducing foreign pigments or coatings. The resulting color zones may be precisely controlled and integrated into the manufacturing workflow.

In other embodiments, the visual indicators may be produced in a multi-step process. For example, a first step may involve generating a uniform color layer over a selected surface region, and a second step may involve selectively removing or modifying parts of this color layer using subtractive processes such as machining, laser ablation, etching, or chemical treatment. This layered approach may enable the creation of fine, high-contrast markings with excellent durability and surgical visibility.

In certain applications, the visual indicators may be tailored to individual patients. For example, patient-specific indicators may be provided to reflect a personalized implantation depth, orientation, or suture positioning scheme. This may enhance precision and reproducibility in procedures involving custom-shaped implants or unique anatomical configurations.

In one embodiment, the implant comprises one or more visual indicators configured to guide implantation at a predetermined depth. Correct positioning of the implant at a defined tissue depth may be critical for achieving optimal functional performance, ensuring mechanical stability, and minimizing post-operative complications. The visual indicators may provide the surgeon with immediate visual cues during the procedure, thereby facilitating accurate placement of the implant relative to anatomical reference points. In certain configurations, the predetermined depth may correspond to a position at which a particular structural feature of the implant — such as an anchoring flange, shoulder, or tissue interface surface — is aligned with a predefined tissue layer. For example, the implant may be designed so that the anchoring flange is positioned directly beneath the dermis. Proper placement of the flange within this region may promote stable anchoring, enhance tissue integration, and reduce the risk of dislodgement or undesirable movement during healing or normal body activity. In another embodiment, the visual indicators may be arranged to distinguish between an interior part of the implant, intended for placement within the patient's body, and an exterior part configured to protrude outwardly when the implant is correctly seated. This distinction may assist the surgeon in verifying that the correct orientation and positioning of the implant has been achieved. For example, the interior region may be provided with one visual scheme, such as a specific color or texture, while the exterior portion may display a contrasting visual treatment. This arrangement may help prevent over-insertion or under-insertion and ensure proper exposure of the external interface, which may be required for connecting ostomy appliances or accessing the implant post-operatively.

In certain embodiments, the visual indicators may additionally or alternatively be adapted to highlight one or more key structural components of the implant. These may include, for example, the locations of suture anchors, fastening elements, or engaging elements. The use of visual markers to identify such features may assist the surgeon in targeting these regions during implantation, particularly during suturing or fixation. By clearly identifying these components, the indicators may simplify the procedural steps and help ensure that each element is engaged as intended. This may contribute to the secure retention of the implant, effective sealing or coupling with surrounding tissue, and reliable long-term integration.

In a further embodiment, the visual indicators may be designed for enhanced visibility under typical surgical lighting conditions. Surgical environments often involve high- intensity, directional lighting, shadows, and variable reflectivity. The visual indicators may be formed or treated in a manner that maintains sufficient contrast and clarity under such conditions, thereby reducing the likelihood of misinterpretation or error during implantation. For example, high-contrast patterns, reflective surfaces, or specialized coatings may be used to optimize visibility during exposure to direct surgical light.

In one embodiment, the visual indicators may be made of or incorporate biocompatible materials. These materials may be selected to ensure chemical stability, non-toxicity, and compatibility with bodily tissues and fluids. The use of biocompatible visual indicators ensures that the implant remains safe for long-term contact with the body and does not trigger inflammatory, allergic, or other adverse biological responses. The indicators may be integrated into the body of the implant, formed as part of the surface, or applied as a separate biocompatible layer.

In one embodiment, the visual indicators may be configured to retain their visibility over time. The long-term durability of the indicators may ensure that they remain functional not only during the initial surgical implantation, but also during any subsequent procedures, adjustments, or clinical inspections. This persistent visibility may be important for implants intended for long-term or permanent placement, where reidentification of specific implant regions may be necessary post-operatively.

In certain embodiments, the visual indicators, or parts thereof, may be integrated into a surface feature of the implant. This integration may include a surface texture, surface finish, or coating that is formed on or applied to the body of the implant. Embedding the visual indicators into these features may improve their mechanical and chemical stability, making them resistant to wear, degradation, or erasure during handling, cleaning, or exposure to bodily fluids. As a result, the indicators may maintain their guidance function throughout the implant's lifespan.

In one example, the visual indicators may be produced by applying an initial coloring to at least a portion of the implant surface, followed by a secondary step in which selected parts of the coloring are removed, such as by machining or other subtractive methods. This selective removal may expose the underlying material, for instance restoring the native surface color, and thereby generate high-contrast visual zones. These zones may be used to highlight transitions, component boundaries, or orientation markers. This approach enables permanent, visually distinct regions to be defined with precision and without the need for separate attachments or printed markings.

In other configurations, the visual indicators may be applied directly using coatings or paints selected to be biocompatible and durable. These materials may be chosen for their ability to adhere reliably to implant surfaces and to maintain their visual characteristics after implantation. Alternatively or additionally, certain parts of the implant may be machined or otherwise surface-processed to achieve a specific texture. This may involve forming either smooth or rough regions, or a combination of both, to create visible or tactile contrast that functions as a visual guide. For example, roughened surfaces may scatter light differently than polished regions, thereby providing natural visual cues under surgical lighting conditions. In further embodiments, the visual indicators may be produced using various manufacturing techniques that alter the physical or chemical properties of the implant surface. These techniques may include, for example, electrochemical processes such as anodizing, or physical techniques such as laser marking or chemical etching. Anodizing may be used to modify the oxide layer of a titanium or titanium-alloy implant, resulting in the generation of visible interference colors without introducing foreign substances. Laser marking may be used to etch permanent, high-resolution patterns into the surface, while chemical etching may selectively remove surface material to expose underlying layers or generate contrast in defined zones. These processes enable the creation of durable and highly visible indicators that can withstand physiological conditions and maintain their effectiveness over time.

In one embodiment, the visual indicators may be produced using a multi-step process in which an initial surface treatment is applied to a defined area of the implant — such as through coloring, coating, or surface texturing — and is then selectively modified by a secondary process, such as machining, laser ablation, or other subtractive processing. This controlled, layered approach may allow the formation of intricate, high-contrast indicators tailored to specific implantation needs. The resulting visual indicators may contribute significantly to the ease, accuracy, and repeatability of surgical implantation procedures.

Anchoring flange with varying stiffness

In one embodiment, the first part of the transcutaneous ostomy implant may comprise an anchoring flange that extends outwardly from a region surrounding the central axis of the opening. The anchoring flange, and/or a radially extending part of the implant located at the interior end of the first part, may be configured such that the stiffness varies across different regions. This spatial variation in stiffness may serve to balance mechanical support with physiological compatibility, allowing the implant to conform to anatomical curvature while maintaining secure fixation. By improving anatomical conformity and fixation reliability, the stiffness variation contributes directly to secure and efficient implantation.

For example, the radially extending part may have a cone-shaped or trumpet-like geometry, and may itself exhibit flexibility or variable stiffness to accommodate tissue movement and reduce mechanical mismatch. In some embodiments, the stiffness of the anchoring flange may be lower at the outer portion than at the inner portion. This gradient in stiffness may create a gradual mechanical transition from a relatively rigid central region near the implant’s body to a more compliant outer periphery. Such a design may help reduce localized pressure on surrounding tissue and promote better distribution of stress. This not only enhances patient comfort but also reduces the likelihood of displacement, supporting stable implantation during the healing phase.

In certain embodiments, the stiffness may decrease gradually from the inner portion of the anchoring flange toward the outer edge. A smooth gradient in stiffness, as opposed to an abrupt transition, may reduce the risk of pressure points and promote uniform force transfer across the tissue-implant interface. This can facilitate more predictable healing, improve patient comfort, and decrease the risk of chronic irritation or tissue breakdown. Taken together, these mechanical features enhance the overall surgical efficiency and long-term fixation of the implant, aligning with the central objective of secure and efficient implantation.

In some embodiments, the anchoring flange may extend outwardly at an angle relative to the central axis of the opening. For instance, the flange may extend at an angle of 90° or less, or in a range from approximately three degrees to nine degrees, or at a selected angle such as six degrees. This angulation may be tailored to follow the natural curvature of the body and enhance tissue contact. In certain configurations, the flange may also exhibit curvature, such as a concave or convex profile, to better conform to anatomical contours. In further embodiments, the curvature of the flange may vary along different radial directions, or within the same radial direction, for optimized contact and anchoring.

In another embodiment, the anchoring flange may comprise one or more features configured to promote the ingrowth of body tissue. Such “ingrowth means” may enhance the biological fixation of the implant and contribute to long-term stability. In some configurations, the ingrowth means may take the form of a mesh structure that allows tissue to grow into and around it. A mesh provides multiple anchoring points for cellular integration and may facilitate vascularization and fibrous attachment.

In one embodiment, the mesh structure may be at least partly formed by a plurality of interconnected bars. These bars may provide a framework that maintains the mechanical integrity of the mesh while remaining flexible enough to conform to tissue movement. In some embodiments, the bars may have a maximum diameter selected from a range including 0.6 mm, 0.5 mm, 0.4 mm, or 0.3 mm. The selected diameter may influence both the mechanical characteristics of the mesh and its ability to support soft tissue ingrowth without obstructing perfusion.

In further embodiments, the mesh structure may define a plurality of mesh openings, which may have a minimum diameter selected from a range including 0.7 mm, 0.8 mm, 0.9 mm, or 1.0 mm. The size of these openings may be optimized to facilitate the penetration and proliferation of host tissue while minimizing the risk of fibrosis or encapsulation. In some configurations, the mesh structure may include smaller openings closer to the central axis of the implant and larger openings toward the periphery, thereby tailoring ingrowth behavior across different regions of the implant.

In another embodiment, the anchoring flange may include a continuous solid ring at its outer edge. This ring may serve to reinforce the perimeter of the flange, maintain its shape during implantation, and provide a defined boundary to limit the extent of tissue contact. In some embodiments, the anchoring flange may have an outer diameter selected from a range including at least 30 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, or 70 mm. This range may accommodate different anatomical locations and surgical preferences.

In further embodiments, the anchoring flange may extend to a greater radius than an adjacent radially extending part of the first portion of the implant. This differential sizing may support layered fixation and improve the overall integration of the implant with surrounding soft tissue.

In one embodiment, the first part of the transcutaneous ostomy implant may comprise an anchoring flange extending radially outward from a region around the central axis of the opening. The anchoring flange may be configured such that its stiffness varies across different regions, and/or such that a radially extending part at the interior end of the first part exhibits a corresponding variation in stiffness or flexibility. This variation in stiffness may be tailored to enhance the mechanical and anatomical performance of the implant, allowing for stable tissue contact at the base while accommodating physiological movement at the periphery.

In some embodiments, the outer part of the anchoring flange may exhibit a lower stiffness than the inner part, enabling a smooth transition from a rigid central zone to a more compliant periphery. This stiffness gradient may reduce local pressure concentrations, enhance comfort, and reduce the risk of tissue trauma. In further embodiments, the stiffness may decrease gradually from the inner to the outer regions of the flange, which may help to evenly distribute stress and avoid sharp mechanical transitions. The variation in stiffness may be achieved through one or more means, including gradual changes in material composition, variation in thickness, alteration of mesh opening sizes, and/or differences in mesh density.

The materials used for forming the anchoring flange may include metallic alloys, such as titanium, as well as medical-grade polymers, including both flexible and semi-rigid biocompatible materials. Different regions of the flange may comprise different materials or blends to tailor local mechanical properties. For example, the central region may be formed of a stiffer metallic component, while outer portions may comprise more elastic polymer-based extensions. The use of polymers may also facilitate patient-specific customization or post-manufacturing flexibility.

In one embodiment, the anchoring flange may be configured to conform to the natural curvature of the body. For this purpose, the flange may extend at an angle of 90° or less relative to the central axis, such as at an angle between three to nine degrees, or at a specifically selected angle, such as six degrees, to match anatomical contours. This angled extension may allow the implant to seat more naturally against tissue surfaces. In further embodiments, the flange may have a defined curvature, either symmetric or asymmetric. For example, the curvature may differ between the lateral and vertical planes, enabling a more anatomically adapted and comfortable interface with the patient's body.

In certain configurations, the flange may exhibit a varying angle of curvature along different radial directions or within the same radial direction. This variability may accommodate complex topographies of the implantation site and reduce the formation of pressure points, which could otherwise lead to irritation or ischemia. In one embodiment, the radial outer ends of the flange may be rounded, and the outermost portion of the flange may include a larger curvature radius, specifically designed to avoid the presence of sharp or prominent edges that could contact the skin or soft tissue externally. These design features may contribute to improved comfort, reduce tissue abrasion, and support healing. The anchoring flange may further comprise ingrowth means to support biological fixation. In one embodiment, the ingrowth means may comprise a mesh structure, allowing tissue to penetrate, attach, and integrate into the flange. The mesh may be formed, at least in part, by a plurality of connected bars, which may provide a supportive yet flexible framework. In specific embodiments, the bars may have a maximum diameter selected from 0.6 mm, 0.5 mm, 0.4 mm, or 0.3 mm, to ensure adequate mechanical strength while preserving flexibility.

The mesh structure may also define a plurality of openings, whose minimum diameter may be selected from 0.7 mm, 0.8 mm, 0.9 mm, or 1.0 mm. These openings may promote tissue ingrowth while minimizing fibrosis. In some embodiments, the mesh openings may be smaller closer to the central axis, allowing for increased density and structural reinforcement in critical zones near the duct opening or internal anchoring points.

In one embodiment, the flange may be provided with a continuous solid ring at its outer edge. This ring may reinforce the flange, ensuring shape retention and preventing edge deformation during or after implantation. It may also help to distribute mechanical loads more evenly across the flange, thereby minimizing strain on any single area.

The anchoring flange may be dimensioned with an outer diameter of at least 30 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, or 70 mm, depending on anatomical location or intended application. A larger diameter may increase the available surface area for tissue attachment, improving overall fixation and minimizing implant migration. In some embodiments, the anchoring flange may extend to a greater radius than the radially extending part, thereby establishing a tiered or layered profile that facilitates multi-level support and improved tissue integration.

In one embodiment, the anchoring flange may be formed as a composite structure, for example comprising a laminated or co-molded configuration with two or more material layers of differing stiffness or flexibility. This may allow the inner portion of the flange to remain rigid for structural support, while the outer portion remains compliant to conform with adjacent tissue.

Resorbable anchoring flange In one embodiment, the first part of the transcutaneous ostomy implant may comprise a resorbable anchoring flange, which extends outwardly from a region surrounding the central axis of the implant’s opening. At least a portion of this anchoring flange may be formed from a resorbable material, selected to provide temporary mechanical support during the initial healing phase following implantation. This temporary support stabilizes the implant during the critical early post-operative period, contributing to secure and efficient implantation. Over time, the resorbable flange may gradually degrade in situ, reducing the amount of permanent material retained in the body and minimizing the long-term physical footprint of the implant.

The purpose of the resorbable flange may be to ensure that the implant remains stably anchored during tissue integration. Once healing has progressed and sufficient biological fixation — such as tissue ingrowth into a mesh structure or surrounding interface — has occurred, the flange, or part thereof, may no longer be needed and may be safely resorbed. In some anatomical contexts, continued presence of a large flange may interfere with tissue movement or patient comfort; the resorption process can therefore improve both functional outcomes and patient experience over time. This adaptability further enhances implantation efficiency and long-term usability.

In certain embodiments, the resorbable anchoring flange may comprise a resorbable material selected from one or more of: Polylactic Acid (PLA), Polyglycolic Acid (PGA), Poly(lactic-co-glycolic acid) (PLGA), Polydioxanone (PDO), Polycaprolactone (PCL), Polytrimethylene Carbonate (PTMC), Magnesium Alloys, Calcium Phosphate Ceramics such as Hydroxyapatite and Tricalcium Phosphate, Collagen, polyglactin 910, and/or Chitosan. These materials are known for their biocompatibility and their ability to degrade under physiological conditions in a controlled and predictable manner.

The degradation of the resorbable flange may occur via hydrolytic cleavage, enzymatic breakdown, or mechanically assisted disintegration, depending on the selected material and its interaction with surrounding tissue environments.

In one embodiment, the degradation profile of the resorbable material may be selected such that the anchoring flange degrades within a period of 1 to 6 months, such as within 3 months, or more specifically within 2 months, depending on the clinical requirement. This time frame may ensure that the implant is well-supported during the critical early post-operative period, while avoiding long-term retention of bulk material that may hinder mobility or tissue adaptation. Such a time-controlled degradation profile enables an optimal balance between immediate implantation security and long-term comfort.

In certain embodiments, the resorbable anchoring flange may be constructed as a hybrid structure, comprising both resorbable and non-resorbable parts. For example, the flange may include a core or reinforcement made from a non-resorbable material that remains after the outer resorbable layer has degraded. This configuration may balance immediate post-operative support with long-term stability, and may be particularly useful in situations where partial structural persistence is beneficial.

In a further embodiment, the transcutaneous ostomy implant may comprise a secondary anchoring flange formed entirely of a non-resorbable material. The secondary anchoring flange may extend radially outward from a region surrounding the central axis of the opening, similarly to the resorbable anchoring flange. This outward extension may provide a surface or interface for long-term engagement with surrounding tissue, thereby contributing to the mechanical stability of the implant. The secondary anchoring flange is configured to remain in place after the resorbable anchoring flange has degraded or been resorbed, ensuring continued fixation and durable structural support beyond the initial healing phase. Together, these features provide a layered fixation strategy that supports both short-term surgical efficiency and long-term implant stability, fully aligned with the goal of secure and efficient implantation.

In some embodiments, the secondary anchoring flange may have a smaller radial extent than the resorbable anchoring flange. This difference in size allows the larger, resorbable flange to provide broad initial coverage and distribute forces over a wider area, while the secondary flange maintains targeted anchoring once the resorbable structure is no longer present. The anchoring flanges may be provided as flat or curved structures and may differ in thickness, stiffness, or flexibility.

In certain configurations, the secondary and resorbable anchoring flanges may be axially offset along the central axis of the implant. For example, the secondary flange may be arranged axially closer to the first part or the second part of the implant, relative to the resorbable flange. This spatial separation allows for functional layering and may be selected based on anatomical positioning or surgical preference. The axial and radial arrangement of the flanges may influence the manner in which forces are transferred to the surrounding tissue and may help guide tissue integration over time, such as by directing ingrowth toward a specific structural zone of the implant.

Method for processing

In a further aspect, the present disclosure relates to a method of processing a surgical implant, the method comprising applying one or more visual indicators to the implant to facilitate or guide surgical implantation. The implant may be a transcutaneous ostomy implant as disclosed elsewhere herein, or may alternatively be selected from a broad range of other medical implant types, including but not limited to orthopedic implants, dental implants, spinal implants, craniofacial implants, neurosurgical devices, subcutaneous anchor systems, and soft tissue interface implants. This processing method contributes to secure and efficient implantation by enabling visual guidance during critical surgical steps.

In one embodiment, the method comprises providing the surgical implant, and applying one or more visual indicators to at least a part of the implant surface. These visual indicators may be configured to guide various aspects of surgical implantation, such as alignment, insertion depth, rotational orientation, or engagement with surrounding anatomy. The application of visual indicators may assist the surgeon in correctly positioning and securing the implant, reduce the risk of misplacement, and enhance the repeatability and efficiency of the surgical procedure. Such benefits directly support improved surgical outcomes and reduce procedural variability, consistent with the objective of secure and efficient implantation. The visual indicators may be configured as described elsewhere herein.

In one embodiment, the step of applying visual indicators comprises a two-step process, wherein a first step includes applying an initial coloring to a defined surface region of the implant, and a second step comprises selectively removing a portion of the applied coloring. This selective removal may create a visual contrast between colored and uncolored regions, forming distinct visual markers that remain visible under surgical lighting and operative conditions. The resulting indicators improve intraoperative visibility and precision, thereby facilitating secure and efficient placement of the implant.

The initial coloring may be applied using an electrochemical surface modification process, such as anodizing, particularly when the implant includes metallic components such as titanium or its alloys. Anodizing may modify the oxide layer of the surface to generate vibrant and durable interference colors without adding external pigments or coatings. The resulting coloration may be biocompatible, long-lasting, and highly resistant to fading under physiological conditions.

In one embodiment, the step of selectively removing the initial coloring may be performed using machining, such as turning, milling, grinding, or laser ablation. Alternatively or additionally, chemical etching or abrasive blasting may be used. These methods allow for the precise removal of coloring in localized areas, creating sharp visual transitions or defined markings that guide the surgeon during implantation.

The visual indicators produced by this method may be configured to identify anatomical alignment points, component interfaces, implantation depth targets, or regions for suture or tool engagement. They may also be used to differentiate between interior and exterior portions of the implant, or to distinguish functionally distinct structural features, such as anchoring flanges, suture anchors, fastening elements, or engaging members.

While this method is applicable to implants generally, in one preferred embodiment, the implant comprises a transcutaneous ostomy implant, such as described elsewhere in the present disclosure. In such a configuration, the visual indicators may serve to guide positioning through the skin, alignment with a tissue plane, or connection to a stoma management device. The visual indicators may highlight structural elements such as the anchoring flange, engaging elements, or an interior/exterior boundary.

In a further aspect, the present disclosure relates to a method of manufacturing a surgical implant, comprising shaping the implant using at least one manufacturing process, such as additive manufacturing, molding, machining, or assembly. These fabrication techniques may be used to form complex, multi-material or multi-geometry structures suitable for implantation in soft or hard tissues.

In one embodiment, machining may include one or more of: turning, milling, grinding, blasting, etching, and/or drilling. These processes may be used to produce precise geometries, smooth or textured surfaces, and to refine interfaces between implant parts. For example, features such as suture holes, flanges, or mesh structures may be formed or finished using these techniques. In another embodiment, the method may further comprise the assembly of at least a portion of the implant from multiple components. For example, the first and second parts of a transcutaneous ostomy implant may be separately manufactured and then joined through mechanical coupling, thermal bonding, or adhesive fixation. This modular approach may allow for customization, material hybridization, and efficient mass production.

The implants processed or manufactured according to any of the foregoing methods may incorporate one or more visual indicators, anchoring flanges, mesh zones, resorbable components, or fixation elements as disclosed elsewhere in the present application.

Method of manufacturing

In a further aspect, the present disclosure relates to a method of manufacturing a transcutaneous ostomy implant. The implant may, for example, be arranged as described elsewhere herein, comprising a first part configured for implantation into a patient, a second part configured to extend at least partially externally, and an opening extending along a central axis.

In one embodiment, the method comprises shaping the implant using at least one manufacturing process to form at least a portion of the implant. The shaping process may include, for example, additive manufacturing, molding, machining, and/or assembly. These processes may be used individually or in combination, depending on the geometry, material, and functional requirements of the implant. By enabling precise structural definition and material integration, the selected manufacturing methods contribute to secure and efficient implantation by ensuring consistency in implant geometry, fit, and function.

In one embodiment, the machining process may comprise one or more of the following techniques: turning, milling, grinding, blasting, etching, drilling, laser cutting, and/or electrical discharge machining. These machining steps may be used to refine or define surface features, connection interfaces, mesh structures, flanges, or openings in the implant body. The selected process may be chosen based on the implant’s material properties, surface tolerances, or dimensional complexity. Accurate machining of these features supports tissue integration and reliable fixation, facilitating secure surgical placement and improved post-operative performance. In a further embodiment, the method may comprise the assembly of at least part of the transcutaneous ostomy implant. For example, the first part and second part of the implant may be individually fabricated and subsequently assembled to form a cohesive implant structure. The assembly may involve mechanical interlocking, adhesive bonding, thermal joining, or other suitable joining techniques, depending on the material and configuration. Assembly may also allow for the integration of different material types, such as combining resorbable and non-resorbable components. This flexibility enables customization and optimization of implant features for improved surgical handling and long-term function, thereby contributing to the overarching goal of secure and efficient implantation.

The method of manufacturing may be used to produce implants incorporating additional features as described elsewhere in the present disclosure, including visual indicators, anchoring flanges, mesh structures, suture anchors, fastening elements, engaging elements, or features promoting tissue ingrowth. The ability to manufacture these functional features with precision directly supports the implant’s clinical performance, surgical reliability, and patient outcomes.

Example 1 : Implanting the Transcutaneous Ostomy Implant of the present disclosure

The following is a non-limiting example of how a transcutaneous ostomy implant 1 , in accordance with embodiments of the present disclosure, may be implanted in a patient. This example is intended to illustrate one possible clinical use case, without restricting the scope of the disclosure or the claims. Unless otherwise indicated, all component references correspond to those identified in the figure reference list provided herein.

This particular example relates to implantation of a transcutaneous ostomy implant 1 in a patient either undergoing initial ileostomy formation, such as during a colectomy, or in a patient with a pre-existing end ileostomy.

For patients undergoing new stoma formation, the stoma incision is sized to ensure a snug fit of the bowel through the implant opening 6, which extends along the central axis 8. A sizer may optionally be used to optimize the diameter of the skin and fascial opening for correct placement.

In patients with a pre-existing stoma, the bowel segment is carefully mobilized by separating it from the skin and subcutaneous tissue layers above the fascial sheath. Complete mobilization of the proximal stoma or entry into the peritoneal cavity is not required. Care is taken not to create an excessively large peristomal incision to avoid leaving redundant tissue around the implant 1.

The prepared bowel segment is passed through the opening 6 of the implant. The implant may be preconfigured with engaging elements 10 projecting inwardly from the inner surface of the second part 3, and/or with inner suture anchors (19), positioned near the transition between the first part 2 and second part 3. The bowel segment is then secured using eight absorbable sutures passed through the fastening elements 12 located at or near the exterior end 13 of the second part 3. These sutures provide initial retention of the bowel against the inner surface of the implant.

The implant 1 is then inserted into the subcutaneous tissue such that the anchoring flange 7 is positioned just beneath the dermis. This flange 7, which may optionally include an ingrowth means 14, such as a mesh structure with openings 15, facilitates secure tissue integration.

A 3-0 absorbable suture with a half-circle needle is used to place a subcuticular stitch through the skin and into the free space 22 defined by the inner suture anchors 19. Pulling this suture snug draws the skin surface into close contact with the port’s outer structure, improving sealing and soft tissue adaptation.

To stabilize the flange 7, six to eight non-absorbable sutures are passed through the outer suture anchors 24, traversing the full skin thickness. These sutures secure the outer margin of the anchoring flange 7 to the overlying skin and minimize micromotion during the early healing period.

Following fixation, a tissue sealant is applied circumferentially at the interface between the exterior part 5 of the implant and the patient’s skin. This sealant helps form an airtight seal and reduces the risk of granulation tissue formation during early postoperative healing.

The non-absorbable sutures are typically removed by the operating surgeon approximately 14 days post-implantation, once initial skin healing and anchoring have occurred.

Following implantation, the transcutaneous ostomy implant may initially be used only intermittently, starting from approximately 8 weeks post-operation, with gradual increases in duration of external appliance attachment. Full-time use may typically commence around 16 weeks, depending on patient-specific healing and integration. The operating surgeon may conduct periodic inspections to assess ingrowth into the ingrowth means 14 and the condition of the surrounding tissues.

This implantation procedure illustrates how the implant design supports secure and efficient implantation, stable tissue fixation, and improved healing, in accordance with the technical objectives of the present disclosure.

Detailed description of drawings

The accompanying drawings illustrate exemplary embodiments of the present disclosure and are provided for illustrative purposes only. The figures are schematic in nature, not necessarily to scale, and are intended to aid in understanding structural and functional features of the invention. Identical reference numerals are used throughout the figures to denote corresponding or equivalent elements. While specific embodiments are depicted, it should be understood that variations and modifications may be made without departing from the scope of the disclosure as defined by the appended claims.

Fig. 1 is a schematic side view of a transcutaneous ostomy implant 1 according to an embodiment of the present disclosure. The implant comprises a first part 2 configured for implantation into a patient, and a second part 3 connected to the first part 2. The implant includes an opening 6 extending from an interior end 28 of the first part to an exterior end 13 of the second part. The opening 6 defines a central axis 8 and is adapted to accommodate at least a segment of a body duct.

In the illustrated embodiment, the implant comprises an interior part 4 arranged for placement inside the body, and an exterior part 5 adapted to protrude from the patient following implantation. The interior part 4 includes the first part 2 and may optionally include a portion of the second part 3. The exterior part 5 includes at least a portion of the second part 3 and extends toward the exterior end 13 of the implant.

The second part 3 comprises a plurality of engaging elements 10 arranged on an inner surface of the second part, within the opening 6. Each engaging element 10 includes at least one tip 11 directed inwardly, for example radially and/or axially toward the central axis 8, and is configured to engage the body duct. The engaging elements 10 may contact and retain a portion of the body duct such that the body duct extends through at least part of the opening 6, and may be configured to invoke a local inflammatory response, such as by scratching or irritating the surface of the duct.

Near the exterior end 13, the second part 3 further comprises one or more fastening elements 12 protruding radially inwardly into the opening 6, for securing the body duct. The fastening elements 12 may be arranged in a plane that is perpendicular to the central axis 8, and may extend at an angle of from 0° to 90°, such as 30° or 45°. In the illustrated embodiment, the fastening elements 12 comprise loop structures configured to receive a suture thread for fastening the body duct to the implant. The edges of the fastening elements 12 may be rounded 18 to minimize tissue trauma.

The implant comprises an anchoring flange 7 extending radially outwardly from a region around the central axis 8. The anchoring flange 7 may be formed integrally with the first part 2 and may extend at an angle (30) of 90° or less, for example between three and nine degrees, such as six degrees, to follow the body's curvature. The anchoring flange 7 includes an outer part 25 and an outer edge 27, which in this embodiment is provided as a continuous rounded edge to reduce irritation. The flange may optionally comprise ingrowth means 14, such as a mesh structure formed by connected bars 26 defining a plurality of mesh structure openings 15. The mesh openings may vary in size, for example having smaller openings toward the central axis 8.

A plurality of inner suture anchors 19 are distributed around an outer part of the implant, for example near the interface between the first part 2 and second part 3. Each inner suture anchor 19 may extend, at least partly, in a radial plane that is parallel to a radial direction from the central axis 8. The inner suture anchors 19 are configured to define a free space 22 for securing a suture thread and/or needle, and are positioned to be accessible without requiring needle movement toward the body duct. The inner suture anchors 19 are part of a plurality of connecting elements 20 that extend toward and connect the first part 2 with the second part 3. These connecting elements 20 may also comprise support columns 21 that provide axial structural reinforcement. In the illustrated embodiment, the support columns 21 extend in a substantially straight direction, allowing a suturing needle to be passed behind the inner suture anchors 19 but in front of the support columns 21.

The implant further comprises a radially extending part 29 at the interior end 28, which serves to stabilize the implant and assist in proper positioning. Fig. 2 is a schematic top-view illustration of the transcutaneous ostomy implant 1 according to an embodiment of the present disclosure, showing various structural components and their arrangement. The implant includes an opening 6 that extends through the implant along the central axis 8. The anchoring flange 7 extends radially outward from the central opening 6, and comprises a plurality of mesh structure openings 15 configured to promote tissue integration and secure anchoring of the implant within subcutaneous layers.

The second part 3 comprises a plurality of engaging elements 10 arranged within the central opening 6, in this embodiment on an inner surface of the second part 3. Each engaging element 10 comprises at least one tip 11 that protrudes inwardly toward the central axis 8, and is adapted to contact and engage the body duct, such as to secure it in a position extending through the implant.

A plurality of fastening elements 12 are also included, positioned near the exterior end 13 of the second part 3. These may be implemented as loop structures or functionally similar elements, and are configured to accommodate suture threads for securing the body duct to the implant. The inner part 9 of the second part 3 may comprise a mesh structure, optionally three-dimensional, providing both flexibility and tissue integration capacity.

In the illustrated embodiment, the fastening elements 12 may comprise or consist of structures having rounded edges 18, thereby reducing local stress and minimizing tissue damage during suture placement. The mesh structure is formed from a plurality of connected bars 26 that reinforce the geometry of the implant, provide structural integrity, and promote soft tissue ingrowth.

Fig. 3 is a cut-away view along the plane marked A-A in Fig. 1, illustrating internal components of the transcutaneous ostomy implant 1 in greater detail. The figure shows the first part 2 and interior part 4, which are configured to reside subcutaneously, as well as the second part 3 and exterior part 5, which extend externally from the patient’s body.

The inner part 9 of the second part 3 includes a plurality of engaging elements 10 having tips 11 that protrude inwardly to engage the body duct. In the illustrated embodiment, the engaging elements 10 extend radially inwardly and upwardly, i.e. , in a direction toward the exterior end 13. This configuration means that the radial extent of each engaging element 10 is shorter than its total slanted length, since the elements are oriented at an angle with respect to the surface from which they protrude, typically the inner surface of the second part 3 or the inner surface of the exterior part 5. In alternative embodiments, the engaging elements 10 may extend perpendicularly to the central axis 8 and/or to the supporting surface.

A plurality of inner suture anchors 19 are distributed around the opening 6. Each inner suture anchor 19 includes a rounding, defining a free space 22 inside the curvature of the anchor for receiving and securing a suture thread. The geometry of the inner suture anchors 19 is such that the surgeon can direct the suture needle in a direction generally perpendicular to the body duct, thus avoiding accidental injury or perforation of the duct.

The engaging elements 10 have optimized slanted lengths and radial extensions to balance mechanical retention of the body duct with atraumatic engagement, such that secure positioning is achieved without piercing or damaging the duct wall.

The implant also includes ingrowth means 14, such as a three-dimensional mesh structure, designed to promote tissue integration and long-term stabilization. The anchoring flange 7 extends radially outward and terminates at an outer edge 27, which may be rounded to reduce skin irritation and enhance comfort.

An outer radial portion of the anchoring flange 7 comprises a plurality of outer suture anchors 24. In this embodiment, the outer suture anchors 24 are implemented as part of the mesh structure of the flange. For example, each inner suture anchor 19 may be associated with a corresponding outer suture anchor 24 located radially outward of it. This paired configuration supports a concentric, distributed suturing scheme that stabilizes the implant across multiple tissue planes.

The radially extending part 29 helps maintain implant position and may include support columns 21 and connecting elements 20 extending between the first part 2 and the second part 3. These structures contribute to the mechanical integrity of the implant, helping to resist deformation and maintain axial alignment.

In this embodiment, the fastening elements 12 are loop structures arranged to facilitate secure suturing of the body duct to the implant. Their geometry allows for repeated manipulation and firm fixation without excessive deformation. Fig. 4A is a cut-away view along the plane marked B-B in Fig. 2, further detailing internal components of the transcutaneous ostomy implant 1. The implant includes a first part 2 and an interior part 4 arranged for subcutaneous placement, as well as a second part 3 and an exterior part 5 extending toward the exterior end 13. The inner part 9 of the second part 3 includes a plurality of engaging elements 10, in this embodiment eight, each with a tip 11 configured to contact and/or retain the body duct within the opening 6.

A plurality of fastening elements 12, such as loop structures, are provided near the exterior end and are configured to accommodate suture threads. A series of inner suture anchors 19 are distributed around the opening 6 and define a free space 22 for receiving sutures. The implant includes ingrowth means 14, such as a three- dimensional mesh structure, configured to promote tissue integration.

The anchoring flange 7 extends radially outward and includes an outer edge 27. In this embodiment, the flange is designed with variable stiffness, facilitating conformance to surrounding tissue and maintaining implant positioning. Additional stability is provided by a radially extending part 29 and support columns 21. A plurality of connecting elements 20 link the first part 2 with the second part 3. The mesh structure is formed by connected bars 26, enhancing mechanical performance and biological integration.

Fig. 4B is a similar sectional view to Fig. 4A, illustrating an alternative embodiment of the transcutaneous ostomy implant 1 comprising an enlarged anchoring flange 7. In this embodiment, the anchoring flange includes a curved peripheral portion 16 configured to follow the anatomical curvature of the patient's abdominal wall. The curvature of the flange facilitates close tissue conformity and supports even distribution of mechanical loads during and after implantation.

The anchoring flange 7 further comprises a rounded outer edge 27 configured to minimize pressure points and ensure atraumatic skin contact. The outer part of the anchoring flange 25 adjacent to the rounded edge forms a curved zone suitable for secure fixation. Within this curved peripheral portion 16, the implant includes one or more outer suture anchors 24, which may be configured as loop-shaped or tab-like structures including defined apertures adapted to receive surgical suture threads. These outer suture anchors can be positioned within 20 mm of the outer edge 27, e.g. along the profile of the anchoring flange, enabling stable peripheral fixation while minimizing micromotion at the implant-tissue interface. In certain embodiments, the curved peripheral portion 16 includes a material region of reduced stiffness compared to more central portions of the flange. This flexible region allows the flange to conform dynamically to patient anatomy during movement or healing, while still supporting secure suture-based attachment through the outer suture anchors 24.

The overall diameter of the anchoring flange in the embodiment shown in Fig. 4B may be at least 100 mm, such as 150 mm, 180 mm, or 200 mm, allowing for broad tissue coverage. The inclusion of suture anchors within the curved region — rather than at the extreme edge — enables the full mechanical advantage of a large flange without compromising skin comfort or anatomical fit.

As with other embodiments, the implant may include inner suture anchors 19 distributed around the central opening 6 and optionally radially aligned with the outer suture anchors 24. This configuration may support a circular purse-string suture path between inner and outer anchor points, contributing to secure and efficient implantation with balanced tissue approximation.

The embodiment shown in Fig. 4B reflects one variation of the overall implant system, in which the anchoring flange geometry and suture anchor positioning cooperate to enhance implant stability, reduce the risk of edge lifting or displacement, and support improved healing and integration. These features contribute to the overarching objective of the present disclosure — secure and efficient implantation of a transcutaneous ostomy implant with reduced complication risks and improved clinical outcomes.

Fig. 5 is a perspective view of the transcutaneous ostomy implant 1 , illustrating its overall structure. The implant comprises a first part 2 and a second part 3 connected along the implant body. The first part 2 includes an anchoring flange 7 for securing the implant subcutaneously. The second part 3 includes fastening elements 12 arranged near the exterior end 13, and engaging elements 10 positioned along an inner surface of the second part 3, configured to secure a body duct passing through the implant.

Fig. 6 is a perspective view of an example of a lid 17 that may be used in conjunction with the transcutaneous ostomy implant of the present disclosure. The lid includes a ring-shaped base part configured to engage with the open end of the ostomy implant. A cap part is positioned within the ring-shaped base and is rotatable relative to the base to allow locking and unlocking of the lid with respect to the implant. The cap part comprises a through-hole, and a slider is arranged to move radially within a recess of the cap part. In a closed configuration, the slider covers the through-hole entirely, while in an open configuration, the slider is retracted to uncover the through-hole. This lid is consistent with the design disclosed in WO 2017/16302 and may be adapted for use with the presently disclosed implant.

Fig. 7 is a schematic illustration of an emptying device 32 configured for stoma evacuation. The device comprises a first film layer and a second film layer joined along their periphery to form a flexible enclosure. The first film layer defines a hole aligned with a second hole in an integrated connector ring. The connector ring includes an annular base fixed to an annular attachment area surrounding the hole in the first film layer. A plurality of radially inwardly protruding flanges extend from the annular base, and at least some of these flanges are adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or the lid described in Fig. 6. The emptying device is thus arranged for detachable connection to the implant, allowing temporary drainage or cleaning.

Fig. 8 is a flowchart illustrating a method of processing 33 a transcutaneous ostomy implant according to an embodiment of the present disclosure. The method comprises a step of providing the transcutaneous ostomy implant 34, which may include any of the implant configurations described herein. This is followed by a step of applying one or more visual indicators 35 to at least a portion of the implant surface. The visual indicators are configured to assist in surgical implantation by providing clear and reliable guidance to the surgeon. These indicators may be used to mark insertion depth, differentiate between internal and external regions, or identify critical structural features such as fastening elements, suture anchors, or anatomical orientation zones. The indicators may be applied using one or more techniques such as electrochemical coloring, surface texturing, or coating, and may be subsequently refined through selective material removal to generate high-contrast, durable markings. The method improves procedural accuracy and facilitates consistent implantation outcomes.

Fig. 9 is a flowchart illustrating a method of manufacturing 36 a transcutaneous ostomy implant. The method comprises a step of shaping the implant 37 using at least one fabrication process. Suitable processes include additive manufacturing, molding, machining, and/or assembly, each of which may be used individually or in combination depending on the material, geometry, and intended function of the implant. The shaping step may be applied to create a complete implant or to form one or more constituent parts, such as the first part, second part, or anchoring flange. Machining operations may be used to refine openings, form suture anchors, or generate surface textures, while additive techniques may enable the creation of integrated mesh structures or internal geometries. Assembly may include the joining of premanufactured components into a cohesive unit. This method allows for the production of implants with complex geometries and feature sets, tailored to support tissue integration, mechanical anchoring, and surgical usability.

Reference list:

1. transcutaneous ostomy implant

2. first part

3. second part

4. interior part

5. exterior part

6. opening

7. anchoring flange

8. central axis (of the opening)

9. inner part of the second part

10. engaging elements

11. tip

12. fastening elements

13. exterior end of the second part

14. ingrowth means

15. mesh structure openings

16. curved peripheral portion

17. lid for a transcutaneous ostomy implant

18. rounded edges

19. inner suture anchors

20. connecting elements

21. support columns

22. free space

24. outer suture anchors

25. outer part of the anchoring flange 26. connected bars

27. outer edge of the anchoring flange

28. interior end of the first part

29. radially extending part 30. anchoring flange angle

32. emptying pouch

33. method for processing a transcutaneous ostomy implant

34. providing the transcutaneous ostomy implant

35. applying one or more visual indicators to the transcutaneous ostomy implant 36. method of manufacturing a transcutaneous ostomy implant

37. shaping the implant using at least one process

Objects

1. A transcutaneous ostomy implant comprising:

• a first part configured for implantation into a patient;

• a second part connected to the first part; and

• an opening extending from the first part to the second part, the opening having a central axis, and wherein the opening is adapted to accommodate a part of a body duct; wherein the transcutaneous ostomy implant is adapted for a secure and efficient implantation.

2. The transcutaneous ostomy implant according to object 1 , wherein an inner part of the second part comprises one or more radially inwardly protruding engaging elements extending into the opening, and wherein said engaging elements are arranged for securing the body duct during implantation in a position wherein the body duct extends through at least a part of the opening.

3. The transcutaneous ostomy implant according to object 2, wherein the engaging elements extend from the inner part of the second part towards the central axis, such as at a slanted angle away from the first part.

4. The transcutaneous ostomy implant of any of objects 2 to 3, wherein the engaging elements extend radially inwardly less than 3 mm, such as less than 2 mm.

5. The transcutaneous ostomy implant according to any one of the preceding objects, wherein the second part comprises one or more fastening elements for securing the body duct, wherein the fastening elements are loop structures arranged for accommodating a suturing thread, and wherein the fastening elements are integral to the second part.

6. The transcutaneous ostomy implant according to object 5, wherein the fastening elements are provided on an inner part of the second part, such that they protrude radially inwardly into the opening, at or near an exterior end of the second part. 7. The transcutaneous ostomy implant according to any one of the preceding objects wherein the transcutaneous ostomy implant comprises a plurality of inner suture anchors distributed around the opening, wherein the inner suture anchors are arranged for accommodating a circular purse string suture around the transcutaneous ostomy implant, in order to tighten the surrounding skin towards the transcutaneous ostomy implant; and wherein the first part comprises a plurality of connecting elements, arranged around the opening in a plane perpendicular to the central axis, connecting the first part with the second part, and wherein said connecting elements comprises the inner suture anchors and optionally one or more support columns.

8. The transcutaneous ostomy implant according to object 7, wherein the inner suture anchors have a rounding, and wherein the rounding extends between the second part and the first part, and wherein the rounding results in a free space for securing of the suture thread, such as at a concave side of the rounding.

9. The transcutaneous ostomy implant according to any one of objects 7-8, wherein the ostomy implant comprises a plurality of outer suture anchors, located at an outer radial position of the anchoring flange with respect to each inner suture anchor.

10. The transcutaneous ostomy implant according to any one of the preceding objects, wherein the transcutaneous ostomy implant comprises one or more visual indicators, such as color indicators, markings, and/or patterns, for guiding implantation of the transcutaneous ostomy implant.

11. The transcutaneous ostomy implant according to object 10, wherein the visual indicators indicate an interface between different parts of the transcutaneous ostomy implant, such as an interior part arranged to be implanted in the patient and an exterior part arranged to protrude outside of the patient after implantation.

12. The transcutaneous ostomy implant according to any one of objects 10-11, wherein the visual indicators are provided for guiding implantation of the transcutaneous ostomy implant at a predetermined depth in the patient. 13. The transcutaneous ostomy implant according to any one of the preceding objects, wherein the first part comprises an anchoring flange extending outwardly from a region around the central axis of the opening, and wherein the stiffness of the anchoring flange varies across different regions of the anchoring flange.

14. The transcutaneous ostomy implant according to object 13, wherein the stiffness of the anchoring flange is lower at an outer part of the anchoring flange than the stiffness of an inner part of the anchoring flange.

15. The transcutaneous ostomy implant according to any one of the preceding objects, wherein the first part comprises an anchoring flange extending outwardly from a region around the central axis of the opening, and wherein at least a part of the anchoring flange is resorbable.

Items

1. A transcutaneous ostomy implant comprising:

• a first part configured for implantation into a patient;

• a second part connected to the first part; and

2. The transcutaneous ostomy implant according to item 1, wherein the transcutaneous ostomy implant is adapted to achieve a secure and efficient anchoring within the patient.

3. The transcutaneous ostomy implant according to any one of the preceding items, wherein the opening extends from an interior end of the first part to an exterior end of the second part.

4. The transcutaneous ostomy implant according to any one of the preceding items, wherein the implant is arranged such that, when implanted, at least a part of the second part protrudes outside of the patient.

5. The transcutaneous ostomy implant of any one of the preceding items, wherein one or more engaging elements protrude inwardly from an inner part of the implant toward the central axis, the engaging elements being arranged to engage the body duct.

6. The transcutaneous ostomy implant according to item 5, wherein the engaging elements are arranged to contact and retain a portion of the body duct.

7. The transcutaneous ostomy implant according to any one of items 5-6, wherein the engaging elements are arranged to retain the body duct in a position such that the body duct extends through the transcutaneous ostomy implant, such as through at least a part of the opening of the implant.

8. The transcutaneous ostomy implant according to any one of items 5-7, wherein the engaging elements are arranged to invoke a local inflammatory response in the body duct, thereby promoting healing, such as by scratching or irritating the surface of the body duct.

9. The transcutaneous ostomy implant according to any one of items 5-8, wherein the engaging elements have a tapered shape narrowing toward a tip directed inwardly, for example radially and/or axially, such as toward the central axis and/or toward the exterior end of the implant.

10. The transcutaneous ostomy implant according to item 9, wherein each engaging element terminates in a tip positioned at a radially innermost portion of the element, the tip being directed radially inwardly and/or toward an exterior end of the implant.

11 . The transcutaneous ostomy implant according to any one of items 5-10, wherein at least a portion of the inner part comprises a mesh structure, and such as wherein the engaging elements extend from the mesh structure.

12. The transcutaneous ostomy implant according to any one of items 5-11 , wherein each engaging element extends radially inwardly by a distance of less than 3 mm, such as less than 2 mm.

13. The transcutaneous ostomy implant according to any one of items 5-12, wherein each engaging element extends radially inwardly by a distance in the range from 0.1 mm to 3 mm, such as in the range from 0.3 mm to 2.5 mm, such as in the range from 0.5 mm to 1 mm, such as around 0.8 mm. The transcutaneous ostomy implant according to any one of items 5-13, wherein each engaging element has a slanted length of less than 3 mm, such as less than 2 mm, such as around 1.25 mm. The transcutaneous ostomy implant according to any one of items 5-14, wherein the engaging elements have a slanted length in the range from 0.1 mm to 3 mm, such as in the range from 0.5 mm to 2.5 mm, such as in the range from 0.8 mm to 2 mm, such as around 1.3 mm. The transcutaneous ostomy implant according to any one of the preceding items, wherein the second part comprises one or more fastening elements protruding radially inwardly into the opening, for securing the body duct. The transcutaneous ostomy implant according to item 16, wherein the fastening elements are located, such as distributed, on an inner part of the second part. The transcutaneous ostomy implant according to any one of items 16-17, wherein the fastening elements are provided at or near an exterior end of the second part, such as within 10 mm, within 5 mm or within 2 mm of the exterior end. The transcutaneous ostomy implant according to any one of items 16-18, wherein the fastening elements are spaced from the exterior end of the second part, such as being located in a plane perpendicular to the central axis of the opening, such as spaced by at least 0.05 mm, such as at least 0.1 mm. The transcutaneous ostomy implant according to any one of items 16-19, wherein the fastening elements are arranged in a plane that is perpendicular to the central axis of the opening. The transcutaneous ostomy implant according to any one of items 16-20, wherein the fastening elements extend at an angle with respect to the central axis of the opening, such as at an angle of from 0° to 90°, for example 0°, 30° or 45°. The transcutaneous ostomy implant according to any one of items 16-21 , wherein the fastening elements comprise loop structures configured to receive a suture thread, such that the body duct can be fastened to the implant. 23. The transcutaneous ostomy implant according to any one of items 16-22, wherein the fastening elements are integral with the second part.

24. The transcutaneous ostomy implant according to any one of items 16-23, wherein the fastening elements have an inner diameter of at least 1 mm, such as at least 1.25 mm, such as at least 1.5 mm.

25. The transcutaneous ostomy implant according to any one of items 16-24, wherein the edges of the fastening elements are rounded.

26. The transcutaneous ostomy implant according to any one of items 16-25, wherein one or more, such as all, of the fastening elements are temporary fastening elements, configured to be removed or rendered non-obstructive after initial healing, for example by resorption, detachment, deformation, or a combination thereof.

27. The transcutaneous ostomy implant according to any one of items 16-26, wherein the arrangement of the fastening elements allows the opening to be closed by a sealing element, such as a lid, after implantation, thereby forming a sealed environment that promotes healing of the secured body duct.

28. The transcutaneous ostomy implant according to any one of items 16-27, wherein the fastening elements are arranged to retain the body duct at or near an end of the body duct.

29. The transcutaneous ostomy implant according to any one of items 16-28, wherein the transcutaneous ostomy implant comprises a plurality of fastening elements, such as at least 3, or at least 5, or at least 7, or at least 8, for example between 1 and 20.

30. The transcutaneous ostomy implant according to any one of items 16-29, wherein the fastening elements are distributed circumferentially around the opening at regular angular intervals

31. The transcutaneous ostomy implant according to any one of the preceding items, wherein the transcutaneous ostomy implant comprises a plurality of inner suture anchors distributed around an outer part of the transcutaneous ostomy implant. 32. The transcutaneous ostomy implant according to item 31 , wherein the inner suture anchors are distributed in a plane that is substantially perpendicular to the central axis of the opening.

33. The transcutaneous ostomy implant according to any one of items 31-32, wherein each inner suture anchor extends, at least partly, in a radial plane that is parallel to a radial direction from the central axis of the opening.

34. The transcutaneous ostomy implant according to item 33, wherein each inner suture anchor is, at least partly, located in said radial plane.

35. The transcutaneous ostomy implant according to any one of items 31-34, wherein the first part comprises a plurality of connecting elements that extend toward and connect to the second part.

36. The transcutaneous ostomy implant according to item 35, wherein the inner suture anchors are formed as part of the connecting element.

37. The transcutaneous ostomy implant according to any one of items 31-36, wherein the connecting elements comprise both inner suture anchors and support columns.

38. The transcutaneous ostomy implant according to any one of items 31-37, wherein the connecting elements have a thickness, such as a diameter, in the range of 0.1 mm to 0.5 mm.

39. The transcutaneous ostomy implant according to any one of items 31-38, wherein the inner suture anchors are configured to accommodate a suture thread and/or a suture needle.

40. The transcutaneous ostomy implant according to any one of items 31-39, wherein the inner suture anchors are arranged to accommodate a circular purse string suture around the implant, in order to tighten surrounding tissue toward implant.

41. The transcutaneous ostomy implant according to item 31-40, wherein each inner suture anchor includes a rounded portion, and wherein the rounding extends between the second part and the first part. 42. The transcutaneous ostomy implant according to item 41 , wherein the rounding of the inner suture anchors defines a free space for securing the suture on the inside of the rounding.

43. The transcutaneous ostomy implant according to item 42, wherein the free space has a diameter of at least 1 mm, such as at least 1.2 mm, or at least 1.5 mm.

44. The transcutaneous ostomy implant according to any one of items 31-43, wherein the implant comprises a plurality of outer suture anchors, located at a radial position outward of the inner suture anchors, such as on an anchoring flange.

45. The transcutaneous ostomy implant according to item 44, wherein the first part of the transcutaneous ostomy implant comprises an anchoring flange, extending radially outwardly, and wherein the outer suture anchors are provided on a part of the anchoring flange.

46. The transcutaneous ostomy implant according to any one of the preceding items, wherein the anchoring flange comprises a curved peripheral portion configured to conform to the curvature of a patient’s abdominal wall, and wherein the anchoring flange further comprises one or more outer suture anchors positioned within said curved peripheral portion, each outer suture anchor being configured to receive a suture thread for fixation to surrounding tissue.

47. The transcutaneous ostomy implant according to item 46, wherein the curved peripheral portion of the anchoring flange comprises a material region of reduced stiffness relative to an inner portion of the flange, the reduced stiffness being configured to allow conformal flexure of the flange during implantation and anatomical movement, while maintaining reliable fixation via the outer suture anchors.

48. The transcutaneous ostomy implant according to any one of items 46-47, wherein the outer suture anchors are positioned within 20 mm of the outer edge of the anchoring flange, and are configured to enable peripheral fixation of the implant with minimized micromotion.

49. The transcutaneous ostomy implant according to any one of items 46-48, wherein each outer suture anchor comprises a loop-shaped or tab-like structure including a defined aperture adapted to receive and guide a standard surgical suture thread.

50. The transcutaneous ostomy implant according to item 49, wherein the suturecontacting surface of each anchor comprises a smooth finish or biocompatible coating, configured to reduce intraoperative and postoperative friction, abrasion, or thread damage.

51 . The transcutaneous ostomy implant according to any one of items 46-50, wherein the outer suture anchors are circumferentially spaced around the curved peripheral portion.

52. The transcutaneous ostomy implant according to any one of items 46-51 , wherein each outer suture anchor is radially aligned with a corresponding inner suture anchor located nearer to the central axis, aligned to enable a circular purse-string suture path traversing the flange and surrounding skin.

53. The transcutaneous ostomy implant according to any one of items 46-52, wherein the anchoring flange has an outer diameter of at least 100 mm.

54. The transcutaneous ostomy implant according to any one of the preceding items wherein the implant comprises one or more visual indicators arranged to assist in surgical implantation of the implant.

55. The transcutaneous ostomy implant according to item 54, wherein the visual indicators comprise one or more of color zones, surface markings, contrast patterns or textured regions.

56. The transcutaneous ostomy implant according to any one of items 54-55, wherein each visual indicator is associated with a distinct implantation function, such as indicating an insertion depth, a structural interface, or a critical anatomical reference. 57. The transcutaneous ostomy implant according to any one of items 54-56, wherein the visual indicators are configured to identify and distinguish structural components of the implant, such as suture anchors, fastening elements, or engaging elements.

58. The transcutaneous ostomy implant according to any one of items 54-57, wherein the visual indicators are positioned to identify an interface between structurally distinct regions of the implant.

59. The transcutaneous ostomy implant according to any one of items 54-58, wherein the visual indicators distinguish between an interior part of the implant, for being implanted into the patient, and an exterior part configured to protrude from the patient when the implant is correctly positioned.

60. The transcutaneous ostomy implant according to any one of items 54-59, wherein the visual indicators are arranged to indicate a target implantation depth.

61. The transcutaneous ostomy implant according to item 60, wherein the target implantation depth corresponds to a position where an anchoring flange or a tissue interface surface of the implant is aligned with a predefined tissue layer.

62. The transcutaneous ostomy implant according to any one of items 54-61 , wherein the visual indicators are designed to remain visible under surgical lighting conditions.

63. The transcutaneous ostomy implant according to any one of items 54-62, wherein the visual indicators are made of biocompatible materials.

64. The transcutaneous ostomy implant according to any one of items 54-63, wherein the visual indicators are configured to retain their visibility over time following implantation and exposure to bodily conditions.

65. The transcutaneous ostomy implant according to any one of items 54-64, wherein the visual indicators are provided as part of the surface texture, finish, and/or coating of the implant.

66. The transcutaneous ostomy implant according to any one of items 54-65, wherein the visual indicators are formed using an electrochemical surface modification process, such as anodizing, for example to alter the oxide layer of the implant and generate a visible color shift, such as interference colors.

67. The transcutaneous ostomy implant according to any one of items 54-66, wherein the visual indicators are created in a multi-step process comprising a first step of applying or generating a color layer and a second step of selectively removing or altering the color, such as by machining, etching or other subtractive processing.

68. The transcutaneous ostomy implant according to any one of the preceding items, wherein the first part comprises an anchoring flange extending outwardly from a region around the central axis of the opening, and wherein the stiffness of the anchoring flange varies across different regions of the anchoring flange.

69. The transcutaneous ostomy implant according to item 68, wherein the stiffness is lower at an outer part of the anchoring flange than an inner part of the anchoring flange.

70. The transcutaneous ostomy implant according to any one of items 68-69, wherein the stiffness of the anchoring flange decreases gradually from an inner part of the anchoring flange towards an outer part of the anchoring flange.

71. The transcutaneous ostomy implant according to any one of items 68-70, wherein the anchoring flange extends at an angle of 90° or less with respect to the central axis.

72. The transcutaneous ostomy implant according to any one of items 68-71 , wherein the anchoring flange extends at an angle of from three to nine degrees, with respect to the central axis, to follow the body's curvature.

73. The transcutaneous ostomy implant according to any one of items 68-72, wherein the anchoring flange extends at an angle selected to follow the body's curvature, such as six degrees, with respect to the central axis.

74. The transcutaneous ostomy implant according to any one of items 68-73, wherein the anchoring flange has a curvature. The transcutaneous ostomy implant according to any one of items 68-74, wherein the anchoring flange has a varying angle of curvature, such as along different radial directions and/or the same radial direction. The transcutaneous ostomy implant according to any one of items 68-75, wherein the anchoring flange comprises an ingrowth means, for ingrowth of body tissue. The transcutaneous ostomy implant according to item 76, wherein the ingrowth means is a mesh structure. The transcutaneous ostomy implant according to item 77, wherein the mesh structure is, at least partly, formed by a plurality of connected bars. The transcutaneous ostomy implant according to item 78, wherein the bars have a maximum diameter of 0.6 mm, such as a maximum diameter of 0.5 mm, such as a maximum diameter of 0.4 mm, such as a maximum diameter of 0.3 mm. The transcutaneous ostomy implant according to any one of items 68-79, wherein the mesh structure forms a plurality of mesh openings having a minimum diameter of 0.7 mm, such as a minimum diameter of 0.8 mm, such as a minimum diameter of 0.9 mm, such as a minimum diameter of 1.0 mm. The transcutaneous ostomy implant according to any one of items 68-80, wherein the mesh structure has smaller mesh openings towards the central axis. The transcutaneous ostomy implant according to any one of items 68-81 , wherein the anchoring flange has, at its outer edge, a continuous solid ring. The transcutaneous ostomy implant according to any one of items 68-82, wherein the anchoring flange has an outer diameter of at least 30 mm, such as at least 40 mm, such as at least 45 mm, such as at least 50 mm, such as at least 55 mm, such as at least 60 mm, such as at least 65 mm, such as at least 70 mm. The transcutaneous ostomy implant according to any one of items 68-83, wherein the first part, at an interior end, comprises a radially extending part, for example in a cone or trumpet-like shape, such as and wherein the stiffness of the radially extending part varies across different regions of the radially extending part and/or wherein the radially extending part is flexible.

85. The transcutaneous ostomy implant according to any one of items 68-84, wherein the anchoring flange extends to a greater radius than the radially extending part.

86. The transcutaneous ostomy implant according to any one of the preceding items wherein the first part comprises a resorbable anchoring flange, at least a portion of which is formed of a resorbable material, the resorbable anchoring flange extending outwardly from a region around the central axis of the opening.

87. The transcutaneous ostomy implant of item 86, wherein the resorbable material is selected from one or more of: Polylactic Acid (PLA), Polyglycolic Acid (PGA), Poly(lactic-co-glycolic acid) (PLGA), Polydioxanone (PDO), Polycaprolactone (POL), Polytrimethylene Carbonate (PTMC), Magnesium Alloys, Calcium Phosphate Ceramics (e.g., Hydroxyapatite and Tricalcium Phosphate), Collagen, polyglactin 910, and/or Chitosan.

88. The transcutaneous ostomy implant according to any one of items 86-87, wherein the resorbable material is selected to degrade within a period of within 6 months, such as within 3 months, such as within 2 months.

89. The transcutaneous ostomy implant of any one of items 86-88, wherein the resorbable anchoring flange comprises both resorbable and non-resorbable parts.

90. The transcutaneous ostomy implant of any one of items 86-89, wherein the transcutaneous ostomy implant further comprises a secondary anchoring flange formed of a non-resorbable material.

91. The transcutaneous ostomy implant of item 90, wherein the secondary anchoring flange has a smaller diameter than the resorbable anchoring flange.

92. The transcutaneous ostomy implant of any one of items 86-91 , wherein the secondary anchoring flange is arranged, closer to the first part or the second part, along the central axis of the opening, relative to the resorbable anchoring flange. A method of processing a transcutaneous ostomy implant comprising:

• providing the transcutaneous ostomy implant; and

• applying one or more visual indicators to the transcutaneous ostomy implant to guide surgical implantation. The method of processing a transcutaneous ostomy implant according to item 93, wherein the transcutaneous ostomy implant is arranged according to any one of items 54-67. The method of processing a transcutaneous ostomy implant according to any one of items 93-94, wherein the step of applying comprises:

• applying, to a part of the transcutaneous ostomy implant, an initial coloring; and

• selectively removing said initial coloring, thereby creating one or more visual indicators. The method of processing a transcutaneous ostomy implant according to item

95, wherein the step of applying comprises applying a color by an electrochemical process. The method of processing a transcutaneous ostomy implant according to item

96, wherein the electrochemical process is anodizing. The method of processing a transcutaneous ostomy implant according to any one of items 95-97, wherein the step of selectively removing comprises selectively removing by machining. A method of manufacturing a transcutaneous ostomy implant according to any one of items 1-92, the method comprising shaping said implant using at least one process, such as additive manufacturing, assembly, moulding and/or machining, to manufacture at least part of the transcutaneous ostomy implant. . The method of item 99, wherein machining comprises one or more of the list including: turning, milling, grinding, blasting, etching, and/or drilling. . The method of any one of items 99-100, wherein the method comprises assembly of at least a part of the transcutaneous ostomy implant, such as the first part and the second part. . An implant comprising a body and one or more visual indicators provided on a surface of the body, the visual indicators being configured to guide surgical implantation of the implant.

Claims

1. A transcutaneous ostomy implant comprising:

• a first part configured for implantation into a patient;

• a second part connected to the first part; and

• an opening extending through at least a portion of the first part and the second part, the opening defining a central axis and being adapted to accommodate at least a segment of a body duct; wherein the implant is configured to allow secure and efficient implantation.

2. The transcutaneous ostomy implant according to claim 1 , wherein one or more engaging elements protrude inwardly from an inner part of the implant toward the central axis, the engaging elements being arranged to engage and/or retain a portion of the body duct.

3. The transcutaneous ostomy implant according to claim 2, wherein the engaging elements are arranged to invoke a local inflammatory response in the body duct, thereby promoting healing, such as by scratching or irritating the surface of the body duct.

4. The transcutaneous ostomy implant according to any one of claims 2-3, wherein the engaging elements each comprise a narrowing portion terminating in a tip that is directed toward the central axis and/or toward an exterior end of the implant.

5. The transcutaneous ostomy implant according to claim 4, wherein each engaging element has a length from the inner part to the tip of from 1 mm to 3 mm.

6. The transcutaneous ostomy implant according to any one of claims 2-5, wherein at least a portion of the inner part comprises a mesh structure, and wherein the engaging elements protrude inwardly from the mesh structure.

7. The transcutaneous ostomy implant according to any one of claims 2-6, wherein each engaging element has a slanted length of less than 3 mm, such as less than 2 mm, such as around 1.25 mm.

8. The transcutaneous ostomy implant according to any one of the preceding claims, wherein the second part comprises one or more fastening elements that protrude inwardly into the opening and are configured to secure the body duct.

9. The transcutaneous ostomy implant according to claim 8, wherein the fastening elements are located, such as distributed, on an inner part of the second part.

10. The transcutaneous ostomy implant according to any one of claims 8-9, wherein the fastening elements are located within 10 mm of the exterior end of the second part.

11. The transcutaneous ostomy implant according to any one of claims 8-10, wherein the fastening elements are arranged in a plane that is perpendicular to the central axis of the opening.

12. The transcutaneous ostomy implant according to any one of claims 8-11 , wherein the fastening elements are inclined at an angle from 0° to 90° relative to the central axis.

13. The transcutaneous ostomy implant according to any one of claims 8-12, wherein the fastening elements comprise loop structures configured to receive a suture thread .

14. The transcutaneous ostomy implant according to any one of claims 8-13, wherein the fastening elements are temporary fastening elements configured to be removed or rendered non-obstructive after initial healing, for example by resorption, detachment, deformation, or a combination thereof.

15. The transcutaneous ostomy implant according to any one of claims 8-14, wherein the transcutaneous ostomy implant comprises a plurality of fastening elements.

16. The transcutaneous ostomy implant according to claims 15, wherein the fastening elements are distributed circumferentially around the opening at regular angular intervals

17. The transcutaneous ostomy implant according to any one of the preceding claims, wherein the implant comprises a plurality of inner suture anchors distributed around an outer part of the implant, such as around the opening.

18. The transcutaneous ostomy implant according to claim 17, wherein the inner suture anchors are distributed in a plane that is substantially perpendicular to the central axis of the opening.

19. The transcutaneous ostomy implant according to any one of claims 17-18, wherein each inner suture anchor extends in a plane oriented radially from the central axis of the opening.

20. The transcutaneous ostomy implant according to any one of claims 17-19, wherein the first part comprises a plurality of connecting elements that extend toward and connect to the second part, wherein the inner suture anchors are formed as part of the connecting element.

21. The transcutaneous ostomy implant according to claim 20, wherein the connecting elements comprise inner suture anchors and support columns.

22. The transcutaneous ostomy implant according to any one of claims 17-21, wherein the inner suture anchors are configured to accommodate a suture thread and/or a suture needle.

23. The transcutaneous ostomy implant according to any one of claims 17-22, wherein the inner suture anchors are arranged to accommodate a circular purse string suture around the implant, in order to tighten surrounding tissue, such as subcutaneous tissue or dermal layers, toward implant.

24. The transcutaneous ostomy implant according to claim 17-23, wherein each inner suture anchor includes a rounded portion, the rounded portion being arranged to extend between the first part and the second part of the implant.

25. The transcutaneous ostomy implant according to claim 24, wherein the rounding of the inner suture anchors defines a free space configured to receive a suture thread on the interior side of the rounding.

26. The transcutaneous ostomy implant according to any one of the preceding claims, wherein the implant comprises a plurality of outer suture anchors.

27. The transcutaneous ostomy implant according to claim 26 and any one of claims 17-25, wherein the plurality of outer suture anchors are positioned radially outward of the inner suture anchors, such as on an anchoring flange, and wherein each inner suture anchor is aligned with a corresponding outer suture anchor in a common plane that is perpendicular to the central axis of the opening.

28. The transcutaneous ostomy implant according to any one of the preceding claims, wherein the anchoring flange comprises a curved peripheral portion configured to conform to the curvature of a patient’s abdominal wall, and wherein the anchoring flange further comprises one or more outer suture anchors positioned within said curved peripheral portion, each outer suture anchor being configured to receive a suture thread for fixation to surrounding tissue.

29. The transcutaneous ostomy implant according to claim 28, wherein the anchoring flange has an outer diameter of at least 100 mm, preferably at least 150 mm.

30. The transcutaneous ostomy implant according to any one of the preceding claims, wherein the implant comprises one or more visual indicators configured to assist in guiding surgical implantation .

31. The transcutaneous ostomy implant according to claim 30, wherein the visual indicators comprise one or more of color zones, surface markings, contrast patterns or textured regions.

32. The transcutaneous ostomy implant according to any one of claims 30-31, wherein each type of visual indicator is associated with a distinct implantation function, such as indicating an insertion depth, identifying a structural interface, marking an anatomical reference, or distinguishing a specific component of the implant.

33. The transcutaneous ostomy implant according to any one of claims 30-32, wherein the visual indicators are configured to identify and distinguish structural components of the implant, such as suture anchors, fastening elements, or engaging elements.

34. The transcutaneous ostomy implant according to any one of claims 30-33, wherein the visual indicators are configured to distinguish between an interior part of the implant, which is intended to be implanted into the patient, and an exterior part that is configured to protrude from the patient when the implant is correctly positioned.

35. The transcutaneous ostomy implant according to any one of the preceding claims, wherein the first part comprises an anchoring flange extending outwardly from a region surrounding the central axis of the opening, and wherein the stiffness of the anchoring flange varies across different regions of the anchoring flange.

36. The transcutaneous ostomy implant according to claim 35, wherein the stiffness is lower at a radially outer part of the anchoring flange than at a radially inner part of the anchoring flange.

37. The transcutaneous ostomy implant according to any one of claims 35-36, wherein the anchoring flange extends at an angle of from 3° to 9° with respect to the central axis, the angle being selected to follow a curvature of the body.

38. The transcutaneous ostomy implant according to any one of claims 35-37, wherein the anchoring flange has a varying angle of curvature, such as along different radial directions and/or along a single radial direction.

39. The transcutaneous ostomy implant according to any one of claims 35-38, wherein the anchoring flange comprises an ingrowth means for ingrowth of body tissue, the ingrowth means comprising a mesh structure having smaller mesh openings toward the central axis.

40. The transcutaneous ostomy implant according to any one of claims 35-39, wherein the anchoring flange comprises, at its radially outer edge, a continuous solid ring.

41. The transcutaneous ostomy implant according to any one of claims 35-40, wherein the anchoring flange has an outer diameter of at least 30 mm, such as at least 40 mm, such as at least 45 mm, such as at least 50 mm, such as at least 55 mm, such as at least 60 mm, such as at least 65 mm, such as at least 70 mm.

42. The transcutaneous ostomy implant according to any one of the preceding claims, wherein the first part comprises a resorbable anchoring flange extending outwardly from a region surrounding the central axis of the opening, at least a portion of the anchoring flange being formed of a resorbable material.

43. The transcutaneous ostomy implant of claim 42, wherein the resorbable material is selected from one or more of: polylactic acid (PLA), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) (PLGA), polydioxanone (PDO), polycaprolactone (PCL), polytrimethylene carbonate (PTMC), magnesium alloys, calcium phosphate ceramics including hydroxyapatite and tricalcium phosphate, collagen, polyglactin 910, and chitosan.

44. The transcutaneous ostomy implant according to any one of claims 42-43, wherein the resorbable material is selected to degrade within a period of within 6 months, such as within 3 months, such as within 2 months.

45. The transcutaneous ostomy implant of any one of claims 42-44, wherein the resorbable anchoring flange comprises both resorbable and non-resorbable parts.

46. The transcutaneous ostomy implant of any one of claims 42-45, wherein the transcutaneous ostomy implant further comprises a secondary anchoring flange formed of a non-resorbable material, the secondary anchoring flange extending outwardly from a region surrounding the central axis of the opening and being arranged to provide long-term structural support following resorption of the resorbable anchoring flange.

47. An implant comprising a body and one or more visual indicators provided on a surface of the body, the visual indicators being configured to guide surgical implantation of the implant.

48. A method of processing a transcutaneous ostomy implant comprising:

• providing the transcutaneous ostomy implant; and

• applying one or more visual indicators to the transcutaneous ostomy implant to guide surgical implantation.

49. The method of processing a transcutaneous ostomy implant according to claim 48, wherein the step of applying comprises: • applying, such as by an electrochemical process, to a part of the transcutaneous ostomy implant, an initial coloring; and

• selectively removing said initial coloring, such as by machining, thereby creating one or more visual indicators.

50. A method of manufacturing a transcutaneous ostomy implant according to any one of claims 1-46, the method comprising shaping at least a part of the implant using at least one process selected from the group consisting of additive manufacturing, assembly, moulding, and machining.