Backflow prevention stoma device

Abstract

The present invention relates to a stoma plug suitable for controlling the discharge of biological fluids from the colon, ileum and / or ureter (50) respectively through a stoma (45) formed by colostomy, ileostomy or urostomy. The stoma plug comprises a tube (10) having an opening (12) in its proximal part and at least one opening (14) in its distal part, and a two-way valve system (20) comprising a base element (22) and a plug (24), which is connected to the tube (10) via the base element (22) and is configured to control the flow of fluid through the opening (12) in the proximal part of the tube (10), a two-way valve system (20), and a cap (30) configured to cover the two-way valve system (20) and the stoma (45) and including an opening (32) for direct access to the two-way valve system (20) from the outside. The tube (10) is configured to be inserted into the colon, ileum and / or ureter (50) through its distal part, and the two-way valve system (20) is configured to remain passively closed and to open when the plug (24) is displaced from at least one opening (21).

Description

Technical Field

[0001] The present invention relates to the field of stoma devices, and more particularly to a stoma plug for controlling the discharge of biological fluids through a stoma formed by colostomy, ileostomy or urostomy, and a system comprising such a stoma plug and an element for controlling the discharged biological fluids.

Background Art

[0002] A stoma is an opening in the abdominal wall through which the intestine is brought out to enable the excretion of feces / urine due to medical problems that prevent natural excretion through the anus or urethra. Patients may require a stoma for various reasons, such as colorectal cancer, inflammatory bowel disease (IBD) such as Crohn's disease and ulcerative colitis, severe diverticulitis with peritonitis, severe trauma, congenital defects and spinal cord injuries.

[0003] The stoma can be temporary or permanent and may require a collection system (collection bag) for feces or urine. Currently, various types of collection bags are available, including open / closed bags, one-piece bags or two-piece bags, transparent or opaque bags of different sizes and brands. The bag needs to be emptied or replaced when it is 1 / 3 or half full. Closed bags are suitable for hard stools, and open bags are suitable for liquid feces / urine that can be reused. With this type of bag, there is a possibility of contact with feces each time the bag is emptied and closed again.

[0004] There are three types of stomas, namely ileostomy, colostomy and urostomy, which can be temporary or permanent. Ileostomy is the formation of an opening from the ileum through the abdominal wall to the outside of the body.

[0005] Colostomy creates an opening from the colon through the abdominal wall to the outside of the body. Depending on the part of the colon where the colostomy is performed, there are four types of colostomy, namely ascending colostomy, transverse colostomy, descending colostomy, or sigmoid colostomy. · Ascending colostomy is performed in the ascending part of the colon, starting from the cecum and rising up the right side of the abdomen. The ascending colostomy is located in the right flank of the abdomen. The biological substances are usually from liquid to semi-liquid, and gas is discharged. This type of colostomy is rare and usually not performed as doctors choose ileostomy. · Transverse colostomy is performed in the transverse part of the colon. The transverse colostomy is usually located in the center of the abdomen, above the navel. The biological substances are usually from liquid to paste-like, and gas is frequently generated. · Descending colostomy is performed in the descending part of the colon. The descending colostomy is located in the lower left abdomen. The biological substances vary from paste-like to formed consistency, and gas is frequently generated. · Sigmoid colostomy is performed in the sigmoid colon (a part of the colon connecting to the rectum). The sigmoid colostomy is located in the lower left abdomen. The feces range from paste-like to formed consistency, and gas is frequently generated. Sigmoid colostomy is the most common type of colostomy.

[0006] Urostomy creates an opening from the intestine (usually the ileum) through the abdominal wall to the outside of the body, allowing urine to be discharged outside the body. The ureter is separated from the bladder and reconnected to a part of the ileum (a part of the ileum is cut and the remaining ileum is connected to the large intestine) to function as a small container for storing urine.

[0007] According to the International Agency for Research on Cancer (IARC), colorectal cancer is the third most common cancer in the world, with an incidence rate of 19.5% in 2020. Furthermore, colorectal cancer is the second leading cause of cancer death, with nearly 1 million deaths annually, and is one of the main reasons (80%) for stoma construction surgery in Spain. It is estimated that 1.5 out of every 1,000 Spaniards have a stoma, which corresponds to 70,000 people, and there are more than 13,000 new cases each year. The number of ileostomy construction surgeries in Europe was 241,406 in 2019, and currently, 13.4 million people worldwide have a stoma, of which 7.7 million have a stoma with liquid excrement.

[0008] The risk of colorectal cancer increases with age, and generally, people aged 65 to 74 are diagnosed. However, a tendency has been observed that 25% of colorectal cancer patients are under 50 years old. In addition, the prevalence of colorectal cancer is increasing in Asian countries such as India, China, and Japan. According to the American Cancer Society's estimate, the number of new cases of colon cancer and rectal cancer in the United States in 2020 was 104,610 and 43,340 respectively.

[0009] According to a 2019 report from the Crohn’s and Colitis Foundation, currently about 1.6 million Americans have inflammatory bowel disease, and 70,000 new IBD cases are diagnosed in the United States every year. Similarly, according to a 2016 WHO report, the global prevalence of stomas is 42% for colostomies, 41% for ileostomies, and 16% for urostomies.

[0010] The increase in the elderly population is an important factor in the expansion of the stoma care market. According to the WHO, the proportion of people over 65 years old is expected to increase from 7% in 2000 to 16% in 2050. In addition, most people with a stoma are over 50 years old, and according to the American Medical Association, stoma surgery is more common in the elderly. Furthermore, according to the NCBI, patients over 70 years old are more likely to undergo permanent stoma surgery, have a longer hospital stay, and a higher mortality rate.

[0011] According to the report of the Crohn's Colitis Foundation 2019, currently about 1.6 million Americans have inflammatory bowel disease (IBD), and 70,000 new cases of IBD are diagnosed each year in the United States. Furthermore, according to the WHO report in 2016, the worldwide prevalence rates of colostomy, ileostomy, and urostomy were 43.0%, 41.0%, and 18.0% respectively. According to the NCBI, IBD includes ulcerative colitis or Crohn's disease, and its occurrence in European countries is gradually increasing. In Europe, about 731,000 people live with a stoma, and about 0.3% of the total population suffers from IBD. Furthermore, according to the Colostomy Association Ltd. in the UK, one in 500 people in the UK is an ostomate.

[0012] Currently, there is no self - controlling device for stomas that involves liquid or semi - liquid excrement. Therefore, patients who have had a stoma created may face physical, psychological, and economic impacts such as changes in body image, continuous loss of feces and urine, odors, sexual dysfunction, anxiety, depression, and emotional concerns related to the stoma, the need for psychological preparation and support, as well as the economic cost of purchasing stoma wafers and collection bags. As mentioned above, the existing device is a collection bag, which does not provide control over urination and defecation for patients with a stoma. The main function of this bag is to collect feces / urine that is continuously excreted unconsciously.

[0013] When the colostomy excretes feces at regular (scheduled) times, it may be possible to use a stoma cover instead of always wearing a pouch. Ready - made plastic stoma caps are also available. However, in the case of an ileostomy or urostomy where the feces are more liquid, the stoma cap is not an efficient solution to prevent feces from spilling, especially when attaching a pouch.

[0014] Therefore, there is a need for a stoma device that can self-control the ability to suppress fecal excretion, does not require replacement of the anti-reflux cap every time feces are discharged (reusable), is low-cost, can insert the device without pain, and can enhance the self-esteem of the carrier.

SUMMARY OF THE INVENTION

[0015] A first aspect of the present invention relates to a stoma plug suitable for controlling the discharge of biological fluids from the colon, ileum, and / or ureter (50) through a stoma (45) formed by colostomy, ileostomy, or urinary stoma surgery, respectively. The stoma plug includes a tube (10) having an opening (12) at a proximal portion and at least one opening (14) at a distal portion, and a two-way valve system (20) having a base element (22) and a plug (24). The two-way valve system (20) is connected to the tube (10) via the base element (22), and the two-way valve system (20) is configured to control the flow of fluid through the opening (12) at the proximal portion of the tube (10). The cap (30) is configured to cover the two-way valve system (20) and the stoma (45), and the cap (30) includes an opening (32) for direct access to the two-way valve system (20) from the outside. The tube (10) is configured to be inserted into the colon, ileum, and / or ureter (45) through its distal portion. Preferably, the tube (10) is configured to be inserted into the stoma of the colon, ileum, and / or ureter (45).

[0016] The two-way valve system (20) is selected from one of the following two options. i. The two-way valve system (20) further comprises an actuator (26), the base element (22) comprises at least one opening (21), and the two-way valve system (20) is configured to remain passively closed such that when the actuator (26) is not actuated, the plug (24) covers the base element (22) and seals the at least one opening (21). Also, the actuator (26) is configured to displace the plug (24) when actuated to release the sealing of at least one opening (21) of the two-way valve system (20), and the two-way valve system (20) is further configured to open when the plug (24) is displaced from the at least one opening (21). The plug (24) is further configured to reseal the at least one opening (21) of the two-way valve system (20) when the actuator (26) stops actuating, or, ii. The two-way valve system (20) further comprises a spring (27) and a plug stopper (29) having at least one opening (21), the base element (22) is configured to be slidably received by the spring (27), and the two-way valve system (20) is configured to remain passively closed such that the spring (27) presses the plug (24) against the plug stopper (29) to close the at least one opening (21) of the two-way valve system (20). Also, the two-way valve system (20) is further configured such that when a force is applied, the spring (27) is longitudinally displaced from the plug stopper (29), whereby the plug (24) is displaced from the at least one opening (21), and thus the at least one opening (21) of the two-way valve system (20) opens.

[0017] In a preferred embodiment, the two-way valve system (20) is selected from the first option i). In an alternative preferred embodiment, the two-way valve system (20) is selected from the second alternative ii).

[0018] In a preferred embodiment, when the two-way valve system (20) follows the first alternative i), the base element (22) is configured to pierce the plug (24) when the plug (24) is displaced by the actuator (26). In a more preferred embodiment, the base element (22) has a pointed shape, and more preferably, the pointed shape is essentially conical. In a preferred embodiment, when the two-way valve system (20) follows the second alternative ii), the plug (24) comprises two parts (24A, 24B). The two parts (24A, 24B) are configured to remain in contact when the spring (27) presses them against the plug stopper (29) and to separate separately when the spring (27) is displaced longitudinally, so that an opening is formed between the two parts (24A, 24B) and at least one opening (21) of the two-way valve system (20) can be accessed through the opening formed between the two parts (24A, 24B).

[0019] In another preferred embodiment of any of the foregoing embodiments, the tube (10) comprises a support element configured to receive the base element (22) of the two-way valve system (20), and the two-way valve system (20) is provided within the tube (10).

[0020] In a preferred embodiment of any of the foregoing embodiments, at least one opening (14) in the distal portion of the tube (10) is disposed at least laterally on the tube (10).

[0021] In another preferred embodiment of any of the foregoing embodiments, at least one opening (14) in the distal portion of the tube (10) is less than 15 mm.

[0022] In another preferred embodiment of any of the foregoing embodiments, the tube (10) comprises a rounded tip (15) at its distal portion and is configured to facilitate the insertion of the tube (10) through the stoma (45). In a more preferred embodiment, the rounded tip (15) at the distal portion of the tube (10) has a rounded conical shape.

[0023] In another preferred embodiment of any of the foregoing embodiments, the outer surface of the tube (10) further comprises at least a helical portion configured to increase the contact surface between the tube (10) and the stoma (50).

[0024] In another preferred embodiment of any of the foregoing embodiments, the tube (10) is composed of any of the materials selected from medical grade silicone, surgical plastic thermoplastic elastomer, or any other biocompatible material including biocompatible polymers.

[0025] In another preferred embodiment of any of the foregoing embodiments, the tube (10) further comprises a lubricating layer on its outer surface configured to reduce friction with the stoma (45) during its insertion.

[0026] In another preferred embodiment of any of the foregoing embodiments, the two-way valve system (20) further comprises a thermosensitive hydrophilic colloid surface or an adaptable biocompatible material surface configured to adhere to or conform to the external stoma mucosa (45). In a more preferred embodiment, the thermosensitive hydrophilic colloid or adaptable biocompatible material surface comprises a dressing configured to adhere to the skin (40) of the subject to be treated extending radially from the two-way valve system (20). In a more preferred embodiment, the dressing is transparent.

[0027] In another preferred embodiment of any of the foregoing embodiments, at least one opening (14) at the distal portion of the tube (10) is disposed at least laterally on the tube (10).

[0028] The second aspect of the present invention relates to a stoma plug system. The stoma plug system comprises the stoma plug according to any one of the preceding claims and a collection bag or a vacuum device. The collection bag or the vacuum device is connected to a two-way valve system (20) and is configured to open at least one opening (21) by shifting the plug (24) from at least one opening (21). In a preferred embodiment, the collection bag or the vacuum device opens at least one opening (21) through the connection to the two-way valve system (20). In another preferred embodiment, the vacuum device is a syringe.

Brief Description of the Drawings

[0029] To enable a better understanding of the present disclosure and to show how the present disclosure may be implemented, reference is now made, by way of example only, to the accompanying schematic drawings.

[0030]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Mode for Carrying Out the Invention

[0031] Description of the Invention Definition The term "two-way valve system" is preferably understood as a valve system that can enable fluid to flow in both senses. The sense of fluid flow is determined by the pressure on each side of the valve such that the fluid flow is from the side of higher fluid pressure to the side of lower fluid pressure.

[0032] The term "vacuum device" is preferably understood as any device capable of generating a negative pressure. Thus, the vacuum device may be a more simple device such as a vacuum connection from a hospital, a portable fluid vacuum device, or a syringe.

[0033] Description A first aspect of the present invention relates to a stoma plug suitable for controlling the discharge of biological fluids from the colon, ileum and / or ureter (50) via a stoma (45) formed by a colostomy, ileostomy or urostomy. As shown with respect to FIG. 1, the stoma plug 100 comprises a tube 10 having an opening 12 in its proximal portion and at least one opening 14 in its distal portion. In FIG. 1, the tube 10 includes two openings 14 in its distal portion, but it should be noted that in other embodiments, the tube may include only one opening 14 or three or more openings 14 in its distal portion. The stoma plug 100 further comprises a two-way valve system 20 comprising at least one opening 21 and a plug 24 configured to close the at least one opening 21. The two-way valve system 20 is connected to the tube 10 via its proximal portion. In FIG. 1, the two-way valve system 20 includes other optional elements 22 and 26, but it should be noted that in other embodiments, the plug may include only at least one opening 21 and a plug 24 configured to close the at least one opening 21. Finally, the stoma plug 100 comprises a cap 30 configured to cover the two-way valve system 20 and the stoma 45. The cap 30 comprises an opening 32 for direct access to the two-way valve system 20 covered from the outside.

[0034] The tube 10 is configured to be inserted through its distal portion into the colon, ileum and / or ureter 50, and the two-way valve system 20 is configured to remain passively closed and to open when the plug 24 is displaced from the at least one opening 21.

[0035] By having a tube that includes an opening 12 in the proximal portion and at least one opening 14 in the distal portion, advantageously, biological fluids in the colon, ileum, and / or ureter 50 can be placed in fluid communication with the two-way valve system 20 via at least one opening 14 in the distal portion. In use, the tube 10 is inserted through its distal portion into the colon, ileum, and / or ureter 50, and according to a preferred embodiment of the invention, the two-way valve system 20 is connected to the tube 10 through the proximal portion of the tube 10. Thus, biological fluids present in the colon, ileum, and / or ureter 50 can pass through the opening 14 of the tube 10 and reach the opening 12 to which the two-way valve system 20 is connected. Thus, the two-way valve system 20 is configured to control the passage of biological fluids through the stoma 45. Preferably, the two-way valve system 20 is configured to control the flow of fluid through the opening 12 in the proximal portion of the tube 10.

[0036] The two-way valve system 20 may be connected to the tube 10 in different ways. The two-way valve system 20 is preferably connected to the tube via a base element 22. For the base element 22, it may be screwed to the tube 10 or adhered to the tube 10. Alternatively, the base element 22 may be snap-fitted into the tube 10. Those skilled in the art can foresee many other options by which the base element and the tube 10 can be connected to each other.

[0037] Note that the two-way valve system 20 and the tube 10 may be connected at different locations. According to a preferred embodiment of the present invention, the two-way valve system 20 is connected to the tube 10 via the proximal portion of the tube 10. According to another alternative preferred embodiment of the present invention, the two-way valve system 20 is included within the tube 10. In this preferred embodiment, the two-way valve system 20 may be provided within the tube 10 at the distal portion of the tube 10, its proximal portion, or any location between the proximal and distal portions of the tube 10. Further, in this preferred embodiment, note that the two-way valve system 20 may extend along the tube 10 toward the proximal portion of the tube 10 and may further extend from the tube 10 through the opening 12 in the proximal portion of the tube 10.

[0038] Using the two-way valve system 20, advantageously, it is possible to provide a method for controlling the flow of fluid in both directions, the flow of biological fluid from the colon, ileum, and / or ureter 50 outward through the tube 10, and the flow of any fluid from the outside through the tube 10 toward the colon, ileum, and / or ureter 50. Thus, the two-way valve system 20 enables the control of the passage of any fluid at the stoma level. In FIG. 1, the two-way valve system 20 further includes elements 22 and 26, but note that in other embodiments, other elements can be used to achieve the same advantages.

[0039] Note that those skilled in the art can devise several methods for fabricating the two-way valve system 20. The present invention mainly describes two alternative methods for such a two-way valve system 20, but is not limited to any specific type of two-way valve system 20 comprising at least one opening 21 and a plug 24 configured to passively close and open when the plug 24 is displaced from the at least one opening 21. Also, more complex systems with two or more plugs 24, configured to be actively (manually or mechanically) closed rather than passively closed, can be envisioned by those skilled in the art.

[0040] The cap 30, advantageously, covers both the two-way valve system 20, the peristomal mucosa 45 and the peristomal skin, so that external elements such as clothing do not interact either with the two-way valve system 20 which could lead to an unwanted opening of the valve or with the peristomal mucosa 45 which could be a cause of pain. The cap 30 is provided with an opening 32 for accessing the two-way valve system 20 so that fluid can be extracted and the valve can be operated, i.e. opened, if necessary. The opening 32 is in the center of the cap surface in FIG. 1, but it should be noted that the opening 32 may be arranged in any part of the surface of the cap 30. The cap may be configured in different shapes in order to provide a more slender and less obtrusive device. The cap may also be made of different materials, for example elastic and / or flexible materials that can adapt to the user's skin surface 40 and / or the peristomal mucosa 45.

[0041] It should be noted that even when the two-way valve system 20 is included within the tube 10, the cap 30 of the opening 32 still provides access to the two-way valve system 20. This is done through the opening 12 in the proximal part of the tube 10 and through the tube itself. Thus, the two-way valve system 20 can still be actuated from the outside to open and thus allow the flow of fluid through the opening (12) in the proximal part of the tube (10).

[0042] It should also be noted that the shapes and designs of the tube 10, the two-way valve system 20, and the cap 30 in FIG. 1 are for illustrative purposes only. Thus, the tube 10 may have a cross-section different from circular, and may be longer or shorter. The two-way valve system 20 may be more or less compact and may have different functional modes. Also, the cap 30 may take a different shape other than cylindrical to cover the two-way valve system 20 and the stoma 45. Similarly, the different openings 12, 14, 21, 32 may have different shapes, and the circular and elliptical ones in the drawings are for illustrative purposes. Thus, as will be appreciated by those skilled in the art, different opening shapes and patterns may be used. For example, the opening shape may be formed into an ellipse or an oblong, or when there are two or more of one type of opening, the opening shapes may be arranged in different configurations to maximize the flow capacity and / or reduce the turbulence of the fluid as the fluid flows through there.

[0043] FIG. 1 shows a distal portion of the tube 10 with an optionally rounded tip 15, but in other embodiments, the rounded tip 15 may not be present. Also, the shape of such a tip may have different shapes.

[0044] The two-way valve system 20 is configured to remain passively closed. Advantageously, this makes it possible to configure the stoma plug to prevent the flow of biological fluid during use. Thus, the stoma plug according to any embodiment of the first aspect of the present invention provides a stoma device capable of self-controlling the fecal excretion inhibitory ability because biological fluid such as feces can flow out to the outside through the stoma 45 from the colon, ileum, and / or ureter 50 only when the plug 24 is removed from the opening 21. Further, since the two-way valve system 20 can be opened and then closed again, it is not necessary to replace the backflow prevention cap every time feces are taken out, and it becomes reusable. Overall, this is low-cost and enhances the self-esteem of the carrier. Further, since the tube 10 is configured to be inserted into the stoma, the insertion of the device is painless and provides all these advantages.

[0045] Figure 2 shows a perspective view of a stoma plug according to at least one embodiment of the present invention. This includes a tube 10, a two-way valve system 20 (not shown), and a cap 30. The cap 30 covers the two-way valve system 20, and it can be seen that the opening 32 of the cap 30 allows direct access to the two-way valve system 20 from the outside. The tube 10 includes two or more openings 14 in the distal portion, but these are optional. It should be noted that in other embodiments, the tube 10 may include only one, or a different number of openings 14 in the distal portion of the tube 10. Further, the stoma plug of Figure 2 further includes an optional rounded tip 15 at the distal portion of the cap 10, and other embodiments may not include such a rounded tip 15.

[0046] In a preferred embodiment, as shown in FIG. 1, the two-way valve system 20 further comprises a base element 22 having at least one opening 21 of the two-way valve system 20 and an actuator 26. The plug 24 is configured to cover the base element 22 and seal the at least one opening 21 when the actuator 26 is not actuated. Further, the actuator 26 is configured to displace the plug 24 during actuation and release the sealing of the at least one opening 21 of the two-way valve system 20. The actuator 26 may be actuated in different ways. For example, as shown in FIG. 1, the actuator 26 can displace the plug 24 longitudinally towards the base element 22, enabling the release of the sealing of the at least one opening 21. However, those skilled in the art can understand that there are numerous ways to displace the plug 24 from the opening 21 by the actuator. For example, the plug 24 may be composed of a plurality of components configured to displace laterally when the plug is displaced longitudinally, and thus can be displaced from the opening 21. Alternatively, the plug 24 may simply be shaped such that the opening 21 is no longer covered by the seal 24 when the plug 24 is displaced longitudinally. For example, this can be achieved through a special design of the plug 24 or through a rotating means configured to rotate the plug 24 when the plug 24 is displaced longitudinally. According to another exemplary embodiment of this preferred embodiment, the plug 24 is made of an elastic material such as rubber that can be perforated by the base element 22 to release the sealing of the opening 21, as shown with reference to FIG. 1.

[0047] Furthermore, in this preferred embodiment, the plug 24 is further configured to re-seal at least one opening 21 of the two-way valve system 20 when the actuator 26 stops operating. Thus, after the actuator 26 operates, at least one opening 21 is re-sealed by the plug 24. For example, in the embodiment of FIG. 1, when the operation of the actuator 26 stops, the plug 24 assumes a spring-like shape and, if made of an elastic material, returns to its original position after being compressed during displacement by the actuator 26, thus re-sealing at least one opening 21 of the two-way valve system 20. Advantageously, this causes the two-way valve 20 to be configured to always remain passively closed when the actuator 26 is not operating. That is, since the stoma plug is configured to always be closed and sealed when the valve is not operating, it can further prevent the flow of biological fluids and self-regulate the fecal excretion suppression ability during use, i.e., in the user's daily life. Furthermore, since the two-way valve system 20 can be opened and then closed again, there is no need to replace the backflow prevention cap every time feces are removed, making it reusable. The plug 24 can include an elastic material and / or a flexible material that can return to its original shape when no external force is applied. Thus, the plug 24 can act as a spring element.

[0048] More preferably, the base element 22 is configured to pierce the plug 24 when the plug 24 is displaced by the actuator 26. FIG. 3 shows a schematic cross-sectional view of a stoma plug 100 according to at least one embodiment of the present invention. It should be noted that the stoma plug 100 of FIG. 3 includes a tube 10, a two-way valve system 20, and a cap 30. However, this further includes optional elements, namely, several openings 14 in the distal portion of the tube 10, a rounded tip 15 in the distal portion of the tube 10, and two openings 21. However, in other embodiments, there may be one or a different number of openings 14 in the distal portion of the tube 10, there may be no rounded tip 15 in the distal portion of the tube 10, and there may be one or three or more openings 21. It should be noted that the base element 22 can pierce the plug in several ways. Those skilled in the art may devise different ways in which the base element 22 is configured to pierce the plug 24 when the plug 24 is displaced by the actuator 26. For example, the base element 22 may include a piercing element actuated by the actuator 26 when the actuator is activated, so that when the plug 24 is displaced towards the base element 22, the piercing element is also activated to pierce the plug 24.

[0049] In FIG. 3, it can be seen that the plug 24 is configured to seal at least one opening 21 of the base element 22, and the actuator 26 is configured to displace the plug 24 longitudinally towards the base element 22 to unseal at least one opening 21. However, it can be known that the element cannot be unsealed unless the base element 22 pierces the plug 24 when the plug 24 is displaced by the actuator 26, and thus unless an opening through which fluid can flow is generated.

[0050] Advantageously, this causes the plug 24 to be configured to be pre-sealed before first use, and thus provides an additional safety measure against leakage of biological fluid from the stoma to the outside when used up to the first opening of the two-way valve system by actuation of the actuator. When the plug 24 is pierced by the base element 22 and the actuation of the actuator 26 stops, the plug 24 re-seals the opening 21, but the plug 24 remains pierced. Note that the sealing of the opening 21 is not impaired by the piercing of the plug 24.

[0051] In an even more preferred embodiment, the base element 22 has a pointed shape, and more preferably the pointed shape is essentially conical. Advantageously, this configures the base element 22 such that the plug 24 can be pierced when displaced towards the base element 22 by the actuator 26. Thus, the displacement of the plug 24 by the actuator 26 causes the base element 22 to pierce the plug 24.

[0052] FIG. 4 shows a schematic cross-sectional view of an actuated stoma plug 100 inserted into a stoma 50 according to at least one of the embodiments of the present invention. Note that the stoma plug 100 of FIG. 4 comprises a tube 10, a two-way valve system 20, and a cap 30. However, this further comprises optional elements, namely, several openings 14 in the distal portion of the tube 10, a rounded tip 15 in the distal portion of the tube 10, and two openings 21. However, in other embodiments, there may be one or a different number of openings 14 in the distal portion of the tube 10, there may be no rounded tip 15 in the distal portion of the tube 10, and there may be one or three or more openings 21. Further note that the stoma plug 100 is inserted into the stoma 40, and the cap 30 is configured to cover the two-way valve system 20 and the external mucosal surface of the stoma 45 and is adapted to the skin surface 40. Note that the cap 30 can take several shapes that conform to the skin surface 40.

[0053] The stoma plug 100 of FIG. 4 is actuated as shown by arrow 260 through the opening 32 of the cap 30, whereby the actuator 26 displaces the plug 24 and unseals at least one opening 21 of the base element 22. Further, the base element 22 has a conical pointed shape that pierces the plug 24. In this configuration, the two-way valve system 20 has the plug 24 displaced from at least one opening 21, and thus, biological fluids (such as feces) in the colon, ileum, and / or ureter 50 are placed in fluid communication through the opening 14 at the distal portion of the tube 10, such that access to the opening 21 of the base element 22 is available through the opening 12 at the proximal portion of the tube 10. Further, when the actuator 26 is actuated (as shown by arrow 260), the plug 24 unseals the opening 21, and the biological fluids in the colon, ileum, and / or ureter 50 can reach the outside through the opening 32 of the cap 30. Thus, when the actuator 26 is actuated, the biological fluids of the stoma 50 are placed in fluid communication with the outside of the body.

[0054] It should be noted that since the two-way valve system 20 is in fluid communication with the interior of the colon, ileum, and / or ureter 50, actuation of the actuator 26 enables external fluid to be inserted into the colon, ileum, and / or ureter 50 through the stoma 45. For example, a mixture of lactulose and water or lactulose and a cola beverage can be introduced into the colon, ileum, and / or ureter 50 via the stoma 45 to combat or prevent intestinal obstruction.

[0055] Alternatively, in another preferred embodiment, as shown in FIG. 5, the two-way valve system further comprises a spring 27, a base element 22 configured to be slidably received by the spring 27, and a plug stopper 29 having at least one opening 21 of the two-way valve system 20. Note that the stoma plug 200 of FIG. 5 comprises a tube 10, a two-way valve system 20, and a cap 30. However, this further comprises optional elements, namely, some openings 14 in the distal portion of the tube 10, a rounded tip 15 in the distal portion of the tube 10, and a two-piece plug 24. However, in other embodiments, there may be one or a different number of openings 14 in the distal portion of the tube 10, the distal portion of the tube 10 may not have a rounded tip 15, the plug 24 may not include more than two parts, or may comprise several parts. In some embodiments, as shown in FIG. 5, the base element 22 is a fixed element of the two-way valve system that prevents displacement when the spring is compressed. The base element 22 holds the spring in a specific direction so that the compression direction is constant. The base element 22 is further an element of the two-way valve system 20, through which the two-way valve system 20 is connected to the proximal portion of the tube 10.

[0056] Spring 27 is configured to press plug 24 against plug stopper 29 and close at least one opening 21 of the two-way valve system 20. It should be noted that those skilled in the art can envision several ways in which spring 27 can press plug 24 against plug stopper 29 to close at least one opening 21 of the two-way valve system 20. For example, spring 27 may be a compression spring and is at least partially compressed to exert a stretching force. When plug 24 is on one side of spring 27 and base element 22 is on the other side as a support, when plug 24 is directed towards the plug stopper, spring 27 presses plug 24 against plug stopper 29 and closes at least one opening 21 of the two-way valve system 20. Alternatively, spring 27 may be a tension spring and may be at least partially stretched to exert a compressive force. When plug 24 is attached to one side of spring 27 and base element 22 is on the other side as a support, when plug stopper 29 is between spring 27 and base element 22, spring 27 presses plug 24 against plug stopper 29 and closes at least one opening 21 of the two-way valve system 20. Those skilled in the art can design an equivalent system using one or more torsion springs, tension springs, spiral springs, and any other types of springs known in the art. In Figure 5, spring 27 is a compression spring that presses plug 24 against plug stopper 29 and thus closes at least one opening 21.

[0057] Furthermore, spring 27 is further configured to be longitudinally displaced from plug stopper 29 when a force is applied, thus displacing plug 24 from at least one opening 21, and thus opening at least one opening 21 of two-way valve system 20. It should be noted that one skilled in the art can envision several ways to displace spring 27 from plug stopper 29 when a force is applied. Depending on the type of spring defined above, several options can be defined. For example, in FIG. 5, compression spring 27 can be compressed, and since base element 22 is fixed, plug 24 is displaced from at least one opening 21 of two-way valve system 20, leading to the opening of at least one opening 21.

[0058] Advantageously, having a spring-actuated two-way valve system 20 enables a reliable opening and closing mechanism that operates with reliable feedback to reinforce the sealing of at least one opening 21 of the two-way valve system 20. For example, in the embodiment shown in FIG. 5, when the pressure of the biological fluid in the stoma increases, that pressure further presses plug 24 against plug stopper 29, further closing at least one opening 21 of two-way valve system 20. In this way, the stoma plug is configured to further prevent involuntary outflow of biological fluid during use.

[0059] In a more preferred embodiment, as shown in FIG. 5, plug 24 comprises two parts 24A, 24B. The two parts (24A, 24B) are configured to remain in contact when spring (27) presses them against plug stopper (29) and to separate separately when spring (27) is longitudinally displaced, thus forming an opening between the two parts (24A, 24B) and enabling at least one opening (21) of two-way valve system (20) to be accessible through the opening formed between the two parts 24A, 24B.

[0060] The two parts 24A, 24B may be two equal parts or parts having different shapes. Overall, when the two parts 24A, 24B come into contact, they completely close at least one opening 21 of the two-way valve system 20. One skilled in the art will notice that this can be achieved in several ways. For example, one part 24A can be a ring and the other part 24B can be a plug that closes the inner circle left by the ring of the first part 24A. In the example of FIG. 5, the two parts 24A, 24B are parts that each cover half of the circumference left by at least one opening 21. Thus, both parts 24A, 24B have the same shape. However, in other embodiments, they may have different shapes. Note that in embodiments where there are two or more openings 21, each of the two parts 24A, 24B can close one or more of the openings 21.

[0061] The two parts 24A, 24B may be configured to separate separately when the spring 27 is displaced longitudinally in several ways. For example, each of the two parts 24A, 24B can have a lever or ramp that interacts with either the spring 27 or a surrounding element such as the base element 22 such that the two parts 24A, 24B move in opposite directions outwardly, thus creating an opening between the two parts 24A, 24B. Through this opening, internal access can be made to at least one opening 21 of the two-way valve system 20, i.e., the plug 24 no longer closes at least one opening 21. As a result, since at least one opening 21 is in fluid communication with the biological fluid at the distal portion of the tube 10 via the opening 12 at the proximal portion of the tube 10 and at least one opening 14 at the distal portion of the tube 10, the biological fluid at the distal portion of the tube 10 is in fluid communication with the outside.

[0062] In use, the two-way valve system 20 of the embodiment according to FIG. 5 is configured to open when the spring 27 is longitudinally displaced towards the base element 22, i.e., by compressing the spring. Thereby, the two parts 24A, 24B each have an inclined base that interacts with the base element 22 and is displaced outwardly, so that they separate separately, and biological fluid from the colon, ileum and / or ureter 50 can flow through the opening created between the two parts 24A, 24B and communicate fluidly with at least one opening 21 of the two-way valve system 20.

[0063] Advantageously, at least one opening 21 of the two-way valve system 20 is accessible through the opening created between the two parts 24A, 24B, so that the opening created between the two parts 24A, 24B is aligned with at least one opening 21, which can improve the flow through at least one opening 21. Their alignment reduces the turbulence of the fluid flow and can reduce the possibility of the two-way valve system being blocked by any small solids present in the fluid.

[0064] It should be noted that in this alternative preferred embodiment, the spring 27 is configured to be longitudinally displaced from the plug stopper 29 when a force is applied. However, this force can be applied by the user at will or using any external element through the opening 32 of the cap 30.

[0065] In a preferred embodiment of any of the foregoing embodiments, the tube 10 comprises a support element configured to receive the base element 22 of the two-way valve system 20. Also, the two-way valve system 20 is provided within the tube 10. It should be noted that the two-way valve system 20 may be provided entirely or only partially within the tube 10 as long as direct access to the two-way valve system 20 can be achieved through the opening 32 of the cap 30.

[0066] Advantageously, in this preferred embodiment, the two-way valve system 20 can be at least partially received within the tube 10, allowing the stoma plug to be designed very compactly, and thus the cap 30 can be made smaller, the cap 30 can be designed to be more slender, and the self-esteem of the carrier can be further enhanced.

[0067] In a preferred embodiment of any of the foregoing embodiments, the plug 24 comprises a spring-like portion configured to assist in re-sealing at least one opening 21 of the two-way valve system 20 when the actuator 26 stops operating. The spring-like portion may comprise a metallic material. In these embodiments where the base element 22 is configured to pierce the plug 24 when the plug 24 is displaced by the actuator 26, the surface to be pierced may be disposed at the proximal portion of the plug and the spring-like portion may be disposed at the distal portion of the plug 24 to facilitate providing both the surface to be pierced and the spring-like portion. The surface to be pierced and the spring-like portion may be connected via a frame.

[0068] In a preferred embodiment of any of the foregoing embodiments, at least one opening 14 in the distal portion of the tube 10 is disposed at least laterally on the tube 10. As shown in FIGS. 1-5, some of the openings 14 in the distal portion of the tube 10 are disposed laterally. However, in other embodiments, the opening 14 may be at the tip, may be partially disposed laterally, or if the stoma plug has only one opening 14 in the distal portion of the tube 10, the opening may be disposed only laterally or at least laterally on the tube 10 such that a portion of the opening is at the tip of the tube 10 and a portion is on the side of the tube 10. Advantageously, this allows biological fluid in the colon, ileum and / or ureter 50 to continue to flow into the tube 10 through at least one opening 14 each time a large stool fragment is placed at the tip of the tube 10. Stool applies pressure at the end of the colon, ileum and / or ureter 50 due to peristaltic movement at that location, so at least one opening 14 at the tip in the distal portion of the tube 10 may be blocked, but the portion of at least one opening 14 disposed at least laterally is away from the stool, and biological fluid can continue to reach the at least one lateral opening 14 disposed at least laterally on the tube 10.

[0069] In another preferred embodiment of any of the foregoing embodiments, at least one opening 14 in the distal portion of the tube 10 is less than 15 mm. The stoma plug of the present invention is preferably designed for controlling the liquid of ileostomy, urostomy, and some colostomies. Therefore, at least one opening 14 in the distal portion of the tube 10 can be used to control the size of the element reaching the two-way valve system 20. Advantageously, by having at least one opening 14 in the distal portion of the tube 10 that is less than 15 mm, the stoma plug is configured to prevent any element such as feces larger than 15 mm that could clog the two-way valve system 20 when the two-way valve system 20 is opened from being removed. In FIGS. 1-5, at least one opening 14 is circular, but in other embodiments, these one openings can take different shapes such as oval, square, or any other shape foreseeable by those skilled in the art. In the case of FIGS. 1-5, the size of at least one opening 14 is determined by the diameter of the opening, but in other embodiments, the size of at least one opening 14 is defined by the maximum diameter of the opening 14 in any direction on the surface of the tube 10. In a more preferred embodiment, at least one opening 14 in the distal portion of the tube 10 is less than 10 mm.

[0070] In another preferred embodiment of any of the foregoing embodiments, the tube 10 has a rounded tip 15 at its distal portion and is configured to facilitate the insertion of the tube 10 into the stoma 50. Since the tube 10 is configured to be introduced into the colon, ileum, and / or ureter 50, having a rounded tip 15 further facilitates the insertion of the tube through the stoma 45, thereby allowing the internal mucosa of the colon, ileum, and / or ureter 50 to slide when the tube 10 is introduced into the colon, ileum, and / or ureter 50 through the stoma 45. Therefore, this feature further enables the painless insertion of the stoma plug.

[0071] In a more preferred embodiment of the foregoing embodiment, the rounded tip portion 15 at the distal portion of the tube 10 has a rounded conical shape. Advantageously, the rounded conical tip portion 15 not only facilitates the insertion of the tube 10 into the stoma 45, but also further increases the contact surface between the tube 10 and the inner mucosa of the colon, ileum and / or ureter 50. The term "rounded cone" is preferably understood to mean that the tip portion is a rounded cone. It should be noted that in the context of the present invention, a tip portion having a rounded conical shape is a tip portion in which the tip of the cone is at the distal end of the tip portion. Those skilled in the art can envision many different alternative forms of tip portions shaped like rounded cones with different widths and cone tip radii, all of which are included within this particular embodiment.

[0072] In another preferred embodiment of any of the foregoing embodiments, the outer surface of the tube 10 further comprises at least a helical portion configured to increase the contact surface between the tube 10 and the colon, ileum and / or ureter 50. By having at least a helical portion on the outer surface of the tube, a rougher surface is created to which the mucosa of the colon, ileum and / or ureter 50 can adhere. Advantageously, this improves the grip between the inner mucosa of the colon, ileum and / or ureter 50 and the tube 10, and the stoma plug can be more securely attached to the colon, ileum and / or ureter 50. Note that many helical configurations can be envisioned. For example, the helix may extend radially outward from the outer surface of the tube 10, or may extend radially inward within the outer surface of the tube 10. In some embodiments, the helix may have a different degree of rotation for each length of the tube 10 and can rotate in one or the other sense (i.e., clockwise or counterclockwise). This can also rotate in one sense in one portion of the tube 10 and in the other sense in another portion of the tube 10.

[0073] In another preferred embodiment of any of the foregoing embodiments, the tube 10 is composed of any material selected from medical grade silicone, surgical plastic, thermoplastic elastomer, or any other biocompatible material including biocompatible polymers. Advantageously, this allows the tube 10 inserted through the stoma 45 into the colon, ileum and / or ureter 50 to be biocompatible and at least partially flexible so as to adapt to the shape of the colon, ileum and / or ureter 50. This means that during use, the tube 10 can bend when the colon, ileum and / or ureter 50 bends, thus reducing pain and enhancing the user's self-esteem.

[0074] In another preferred embodiment of any of the foregoing embodiments, the tube 10 further comprises a lubricating layer on its outer surface configured to reduce friction as it passes through the stoma 45 during insertion. This layer may include any anti-friction substance such as an oily substance or an aqueous lubricant, and may further include an anesthetic component such as tetracaine or lidocaine. Advantageously, this configures the tube 10 to be inserted through the stoma 45 without friction, thus improving usability and reducing the pain felt by the user.

[0075] In another preferred embodiment of any of the foregoing embodiments, the two-way valve system 20 further comprises a thermosensitive hydrophilic colloid surface configured to adhere to or conform to the stoma 45. Since the biological fluids in the colon, ileum and / or ureter 50 can be at a pressure higher than atmospheric pressure within the stoma, it is desirable to firmly attach the stoma plug 100 to the stoma 45. For example, as shown with respect to FIG. 4, the two-way valve system 20 interacts with the stoma 45 and secures the stoma plug 100 within the colon, ileum and / or ureter 50. Thus, by having a hydrophilic colloid surface that is absorbent, self-adhesive, and waterproof, the stoma plug 100 can be firmly fixed to the stoma. Further, the thermosensitive surface can only adhere to a heated surface such as the stoma, making it easier to easily manipulate the stoma plug 100 before insertion into the colon, ileum and / or ureter 50. Advantageously, by further comprising a thermosensitive hydrophilic colloid surface configured to adhere to the external stoma mucosa 45, the stoma plugs 100, 200 are configured to be held in place when the internal pressure within the colon, ileum and / or ureter 50 rises above atmospheric pressure.

[0076] In a more preferred embodiment, the thermosensitive hydrophilic colloid surface includes a dressing configured to adhere to the skin 40 of the subject radiating from the two-way valve system 20. Advantageously, this further enhances the adhesiveness of the stoma plugs 100, 200 by further adhering to the user's skin. It should be noted that the dressing may extend radially in different lengths in each direction and the shape can be adjusted according to the position of the stoma 45 and / or the size of the stoma 45. In an even more preferred embodiment, the dressing is transparent, providing a discreet design and further enhancing the self-esteem of the subject.

[0077] In another preferred embodiment of any of the foregoing embodiments, the two-way valve system 20 further comprises an adaptable biocompatible material configured to conform to or adapt to the stoma 45. The adaptable biocompatible material is configured to conform to the external mucosa of the stoma and the skin surface around the stoma, thereby achieving a stronger fixation between the stoma plug and the stoma.

[0078] In another preferred embodiment, the stoma plugs 100, 200 further comprise pressure sensors for monitoring the pressure inside the colon, ileum and / or ureter 50. The two-way valve system 20 can then automatically open when it detects that the pressure sensor has reached a certain pressure threshold, or, through a feedback element, indicate to the user that the two-way valve system 20 must be opened to drain the biological fluid from the colon, ileum and / or ureter 50.

[0079] A second aspect of the present invention relates to a stoma plug system comprising a stoma plug 100, 200 by any of the stoma plugs of the first aspect of the present invention and a collection bag or a vacuum device. The collection bag or vacuum device is connected to the two-way valve system 20 and is configured to open at least one opening 21 and displace the plug 24 from at least one opening 21. Preferably, the collection bag or vacuum device is configured to be connected to the two-way valve system 20 via the opening 32 of the cap 30.

[0080] Thus, when the collection bag or the vacuum device is connected to the two-way valve system 20, the stoma plug opens, and the biological fluids of the colon, ileum, and / or ureter 50 can reach the outside through the stoma plug. Thus, both the collection bag and the vacuum device are configured to handle the biological fluids that may come out of the stoma plug. The collection bag can be of any type of collection bag as known in the stoma device industry. Thus, the collection bag may be a pouch with an open bottom so that the collected contents can be discarded through the bottom opening, or it may be a pouch with a closed bottom and thus may be replaced when the contents need to be discarded. Thus, the vacuum device is provided with a collection container for storing the biological fluids or is connected to a container that can store them.

[0081] Note that the collection bag collects the biological fluids of the colon, ileum, and / or ureter 50 that passively exit from the stoma plug, while the vacuum device actively extracts the biological fluids of the colon, ileum, and / or ureter 50 by using a negative pressure compared to the internal pressure of the colon, ileum, and / or ureter 50.

[0082] The collection bag or the vacuum device can displace the plug 24 from at least one opening 21 in several ways to open at least one opening 21. For example, when connected to the two-way valve system 20, at least one opening 21 can be opened by directly displacing the plug 24 from at least one opening 21, or it can also be opened by activating the actuator 26 at the moment of connection to the two-way valve system 20. Alternatively, the collection bag or the vacuum device may be provided with a second mechanism on the connection element to at least one opening 21 of the two-way valve system 20 that can be manually or electrically activated to open the two-way valve system 20.

[0083] In an embodiment where the stoma plugs 100, 200 include a pressure sensor for monitoring the pressure inside the colon, ileum, and / or ureter 50, the sensor can send a signal to the user indicating when it is appropriate to drain the biological fluid of the colon, ileum, and / or ureter 50 using a collection bag or a vacuum device.

[0084] Advantageously, with a stoma plug system comprising a stoma plug 100, 200 according to any of the stoma plugs of the first aspect of the present invention and a collection bag or a vacuum device, the user can passively drain the biological fluid of the colon, ileum, and / or ureter 50 using the collection bag, or actively manually drain the biological fluid of the colon, ileum, and / or ureter 50 using the vacuum supplied by the vacuum device.

[0085] In a preferred embodiment, the vacuum device is a syringe. Advantageously, the user can use the syringe to quickly remove the biological fluid of the colon, ileum, and / or ureter 50 through the stoma plug in a short time. Thus, the user can easily and quickly and cleanly discharge the biological fluid of the colon, ileum, and / or ureter 50 through the stoma 45. Then, the syringe can be emptied in the toilet. The syringe may be reusable or disposable.

Claims

1. A stoma plug suitable for controlling the discharge of biological fluids from the colon, ileum and / or ureter (50) respectively through a stoma (45) formed by colostomy, ileostomy or urostomy, a) a tube (10) having an opening (12) in the proximal portion and at least one opening (14) in the distal portion, b) a two-way valve system (20) comprising a base element (22) and a plug (24), connected to the tube (10) via the base element (22) and configured to control the flow of the fluid through the opening (12) in the proximal portion of the tube (10), a two-way valve system (20), c) a cap (30) configured to cover the two-way valve system (20) and the stoma (45) and having an opening (32) for direct access to the two-way valve system (20) from the outside comprising, the tube (10) is configured to be inserted into the colon, ileum and / or ureter (50) through its distal portion, the two-way valve system (20) is, i. the two-way valve system (20) further comprises an actuator (26), the base element (22) comprises at least one opening (21), the two-way valve system (20) is configured to remain passively closed such that the plug (24) covers the base element (22) and seals the at least one opening (21) when the actuator (26) is not actuated, and the actuator (26) is configured to displace the plug (24) when actuated to release the sealing of the at least one opening (21) of the two-way valve system (20), and is further configured to open when the plug (24) is displaced from the at least one opening (21), and the plug (24) is further configured to reseal the at least one opening (21) of the two-way valve system (20) when the actuator (26) stops actuating, or, ii. The two-way valve system (20) further comprises a spring (27) and a plug stopper (29) having at least one opening (21), the base element (22) being configured to be slidably received by the spring (27), the two-way valve system (20) being configured to remain passively closed such that the spring (27) presses the plug (24) against the plug stopper (29) to close the at least one opening (21) of the two-way valve system (20), and further configured such that when a force is applied, the spring (27) is longitudinally displaced from the plug stopper (29), whereby the plug (24) is displaced from the at least one opening (21), and thus the at least one opening (21) of the two-way valve system (20) is opened. A stoma plug selected from one of two options. **Claim 2** The two-way valve system (20) further comprises an actuator (26), the base element (22) comprising at least one opening (21), the two-way valve system (20) being configured to remain passively closed such that the plug (24) covers the base element (22) and seals the at least one opening (21) when the actuator (26) is not actuated, and the actuator (26) being configured to displace the plug (24) when actuated to release the sealing of the at least one opening (21) of the two-way valve system (20), and further configured to open when the plug (24) is displaced from the at least one opening (21), the plug (24) being further configured to reseal the at least one opening (21) of the two-way valve system (20) when the actuator (26) stops actuating. The stoma plug according to claim 1. **Claim 3** The two-way valve system (20) further comprises a spring (27) and a plug stopper (29) having at least one opening (21), the base element (22) being configured to be slidably received by the spring (27), the two-way valve system (20) being configured to remain passively closed such that the spring (27) presses the plug (24) against the plug stopper (29) to close the at least one opening (21) of the two-way valve system (20), and further configured such that when a force is applied, the spring (27) is longitudinally displaced from the plug stopper (29), whereby the plug (24) is displaced from the at least one opening (21), and thus the at least one opening (21) of the two-way valve system (20) is opened. The stoma plug according to claim 1.

4. The stoma plug according to claim 2, wherein the base element (22) is configured to pierce the plug (24) when the plug (24) is displaced by the actuator (26).

5. The stoma plug according to claim 2 or 4, wherein the base element (22) has a pointed shape, and more preferably, the pointed shape is essentially conical.

6. The plug (24) comprises two parts (24A, 24B), the two parts (24A, 24B) remaining in contact when the spring (27) presses them against the plug stopper (29) and being configured to separate separately when the spring (27) is longitudinally displaced, so that an opening is formed between the two parts (24A, 24B), and the at least one opening (21) of the two-way valve system (20) can be accessed through the opening formed between the two parts (24A, 24B). The stoma plug according to claim 3.

7. The tube (10) comprises a support element configured to receive the base element (22) of the two-way valve system (20), the two-way valve system (20) being provided within the tube (10). The stoma plug according to any one of claims 1 to 6.

8. The at least one opening (14) in the distal portion of the tube (10) is less than 15 mm, the stoma plug according to any one of claims 1 to 7.

9. The tube (10) comprises a rounded tip (15) at its distal portion and is configured to facilitate insertion of the tube (10) through the stoma (45), the stoma plug according to any one of claims 1 to 8.

10. The rounded tip (15) in the distal portion of the tube (10) has a rounded conical shape, the stoma plug according to claim 9.

11. The outer surface of the tube (10) further comprises at least a helical portion configured to increase the contact surface with the inner surface of the colon, ileum and / or ureter (50) of the tube (10), the stoma plug according to any one of claims 1 to 10.

12. The tube (10) is composed of any of materials selected from medical grade silicone, surgical plastic thermoplastic elastomer, or any biocompatible material, the stoma plug according to any one of claims 1 to 11.

13. The tube (10) further comprises a lubricating layer on its outer surface configured to reduce friction with the stoma (45) during its insertion, the stoma plug according to any one of claims 1 to 12.

14. The two-way valve system (20) further comprises a heat-sensitive hydrophilic colloid surface or an adaptable biocompatible material surface configured to adhere to or conform to the external stoma mucosa (45), the stoma plug according to any one of claims 1 to 13.

15. The heat-sensitive hydrophilic colloid or the adaptable biocompatible material surface comprises a dressing configured to adhere to the skin (40) of the subject to be treated extending radially from the two-way valve system (20), preferably the dressing is transparent, the stoma plug according to claims 1 to 14.

16. The at least one opening (14) in the distal portion of the tube (10) is disposed at least laterally on the tube (10), the stoma plug according to any one of claims 1 to 15.

17. A stoma plug system, a) a stoma plug according to any one of claims 1 to 16; and b) a collection bag or a vacuum device and comprising. More preferably, the collection bag or the vacuum device is connected to the two-way valve system (20) and is configured to open the at least one opening (21) by displacing the plug (24) from the at least one opening (21), and the collection bag or the vacuum device opens the at least one opening (21) via the connection to the two-way valve system (20), a stoma plug system.

18. The stoma system according to claim 17, wherein the vacuum device is a syringe.

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