Anti-reflux ostomy device

Abstract

The present invention relates to a stoma plug adapted to control the output of biological fluid from the colon, ileum and / or ureter (50) through stomas (45) created by colostomy, ileum stomy or urostomy, respectively. The stoma plug comprises: a tube (10) comprising an opening (12) in a proximal portion and at least one opening (14) in a distal portion; a two-way valve system (20) comprising a base element (22) and a plug (24), the two-way valve system (20) being connected to the tube (10) through the base element (22), the two-way valve system (20) being configured to control a flow of fluid through the opening (12) of the proximal end portion of the tube (10); and a cap (30) configured to cover the two-way valve system (20) and the stoma (45), the cap (30) comprising an opening (32) directly into the two-way valve system (20) from the outside. The tube (10) is configured to be inserted through its distal end portion into the colon, ileum and / or ureter (50), and the two-way valve system (20) is configured to be passively held closed and to be opened when the plug (24) is displaced from the at least one opening (21).

Description

Technical Field

[0001] The present invention relates to the field of ostomy devices, in particular to a stoma plug for controlling the output of biological fluids through a stoma formed by a colostomy, ileostomy or urostomy, and to a system comprising such a stoma plug and elements for managing the output of biological fluids. Background Art

[0002] An ostomy is an opening in the abdominal wall through which the intestines are brought out to allow stool / urine to pass out because a medical problem prevents stool / urine from passing out naturally through the anus or urethra. Patients may need an ostomy for a variety of reasons, such as colorectal cancer, inflammatory bowel disease (IBD) (such as Crohn's disease and ulcerative colitis), severe diverticulitis with peritonitis, severe trauma, birth defects, and spinal cord injuries.

[0003] The stoma may be temporary or permanent and may require a collection system (collection bag) for fecal or urinary material. Currently, there are various types of collection bags available, including open and closed bags, one-piece bags or two-piece bags, transparent bags or opaque bags, in different sizes and brands. The bag should be emptied or replaced when it is one-third or half full. Closed bags are suitable for fecal material of a hard and sticky consistency, while open bags are suitable for reusable liquid fecal / urinary material. With this type of bag, there is a potential for contact with feces each time the bag is emptied and closed again.

[0004] There are three types of ostomies: ileostomy, colostomy, and urostomy, and these can be temporary or permanent. An ileostomy creates an opening through the abdominal wall from the ileum to the outside of the body.

[0005] A colostomy creates an opening through the abdominal wall from the colon to the outside of the body. Four types of colostomies are identified based on the part of the colon where the colostomy is made: ascending colon, transverse colon, descending colon, or sigmoid colon.

[0006] An ascending colostomy is done in the ascending portion of the colon (starting from the cecum and going up toward the right side of the abdomen). An ascending colostomy is located on the right side of the abdomen. The biopsy is usually liquid to semi-liquid and passes gas. This type of colostomy is rare and is not usually done because doctors would choose an ileostomy instead.

[0007] A transverse colostomy is made in the sideways portion of the colon. The transverse colostomy is usually located in the center of the abdomen, above the navel. The biopsy is usually of a liquid to pasty consistency, and there is often flatulence.

[0008] · A descending colostomy is made in the descending portion of the colon. The descending colostomy is located in the left lower abdomen. The biomass changes from a pasty consistency to a formed consistency, and there is often flatulence.

[0009] A sigmoid colostomy is a procedure in which a sigmoid colon (the part of the colon that connects to the rectum) is placed. The sigmoid colostomy is located in the lower left abdomen. The stools are mushy to formed in consistency and are often accompanied by gas. A sigmoid colostomy is the most common type of colostomy.

[0010] A urostomy creates an opening through the abdominal wall from the intestine (usually the ileum) to the outside of the body, allowing urine to exit the body. The ureters are separated from the bladder and reconnected to a portion of the ileum (a portion of the ileum is cut and the rest of the ileum is connected to the large intestine), making the ileum a small reservoir for storing urine.

[0011] According to the International Agency for Research on Cancer (IARC), colorectal cancer is the third most prevalent cancer worldwide, with an incidence of 19.5% in 2020. In addition, colorectal cancer is the second most common cause of cancer death, causing nearly 1 million deaths per year in Spain and is one of the main reasons for ostomy surgery (80%). It is estimated that 1.5 out of every 1,000 Spanish citizens have an ostomy, equivalent to 70,000 people and more than 13,000 new cases per year. The number of ileostomy operations in Europe in 2019 was 241,406, and there are currently 13.4 million people with a stoma worldwide, of which 7.7 million have an ostomy and leave liquid waste.

[0012] The risk of colorectal cancer increases with age as it is usually diagnosed in people aged 65 to 74 years. However, a trend is observed that 25% of colon cancer patients are younger than 50 years old. Moreover, the prevalence of colorectal cancer is also increasing in Asian countries such as India, China, and Japan. According to the American Cancer Society, in 2020, the number of new cases of colon cancer and rectal cancer in the United States will be 104,610 and 43,340, respectively.

[0013] According to a 2019 report from the Crohn's and Colitis Foundation, approximately 1.6 million Americans currently have inflammatory bowel disease, with 70,000 new cases of IBD diagnosed each year in the U.S. Similarly, according to a 2016 WHO report on the prevalence of ostomies worldwide, 42% are colostomies, 41% are ileostomies, and 16% are urostomies.

[0014] The growing geriatric population is a key factor in the growing ostomy care market. According to the WHO, the percentage of the population aged 65 years and above is expected to increase from 7% in 2000 to 16% in 2050. In addition, most ostomy patients are over the age of 50, and according to the American Medical Association, ostomy surgery is more common among the elderly. In addition, according to the NCBI, patients aged 70 years and above are more likely to undergo permanent ostomy surgery, have longer hospital stays, and have higher mortality rates.

[0015] According to a 2019 report by the Crohn's Colitis Foundation, approximately 1.6 million Americans currently suffer from inflammatory bowel disease (IBD), and 70,000 new cases of IBD are diagnosed in the United States each year. In addition, according to a 2016 report by the WHO, the global prevalence of colostomy, ileostomy, and urostomy is 43.0%, 41.0%, and 18.0%, respectively. According to NCBI data, IBD includes ulcerative colitis or Crohn's disease, and its incidence in European countries is gradually increasing. In Europe, approximately 731,000 people receive ostomy treatment, and people with IBD account for approximately 0.3% of the total population. In addition, according to the Colostomy Association Ltd. (doing business as Colostomy UK), in the UK, 1 in 500 people is an ostomy patient.

[0016] Currently, there are no self-contained devices for ostomies with liquid or semi-liquid waste, so ostomy patients may face physical, psychological and economic impacts, such as changes in body image, continuous loss of feces or urine, odor, sexual dysfunction, anxiety, depression and emotional problems related to stomas, which require psychological preparation and support, as well as the financial cost of purchasing stoma patches and collection bags. As mentioned above, the existing devices are collection bags, which cannot provide ostomy patients with control over their excretion. The main function of these bags is to collect fecal / urine materials that are constantly and unconsciously discharged.

[0017] When the colostomy is draining stool regularly (expected time), a stoma cover can be used instead of always carrying a bag. Plastic, off-the-shelf stoma covers are also available. However, for ileostomies and urostomies, where stool is more liquid, stoma covers do not provide an effective solution to avoid spillage, especially when a pouch needs to be attached.

[0018] Therefore, there is a need for an ostomy device that provides self-control over stool elimination, does not require replacement of the anti-reflux cap each time stool is removed (is reusable), increases the wearer's self-esteem, and is inexpensive and painless to insert. Summary of the invention

[0019] A first aspect of the present invention relates to a stoma plug adapted to control the output of biological fluids from the colon, ileum and / or ureter (50) through a stoma (45) formed by a colostomy, ileostomy or urostomy, respectively. The stoma plug comprises: a tube (10) comprising an opening (12) in a proximal portion and at least one opening (14) in a distal portion; a two-way valve system (20) comprising a base element (22) and a plug (24), the two-way valve system (20) being connected to the tube (10) via the base element (22), the two-way valve system (20) being configured to control the flow of fluid through the opening (12) in the proximal portion of the tube (10); and a cover (30) being configured to cover the two-way valve system (20) and the stoma (45), the cover (30) comprising an opening (32) directly accessible from the outside to the two-way valve system (20). The tube (10) is configured to be inserted through its distal portion into the colon, ileum and / or ureter (45). Preferably, the tube (10) is configured to be inserted into a stoma of the colon, ileum and / or ureter (45).

[0020] The two-way valve system (20) is selected from one of the following two alternatives:

[0021] i. The two-way valve system (20) further comprises an actuator (26), the base element (22) comprises at least one opening (21), wherein the two-way valve system (20) is configured to remain closed passively, such that when the actuator (26) is not actuated, the plug (24) is configured to cover the base element (22) and seal the at least one opening (21); and the two-way valve system (20) is also configured to be opened when the plug (24) is displaced from the at least one opening (21), such that the actuator (26) is configured to displace the plug (24) and unseal the at least one opening (21) of the two-way valve system (20) when actuated. The plug (24) is also configured to reseal the at least one opening (21) of the two-way valve system (20) when the actuator (26) is deactivated; or

[0022] ii. The two-way valve system (20) further comprises a spring (27) and a plug stopper (29) comprising at least one opening (21), the base element (22) being configured to be slidably received by the spring (27), wherein the two-way valve system (20) is configured to be passively held closed, such that the spring (27) is configured to cause the plug (24) to be pressed against the plug stopper (29) and close the at least one opening (21) of the two-way valve system (20); and the two-way valve system (20) is further configured to be opened when a force is applied and the spring (27) is longitudinally displaced from the plug stopper (29), thereby displacing the plug (24) from the at least one opening (21) and thereby opening the at least one opening (21) of the two-way valve system (20).

[0023] In a preferred embodiment, the two-way valve system (20) is selected from the first alternative i). In an alternative preferred embodiment, the two-way valve system (20) is selected from the second alternative ii).

[0024] In a preferred embodiment, wherein the two-way valve system (20) is a two-way valve system (20) according to the first alternative i), the base element (22) is configured to perforate the plug (24) when the plug (24) is displaced by the actuator (26). In a more preferred embodiment, the base element (22) has a spike shape, more preferably wherein the spike shape is substantially conical. In a more preferred embodiment, wherein the two-way valve system (20) is a two-way valve system (20) according to the second alternative ii), the plug (24) comprises two parts (24A, 24B). The two parts (24A, 24B) are configured to remain in contact when a spring (27) presses them against a plug stopper (29), and to separate when the spring (27) is longitudinally displaced, thereby creating a gap between the two parts (24A, 24B) and allowing at least one opening (21) of the two-way valve system (20) to be opened through the gap created between the two parts (24A, 24B).

[0025] In another preferred embodiment of any of the preceding embodiments, the tube (10) comprises a support element configured to receive a base element (22) of a two-way valve system (20), and wherein the two-way valve system (20) is included within the tube (10).

[0026] In a preferred embodiment of any of the aforementioned embodiments, the at least one opening (14) in the distal portion of the tube (10) is placed at least laterally on the tube (10).

[0027] In another preferred embodiment of any of the foregoing embodiments, at least one opening (14) in the distal portion of the tube (10) is smaller than 15 mm.

[0028] In another preferred embodiment of any of the aforementioned embodiments, wherein the tube (10) comprises a rounded end portion (15) in a distal portion thereof, the rounded end portion (15) being configured to facilitate insertion of the tube (10) through the stoma (45). In a more preferred embodiment, the rounded end portion 15 in the distal portion of the tube 10 has a rounded conical shape.

[0029] In another preferred embodiment of any of the aforementioned embodiments, the outer surface of the tube (10) further comprises at least one spiral portion configured to increase the contact surface of the tube (10) with the stoma (50).

[0030] In another preferred embodiment of any of the aforementioned embodiments, the tube (10) is composed of any material selected from the group consisting of medical grade silicone, surgical plastic thermoplastic elastomers, or any other biocompatible material including biocompatible polymers.

[0031] In another preferred embodiment of any of the foregoing embodiments, the tube (10) further comprises a lubricating layer on an outer surface thereof, the lubricating layer being configured to reduce friction with the stoma (45) during insertion thereof.

[0032] In another preferred embodiment of any of the foregoing embodiments, the two-way valve system (20) further comprises a thermosensitive hydrocolloid surface or an adaptable biocompatible material surface configured to adhere to or adapt to an external mucosa of the stoma (45). In a further preferred embodiment, the thermosensitive hydrocolloid or adaptable biocompatible material surface comprises a dressing configured to adhere to the skin (40) of the subject extending radially from the two-way valve system (20). In a further preferred embodiment, the dressing is transparent.

[0033] In another preferred embodiment of any of the aforementioned embodiments, the at least one opening (14) in the distal portion of the tube (10) is placed at least laterally on the tube (10).

[0034] A second aspect of the invention relates to a stoma plug system. The stoma plug system comprises a stoma plug according to any of the preceding claims, and a collecting bag or a vacuum device. The collecting bag or the vacuum device is configured to be connected to a two-way valve system (20) and to open at least one opening (21) by displacing a plug (24) from the at least one opening (21). In a preferred embodiment, the collecting bag or the vacuum device opens at least one opening (21) by its connection to the two-way valve system (20). In another preferred embodiment, the vacuum device is a syringe. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to better understand the present disclosure and to illustrate how to implement the present disclosure, reference is now made to the attached schematic diagrams by way of example only, in which:

[0036] Figure 1 An exploded view of an ostomy plug according to at least one embodiment of the present invention is shown.

[0037] Figure 2 A perspective view of an ostomy plug according to at least one embodiment of the present invention is shown.

[0038] Figure 3 A schematic cross-sectional view of a stoma plug according to at least one embodiment of the present invention is shown.

[0039] Figure 4A schematic cross-sectional view of an actuated stomal plug according to at least one embodiment of the present invention is shown.

[0040] Figure 5 Another schematic cross-sectional view of a stoma plug according to at least one embodiment of the present invention is shown. DETAILED DESCRIPTION

[0041] definition

[0042] The term "two-way valve system" is preferably understood as a valve system that can allow fluid to flow in two directions. The fluid flow direction will be determined by the pressure at each side of the valve, so that the fluid will flow from the side with higher fluid pressure to the side with lower fluid pressure.

[0043] The term "vacuum device" is preferably understood as any device capable of generating negative pressure. Thus, it may be a vacuum connection from a hospital, a portable fluid vacuum device or a simpler device such as a syringe.

[0044] describe

[0045] A first aspect of the present invention relates to a stoma plug adapted to control the output of biological fluids from the colon, ileum and / or ureters (50) through a stoma (45) formed by a colostomy, ileostomy or urostomy. Figure 1 As shown, the stoma plug 100 comprises: a tube 10, which includes an opening 12 in the proximal portion and at least one opening 14 in the distal portion. Figure 1 In the embodiment, the tube 10 includes two openings 14 in the distal portion, but in other embodiments, the tube may include only one opening 14 or more than two openings 14 in the distal portion. The stoma plug 100 also includes a two-way valve system 20, which includes 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 through its proximal portion. It should be noted that in Figure 1 In the embodiment, the two-way valve system 20 includes other optional elements 22 and 26, but in other embodiments, the plug may only include at least one opening 21 and a plug 24 configured to close the at least one opening 21. Finally, the stoma plug 100 includes a cover 30 configured to cover the two-way valve system 20 and the stoma 45. The cover 30 includes an opening 32, which directly enters the covered two-way valve system 20 from the outside.

[0046] The tube 10 is configured to be inserted into the colon, ileum and / or ureter 50 through its distal end portion, and the two-way valve system 20 is configured to be passively maintained closed and to open when the plug 24 is displaced from the at least one opening 21 .

[0047] The tube having an opening 12 in the proximal portion and at least one opening 14 in the distal portion advantageously allows it to fluidly connect the biological fluid of the colon, ileum and / or ureter 50 with the two-way valve system 20 through the at least one opening 14 in the distal portion. In use, the tube 10 is inserted into the colon, ileum and / or ureter 50 through its distal portion, and according to a preferred embodiment of the present invention, the two-way valve system 20 is connected to the tube 10 through the proximal portion of the tube 10. Therefore, the biological fluid present in the colon, ileum and / or ureter 50 can pass through the opening 14 of the tube 10 and reach the opening 12 connected to the two-way valve system 20. Therefore, the two-way valve system 20 is configured to control the flow of the biological fluid through the stoma 45. Preferably, the two-way valve system 20 is configured to control the flow of the fluid through the opening 12 of the proximal portion of the tube 10.

[0048] The two-way valve system 20 can be connected to the tube 10 in different ways. Preferably, the two-way valve system 20 is connected to the tube via a base element 22. The base element 22 can be screwed to the tube 10, or glued to the tube 10. Alternatively, the base element 22 can be snapped into the tube 10. A person skilled in the art can foresee many other alternatives in which the base element and the tube 10 can be connected to each other.

[0049] It should be noted that the two-way valve system 20 and the tube 10 can 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 through 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 in the tube 10. In this preferred embodiment, the two-way valve system 20 can be included in the distal portion of the tube 10, in the proximal portion of the tube 10, or anywhere between the proximal and distal portions of the tube 10. It should also be noted that in this preferred embodiment, the two-way valve system 20 can extend along the tube 10 toward the proximal portion of the tube 10, and can further extend out of the tube 10 through the opening 12 in the proximal portion of the tube 10.

[0050] The two-way valve system 20 advantageously allows it to provide a way to control the flow of fluids in two directions, namely the flow of biological fluids from the colon, ileum and / or ureters 50 through the tube 10 towards the outside, and the flow of any fluid from the outside through the tube 10 to the colon, ileum and / or ureters 50. Thus, it allows the control of the passage of any fluid at the level of the stoma. It should be noted that at Figure 1 In the embodiment, the two-way valve system 20 further includes the element 22 and the element 26, but in other embodiments, other elements may be used to achieve the same advantages.

[0051] It should be noted that a person skilled in the art can devise several ways of making the two-way valve system 20. Although the present invention mainly describes two alternative ways of such a two-way valve system 20, it is not limited to any particular type of two-way valve system 20, which includes at least one opening 21 and a plug 24, and which is configured to passively close the plug and open when the plug 24 is displaced from the at least one opening 21. In addition, a person skilled in the art can envision a more complex system that includes more than one plug 24 and is not configured to be passively closed but actively closed (manually or mechanically).

[0052] The cover 30 advantageously covers the two-way valve system 20, the stoma external mucosa 45 and the surrounding skin so that external elements such as clothing do not interact with the two-way valve system 20 (such interaction may cause the valve to open undesirably) nor with the stoma external mucosa 45 (such interaction may cause a source of pain). The cover 30 includes an opening 32 into the two-way valve system 20 so that fluid can be withdrawn and the valve can be optionally operated, i.e., opened when desired. It should be noted that although in Figure 1 The central opening 32 is located at the center of the cover surface, but the opening 32 can be located at any part of the cover surface 30. The cover can have different shapes to provide a thinner and less noticeable device. The cover can also have different materials, such as elastic and / or flexible materials that can adapt to the user's skin surface 40 and / or the external mucosa 45 of the stoma.

[0053] It should be noted that when the two-way valve system 20 is included in the tube 10, the opening 32 of the cover 30 still provides access to the two-way valve system 20. This is achieved through the opening 12 of the proximal portion of the tube 10 and the tube itself. Therefore, the two-way valve system 20 can still be actuated from the outside to open it and thus allow fluid to flow through the opening 12 of the proximal portion of the tube 10.

[0054] It should also be noted that Figure 1 The shapes and designs of the tube 10, the two-way valve system 20 and the cover 30 are for illustration purposes only. Thus, the tube 10 may have a cross-section different from that of a circular tube, or may be longer or shorter. The two-way valve system 20 may be more compact or less compact, and have different functional modes. In addition, the cover 30 may take different shapes other than cylindrical to cover the two-way valve system 20 and the stoma 45. Similarly, the different openings 12, 14, 21, 32 may take different shapes, and the circular and elliptical shapes in the accompanying drawings are for illustration purposes. Therefore, those skilled in the art will note that different opening shapes and patterns may be used. For example, the openings may be oval or elliptical, or when there are multiple openings of one type, they may be arranged in different configurations to maximize flow capacity and / or reduce fluid turbulence when the fluid flows through them.

[0055] Figure 1 An optional rounded end 15 is included at the distal end portion of the tube 10, which may not be present in other embodiments. Furthermore, the shape of such an end may have different shapes.

[0056] The two-way valve system 20 is configured to remain closed passively. Advantageously, this allows the stoma plug to be configured to prevent biological fluid from flowing when in use. Therefore, the stoma plug according to any embodiment of the first aspect of the present invention provides an ostomy device that can provide self-control for fecal excretion, because only when the plug 24 is removed from the opening 21, biological fluid (such as feces) can flow outward from the colon, ileum and / or ureter 50 through the stoma 45. In addition, since the two-way valve system 20 can be closed again once opened, it is not necessary to replace the anti-reflux cover each time the feces is removed, thereby making it reusable. In short, the self-esteem of the carrier is enhanced under low-cost conditions. In addition, since the tube 10 is configured to be inserted into the stoma, it provides all these advantages, and the insertion device is painless.

[0057] Figure 2 A perspective view of an ostomy plug according to at least one embodiment of the present invention is shown. It comprises a tube 10, a two-way valve system 20 (not shown) and a cover 30. It can be seen that the cover (30) covers the two-way valve system (20) and that the opening 32 of the cover 30 allows direct access to the two-way valve system 20 from the outside. It should be noted that the tube 10 comprises more than one opening 14 in the distal portion, but these are optional and in other embodiments the tube 10 may comprise only one or a different number of openings 14 in the distal portion of the tube 10. In addition, Figure 2 The ostomy plug also includes an optional rounded end 15 in the distal portion of the cap 10 , and other embodiments may not include such a rounded end 15 .

[0058] In a preferred embodiment, Figure 1 As shown, the two-way valve system 20 further includes: a base element 22 including 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. In addition, the actuator 26 is configured to displace the plug 24 and unseal the at least one opening 21 of the two-way valve system 20 when actuated. The actuator 26 can be actuated in different ways. For example, Figure 1As shown, the actuator 26 can displace the plug 24 longitudinally toward the base element 22 and allow at least one opening 21 to be unsealed. However, it will be appreciated by those skilled in the art that the actuator can displace the plug 24 from the opening 21 in many ways. For example, the plug 24 can be composed of multiple components, and the multiple components are configured so that when the plug is displaced longitudinally, these multiple components are displaced laterally, so that the plug is displaced from the opening 21. Alternatively, the plug 24 can be simply formed so that when it is displaced longitudinally, the opening 21 is no longer covered by the seal 24. For example, this can be achieved by a specific design of the plug 24, or by a rotating device, which is 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, which can be perforated by the base element 22 to unseal the opening 21, as shown in reference Figure 1 shown.

[0059] Furthermore, in the preferred embodiment, the plug 24 is also configured to reseal the at least one opening 21 of the two-way valve system 20 when the actuator 26 is deactivated. Thus, after the actuator 26 has completed actuation, the at least one opening 21 is resealed by the plug 24. Figure 1 In the embodiment, when the actuator 26 is stopped from actuating, the plug 24 is formed into a spring-like pattern, and when the plug 24 is made of an elastic material, the plug 24 recovers its original position after being compressed during the displacement of the actuator 26, thereby resealing at least one opening 21 of the two-way valve system 20. Advantageously, this configures the two-way valve 20 to passively remain closed whenever the actuator 26 is not actuated. This means that the stoma plug is configured to be closed and sealed whenever the valve is not actuated, so it further prevents the flow of biological fluids during use (i.e., in the daily life of the user) and provides self-control for fecal control. In addition, since the two-way valve system 20 can be closed again once opened, it is not necessary to replace the anti-reflux cover each time the feces is removed, so that the reflux cover can be reused. The plug 24 can include elastic and / or flexible materials, and once the external force stops being applied to the plug 24, the plug 24 can recover its original shape. Therefore, the plug 24 can be used as a spring element.

[0060] More preferably, the base element 22 is configured to perforate the plug 24 when the plug 24 is displaced by the actuator 26 . Figure 3 1 shows a schematic cross-sectional view of an ostomy plug 100 according to at least one embodiment of the present invention. It should be noted that Figure 3The stoma plug 100 comprises a tube 10, a two-way valve system 20 and a cap 30. However, the stoma plug 100 also comprises optional elements: a number of openings 14 in the distal portion of the tube 10, a rounded end 15 in the distal portion of the tube 10, including 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 end 15 in the distal portion of the tube 10, and there may be one or more than two openings 21. It should be noted that the base element 22 can perforate the plug in several ways. A person skilled in the art can design different ways in which the base element 22 is configured to perforate the plug 24 when the plug 24 is displaced by the actuator 26. For example, the base element 22 may include a perforating element, which is actuated by the actuator 26 when the actuator is actuated, so that when the plug 24 is displaced toward the base element 22, the perforating element is also actuated and perforates the plug 24.

[0061] It can be seen that in Figure 3 In the embodiment of the present invention, 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 toward the base element 22 to unseal the at least one opening 21. However, it can be noted that when the plug 24 is displaced by the actuator 26, the element is not allowed to unseal unless the base element 22 perforates the plug 24, thereby creating a pore through which the fluid can flow.

[0062] Advantageously, this configures the plug 24 to be pre-sealed before the first use, thus providing an additional safety measure to prevent leakage of biological fluid from the stoma to the outside during use until the first aperture of the two-way valve system is created by actuation of the actuator. Once the plug 24 is perforated by the base element 22 and after the actuator 26 is stopped from being actuated, the plug 24 reseals the opening 21, but the plug 24 remains perforated. It should be noted that the sealing of the opening 21 is not compromised by the perforation of the plug 24.

[0063] In an even more preferred embodiment, the base element 22 has a spike shape, more preferably, wherein the spike shape is substantially conical. Advantageously, this configures the base element 22 to enable the plug 24 to pierce the hole when the plug 24 is displaced toward the base element 22 by the actuator 26. Thus, displacement of the plug 24 by the actuator 26 causes the base element 22 to pierce the plug 24.

[0064] Figure 4 Schematic cross-sectional view of an actuated stoma plug 100 inserted into a stoma 50 according to at least one embodiment of the present invention is shown. It should be noted that Figure 4The stoma plug 100 includes a tube 10, a two-way valve system 20 and a cover 30. However, the stoma plug 100 also includes optional elements: a plurality of openings 14 in the distal portion of the tube 10, a rounded end 15 in the distal portion of the tube 10, including 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 end 15 in the distal portion of the tube 10, and there may be one or more than two openings 21. In addition, it should be noted that the stoma plug 100 is inserted into the stoma 40, and the cover 30 is configured to cover the two-way valve system 20 and the stoma external mucosa 45, and is adapted to the skin surface 40. It should be noted that the cover 30 can take several shapes to adapt to the skin surface 40.

[0065] Figure 4 The stoma plug 100 is actuated (as shown by arrow 260) through the opening 32 of the cover 30, so that the actuator 26 displaces the plug 24 and unseals at least one opening 21 of the base element 22. In addition, the base element 22 has a conical spike shape, which has perforated the plug 24. In this configuration, the two-way valve system 20 has the plug 24 displaced from at least one opening 21, thereby fluidly connecting the biological fluid (e.g., feces) of the colon, ileum and / or ureter 50 through the opening 14 of the distal portion of the tube 10, which in turn provides a passage to the opening 21 of the base element 22 through the opening 12 of the proximal portion of the tube 10. In addition, when the actuator 26 has been actuated (as shown by arrow 260), the plug 24 has unsealed the opening 21, and the biological fluid of the colon, ileum and / or ureter 50 can reach the outside through the opening 32 of the cover 30. Thus, when the actuator 26 is actuated, the biological fluid of the stoma 50 is fluidly connected to the outside of the body.

[0066] It should be noted that when the actuator 26 is actuated, the two-way valve system 20 allows external fluid to be injected into the colon, ileum and / or ureter 50 through the stoma 45 because the two-way valve system 20 is fluidly connected to the interior of the colon, ileum and / or ureter 50. For example, a mixture of lactulose and water or lactulose and cola drink can be introduced into the colon, ileum and / or ureter 50 through the stoma 45 to combat or prevent intestinal obstruction.

[0067] Alternatively, in another preferred embodiment, Figure 5 As shown, the two-way valve system further includes: a spring 27, a base element 22 configured to be slidably received by the spring 27, and a plug stopper 29 including at least one opening 21 of the two-way valve system 20. It should be noted that Figure 5The stoma plug 200 comprises a tube 10, a two-way valve system 20 and a cap 30. However, the stoma plug 200 also comprises optional elements: a plurality of openings 14 in the distal portion of the tube 10, a rounded end 15 in the distal portion of the tube 10, and a two-part 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, there may be no rounded end 15 in the distal portion of the tube 10, and the plug 24 may not include more than one part or include several parts. In some embodiments, as Figure 5 As shown, the base element 22 is a fixed element of the two-way valve system, so that when the spring is compressed, the base element 22 does not move. 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, and the two-way valve system 20 is connected to the proximal portion of the tube 10 through the base element 22.

[0068] The spring 27 is configured to press the plug 24 against the plug stop 29 and close the at least one opening 21 of the two-way valve system 20. It should be noted that a person skilled in the art can envision several ways in which the spring 27 can press the plug 24 against the plug stop 29 to close the at least one opening 21 of the two-way valve system 20. For example, the spring 27 can be a compression spring and at least partially compressed so that it applies a tensile force. If the plug 24 is located on one side of the spring 27 and the base element 22 is located on the other side of the spring 27 as a support, the spring 27 presses the plug 24 against the plug stop 29 and closes the at least one opening 21 of the two-way valve system 20 when the plug 24 is oriented toward the plug stop. Alternatively, the spring 27 can be a tension spring and at least partially stretched so that it applies a compressive force. If the plug 24 is attached to one side of the spring 27 and the base element 22 is located as a support on the other side of the spring 27, when the plug stop 29 is located between the spring 27 and the base element 22, the spring 27 causes the plug 24 to press against the plug stop 29 and close the at least one opening 21 of the two-way valve system 20. A person skilled in the art can design an equivalent system using one or more torsion springs, traction springs, spiral springs and any other type of spring known in the art. Figure 5 In the embodiment, the spring 27 is a compression spring, which presses the plug 24 against the plug stop 29, thereby closing the at least one opening 21.

[0069] Furthermore, the spring 27 is also configured to be longitudinally displaced from the plug stop 29 when a force is applied, thereby displacing the plug 24 from the at least one opening 21 and thus opening the at least one opening 21 of the two-way valve system 20. It should be noted that a person skilled in the art can envision several ways in which the spring 27 can be displaced from the plug stop 29 when a force is applied. Several options can be defined based on the spring types defined above. For example, in Figure 5 In the embodiment of the present invention, the compression spring 27 can be compressed and, when the base element 22 is fixed, the plug 24 is thereby displaced from the at least one opening 21 of the two-way valve system 20 , resulting in the opening of the at least one opening 21 .

[0070] Advantageously, the two-way valve system 20 with spring actuation allows a reliable opening and closing mechanism which works in positive feedback to strengthen the sealing of the at least one opening 21 of the two-way valve system 20. Figure 5 In the illustrated embodiment, if the pressure of the biological fluid in the stoma increases, the pressure further presses the plug 24 against the plug stopper 29 and further closes the at least one opening 21 of the two-way valve system 20. In this way, the stoma plug is configured to further prevent the involuntary flow of biological fluid when in use.

[0071] In a further preferred embodiment, Figure 5 As shown, the plug 24 includes two parts 24A, 24B. The two parts 24A, 24B are configured so that they remain in contact when the spring 27 presses them against the plug stopper 29, and they separate when the spring 27 is longitudinally displaced, thereby creating a gap between the two parts 24A, 24B and allowing at least one opening 21 of the two-way valve system 20 to be opened through the gap created between the two parts 24A, 24B.

[0072] The two parts 24A, 24B can be two identical parts, or can be parts with different shapes. In general, when the two parts 24A, 24B are in contact, they completely close at least one opening 21 of the two-way valve system 20. A person skilled in the art will note that this can be done 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 ring left by the ring portion of the first part 24A. Figure 5 In the example of the embodiment, the two parts 24A, 24B are parts that each cover half of the perimeter left by at least one opening 21. Therefore, the two parts 24A, 24B have the same shape. However, in other embodiments, these can have different shapes. It should be noted that in embodiments where there is more than one opening 21, each of the two parts 24A, 24B can close one or more than one opening 21.

[0073] The two parts 24A, 24B can be configured to separate when the spring 27 is longitudinally displaced in several ways. For example, each of the two parts 24A, 24B can have a lever or a ramp that interacts with the spring 27 or any surrounding element (e.g., the base element 22) so that the two parts 24A, 24B move outward in opposite directions, thereby creating a gap between the two parts 24A, 24B. Through the gap, at least one opening 21 of the two-way valve system 20 can be opened from the inside, that is, the plug 24 no longer closes the at least one opening 21. Therefore, since the at least one opening 21 is fluidly connected to the biological fluid in the distal part of the tube 10 through the opening 12 of the proximal part of the tube 10 and the at least one opening 14 of the distal part of the tube 10, the biological fluid at the distal part of the tube 10 is in fluid communication with the external fluid.

[0074] In use, according to Figure 5 The two-way valve system 20 of the embodiment is configured to open when the spring 27 is longitudinally displaced toward the base element 22, i.e., by compressing the spring. This allows the two components 24A, 24B to separate, since each component has a ramp-shaped base that interacts with the base element 22 and displaces them outward, thereby allowing biological fluids from the colon, ileum and / or ureter 50 to be fluidly connected to at least one opening 21 of the two-way valve system 20 through the pores created between the two components 24A, 24B.

[0075] Advantageously, the at least one opening 21 of the two-way valve system 20 can be opened by the aperture created between the two parts 24A, 24B, allowing for better flow through the at least one opening 21 because the aperture created between the two parts 24A, 24B is aligned with the at least one opening 21. With these alignments, the turbidity of the fluid flow is reduced, which can reduce the likelihood of any smaller solids present in the fluid clogging the two-way valve system.

[0076] It should be noted that in this alternative preferred embodiment, the spring 27 is configured to be longitudinally displaced from the plug stop 29 when a force is applied. However, the force may be applied by the user at will or through the opening 32 of the cover 30 using any external element.

[0077] In a preferred embodiment of any of the aforementioned embodiments, the tube 10 comprises a support element configured to receive a base element 22 of a two-way valve system 20. Furthermore, the two-way valve system 20 is included in the tube 10. It should be noted that the two-way valve system 20 may be completely or only partially included in the tube 10, as long as the two-way valve system 20 is directly accessible through the opening 32 of the cover 30.

[0078] Advantageously, this preferred embodiment allows a more compact design of the ostomy plug, as the two-way valve system 20 may be at least partially housed by the tube 10 and the cap 30 may therefore be reduced, allowing a more slender design of the cap 30, further increasing the wearer's self-esteem.

[0079] In a preferred embodiment of any of the aforementioned embodiments, the plug 24 includes a spring-like portion configured to help the plug reseal at least one opening 21 of the two-way valve system 20 when the actuator 26 stops actuating. The spring-like portion may include a metal material. In those embodiments in which the base element 22 is configured to perforate the plug 24 when the plug 24 is displaced by the actuator 26, in order to facilitate the plug 24 to include both the surface to be perforated and the spring-like portion, the surface to be perforated may be located in the proximal portion of the plug, and the spring-like portion may be located in the distal portion of the plug 24. The surface to be perforated and the spring-like portion may be connected by a frame.

[0080] In a preferred embodiment of any of the foregoing embodiments, at least one opening 14 in the distal portion of the tube 10 is at least laterally disposed on the tube (10). Figures 1 to 5 As shown, some of the openings 14 in the distal portion of the tube 10 are placed laterally. However, in other embodiments, the openings 14 may be located on the end, but partly placed laterally, or when the stoma plug includes only one opening 14 in the distal portion of the tube 10, the opening may be placed only laterally or at least laterally on the tube 10, so that part of the opening is at the end and partly on the side of the tube 10. Advantageously, whenever a large piece of feces is located at the end of the tube 10, this allows biological fluids in the colon, ileum and / or ureter 50 to keep flowing into the tube 10 through at least one opening 14. When feces exert pressure at the colon, ileum and / or ureter 50, due to peristaltic motion therein, at least one opening 14 at the end of the distal portion of the tube 10 may be blocked, but at least a part of the at least one opening 14 located laterally keeps the feces unobstructed. At the same time, the biological fluid can keep reaching at least one lateral opening 14 located at least laterally on the tube 10.

[0081] In another preferred embodiment of any of the foregoing embodiments, at least one opening 14 in the distal portion of the tube 10 is smaller than 15 mm. The stoma plug of the present invention is preferably designed for controlling fluids, such as fluids of ileostomies and urostomies 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 elements reaching the two-way valve system 20. Advantageously, at least one opening 14 in the distal portion of the tube 10 is smaller than 15 mm, so that the stoma plug is configured to prevent the extraction of any elements larger than 15 mm (such as feces) when the two-way valve system 20 is open, which may block the two-way valve system 20. It should be noted that in Figures 1 to 5In the embodiment, at least one opening 14 is circular, but in other embodiments, this one opening may have different shapes that can be foreseen by those skilled in the art, such as oval, square or any other shape. Figures 1 to 5 In some embodiments, the size of at least one opening 14 is determined by the diameter of the opening, while 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.

[0082] In another preferred embodiment of any of the foregoing embodiments, the tube 10 includes a rounded end 15 in its distal portion, which is configured to facilitate 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 the rounded end 15 further facilitates insertion of the tube through the stoma 45, so that the inner mucosa of the colon, ileum and / or ureter 50 can slide when the tube 10 is introduced into the colon, ileum and / or ureter 50 through the stoma 45. Therefore, this feature also allows painless insertion of the stoma plug.

[0083] In a more preferred embodiment of the aforementioned embodiment, the rounded end 15 in the distal portion of the tube 10 has a rounded conical shape. Advantageously, the rounded conical end 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 internal mucosa of the colon, ileum and / or ureter 50. The term "rounded cone" is preferably understood to be a cone whose ends have been rounded. It should be noted that in the context of the present invention, an end having a rounded conical shape is an end in which the end of the cone is at the distal end of the end. A person skilled in the art can conceive of many different alternatives for an end having a shape similar to a rounded cone with different widths and radii of the tapered end, all of which are included in this particular embodiment.

[0084] In another preferred embodiment of any of the foregoing embodiments, the outer surface of the tube 10 further includes at least one spiral portion, which is configured to increase the contact surface of the tube 10 with the colon, ileum and / or ureter 50. Having at least one spiral portion on the outer surface of the tube creates a rougher surface to which the mucosa of the colon, ileum and / or ureter 50 can be attached. Advantageously, this provides a better clamping between the inner mucosa of the colon, ileum and / or ureter 50 and the tube 10, providing a more secure connection of the stoma plug to the colon, ileum and / or ureter 50. It should be noted that many spiral configurations can be envisioned. For example, the spiral portion can extend radially outward from the outer surface of the tube 10, or the spiral portion can extend radially inward to the outer surface of the tube 10. In some embodiments, the spiral portion can have different rotation angles on each length of the tube 10, and can rotate in one or another direction (i.e., clockwise or counterclockwise). It can also rotate in one direction in one part of the tube 10 and in another direction in another part of the tube 10.

[0085] In another preferred embodiment of any of the foregoing embodiments, the tube 10 is composed of any material selected from the group consisting of medical grade silicone, surgical plastics, thermoplastic elastomers, or any other biocompatible material including biocompatible polymers. Advantageously, the tube 10 inserted into the colon, ileum, and / or ureter 50 through the stoma 45 is configured to be biocompatible and at least partially flexible so that it can adapt to the shape of the colon, ileum, and / or ureter 50. This means that in use, the tube 10 can bend when the colon, ileum, and / or ureter 50 bends, thereby reducing pain and increasing the self-esteem of the user.

[0086] In another preferred embodiment of any of the foregoing embodiments, the tube 10 further comprises a lubricating layer on its outer surface, the lubricating layer being configured to reduce friction during insertion of the tube 10 through the stoma 45. The layer may comprise any friction-resistant substance, such as an oily substance or a water-based lubricant, and may also comprise an anesthetic component, such as tetracaine or lidocaine. Advantageously, this configures the tube 10 to be inserted through the stoma 45 without friction, thus increasing the ease of use and reducing the pain felt by the user.

[0087] In another preferred embodiment of any of the foregoing embodiments, the two-way valve system further comprises a thermosensitive hydrocolloid surface configured to adhere to or conform to the stoma. Since the pressure of the biological fluid of the colon, ileum and / or ureter 50 within the stoma may be higher than atmospheric pressure, it is desirable to securely attach the stoma plug 100 to the stoma 45. As for example, Figure 4As shown, the two-way valve system 20 interacts with the stoma 45 to secure the stoma plug 100 into the colon, ileum and / or ureter 50. Thus, the hydrocolloid surface having absorbency, self-adhesion and water-repellency allows the stoma plug 100 to be firmly bonded to the stoma. In addition, the thermosensitive surface can only be adhered to, for example, a heated surface of the stoma, making the stoma plug 100 easy to manipulate before being inserted into the colon, ileum and / or ureter 50. Advantageously, the two-way valve system 20 also includes a thermosensitive hydrocolloid surface configured to adhere to the external mucosa of the stoma 45, so that the stoma plug 100, 200 is configured to remain in place when the internal pressure in the colon, ileum and / or ureter 50 increases above atmospheric pressure.

[0088] In a more preferred embodiment, the thermosensitive hydrocolloid surface comprises a dressing configured to adhere to the subject's skin 40 and to extend radially from the two-way valve system 20. Advantageously, the adhesion of the stoma plug 100, 200 is further increased by adhering to the user's skin. It should be noted that the dressing can extend radially at different lengths in each direction, and the shape can be adapted to the location of the stoma 45 and / or the size of the stoma 45. In an even more preferred embodiment, the dressing is transparent, providing a less noticeable design and further increasing the self-esteem of the subject.

[0089] In another preferred embodiment of any of the foregoing embodiments, the two-way valve system 20 further comprises an adaptable biocompatible material configured to adhere to or adapt to the stoma 45. The adaptable biocompatible material is configured to adapt to the stoma external mucosa and surrounding skin surface so that a tighter bond between the stoma plug and the stoma is achieved.

[0090] In another preferred embodiment, the stoma plug 100, 200 further includes a pressure sensor to monitor the pressure in the colon, ileum and / or ureter 50. Then, when the pressure sensor detects that a certain pressure threshold is reached, the two-way valve system 20 can be opened automatically, or a feedback element can be used to indicate to the user that the two-way valve system 20 should be opened to discharge the biological fluid in the colon, ileum and / or ureter 50.

[0091] A second aspect of the present invention relates to a stoma plug system, comprising a stoma plug 100, 200 of any one of the stoma plugs according to the first aspect of the present invention and a collecting bag or a vacuum device. The collecting bag or the vacuum device is configured to be connected to a two-way valve system 20 and to open at least one opening 21 by displacing a plug 24 from at least one opening 21. Preferably, the collecting bag or the vacuum device is configured to be connected to the two-way valve system 20 through an opening 32 of a cover 30.

[0092] Thus, when the collecting bag or vacuum device is connected to the two-way valve system 20, the stoma plug is opened and biological fluids from the colon, ileum and / or ureter 50 can reach the outside through the stoma plug. Thus, both the collecting bag and the vacuum device are configured to handle biological fluids that may come out of the stoma plug. The collecting bag can be any type of collecting bag known in the stoma device industry. Thus, the collecting bag can be a small bag that is open at the bottom so that the collected contents can be disposed of through the opening on the bottom, or the collecting bag can be a small bag that is closed at the bottom so that the collecting bag can be replaced when the contents need to be disposed of. Thus, the vacuum device either includes a collection container for storing biological fluids or is connected to a container that can store biological fluids.

[0093] It should be noted that while the collecting bag collects biological fluids from the colon, ileum and / or ureters 50 that passively leave the stoma plug, the vacuum device actively extracts biological fluids from the colon, ileum and / or ureters 50 by using a negative pressure compared to the internal pressure of the colon, ileum and / or ureters 50.

[0094] The collecting bag or vacuum device opens the at least one opening 21 by displacing the plug 24 from the at least one opening 21 in several ways. For example, when the collecting bag or vacuum device is connected to the two-way valve system 20, the collecting bag or vacuum device may open the at least one opening 21 by displacing the plug 24 directly from the at least one opening 21, or the collecting bag or vacuum device may do this by actuating the actuator 26 at the moment it is connected to the two-way valve system 20. Alternatively, the collecting bag or vacuum device may include a second mechanism on the connecting element connected to the at least one opening 21 of the two-way valve system 20, which second mechanism may be actuated manually or electrically to open the two-way valve system 20.

[0095] In this embodiment, where the ostomy plug 100, 200 includes a pressure sensor to monitor the pressure within the colon, ileum and / or ureter 50, the sensor can send a signal to the user indicating when it is the appropriate time to drain the biological fluid from the colon, ileum and / or ureter 50 by using a collection bag or a vacuum device.

[0096] Advantageously, a stoma plug system comprising any one of the stoma plugs 100, 200 according to the first aspect of the invention and a collecting bag or a vacuum device allows a user to passively drain biological fluids from the colon, ileum and / or ureter 50 by using a collecting bag; or to manually and actively drain biological fluids from the colon, ileum and / or ureter 50 by using a vacuum provided by a vacuum device.

[0097] In a preferred embodiment, the vacuum device is a syringe. Advantageously, the user can use the syringe to extract biological fluids of the colon, ileum and / or ureter 50 through the stoma plug in a short period of time. Thus, the user can easily release biological fluids of the colon, ileum and / or ureter 50 through the stoma 45 in a quick and clean manner. The syringe can then be emptied in a toilet. The syringe can be reusable or disposable.

Claims

1. A stoma plug adapted to control the output of biological fluids from the colon, ileum and / or ureter (50) through a stoma (45) formed by a colostomy, ileostomy or urostomy, respectively, the stoma plug comprising: a) a tube (10) comprising an opening (12) in a proximal portion and at least one opening (14) in a distal portion, b) a two-way valve system (20) comprising a base element (22) and a plug (24), the two-way valve system (20) being connected to the tube (10) via the base element (22), the two-way valve system (20) being configured to control the flow of a fluid through the opening (12) of the proximal portion of the tube (10), and c) a cover (30) configured to cover the two-way valve system (20) and the stoma (45), comprising an opening (32) for direct access to the two-way valve system (20) from the outside, wherein the tube (10) is configured to be inserted into the colon, ileum and / or ureter (50) via its distal end portion, and The two-way valve system (20) is selected from one of the following two alternatives: i. the two-way valve system (20) further comprising an actuator (26), the base element (22) comprising at least one opening (21), wherein the two-way valve system (20) is configured to remain closed passively, such that when the actuator (26) is not actuated, the plug (24) is configured to cover the base element (22) and seal the at least one opening (21); and the two-way valve system (20) is further configured to be opened when the plug (24) is displaced from the at least one opening (21), such that the actuator (26) is configured to displace the plug (24) and unseal the at least one opening (21) of the two-way valve system (20) when actuated, and wherein 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) is deactivated; or ii. The two-way valve system (20) further comprises a spring (27) and a plug stopper (29) comprising at least one opening (21), the base element (22) being configured to be slidably received by the spring (27), wherein the two-way valve system (20) is configured to be passively held closed, such that the spring (27) is configured to cause the plug (24) to be pressed against the plug stopper (29) and close the at least one opening (21) of the two-way valve system (20); and the two-way valve system (20) is further configured to be opened when a force is applied and the spring (27) is longitudinally displaced from the plug stopper (29), thereby displacing the plug (24) from the at least one opening (21) and thereby opening the at least one opening (21) of the two-way valve system (20).

2. A stoma plug according to claim 1, wherein the two-way valve system (20) further comprises an actuator (26), the base element (22) comprises at least one opening (21), wherein the two-way valve system (20) is configured to remain closed passively, so that when the actuator (26) is not actuated, the plug (24) is configured to cover the base element (22) and seal the at least one opening (21); and the two-way valve system (20) is also configured to be opened when the plug (24) is displaced from the at least one opening (21), so that the actuator (26) is configured to displace the plug (24) and unseal the at least one opening (21) of the two-way valve system (20) when actuated, and wherein the plug (24) is also configured to reseal the at least one opening (21) of the two-way valve system (20) when the actuator (26) is stopped from being actuated.

3. A stoma plug according to claim 1, wherein the two-way valve system (20) further comprises a spring (27) and a plug stopper (29) comprising at least one opening (21), the base element (22) being configured to be slidably received by the spring (27), wherein the two-way valve system (20) is configured to be passively kept closed, so that the spring (27) is configured to cause the plug (24) to be pressed against the plug stopper (29) and close the at least one opening (21) of the two-way valve system (20); and the two-way valve system (20) is also configured to be opened when force is applied and the spring (27) is longitudinally displaced from the plug stopper (29), thereby displacing the plug (24) from the at least one opening (21) and thereby opening the at least one opening (21) of the two-way valve system (20).

4. An ostomy plug according to claim 2, wherein the base element (22) is configured to perforate the plug (24) when the plug (24) is displaced by the actuator (26).

5. The ostomy plug according to claim 2 or 4, wherein the base element (22) has a spike shape, more preferably, wherein the spike shape is substantially conical.

6. An ostomy plug according to claim 3, wherein the plug (24) comprises two parts (24A, 24B), and wherein 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 them when the spring (27) is longitudinally displaced, thereby creating a pore between the two parts (24A, 24B) and allowing the at least one opening (21) of the two-way valve system (20) to be opened through the pore created between the two parts (24A, 24B).

7. A stoma plug according to any one of the preceding claims, wherein the tube (10) comprises a support element, the support element being configured to receive the base element (22) of the two-way valve system (20), and wherein the two-way valve system (20) is included in the tube (10).

8. An ostomy plug according to any one of the preceding claims, wherein the at least one opening (14) in the distal portion of the tube (10) is smaller than 15 mm.

9. A stoma plug according to any one of the preceding claims, wherein the tube (10) comprises a rounded end (15) in its distal portion, the rounded end (15) being configured to facilitate insertion of the tube (10) through the stoma (45).

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

11. A stoma plug according to any one of the preceding claims, wherein the outer surface of the tube (10) further comprises at least one spiral portion, the spiral portion being configured to increase the contact surface of the tube (10) with the inner surface of the colon, ileum and / or ureter (50).

12. The ostomy plug according to any one of the preceding claims, wherein the tube (10) consists of any material selected from the group consisting of: Medical grade silicone, surgical plastic thermoplastic elastomer or any biocompatible material.

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

14. The stoma plug according to any one of the preceding claims, wherein the two-way valve system (20) further comprises a thermosensitive hydrocolloid surface or an adaptive biocompatible material surface configured to adhere to or adapt to the external mucosa of the stoma (45).

15. An ostomy plug according to the preceding claim, wherein the thermosensitive hydrocolloid or the adaptable biocompatible material surface comprises a dressing configured to adhere to the skin (40) of a subject extending radially from the two-way valve system (20), preferably wherein the dressing is transparent.

16. The ostomy plug according to any of the preceding claims, wherein the at least one opening (14) in the distal portion of the tube (10) is placed at least laterally on the tube (10).

17. A stoma plug system, comprising: a) a stoma plug according to any one of the preceding claims, and b) Collection bags or vacuum equipment, wherein the collecting bag or vacuum device is configured to be connected to the two-way valve system (20) and to open the at least one opening (21) by displacing the plug (24) from the at least one opening (21), more preferably wherein the collecting bag or vacuum device opens the at least one opening (21) by its connection to the two-way valve system (20).

18. An ostomy system according to claim 17, wherein the vacuum device is a syringe.

Images