Resumen
The present invention refers to a stoma plug suitable for controlling the output of biological fluids from a colon, ileum and/or ureter (50) through a stoma (45) created 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) connected to the tube (10) through the base element (22), the two-way valve system (20) configured to control the fluid flow through the opening (12) of the proximal portion of the tube (10), and a cap (30) configured to cover the two-way valve system (20) and the stoma (45), comprising an opening (32) to directly access 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 portion, and the two-way valve system (20) is configured to passively remain closed and to be opened when the plug (24) is displaced from the at least one opening (21).
Reivindicaciones
1. A stoma plug suitable for controlling the output of biological fluids from a colon, ileum and/or ureter (50) through a stoma (45) created by a colostomy, ileostomy or urostomy respectively, 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 at least one opening (21) and a plug (24) configured to close the at least one opening (21), the two-way valve system (20) connected to the tube (10) through its proximal portion, and c) a cap (30) configured to cover the two-way valve system (20) and the stoma (45), comprising an opening (32) to directly access 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) through its distal portion, and wherein the two-way valve system (20) is configured to passively remain closed and to be opened when the plug (24) is displaced from the at least one opening (21). 2. The stoma plug according to the previous claim, wherein the two-way valve system (20) further comprises: a base element (22) comprising the at least one opening (21) of the two-way valve system (20), and an actuator (26), wherein 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, wherein 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) stops being actuated. 3. The stoma plug according to the previous claim, wherein the base element (22) is configured to perforate the plug (24) when the plug (24) is displaced by the actuator (26). 4. The stoma plug according to claims 2 or 3, wherein the base element (22) has a spiky shape, more preferably wherein the spiky shape is essentially of a cone shape. 5. The stoma plug according to claim 1, wherein the two-way valve system (20) further comprises: a spring (27), a base element (22) configured to be slidably receivable by the spring (27), and a plug stopper (29) comprising the at least one opening (21) of the two-way valve system (20), wherein the spring (27) is configured to press the plug (24) against the plug stopper (29) and close the at least one opening (21) of the two-way valve system (20) and wherein the spring (27) is further configured to longitudinally displace from the plug stopper (29) when a force is applied, thus displacing the plug (24) from the at least one opening (21) and therefore opening the at least one opening (21) of the two-way valve system (20). 6. The stoma plug according to the previous claim, wherein the plug (24) comprises two pieces (24A, 24B), and wherein the two pieces (24A, 24B) are configured to remain in contact when the spring (27) presses them against the plug stopper (29) and to separate apart when the spring (27) is longitudinally displaced, thus generating an aperture between the two pieces (24A, 24B) and allowing the at least one opening (21) of the two-way valve system (20) to be accessible through the aperture generated between the two pieces (24A, 24B). 7. The stoma plug according to any of the previous claims, wherein the at least one opening (14) on the distal portion of the tube (10) is smaller than 15 mm. 8. The stoma plug according to any of the previous claims, wherein the tube (10) comprises a rounded tip (15) on its distal portion, configured to facilitate the insertion of the tube (10) through the stoma (45). 9. The stoma plug according to any of the previous claims, wherein the tube (10) external surface further comprises at least a spiral portion configured to increase the contact surface of the tube (10) with the inner surface of the colon, ileum and/or ureter (50). 10. The stoma plug according to any of the previous claims, wherein the tube (10) is comprised of any of the materials selected from: medical grade silicone, surgical plastic or thermoplastic elastomers. 11. The stoma plug according to any of the previous claims, wherein the tube (10) further comprises a lubricated layer on its external surface, configured to reduce the friction with the stoma (45) during its insertion. 12. The stoma plug according to any of the previous claims, wherein the two-way valve system (20) further comprises a heat-sensitive hydrocolloid surface configured to stick to the external stoma mucosa (45). 13. The stoma plug according to the previous claim, wherein the heat-sensitive hydrocolloid surface comprises a dressing configured to adhere to the subject's skin (40) extending radially from the two-way valve system (20), preferably wherein the dressing is transparent. 14. A stoma plug system comprising: a) a stoma plug according to any of the previous claims, and b) a collecting bag or a vacuum device wherein the collecting bag or vacuum device is configured to connect 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) through its connection to the two-way valve system (20). 15. The stoma system according to claim 14, wherein the vacuum device is a syringe.
