Ostomy pocket

Abstract

The invention relates to the technical field of medical auxiliary devices, and discloses a stoma pocket which comprises a base plate and a collecting bag, the base plate is provided with a bonding layer used for being attached to the periphery of a stoma, and the collecting bag is detachably connected with the base plate and used for collecting stoma discharge. The device is characterized in that the collecting bag comprises a collecting area located on the lower portion and a drug delivery area located at the stoma, a transparent observation window is arranged at the position, corresponding to the stoma, of the drug delivery area, a layer of sustained-release drug carrier is attached to the drug delivery area of the collecting bag, a porous hydrophobic membrane is attached to the surface of the sustained-release drug carrier, the sustained-release drug carrier carries sustained-release drugs, and the hydrophobic membrane is attached to the surface of the sustained-release drug carrier. The sustained-release drug comprises composite microspheres carrying polylactic acid / polycaprolactone, the drug is wrapped in the microspheres, and the problem of stoma infection caused by frequent opening of a stoma bag during drug administration is solved by performing sustained drug release on the stoma.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical auxiliary devices, in particular to a stoma bag. BACKGROUND

[0002] The stoma bag is used for patients with stoma surgery, and is attached to the abdominal skin wound to collect intestinal accumulations. After stoma surgery, patients often need to use the stoma bag for a long time to collect excretions. Some patients need local medication, such as applying antibiotics to the stoma to avoid stoma infection, injecting probiotic preparations, glutamine and other drugs into the intestinal tract to avoid intestinal infection, and mucosal repair.

[0003] The stoma bag currently in use only has a single collection function. The stoma bag is usually divided into one-piece and two-piece types. The one-piece stoma bag is an integral whole of the part fixed to the skin and the collection bag, and is generally disposable. The two-piece stoma bag is a split structure of the part fixed to the skin and the collection bag. The part fixed to the skin is called a fixing part, and the part for collecting liquid is called a collection bag. The fixing part is pasted at the initial stage of stoma collection, and only the collection bag needs to be replaced in the later stage. Whether it is one-piece or two-piece, the following problems exist: 1. When medication is needed, the stoma bag needs to be frequently opened, and medical personnel need to be specially nursed, but stoma infection may still occur due to repeated opening of the stoma bag; 2. It is difficult to detect whether the stoma bag leaks when it is used to be fixed to the skin of a person, and the leakage causes the healthy skin to be in contact with the leakage for a long time, resulting in symptoms such as itching of the healthy skin. SUMMARY

[0004] The present application aims to provide a stoma bag to solve the problem of stoma infection caused by frequent opening of the stoma bag when medication is needed.

[0005] To achieve the above-mentioned purpose, the present application provides a stoma bag, which comprises a bottom disc and a collection bag. The bottom disc is provided with an adhesive layer for being attached around the stoma. The collection bag is detachably connected with the bottom disc and is used for collecting excretions of the stoma. The collection bag comprises a collection area at the lower part and a medication area at the stoma. The medication area is provided with a transparent observation window at the position corresponding to the stoma. The medication area of the collection bag is attached with a sustained-release drug carrier. A porous hydrophobic membrane is attached to the surface of the sustained-release drug carrier. The sustained-release drug carrier carries sustained-release drugs. The sustained-release drugs comprise polylactic acid / polycaprolactone composite microspheres, and the microspheres encapsulate drugs.

[0006] The beneficial effects of the present application are as follows: 1. In the use process, the stoma bag does not need to be frequently opened. The sustained-release drug carrier structure of the medication area of the collection bag can continuously release drugs to the stoma, avoid the problems of exposure of the stoma and invasion of external bacteria caused by repeated disassembly of the stoma bag, reduce the frequency of nursing by medical personnel, and reduce the operation complexity.

[0007] 2. The drug is released in a sustained-release manner. The polylactic acid / polycaprolactone composite microspheres in the sustained-release drug carrier can precisely control the drug release rate by adjusting the particle size. According to the requirements, the drug is continuously released for 7-10 days; the microspheres have good biocompatibility and no risk of human rejection.

[0008] 3. The surface of the sustained-release drug carrier is attached with a porous hydrophobic film; the porous hydrophobic film can block the excrement of the stoma from penetrating into the sustained-release drug carrier, avoiding the dilution or contamination of the drug, while not affecting the penetration of the drug molecules to the stoma area, ensuring the accuracy of the drug dose.

[0009] 4. The transparent observation window of the drug administration area can directly observe the stoma state, such as redness, bleeding, and excrement properties, without disassembling the fistula bag to complete daily inspection, simplifying the nursing process.

[0010] Further, the particle size of the polylactic acid / polycaprolactone composite microspheres is 5-20 μm, and the drug release rate is controlled by adjusting the particle size to control the drug administration time.

[0011] Further, the detachable connection structure of the collection bag and the bottom disc includes a clasp arranged on the top surface of the bottom disc and a lock arranged on the collection bag to cooperate with the clasp. The clasp and the lock are connected to fix the connection between the collection bag and the bottom disc, and the lock is opened to disconnect the connection between the collection bag and the bottom disc. Through the detachable connection structure, the collection bag can be replaced or cleaned.

[0012] Further, the bottom of the bottom disc is provided with an adhesive layer, and a drug layer is fixed between the adhesive layer and the bottom disc. The drug layer is soaked with a drug solution for anti-inflammatory and sterilization. The surface of the drug layer is covered with a surface layer with enhanced tensile strength.

[0013] The drug layer arranged on the bottom disc is mainly used to prevent infection at the stoma. The drug layer between the adhesive layer and the surface layer of the bottom disc is soaked with an anti-inflammatory and sterilization drug solution, such as iodophor and gentamicin solution, which can continuously act on the skin around the stoma through skin penetration to prevent skin inflammation, especially suitable for patients with sensitive or susceptible stoma skin.

[0014] Further, the adhesive layer extends to both sides of a straight line to form two auxiliary adhesive strips, and the surface layer covers the upper surface of the auxiliary adhesive strips. The end of the surface layer on the upper surface of the auxiliary adhesive strip is provided with a connecting buckle for connecting the fixing belt.

[0015] Further, the surface layer is a fabric made of nylon elastic filament with high tensile strength.

[0016] Further, the adhesive layer center part is left with excess material for stoma passing, a heating coil is arranged between the adhesive layer and the drug layer, and in the horizontal direction, the heating coil is between the excess material and the snap ring. One of the auxiliary adhesive tapes is provided with a battery, which provides heating power for the heating coil.

[0017] The battery on the auxiliary adhesive tape provides power for the heating coil, which can maintain the temperature around the stoma at 36-37℃ (close to normal human body temperature), avoid low-temperature liquid or exudate stimulating the skin, improve patient comfort, and also strengthen the drug dispersion of the drug layer.

[0018] Further, a leakage detection sensor is arranged between the adhesive layer and the drug layer for leakage detection. The leakage detection sensor is a capacitive sensor, and the two electrodes of the capacitive sensor are annular and arranged outside the heating coil. Another auxiliary adhesive tape is provided with a flexible circuit board, and the circuit board is provided with a control circuit including a control chip. The control chip is used for receiving the input signal of the leakage detection sensor and controlling the heating temperature and time of the heating coil. A prompt light is connected to the output end of the control chip, which is used to prompt whether the leakage detection sensor detects leakage.

[0019] Through the annular capacitive leakage detection sensor in the chassis, the stoma exudate can be quickly captured. When the exudate contacts the sensor electrode and causes the capacitance value to change, the control chip immediately triggers the prompt light (such as red flashing) to remind the patient or medical staff to handle it in time, avoiding long-term contact of the exudate with healthy skin to cause itching, swelling or infection.

[0020] Further, a storage pocket is arranged outside the chassis, and the connection points on both sides of the storage pocket are on the surface layer at the position of the auxiliary adhesive tape. The auxiliary adhesive tape extended by the adhesive layer of the chassis can increase the contact area with the skin, and cooperate with the high tensile strength of the surface layer to prevent the stoma bag from moving due to activity.

[0021] Finally, the surface of the storage pocket is connected with a cover through a zipper, and the cover completely covers the adhesive layer and the collection bag. The bag body of the collection bag is accommodated and supported in the storage pocket. The storage pocket can completely fix the collection bag, and the cover is sealed through the zipper, further blocking the exudate from leaking outside, and protecting the collection bag from external friction damage. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 The figure is a schematic view of the connection state of the chassis and the collection bag in the stoma bag. Figure 2 The figure is a schematic view of the state of the chassis not connected to the collection bag in the stoma bag. Figure 3 The figure is a schematic view of the structure of the collection bag in the stoma bag. Figure 4The structure of the bottom plate of the stoma bag is shown in the figure.

[0023] The reference signs in the attached drawings of the specification include: bottom plate 1; adhesive layer 11; auxiliary adhesive band 12; connecting buckle 121; clasp 13; collecting bag 2; transparent observation window 21; lock buckle 22; slow-release drug carrier 23; storage pocket 3; cover 31; heating coil 4; leakage detection sensor 5; battery 6; flexible circuit board 7; control chip 71; prompt light 72; drug layer 8; surface layer 9. DETAILED DESCRIPTION

[0024] The following is further described in detail through a specific embodiment: As shown in the attached Figure 1 , Figure 2 , Figure 3 and Figure 4 ; the embodiment discloses a stoma bag, which comprises a bottom plate 1 and a collecting bag 2, the bottom plate 1 is provided with an adhesive layer 11 for adhering around the stoma, the collecting bag 2 is detachably connected with the bottom plate 1, and is used for collecting the stoma discharge; the collecting bag 2 comprises a collecting area at the lower part and a drug delivery area at the stoma; the drug delivery area is provided with a transparent observation window 21 at the position corresponding to the stoma; the drug delivery area of the collecting bag is adhered with a slow-release drug carrier 23; the surface of the slow-release drug carrier 23 is adhered with a porous hydrophobic membrane; the slow-release drug carrier carries slow-release drugs; the slow-release drugs comprise polylactic acid / polycaprolactone composite microspheres, and the microspheres encapsulate drugs; the particle size of the polylactic acid / polycaprolactone composite microspheres is 5-20 μm, and the drug release rate is controlled by adjusting the particle size, so as to control the drug delivery time.

[0025] The detachable connection structure of the collecting bag 2 and the bottom plate 1 comprises a clasp 13 arranged on the top surface of the bottom plate and a lock buckle 22 arranged on the collecting bag and matched with the clasp; the clasp 13 and the lock buckle 22 are clamped to fix the collecting bag 2 and the bottom plate 1 in connection, and the lock buckle is opened to disconnect the collecting bag and the bottom plate; through the detachable connection structure, the collecting bag can be replaced or cleaned.

[0026] The bottom plate 1 is provided with an adhesive layer 11 at the bottom, and a drug layer 8 is fixed between the adhesive layer 11 and the bottom plate 1; the drug layer 13 is soaked with a drug solution for anti-inflammatory and sterilization; and the drug layer 13 is covered with a surface layer 9 for enhancing the tensile strength.

[0027] The adhesive layer 11 extends to form two auxiliary adhesive bands 12 in the directions of both sides of a straight line; the surface layer on the upper surface of the auxiliary adhesive band 12 is a fabric made of spandex elastic silk and has high tensile strength; and the end of the surface layer on the upper surface of the auxiliary adhesive band 12 is provided with a connecting buckle 121 for connecting and fixing the band.

[0028] The center part of the adhesive layer 11 is left with a surplus for the stoma to pass through, and a heating coil 4 is arranged between the adhesive layer 11 and the drug layer 8. In the horizontal direction, the heating coil 4 is between the surplus and the snap ring 13. One of the auxiliary adhesive tapes 12 is provided with a battery 6, which provides heating power for the heating coil 4.

[0029] A leakage detection sensor 5 for leakage detection is also arranged between the adhesive layer 11 and the drug layer 9. The leakage detection sensor 5 is a capacitive sensor, and the two electrodes of the capacitive sensor are made into a ring shape and arranged outside the heating coil 4. The other auxiliary adhesive tape 12 is provided with a flexible circuit board 7, and the flexible circuit board 7 is provided with a control circuit including a control chip 71. The control chip 71 is used to receive the input signal of the leakage detection sensor 5 and control the heating temperature and time of the heating coil 4. A prompt light 72 is connected to the output end of the control chip 71, which is used to prompt whether the leakage detection sensor detects leakage.

[0030] The bottom disc 1 is provided with a storage pocket 3, and the connection points on both sides of the storage pocket 3 are on the surface layer at the position of the auxiliary adhesive tape 12. The auxiliary adhesive tape of the adhesive layer 11 can increase the contact area with the skin, and cooperate with the high tensile strength of the surface layer to prevent the ostomy bag from moving due to activity. The surface of the storage pocket 3 is connected with a cover 31 through a zipper, and the cover 31 completely covers the adhesive layer and the collection bag. The bag body of the collection bag is accommodated and supported in the storage pocket 3. The storage pocket 3 can completely fix the collection bag, and the cover 31 seals and protects the collection bag from external friction damage through the zipper.

[0031] The main body of the bottom disc 1 is made of medical silicone material, with a thickness of 1.5 mm and a diameter of 8-12 cm. A stoma passage with a diameter of 2-4 cm is reserved in the center.

[0032] The adhesive layer is made of medical pressure-sensitive adhesive, which is coated on the bottom of the bottom disc. An annular surplus with a width of 0.5 cm is reserved at the center corresponding to the stoma passage, and two auxiliary adhesive tapes with a width of 2 cm and a length of 10 cm are extended from the edges.

[0033] During manufacturing, the medical absorbent cotton is cut into a ring shape with the same diameter as the bottom disc, soaked in a 0.5% iodophor solution, and then fixed on the adhesive layer after draining. The drug layer covers the outside area of the surplus.

[0034] The surface layer is made of nylon elastic silk tight-woven fabric, which is cut into a shape matching the bottom disc and the auxiliary adhesive tape, and covers the surface of the drug layer and the auxiliary adhesive tape. Plastic connection buckles are sewn on the end of the surface layer of the auxiliary adhesive tape, which are used for subsequent connection and fixation of the belt.

[0035] The capacitive sensor is pasted outside the drug layer, the heating coil adopts 10 turns of copper wire, the copper wire is spirally arranged and pasted inside the sensor and between the excess material and the snap ring; a lithium battery is fixed on the surface of one of the auxiliary adhesive tapes, and a flexible circuit board is fixed on the other auxiliary adhesive tape, and the flexible circuit board is integrated with an STM32L4 control chip, a prompt light and a charging interface; the wires are connected with the sensor, the heating coil and the circuit board; the wires are buried below the surface layer to avoid contacting the skin.

[0036] The collecting bag body is made of medical transparent PE material and is divided into upper and lower parts. The upper part is for drug administration and the lower part is for collecting area. The capacity of the lower collecting area is 500-800 mL, and a drainage valve is arranged at the bottom.

[0037] The slow-release drug carrier is prepared by mixing polylactic acid (PLA) and polycaprolactone (PCL) at a mass ratio of 7:3, and then preparing composite microspheres with a particle size of 10 μm by emulsification-solvent evaporation method. The microspheres are wrapped with probiotic preparations; the microspheres are mixed with medical hydroxypropyl methylcellulose to form a film-shaped carrier with a thickness of 0.2 cm, which is cut into a circular shape with the same diameter as the drug administration area and pasted on the inner side of the drug administration area.

[0038] Hydrophobic membrane: polytetrafluoroethylene porous membrane with a pore size of 0.22 μm and a thickness of 0.1 mm is selected and covered on the surface of the slow-release drug carrier and fixed by heat pressing to ensure no shedding.

[0039] The lock is fixed at the opening of the collecting bag drug administration area, and the inner side is provided with three grooves matched with the protruding buckles of the snap ring to realize clamping fixation.

[0040] The specific use process of the stoma bag is as follows: The patient cleans the skin around the stoma, removes the protective film of the bottom disc adhesive layer after drying, aligns the center channel of the bottom disc with the stoma, gently presses the bottom disc and the auxiliary adhesive tape, and ensures that the adhesive layer is completely attached to the skin without air bubbles; charge the lithium battery through the charging interface of the flexible circuit board, turn on the power switch, start the heating coil, and the control chip automatically adjusts the temperature to 36.5℃, and the prompt light is green and always on; indicating normal operation.

[0041] If the patient needs intestinal administration, such as probiotic supplementation, the collecting bag does not need to be disassembled, and the composite microspheres in the slow-release drug carrier will continuously release probiotics within 3 days, penetrate through the hydrophobic membrane into the stoma, and enter the intestine.

[0042] Observe the stoma condition through the transparent observation window daily, and replace the drug layer in the bottom disc if the stoma is found to be red and swollen; lift the surface layer, remove the old drug layer, and replace the new iodophor soaked degreasing cotton.

[0043] When the leakage detection sensor detects leakage, the prompt light flashes red, at which point the outer cover zipper is opened and the collection bag is checked for displacement. If the leakage is small, the sensor area is wiped with medical gauze and repositioned. If the leakage is large, the heating coil power is turned off, the fixing belt is unfastened, the lock catch is opened, the collection bag is replaced, the lock catch is re-fastened, and the power is turned on.

[0044] When the collection bag is 2 / 3 full, the bottom drain valve is closed, the fixing belt is unfastened, the lock catch is separated from the clasp protrusion, and the old collection bag is removed.

[0045] A new collection bag is taken, the "clasp-lock" connection steps are repeated, ensuring a tight fit, the drain valve is opened, the outer cover zipper is closed, and the replacement is complete (the entire process takes about 1-2 minutes and does not require moving the base plate.

[0046] The base plate is replaced every 7 days. When replacing, the fixing belt and the storage pocket outer cover are removed, the battery and circuit board are disconnected, the auxiliary adhesive tape is gently lifted to avoid tearing the skin, the remaining adhesive is wiped with a medical alcohol cotton ball, the skin is cleaned, and a new base plate is installed according to the initial installation steps.

[0047] The above is only an embodiment of the present application, and well-known specific technical solutions and / or common knowledge of characteristics in the scheme are not described in detail. It should be noted that for those skilled in the art, without departing from the technical solutions of the present application, a number of modifications and improvements can be made, which should also be considered as the protection scope of the present application, which will not affect the effect and practicality of the patent. The protection scope of the present application should be subject to the content of its claims, and the specific implementation mode and the like in the specification can be used to explain the content of the claims.

Claims

1. An ostomy pouch comprising a base plate and a collecting bag, the base plate being provided with an adhesive layer for attachment around a stoma, the collecting bag being detachably connected to the base plate for collecting stoma discharge, characterised in that: The collecting bag comprises a collecting area at the lower part and a drug administration area at the stoma, the drug administration area is provided with a transparent observation window at the corresponding part of the stoma, the drug administration area of the collecting bag is attached to a slow-release drug carrier, a porous hydrophobic membrane is attached to the surface of the slow-release drug carrier, and the slow-release drug carrier carries slow-release drugs.

2. The stoma pouch of claim 1, wherein: The poly-lactic acid / polycaprolactone composite microspheres have a particle size of 5-20 μm, and the drug release rate and the drug administration time are controlled by adjusting the particle size.

3. The stoma pouch of claim 1, wherein: The detachable connection structure of the collecting bag and the bottom disc comprises a snap ring arranged on the top surface of the bottom disc and a lock catch arranged on the collecting bag to cooperate with the snap ring, the snap ring and the lock catch are connected to fix the collecting bag and the bottom disc, and the lock catch is opened to disconnect the collecting bag and the bottom disc.

4. The stoma pouch of claim 1, wherein: A drug layer is fixed between the adhesive layer and the bottom disc, the drug layer is soaked with a drug solution for anti-inflammatory and sterilization, and the drug layer is covered with a surface layer with high tensile strength.

5. The stoma pouch of claim 4, wherein: The adhesive layer extends to both sides of a straight line to form two auxiliary adhesive strips, the surface layer is covered on the upper surface of the auxiliary adhesive strips, and the end of the surface layer on the upper surface of the auxiliary adhesive strips is provided with a connecting buckle for connecting the fixing belt.

6. The stoma pouch of claim 5, wherein: The surface layer is a fabric made of spandex elastic yarn with high tensile strength.

7. The stoma pouch of claim 6, wherein: The center part of the adhesive layer is left with a surplus for the stoma to pass through, a heating coil is arranged between the adhesive layer and the drug layer, in the horizontal direction, the heating coil is between the surplus and the snap ring, one of the auxiliary adhesive strips is provided with a battery, and the battery provides heating power for the heating coil.

8. The stoma pouch of claim 7, wherein: A leakage detection sensor is further arranged between the adhesive layer and the drug layer, the leakage detection sensor is a capacitive sensor, the two electrodes of the capacitive sensor are annular, and are arranged outside the heating coil, a flexible circuit board is arranged on the other auxiliary adhesive strip, a control circuit including a control chip is arranged on the circuit board, the control chip is used for receiving the input signal of the leakage detection sensor, and is used for controlling the heating temperature and the heating time of the heating coil, a prompt lamp is connected to the output end of the control chip, and the prompt lamp is used for prompting whether the leakage detection sensor detects the leakage phenomenon.

9. The stoma pouch of claim 8, wherein: A storage pocket is arranged outside the bottom disc, and the connecting points on both sides of the storage pocket are on the surface layer at the auxiliary adhesive strips.

10. The stoma pouch of claim 9, wherein: An outer cover is connected to the surface of the storage pocket through a zipper, the outer cover completely covers the adhesive layer and the collecting bag, and the bag body of the collecting bag is accommodated and supported in the storage pocket.

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