WO2023174024A1

WO2023174024A1 - Multi-liner-protected stoma baseplate and ostomy bag

Info

Publication number: WO2023174024A1
Application number: PCT/CN2023/077632
Authority: WO
Inventors: 黄海燕
Original assignee: 赖锦坤
Priority date: 2022-03-18
Filing date: 2023-02-22
Publication date: 2023-09-21
Also published as: CN217245086U

Abstract

A multi-liner-protected stoma baseplate, comprising a moisture absorption layer (1), a middle liner layer (2), a strong adhesion layer (3), and a backing layer (4). The moisture absorption layer (1) and the strong adhesion layer (3) are both flexible. The middle liner layer (2) is a non-absorbent material, such as a polymeric film. The moisture absorption layer (1), the middle liner layer (2), the strong adhesion layer (3) and the backing layer (4) are sequentially adhered together from bottom to top. The stoma baseplate is further provided with a through hole (5) penetrating from the moisture absorption layer (1) to the backing layer (4). The strong adhesion layer (3) covers the middle liner layer (2) and extends to the peripheral side of the moisture absorption layer (1). The bottom surface of the strong adhesion layer (3) extending to the peripheral side of the moisture absorption layer (1) is flush with the bottom surface of the moisture absorption layer (1) to form an integrated plane. The strong adhesion layer (3) and the moisture absorption layer (1) of the stoma baseplate are flush on the bottom surface, there is no height difference, and the bonding is tighter. The non-absorbent middle liner layer (2) does not expand and deform when soaked in the water, and seepage liquid eroding the moisture absorption layer (1) through the strong adhesion layer (3) is reduced. The middle liner layer (2) also supports the moisture absorption layer (1) and the strong adhesion layer (3), and the service life of the base is prolonged.

Description

Multi-lined stoma floor and pouch

Technical field

The utility model relates to the field of human body excretion care devices, and in particular to a stoma floor protected by multiple linings and an ostomy bag containing the stoma floor.

Background technique

When a disease of the digestive system or urinary system requires surgical separation of the intestinal tube, one end of the intestinal tube is led out to the body surface (the anus or urethra is moved to the abdominal wall) to form an opening, that is, a stoma. Ostomy is generally used for rectal and bladder lesions (such as rectal cancer, bladder cancer, intestinal obstruction, etc.). In order to save the patient's life, doctors surgically remove the diseased parts. For example, the rectum and anal canal will be removed for rectal cancer, and the rectum and anal canal will be removed for bladder cancer. bladder, and then make an opening on the left or right side of the patient's abdomen. Stool or urine is involuntarily discharged from the body through the stoma. Such patients will need a bag (ostomy bag) attached to the stoma after discharge from the hospital to contain the discharge.

Ostomy bags generally have an adhesive bottom plate with a hole in the middle, which is connected to the bag body of the stoma bag. The bottom plate is used to adhere to the skin around the stoma. Some of the stoma base plates currently on the market are made of a whole piece of sticky hygroscopic layer, which cannot be effectively adhered to the skin around the fistula or on this whole piece of sticky hygroscopic layer. It is covered with a layer of expanded non-woven adhesive edge. Since the two layers will produce a height difference, the adhesion effect is not good or the area of the non-woven adhesive edge must be increased. Excessive adhesive edge area affects the patient's mobility and comfort. If the sticky edge area is too small, the adhesion will be small and it will fall off easily.

Utility model content

In order to solve the problem, some of the stoma base plates currently on the market are made of a whole piece with a sticky moisture-absorbing layer, which cannot be effectively adhered to the skin around the human fistula, or the whole piece is made of a sticky moisture-absorbing layer. The layer is covered with an expanded non-woven adhesive edge. Due to the height difference between the two layers, the adhesion effect is not good or the area of the non-woven adhesive edge must be increased. If the adhesive edge area is too large, it affects the patient's mobility. and comfort. If the adhesive edge area is too small, the adhesion force will also be small and it is easy to fall off. The utility model proposes a base plate including a strong adhesive layer, and the bottoms of the strong adhesive layer and the moisture-absorbing layer are flat, and a product including the base plate. pocket.

The utility model first proposes a stoma base plate protected by multiple lining layers, including a hygroscopic layer, a middle lining layer, a strong adhesive layer and a backing layer. Both the moisture-absorbing layer and the strong-adhesive layer are flexible as a whole. The middle lining layer is made of a non-water-absorbing material, such as a polymer film. The moisture-absorbing layer, the middle lining layer, the strong adhesive layer and the backing layer are adhered to each other in sequence from bottom to top. The stoma bottom plate is also provided with a through hole penetrating from the moisture-absorbent layer to the backing layer. The strong adhesive layer covers the middle lining layer and extends to the peripheral side of the moisture absorbing layer. The bottom surface of the strong adhesive layer extending to the peripheral side of the moisture absorbing layer is flush with the bottom surface of the moisture absorbing layer, forming a One-piece flat surface. Both the bottom surface of the strong adhesive layer and the bottom surface of the hygroscopic layer are sticky. Since each layer is flexible, the bottom surface of the stoma floor can be bent into a curved surface, or it can be unbent and used as an integrated standard plane.

As a further improvement of the stoma floor protected by multiple lining layers of the present invention, the top surface of the hygroscopic layer is spherical, so that the peripheral side of the hygroscopic layer becomes a part of the top surface of the hygroscopic layer; the middle The lining layer at least partially covers the top surface of the moisture-absorbent layer; the strong adhesive layer completely covers the top surface of the moisture-absorbent layer.

As a further improvement of the stoma floor protected by multiple lining layers of the present invention, the top surface of the hygroscopic layer is flat.

As a further improvement of the stoma floor protected by multiple lining layers of the present invention, the middle lining layer is exactly The top surface of the moisture-absorbent layer is completely covered, and the strong adhesive layer and the peripheral side of the moisture-absorbent layer are seamlessly bonded.

As a further improvement of the stoma base plate protected by multiple lining layers of the present invention, the top surface of the strong adhesive layer is curved, and the outer contour of the bottom surface is oval, circular or square; the outer contour of the bottom surface of the hygroscopic layer and The outer contours of the bottom surfaces of the strong adhesive layer have the same shape.

As a further improvement of the stoma base plate protected by multiple lining layers of the present invention, the hygroscopicity of the hygroscopic layer is stronger than that of the strong adhesive layer, and the viscosity and flexibility of the strong adhesive layer are stronger than those of the hygroscopic layer.

As a further improvement of the stoma floor protected by multiple lining layers of the present invention, the middle lining layer is a polymer film or non-woven fabric, and the backing layer is a polymer film or non-woven fabric.

As a further improvement of the stoma floor protected by multiple lining layers of the present invention, the middle lining layer is a polyurethane film, and the backing layer is a polyurethane film.

As a further improvement of the stoma floor protected by multiple lining layers of the present invention, the strong adhesive layer is made of medical pressure-sensitive adhesive, silicone or hydrogel.

Finally, the present invention also proposes an ostomy bag, which includes a bag body and any one of the above-mentioned multi-lining-protected ostomy bottom plates, and the bag body is connected to the ostomy bottom plate.

The beneficial effects of this utility model are:

(1) The strong adhesive layer and moisture-absorbent layer of the stoma floor are flush with each other on the bottom surface. They are an integrated design with no height difference. They are made of flexible materials and fit more closely, increasing the patient's freedom of movement and comfort.

(2) Since the hygroscopic layer and the materials of each layer at the through hole are in the source of moisture, and the hygroscopic layer is easy to absorb moisture and expand and become warped and fall off, the designed non-absorbent middle lining layer will not swell and deform when soaked in water, and can block seepage. The route of entering the moisture-absorbing layer through the strong-adhesive layer, since the middle lining itself is not affected by seepage, also plays a role in supporting the moisture-absorbing layer and the strong-adhesive layer, extending the service life of the chassis.

Description of the drawings

Figure 1 is a cross-sectional view of the layered structure of the stoma floor protected by multiple linings.

Figure 2 is a layered structure diagram of a stoma base plate in which both the top surface of the hygroscopic layer and the top surface of the strong adhesive layer are curved, and the middle lining layer completely covers the top surface of the hygroscopic layer.

Figure 3 is a layered structure diagram of a stoma base plate in which both the top surface of the hygroscopic layer and the top surface of the strong adhesive layer are curved, and the middle lining layer does not completely cover the top surface of the hygroscopic layer.

Figure 4 is a layered structure diagram of a stoma base plate in which the top surface of the strong adhesive layer is curved, the top surface of the hygroscopic layer is flat, and the middle lining layer completely covers the top surface of the hygroscopic layer.

Figure 5 is a schematic diagram of the bottom structure of the stoma floor protected by multiple linings when it is circular.

Figure 6 is a schematic diagram of the bottom structure of the stoma floor protected by multiple linings when it is oval.

Figure 7 is a schematic diagram of the bottom structure of the stoma floor protected by multiple linings when it is square.

Reference signs: 1-hygroscopic layer, 2-middle lining layer, 3-strong adhesive layer, 4-backing layer, 5-through hole.

Detailed ways

Some embodiments of the stoma floor of the present invention will be described below with reference to the accompanying drawings.

First, a stoma floor protected by multiple lining layers has a layered structure as shown in Figure 1, including a hygroscopic layer 1, a middle lining layer 2, a strong adhesive layer 3 and a backing layer 4 that are mutually adhered from bottom to top. Wherein, the moisture absorption layer 1 and the strong adhesive layer 3 can both be made of soft viscose material, so that the moisture absorption layer 1, the middle lining layer 2, the strong adhesive layer 3 and the backing layer 4 are adhered in sequence. Alternatively, the backing layer 4 may be adhesively adhered to the strong adhesive layer 3 , and the strong adhesive layer 3 may be bonded by applying glue toward the middle lining layer 2 .

The middle lining layer 2 is made of a non-water-absorbing flexible material, and the backing layer 4 can also be made of a non-water-absorbing flexible material, so that the middle lining layer 2 and the backing layer 4 serve as protective layers that block water. The stoma floor tool There is a through hole 5 penetrating from the hygroscopic layer 1 to the backing layer 4. The through hole 5 can be set in a circular or oval shape, and is opened in the center of the stoma floor. This through hole 5 serves as an outlet for discharging excreta and leads to the ostomy bag body.

Please continue to refer to FIG. 1 . The strong adhesive layer 3 completely covers the middle lining layer 2 and extends to the peripheral side of the hygroscopic layer 1 . The bottom surface of the strong adhesive layer 3 extending to the circumferential side of the moisture-absorbent layer 1 is flush with the bottom surface of the moisture-absorbent layer 1 to form an integrated plane. The bottom surface of the strong adhesion layer 3 and the bottom surface of the hygroscopic layer 1 both have viscosity, which can be due to the material itself having viscosity, or the bottom surface of the strong adhesion layer 3 can be coated with glue, while the hygroscopic layer 1 is a hydrogel that easily absorbs water. Glue, the bottom surface of the strong adhesive layer 3 and the bottom surface of the hygroscopic layer 1 can be attached to the skin around the stoma of the human body. Since each layer is flexible, the bottom surface of the stoma floor can be bent into a curved surface, or it can be unbent and used as an integrated standard flat surface.

The strong adhesive layer 3 and the hygroscopic layer 1 of this stoma base plate are flat on the bottom surface. They are integrated designs with no height difference. They are both made of flexible materials and can fit more closely with the skin around the stoma, increasing the number of patients. Freedom of movement and comfort.

Since the materials of the hygroscopic layer 1 and the through holes 5 are in the source of moisture, and the hygroscopic layer 1 is easy to absorb moisture and expand and become warped and fall off, the non-absorbent middle lining layer 2 of this design will not expand and deform when soaked in water, which can reduce leakage. The liquid passes through the strong adhesion layer 3 and erodes the hygroscopic layer 1. Since the middle lining layer 2 itself is not affected by the seepage, it also plays a role in supporting the hygroscopic layer 1 and the strong adhesion layer 3, thereby increasing the service life of the chassis.

As an embodiment, as shown in FIGS. 2 and 3 , the top surface of the moisture absorption layer 1 is spherical, so that the peripheral side of the moisture absorption layer 1 becomes a part of the top surface of the moisture absorption layer 1 . The spherical shape here may be a standard spherical shape or an approximately spherical dome shape, such as an elliptical sphere, etc.

Among them, the middle lining layer 2 can completely cover the top surface of the hygroscopic layer 1 (as shown in Figure 2), or can only cover the middle position of the top surface of the hygroscopic layer 1, and the outer ring portion is not covered (as shown in Figure 3) , 2 pairs of middle linings The penetration of liquid water is hindered, but water vapor and air are easily permeable. The strong adhesive layer 3 completely covers the top surface of the hygroscopic layer 1, that is, the middle liner 2 is sandwiched therein. Optionally, the top surface of the hygroscopic layer 1 can also be in other forms of curved surfaces, such as semi-expanded cylindrical side surfaces, etc.

As another embodiment, as shown in Figure 4, the top surface of the hygroscopic layer 1 is flat, the middle lining layer 2 just completely covers the top surface of the hygroscopic layer 1, the strong adhesive layer 3 and the The circumferential side of the hygroscopic layer 1 is seamlessly bonded. In other embodiments, the top surface of the moisture-absorbent layer 1 is flat, and the middle lining layer 2 may not completely cover the top surface of the moisture-absorbent layer 1 .

Preferably, as shown in Figures 2 to 4, the top surface of the strong adhesive layer 3 is curved, such as spherical, ellipsoid, etc., so that the backing layer 4 can completely cover the curved top surface without creases. .

As shown in Figures 5 to 7, the outer contour of the bottom surface of the strong adhesive layer 3 can be circular (Figure 5), oval (Figure 6) or square (Figure 7). The outer contour of the bottom surface of the hygroscopic layer 1 may have the same shape as the outer contour of the bottom surface of the strong adhesive layer 3, or may be different.

The hygroscopicity of the hygroscopic layer 1 is stronger than that of the strong adhesive layer 3, and the viscosity and flexibility of the strong adhesive layer 3 are stronger than those of the hygroscopic layer 1, which can make the stoma floor reliably adhere to the fistula. On the side skin, it has a long service life and is not easy to fall off. Among them, the hygroscopic layer 1 and the strong adhesive layer 3 can be prepared using the same ingredients such as carboxymethyl cellulose salt, hydroxypropyl methyl cellulose, styrene copolymer, hot melt pressure-sensitive adhesive, etc., and the distribution of each ingredient is adjusted. Ratio, a hygroscopic layer 1 with strong hygroscopicity and a strong adhesive layer 3 with strong viscosity are prepared. The strong adhesive layer 3 may be made of medical pressure-sensitive adhesive, silicone or hydrogel.

Wherein, the material of the middle lining layer 2 is a polymer film or non-woven fabric, such as a polyurethane film, which hinders the penetration of liquid water, but easily permeates water vapor and air. The backing layer 4 may also be made of polymer film or non-woven fabric, such as polyurethane film.

The utility model also proposes an ostomy bag, which includes a bag body and the above-mentioned multi-lining-protected ostomy bottom plate. The bag body is connected to the stoma bottom plate.

Test example

The following is an experiment to verify the lining's ability to reduce water erosion colloid, simulating the environment where each layer is in the maximum exposure state at the through hole of the bottom plate:

Cut the hygroscopic layer discs and the strong adhesive layer discs with a diameter of 3cm respectively, both of which are made of colloid material. The thickness of the hygroscopic layer discs is 1mm and 2mm, and the thickness of the strong adhesive layer discs is 1mm. Take a polyurethane film with a diameter of 3cm and a film thickness of 0.1mm, which can be used as both the middle lining layer and the backing layer. Among them, the hygroscopic layer and the strong adhesive layer use the same ingredients such as carboxymethylcellulose salt, hydroxypropylmethylcellulose, styrene copolymer and hot-melt pressure-sensitive adhesive, but the proportions of each ingredient are different, so The prepared hygroscopic layer colloid with strong hygroscopicity and strong adhesive layer colloid with strong viscosity.

Group A: Hygroscopic layer discs with a thickness of 2mm;

Group B: composed of 2mm thick hygroscopic layer disc + middle lining polyurethane film;

Group C: A composite body of 1mm thick hygroscopic layer disc + 1mm thick strong adhesive layer disc + backing layer;

Group D: A composite body of 1mm thick hygroscopic layer disc + middle lining layer + 1mm thick strong adhesive layer disc + backing layer;

The total thickness of the colloid layer of groups A, B, C, and D is 2 mm. Glue groups A, B, C, and D face down in the same container, soak in distilled water, and observe changes in the area of bubbles eroded by the glue in different groups every 3 hours as shown in Table 1.

Table 1 Comparative verification of lining’s effect on colloid swelling and whitening caused by water immersion

Experimental results: The three groups of viscose eroded and turned white at a linear relationship, and the whitening speed was: Group A>Group B>Group C>Group D. During the experiment, it was observed that the blistering position of the experimental products in each group was mainly on the colloid of the hygroscopic layer. The strong adhesive layer also had weak water absorption and blanching. The middle lining layer and the backing layer did not absorb water and did not blanch. The blistering phenomenon was from It starts from the edge of the hygroscopic layer and continues to advance to the inside of the hygroscopic layer to simulate the environment of the stoma through hole 5. Group A has the fastest blanching speed because it is not attached with a lining protective surface, and water can penetrate from the upper surface and sides, causing the experimental products of Group A to quickly blanching; the experimental products of Group B have a slower blanching speed than Group A. Because the experimental products in Group B have a middle lining polyurethane film, which prevents water from penetrating into the colloid of the hygroscopic layer from the upper surface, slowing down the bubbling speed; the experimental products in Group C have a blanching speed less than that of Group B because the thickness of the hygroscopic layer is only that of Group B Half of the experimental product, and the added strong adhesive layer has less water absorption; the soaking speed of the experimental product in group D is smaller than that of group C, because it adds a middle liner protective film between the moisture absorption layer and the strong adhesive layer. Due to the middle lining The first layer of protective film can prevent liquid water from seeping through, thereby preventing liquid water from entering the hygroscopic layer through the strong adhesive layer, while the strong adhesive layer of group C can penetrate a certain amount of liquid water and enter the hygroscopic layer, so the experimental product of group D The whitening speed is lower than that of group C.

The stoma bottom plate of the present invention is used to be attached to the skin around the stoma of the human body, and the hygroscopic layer is used to absorb moisture on the skin side. The moisture absorption on the through hole side should be reduced while maintaining the function of absorbing moisture on the skin side. The stoma floor is at the position of through hole 5, and all layers are exposed and prone to water seepage. If a large amount of water penetrates into the hygroscopic layer from the through hole position and gradually spreads, it will eventually cause the hygroscopic layer to lift and lose its adhesion to the skin. The above experiment is an experiment to simulate the stoma environment. The white bubble condition at the edge of the test product is used to simulate the moisture absorption around the through hole 5. This solution adds a middle lining layer between the moisture absorption layer and the strong adhesive layer to make it difficult for water to pass through the strong adhesive layer. The moisture-absorbing layer penetrates into the moisture-absorbing layer, thereby reducing the blanching speed of the moisture-absorbing layer and protecting the function of the product.

Experiments have shown that the multi-lining floor structure of this embodiment can reduce the erosion of the entire floor adhesive by excrement, seepage, etc., thereby increasing the service life of the chassis and reducing excrement leakage.

The above-mentioned specific embodiments are only exemplary and are intended to better enable those skilled in the art to understand the present utility model, and cannot be understood as limiting the scope of protection claimed by the present utility model; as long as they are made according to the spirit disclosed by the present utility model Any equivalent changes or modifications fall within the scope of protection claimed by this utility model.

Claims

A stoma floor protected by multiple lining layers, characterized by: including a hygroscopic layer, a middle lining layer, a strong adhesive layer and a backing layer; both the moisture absorbing layer and the strong adhesive layer are flexible as a whole; the middle lining The layer is made of non-absorbent material; the hygroscopic layer, the middle lining layer, the strong adhesive layer and the backing layer are adhered to each other in order from bottom to top; the stoma floor is also configured to penetrate from the hygroscopic layer to the back through-holes in the liner;

The strong adhesive layer covers the middle lining layer and extends to the peripheral side of the moisture absorbing layer; the bottom surface of the strong adhesive layer extended to the peripheral side of the moisture absorbing layer is flush with the bottom surface of the moisture absorbing layer, forming a Integrated plane; both the bottom surface of the strong adhesive layer and the bottom surface of the hygroscopic layer are sticky.
The stoma base plate protected by multiple lining layers according to claim 1, characterized in that: the top surface of the hygroscopic layer is spherical, so that the peripheral side of the hygroscopic layer becomes a part of the top surface of the hygroscopic layer; The middle lining layer at least partially covers the top surface of the moisture-absorbent layer; the strong adhesive layer completely covers the top surface of the moisture-absorbent layer.
The stoma floor protected by multiple lining layers according to claim 1, wherein the top surface of the moisture-absorbing layer is flat.
The stoma base plate protected by multiple lining layers according to claim 3, characterized in that: the middle lining layer just completely covers the top surface of the hygroscopic layer, and the strong adhesive layer and the peripheral side of the hygroscopic layer Seamless bonding.
The stoma floor protected by multiple lining layers according to any one of claims 1 to 4, characterized in that: the top surface of the strong adhesive layer is curved, and the outer contour of the bottom surface is oval, circular or square; The outer contour of the bottom surface of the hygroscopic layer and the outer contour of the bottom surface of the strong adhesive layer have the same shape.
The stoma base plate protected by multiple lining layers according to any one of claims 1 to 4, characterized in that: the hygroscopicity of the hygroscopic layer is stronger than that of the strong adhesive layer, and the strong adhesive layer has better viscosity and flexibility. are stronger than the hygroscopic layer.
The stoma base plate protected by multiple lining layers according to any one of claims 1 to 4, characterized in that: the middle lining layer is a polymer film or non-woven fabric, and the backing layer is a polymer film or non-woven fabric .
The stoma floor protected by multiple lining layers according to any one of claims 1 to 4, characterized in that: the middle lining layer is a polyurethane film, and the backing layer is a polyurethane film.
The stoma base plate protected by multiple lining layers according to any one of claims 1 to 4, characterized in that: the material of the strong adhesive layer is medical pressure-sensitive adhesive, silica gel or hydrogel.
An ostomy bag, characterized in that it includes a bag body and the ostomy floor protected by multiple linings according to any one of claims 1 to 9, and the bag body is connected to the ostomy floor.