Gel-based anti-seepage medical application based on deformation adsorption and gradient pressurization

Abstract

The gel-based anti-seepage medical application comprises an adsorption layer, a gel base layer, a pressurization layer and an anti-seepage isolation layer which are sequentially arranged from inside to outside, and the adsorption layer comprises an adsorption body and a plurality of air holes evenly and densely distributed in the adsorption body; a gel plug used for filling a puncture point gap is arranged on the lower end face of the gel base layer, the pressurizing layer comprises an arch support, the anti-seepage isolation layer comprises an isolation layer body and a puncture positioning ring arranged at the top of the isolation layer body, and after the adsorption body expands, the outer circle adsorption area generates radial contraction force to be matched with the arch support to achieve puncture. According to the body temperature change of a user, deformation is generated, controllable pressure is applied to the adsorption layer, so that dynamic sealing is achieved, a puncture point notch is blocked through the gel base layer and the gel plug, drainage liquid is drained to an in-vitro drainage bag, and the anti-seepage effect is further improved.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and more particularly relates to a gel-based anti-seepage medical dressing based on deformation adsorption and gradient pressurization. Background Art

[0002] During the indwelling period of various drainage tubes and intravenous catheters, due to the abdominal cavity or venous pressure being greater than the atmospheric pressure, or the patient turning over, walking, moving the punctured arm or neck, the abdominal cavity pressure or venous pressure increases, resulting in adverse events such as the leakage of drainage fluid or blood, the formation of drainage dermatitis, medical device-related pressure ulcers, and unplanned extubation, increasing the workload of medical staff and affecting the recovery of the condition. Medical dressings have the advantages of being easy to use, reducing the risk of infection, and painless removal, and have been widely used.

[0003] However, traditional gauze or non-woven fabric dressings have the following defects: First, they rely on fiber capillary action for passive absorption, and when the exudate at the puncture site during the indwelling period of various tubes or the exudate volume after extubation is greater than 50 mL / 24 h, saturation failure occurs, the adsorption of the dressing weakens, and even the drainage fluid leaks out, contaminating the wound and causing local skin maceration and damage; Second, there are physical fixation defects. The flat dressing cannot adapt to the curved surface change of the skin around the puncture site, and it is easy to produce edge warping during abdominal pressure fluctuation, thoracic respiration, and neck and arm movement; Third, there is a lack of pressure control: Existing pressurized dressings or abdominal and thoracic belts use elastic bandages for external fixation, and it is impossible to achieve precise local pressurization at the puncture site, resulting in uneven pressure gradient distribution; Fourth, there are blind spots in observing the tube. Most conventional indwelling drainage tubes use the method of full coverage with non-woven fabric or sterile gauze plus a transparent dressing. There are visual blind spots in the coverage of the puncture site and the tube length, and it is only possible to judge the puncture site based on experience or hand feeling, which affects the observation of the condition and increases the risk of tube slippage.

[0004] Therefore, there is an urgent need for an innovative dressing structure that can achieve dynamic sealing and controllable pressurization. Summary of the Invention

[0005] The main purpose of the present invention is to provide a gel-based anti-seepage medical dressing based on deformation adsorption and gradient pressurization, further improving the sealing effect and the anti-seepage property of the dressing.

[0006] To achieve the above object, the technical solution of the present invention is as follows:

[0007] A gel-based anti-seepage medical dressing based on deformation adsorption and gradient pressurization, comprising an adsorption layer, a gel base layer, a pressurization layer, and an anti-seepage isolation layer arranged in sequence from inside to outside. The adsorption layer includes an adsorption body with a gradually decreasing thickness from the center to the edge and a number of air holes uniformly distributed in the adsorption body. After the adsorption body expands, a radial contraction force can be generated in the outer circular adsorption area. A gel plug for filling the puncture point gap is provided on the lower end surface of the gel base layer. A leakage hole for accommodating the gel plug is provided at the center of the adsorption body. The pressurization layer is located between the anti-seepage isolation layer and the gel base layer. The pressurization layer includes an arched bracket made of an alloy material member, and the arched bracket can deform according to the change of the user's body temperature to apply a controllable pressure to the adsorption layer. The anti-seepage isolation layer includes an isolation layer body and a puncture positioning ring provided on the top of the isolation layer body, and the puncture positioning ring is arranged opposite to the leakage hole.

[0008] According to the embodiment of the first aspect of the present invention, the central thickness of the adsorption body is 3 mm, and the edge thickness of the adsorption body is 0.5 mm.

[0009] According to the embodiment of the first aspect of the present invention, the adsorption layer further includes a plurality of vacuum suction cups uniformly arranged on the lower end surface of the adsorption body.

[0010] According to the embodiment of the first aspect of the present invention, the diameter of the vacuum suction cup is 200 - 500 μm.

[0011] According to the embodiment of the first aspect of the present invention, the gel base layer includes one or several of a composite formed by acrylate copolymer, chitosan, and zinc oxide particles.

[0012] According to the embodiment of the first aspect of the present invention, the anti-seepage isolation layer further includes a scale bar provided on the top of the isolation layer body and a cover made of a transparent material member provided outside the puncture positioning ring.

[0013] According to the embodiment of the first aspect of the present invention, the isolation layer body is a polyurethane material member, and the thickness of the isolation layer body is 0.05 - 0.1 mm.

[0014] According to the embodiment of the first aspect of the present invention, the length of the scale bar is from the center of the puncture positioning ring to the outer circular surface of the isolation layer body.

[0015] According to the embodiment of the first aspect of the present invention, the width of the cover is 2 - 3 cm.

[0016] According to the embodiment of the first aspect of the present invention, the arched bracket is a nickel-titanium alloy material member.

[0017] One of the technical solutions in the above technical solutions of the present invention has at least the following advantages or beneficial effects:

[0018] After the adsorption body expands in the present invention, a radial contraction force is generated in the outer circular adsorption area, and in cooperation with the arched bracket, deformation occurs according to the change in the user's body temperature to apply a controllable pressure to the adsorption layer, thereby achieving dynamic sealing. Moreover, the puncture point gap can be blocked by the gel base layer and the gel plug, and the drainage fluid is drained to the external drainage bag, further improving the anti-seepage effect. Description of the Drawings

[0019] The following further describes the present invention in conjunction with the drawings and embodiments;

[0020] Attached Figure 1 is the overall structure diagram of an embodiment of the present invention;

[0021] Attached Figure 2 is the side view of an embodiment of the present invention;

[0022] Attached Figure 3 is the cross-sectional view of an embodiment of the present invention;

[0023] Attached Figure 4 is the bottom view of an embodiment of the present invention;

[0024] Attached Figure 5 is the structure diagram of the pressure layer of an embodiment of the present invention. Detailed Embodiments

[0025] The following details the embodiments of the present invention. The examples of the embodiments are shown in the drawings, wherein the same or similar reference numerals always denote the same or similar elements or elements having the same or similar functions. The embodiments described below by referring to the drawings are exemplary and are only used to explain the present invention and should not be construed as a limitation of the present invention.

[0026] In the description of the present invention, it should be understood that for the orientation description, such as the upper, lower, front, rear, left, right, etc., the orientation or positional relationship indicated is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation of the present invention.

[0027] In the description of the present invention, the meaning of several is one or more, the meaning of multiple is two or more, greater than, less than, exceeding, etc. are understood as not including the present number, and above, below, within, etc. are understood as including the present number. If there is a description of first and second, it is only for the purpose of distinguishing technical features and should not be construed as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features or implicitly indicating the sequence relationship of the indicated technical features.

[0028] In addition, the terms "first" and "second" are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more features.

[0029] In the description of the present invention, it should be noted that unless otherwise clearly specified and limited, the term "connection" should be understood in a broad sense. For example, it can be a fixed connection or a movable connection, or a detachable connection or a non-detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection or a connection capable of mutual communication; it can be directly connected, or indirectly connected through an intermediate medium, and can be the communication inside two components, indirect communication or the interaction relationship between two components.

[0030] The following disclosure provides many different embodiments or examples for implementing different solutions of the present invention.

[0031] Referring to the attached Figure 1 to the attached Figure 5 As shown, a gel-based anti-seepage medical dressing based on deformation adsorption and gradient pressurization includes an adsorption layer 1, a gel base layer 2, a pressurization layer 3, and an anti-seepage isolation layer 4 arranged in sequence from inside to outside. The bonding method between each layer can adopt a hot melt adhesive dot coating process.

[0032] In one embodiment of the present invention, the adsorption layer 1 includes an adsorption body 11 with a thickness gradually decreasing from the center to the edge, a number of air holes 12 uniformly distributed in the adsorption body 11, and a plurality of groups of vacuum suction cups uniformly arranged on the lower end surface of the adsorption body 11. The central thickness of the adsorption body 11 is 3 mm, and the edge thickness of the adsorption body 11 is 0.5 mm, that is, a gradient extension structure is realized. The thickness of the adsorption body 11 gradually decreases from 3 mm to 0.5 mm from the center to the edge. Thus, after the adsorption body 11 expands, a radial contraction force is generated in the outer circular adsorption area, and it is experimentally measured to be greater than or equal to 0.8 N / cm.

[0033] In one embodiment of the present invention, the secondary micro-nano structure is shown through SEM images. The diameter of the vacuum suction cup is 200 - 500 μm, and the density is 200 - 500 pieces / cm 2 , and 50 nm grooves are provided on the surface to enhance the adsorption force. By arranging a micro-scale vacuum suction cup array on the lower surface of the adsorption body 11 and referring to the contact angle design of the octopus suction cup θ = 15°, the adsorption design of the bionic octopus foot is realized, thereby increasing the pressure of this medical dressing, ensuring close contact with the patient's skin, and avoiding the weakening of the dressing adsorption, or even the leakage of drainage fluid, contamination of the wound, and local skin maceration and damage.

[0034] In one embodiment of the present invention, a gel plug 21 for filling the puncture point gap is provided on the lower end surface of the gel base layer 2. A leakage hole for accommodating the gel plug 21 is provided at the center of the adsorption body 11. The gel base layer 2 is one or several of the composites formed by acrylate copolymer, chitosan and zinc oxide particles, and it is ensured that the water content is greater than or equal to 80%. Functional modification is carried out by incorporating nano zinc oxide particles with a particle size of 50-100 nm and a proportion of 3-5 wt% to achieve the synergistic improvement of antibacterial and mechanical strength.

[0035] Compared with the traditional hydrophilic dressing that uses the absorption method, if the dressing absorbs a large amount of exudate, it will cause the exudate to not be correctly drained out of the body, thus affecting the accurate statistics of the actual drainage volume. This medical dressing uses the blocking method, and uses the water-resistant gel base layer 2 and the gel plug 21 to block the puncture point gap, and drains the exudate to the external drainage bag, thereby further increasing the anti-seepage property.

[0036] In one embodiment of the present invention, the pressure layer 3 is located between the anti-seepage isolation layer 4 and the gel base layer 2. The pressure layer 3 includes an arched bracket 31 made of shape memory alloy wire, preferably a component made of nitinol alloy. The arched bracket 31 can deform according to the change of the user's body temperature. The pressure linear response area is 36-38 °C, and the pressure fluctuation in the clinical applicable temperature range should be less than ±5%. The specific phase change temperature is 32-35 °C, that is, the arched bracket 31 starts to contract at 32 °C and reaches the maximum deformation at 35 °C, and specifically generates a controllable pressure of 5-15 mmHg. The arched bracket 31 is based on the FEA finite element analysis to optimize the bracket topology structure to achieve the best gradient ratio of the central pressure Pc and the edge pressure Pe at the puncture point satisfying Pc / Pe = 1.5-2.0, realizing precise pressure, preventing the long-term excessive fixation and compression of the pipeline joint, and thus preventing the occurrence of pipeline-related pressure sores.

[0037] In one embodiment of the present invention, after the adsorption body 11 expands, a radial contraction force will be generated in its outer circular adsorption area, and in cooperation with the arched bracket 31, it deforms according to the change of the user's body temperature, and uses the human skin temperature to trigger the intelligent pressurization of the memory alloy wire, which is equivalent to installing a "positive pressure joint" at the puncture point to fit different skin surfaces, so as to offset the pressure increase caused by a large amount of abdominal and thoracic effusion, coughing, activities, etc., and then apply a controllable pressure to the adsorption layer 1 to achieve dynamic sealing, improve the anti-seepage effect and compressive resistance.

[0038] In one embodiment of the present invention, the anti-seepage isolation layer 4 includes an isolation layer body 41, a puncture positioning ring 42 provided on the top of the isolation layer body 41, a scale bar 43 provided on the top of the isolation layer body 41, and a cover body 44 made of a transparent material provided outside the puncture positioning ring 42. Among them, the puncture positioning ring 42 is provided opposite to the leakage hole, and the isolation layer body 41 is composed of a medical-grade polyurethane film with a thickness of 0.05-0.1 mm.

[0039] In one embodiment of the present invention, the puncture positioning ring 42 is arranged at the center of the isolation layer body 41, and is used to adapt to puncture needles with a diameter of 8-14G. Moreover, the diameter tolerance marking of the puncture positioning ring 42 should be adapted to the ISO 9626 standard of 8-14G needles.

[0040] In one embodiment of the present invention, the length of the scale bar 43 is from the center of the puncture positioning ring 42 to the outer circular surface of the isolation layer body 41. The scale bar 43 should be scale lines with a 1 cm spacing set up above, below, left, and right with the puncture point as the midpoint. Moreover, the spacing of the scale bar 43 and the surgical positioning specification should meet the relevant puncture point management requirements.

[0041] In one embodiment of the present invention, the width of the cover body 44 is set to 2-3 cm, that is, a transparency observation window with a width of 2-3 cm outward from the puncture point can directly view a range of 5 mm around the puncture point, which increases the visibility of this medical dressing, facilitates observing the in-position situation of the pipeline and the occurrence of any leakage, and also facilitates observing the skin at the puncture point, the length of the outflow or internal pipeline, and prevents the occurrence of unplanned extubation.

[0042] Although the embodiments of the present invention have been shown and described, those of ordinary skill in the art can understand that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and purposes of the present invention. The scope of the present invention is defined by the claims and their equivalents.

Claims

1. A gel-based impermeable medical dressing based on deformation adsorption and gradient pressurization, characterized in that: It comprises an adsorption layer (1), a gel base layer (2), a pressure layer (3) and an anti-seepage isolation layer (4) which are arranged in sequence from the inside to the outside; The adsorption layer (1) comprises an adsorption body (11) whose thickness gradually decreases from the center to the edge, and a plurality of pores (12) evenly and densely distributed in the adsorption body (11); after the adsorption body (11) expands, the outer circular adsorption area can generate a radial contraction force; The lower end surface of the gel base layer (2) is provided with a gel plug (21) for filling the gap at the puncture point, and the center of the adsorption body (11) is provided with a leakage hole for accommodating the gel plug (21); The pressurizing layer (3) is located between the anti-seepage isolation layer (4) and the gel base layer (2), and the pressurizing layer (3) comprises an arched support (31) made of an alloy material, and the arched support (31) can be deformed according to changes in the user's body temperature to apply a controllable pressure to the adsorption layer (1); The anti-seepage isolation layer (4) comprises an isolation layer body (41) and a puncture positioning ring (42) arranged on the top of the isolation layer body (41), and the puncture positioning ring (42) is arranged directly opposite to the leakage hole.

2. The gel-based impermeable medical dressing based on deformation adsorption and gradient pressurization according to claim 1, characterized in that: The center thickness of the adsorption body (11) is 3 mm, and the edge thickness of the adsorption body (11) is 0.5 mm.

3. The gel-based impermeable medical dressing based on deformation adsorption and gradient pressurization according to claim 1, characterized in that: The adsorption layer (1) further comprises a plurality of groups of vacuum suction cups evenly arranged on the lower end surface of the adsorption body (11).

4. The gel-based impermeable medical dressing based on deformation adsorption and gradient pressurization according to claim 3, characterized in that: The vacuum chuck has a diameter of 200-500 μm.

5. The gel-based impermeable medical dressing based on deformation adsorption and gradient pressurization according to claim 1, characterized in that: The gel base layer (2) comprises one or more of a composite formed by an acrylate copolymer, chitosan and zinc oxide particles.

6. The gel-based impermeable medical dressing based on deformation adsorption and gradient pressurization according to claim 1, characterized in that: The anti-seepage isolation layer (4) further comprises a scale bar (43) arranged on the top of the isolation layer body (41) and a cover body (44) made of a transparent material component arranged on the outside of the puncture positioning ring (42).

7. The gel-based impermeable medical dressing based on deformation adsorption and gradient pressurization according to claim 6, characterized in that: The isolation layer body (41) is a polyurethane material component, and the thickness of the isolation layer body (41) is 0.05-0.1 mm.

8. The gel-based impermeable medical dressing based on deformation adsorption and gradient pressurization according to claim 6, characterized in that: The length of the scale bar (43) is from the center of the puncture positioning ring (42) to the outer circumferential surface of the isolation layer body (41).

9. The gel-based impermeable medical dressing based on deformation adsorption and gradient pressurization according to claim 6, characterized in that: The width of the cover body (44) is 2-3 cm.

10. The gel-based impermeable medical dressing based on deformation adsorption and gradient pressurization according to claim 1, characterized in that: The arched support (31) is a component made of nickel-titanium alloy.

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