A hydrocolloid dressing and an arteriovenous fistula wound dressing and use thereof

Abstract

The application provides a hydrocolloid dressing and an arteriovenous fistula wound dressing and application thereof, and belongs to the technical field of medical dressings.The preparation raw materials of the hydrocolloid dressing include SEBS thermoplastic elastomer, chitosan quaternary ammonium salt, polyanionic compound, tackifying resin, antioxidant and thymol.The chitosan quaternary ammonium salt and thymol in the hydrocolloid dressing synergize to achieve good bacteriostatic effect;simultaneously, the hydrocolloid dressing can effectively absorb wound exudate and promote wound healing.The gauze in the arteriovenous fistula wound dressing can keep the wound dry, the far infrared physiotherapy patch can relieve swelling and vascular spasm, reduce the pain of patients, and is favorable for clinical popularization and application.

Description

Technical Field

[0001] This invention relates to the field of medical dressing technology, and more particularly to a hydrocolloid dressing and an arteriovenous fistula wound dressing and their applications. Background Technology

[0002] Hemodialysis (HD) is a renal replacement therapy for patients with acute and chronic renal failure. It involves draining blood from the body and passing it through a dialyzer composed of numerous hollow fibers. The blood exchanges substances with a solution containing electrolytes at similar concentrations to those in the body (dialysis fluid) through diffusion and convection within the hollow fibers. This process removes metabolic waste products, maintains electrolyte and acid-base balance, and removes excess water. The purified blood is then returned to the body.

[0003] An abnormal passage between an artery and a vein is called an arteriovenous fistula (AVC). An artery near the wrist in the forearm is sutured to a nearby vein, allowing arterial blood to flow through the anastomosed vein, forming an AVC. AVCs are primarily used for hemodialysis. This type of fistula provides sufficient blood for hemodialysis, ensuring the adequacy of the treatment. However, AVC wounds can cause redness, swelling, heat, and pain at the fistula site or along the vein's course. If infection occurs at the anastomosis site post-surgery, there is a possibility of rupture and bleeding. Severe local infection of the AVC can lead to abscesses, and uncontrolled ascending infection can cause phlebitis and systemic infection, resulting in sepsis. Persistent vasospasm combined with post-operative damage to the vascular endothelium can lead to secondary thrombosis. Existing hydrocolloid dressings have problems with antibacterial properties and poor absorbency, failing to effectively prevent infection and relieve vasospasm. Summary of the Invention

[0004] The purpose of this invention is to provide a wound dressing for arteriovenous fistulas that can prevent infection of the wound and relieve vasospasm.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0006] This invention provides a hydrocolloid dressing made from the following raw materials in parts by weight: 30-40 parts of SEBS thermoplastic elastomer, 28-38 parts of chitosan quaternary ammonium salt, 20-30 parts of polyanionic compound, 5-10 parts of tackifying resin, 0.5-1.5 parts of antioxidant, and 0.1-1 parts of thymol.

[0007] Preferably, the polyanionic compound is at least one selected from sodium carboxymethyl cellulose, sodium alginate, pectin, carrageenan, and xanthan gum.

[0008] Preferably, the tackifying resin is at least one of rosin glycerol ester, disproportionated rosin ester, and C5 resin.

[0009] Preferably, the antioxidant is at least one selected from 2,6-di-tert-butylcresol, 2,5-di-tert-butylquinoline, and pentaerythritol tetrakis(β-3,5-di-tert-butyl-4-hydroxy)phenylpropionate.

[0010] Preferably, the thickness of the hydrocolloid dressing is 1 to 2 mm.

[0011] The present invention also provides a method for preparing the hydrocolloid dressing, comprising the following steps:

[0012] (1) Stir the SEBS thermoplastic elastomer at 180-220°C until it is completely melted, then mix it with the tackifying resin and continue stirring to obtain mixture A;

[0013] (2) Mix chitosan quaternary ammonium salt, polyanionic compound, antioxidant and thymol and add them to mixture A while stirring to obtain mixture B;

[0014] (3) After the mixture B obtained in step (2) is shaped, it is placed on the backing layer and the back is covered with a release layer to obtain the hydrocolloid dressing.

[0015] The present invention also provides an arteriovenous fistula wound dressing, the arteriovenous fistula wound dressing comprising gauze, the aforementioned hydrocolloid dressing, and far-infrared physiotherapy patch;

[0016] The hydrocolloid dressing is in sheet form, with gauze placed on one side and a far-infrared therapy patch attached to the other side.

[0017] Preferably, the far-infrared therapy patches are arranged in parallel, and the distance between two adjacent far-infrared therapy patches is 1 to 2 cm.

[0018] The present invention also provides the application of the hydrocolloid dressing or the arteriovenous fistula wound dressing in the preparation of medical materials that promote wound healing and wound repair.

[0019] By adopting the above technical solution, the present invention has the following beneficial effects: the chitosan quaternary ammonium salt and thymol in the hydrocolloid dressing of the present invention work synergistically to achieve a good antibacterial effect; at the same time, the hydrocolloid dressing can effectively absorb wound exudate and promote wound healing. The gauze in the arteriovenous fistula wound dressing of the present invention can keep the wound dry, and the far-infrared physiotherapy patch can relieve swelling and vasospasm, reduce patient pain, and is conducive to clinical application. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of an arteriovenous fistula.

[0021] Figure 2 This is a top view of the dressing for an arteriovenous fistula wound.

[0022] Figure 3 This is a top view of the dressing for an arteriovenous fistula wound. Detailed Implementation

[0023] This invention provides a hydrocolloid dressing made from the following raw materials in parts by weight: 30-40 parts of SEBS thermoplastic elastomer, 28-38 parts of chitosan quaternary ammonium salt, 20-30 parts of polyanionic compound, 5-10 parts of tackifying resin, 0.5-1.5 parts of antioxidant, and 0.1-1 parts of thymol.

[0024] In the raw materials of the hydrocolloid dressing of the present invention, the weight parts of SEBS thermoplastic elastomer are 30 to 40 parts, more preferably 33 to 38 parts, and more preferably 35 parts;

[0025] The chitosan quaternary ammonium salt is present in 28 to 38 parts by weight, more preferably 30 to 36 parts, and even more preferably 33 parts;

[0026] The polyanionic compound is present in 20 to 30 parts by weight, more preferably 22 to 37 parts, and even more preferably 35 parts;

[0027] The tackifying resin is 5 to 10 parts by weight, more preferably 6 to 9 parts, and more preferably 8 parts;

[0028] The antioxidant is present in 0.5 to 1.5 parts by weight, more preferably 0.8 to 1.2 parts, and even more preferably 1 part;

[0029] The thymol is present in 0.1 to 1 part by weight, more preferably 0.3 to 0.8 parts, and even more preferably 0.5 parts.

[0030] In this invention, chitosan quaternary ammonium salt has antibacterial, anti-inflammatory, and anti-exudation effects.

[0031] In this invention, the polyanionic compound is at least one of sodium carboxymethyl cellulose, sodium alginate, pectin, carrageenan, and xanthan gum, and its purpose is to absorb water and keep the wound dry.

[0032] In this invention, the tackifying resin is at least one of rosin glycerol ester, disproportionated rosin ester, and C5 resin.

[0033] In this invention, the antioxidant is at least one of 2,6-di-tert-butylcresol, 2,5-di-tert-butylquinoline, and pentaerythritol tetrakis(β-3,5-di-tert-butyl-4-hydroxy)phenylpropionate.

[0034] The thymol of this invention acts as an antibacterial agent, and the synergistic effect of thymol and chitosan quaternary ammonium salt results in a significant antibacterial effect.

[0035] The thickness of the hydrocolloid dressing of the present invention is 1-2 mm, more preferably 1.2-1.8 mm, and even more preferably 1.5 mm.

[0036] The method for preparing the hydrocolloid dressing of the present invention includes the following steps:

[0037] (1) Stir the SEBS thermoplastic elastomer at 180-220°C until it is completely melted, then mix it with the tackifying resin and continue stirring to obtain mixture A;

[0038] (2) Mix chitosan quaternary ammonium salt, polyanionic compound, antioxidant and thymol and add them to mixture A while stirring to obtain mixture B;

[0039] (3) After the mixture B obtained in step (2) is shaped, it is placed on the backing layer and the back is covered with a release layer to obtain the hydrocolloid dressing.

[0040] This invention involves stirring SEBS thermoplastic elastomer under heating conditions. The stirring temperature is 180–220°C, more preferably 190–210°C, and even more preferably 200°C. The stirring speed is 100–120 rpm, more preferably 105–115 rpm, and even more preferably 110 rpm. This operation is preferably carried out in an internal mixer. After complete melting, a thickening resin is added to the internal mixer, and stirring continues until the mixture is homogeneous, yielding mixture A.

[0041] After mixing chitosan quaternary ammonium salt, polyanionic compound, antioxidant, and thymol, add it to mixture A while stirring until homogeneous to obtain mixture B.

[0042] Mixture B is placed in a flat vulcanizing machine for vulcanization and molding. The temperature of the flat vulcanizing machine is 130–150°C, more preferably 135–145°C, and even more preferably 140°C. The vulcanization time is 20–30 min, more preferably 22–28 min, and even more preferably 25 min. When cooled to 25–30°C, the molded hydrocolloid is placed on a backing layer, and a release layer is applied to the back to obtain the hydrocolloid dressing. The backing layer is preferably a polymer film, and the release layer is preferably a polymer film or glassine paper.

[0043] The present invention also provides an arteriovenous fistula wound dressing, the arteriovenous fistula wound dressing comprising gauze, the aforementioned hydrocolloid dressing, and far-infrared physiotherapy patch;

[0044] The hydrocolloid dressing is in sheet form, with gauze placed on one side and a far-infrared therapy patch attached to the other side. Gauze is placed in the middle of the side of the hydrocolloid dressing facing upwards, and a far-infrared therapy patch is attached to the side of the hydrocolloid dressing facing downwards. The far-infrared therapy patch is long and narrow.

[0045] The far-infrared therapy patches of this invention are arranged in parallel, with the distance between two adjacent patches being 1-2 cm, more preferably 1.2-1.8 cm, and even more preferably 1.5 cm. The gap between two patches is used to observe bleeding.

[0046] The gauze absorbs blood seepage, the hydrocolloid dressing absorbs inflammatory exudate, keeping the wound dry and providing local anti-inflammatory and analgesic effects, while the far-infrared heat patch relieves vasospasm. The combined effect of these three elements keeps the wound dry and sterile, while also reducing local swelling and vasospasm, effectively promoting the healing of infected arteriovenous fistula wounds.

[0047] The present invention also provides the application of the hydrocolloid dressing or the arteriovenous fistula wound dressing in the preparation of medical materials that promote wound healing and wound repair.

[0048] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0049] The far-infrared therapy patch in this embodiment of the invention is the Yunnan Baiyao Taibang Plaster Far-infrared Therapy Patch.

[0050] Example 1

[0051] In this embodiment, the hydrocolloid dressing is made from the following raw materials by weight:

[0052] SEBS thermoplastic elastomer 30g, chitosan quaternary ammonium salt 28g, sodium carboxymethyl cellulose 20g, rosin glycerol ester 5g, 2,6-di-tert-butylcresol 0.5g, thymol 0.1g.

[0053] SEBS thermoplastic elastomer was added to a mixer and heated and stirred at 180°C and 100 rpm until it was completely melted. Then, rosin glycerol ester was added to the mixer and stirred until it was mixed evenly to obtain mixture A.

[0054] Mix chitosan quaternary ammonium salt, sodium carboxymethyl cellulose, 2,6-di-tert-butylcresol, and thymol, and add them to mixture A while stirring until homogeneous to obtain mixture B.

[0055] Mixture B was placed in a flat vulcanizing machine and vulcanized at 130°C for 20 minutes. It was then cooled to 25°C and molded. The molded hydrocolloid was placed on a polymer film, covered with glassine paper on the back, and cut to obtain a hydrocolloid dressing with a thickness of 1 mm.

[0056] Place the gauze in the middle of the hydrocolloid dressing, cut the far-infrared therapy patch into a long strip, and attach it parallel to the other side of the hydrocolloid dressing. The distance between the two far-infrared therapy patches is 1cm, thus obtaining the arteriovenous fistula wound dressing.

[0057] Example 2

[0058] In this embodiment, the hydrocolloid dressing is made from the following raw materials by weight:

[0059] SEBS thermoplastic elastomer 35g, chitosan quaternary ammonium salt 32g, sodium alginate 25g, disproportionated rosin ester 8g, 2,5-di-tert-butylquinoline 1.0g, thymol 0.5g.

[0060] SEBS thermoplastic elastomer was added to a mixer and heated and stirred at 190°C and 110 rpm until it was completely melted. Then, rosin glycerol ester was added to the mixer and stirred until it was mixed evenly to obtain mixture A.

[0061] Chitosan quaternary ammonium salt, sodium carboxymethyl cellulose, 2,5-di-tert-butylquinoline, and thymol were mixed and added to mixture A while stirring until homogeneous, resulting in mixture B.

[0062] Mixture B was placed in a flat vulcanizing machine and vulcanized at 140°C for 25 minutes. It was then cooled to 28°C and molded. The molded hydrocolloid was placed on a polymer film, covered with glassine paper on the back, and cut into the required size to obtain a hydrocolloid dressing with a thickness of 1.5 mm.

[0063] Place the gauze in the middle of the hydrocolloid dressing, cut the far-infrared therapy patch into a long strip, and attach it parallel to the other side of the hydrocolloid dressing. The distance between the two far-infrared therapy patches is 1.5cm, thus obtaining the arteriovenous fistula wound dressing.

[0064] Example 3

[0065] In this embodiment, the hydrocolloid dressing is made from the following raw materials by weight:

[0066] SEBS thermoplastic elastomer 40g, chitosan quaternary ammonium salt 38g, xanthan gum 30g, C5 resin 10g, pentaerythritol tetrakis(β-3,5-di-tert-butyl-4-hydroxyphenylpropionate) 1.5g, thymol 1.0g.

[0067] SEBS thermoplastic elastomer was added to a mixer and heated and stirred at 200°C and 120 rpm until it was completely melted. Then, rosin glycerol ester was added to the mixer and stirred until it was mixed evenly to obtain mixture A.

[0068] Chitosan quaternary ammonium salt, sodium carboxymethyl cellulose, pentaerythritol tetrakis(β-3,5-di-tert-butyl-4-hydroxyphenylpropionate), and thymol were mixed and added to mixture A while stirring until homogeneous, thus obtaining mixture B.

[0069] Mixture B is placed in a flat vulcanizing machine and vulcanized at 150°C for 30 minutes. It is then cooled to 30°C to form a hydrocolloid. The formed hydrocolloid is placed on a polymer film, covered with glassine paper on the back, and cut into the required size to obtain a hydrocolloid dressing with a thickness of 2 mm.

[0070] Place the gauze in the middle of the hydrocolloid dressing, cut the far-infrared therapy patch into a long strip, and attach it parallel to the other side of the hydrocolloid dressing. The distance between the two far-infrared therapy patches is 2cm, thus obtaining the arteriovenous fistula wound dressing.

[0071] Comparative Example 1

[0072] Unlike Example 1, the hydrocolloid dressing of Comparative Example 1 did not contain chitosan quaternary ammonium salt.

[0073] Comparative Example 2

[0074] Unlike Example 1, the hydrocolloid dressing in Comparative Example 2 did not contain thymol.

[0075] Comparative Example 3

[0076] Unlike Example 1, the sodium carboxymethyl cellulose weighs 12g.

[0077] Comparative Example 4

[0078] Unlike Example 1, the sodium carboxymethyl cellulose weighs 20g.

[0079] Comparative Example 5

[0080] Unlike Example 1, the arteriovenous fistula wound dressing in Comparative Example 5 does not contain far-infrared physiotherapy patches.

[0081] Experimental Example 1: Antibacterial Test of Hydrocolloid Dressing

[0082] 1. Test strains: Staphylococcus aureus ATCC27692, Pseudomonas aeruginosa ATCC27317 and Candida albicans ATCC18814.

[0083] 2. Experimental Method: The antibacterial hydrocolloid dressings prepared in Examples 1-3 and Comparative Examples 1-2 were uniformly cut into 1.0*1.0cm pieces and placed in Erlenmeyer flasks. Then, equal volumes of phosphate buffer and three different bacterial suspensions were added to each flask, ensuring the concentration of the bacterial suspensions in PBS was 1×10⁻⁶. 4 ~9×10 4The concentration of CFU / mL was measured. The Erlenmeyer flask was fixed on a shaking table and shaken at 200 rpm for 1 hour. Samples were taken before and after shaking, diluted appropriately with PBS, and inoculated into Petri dishes using the agar pouring method. Colony counting was performed. The inhibition rate was the ratio of the difference in the average number of colonies before and after shaking to the average number of colonies before shaking, expressed as a percentage. The test results are shown in Table 1.

[0084] Table 1. Results of antibacterial experiments on hydrocolloid dressings

[0085]

[0086] As shown in Table 1, the hydrocolloid dressings prepared in Examples 1-3 all showed good inhibitory effects on Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans. Furthermore, the inhibition rates of Examples 1-3 on Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans were significantly higher than those in Comparative Examples 1 and 2, indicating that the chitosan quaternary ammonium salt and thymol of the present invention have a synergistic antibacterial effect.

[0087] Experiment Example 2: Liquid Absorption and Air Permeability Test of Hydrocolloid Dressings

[0088] The hydrocolloid dressings prepared in Examples 1-3 and Comparative Examples 1-2 were tested for various properties, including liquid absorption (YY / T0471.1-2004) and water vapor transmission (YY / T0148-2006 Appendix C). The test results are shown in Table 2.

[0089] Table 2. Performance test results of hydrocolloid dressings

[0090]

[0091] As shown in Table 2, the liquid absorption of the hydrocolloid dressings prepared in Examples 1-3 reached 2858 g / m³. 3 The water vapor permeability of all of the above reached 1153 g / m³. 3 That's all. Compared to the comparative examples, Comparative Examples 3 and 4, by changing the ratio of SEBS thermoplastic elastomer and polyanionic compound, significantly reduced the liquid absorption and water vapor permeation of the resulting hydrocolloids.

[0092] Experimental Example 3: Clinical Trial

[0093] Sixty patients with arteriovenous fistulas were selected as the study subjects and randomly divided into eight groups of 20 patients each. Each group used the arteriovenous fistula wound dressings prepared in Examples 1-3 and Comparative Examples 1-5 of this invention for 10 days. The clinical efficacy of the treatment was observed in the eight groups, and the patients were categorized into three groups: cured, improved, and ineffective. Judgment criteria:

[0094] Healed: The skin wound healed, the infected ulcer disappeared, and there was no pain, swelling, or vasospasm.

[0095] Improvement: The sinus tract becomes shallower, granulation tissue grows, the wound area shrinks significantly, the infected ulcer area shrinks, and pain, swelling, and vasospasm are relieved;

[0096] Ineffective: The wound did not shrink, and bleeding, infection, thrombosis, etc. occurred after the arteriovenous fistula surgery, with no improvement or even deterioration. The treatment results are shown in Table 3.

[0097] Table 3 Clinical trial results

[0098]

[0099]

[0100] As shown in Table 3, the arteriovenous fistula wound dressing of the present invention has an efficacy rate of over 95%, and more than 80% of patients reported relief from swelling and vasospasm after use. In contrast, comparative examples 1-4 only had an efficacy rate of 60-75%. Comparative example 5's arteriovenous fistula wound dressing lacked a far-infrared therapy patch; although it had a reasonable effect on promoting wound healing, patients reported no relief from swelling and vasospasm. Therefore, comparative example 5's arteriovenous fistula wound dressing cannot alleviate patient suffering and is not suitable for clinical application.

[0101] As can be seen from the above embodiments, the present invention provides a hydrocolloid dressing and an arteriovenous fistula wound dressing and their applications. The hydrocolloid dressing of the present invention contains chitosan quaternary ammonium salt and thymol, which can exert a good antibacterial effect. The hydrocolloid dressing of the present invention has good absorption capacity for wound exudate, promoting wound healing. The gauze in the arteriovenous fistula wound dressing of the present invention can keep the wound dry, and the far-infrared physiotherapy patch can relieve swelling and vascular spasm, reducing patient pain, which is beneficial for clinical application.

[0102] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A hydrocolloid dressing, characterized in that, It is made from the following raw materials in parts by weight: 30-40 parts of SEBS thermoplastic elastomer, 28-38 parts of chitosan quaternary ammonium salt, 20-30 parts of polyanionic compound, 5-10 parts of tackifying resin, 0.5-1.5 parts of antioxidant, and 0.1-1 parts of thymol; The polyanionic compound is at least one of sodium carboxymethyl cellulose, sodium alginate, pectin, carrageenan, and xanthan gum; The tackifying resin is at least one of rosin glycerol ester, disproportionated rosin ester, and C5 resin; The antioxidant is at least one of 2,6-di-tert-butylcresol, 2,5-di-tert-butylquinoline, and pentaerythritol tetrakis(β-3,5-di-tert-butyl-4-hydroxyphenylpropionate); The hydrocolloid dressing is used for arteriovenous fistula wounds.

2. The hydrocolloid dressing according to claim 1, characterized in that: The thickness of the hydrocolloid dressing is 1~2mm.

3. The method for preparing the hydrocolloid dressing according to claim 1 or 2, characterized in that, Includes the following steps: (1) Stir the SEBS thermoplastic elastomer at 180~220℃ until it is completely melted, then mix it with the tackifying resin and continue stirring to obtain mixture A; (2) Mix chitosan quaternary ammonium salt, polyanionic compound, antioxidant and thymol, and add them to mixture A while stirring to obtain mixture B; (3) After the mixture B obtained in step (2) is shaped, it is placed on the backing layer and the back is covered with a release layer to obtain the hydrocolloid dressing.

4. A wound dressing for arteriovenous fistulas, characterized in that, The arteriovenous fistula wound dressing includes gauze, the hydrocolloid dressing as described in claim 1 or 2, and far-infrared physiotherapy patch. The hydrocolloid dressing is in sheet form, with gauze placed on one side and a far-infrared therapy patch attached to the other side.

5. The arteriovenous fistula wound dressing according to claim 4, characterized in that, The far-infrared therapy patches are arranged in parallel, with a distance of 1-2 cm between two adjacent far-infrared therapy patches.

6. The use of the hydrocolloid dressing of claim 1 or 2 or the arteriovenous fistula wound dressing of claim 4 in the preparation of medical materials that promote wound healing and wound repair.

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