Transparent dressing with hemostatic and analgesic functions

The transparent dressing prepared by irradiation crosslinking technology of polyethylene oxide and acrylamide, combined with calcium alginate and lidocaine hydrochloride, solved the bleeding and pain problems at the puncture point during central venous catheterization, and achieved significant hemostasis The effect and good mechanical properties improve the patient's treatment effect and comfort.

CN119280454AInactive Publication Date: 2025-01-10SHANDONG BRANDEN MEDICAL DEVICE
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Patent Information

Application Number
CN202411844734.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-16
Publication Date
2025-01-10
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

During the central venous catheter arrangement, blood seepage at the puncture point, infection at the puncture point and complications caused by pain seriously affect the patient's treatment effect. Existing transparent dressings are difficult to effectively solve the problems of hemostasis and pain relief.

Method used

Using polyethylene oxide and acrylamide irradiation crosslinking technology, calcium alginate and lidocaine hydrochloride are introduced into the crosslinking system to prepare transparent dressings with hemostatic and pain-relieving functions, and through polyurethane dressings, dressing cores, adhesives, and release paper Combined with the release frame, a transparent dressing is formed, and a dressing core is prepared by γ-ray irradiation crosslinking and attached to the middle of the polyurethane dressing.

Benefits of technology

It significantly reduces the coagulation time of the puncture point, has good hemostasis effect and promotes wound healing function, and improves the mechanical properties of the dressing, reduces the incidence of complications, and improves the comfort of the patient.

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Abstract

The dressing consists of a polyurethane dressing, a dressing core, an adhesive, release paper and a release frame, wherein the dressing core is positioned in the middle of the transparent polyurethane dressing. The preparation method of the dressing core comprises the following steps: dissolving polyoxyethylene in water, respectively adding anhydrous isopropanol and a lidocaine hydrochloride aqueous solution under stirring, uniformly mixing, and respectively adding calcium alginate and an acrylamide solution under magnetic stirring. And spin-coating the mixed solution on a polyurethane film, and performing gamma-ray irradiation crosslinking to obtain the dressing core. The dressing core is cut into a required shape and size and then attached to the middle of the polyurethane dressing through medical pressure-sensitive adhesive, and then the transparent dressing with the hemostatic and analgesic functions is obtained after the dressing core is combined with release paper and a release frame through an adhesive.
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Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a transparent dressing with hemostasis and analgesia functions. Background Art

[0002] Since chemotherapy drugs, antibiotics, parenteral nutrition and other infused substances are destructive to human blood vessels, such drugs must be infused through the central vein to avoid damage to the vascular endothelial wall. Peripherally Inserted Central Catheter (PICC) is a medium- and long-term central venous access inserted through the basilic vein, median cubital vein, cephalic vein, and brachial vein of the upper limb, opening a declaration channel for patients with such infusion needs. PICC can effectively avoid repeated punctures of peripheral veins, protect blood vessels, and thus alleviate patient pain. Ultrasound-guided PICC insertion combined with the Seldinger puncture method can effectively improve the success rate of catheterization and reduce the incidence of complications. However, complications caused by bleeding at the puncture site, infection at the puncture site, and pain seriously affect the patient's treatment effect.

[0003] At present, sterile transparent dressings are used to fix the catheter after clinical catheterization, isolate bacterial infection and change the dressing regularly to reduce the incidence of complications at the puncture site. Polyethylene oxide hydrogel has good biocompatibility, wound exudate absorption, and wound adhesion prevention, and can be used as a preparation material for wound dressings. Alginate has a good hemostatic effect. Patent 201510845519.4 The substrate is activated and reacted with chitosan and sodium alginate to obtain an antibacterial hemostatic dressing; the dressing can have a long-lasting antibacterial effect and has good hemostasis, adhesion prevention and wound healing functions. Patent 201511033800.4 The composite antibacterial hemostatic dressing prepared with chitosan, carboxymethyl chitosan and sodium alginate as raw materials has high biocompatibility, can effectively prevent bacteria from entering the wound, and promote skin regeneration. Calcium alginate can react with Na when in contact with blood. + exchange, generate soluble sodium alginate and release Ca 2+ The invention uses polyethylene oxide and acrylamide radiation cross-linking to introduce calcium alginate and lidocaine hydrochloride into the cross-linking system to obtain a transparent dressing with hemostasis and analgesia functions. Summary of the invention

[0004] In order to strengthen the care of the puncture site and reduce the incidence of complications at the puncture site, the present invention prepares a transparent dressing with hemostasis and analgesia functions: A transparent dressing with hemostasis and analgesia function, characterized in that it is composed of a polyurethane dressing, a dressing core, an adhesive, a release paper and a release frame, wherein the dressing core is located in the middle of the transparent dressing, and the preparation method of the dressing core is as follows: Step 1: Take m parts of polyethylene oxide and dissolve it in water, add anhydrous isopropanol and stir evenly, then add lidocaine hydrochloride aqueous solution, and add calcium alginate under magnetic stirring; Step 2: Take n parts of acrylamide and dissolve them in water, stir them evenly, then add them to the solution in step 1 and stir them evenly with a magnetic stirrer; Step 3: Take the solution obtained in step 2, spin-coat it on a polyurethane film, and then irradiate and cross-link it with gamma rays to obtain a dressing core; Step 4: Cut the dressing core obtained in step 3 into the required shape and size and attach it to the middle of the polyurethane dressing with a medical pressure-sensitive adhesive, and then combine the adhesive with the release paper and the release frame to obtain a transparent dressing with hemostasis and analgesia functions;

[0005] Preferably, the mass of the anhydrous isopropanol in step 1 is 6%-9% of the mass of the polyethylene oxide;

[0006] Preferably, the mass of lidocaine hydrochloride in step 1 is 20%-40% of the mass of polyethylene oxide;

[0007] Preferably, the molar ratio of polyethylene oxide to acrylamide is m:n 1:(3-6);

[0008] Preferably, the molecular weight of the polyethylene oxide is 300,000 to 600,000;

[0009] Preferably, the mass of calcium alginate in step 1 is 10%-20% of the mass of polyethylene oxide;

[0010] Preferably, the gamma ray irradiation dose in step 3 is 30-70 kGy;

[0011] Preferably, the γ-ray irradiation time in step 3 is 0.05-0.3s;

[0012] Preferably, the thickness of the dressing core in step 3 is 0.2-2 mm.

[0013] The dressing of the present invention is composed of a polyurethane dressing, a dressing core, an adhesive, a release paper and a release frame, and the dressing core is located in the middle of a transparent polyurethane dressing. The dressing core preparation method is as follows: after polyethylene oxide is dissolved in water, anhydrous isopropyl alcohol and a lidocaine hydrochloride aqueous solution are added under stirring respectively, and after uniform mixing, calcium alginate and acrylamide solution are added under magnetic stirring respectively. The mixed solution is spin-coated on a polyurethane film and cross-linked by γ-ray irradiation to obtain a dressing core. After the dressing core is cut into a desired shape and size, it is attached to the middle of the polyurethane dressing by a medical pressure-sensitive adhesive, and then a transparent dressing with hemostatic and analgesic functions is obtained by combining the adhesive with the release paper and the release frame. The dressing preparation method of the present invention is simple and has obvious hemostatic and analgesic effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1It is a transparent dressing with hemostatic and analgesic functions. Front view; Figure 2 It is a transparent dressing with hemostatic and analgesic functions. Back view; Among them, 1-polyurethane dressing, 2-dressing core, 3-release paper, 4-release frame. DETAILED DESCRIPTION

[0015] In order to better illustrate the present invention, the technical solution of the present invention is described below in conjunction with the embodiments of the present invention.

[0016] Example 1 Step 1: Dissolve 1 part of polyethylene oxide in water, add anhydrous isopropanol with a polyethylene oxide mass fraction of 6%, stir evenly, then add an aqueous solution of lidocaine hydrochloride with a polyethylene oxide mass fraction of 20%, and add calcium alginate with a polyethylene oxide mass fraction of 10% under magnetic stirring; Step 2: Dissolve 3 parts of acrylamide in water, stir well, then add to the solution in step 1 and stir evenly with a magnetic stirrer; Step 3: Take the solution obtained in step 2, spin-coat it on a polyurethane film, and then irradiate it with γ-rays of 30 kGy intensity for 0.05 s to prepare a dressing core 2 with a thickness of 0.2 mm by irradiation cross-linking; Step 4: Cut the dressing core 2 obtained in step 3 into the required shape and size and attach it to the middle of the polyurethane dressing 1 through a medical pressure-sensitive adhesive, and then combine it with the release paper 3 and the release frame 4 through the adhesive to obtain a transparent dressing with hemostatic and analgesic functions.

[0017] Example 2 Step 1: Dissolve 1 part of polyethylene oxide in water, add anhydrous isopropanol with a polyethylene oxide mass fraction of 9%, stir evenly, then add an aqueous solution of lidocaine hydrochloride with a polyethylene oxide mass fraction of 40%, and add calcium alginate with a polyethylene oxide mass fraction of 20% under magnetic stirring; Step 2: Dissolve 6 parts of acrylamide in water, stir well, then add to the solution in step 1 and stir evenly with a magnetic stirrer; Step 3: Take the solution obtained in step 2, spin-coat it on a polyurethane film, and then irradiate it with γ-rays of 70 kGy intensity for 0.15 s to prepare a dressing core 2 with a thickness of 2 mm by irradiation cross-linking; Step 4: Cut the dressing core 2 obtained in step 3 into the required shape and size and attach it to the middle of the polyurethane dressing 1 through a medical pressure-sensitive adhesive, and then combine it with the release paper 3 and the release frame 4 through the adhesive to obtain a transparent dressing with hemostatic and analgesic functions.

[0018] Example 3 Step 1: Dissolve 1 part of polyethylene oxide in water, add anhydrous isopropanol with a polyethylene oxide mass fraction of 8%, stir evenly, then add an aqueous solution of lidocaine hydrochloride with a polyethylene oxide mass fraction of 30%, and add calcium alginate with a polyethylene oxide mass fraction of 15% under magnetic stirring; Step 2: Dissolve 5 parts of acrylamide in water, stir evenly, then add to the solution in step 1 and stir evenly with a magnetic stirrer; Step 3: Take the solution obtained in step 2, spin-coat it on a polyurethane film, and then irradiate it with γ-rays of 40 kGy intensity for 0.1 s to prepare a dressing core 2 with a thickness of 1 mm by irradiation cross-linking; Step 4: Cut the dressing core 2 obtained in step 3 into the required shape and size and attach it to the middle of the polyurethane dressing 1 through a medical pressure-sensitive adhesive, and then combine it with the release paper 3 and the release frame 4 through the adhesive to obtain a transparent dressing with hemostatic and analgesic functions.

[0019] Comparative Example 1 Step 1: Dissolve 1 part of polyethylene oxide in water, add anhydrous isopropanol with a polyethylene oxide mass fraction of 8%, stir evenly, then add an aqueous solution of lidocaine hydrochloride with a polyethylene oxide mass fraction of 30%, and add calcium alginate with a polyethylene oxide mass fraction of 15% under magnetic stirring; Step 2: Dissolve 5 parts of acrylamide in water, stir evenly, then add to the solution in step 1 and stir evenly with a magnetic stirrer; Step 3: Take the solution obtained in step 2, spin-coat it on a polyurethane film, and then irradiate it with γ-rays of 20 kGy intensity for 0.15 s to prepare a dressing core 2 with a thickness of 1 mm by irradiation cross-linking; Step 4: Cut the dressing core 2 obtained in step 3 into the required shape and size and attach it to the middle of the polyurethane dressing 1 through a medical pressure-sensitive adhesive, and then combine it with the release paper 3 and the release frame 4 through the adhesive to obtain a transparent dressing with hemostatic and analgesic functions.

[0020] Comparative Example 2 Step 1: Dissolve 1 part of polyethylene oxide in water, add anhydrous isopropanol with a polyethylene oxide mass fraction of 8%, stir evenly, and then add an aqueous solution of lidocaine hydrochloride with a polyethylene oxide mass fraction of 30%; Step 2: Dissolve 5 parts of acrylamide in water, stir evenly, then add to the solution in step 1 and stir evenly with a magnetic stirrer; Step 3: Take the solution obtained in step 2, spin-coat it on a polyurethane film, and then irradiate it with γ-rays of 40 kGy intensity for 0.1 s to prepare a dressing core 2 with a thickness of 1 mm by irradiation cross-linking; Step 4: Cut the dressing core 2 obtained in step 3 into the required shape and size and attach it to the middle of the polyurethane dressing 1 through a medical pressure-sensitive adhesive, and then combine it with the release paper 3 and the release frame 4 through the adhesive to obtain a transparent dressing with hemostatic and analgesic functions.

[0021] Comparative Example 3 Step 1: Dissolve 1 part of polyethylene oxide in water, add anhydrous isopropanol with a polyethylene oxide mass fraction of 8%, stir evenly, then add an aqueous solution of lidocaine hydrochloride with a polyethylene oxide mass fraction of 30%, and add calcium alginate with a polyethylene oxide mass fraction of 15% under magnetic stirring; Step 2: Dissolve 5 parts of acrylamide in water, stir evenly, then add to the solution in step 1 and stir evenly with a magnetic stirrer; Step 3: Take the solution obtained in step 2, spin-coat it on a polyurethane film, and then irradiate it with 80 kGy gamma rays for 0.2 s to prepare a dressing core 2 with a thickness of 1 mm by irradiation cross-linking; Step 4: Cut the dressing core 2 obtained in step 3 into the required shape and size and attach it to the middle of the polyurethane dressing 1 through a medical pressure-sensitive adhesive, and then combine it with the release paper 3 and the release frame 4 through the adhesive to obtain a transparent dressing with hemostatic and analgesic functions.

[0022] Example 4 In vitro coagulation experiment: Take 4 test tubes, add 5 mL of rabbit blood to each, add 2 g of the hemostatic and analgesic transparent dressing core prepared in Example 1-3 and 2 g of a blank dressing to each, tilt the test tube every few seconds, and record the blood coagulation time. The experimental results are as follows: sample Example 1 Example 2 Example 3 Comparative Example 1 Comparative Example 2 Comparative Example 3 Blank Dressing Coagulation time 89s 91s 94s 90s 320s 82s 430s It can be seen from the data in the table that the dressing prepared by the method of the present invention has a significantly reduced coagulation time and has an obvious hemostatic effect.

[0023] Example 5 The dressing core 2 obtained in Examples 1-3 and Comparative Examples 1-4 was tested for tensile strength and elongation at break using a tensile testing machine. The results are as follows: sample Example 1 Example 2 Example 3 Comparative Example 1 Comparative Example 2 Comparative Example 3 Tensile strength (Mpa) 0.48 0.52 0.46 0.12 0.71 0.14 Elongation at break (%) 560 574 536 237 682 253 It can be seen from the data in the table that the dressing core 2 prepared in Examples 1-3 has good mechanical properties, which is not only conducive to later processing and manufacturing, but also can improve the comfort of patients.

Claims

1. A transparent dressing with hemostasis and analgesia function, characterized in that: It consists of a polyurethane dressing, a dressing core, a release paper and a release frame. The dressing core is located in the middle of the transparent dressing. The preparation method of the dressing core is as follows: Step 1: Take m parts of polyethylene oxide and dissolve it in water, add anhydrous isopropanol and stir evenly, then add lidocaine hydrochloride aqueous solution, and add calcium alginate under magnetic stirring; Step 2: Take n parts of acrylamide and dissolve them in water, stir them evenly, then add them to the solution in step 1 and stir them evenly with a magnetic stirrer; Step 3: Take the solution obtained in step 2, spin-coat it on a polyurethane film, and then irradiate and cross-link it with gamma rays to obtain a dressing core; Step 4: cutting the dressing core obtained in step 3 into the required shape and size and attaching it to the middle of the polyurethane dressing through a medical pressure-sensitive adhesive, and then combining the adhesive with the release paper and the release frame to obtain a transparent dressing with hemostatic and analgesic functions; wherein the mass of the anhydrous isopropyl alcohol in step 1 is 6%-9% of the mass of polyethylene oxide, the mass of the lidocaine hydrochloride is 20%-40% of the mass of polyethylene oxide, the molar ratio m:n of the polyethylene oxide to acrylamide is 1:(3-6), the molecular weight of the polyethylene oxide is 300,000-600,000, and the mass of the calcium alginate is 10%-20% of the mass of the polyethylene oxide.

2. The transparent dressing with hemostasis and analgesia function according to claim 1 is characterized in that: The gamma ray irradiation dose in step 3 is 30-70 kGy.

3. The transparent dressing with hemostasis and analgesia function according to claim 1 is characterized in that: The gamma ray irradiation time in step 3 is 0.05-0.15s.

4. The transparent dressing with hemostasis and analgesia function according to claim 1 is characterized in that: The thickness of the dressing core in step 3 is 0.2-2 mm.

Citation Information

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