A chemotherapy leakage detection patch and a detection method thereof

Abstract

The application discloses a chemotherapy leakage detection patch and a detection method thereof, and belongs to the technical field of medical devices. The patch comprises a substrate layer and a chemical recognition response layer, and the chemical recognition response layer contains a selective response unit encapsulating a visual indicator. The selective response unit is configured to produce a visual signal change when contacting a chemotherapy drug containing a surfactant or an organic solvent, and to maintain signal stability when contacting human sweat. The application utilizes the selective recognition mechanism of the selective response unit for the solubilizing agent of the chemotherapy drug, effectively distinguishes the chemotherapy liquid from sweat, and solves the technical problem that the existing detection patch is easily interfered by sweat to produce false positives.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a visual warning patch for detecting extravasation of chemotherapy drugs and its usage method. Background Technology

[0002] Chemotherapy drug extravasation is a common and serious complication of intravenous tumor therapy, which can lead to local tissue necrosis, ulceration, and functional impairment. The incidence rate varies across different studies and institutions, and it can have severe consequences. Early detection and timely treatment are crucial to mitigating the harm caused by extravasation.

[0003] Currently, commonly used clinical methods for detecting extravasation mainly include: Visual observation: This method relies on nursing staff to regularly observe changes in skin color and swelling around the puncture site. This method is highly subjective and difficult to detect in the early stages when extravasation signals are weak. pH test strip method: This method detects pH changes at the site of leakage. However, pH fluctuations in sweat may overlap with pH changes at the site of leakage, easily leading to false positive results. Temperature sensor method: This method detects leakage by monitoring local temperature changes. However, it requires additional equipment, is costly, and complex to operate. Near-infrared spectroscopy: This method detects extravasation by utilizing changes in the spectral characteristics of tissue components. However, the equipment used is expensive, making rapid bedside detection impossible. Existing technologies suffer from the following common problems: high false positive rate, long response time, strong equipment dependence, and high cost. Therefore, there is an urgent need to develop a detection patch that can effectively distinguish between chemotherapy drugs and sweat, is easy to use, and is inexpensive. Summary of the Invention

[0004] The purpose of this invention is to provide a chemotherapy leakage detection patch and its detection method, which utilizes the chemical recognition function of a selective response unit for specific components in chemotherapy drugs to effectively distinguish between chemotherapy solutions and sweat, thus solving the technical problem that existing detection patches are easily affected by sweat and produce false positives.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: Detection principle: After specific treatment, the wall material or matrix material of the selective response unit has a network structure that repels strongly polar water molecules, making it difficult for water molecules in sweat to penetrate into the interior of the wall material; while the cosolvents in chemotherapy drugs (such as non-polar or weakly polar organic solvents such as polysorbates, ethanol, and propylene glycol) can penetrate the wall material network, causing the wall material to swell or dissolve, thereby releasing a visual indicator to produce a color change.

[0006] Explanation of the composition of sweat: The main component of sweat is a highly polar aqueous solution (reportedly accounting for approximately 95-98% in literature), in addition to sodium chloride, potassium ions, calcium ions, lactic acid, urea, and small amounts of lipids and proteins. Its pH value typically fluctuates between 5.4 and 7.5. In contrast, the co-solvents for chemotherapy drugs are non-polar or weakly polar organic solvents. This significant difference in polarity makes selective identification possible in this invention.

[0007] Explanation of the selective response unit: Selective response units can be implemented in various ways, including but not limited to: Microencapsulation type: The indicator is encapsulated in the wall material, which dissolves or swells when in contact with the cosolvent; Molecularly imprinted polymers: utilize imprinted holes to recognize specific molecules; Immobilized indicator formulation: The indicator is immobilized inside a porous carrier; Photosensitive color-changing material type: Utilizing the color-changing properties of photosensitive materials; Any of the above solutions can achieve the technical effects of the present invention, and those skilled in the art can choose the appropriate solution according to actual needs.

[0008] The beneficial effects of this invention include: Selective identification: effectively distinguishes chemotherapy fluid from sweat, significantly reducing the false positive rate; Easy to use: simply attach it to the skin near the puncture point, and it can be read with the naked eye; no professional equipment is required. Low cost: Raw materials are widely available, and the technology is relatively mature; Wide applicability: It can detect chemotherapy drugs containing various types of solubilizers. Attached Figure Description

[0009] Figure 1 Schematic diagram of the overall structure of the detection patch Figure 2 Schematic diagram of the working principle of the selective response unit Detailed Implementation

[0010] Instructions regarding chemotherapy drug solubilizers: The chemotherapy drug solubilizers referred to in this invention include, but are not limited to: Surfactants: Polysorbate 80 (Tween 80), Polysorbate 20 (Tween 20), Poloxamer 188, Sucrose fatty acid esters, Alkyl glycosides, etc. Organic solvents: ethanol, propylene glycol, glycerol, dimethyl sulfoxide, etc.

[0011] According to literature reports, the following types of chemotherapy drugs may be suitable for this invention: Drugs containing polysorbate 80: such as paclitaxel, docetaxel, etc.; Drugs containing ethanol or propylene glycol: some adjuvant chemotherapy drugs; Other pharmaceutical preparations containing nonpolar or weakly polar organic solvents; Note: Some chemotherapy drugs may not contain the above-mentioned solubilizing ingredients (such as certain solution-type or purely water-soluble formulations), and their leakage may not be detected by this patch. Users are advised to determine whether it is suitable based on the specific properties of the drug.

[0012] Example 1: Microcapsule-type detection patch Base layer: According to literature reports, medical transparent polymer films are usually made of materials such as PET and PU, with a thickness typically in the range of 0.03-0.1mm, which makes it easy for medical staff to observe color changes; Chemical recognition response layer: Visual indicators are encapsulated in gelatin-gum arabic microcapsules using a complex coagulation method. According to literature, the microcapsule particle size prepared by the complex coagulation method is typically in the range of 10-50 μm. The microcapsules are dispersed in a medical polyurethane adhesive at a certain weight ratio (referring to empirical values ​​from similar processes, typically 10%-30%) and coated onto the substrate layer. Skin contact adhesive layer: Utilizes medical-grade acrylic pressure-sensitive adhesive in a ring-shaped distribution. Based on experience with similar dressing products, the diameter of the central detection area is typically within the range of 15-30 mm. Instructions regarding indicator selection: Redox indicators (such as methylene blue) have the advantage of clear color contrast, changing from blue to colorless or light-colored, making them easily distinguishable among people of different skin tones. Acid-base indicators (such as phenol red) also have a clear color contrast, changing from yellow to red. The applicant believes that these two indicators have good technical effects in the application of this invention, but the scope of protection of this invention is not limited thereto. Explanation regarding crosslinking modification of wall materials: To improve the water resistance and chemical stability of the selective response unit, the following crosslinking methods can be used: Option A (Recommended): Thermosetting crosslinking. According to literature, thermosetting is a commonly used method for protein crosslinking. Drying at certain temperatures (e.g., 40-60°C) can cause moderate crosslinking of protein materials such as gelatin. This method requires no chemical crosslinking agents, poses no residual risk, and meets the safety requirements for medical device materials. Option B (safest): Enzymatic cross-linking using food-grade transglutaminase (TG enzyme). According to literature, TG enzyme can catalyze specific cross-linking reactions between protein molecules, achieving mild cross-linking, and is suitable for the food and medical device fields. Option C (Alternative): Glutaraldehyde cross-linking. Glutaraldehyde is a commonly used protein cross-linking agent, and literature reports good cross-linking effects. This option requires multiple water washing and dialysis treatments to ensure that the residual concentration meets the relevant biocompatibility standards of GB / T 16886.

[0013] Explanation regarding the reinforced structure: Reinforcing structures can be incorporated into the edges of the adhesive layer where it contacts the skin, using methods such as semi-transparent reinforcing borders, serrated edges, or mesh structures. Based on design experience with similar patch products, these reinforcing structures help enhance the patch's adhesion to the skin during sweating or activity, reducing the risk of detachment.

[0014] Example 2: Molecularly Imprinted Polymer-Based Detection Patch Base layer: made of transparent PU film; Chemical recognition response layer: Using polysorbate 80 as a template molecule, a molecularly imprinted polymer was prepared by bulk polymerization, and the visualization indicator was immobilized in the polymer pores. According to literature reports, the particle size of the molecularly imprinted polymer is usually in the range of 10-50 μm, and it is dispersed in the binder at a certain weight ratio.

[0015] Example 3: Immobilized indicator-based detection patch Base layer: made of transparent PVC film; Chemical recognition response layer: The immobilized indicator is prepared by adsorbing the mesoporous silica gel and dispersed in the silicone rubber binder at a certain weight ratio.

[0016] Example 4: Colorimetric Reference Scale A colorimetric reference scale can be set on the patch surface or the accompanying card. Based on design experience with similar testing reagents, the color levels can be set to three to five, corresponding to normal conditions, suspicious changes, and significant changes, respectively. Specific color standards and interpretation thresholds need to be determined through clinical validation.

[0017] Example of detection method: Step 1: Before the patient receives chemotherapy, apply the testing patch to the skin on the side of the puncture site. Based on experience with similar patch products, the distance from the puncture site is usually about 1-3 cm. Step 2: During and for a period of time after chemotherapy, follow clinical nursing guidelines and regularly observe changes in the patch color. The routine monitoring interval can be set at 15-30 minutes; the specific interval needs to be determined based on clinical practice. Step 3: If the color change of the patch exceeds the preset threshold, notify the nursing staff for evaluation; Step 4: If the color change of the patch exceeds the significant change threshold, activate the extravasation treatment plan.

[0018] Explanation regarding response time: Based on diffusion kinetics, the response time of the selective response unit may be related to factors such as leakage rate, drug concentration, and contact area. According to literature, microencapsulated response units typically begin to change color within seconds to minutes after contact with organic solvents. The specific response time and detection sensitivity threshold need to be determined through in vitro simulation experiments.

[0019] Explanation regarding shelf life: Based on experience with similar transdermal medical device products, shelf life is typically around 18-24 months. The specific shelf life needs to be determined through accelerated aging tests and real-time stability studies. According to literature, shelf life studies for medical devices usually include comparative verification under accelerated aging conditions (such as 40°C / 75%RH) and real-time aging conditions.

Claims

1. A chemotherapy leakage detection patch, characterized in that, include: Basal layer (1); A chemical recognition response layer (2) is disposed on or within the substrate layer (1), and the chemical recognition response layer (2) contains selective response units (21). The selective response unit (21) is encapsulated with a visual indicator; The selective response unit (21) is configured to generate a visual signal change upon contact with a chemotherapeutic drug containing surfactant components and / or organic solvent components; The selective response unit (21) is configured to maintain a stable signal when in contact with human sweat.

2. A method for detecting chemotherapy extravasation, characterized in that, Includes the following steps: The detection patch as described in claim 1 is attached to the skin near the puncture point; Monitor the color change of the detection patch; When the detection patch undergoes a preset color change, it is determined that chemotherapy drug extravasation has occurred.

3. The detection patch according to claim 1, characterized in that, The selective response unit (21) is at least one of microcapsules, molecularly imprinted polymers, immobilized indicators, or photosensitive color-changing materials.

4. The detection patch according to claim 1, characterized in that, The wall material or matrix material of the selective response unit (21) is selected from hydrophilic natural polymer materials or biodegradable polyester.

5. The detection patch according to claim 1, characterized in that, The visualization indicator is selected from redox indicators or acid-base indicators.

6. The detection patch according to claim 1, characterized in that, The chemical recognition response layer (2) also includes a binder, in which the selective response unit (21) is dispersed.

7. The detection patch according to claim 1, characterized in that, The base layer (1) is a light-transmitting material layer, used to observe the changes in the visualized signal.

8. The detection patch according to claim 1, characterized in that, The detection patch also includes a skin contact adhesive layer (3), which is disposed at the edge region of the chemical recognition response layer (2) or the base layer (1).

9. The detection patch according to claim 8, characterized in that, The skin-contact adhesive layer (3) is distributed in a ring-shaped or semi-ring-shaped manner, forming a detection area without adhesive in the center.

10. The detection patch according to any one of claims 1 to 9, characterized in that, The wall material or matrix material of the selective response unit (21) is cross-linked modified to improve chemical stability and water resistance.

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