Thermosensitive catheter fixing patch and preparation method thereof

Abstract

The invention provides a thermo-sensitive catheter fixing patch and a preparation method thereof. The thermo-sensitive catheter fixing patch is used for solving the problem that a catheter fixing patch cannot be firmly fixed when being pasted and is easy to take down when being detached. The invention relates to a temperature-sensitive catheter fixing patch and a preparation method thereof, the fixing patch is composed of a hydrogel main body, the hydrogel main body is completely or partially made of temperature-sensitive gel, and a catheter hole penetrating through the upper surface and the lower surface is formed in the center of the hydrogel main body and used for placing and fixing a catheter. One side of the catheter hole extends outwards to form a leading-in groove penetrating through the upper surface and the lower surface, and a catheter can penetrate through the leading-in groove.

Description

Technical Field

[0001] The invention relates to the technical field of catheter fixing devices, and in particular to a temperature-sensitive catheter fixing patch and a preparation method thereof. Background Art

[0002] As an important medical auxiliary product, catheter fixation patches play a key role in the fixation of infusion catheters, drainage catheters, etc. At present, the commonly used catheter fixation patches in clinical practice mainly include transparent dressings, hydrocolloid dressings, non-woven self-adhesive dressings and other adhesive products, which are generally three-layer structures, including a release layer, a backing layer and an adhesive layer. When in use, remove the release layer and stick it to the position where the catheter needs to be fixed. However, there are some problems with the existing catheter fixation patches in clinical applications, such as easy warping, bubbling, and channeling, which will cause the fixed catheter to loosen, not only causing discomfort to the patient, but also increasing the workload of the nursing staff; and when replacing the fixation patch, it is easy to pull the skin, resulting in tension damage, skin damage and blistering, etc., and poor adhesion will cause the fixation patch to come off, and resetting the catheter will further increase the patient's pain. These problems have affected the effect of clinical treatment and the patient's recovery process to a certain extent. Summary of the invention

[0003] The invention provides a temperature-sensitive catheter fixing patch and a preparation method thereof, which are used to solve the problem that the catheter fixing patch cannot be firmly fixed when pasted and easily removed when disassembled.

[0004] In order to achieve the above object, the present invention adopts the following technical solutions: A temperature-sensitive catheter fixing patch and a preparation method thereof, wherein the fixing patch is composed of a hydrogel main body, wherein all or part of the hydrogel main body is a temperature-sensitive gel, wherein a catheter hole penetrating the upper and lower surfaces is provided at the center of the hydrogel main body for placing and fixing the catheter, and an introduction groove penetrating the upper and lower surfaces is extended outwardly from one side of the catheter hole for passing the catheter.

[0005] Furthermore, the preparation method of the thermosensitive gel is: S1: Add ammonium persulfate and distilled water into a container and stir to dissolve, add N-isopropylacrylamide and N,N'-methylenebisacrylamide, raise the temperature to 65°C and react for 30-60 minutes. During the process, observe that the solution becomes turbid; S2: Turn off the heating and cool to room temperature, add N-isopropylacrylamide, N,N,N',N'-tetramethylethylenediamine and sodium alginate, and continue the reaction for 2-4 hours; S3: Pour out the upper reaction liquid, wash the lower gel with distilled water for 3-5 times, and vacuum dry to obtain a modified thermosensitive gel.

[0006] Wherein, in step S1, the weight ratio of ammonium sulfate to N-isopropylacrylamide and N,N'-methylenebisacrylamide is 1:(40-50):2; in step S2, the weight ratio of N-isopropylacrylamide, N,N,N',N'-tetramethylethylenediamine and sodium alginate is: (80-90):1:(115-125); and in step S3, the temperature of vacuum drying is 25°C.

[0007] Furthermore, the fixing patch is composed of a hydrogel and a plurality of temperature-sensitive gels evenly distributed on the lower surface of the hydrogel.

[0008] Furthermore, the preparation method of the fixing patch is: S11: Add 10 g acrylamide monomer, 0.05 g MBA crosslinker, and 0.05 g APS initiator to 100 ml deionized water and stir evenly; S12: pour the mixed solution into a mold, and place the mold in a constant temperature water bath at 60° C. to react for 2 h; S13: Cut the thermosensitive gel obtained in step S3 into small pieces, place them on the upper surface of the hydrogel in step S12, and place the whole in a constant temperature water bath at 40° C. for reaction for 0.5-1 h.

[0009] Furthermore, the phase transition temperature of the thermosensitive gel is 32.8° C., and the viscosity after the phase transition is 8000 Pa·s.

[0010] Furthermore, the introduction groove consists of an upper rectangular groove and a lower inverted trapezoidal groove, and the upper surface of the rectangular groove passes through the upper surface of the hydrogel body, and the lower surface of the inverted trapezoidal groove passes through the lower surface of the hydrogel body.

[0011] Furthermore, the width of the rectangular groove is less than 1 cm.

[0012] Furthermore, the catheter hole is 1-3 mm smaller than the diameter of the catheter.

[0013] Furthermore, the fixing patch is placed in the fixing groove for storage or use, the fixing groove body is a shell structure with an upper opening, and the lower surface of the fixing groove is provided with a plurality of inwardly recessed temperature-sensitive protrusion fixing grooves for fixing the temperature-sensitive protrusions.

[0014] Furthermore, the method for using the fixing groove is as follows: after tearing off the protective film sealing the fixing groove, cutting the fixing patch, placing the entire fixing groove in a water bath at phase change temperature and heating it for 30-60 seconds, taking out the fixing patch and sticking it on the skin.

[0015] Compared with the prior art, the present invention has the following beneficial effects: The present invention provides a fixing patch with hydrogel as the main body, and at least part of it is thermosensitive gel. The advantage of thermosensitive gel is that it can undergo phase change at body temperature, and the viscosity increases significantly after the phase change, up to 8000 Pa·s. It can be well adhered to the skin surface, and when it needs to be removed, it only needs to be heated or cooled, and its temperature is adjusted to outside the phase change temperature range, so that it can be removed without traces and pains. The present invention provides a modified composite thermosensitive gel, which solves the problem that the thermosensitive gel is in liquid state outside the phase transition temperature and precipitates some water at the phase transition temperature. The thermosensitive gel is compounded with sodium alginate. Outside the phase transition temperature, the sodium alginate absorbs the thermosensitive gel to form an integral body. At the phase transition temperature, the thermosensitive gel gradually becomes sticky and precipitates, and the generated water can also be stored in the sodium alginate. The catheter fixing sticker provided by the present invention is provided with a catheter hole and an introduction groove, wherein the introduction groove allows the catheter to pass through, and the size of the catheter hole is slightly smaller than the diameter of the catheter, so that the catheter can be strengthened and sealed from above, and the width above the introduction groove is also very narrow, which can allow the catheter to pass through and can be easily closed when the introduction groove is moved inwardly, thereby protecting the wound surface around the catheter; and absorbent cotton can be placed inside the inverted trapezoidal groove after the catheter is in place, so as to absorb the exudate exuded from the wound around the catheter; The present invention uses hydrogel as the main body, which is also a good drug carrier and can be used to load antibacterial and anti-inflammatory drugs to avoid inflammation of the wound surface around the catheter; The fixing groove of the present invention can not only fix and store the fixing patch, but also assist in its use. Heating the fixing patch before use can make it adhere well to the skin when it comes into contact with the skin. The direct use method has the advantage of convenience, but it needs to wait for 30-60 seconds for the temperature-sensitive gel reaction to have sufficient viscosity. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 This is a schematic structural diagram of a temperature-sensitive catheter fixing patch according to Example 1 of the present invention; Figure 2 This is a schematic cross-sectional view of an introduction groove in a temperature-sensitive catheter fixing patch according to Example 1 of the present invention; Figure 3 This is a top view schematic diagram of a temperature-sensitive catheter fixing patch according to Example 1 of the present invention; Figure 4 This is a bottom view schematic diagram of a temperature-sensitive catheter fixing patch according to embodiment 1 of the present invention; Figure 5 This is a schematic diagram of the structure of a fixing groove of a temperature-sensitive catheter fixing patch according to embodiment 2 of the present invention; Figure 6 This is a sample diagram of the modified thermosensitive gel of Example 3 of the present invention; Figure 7This is a phase transition temperature test diagram of the modified thermosensitive gel of Example 3 of the present invention; Figure 8 This is a phase transition viscosity change diagram of the modified thermosensitive gel of Example 3 of the present invention.

[0017] Among them, 10-fixing patch, 100-main body, 110-catheter hole, 120-introduction groove, 121-inverted trapezoidal groove, 122-rectangular groove, 130-temperature-sensitive protrusion, 20-fixing groove, 210-groove body, 220-temperature-sensitive protrusion fixing groove. DETAILED DESCRIPTION

[0018] The technical solution of the present invention will be clearly and completely described below through embodiments.

[0019] Patent CN116139330A discloses a method for fixing a catheter by liquid dressing, which fixes the catheter by spraying quick-drying glue and film-forming liquid successively, wherein the quick-drying time of quick-drying glue is 60s, and the film-forming time of film-forming liquid is 70s, which takes more than two minutes in total. It is still very difficult to use clinically. During the process, the movement or shaking of the catheter may lead to loose fixation and gaps. Moreover, each catheter needs such a long time, which increases the burden of nursing. The present invention is also based on an integrated formed dressing, and the purpose of the invention is achieved through material optimization. Example 1

[0020] Temperature-sensitive catheter fixation patch, such as Figure 1 As shown, the main body 100 of the fixing patch 10 is made of hydrogel or thermosensitive hydrogel. In this embodiment, the main body 100 is made of hydrogel. After cutting, a circular catheter hole 110 is provided at the center of the main body 100, which passes through the upper and lower surfaces of the main body 100, and is used for placing a catheter. The size of the catheter hole 110 is adjusted according to the diameter of the catheter to be placed, so that the sizes of the two are matched. In this embodiment, the diameter of the catheter hole 110 is slightly smaller than the diameter of the catheter (1-3mm smaller), so that after the catheter is placed in the catheter hole 110, the catheter hole 110 can be completely and closely contacted with the outer surface of the catheter.

[0021] After cutting, the catheter hole 100 is connected to an introduction groove 120 in any direction, and the introduction groove 120 is used for the catheter to pass through it to reach the predetermined catheter hole 110, such as Figure 2As shown, the introduction groove 120 is formed by an upper rectangular groove 122 and a lower inverted trapezoidal groove 121 in one piece. The introduction groove 120 passes through the upper and lower surfaces of the main body 100, thereby forming a channel for the catheter to enter the catheter hole 110 area. The lower part of the introduction groove 120 is in the shape of an inverted trapezoidal cross-section, and its width is greater than the diameter of the catheter, which is convenient for the movement of the catheter. The upper part is a rectangular groove 122 with a rectangular cross-section. The width of the rectangular groove 122 is less than 1 cm, preferably 0.3-0.5 mm. The advantage is that the hydrogel dressing is elastic. When the catheter passes through the introduction groove 120, it can pass through the rectangular groove 122 and the inverted trapezoidal groove 121. After the catheter reaches the catheter hole 110, the rectangular groove 122 also returns to a smaller width. When pasting, the rectangular groove 122 is actively moved to the middle and then fixed to close the gap above the rectangular groove 122. Figure 3 shown.

[0022] like Figure 4 As shown, there are several evenly arranged temperature-sensitive protrusions 130 on the back of the main body 100. The temperature-sensitive protrusions 130 are composed of temperature-sensitive hydrogel. The temperature-sensitive protrusions 130 become more sticky within the body temperature range and can be firmly adhered to the skin. When heated or cooled to above or below a certain temperature, the adhesion becomes worse, and the fixing patch 10 can be easily removed. The hydrogel as the main body of the fixing patch 10 itself has a good skin feel, and the hydrogel is a good carrier. Adding antibacterial and anti-inflammatory ingredients to it is beneficial to maintain the stability and safety of the environment around the catheter. Example 2

[0023] The fixing patch 10 in Example 1 is obtained after cutting according to the diameter of the catheter. Since the hydrogel material is easily deformed during cutting, the expected cutting pattern cannot be obtained. Therefore, it needs to be used in conjunction with the fixing groove 20, and the fixing groove 20 can also be used as a carrier for storing the fixing patch 10. The main body of the fixing groove 20 is a groove body 210. The groove body 210 is a shell structure with an opening on the top. The fixing patch 10 is placed in the groove body 210. A sealing film is fixed on the top of the groove body 210. When in use, the sealing film can be opened and cut for use. There are several temperature-sensitive protrusion fixing grooves 220 formed by downward depressions on the bottom surface of the groove body 210. The temperature-sensitive protrusion 130 is placed in the temperature-sensitive protrusion fixing groove 220 for fixing. The advantage is that the temperature-sensitive protrusion 130 also plays a fixing effect, so that the fixing patch 10 is not easy to shift during the cutting process.

[0024] If pure thermosensitive gel is used as the thermosensitive protrusion 130, the viscosity of the thermosensitive protrusion 130 made of the thermosensitive gel before use is not enough to form, so it is also necessary to use the thermosensitive protrusion fixing groove 220. After cutting, the fixing groove 20 is placed in a constant temperature water bath (phase transition temperature of the thermosensitive gel) and heated for 30-60s. At this time, the fixing patch 10 is taken out and pasted on the skin. The phase transition temperature is also the skin temperature, which can maintain sufficient viscosity. When it needs to be removed, heating or cooling can reduce the viscosity of the thermosensitive gel, so as to achieve the purpose of safe removal without traces. Of course, the modified thermosensitive protrusion 130 that is sufficient for forming can also use the above method. Example 3

[0025] This embodiment shows the preparation method of the thermosensitive hydrogel in Embodiment 1. The thermosensitive hydrogel in this embodiment is a modified thermosensitive hydrogel, which has a certain viscosity outside the phase transition temperature and can maintain the predetermined shape of the fixing patch 10.

[0026] S1: Add ammonium persulfate and distilled water into a container and stir to dissolve, add N-isopropylacrylamide and N,N'-methylenebisacrylamide, raise the temperature to 65°C and react for 30-60 minutes. During the process, observe that the solution becomes turbid; S2: Turn off the heating and cool to room temperature, add N-isopropylacrylamide, N,N,N',N'-tetramethylethylenediamine and sodium alginate, and continue the reaction for 2-4 hours; S3: Pour out the upper reaction liquid, wash the lower gel with distilled water for 3-5 times, and vacuum dry to obtain a modified thermosensitive gel.

[0027] Wherein, in step S1, the weight ratio of ammonium sulfate to N-isopropylacrylamide and N,N'-methylenebisacrylamide is 1:(40-50):2; in step S2, the weight ratio of N-isopropylacrylamide, N,N,N',N'-tetramethylethylenediamine and sodium alginate is: (80-90):1:(115-125); and in step S3, the temperature of vacuum drying is 25°C.

[0028] like Figure 6 As shown, the prepared thermosensitive hydrogel has been formed. The reason is that sodium alginate has good viscosity and liquid absorption capacity, so it can absorb PNIPAm below the phase change temperature and form it. Moreover, after heating, the liquid precipitated from PNIPAm can continue to remain in the absorption state, thereby keeping the surface of the fixed patch relatively dry.

[0029] like Figure 7 As shown in Figure 2, the phase transition temperature of the modified thermosensitive gel is 32.8 °C. Figure 8As shown, the viscosity of the modified thermosensitive gel is increased from 26 Pa·s before the phase change to 8000 Pa·s, which is sufficient to adhere firmly to the skin. The phase change temperature can also be slightly adjusted as needed to suit the skin temperature of different people. Example 4

[0030] The preparation method of the fixing patch 10 composed of a hydrogel as the main body 100 and a thermosensitive hydrogel as the thermosensitive protrusion 130 in Example 1 has the advantage of not only reducing costs but also being faster to remove. It can be removed quickly, painlessly and without marks by simply heating or cooling part of the hydrogel.

[0031] S11: Add 10 g acrylamide monomer, 0.05 g MBA crosslinker, and 0.05 g APS initiator to 100 ml deionized water and stir evenly; S12: pour the mixed solution into a mold, and place the mold in a constant temperature water bath at 60° C. to react for 2 h; S13: Cut the thermosensitive gel obtained in step S3 into small pieces, place them on the upper surface of the hydrogel in step S12, and place the whole in a constant temperature water bath at 40° C. for reaction for 0.5-1 h.

[0032] The above embodiments are only some embodiments of the present invention and are not any formal or substantial limitations of the present invention. It should be pointed out that a person skilled in the art can make several improvements and supplements without departing from the concept of the present invention, and these improvements and supplements should also be regarded as the protection scope of the present invention.

Claims

1. A temperature-sensitive catheter fixing patch and a preparation method thereof, characterized in that: The fixing patch is composed of a hydrogel body, which is wholly or partially a thermosensitive gel. A catheter hole penetrating the upper and lower surfaces is provided at the center of the hydrogel body for placing and fixing the catheter. An introduction groove penetrating the upper and lower surfaces is extended outward on one side of the catheter hole for the catheter to pass through.

2. A temperature-sensitive catheter fixing patch and a preparation method thereof according to claim 1, characterized in that: The preparation method of the thermosensitive gel is as follows: S1: Add ammonium persulfate and distilled water into a container and stir to dissolve, add N-isopropylacrylamide and N,N'-methylenebisacrylamide, raise the temperature to 65°C and react for 30-60 minutes. During the process, observe that the solution becomes turbid; S2: Turn off the heating and cool to room temperature, add N-isopropylacrylamide, N,N,N',N'-tetramethylethylenediamine and sodium alginate, and continue the reaction for 2-4 hours; S3: pour out the upper reaction solution, wash the lower gel with distilled water 3-5 times, and vacuum dry to obtain a modified thermosensitive gel; Wherein, in step S1, the weight ratio of ammonium sulfate to N-isopropylacrylamide and N,N'-methylenebisacrylamide is 1:(40-50):2; in step S2, the weight ratio of N-isopropylacrylamide, N,N,N',N'-tetramethylethylenediamine and sodium alginate is: (80-90):1:(115-125); and in step S3, the temperature of vacuum drying is 25°C.

3. A temperature-sensitive catheter fixing patch and a preparation method thereof according to claim 2, characterized in that: The fixing patch is composed of a hydrogel and a plurality of temperature-sensitive gels evenly distributed on the lower surface of the hydrogel.

4. A temperature-sensitive catheter fixing patch and a preparation method thereof according to claim 3, characterized in that: The preparation method of the fixing patch is as follows: S11: Add 10 g acrylamide monomer, 0.05 g MBA crosslinker, and 0.05 g APS initiator to 100 ml deionized water and stir evenly; S12: pour the mixed solution into a mold, and place the mold in a constant temperature water bath at 60° C. to react for 2 h; S13: Cut the thermosensitive gel obtained in step S3 into small pieces, place them on the upper surface of the hydrogel in step S12, and place the whole in a constant temperature water bath at 40° C. for reaction for 0.5-1 h.

5. A temperature-sensitive catheter fixing patch and a preparation method thereof according to claim 1, characterized in that: The phase transition temperature of the thermosensitive gel is 32.8°C, and the viscosity after the phase transition is 8000 Pa·s.

6. A temperature-sensitive catheter fixing patch and a preparation method thereof according to claim 1, characterized in that: The introduction groove consists of an upper rectangular groove and a lower inverted trapezoidal groove, and the upper surface of the rectangular groove penetrates the upper surface of the hydrogel body, and the lower surface of the inverted trapezoidal groove penetrates the lower surface of the hydrogel body.

7. A temperature-sensitive catheter fixing patch and a preparation method thereof according to claim 6, characterized in that: The width of the rectangular groove is less than 1 cm.

8. A temperature-sensitive catheter fixing patch and a preparation method thereof according to claim 6, characterized in that: The catheter hole is 1-3 mm smaller than the diameter of the catheter.

9. A temperature-sensitive catheter fixing patch and a preparation method thereof according to claim 3, characterized in that: The fixing patch is placed in the fixing groove for storage or use. The fixing groove body is a shell structure with an upper opening. The lower surface of the fixing groove is provided with a plurality of inwardly recessed temperature-sensitive protrusion fixing grooves for fixing the temperature-sensitive protrusions.

10. A temperature-sensitive catheter fixing patch and a preparation method thereof according to claim 9, characterized in that: The method for using the fixing groove is as follows: when using, the protective film sealing the fixing groove is torn off, the fixing patch is cut, the fixing groove as a whole is placed in a water bath at a phase change temperature and heated for 30-60 seconds, and the fixing patch is taken out and pasted on the skin.

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