Medical puncture site protective dressing, preparation method and application

Abstract

This invention discloses a medical puncture point protective dressing, its preparation method, and its uses, relating to the field of medical dressings. The protective dressing is configured as a multi-layer composite base type protective dressing for puncture point compression hemostasis and has a temperature-sensitive color-changing indication function. The multi-layer composite base type protective dressing includes a second protective layer, a compression function layer, a pre-colored flexible substrate layer, and a peelable protective layer stacked sequentially. The medical puncture point protective dressing, its preparation method, and its uses achieve a visual and objective indication of compression time by setting a visual contrast between the temperature-sensitive color-changing material and the pre-colored background layer, while preventing dressing displacement through an elastic positioning layer.

Description

Technical Field

[0001] This invention relates to medical dressing technology, specifically to medical puncture site protective dressings, their preparation methods, and their uses. Background Technology

[0002] Hemodialysis is a vital treatment for end-stage renal disease patients to maintain their lives. During hemodialysis, percutaneous puncture is performed at the arteriovenous fistula or central venous catheter site to establish extracorporeal blood circulation. After treatment, effective hemostasis at the puncture site is crucial for ensuring patient safety and preventing complications.

[0003] Currently, in clinical practice, the main problems with pressure hemostasis at the puncture site after hemodialysis are that the judgment of pressure time relies on the subjective experience of medical staff, there is a lack of objective and intuitive timing indicators, the accuracy of puncture site positioning is insufficient, and the dressing is prone to displacement during use. To solve the above problems, the following technical solutions are disclosed in the existing technology:

[0004] 1) Patent application CN221617527U discloses a pressure dressing for arteriovenous fistula puncture in hemodialysis. This patent application includes a dressing body and an absorbent pad. Adhesive patches extend diagonally outward from the four corners of the dressing body. The adhesive patches are coated with adhesive near the absorbent pad. One adhesive patch is connected to a secondary pressure tape. The dressing body, adhesive patches, and secondary pressure tape are integrally formed. Easy-tear marks are provided at the connection between the secondary pressure tape and the adhesive patches. The secondary pressure tape is coated with adhesive near the dressing body, and a release liner is provided on the adhesive side of the secondary pressure tape. Release liner is also provided on the adhesive sides of both the dressing body and the adhesive patches. This technical solution better protects the needle puncture site after needle removal, allows for quick and convenient fixation of the dressing body, and provides secondary pressure by wrapping the secondary pressure tape around the arm, preventing blood from flowing out of the needle puncture site, ensuring cleanliness and hygiene. The secondary pressure tape can be removed after 10-15 minutes to avoid obstructing blood flow, providing good comfort.

[0005] 2) Patent application CN113925684A discloses a special dressing for preventing arteriovenous fistula infection. In this patent application, it consists of a release paper layer, an anti-infection drug-absorbing pad, an adhesive waterproofing material, and an adhesive backing. The anti-infection drug-absorbing pad and the waterproofing material are the same size, while the adhesive backing is larger than the anti-infection drug-absorbing pad but smaller than the release paper. The anti-infection drug-absorbing pad is either a cotton pad or a gel pad, containing 2% chlorhexidine gluconate, 5% povidone-iodine, or 75% alcohol, respectively. This technical solution is rationally designed, providing a disposable sterile external dressing that adheres smoothly to the skin after use. The material is breathable and soft, exhibiting low allergenicity, low irritation, and minimal adhesive residue upon skin contact. It has moderate viscosity, is comfortable to use, and can prevent infection at the arteriovenous fistula puncture site.

[0006] The aforementioned existing technical solutions possess both secondary pressure hemostasis and infection prevention functions, but none of them include a structure or unit that can objectively indicate the compression time. Medical staff and patients still rely on clock timing or subjective experience to judge the compression duration, posing a risk of inaccurate compression time judgment. Furthermore, existing solutions lack effective elastic fitting and anti-displacement structures. Under conditions of skin stretching and vascular pulsation at the arteriovenous fistula site, the dressing is prone to shifting, affecting the accuracy of the compression position and the hemostatic effect. Summary of the Invention

[0007] The purpose of this invention is to provide a medical puncture point protective dressing, its preparation method, and its uses, in order to solve the problems in the prior art where pressure hemostatic dressings cannot accurately determine the duration of pressure and lack an effective anti-displacement structure, which leads to easy displacement of the pressure position.

[0008] To achieve the above objectives, the present invention provides the following technical solution: a medical puncture point protective dressing, wherein the protective dressing is configured as a multi-layer composite medical dressing for puncture point compression hemostasis and has a temperature-sensitive color-changing indication function, the multi-layer composite medical dressing comprising:

[0009] A pre-colored flexible substrate layer, the lower surface of which is provided with an adhesive layer for adhering to the skin;

[0010] A peelable protective layer covers the adhesive layer surface to protect the adhesive layer before use and can be peeled off and removed during use;

[0011] A compression functional layer, located on top of the pre-colored flexible substrate layer, is used to apply pressure to the puncture point;

[0012] The second protective layer is located above the compression functional layer;

[0013] The thermosensitive indicator unit is located on the surface or inside the pressure function layer and is used to visually indicate whether the pressure time has reached the preset duration through color change. The thermosensitive indicator unit includes a thermochromic material that undergoes a reversible color change at a temperature of 35 to 40°C and the color change time is 10 to 15 minutes. The pre-colored flexible substrate layer has a color identification layer that contrasts with the color of the thermochromic material after the color change.

[0014] Furthermore, the thermochromic material is any one of thermosensitive ink, thermosensitive coating, thermosensitive microcapsule or thermosensitive gel, and the thermochromic material is set on the surface of the pressure functional layer in the form of dots, stripes or text, wherein the diameter of the dots is 3 to 8 mm and the width of the stripes is 2 to 5 mm.

[0015] Furthermore, the compression functional layer is a single-layer structure, made of polyurethane foam, polyethylene foam, or medical-grade silicone, with a density of 40–100 kg / m³. 3 The thickness is 3-8mm.

[0016] Furthermore, the compression functional layer has a layered composite structure, including an upper soft compression layer and a lower hard compression layer, with the upper soft compression layer having a density of 30–60 kg / m³. 3 The thickness is 2-6 mm, and the density of the underlying hard compression layer is 80-150 kg / m³. 3 And the thickness is 1-2mm.

[0017] Furthermore, the pre-colored flexible substrate layer is a PU film, PE film, PVC film, or non-woven fabric with a thickness of 0.05 to 0.15 mm and a color of dark blue, dark green, or dark purple.

[0018] Furthermore, the adhesive layer is a medical pressure-sensitive adhesive with a coating thickness of 0.03–0.08 mm and an adhesion strength of 1.0–3.0 N / 25 mm.

[0019] Furthermore, the aforementioned multilayer composite medical dressing also includes an elastic positioning layer, which is disposed between the pre-colored flexible substrate layer and the compression functional layer. The elastic positioning layer is an elastic film or elastic sponge with a thickness of 0.5 to 1.5 mm.

[0020] Furthermore, the aforementioned multi-layer composite medical dressing also includes a visual positioning structure, which is a through hole located at the center of the dressing, with a diameter of 8 to 15 mm.

[0021] Furthermore, the aforementioned multi-layer composite medical dressing also includes a blood-absorbing and blood-storing structure, which is a ring of absorbent material located at the edge of the compression functional layer. This absorbent material ring is made of medical absorbent fiber or absorbent sponge material.

[0022] Furthermore, the preparation method of the medical puncture site protective dressing includes the following steps:

[0023] S1: Select a PU film, PE film, PVC film or non-woven fabric with a thickness of 0.05 to 0.15 mm as the pre-colored flexible substrate layer. The pre-colored flexible substrate layer has a color marking layer.

[0024] S2: A medical pressure-sensitive adhesive layer with a thickness of 0.03 to 0.08 mm is formed on the lower surface of the pre-colored flexible substrate layer by a coating process, and a peelable protective film is laminated on the surface of the medical pressure-sensitive adhesive layer to obtain an adhesive-coated substrate;

[0025] S3: An elastic positioning layer is provided on the upper surface of the pre-colored flexible substrate layer and is fixedly connected to the pre-colored flexible substrate layer by hot pressing or bonding.

[0026] S4: A compression function layer is provided on the upper surface of the elastic positioning layer and is fixed to the elastic positioning layer by hot pressing or bonding.

[0027] S5: Apply a temperature-sensitive indicator material to the surface or interior of the compression functional layer by printing, coating, spraying or impregnation processes;

[0028] S6: Cover the second peelable protective film on top of the compression functional layer, and after die-cutting, seal and sterilize to obtain a medical puncture point protective dressing.

[0029] The aforementioned medical puncture site protective dressing is used to apply pressure to the puncture site for hemostasis after a percutaneous puncture procedure. The percutaneous puncture procedure includes, but is not limited to, arteriovenous fistula puncture during hemodialysis, central venous catheterization, arterial blood gas analysis puncture, percutaneous liver puncture, kidney biopsy, cardiac catheterization, peripheral venous catheterization, and puncture site pressure for hemostasis after various vascular interventional treatments.

[0030] In practical application, the peelable protective layer of the protective dressing is removed, and the dressing is fixed to the skin surface around the patient's puncture point through the adhesive layer. The pressure functional layer is aligned with and covers the puncture point, and uniform pressure is applied to achieve hemostasis. After the dressing is applied, the temperature-sensitive indicator unit on the surface or inside of the pressure functional layer senses the patient's body temperature and undergoes a reversible color change within a temperature range of 35-40℃. The color change time is 10-15 minutes. Medical staff or patients can visually judge whether the compression time has reached the preset duration by observing the color change of the temperature-sensitive indicator unit. When the color changes from the initial color to the target color, it indicates that the compression time has been reached, and the dressing can be removed based on the actual bleeding situation at the puncture point. Protective dressings are especially suitable for compression hemostasis at arteriovenous fistula puncture sites after hemodialysis. Their elastic positioning layer can effectively adapt to the slight pulsation of blood vessels and skin stretching at the fistula site, preventing the compression functional layer from shifting during use and ensuring accurate compression positioning. The blood-absorbing and blood-storing structure can absorb any small amount of blood that may seep from the puncture site, keeping the wound clean. The through-hole design of the visible positioning structure makes it easy for medical staff to accurately align the dressing with the puncture site when applying it.

[0031] Compared with existing technologies, the medical puncture point protective dressing, preparation method, and applications provided by this invention, on the one hand, achieve visual indication of compression time by setting a temperature-sensitive indicator unit containing a thermochromic material that undergoes reversible color change at 35-40°C with a color change time of 10-15 minutes, and a pre-colored flexible substrate layer with a visual contrast to the color after color change. Medical staff or patients can intuitively judge whether the compression time has reached the preset requirement without relying on clock timing or subjective experience, effectively avoiding problems such as bleeding, hematoma, or decreased comfort caused by insufficient or excessive compression time; on the other hand, by adding a pre-colored flexible substrate layer with a temperature-sensitive indicator unit containing a thermochromic material that undergoes reversible color change at 35-40°C with a color change time of 10-15 minutes, the application of this invention achieves visual indication of compression time. The elastic positioning layer between the flexible substrate layer and the compression functional layer allows the dressing to adapt to the stretching of the skin and slight pulsation of the blood vessels at the fistula site of hemodialysis patients, effectively preventing displacement of the compression functional layer during use and ensuring that the pressure is always accurately applied to the puncture point, significantly improving the accuracy and reliability of compression hemostasis. Finally, the central through-hole design with integrated visual positioning structure and the edge absorbent material ring of the blood-absorbing and storage structure achieve precise alignment and adhesion of the puncture point and rapid absorption and storage of oozing blood, further improving the ease of operation and wound cleanliness, and fully meeting the clinical needs of compression hemostasis at the puncture point after hemodialysis. Attached Figure Description

[0032] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this invention. For those skilled in the art, other drawings can be obtained based on these drawings.

[0033] Figure 1 This is a schematic diagram of the basic protective dressing in Embodiment 1 of the present invention;

[0034] Figure 2 This is a schematic diagram of the protective dressing with a visual positioning structure in Embodiment 3 of the present invention;

[0035] Figure 3 This is a schematic diagram of the protective dressing containing a blood-absorbing and blood-storing structure in Embodiment 4 of the present invention;

[0036] Figure 4 This is a schematic diagram of the protective dressing containing an elastic positioning layer in Embodiment 5 of the present invention;

[0037] Figure 5 This is a schematic diagram of the structure of the layered compression functional layer protective dressing in Embodiment Six of the present invention.

[0038] Explanation of reference numerals in the attached figures:

[0039] 1. Second protective layer; 2. Compression function layer; 201. Upper soft compression layer; 202. Lower hard compression layer; 3. Pre-colored flexible substrate layer; 4. Peelable protective layer; 5. Visual positioning structure; 6. Water-absorbing sponge ring; 7. Elastic positioning layer. Detailed Implementation

[0040] To enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings.

[0041] As attached Figure 1 As shown:

[0042] Example 1:

[0043] The present invention provides a medical puncture point protective dressing, wherein the protective dressing is configured as a multi-layer composite base type protective dressing for puncture point compression hemostasis and having a temperature-sensitive color-changing indication function. The multi-layer composite base type protective dressing includes a second protective layer 1, a compression function layer 2, a pre-colored flexible substrate layer 3 and a peelable protective layer 4, which are stacked in sequence.

[0044] 1. In one embodiment of the present invention, the peelable protective layer 4 is release paper with a thickness of 0.08 mm, which covers the surface of the adhesive layer and is used to protect the adhesive layer before use and is to be peeled off when used.

[0045] 2. In one embodiment of the present invention, the pre-colored flexible substrate layer 3 is a dark blue PU film with a thickness of 0.08 mm. An adhesive layer is provided on the lower surface of the pre-colored flexible substrate layer 3. The adhesive layer is a medical pressure-sensitive adhesive with a coating thickness of 0.05 mm and an adhesion strength of 2.0 N / 25 mm, used to fix the dressing to the patient's skin surface. A peelable protective layer 4 covers the surface of the adhesive layer.

[0046] 3. In one embodiment of the present invention, the pre-colored flexible substrate layer 3 has a hue that visually contrasts with the color of the thermochromic material after it changes color, so that medical staff can clearly observe the color change.

[0047] 4. In one embodiment of the present invention, the compression functional layer 2 is disposed on the upper layer of the pre-colored flexible substrate layer 3, and is used to apply uniform pressure to the puncture point. In this embodiment, the compression functional layer 2 is a single-layer structure, made of polyurethane foam with a density of 60 kg / m³. 3 The thickness is 5mm.

[0048] 5. In one embodiment of the present invention, a temperature-sensitive indicator unit is disposed on the surface of the pressure functional layer 2. The temperature-sensitive indicator unit uses temperature-sensitive ink as a thermochromic material, which is printed in the form of dots at the center of the upper surface of the pressure functional layer 2, with a dot diameter of 5 mm. The temperature-sensitive ink undergoes a reversible color change at a temperature of 37°C, changing from dark blue to light blue, with a color change time of 12 minutes.

[0049] 6. In one embodiment of the present invention, the second protective layer 1 is release paper, which is disposed on the upper layer of the pressure functional layer 2 and is used to protect the pressure functional layer 2 and the temperature-sensitive indicator unit on its surface before use, and is torn off when in use.

[0050] 7. In one embodiment of the present invention, the protective dressing is circular in shape with a diameter of 40 mm, and is suitable for compression hemostasis at the puncture site after routine hemodialysis.

[0051] Working principle: In use, first remove the second protective layer 1 and the peelable protective layer 4. Secure the dressing to the patient's skin at the puncture point using the adhesive layer. Apply uniform pressure to the puncture point using the pressure-sensitive layer 2. After the dressing is applied, the temperature-sensitive ink senses the patient's skin temperature and gradually changes from dark blue to light blue after approximately 12 minutes at 37°C. Because the pre-colored flexible substrate layer 3 is dark blue, it creates a visual contrast with the light blue color change, allowing medical staff to clearly observe the color change and intuitively determine whether the pressure time has reached the preset duration.

[0052] Example 2:

[0053] This invention provides a medical puncture site protective dressing. The protective dressing is configured as a temperature-sensitive microcapsule striped protective dressing for puncture site compression hemostasis and has a temperature-sensitive color-changing indication function. Its structure is basically the same as that of Embodiment 1, except that: the pre-colored flexible substrate layer 3 is a dark green PE film with a thickness of 0.10 mm; the compression functional layer 2 is polyethylene foam with a density of 50 kg / m³. 3 The thickness is 6mm.

[0054] 1. In one embodiment of the present invention, the temperature-sensitive indicator unit uses temperature-sensitive microcapsules as thermochromic materials, which are arranged in a cross-shaped stripe pattern on the surface of the pressure functional layer 2, with a stripe width of 3 mm. The temperature-sensitive microcapsules undergo a reversible color change at a temperature of 38°C, changing from dark green to light green, with a color change time of 10 minutes.

[0055] Working Principle: This embodiment uses thermosensitive microcapsules as the thermochromic material, which are distributed in a cross-shaped stripe pattern on the surface of the compression functional layer 2, increasing the coverage area of ​​the color-changing region and facilitating observation of color changes from multiple angles. After application, the thermosensitive microcapsules sense the patient's body surface temperature, gradually changing from dark green to light green after approximately 10 minutes at 38°C. The pre-colored flexible substrate layer 3 is also dark green, creating a contrast in brightness with the light green after the color change. Medical staff can visually judge the compression time by observing the change in stripe color.

[0056] As attached Figure 2 As shown:

[0057] Example 3:

[0058] This invention provides a medical puncture point protective dressing. The protective dressing is configured as a puncture point compression hemostasis dressing with a temperature-sensitive color-changing indicator function, and includes a visual positioning structure 5. Its structure is basically the same as in Embodiment 1, except that: the pre-colored flexible substrate layer 3 is a dark purple PVC film with a thickness of 0.12 mm, and the compression functional layer 2 is medical-grade silicone with a density of 80 kg / m³. 3 The thickness is 4mm.

[0059] 1. In one embodiment of the present invention, the temperature-sensitive indicator unit uses a temperature-sensitive coating, which is applied to the surface of the pressure functional layer 2 by spraying. The temperature-sensitive coating undergoes a reversible color change at a temperature of 37°C, and the color change time is 13 minutes.

[0060] 2. In one embodiment of the present invention, the protective dressing further includes a visual positioning structure 5, which is a through hole located at the center of the dressing, with a diameter of 12mm. During use, medical personnel can directly observe the puncture point location through this through hole to ensure that the compression functional layer 2 is accurately aligned with the puncture point.

[0061] Working principle: This embodiment features a 12mm diameter visual positioning hole at the center of the dressing. Medical personnel can directly observe the exact location of the puncture point through this hole when applying the dressing, ensuring precise alignment and avoiding pressure deviation or ineffective pressure due to inaccurate positioning. After the dressing is fixed, the pressure layer 2 applies uniform pressure to the puncture point. Simultaneously, the temperature-sensitive coating changes color in response to body temperature, with a color change time of approximately 13 minutes. Medical personnel can determine the duration of pressure by observing the color change.

[0062] As attached Figure 3 As shown:

[0063] Example 4:

[0064] This invention provides a medical puncture site protective dressing. The protective dressing is configured for puncture site compression hemostasis and has a temperature-sensitive color-changing indicator function, incorporating a blood-absorbing and storing structure. Its structure is basically the same as in Embodiment 1, except that the temperature-sensitive indicator unit uses a temperature-sensitive gel, which is applied to the surface of the compression functional layer 2 by coating. The temperature-sensitive gel undergoes a reversible color change at 36°C, with a color change time of 15 minutes. The protective dressing also includes a blood-absorbing and storing structure, which is a 5mm wide absorbent sponge ring 6 located at the edge of the compression functional layer 2. The absorbent sponge ring 6 is made of medical absorbent fiber and is used to absorb any small amount of blood that may seep from the puncture site, keeping the wound clean.

[0065] Working principle: In Example 4, an absorbent sponge ring 6 made of medical absorbent fiber is set at the edge of the compression functional layer 2. During the compression hemostasis process, if there is a small amount of bleeding at the puncture point, the blood can be quickly absorbed and stored by the absorbent sponge ring 6, preventing blood from spilling out and contaminating the surrounding skin or clothing, and keeping the wound clean and dry. At the same time, the temperature-sensitive gel undergoes a reversible color change after about 15 minutes at 36°C, making it suitable for patients with low body temperature or those requiring longer compression time.

[0066] As attached Figure 4 As shown:

[0067] Example 5:

[0068] The present invention provides a medical puncture point protective dressing, which is configured as a protective dressing with an elastic positioning layer 7 for puncture point compression hemostasis and temperature-sensitive color-changing indication function. It includes a peelable protective layer 4, a pre-colored flexible substrate layer 3, an elastic positioning layer 7, a compression function layer 2, and a second protective layer 1 stacked in sequence.

[0069] 1. In one embodiment of the present invention, an elastic positioning layer 7 is disposed between the pre-colored flexible substrate layer 3 and the compression functional layer 2, and is made of an elastic film with a thickness of 1.0 mm. The elastic positioning layer 7 is fixedly connected to the pre-colored flexible substrate layer 3 and the compression functional layer 2 by a thermo-pressing composite method. The provision of this elastic positioning layer 7 allows the dressing to better adapt to the skin stretching and slight pulsation of blood vessels at the arteriovenous fistula site of hemodialysis patients, prevents the compression functional layer 2 from shifting during use, and ensures the accuracy of the compression position.

[0070] Working Principle: In Example 5, an elastic positioning layer 7 is added between the pre-colored flexible substrate layer 3 and the compression functional layer 2, giving the entire dressing a certain degree of flexibility and conformability. When the dressing is applied to the skin at the arteriovenous fistula site of a hemodialysis patient, the elastic positioning layer 7 can adapt to the stretching of the skin and the slight pulsation of the blood vessels, effectively buffering the influence of external traction force on the compression functional layer 2, preventing the compression functional layer 2 from shifting during use, thereby ensuring that the compression force is always accurately applied to the puncture point, improving hemostasis and patient comfort.

[0071] As attached Figure 5 As shown:

[0072] Example 6:

[0073] This invention provides a medical puncture point protective dressing. The protective dressing is configured as a layered pressure-functional layer 2 protective dressing for puncture point compression hemostasis and has a temperature-sensitive color-changing indication function. Its structure is basically the same as that of Embodiment 1, except that: the pressure-functional layer 2 is a layered composite structure, including an upper soft pressure layer 201 and a lower hard pressure layer 202. The upper soft pressure layer 201 is a low-density polyurethane sponge with a density of 40 kg / m³. 3 The thickness is 4mm; the lower rigid compression layer 202 is a high-density polyurethane foam with a density of 100kg / m³. 3 It has a thickness of 2mm. This layered structure allows the patch to combine good fit and comfort with effective pressure.

[0074] 1. In one embodiment of the present invention, the temperature-sensitive indicator unit is disposed on the surface of the upper soft pressing layer 201, and is printed in the form of text using temperature-sensitive ink. It changes from colorless to red at a temperature of 37°C, and the color change time is 12 minutes.

[0075] Example 7:

[0076] This invention provides a medical puncture site protective dressing, which is a multi-functional protective dressing configured for puncture site compression hemostasis and has a temperature-sensitive color-changing indication function. It also includes the functions of the visual positioning structure 5, blood absorption and storage structure and elastic positioning layer 7 in the above embodiments one to six, and is particularly suitable for the high standard of nursing care of arteriovenous fistula puncture sites after hemodialysis.

[0077] Working Principle: This embodiment integrates the functions of the visual positioning structure 5, the blood-absorbing and storing structure, and the elastic positioning layer 7. During use, medical personnel precisely align the dressing with the puncture point through the visual positioning through-hole; the elastic positioning layer 7 allows the dressing to adapt to the skin's stretching and vascular pulsation at the fistula site, preventing displacement; the blood-absorbing and storing structure absorbs any leaking blood, keeping the wound clean; and the temperature-sensitive indicator unit visually indicates the compression duration through color changes. The synergistic effect of these functional structures comprehensively improves the accuracy, comfort, and convenience of puncture point compression hemostasis after hemodialysis.

[0078] Comparative Example 1:

[0079] Commercially available medical patches consist of a backing layer, an absorbent pad, and an adhesive layer, and are used to apply pressure to the puncture site for hemostasis after hemodialysis.

[0080] Comparative Example 2:

[0081] Commercially available hemostatic patches with pressure pads consist of a backing layer, a pressure cotton pad, and an adhesive layer, and are used to compress and stop bleeding at the puncture site after hemodialysis.

[0082] Comparison table of the above embodiments and comparative experiments:

[0083] Test Project Example 1 Example 2 Example 3 Example 4 Example 5 Example 6 Example 7 Comparative Example 1 Comparative Example 2 Compression time indication function Yes, color change. Yes, the stripes change color. Yes, color change. Yes, color change. Yes, color change. Yes, the text changes color. Yes, color change. none none Color change response temperature 37℃ 38℃ 37℃ 36℃ 37℃ 37℃ 37℃ / / Color change time 12min 10min 13min 15min 12min 12min 12min / / Visual positioning structure 5 none none have none none none have none none Blood-sucking and blood-storing structures none none none have none none have have none Elastic positioning layer 7 none none none none have none have none none Layered compression structure none none none none none have none none none Hemostasis efficiency 98% 97% 98 98% 99% 98% 99% 82% 88% Accuracy of compression time judgment 95% 94% 95% 95% 96% 97% 97% 45% 48% Incidence of dressing displacement 8% 9% 7% 8% 2% 7% 1% 25% 18% Patient comfort score 8.5 8.3 8.6 8.7 9.2 9.0 9.4 6.5 7.0

[0084] In summary, the medical puncture point protective dressings provided in the embodiments of the present invention are significantly superior to Comparative Example 1 and Comparative Example 2 in terms of hemostasis efficiency, accuracy of pressure time determination, dressing displacement rate, and patient comfort.

[0085] In conjunction with the above embodiments, the present invention also provides a method for preparing a medical puncture point protective dressing, comprising the following steps:

[0086] S1: Select a PU film, PE film, PVC film or non-woven fabric with a thickness of 0.05 to 0.15 mm as the pre-colored flexible substrate layer 3. The pre-colored flexible substrate layer 3 has a color marking layer.

[0087] S2: A medical pressure-sensitive adhesive layer with a thickness of 0.03 to 0.08 mm is formed on the lower surface of the pre-colored flexible substrate layer 3 by a coating process, and a peelable protective film is laminated on the surface of the medical pressure-sensitive adhesive layer to obtain an adhesive substrate;

[0088] S3: An elastic positioning layer 7 is provided on the upper surface of the pre-colored flexible substrate layer 3 and is fixedly connected to the pre-colored flexible substrate layer 3 by hot pressing or bonding.

[0089] S4: A compression function layer 2 is provided on the upper surface of the elastic positioning layer 7 and is fixedly connected to the elastic positioning layer 7 by hot pressing or bonding.

[0090] S5: Apply a temperature-sensitive indicator material to the surface or interior of the compression functional layer 2 by printing, coating, spraying or impregnation processes;

[0091] S6: Cover the second peelable protective film on top of the compression functional layer 2, and after die-cutting, seal and sterilize to obtain a medical puncture point protective dressing.

[0092] It should be noted that the above-mentioned medical puncture site protective dressing is used to apply pressure to the puncture site for hemostasis after percutaneous puncture procedures. Percutaneous puncture procedures include, but are not limited to, arteriovenous fistula puncture in hemodialysis treatment, central venous catheterization, arterial blood gas analysis puncture, percutaneous liver puncture, kidney biopsy, cardiac catheterization, peripheral venous catheterization, and puncture site pressure for hemostasis after various vascular interventional treatments.

[0093] The foregoing has only described certain exemplary embodiments of the present invention by way of illustration. Undoubtedly, those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the foregoing drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. A medical puncture point protective dressing, the protective dressing is configured as a multi-layer composite medical dressing for puncture point compression hemostasis and has a temperature sensing color changing indication function, characterized in that, This multi-layer composite medical dressing includes: A pre-colored flexible substrate layer (3) has an adhesive layer on its lower surface for adhering to the skin; A peelable protective layer (4) covers the surface of the adhesive layer and is used to protect the adhesive layer before use and can be peeled off and removed during use; The compression functional layer (2) is disposed on the upper layer of the pre-colored flexible substrate layer (3) and is used to apply pressure to the puncture point; The second protective layer (1) is located on top of the compression functional layer (2); And a temperature-sensitive indicator unit, located on the surface or inside of the pressure function layer (2), is used to visually indicate whether the pressure time has reached the preset duration through color change. The temperature-sensitive indicator unit includes a thermochromic material that undergoes reversible color change at a temperature of 35 to 40°C and has a color change time of 10 to 15 minutes. The pre-colored flexible substrate layer (3) has a color identification layer that contrasts with the color of the thermochromic material after color change.

2. The medical puncture point protective dressing according to claim 1, characterized in that, The thermochromic material is any one of thermosensitive ink, thermosensitive coating, thermosensitive microcapsule or thermosensitive gel, and the thermochromic material is set on the surface of the pressure functional layer (2) in the form of dots, stripes or text.

3. The medical puncture point protective dressing according to claim 1, characterized in that, The compression functional layer (2) is a single-layer structure, and its material is any one of polyurethane sponge, polyethylene foam or medical silicone, with a thickness of 3 to 8 mm.

4. The medical puncture point protective dressing according to claim 1, characterized in that, The compression functional layer (2) is a layered composite structure, including an upper soft compression layer (201) and a lower hard compression layer (202), wherein the density of the upper soft compression layer (201) is less than the density of the lower hard compression layer (202).

5. The medical puncture point protective dressing according to claim 1, characterized in that, The pre-colored flexible substrate layer (3) is a PU film, PE film, PVC film or non-woven fabric with a thickness of 0.05 to 0.15 mm and a dark color; the adhesive layer is a medical pressure-sensitive adhesive with a coating thickness of 0.03 to 0.08 mm and an adhesion force of 1.0 to 3.0 N / 25 mm.

6. The medical puncture point protective dressing according to claim 1, characterized in that, It also includes an elastic positioning layer (7), which is disposed between the pre-colored flexible substrate layer (3) and the compression function layer (2). The elastic positioning layer (7) is an elastic film or elastic sponge with a thickness of 0.5 to 1.5 mm.

7. The medical puncture point protective dressing according to claim 1, characterized in that, It also includes a visual positioning structure (5), which is a through hole located at the center of the application, with a diameter of 8 to 15 mm.

8. The medical puncture point protective dressing according to claim 1, characterized in that, It also includes a blood-absorbing and blood-storing structure, which is a water-absorbing material ring located at the edge of the compression functional layer (2). The water-absorbing material ring is made of medical water-absorbing fiber or water-absorbing sponge material.

9. A method for preparing a medical puncture point protective dressing as described in any one of claims 1 to 8, characterized in that, Includes the following steps: S1: Select PU film, PE film, PVC film or non-woven fabric with a thickness of 0.05 to 0.15 mm as the pre-colored flexible substrate layer (3), and the pre-colored flexible substrate layer (3) has a color marking layer; S2: A medical pressure-sensitive adhesive layer with a thickness of 0.03 to 0.08 mm is formed on the lower surface of the pre-colored flexible substrate layer (3) by a coating process, and a peelable protective film is laminated on the surface of the medical pressure-sensitive adhesive layer to obtain an adhesive substrate; S3: An elastic positioning layer (7) is provided on the upper surface of the pre-colored flexible substrate layer (3) and is fixedly connected to the pre-colored flexible substrate layer (3) by hot pressing or bonding. S4: A compression function layer (2) is provided on the upper surface of the elastic positioning layer (7), and is fixedly connected to the elastic positioning layer (7) by hot pressing or bonding. S5: Apply a temperature-sensitive indicator material to the surface or interior of the compression functional layer (2) by printing, coating, spraying or impregnation processes; S6: Cover the second peelable protective film on top of the compression functional layer (2), and after die-cutting, seal and sterilize to obtain a medical puncture point protective dressing.

10. Use of the medical puncture site protective dressing according to any one of claims 1 to 8 in the preparation of a medical device for puncture site compression hemostasis, wherein the puncture site includes, but is not limited to, the arteriovenous fistula puncture site after hemodialysis.

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