Puncture dressing

Abstract

[Problem] The present invention provides a dressing material for puncture that allows puncture to be performed while the blood vessel of the puncture site and a puncture needle are being observed using an ultrasonography device, and that can fixate the puncture site as is used during the puncture. Thus, the present invention provides a dressing material for puncture that prevents air from entering between an adhesive and the skin when the dressing material for puncture is applied, and that achieves not only an increase in ultrasound transmissivity but also an increase in moisture permeability. [Solution] A dressing material for puncture according to the present invention comprises a support film, a frame sheet, and a release liner that are stacked in this order from above, wherein the support film and the frame sheet, and the frame sheet and the release liner are bonded together using an adhesive. The dressing material for puncture is characterized in that the support film includes a base material having a thickness of 10 μm to 80 μm, and the adhesive has a mass per unit area of 30 g / m2 to 80 g / m2.

Description

[Technical field]

[0001] The present invention relates to a puncture dressing material that allows a puncture device such as a catheter to be inserted under ultrasound guidance, allows the puncture device to be easily fixed in place, and allows the retention status of the tip of the puncture device to be observed over time. [Background technology]

[0002] When placing a catheter in a peripheral vein, if the puncture or fixation is inappropriate, complications such as phlebitis may occur. For this reason, attempts are being made to standardize the technique of placing a catheter while observing the condition of the blood vessel and the puncture device with ultrasound (ultrasound-guided puncture). However, there are concerns that the ultrasound jelly (hereinafter referred to as ultrasound jelly) may clog the needle or cause an infection when puncturing a site where it has been applied. Currently, in some cases, ultrasound examinations are performed by applying disinfectant or other liquid instead of ultrasound jelly, but because disinfectants are volatile, this makes the examination difficult to perform and makes standardization difficult. Here, by applying ultrasonic jelly on the puncture dressing and performing ultrasonic observation through the puncture dressing, the ultrasonic jelly can be isolated from the surface of the puncture site, which is expected to prevent pain and complications due to clogging of the puncture needle and puncture failure, improve the accuracy of the procedure, and prevent infection. Furthermore, the catheter can be easily fixed after puncture, which is expected to improve operability. An ultrasonic surface puncture aid using a dressing material for ultrasonic puncture has been disclosed (Patent Document 1). However, specifications for excellent ultrasonic transparency (adhesive, type and thickness of base material) have not been considered. In addition, although other products similar to the present invention have been developed (ULTRADRAPE TM , Parker Laboratories Inc., Patent Document 2, Patent Document 3), but previous studies have revealed that the tape's ultrasound permeability is insufficient, which may lead to puncture failure due to poor observation of anatomical structures such as blood vessels, and that the tape's low moisture permeability may lead to bacterial growth if the tape is left on for a long period of time. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication Pamphlet No. 2016 / 031001 [Patent Document 2] Patent No. 6176850 [Patent Document 3] Special table number 2021-511946 Summary of the Invention [Problem to be solved by the invention]

[0004] As can be seen from these circumstances, a puncture dressing material that allows placement and fixation of a puncture device under ultrasound guidance is required to have excellent ultrasonic transmittance and high moisture permeability. The present invention provides a puncture dressing material which, by applying ultrasonic jelly onto the top film after application, allows puncture while observing the anatomical structure and the puncture device with an ultrasonic examination device, allows the puncture device to be fixed in place, and allows the retention status of the tip of the puncture device to be observed over time. The present invention also provides a puncture dressing that can prevent air from getting between the adhesive and the skin when the puncture dressing is applied, thereby improving ultrasound transmittance and moisture permeability. [Means for solving the problem]

[0005] As a result of extensive investigations, the inventors have completed a puncture dressing material which has suitable viscoelasticity to fix a puncture device, and which also has high moisture permeability and excellent ultrasonic transmittance. That is, in a first aspect, the present invention provides a puncture dressing material comprising an ultrasonically transparent support film, a frame sheet having an observation window for observing the holding state of a tip of a puncture device fixed to a body surface, and a release liner, which are laminated in this order from above, and the support film and the frame sheet, and the frame sheet and the release liner are each adhered to each other by an adhesive, The support film is a film substrate having a thickness of 10 μm to 80 μm, and the mass of the adhesive per unit area is 30 g / m 2 ~80g / m 2 The present invention relates to a puncture dressing material comprising: In a second aspect, the present invention relates to the puncture dressing material according to the first aspect, in which the adhesive that bonds the support film and the frame sheet is an acrylic adhesive or a urethane adhesive containing a copolymer having an alkyl (meth)acrylate ester as a main component. In a third aspect, the present invention relates to the puncture dressing material according to the first or second aspect, wherein the adhesive that bonds the support film and the frame sheet has a storage modulus of 15 KPa or less and a loss tangent (tan δ) of 0.4 or more at an angular frequency of 1 rad / s obtained by dynamic viscoelasticity measurement at 32°C. In a fourth aspect, the present invention relates to a puncture dressing material as defined in claim 1 or claim 2, or a puncture dressing material as defined in the first or second aspect, wherein the adhesive that bonds the support film and the frame sheet has a storage modulus of 28 KPa or less at an angular frequency of 1 rad / s obtained by dynamic viscoelasticity measurement at 32°C and a loss tangent (tan δ) of 0.65 or more. According to a fifth aspect, the present invention relates to the puncture dressing material according to any one of the first to fourth aspects, wherein a base material used for the support film is polyethylene terephthalate, polyethylene, polyurethane or oriented polypropylene. In a sixth aspect, the present invention relates to the puncture dressing material according to any one of the first to fifth aspects, wherein a total thickness of the adhesive portion filling the space between the support film and the observation window is 47 μm to 120 μm. A seventh aspect of the present invention relates to the puncture dressing material according to any one of the first to sixth aspects, wherein a base material used for the frame sheet is a polyurethane nonwoven fabric or a polyethylene terephthalate nonwoven fabric. According to an eighth aspect of the present invention, there is provided a puncture dressing material according to any one of the first to seventh aspects, wherein the frame sheet is further provided with a slit portion for exposing the puncture device. A ninth aspect of the present invention relates to the puncture dressing material according to any one of the first to eighth aspects, further comprising a fold-back tape coupled to the release liner. In a tenth aspect, the present invention relates to the puncture dressing material according to the ninth aspect, wherein the fold-over tape is provided on a part of the lower surface of the release liner and is connected to the release liner so as to cover a part of the observation window. In an eleventh aspect, the present invention relates to the puncture dressing material according to the ninth or tenth aspect, wherein the release liner has one notch on each of both longitudinal edges of the release liner, and the edge of the folded tape opposite the device placement side overlaps with a straight line connecting the two notches in the lateral direction. In a twelfth aspect, the present invention relates to a puncture dressing material according to any one of the first to eleventh aspects, further comprising a non-adhesive processed portion between the frame sheet and the release liner so as to prevent the frame sheet and the release liner from adhering to each other. In a thirteenth aspect, the present invention relates to the puncture dressing material according to the twelfth aspect, wherein the non-adhesive processed portion comprises a non-adhesive seal. In a fourteenth aspect, the present invention relates to a puncture dressing material according to any one of the first to thirteenth aspects, further comprising a carrier film above the support film, which is in direct contact with the support film, and the thickness of the carrier film is 10 μm to 80 μm. Effect of the Invention

[0006] By using the puncture dressing material of the present invention, it is possible to puncture an anatomical structure such as a blood vessel and a puncture device while observing an ultrasound image, without the ultrasonic jelly coming into contact with the body surface and a puncture device such as a catheter. This reduces the possibility of clogging or infection of the puncture device due to the ultrasonic jelly, and the puncture device can be easily fixed after puncture, which is expected to improve operability. Furthermore, the holding state of the tip of the fixed puncture device can be confirmed through the observation window.

[0007] In addition, because the skin has a rough surface with skin ridges and skin grooves approximately 20 to 40 μm deep, air may become trapped between the adhesive and the skin when the puncture dressing is applied. This air trapping reduces the ultrasonic permeability to the skin through the puncture dressing. In light of this, the present invention devised the coating thickness and viscoelastic properties of the adhesive necessary to penetrate the skin grooves and prevent air from entering. As a result, by applying an adhesive with moderate viscoelastic properties and high moisture permeability to a coating thickness of 30 μm or more to a support, the risk of discomfort and infection during application is reduced and the dressing can be applied for a long period of time. Furthermore, a puncture dressing is provided that has the remarkable effect of reducing the frequency of re-puncture to replace the puncture device due to failure of the puncture procedure and infection or discomfort at the puncture site, thereby improving the quality of life (QOL) of patients and reducing the burden on medical professionals. [Brief description of the drawings]

[0008] [Figure 1] FIG. 1 shows a plan view (A) and a bottom view (B) of an example of a puncture dressing material (1) of the present invention. [Diagram 2] Fig. 2 is a cross-sectional view taken along line AA' of the puncture dressing material (1) shown in (A) of Fig. 1. The direction of the arrow indicates the side that adheres to the body surface. [Diagram 3] Figure 3 is a cross-sectional view of the puncture dressing shown in Figure 2, in which a non-adhesive part (11) is provided between the frame sheet (3) and the release liner (4). The direction of the arrow indicates the side that adheres to the body surface. [Figure 4]FIG. 4 is a cross-sectional view of an example of the puncture dressing of the present invention, which further has a carrier film (10) above the support film (2) of the puncture dressing of FIG. 3 and which is in direct contact with the support film. [Diagram 5] Figure 5 is a plan view of each layer in the cross section of the puncture dressing material of the present invention shown in Figure 4. (A) to (F) respectively represent (A) carrier film (10), (B) support film (2), (C) frame sheet (3), (D) non-adhesive part (non-adhesive seal) (11), (E) release liner (4), and (F) fold-over tape (7). [Figure 6] Fig. 6 shows a cross-sectional view of an embodiment of the puncture dressing of the present invention that does not have a frame sheet. (A) is the puncture dressing of Fig. 2 without the frame sheet. (B) is a puncture dressing in which a non-adhesive part (11) is further provided between the support film (2) and release liner (4) shown in (A). (C) is a puncture dressing having a carrier film that is directly in contact with the support film above the adhered support film and release liner shown in (A). [Figure 7] 7(A) to 7(F) show an example of a procedure for using the dressing material for puncture of the present invention shown in FIG. 4 and FIG. [Figure 8] Figure 8 shows ultrasound images of the median cutaneous vein of the forearm. The white arrow in the image indicates the body surface just above the vein. (A) to (E) are ultrasound images scored 0 to 4 according to the evaluation criteria in Table 2. [Figure 9] Figure 9 shows photographs showing the method for evaluating the brightness of the Sakamoto artificial arm model. (A) is a photograph of a probe being pressed against the surface of a sample coated with ultrasound jelly that is affixed to the pad of the Sakamoto model. (B) is an ultrasound image of the area around the blood vessels of the Sakamoto model. Note that Figures 1 to 6 are shown for the purpose of explanation only. They do not show actual dressing materials. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] The puncture device of the present invention is, for example, a needle, catheter, cannula, or guidewire, and is used for puncturing a vein or artery or other anatomical structure, including, for example, veins, arteries, nerves, tendons, nerve sheaths, as well as muscle and fat tissue. The body surface of the present invention includes the skin of humans as well as animals such as dogs, cats, cattle, and horses.

[0010] (Structure of puncture dressing material) The puncture dressing of the present invention is a flat medical patch material. Fig. 1 (A) shows an example of a plan view of the puncture dressing of the present invention. Fig. 1 (B) shows an example of a bottom view of the puncture dressing of the present invention. Fig. 2 is a cross-sectional view of the puncture dressing shown in Fig. 1 (A) along line A-A'. The arrow points to the skin side. Although a rectangular puncture dressing is shown in FIG. 1, the shape of the puncture dressing can be freely changed as required.

[0011] One embodiment of the puncture dressing of the present invention is configured by laminating as shown in the cross-sectional view of Fig. 2. From the top, it is configured by laminating an ultrasonically transparent support film (2), a frame sheet (3) having an observation window (5) for observing the holding state of the tip of the puncture device fixed to the body surface, and a release liner (4). The support film (2) and the frame sheet (3), and the frame sheet (3) and the release liner (4) are adhered with an adhesive (9), and the observation window (5) between the release liner (4) and the support film (2) is filled with the adhesive (9). Basically, the dressing is attached so that the tip of the puncture device (12) inserted into the body (see FIG. 7) is located near the center of the dressing. The part of the puncture device that is left outside the body is then fixed by the edge of the dressing. In this invention, the part of the dressing where the puncture device that is left outside is located is referred to as the device placement side of the dressing.

[0012] Fig. 3 is a cross-sectional view of the puncture dressing shown in Fig. 2, in which a non-adhesive processed part (11) described below is provided between the frame sheet (3) and the release liner (4). Fig. 4 is a cross-sectional view of an example of the puncture dressing of the present invention, which further has a carrier film (10) described below that is directly attached to the support film (2) above the support film of the puncture dressing of Fig. 3. Fig. 5 is a plan view of each layer in the cross section of the puncture dressing of the present invention shown in Fig. 4. In addition, since a non-adhesive processed portion (11) is provided, the layer of adhesive adhering the frame sheet (3) and the release liner (4) in Figures 3 and 4 is shown to be thicker than the layer of adhesive adhering the support film (2) and the frame sheet (3), but this is shown merely for the purpose of explanation. Each layer will be described below with reference to FIGS.

[0013] Career Film(10) The carrier film (10) is a film that is provided above the support film (2) so as to be in close contact with the support film (2) so that the ultrasonic jelly does not come into direct contact with the support film (2) or the skin. The carrier film (10) is not essential. The carrier film (10) has a function of placing ultrasonic jelly thereon and removing the carrier film after ultrasonic testing to remove all of the ultrasonic jelly, so there are no limitations on the size or shape as long as it does not affect the function. The carrier film shown in Fig. 5(A) is only one example of a carrier film, but it is preferable that the carrier film (10) is larger than the lower layer so as to cover the lower layer.

[0014] Support Film (2) The support film (2) is a film that performs the function of allowing the retention status of the tip to be checked visually and ultrasonically at any time after the dressing is placed. When the carrier film (10) is not present, it has the function of the carrier film (10), and ultrasonic jelly is applied onto the support film (2) so that the ultrasonic jelly does not come into direct contact with the skin, and the position of an anatomical structure (e.g., a vein) is confirmed through the support film by a probe. The support film (2) shown in Figure 5 (B) is an example. The slit portion (61) and the cutout portion (82) are optional structures as described below.

[0015] Frame sheet (3) The frame sheet (3) mainly functions to support the support film (2) and is not required to be ultrasonically transparent. The frame sheet (3) is not necessary, but it is preferable to have one.

[0016] Slit section (6, 61, 62) As shown in (C) of Fig. 5, the frame sheet (3) may further have a keyhole-shaped slit portion (6) that penetrates from the front to the back of the frame sheet (3) on the device placement side of the frame sheet (3) and is cut out to expose the puncture device from the dressing material. This keyhole shape is designed so that the puncture device, such as a needle that has been inserted into the test subject, is exposed from this keyhole after puncturing is completed, and the frame sheets on both sides of the slit portion are used to prevent the exposed puncture device from coming into direct contact with the body surface, thereby reducing skin irritation such as pressure wounds caused by medical devices. The keyhole-shaped slit portion (6) shown in FIG. 5C is merely one example. In addition to the keyhole, other shapes such as a single straight or curved cut or a cross-shaped cut are also possible. In the case of a cut, the cut may have a certain width. Any shape may be used as long as the pricking device can be exposed from the slit portion, but a keyhole shape is preferable. The size of the slit portion (6) is set according to the size of the tip of the puncture device to be fixed. Basically, the length of the slit portion (6) is 15% to 25% of the longitudinal length of the dressing. In the case of the slit portion of the dressing shown in FIG. 5(C), for example, the longitudinal length of the dressing is 120 mm, and the keyhole-shaped slit portion is 25 mm long. Depending on the usage situation, it is also possible to use a frame sheet (3) that does not have a slit portion (6).

[0017] Furthermore, as shown in Fig. 5(C), an observation window (5) is provided in the frame sheet (3). The observation window (5) is used to visually and ultrasonically observe the holding state of the tip of the puncture device fixed to the body surface after puncture. In the drawing, the observation window is drawn in a shape close to a hexagon, but this shape is not meant to be limited, and the shape can be changed as necessary. Also, the observation window (5) and the slit portion (6) can be connected and integrated.

[0018] The support film (2) and release liner (4) shown in Figure 5 (B) and (E) are arranged to overlap with the frame sheet (3) sandwiched therebetween. When the frame sheet (3) has a slit portion (6), the support film (2) and release liner (4) are also provided with slit portions (61, 62) having a shape similar to that of the slit portion (6) of the frame sheet (3). In the puncture dressing material of the present invention, these slit portions (6, 61, 62) are arranged to overlap closely. In practice, the slit portion (62) of the release liner (4) is not required, but taking into consideration factors such as the manufacturing process and appearance, a slit portion may be provided in the release liner. Furthermore, if the frame sheet (3) does not have the slit portion (6), there is no need to provide the slit portions (61, 62) therein.

[0019] Release Liner(4) In the present invention, this refers to a seal that allows the release liner (4) to be peeled off cleanly when the dressing is used, exposing the adhesive (9). As shown in Figure 5 (E), the release liner (4) has a similar shape to the support film (2). Furthermore, any release liner normally used for tapes can be used as the release liner (4), and there are no limitations on the substrate. As shown in FIG. 3, the observation window (5) is filled with an adhesive (9), and therefore the release liner (4) is adhered to the frame sheet (3) and the support film (2) by the adhesive (9).

[0020] Non-adhesive processing section (11) Although not essential, when a frame sheet (3) is used, a portion of the adhesive between the release liner (4) and the frame sheet (3) is subjected to a glue-killing process to provide a non-adhesive portion (11) that acts as a trigger for peeling off the release liner (4) (see Figure 3 for reference). Also, when a frame sheet (3) is not used, a portion of the adhesive between the release liner (4) and the support film (2) is subjected to a glue-killing process to provide a non-adhesive portion (11).

[0021] The adhesive-killing process can be carried out by a commonly used method, for example, by applying an adhesive-killing agent or by applying a seal to eliminate adhesion. An example of the adhesive killing agent is UV ink. Examples of the UV ink that can be used include UV VNL series ink, UV161 series ink, and UV VP S series ink (all manufactured by T&K TOKA Corporation). The seal may be, for example, polyethylene terephthalate (PET). In this application, such a seal is referred to as a non-adhesive seal. The non-adhesive seal may or may not have an adhesive applied thereto, and may be applied to the release liner (4) side of the adhesive (9) between the frame sheet (3) and the release liner (4) to form a non-adhesive processed portion (11) (see FIG. 5(D)).

[0022] During use, the non-adhesive processed portion (11) eliminates the adhesive on the release liner (4) side of the frame sheet (3), allowing the release liner (4) to be easily picked up and peeled off smoothly. The non-adhesive processed portion (11) does not adhere to the release liner (4), so it does not peel off.

[0023] Also, instead of the non-adhesive processed portion (11), a seal that acts as an access port can be provided on the skin side of the release liner (4) (not shown in the drawings) to trigger the removal of the release liner (4). The seal is connected to a part of the release liner and can be designed so that it is either exposed or not exposed from the dressing material. When removing the release liner (4), the access port seal can be picked up and removed, and the release liner (4) can be removed together with the seal.

[0024] Folding Tape(7) Although not essential, a fold tape (7) that functions as a fold line may be further provided. As shown in Fig. 2, the fold tape (7) is provided on a part of the lower surface of the release liner so as to cover a part of the observation window (5) described below. The folded tape (7) is located near the puncture site, and when used, the release liner (4) on the opposite side to the device placement side is first peeled off up to the folded tape (7) which will be the fold line and folded. For convenience, the edge of the folded tape on the opposite side to the device placement side is basically made straight, and the folded tape is made into a simple rectangular shape (Figure 5 (F)), but there are no limitations on the shape of the folded tape as long as it serves the purpose of functioning as a fold line.

[0025] In one embodiment, in order to easily form a fold, the release liner (4) may be provided with, for example, one or two parallel perforations, which are commonly used in adhesive tapes, instead of a fold-over tape.

[0026] Notch (8, 81, 82) In order to make it easier to fold the release liner (4), it is possible to provide a notch (8) having a recess shape on each of both longitudinal edges of the release liner (4), as shown in (E) of Figure 5. The straight line connecting the two notches in the lateral direction overlaps with the edge of the fold-back tape (7) on the opposite side to the device placement side. Furthermore, for aesthetic reasons, it is possible to provide cutouts (81) and (82) of similar shape in the support film (2) and frame sheet (3) at the same position as the cutout (8) in the release liner (4) so ​​that they overlap perfectly. Also, if the release liner (4) does not have the cutout (8), it is not necessary to provide the cutouts (81, 82).

[0027] As described above, the frame sheet (3) mainly serves the function of supporting the support film (2), and therefore may be omitted if it does not affect the use of the puncture dressing material. That is, in addition to the puncture dressing of the present invention shown in Fig. 2 above, in another embodiment, there is a puncture dressing without a frame sheet (3), as shown in Fig. 6(A). When a non-adhesive processed part (11) is required, it is located between the support film (2) and the release liner (4) (Fig. 6(B)). Similarly, as shown in FIG. 6C, there is an embodiment in which a carrier film (10) is further provided above the support film (2) to be adhered as shown in FIG. 6A and in direct contact with the support film. Although it cannot be shown in the cross-sectional view of the dressing material in Figure 6, slits (61, 62) can be provided in the support film (2) and release liner (4) depending on the usage situation. Also, although there is a fold-over tape (7) in Figures 6(A) and (B), it is not essential and can be omitted. Similarly, although a cutout cannot be shown in the cross-sectional view, it is provided depending on the usage situation.

[0028] (How to use puncture dressing material) The method of using the puncture dressing of the present invention will be described below using the puncture dressing shown in Figs. 4 and 5 as an example. Before using the puncture dressing material of the present invention, first, the course of blood vessels is confirmed by ultrasound examination to determine the puncture site, the echo jelly at the intended puncture site is removed, and the site is disinfected (a marker may be placed on the surface of the body). Thereafter, the position where the puncture dressing of the present invention is applied is determined so that the observation window (5) of the puncture dressing covers the puncture site. Then, the edge of the release liner (4) opposite the device placement side is pinched, and the release liner (4) is removed down to the fold-back tape (7). The exposed frame sheet (3) and the adhesive of the support film (2) are attached to the examination site so that no air gets into the skin (see (A) of Figure 7). If air gets between the ultrasound device and the skin, the air will interfere with the formation of ultrasound signals, so be sure to attach the observation window (5), which will be the scanning area, firmly to the skin. Next, the probe coated with the ultrasound jelly is placed on the carrier film (10). (When using the puncture dressing materials shown in Figures 1, 2, and 3 that do not have a carrier film, the probe coated with the ultrasound jelly is placed directly on the support film (2).) Through the carrier film (10) and the support film (2), the anatomical structures are visualized by an ultrasound device to confirm the puncture site (see Figure 7(B)). While viewing the ultrasound video (e.g., as shown in FIG. 8), the location of the anatomical structure (e.g., a vein) is identified, and the puncture is performed using the puncture device (12) (see FIG. 7C). The puncture device is detected by the ultrasound device, and the correct placement of the puncture device is obtained. After the puncture is successful and the catheter is placed in the blood vessel, the carrier film (10) with the ultrasonic jelly attached is peeled off (see (D) of Figure 7). (If the puncture dressing material of Figures 1, 2, and 3 without the carrier film is used, the ultrasonic jelly attached to the support film is wiped off.) Then, all remaining release liners (4) are peeled off (see (E) in Figure 7). Furthermore, the pricking device (12) is fixed by the frame sheet around the slit portion (6) (see (F) of FIG. 7). If the pricking device comes into direct contact with the skin, the skin may be damaged. When fixing, the pricking device is properly fixed to the skin at the slit portion so that the pricking device does not come into direct contact with the skin, thereby preventing such damage. As shown in (F) of Figure 7, ultimately, only the support film (2) and the frame sheet (3) remain at the test site in addition to the adhesive. If the observation window portion of the support film (2) is transparent, the holding state of the fixed tip of the puncture device can be confirmed through the observation window (5).

[0029] When checking the puncture site using ultrasound, the parts of the frame sheet (3) other than the slit portion (6) serve to fix the puncture dressing material to the subject, and after puncture, the slit portion (6) serves to fix the puncture device (12) to the subject.

[0030] As another method of using the puncture dressing material of the present invention, the step of peeling off the carrier film (10) with the ultrasonic jelly on it after the puncture is completed may be changed to a step of wiping off the ultrasonic jelly and leaving the carrier film (10) as it is.

[0031] The method of using the puncture dressing without the frame sheet (3) is the same as the method of using the puncture dressing with the frame sheet (3). In the end, only the adhesive (9) and the support film (2) remain at the examination site.

[0032] The method of using the puncture dressing of the present invention, which has a single perforation in the center of the release liner, is the same as the method of using the puncture dressing shown in Figure 7, except for the steps of removing the release liner up to the perforation before puncture and attaching the exposed frame sheet and adhesive of the support film to the examination site, and removing the remaining part of the release liner after puncture. In addition, the method of using the puncture dressing of the present invention, which has two perforations in the center of the release liner, is the same as the method of using the puncture dressing shown in Figure 7, except for the steps of removing the center part along the two perforations of the release liner before puncture and attaching the exposed frame sheet and adhesive of the support film to the examination site, and removing both side parts of the release liner after puncture.

[0033] In addition to ultrasonic jelly, the present invention can also use contact means similar to ultrasonic jelly.

[0034] (Materials of each layer of the puncture dressing material) [Base material of carrier film (10)] The carrier film (10) carries ultrasonic jelly during ultrasonic examination and serves as a barrier to prevent the ultrasonic jelly from coming into contact with the puncture device (12). The carrier film (10) needs to use a base material having ultrasonic transparency. Polyolefin-based materials such as polyethylene (PE), oriented polypropylene (OPP), ethylene propylene copolymer, ethylene butene-1 copolymer, ethylene octene copolymer, ethylene vinyl acetate copolymer, and ethylene vinyl alcohol copolymer, polyvinyl alcohol-based materials, acrylic materials such as polymethyl methacrylate, polyester-based materials such as polyethylene terephthalate (PET) and polybutylene terephthalate, polyamide-based materials such as nylon 6 and nylon 6,6, various ionomer-based materials having metal ions such as zinc and sodium in the structure, styrene-based materials such as polystyrene, styrene isoprene copolymer, and styrene butadiene copolymer, polyurethane-based materials, PVC-based materials, fluorine-based materials, and cellulose-based materials such as acetate and cellophane can be obtained with a thickness of 10 μm to 80 μm. The thickness is preferably 10 μm to 60 μm. More preferably, it is 10 μm to 40 μm.

[0035] [Base material of support film (2)] The support film (2) naturally needs to be ultrasonically transparent since it has a scanning area for confirming the puncture location using ultrasound, and furthermore, since it needs to be attached tightly to the skin in the end, it needs to be particularly elastic, flexible and extensible. Examples of substrates that can be used for the support film (2) include polyolefin-based materials such as polyethylene (PE), oriented polypropylene (OPP), ethylene-propylene copolymers, ethylene-butene-1 copolymers, ethylene-octene copolymers, ethylene-vinyl acetate copolymers, and ethylene-vinyl alcohol copolymers, polyvinyl alcohol-based materials, acrylic materials such as polymethyl methacrylate, polyester-based materials such as polyethylene terephthalate (PET) and polybutylene terephthalate, polyamide-based materials such as nylon 6 and nylon 6,6, various ionomer-based materials having metal ions such as zinc and sodium in their structures, styrene-based materials such as polystyrene, styrene-isoprene copolymers, and styrene-butadiene copolymers, polyurethane-based materials such as polyurethane (U), PVC-based materials, fluorine-based materials, and cellulose-based materials such as acetate and cellophane. Basically, as long as the thickness of the obtained support film (2) is 10 μm to 80 μm, good ultrasonic transmission can be obtained for any substrate. The thickness of the support film (2) is preferably 10 μm to 40 μm, and more preferably 10 μm to 20 μm.

[0036] [Base material of frame sheet (3)] The substrate used in the frame sheet (3) does not need to be ultrasonically transparent, but it does need to be flexible and elastic, since it has the role of fixing the substrate to the skin and the role of fixing the puncture device to the subject. Any material that is flexible and elastic can be used. For example, any of the materials listed in the support film (2) above can be used. Since a substrate with a certain degree of strength is preferred, fibrous materials can also be used. In other words, polyurethane nonwoven fabric or polyethylene terephthalate nonwoven fabric is preferred as the substrate used in the frame sheet (3). There are no particular limitations on the thickness.

[0037] [Adhesive] The adhesive for bonding the support film (2) and the frame sheet (3), and the frame sheet (3) and the release liner (4) is required to have sufficient adhesion to the skin surface, as well as ultrasonic transparency, low skin irritation due to long-term contact with the skin after puncturing, and high moisture permeability to prevent bacterial growth. There are no particular limitations on the adhesive as long as it meets the above requirements, and adhesives containing acrylic, urethane, silicone, rubber, polyvinyl alcohol, polyamide, polyvinyl acetate, and other synthetic resins can be used. Among these, acrylic and urethane adhesives are particularly preferred.

[0038] Examples of acrylic adhesives that can be used include homopolymers of (meth)acrylic acid alkyl ester monomers such as butyl acrylate, 2-ethylhexyl acrylate, isononyl acrylate, etc., copolymers of a plurality of these monomers, and further copolymers of the (meth)acrylic acid alkyl ester monomers and other monomers copolymerizable therewith, such as (meth)acrylic acid, hydroxyalkyl esters of (meth)acrylic acid, vinyl acetate, styrene, vinylpyrrolidone, (meth)acrylamide, alkoxyalkyl (meth)acrylates, etc. Among these, acrylic adhesives containing copolymers mainly composed of (meth)acrylic acid alkyl esters are more preferred.

[0039] An example of a urethane-based adhesive is a urethane polymer obtained by using a polyol and a polyisocyanate. From the viewpoint of skin irritation, an adhesive having a mass ratio (OH / NCO) of a polyol or polyurethane polyol containing 1 to 3 hydroxyl groups to a polyisocyanate or polyurethane prepolymer containing 2 to 3 isocyanate groups in the range of 1.55 to 1.90 is preferred, and a range of 1.60 to 1.85 is more preferred. If the OH / NCO is smaller than this range, the adhesiveness to the skin over a long period of time becomes poor, and if it is larger than this range, cohesive failure is likely to occur when peeled off from the skin.

[0040] The polyol is not particularly limited, and examples thereof include hydroxy compounds, amine compounds, carboxylic acid compounds, thiol compounds, polyether polyols having hydroxyl groups, etc. Examples of hydroxy compounds include ethylene glycol, diethylene glycol, propylene glycol, dipropylene glycol, tripropylene glycol, 1,3-propanediol, 1,3-butanediol, 1,4-butanediol, 2,3-butanediol, 1,6-hexanediol, 1,9-nonanediol, 2,5-hexanediol, 1,3-cyclohexanediol, 2-methylpentane-2,4-diol, 2,5-dimethyl-2,5-hexanediol, glycerin, trimethylolpropane, hexanetriol, pentaerythritol, diglycerin, sorbitol, sucrose, glucose, 2-naphthol, bisphenol, etc. Examples of the amine compound include ethylenediamine, 1,3-propylenediamine, 1,4-butylenediamine, and 1,2-butylenediamine. Examples of the carboxylic acid compound include phthalic acid and adipic acid. Examples of the thiol compound include ethanedithiol and butanedithiol. Examples of the polyether polyol having a hydroxyl group include polyether polyol having a molecular weight of 200 or more and 10,000 or less.

[0041] As the polyisocyanate, a compound having at least two isocyanate groups can be used, and is not particularly limited. For example, 2,4-tolylene diisocyanate, 2,6-tolylene diisocyanate, 2,4'-diphenylmethane diisocyanate, 4,4'-diphenylmethane diisocyanate, 1,5-naphthalene diisocyanate, tolidine diisocyanate, xylylene diisocyanate, 1,3-phenylene diisocyanate, 1,4-phenylene diisocyanate, lysine diisocyanate, triphenylmethane triisocyanate, tetramethylxylene diisocyanate, 1,6-hexamethylene diisocyanate, 4,4'-dicyclohexylmethanate, tetramethylxylene diisocy ... Examples of the isocyanate-containing urethane prepolymers include hexane diisocyanate, isophorone diisocyanate, 1,4-cyclohexane diisocyanate, norbornane diisocyanate, lysine ester triisocyanate, 1,6,11-undecane triisocyanate, 1,8-diisocyanate-4-isocyanate methyloctane, 1,3,6-hexamethylene triisocyanate, bicycloheptane triisocyanate, trimethylhexamethylene diisocyanate, isocyanate-containing urethane prepolymers obtained by reacting these with polyols, and mixtures of two or more of these. Furthermore, modified products of these isocyanates (modified products containing a urethane group, a carbodiimide group, an allophanate group, a urea group, a biuret group, an isocyanurate group, an amide group, an imide group, a uretonimine group, a uretdione group, or an oxazolidone group) and condensates (sometimes referred to as polynuclear products) such as polymethylene polyphenylene polyisocyanate (polymeric MDI) are also included.

[0042] Furthermore, the adhesive of the puncture dressing material of the present invention meets requirements regarding specific parameters in dynamic viscoelasticity measurement (measurement temperature: 32°C (constant), strain: 0.1%, normal false: 3N, frequency sweep range: 0.01Hz to 1,000Hz).

[0043] In particular, it was found that a pressure-sensitive adhesive having a storage modulus of 15 KPa or less and a loss tangent (tan δ) of 0.4 or more at an angular frequency of 1 rad / s as measured by dynamic viscoelasticity at 32°C is preferable. Furthermore, it was found that a pressure-sensitive adhesive having a storage modulus of 28 KPa or less and a loss tangent (tan δ) of 0.65 or more at an angular frequency of 1 rad / s as measured by dynamic viscoelasticity at 32°C is preferable.

[0044] In addition, it was found that good ultrasound transmission was achieved by allowing the adhesive to flow into the skin grooves and reducing air entrapment between the support and the skin. Basically, the adhesive was applied thickly, with a coating amount of 30 g / m 2 If it is more than 30g / m, good ultrasonic transmission results can be obtained. 2 ~80g / m 2 Range and 35g / m 2 ~70g / m 2 If it is within this range, it is perfectly safe for practical use.

[0045] The final thickness of the dressing material of the present invention when used, i.e., the total thickness of the support film (2) and the adhesive (9) filling the space of the observation window, is 47 μm to 120 μm, preferably 47 μm to 100 μm, and more preferably 49 μm to 90 μm.

[0046] Furthermore, in order to achieve a storage modulus and obtain good ultrasonic transmission, it is useful to add a plasticizer to the adhesive. Examples of the plasticizer include fatty acid esters consisting of higher fatty acids having 12 to 16 carbon atoms, such as IPM-R (isopropyl myristate), ethyl laurate, and isopropyl palmitate, and lower monohydric alcohols having 1 to 4 carbon atoms; fatty acids having 8 to 10 carbon atoms; glycols such as ethylene glycol, diethylene glycol, triethylene glycol, polyethylene glycol, propylene glycol, and polypropylene glycol; oils and fats such as olive oil, castor oil, squalene, and lanolin; organic solvents such as ethyl acetate, ethyl alcohol, dimethyldecyl sulfoxide, decyl methyl sulfoxide, dimethyl sulfoxide, dimethylformamide, dimethylacetamide, dimethyllaurylamide, dodecylpyrrolidone, isosorbitol, oleyl alcohol, and lauric acid; liquid surfactants; ethoxylated stearyl alcohol, glycerin esters, isotridecyl myristate, N-methylpyrrolidone, ethyl oleate, oleic acid, diisopropyl adipate, octyl palmitate, 1,3-propanediol, and glycerin.

[0047] The adhesive for bonding the support film (2) and the frame sheet (3) and the adhesive for bonding the frame sheet (3) and the release liner (4) may be the same or different. For example, an acrylic adhesive may be used for both adhesives. Alternatively, one may be a urethane adhesive and the other an acrylic adhesive. Furthermore, even if the same acrylic adhesive is used, it may be the same type, two different types, or several different types may be mixed together.

[0048] [Release liner (4), folded tape (7) and non-adhesive processed portion (11) substrate] The base material of the release liner (4) may be any material that can be easily removed from the frame sheet (3) and the support film (2), such as a polyethylene terephthalate (PET) film. The folding tape (7) that functions as the fold line is not particularly limited as long as it can be attached to the release liner (4). For example, an oriented polypropylene (OPP) film can be used. When the non-adhesive processed portion (11) is a seal, a PET film, a urethane film, or the like can be used as the base material.

[0049] The carrier film (10) and the support film (2) may be entirely or partially transparent, and the frame sheet (3) may be entirely or partially transparent. This allows the operator inserting the puncture device to see the mark on the ultrasound device if a mark is placed on the body surface at the examination site during puncture, and the position of the puncture device relative to the anatomical structure can be determined quickly and without causing discomfort to the patient, allowing the puncture device to be inserted correctly relative to the anatomical structure. This leads to improved patient quality of life and reduced burden on medical staff. In addition, the holding status of the tip of the puncture device can be observed over time after puncture.

[0050] The dressing material of the present invention has a moisture permeability of 1,000 (g / m 2 Moisture permeability is preferably 1,000 (g / m 2 By having a moisture permeability of 1,500 (g / m 24 hr) or more, the patch does not become stuffy when applied to the skin, and is less likely to cause skin irritation or itching during application, making it possible to apply the patch for long periods of time. 2 24hr) or more is preferable, and 1,800 (g / m 2 The higher the moisture permeability, the better. There is no particular upper limit to the moisture permeability, but it is usually 10,000 (g / m 2 24hr or less.

[0051] (Manufacturing method of dressing material) As a non-limiting example, the dressing material of the present invention is manufactured by laminating each layer in order with an adhesive. First, an adhesive is applied to the skin side of the support film (2), and if necessary, a frame sheet (3) is laid on top of that. An adhesive is then applied to the frame sheet (3), and a release liner is laid on top of that. If necessary, a carrier film (10) can be provided that directly adheres to the opposite side of the skin side of the support film (2). EXAMPLES

[0052] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples.

[0053] [Example 1 Relationship between the type of substrate of the carrier film (10) and the support film (2) and ultrasonic transmittance] A carrier film (10) and a support film (2) were obtained according to the compositions and manufacturing methods shown in Table 1 below, and ultrasonic jelly was placed on them using a Sakamoto model to evaluate the ultrasonic transmittance and brightness difference of each substrate.

[0054] [Table 1]

[0055] In Table 1, the same adhesive was used. A urethane adhesive with a mass ratio (OH / NCO) of polyol to isocyanate of 1.75 was applied to one side of a substrate with a thickness as shown in the figure in the coating amount (g / m2). 2 ) was applied. The columns with PET, PE, and U in the base material type are samples in which adhesive is applied to the respective base material, simulating the carrier film or support film alone. The column with OPP+U (laminated stretched polypropylene film and polyurethane film) in the base material type is a sample that simulates the use of an actual puncture dressing material with a carrier film, in which a 40μm-thick stretched polypropylene carrier film is in close contact with a 20μm-thick polyurethane support film with adhesive applied on both sides.

[0056] (Evaluation of luminance in Sakamoto model) The luminance of each sample in Table 1 was evaluated using the Sakamoto model. Measurements were performed in a test room at 23°C / 50% RH to suppress the effect of changes in the elasticity of the medium due to temperature changes on the luminance. Figure 9 is a photograph showing the method for evaluating the luminance in the Sakamoto artificial arm model.

[0057] Implementation Procedure 1. Test The pad part of the ultrasound-guided PICC trainer (Sakamoto Model Co., Ltd.) that had been left at room temperature and had its temperature adjusted was used for the test. Sakamoto Model (https: / / www.sakamoto-model.co.jp / product / echo / m196 / index.html#item_discription) 2. To simulate blood, the holes in the pad (blood vessels) were filled with distilled water. 3. Each sample, approximately 50 x 40 mm in size, was attached to the surface of the pad and ultrasonic jelly was applied. 4. The probe (FWL L10-5 linear probe) of the wireless ultrasound imaging diagnostic device iViz air Linear (FUJIFILM Medical Co., Ltd.) was lightly pressed against the sample to obtain ultrasound images of the blood vessels. 5. The obtained ultrasound images were analyzed using the image analysis software ImageJ (NIH, USA) to determine the difference in brightness between the inside of the blood vessel (pad blood vessel part (circle in the middle of Figure 9(B))) and the outside (pad parenchyma part (circles on both sides of Figure 9(B))). For each tape layer sample with different base materials, three images were taken at approximately 10 mm intervals, and the average brightness difference (Δbrightness) at each point was taken as the measurement value (n=3, triplication). The greater the brightness difference, the easier it is to see blood vessels and the better the ultrasonic transparency. (Reference: An example of using Image J to analyze ultrasound images (Nakagawa Tomoya et al., Precision control of sector probes using homemade phantoms in ultrasound diagnostic equipment, Biological Sample Analysis Vol. 42 No.2 (2019).))

[0058] From the samples in Table 1, it can be seen that for the same type of substrate, the luminance difference decreases as the substrate becomes thicker.

[0059] (Evaluation on human skin) To determine whether the samples in Table 1 above could obtain ultrasound images that indicated puncturing, the samples were actually attached to human skin, and ultrasound images of the cutaneous veins of the forearm were evaluated for ultrasound transmittance according to the criteria in Table 2. The ultrasound transmittance scores for (A) to (E) in Fig. 8 are each scored from 0 to 4 according to the evaluation criteria in Table 2. Score 2 or higher indicates that puncturing is possible, so score 2 is set as the threshold. When checking the ultrasound images, the test was carried out in a test room at 23°C / 50% RH in order to suppress the effect of changes in the elasticity of the medium due to temperature changes on ultrasound transmittance.

[0060] Implementation Procedure 1. To facilitate observation of blood vessels, the subject's (male, 30s) upper arm was compressed and blood was removed. 2. The course of the cutaneous vein on the inside of the forearm was observed, and each sample (carrier film (10) (if available) + support film (2)) of approximately 30 x 30 mm in size was attached to the skin above the blood vessel and lightly pressed. Note that the observation was performed near the center of the longitudinal length of the forearm. 3. Immediately, ultrasonic jelly was applied on top of the sample. 4. The probe (FWL L10-5 linear probe) of the wireless ultrasound imaging diagnostic device iViz air Linear (FUJIFILM Medical Co., Ltd.) was lightly pressed against the sample to obtain ultrasound images of the blood vessels (n=1). 5. The obtained ultrasound images were compared with the scoring criteria in Table 2, and scores were assigned based on the ease of observing blood vessels (contrast between the inside and outside of blood vessels and clarity of the blood vessel walls).

[0061] [Table 2]

[0062] From the samples in Table 1, it can be seen that for the same type of substrate, the thicker the substrate, the lower the ultrasonic transparency score.

[0063] The above-mentioned base materials have different elasticity from human skin and ultrasonic jelly, and therefore reduce ultrasonic transmission. This effect becomes more pronounced as the base material becomes thicker. From Table 1, for the same base material type, the brightness difference decreases as the base material becomes thicker, but for the base material thicknesses tested this time, all of them obtained good ultrasonic transmission scores. From these results, it can be seen that good ultrasonic transmission is achieved when the thickness of the carrier film (10) and the support film (2) is between 10 μm and 80 μm, respectively. Within this range, there is almost no difference in the substrate material.

[0064] [Example 2 Relationship between adhesive softness and ultrasonic transmission] Adhesive compositions were prepared using acrylic adhesives with the compositions shown in Tables 3 to 5 below, and their synthetic paper holding power and dynamic viscoelasticity at a temperature of 32° C. were measured. Adhesive compositions were prepared using urethane adhesives with the compositions shown in Table 6 below, and their synthetic paper holding power and dynamic viscoelasticity at a temperature of 32° C. were measured. Furthermore, the carrier film (10) is 40 μm OPP, and a 20 μm urethane support film is coated with an adhesive having the composition shown in Tables 3 and 6. These samples were attached to human skin, ultrasonic jelly was placed on top, and ultrasonic waves were applied to the samples, and the ultrasonic images were evaluated for ultrasonic transparency according to the criteria in Table 2.

[0065] (Measurement of holding power against synthetic paper) The specific measurement method was as follows: a test piece backed with Carton Tape No. 660 (manufactured by Nichiban Co., Ltd.) was attached to a synthetic paper (manufactured by Yupo Corporation Co., Ltd.) measuring 12 mm wide and 20 mm long. A rubber roller weighing approximately 2 kg was used to press the piece back and forth at a speed of approximately 300 mm / min, and the piece was left to stand for 20 to 40 minutes. The test piece and synthetic paper were fixed vertically, a weight weighing 200 g was hung from one end of the test piece, and the length of the test piece that had shifted after 60 minutes was read in 0.1 mm increments using a scale loupe, and this was taken as the measured value. The measurement was performed three times, and the average value was taken as the result.

[0066] (Dynamic viscoelasticity measurement at 32℃) The specific measurement method was to dry each adhesive and prepare a sheet-like test piece with a thickness of about 1 mm. The dynamic viscoelasticity of the test piece was measured using an MCR301 (manufactured by Anton Paar) at the following conditions: measurement temperature: 32°C (constant), strain: 0.1%, normal force: 3N, frequency sweep range: 0.01Hz to 1,000Hz (s -1 The measurements were performed twice for each test piece, and the average value was used as the result.

[0067] [Table 3]

[0068] [Table 4]

[0069] [Table 5]

[0070] [Table 6]

[0071] If the measured value of the synthetic paper retention is small (the adhesive is hard), the adhesive will not flow easily into the skin groove, resulting in reduced ultrasonic transparency. Since rating 2 is the threshold, adhesives with a synthetic paper retention of 0.2 to 0.4 mm or more are soft and provide good ultrasonic transparency. When the storage modulus at an angular frequency of 1 rad / s obtained by dynamic viscoelasticity measurement at 32°C is 15 KPa or less, good ultrasonic transmittance is obtained. In addition, the addition of the plasticizer IPM-R to the formulation of acrylic 1-3 improved ultrasonic transparency (acrylic 1-6, acrylic 1-7).

[0072] [Example 3: Relationship between adhesive coating thickness and ultrasonic transmission and moisture permeability] The same urethane adhesive (OH / NCO=1.75) was applied to a material with a carrier film (10) of 40 μm OPP and a urethane support film of 20 μm, and the relationship between different adhesive coating thicknesses and ultrasonic transparency and moisture permeability as shown in Table 7 was examined. In this example, the use of a dressing material without a frame sheet was assumed and measurements were taken, but when a dressing material with a frame sheet is used, the thickness of the adhesive portion corresponds to the thickness of the adhesive portion filling the space of the observation window. As a comparative example, the conventional ULTRADRAPE TM (manufactured by Parker Laboratories Inc.) was used.

[0073] (Measurement of moisture permeability) In the present invention, the moisture permeability was measured at a temperature of 40°C and a relative humidity of 90% according to the calcium chloride method described in JIS L1099. That is, one side of the patch was adjusted to a temperature of 40°C and a relative humidity of 90%, and a moisture absorbent such as calcium chloride was placed on the other side to absorb the moisture that had passed through the patch, and the weight change of the moisture absorbent was measured over 24 hours, 1 m 2 It was calculated by converting it to per person.

[0074] [Table 7]

[0075] The total thickness in Table 7 above is the total thickness excluding the carrier film, that is, the total thickness of the support film and the adhesive applied to the support film.

[0076] From the scores in Table 7 above, in the case of a urethane adhesive (OH / NCO=1.75), as the adhesive coating thickness increases, the adhesive flows into the skin groove, reducing air entrapment between the tape and the skin, resulting in good ultrasound permeability. The conventional product in the comparative example had a white haze inside the blood vessels, making the blood vessel walls unclear, and so the ultrasound permeability was scored 1, meaning it could not be punctured. To obtain good ultrasonic transmission of score 2 or higher, the coating amount is 30 g / m 2It is expected that the thickness will be 70g / m or more. Even if the thickness is greater than this, the ultrasonic transmission will not change. For example, if the coating amount is 70g / m 2 But 80g / m 2 Good ultrasonic transparency was obtained. It was confirmed that the moisture permeability was significantly improved compared to conventional products.

[0077] The above examples are for the purpose of further illustrating the present invention, and are not intended to limit the scope of protection of the present invention. It goes without saying that those skilled in the art can improve and adjust the content of the present invention in other aspects based on the content of the present invention without exceeding the scope of protection of the present invention. [Explanation of symbols]

[0078] 1 Puncture dressing 2 Support film 3 Frame sheet 4 Release Liner 5 Observation window 6,61,62 Slit section 7 Folding tape 8,81,82 Notch 9. Adhesive 10. Career Film 11 Non-adhesive processing section 12 Puncture Device

Claims

1. A support film having ultrasonic transparency; a frame sheet having an observation window for observing the holding state of the tip of the puncture device fixed to the body surface; A release liner; These are stacked in this order from above, A puncture dressing material, comprising a support film and a frame sheet, and a frame sheet and a release liner, each of which is adhered to the other by an adhesive, the support film being a film substrate having a thickness of 10 μm to 80 μm; The mass of adhesive per unit area is 30 g / m ２ ~80g / m ２ and The pressure-sensitive adhesive for bonding the support film and the frame sheet has a storage modulus of 15 KPa or less at an angular frequency of 1 rad / s obtained by dynamic viscoelasticity measurement at 32° C., and a loss tangent (tan δ) of 0.4 or more. Puncture dressing.

2. The puncture dressing material according to claim 1, wherein the adhesive that bonds the support film and the frame sheet is an acrylic adhesive or a urethane adhesive containing a copolymer mainly composed of an alkyl (meth)acrylate ester.

3. A support film having ultrasonic transparency; a frame sheet having an observation window for observing the holding state of the tip of the puncture device fixed to the body surface; A release liner; These are stacked in this order from above, The support film and frame sheet, and the frame sheet and release liner are each bonded to the adhesive. The dressing material for puncture is adhered to the support film, the support film being a film substrate having a thickness of 10 μm to 80 μm, The mass per unit area of ​​the pressure-sensitive adhesive is 30 g / m 2 to 80 g / m 2 , The pressure-sensitive adhesive for bonding the support film and the frame sheet has a storage modulus of 28 KPa or less at an angular frequency of 1 rad / s obtained by dynamic viscoelasticity measurement at 32° C., and a loss tangent (tan δ) of 0.65 or more. Puncture dressing.

4. A puncture dressing material as described in claim 3, wherein the adhesive that adheres the support film and the frame sheet is an acrylic adhesive or a urethane adhesive containing a copolymer having an alkyl ester of (meth)acrylic acid as its main component.

5. 5. The puncture dressing material according to claim 1, wherein the base material used for the support film is polyethylene terephthalate, polyethylene, polyurethane or oriented polypropylene.

6. 5. The puncture dressing material according to claim 1, wherein a total thickness of the adhesive portion filling the space between the support film and the observation window is 47 μm to 120 μm.

7. 5. The puncture dressing material according to claim 1, wherein a base material used for said frame sheet is a polyurethane nonwoven fabric or a polyethylene terephthalate nonwoven fabric.

8. The puncture dressing according to claim 1 , wherein the frame sheet is further provided with a slit portion for exposing the puncture device.

9. 5. The puncture dressing according to claim 1, further comprising a fold-over tape coupled to the release liner.

10. 10. The puncture dressing of claim 9, wherein the foldback tape is provided on a portion of the lower surface of the release liner and is joined to the release liner so as to cover a portion of the observation window.

11. The puncture dressing material according to claim 9, wherein the release liner has one notch on each of both longitudinal edges of the release liner, and the edge of the folded tape opposite the device placement side overlaps with a straight line connecting the two notches in the lateral direction.

12. A puncture dressing material as described in claim 10, wherein the release liner has one notch on each of both longitudinal edges of the release liner, and the edge of the folded tape opposite the device placement side overlaps with a straight line connecting the two notches in the lateral direction.

13. 5. The puncture dressing material according to claim 1, further comprising a non-adhesive portion between the frame sheet and the release liner to prevent the frame sheet and the release liner from adhering to each other.

14. The puncture dressing material according to claim 13, wherein the non-adhesive portion comprises a non-adhesive seal.

15. 5. The puncture dressing material according to claim 1, further comprising a carrier film above the support film which is in direct contact with the support film, the carrier film having a thickness of 10 μm to 80 μm.

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