Surgical tape

Abstract

To provide a surgical tape composed of a silicone string, with improved operability for a surgical operator.SOLUTION: A surgical tape (10) includes a silicone string to be used in a surgical operation. The surgical tape has an oval shape in a cross section perpendicular to a longer direction. The cross section includes a first area (1) and a second area (2) each having a different material composition. The first area and the second area respectively compose a circumference of the oval shape. A relation c1<c2 is satisfied by a content c1 of an X-ray contrast medium contained in the first area and a content c2 of the X-ray contrast medium contained in the second area.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a surgical tape made of silicone strings for use in surgical procedures. [Background technology]

[0002] In surgical procedures involving abdominal opening, latex-free silicone strings with excellent biocompatibility are sometimes used to temporarily separate and hold or pull arteries, veins, tendons, nerves, ureters, etc. (e.g., Non-Patent Document 1). They are colored red, blue, yellow, or white, allowing color-coding according to the application site, and are highly visible to the surgeon. In addition, the cross section is elliptical, reducing the risk of damaging blood vessels. Furthermore, they are radiopaque, so their position within the body can be detected. [Prior art documents] [Non-patent literature]

[0003] [Non-Patent Document 1] Vessel tape, general medical device, surgical tape, JMDN (Japan Medical Device Nomenclature) code: 70419000, notification number: 13B1X00167000028, Owa Tsusho Co., Ltd., June 2017 (5th edition) catalog, [online], [searched February 22, 2023], Internet <URL:https: / / www.info.pmda.go.jp / downfiles / md / PDF / 180008 / 180008_13B1X00167000028_A_01_05.pdf> Summary of the Invention [Problem to be solved by the invention]

[0004] However, since the long and thin silicone strings have a smooth surface and are flexible, the operability of the surgeon is not necessarily excellent. The present invention provides a surgical tape made of silicone strings that has improved operability for the surgeon.

Means for Solving the Problem

[0005] [1] A surgical tape made of a silicone string used in surgery, the shape of the cross-section orthogonal to the longitudinal direction is an ellipse, the cross-section consists of a first region and a second region with different material compositions, the first region and the second region respectively constitute the circumference of the ellipse, and the content c1 of the X-ray contrast agent contained in the first region and the content c2 of the X-ray contrast agent contained in the second region satisfy the relationship c1 < c2. A surgical tape. [2] For a first sheet with a thickness of 2 mm made of a first material constituting the first region and a second sheet with a thickness of 2 mm made of a second material constituting the second region, when the storage modulus, loss modulus and tanδ are measured respectively under the conditions of 30 ° C and 40 Hz, the surgical tape according to [1] or [2], which satisfies the following relationships (1) to (3). (1) The storage modulus of the first sheet > the storage modulus of the second sheet (2) The loss modulus of the first sheet > the loss modulus of the second sheet (3) The tanδ of the first sheet < the tanδ of the second sheet [3] Among the circumferences of the ellipse, the perimeter L1 belonging to the first region and the perimeter L2 belonging to the second region satisfy the relationship L1 > L2. The surgical tape according to [1] or [2]. [4] The boundary line between the first region and the second region is a curve along the straight line connecting the two foci of the ellipse and does not intersect the straight line. The surgical tape according to any one of [1] to [3].

Advantages of the Invention

[0006] When one end of the surgical tape of the present invention is pulled (handled) in the longitudinal direction, the handled part curls (warps upward) and exhibits a rigidity that is easy to maintain its shape. Since it is easy to operate this one end through the side of a blood vessel or the like or pass through a narrow part, the operability of the surgeon is improved.

Brief Description of the Drawings

[0007] [Figure 1] 1 is a schematic diagram of a cross section of a surgical tape 10 according to an example of the present invention. [Diagram 2] 1 is a schematic diagram showing an operation of curling one end of a surgical tape 10 in the direction of the arrow. [Diagram 3] 1 is a schematic diagram showing one end of a surgical tape 10 curled up due to squeezing. [Figure 4] 4 is a graph showing elastic properties of a first sheet produced in an example. [Diagram 5] 1 is a graph showing elastic properties of a second sheet produced in an example. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] The first aspect of the present invention is a surgical tape made of silicone string for use in surgery. The length of the surgical tape is not particularly limited, and it is in a wound state of, for example, about 0.5 to 2 m, and can be cut to an appropriate length when used.

[0009] The shape of the cross section perpendicular to the longitudinal direction (the axial direction along the length of the string) of the surgical tape is elliptical. Here, elliptical means that it is not a perfect circle in a geometrical strict sense, and in practical terms, it may be an ellipse that is as close to a circle as possible. The flatness of the ellipse can be expressed as the ratio of (long axis / short axis), and is preferably, for example, more than 1.0 and not more than 10.0, more preferably 1.1 or more and not more than 8.0, and preferably 1.5 or more and not more than 5.0. Specifically, the long axis of the ellipse is, for example, more than 1.0 mm and not more than 5.0 mm, and the short axis is, for example, 1.0 to 2.0 mm. Within these preferable ranges, the risk of damaging blood vessels and the like during use is reduced, and the operability for the surgeon is further improved.

[0010] An oval cross-sectional shape of a surgical tape 10, which is an example of an embodiment of this aspect, is shown in FIG. The cross section is divided into a first region 1 and a second region 2 having different material compositions. The first region 1 occupies 30 to 90% of the total area of ​​the ellipse, preferably 40 to 80%, and more preferably 55 to 70%. The second region 2 occupies 10 to 70% of the total area of ​​the ellipse, preferably 20 to 60%, and more preferably 30 to 45%.

[0011] The boundary between the first region 1 and the second region 2 is represented by a continuous curve or straight line. In the example surgical tape 10, the boundary line is a curve that follows a straight line (not shown) connecting two foci on the major axis of the ellipse and does not intersect with the straight line. When the area s1 of the first region 1 is larger than the area s2 of the second region 2, it is preferable that the boundary line is on the second region side of the two foci of the ellipse.

[0012] The first region 1 and the second region 2 each constitute a circumference of the ellipse. The sum of the circumference of the first region 1 facing the outside and the circumference of the second region 2 facing the outside is equal to the circumference of the ellipse. In the surgical tape 10 of this embodiment, both the first region 1 and the second region 2 have a circumference facing the outside, and neither region is surrounded by the other region.

[0013] Of the circumference of the ellipse, it is preferable that the circumference L1 belonging to the first region 1 and the circumference L2 belonging to the second region 2 satisfy the relationship L1>L2. Here, the sum of the circumference L1 and the circumference L2 is equal to the total length of the circumference of the ellipse. With this relationship, as shown in Figures 2 to 3, when the center part a is held, any part from the center part a to one end part b is pinched with fingers and manipulated in the direction of the arrow toward the one end part b, the one end part b is likely to bend in one direction. As a result, the operability of the surgeon is further improved.

[0014] The first region 1 and the second region 2 each contain silicone rubber. Preferably, the content c1 of the X-ray contrast agent contained in the first region 1 and the content c2 of the X-ray contrast agent contained in the second region 2 satisfy the relationship c1 < c2. With this relationship, as shown in FIGS. 2 to 3, when holding the central portion a, pinching any portion from the central portion a to one end portion b with a finger, and handling it in the direction of the arrow toward the one end portion b, the one end portion b is more likely to warp in one direction. As a result, the operability of the surgeon is further enhanced.

[0015] The content c1 of the X-ray contrast agent with respect to the total mass of the first region 1 may be any amount as long as the relationship c1 < c2 holds. The content c2 of the X-ray contrast agent with respect to the total mass of the second region 2 is preferably 2 to 40% by mass, more preferably 5 to 30% by mass, and even more preferably 10 to 20% by mass. When within the above preferred range, as shown in FIGS. 2 to 3, the handled one end portion b is more likely to warp, and the operability of the surgeon is further enhanced.

[0016] The first region 1 and the second region 2 may contain the same X-ray contrast agent or different X-ray contrast agents. As the X-ray contrast agent, for example, known ones such as iodine compounds, barium compounds, gadolinium compounds, bismuth oxide, and tungsten are applicable. Among them, barium sulfate is preferable because it is easy to disperse in silicone rubber, has little influence on the human body, and is also easy to adjust the storage elastic modulus, loss elastic modulus, and tan δ of the first region 1 and the second region 2. The X-ray contrast agent is preferably uniformly dispersed as a powder in each region.

[0017] The content of the silicone rubber in the first region 1 with respect to the total mass of the first region 1 can be the amount of the remainder excluding the X-ray contrast agent as long as the relationship c1 < c2 of the content of the X-ray contrast agent holds. The content of the silicone rubber in the second region 2 with respect to the total mass of the second region 2 can be the amount of the remainder excluding the X-ray contrast agent as long as the relationship c1 < c2 of the content of the X-ray contrast agent holds. For example, it is preferably 30 to 90% by mass, more preferably 40 to 80% by mass, and even more preferably 50 to 70% by mass. When the thickness falls within the above preferred range, the handled end portion b becomes more likely to warp as shown in Figs. 2 and 3, and the operability for the surgeon is further improved.

[0018] The silicone rubber forming the first region 1 and the second region 2 may be the same or different. As the silicone rubber, for example, a known silicone rubber is used. It is preferable to use a silicone rubber which is easy to disperse an X-ray contrast agent, has high affinity for the human body, and allows easy adjustment of the storage modulus, loss modulus, and tan δ of the first region 1 and the second region 2.

[0019] The elasticity of the first region 1 and the second region 2 of the surgical tape 10 are different from each other, and preferably have the following relationship when measured at a predetermined temperature and frequency. With this relationship, the handled end portion b is more likely to warp as shown in Figures 2 and 3, which improves the operability of the surgeon.

[0020] The storage modulus of the first region 1 is preferably greater than the storage modulus of the second region 2 . The loss modulus of the first region 1 is preferably greater than the loss modulus of the second region 2 . It is preferable that the tan δ of the first region 1 is smaller than the tan δ of the second region 2 . Here, tan δ is the ratio expressed as (loss modulus / storage modulus).

[0021] When investigating the above relationship regarding the elasticity of the first region 1 and the second region 2 of the surgical tape 10, it may be difficult to measure the surgical tape 10 itself. A first sheet having a thickness of 2 mm±1 mm and made of a first material constituting the first region 1; A second sheet having a thickness of 2 mm±1 mm and made of a second material constituting the second region 2; When the storage modulus, loss modulus, and tan δ are measured under conditions of 30° C. and 40 Hz, it is preferable that at least one, preferably two, and more preferably all three of the following relationships (1) to (3) are satisfied. (1) Storage modulus of the first sheet>storage modulus of the second sheet (2) the loss modulus of the first sheet>the loss modulus of the second sheet (3) tan δ of the first sheet < tan δ of the second sheet

[0022] If the above relationships (1) to (3) are satisfied, as shown in Figures 2 to 3, when the central portion a is held, any portion from the central portion a to the end portion b is pinched with the fingers, and the end portion b is manipulated in the direction of the arrow, the end portion b is easily warped in one direction. As a result, the operability of the surgeon is improved.

[0023] The method for producing the surgical tape 10 is not particularly limited, and for example, the surgical tape 10 can be produced by preparing a first material for forming the first region 1 and a second material for forming the second region 2, and applying a known multi-color molding method. Among these, extrusion molding is preferred because it is easy to produce the tape at any length. The elliptical shape of the cross section of the surgical tape 10 can be adjusted by the shape of the die.

[0024] The first material and the second material may be prepared by mixing silicone rubber and an X-ray contrast medium in a conventional manner. By setting the composition of these materials within the above-mentioned preferred ranges, the first region 1 and the second region 2 having the desired elasticity can be formed. Each material may contain optional ingredients such as antioxidants, colorants, etc. EXAMPLES

[0025] [Manufacturing the first sheet] The first material for forming the first region 1 was prepared by mixing the following materials in the amounts listed below. To 100 parts by mass of KE-561U (manufactured by Shin-Etsu Chemical Co., Ltd.) as unvulcanized silicone rubber (silicone rubber composition), 0.5 parts by mass of vulcanizing agent C-25A (manufactured by Shin-Etsu Chemical Co., Ltd.) and 2.0 parts by mass of C-25B (manufactured by Shin-Etsu Chemical Co., Ltd.) were added, and the mixture was thoroughly kneaded using a two-roll mill. The unvulcanized rubber compound thus obtained was used to obtain a sheet of a specified thickness using a T-die extrusion molding machine, which was then placed in a 200°C oven for 10 minutes to carry out HAV vulcanization, thereby obtaining the desired first sheet (thickness 2.0 mm). This was molded into a size of length x width x thickness = 10 mm x 5 mm x 2.0 mm, and its elasticity was measured by a dynamic viscoelasticity measurement method that senses the stress and displacement when a tensile vibration strain is applied to the sample, at a temperature increase rate of 5°C / min in the range of 0 to 100°C. A dynamic viscoelasticity measurement device (UBM Corporation, Rheogel-E4000) was used for this. The results are shown in Figure 4. The first sheet (thickness: 2.0 mm) had a storage modulus, a loss modulus and a tan δ of 8.2 MPa, 0.49 MPa and 0.06, respectively, at 30° C. and 40 Hz.

[0026] [Manufacturing the second sheet] In addition to the first material (unvulcanized silicone rubber and two types of vulcanizing agents), 12 parts by mass of barium sulfate was further mixed and thoroughly kneaded with a two-roll mill to obtain a second material for forming the second region 2. Next, a second sheet (thickness 2.0 mm) was obtained in the same manner as the first sheet, and its elasticity was measured in the same manner as the first sheet. The results are shown in FIG. The second sheet (thickness: 2.0 mm) had a storage modulus, a loss modulus and a tan δ of 0.37 MPa, 0.042 MPa and 0.11, respectively, at 30° C. and 40 Hz.

[0027] [Manufacturing of surgical tape] Using the first and second materials prepared above, a surgical tape 10 (length: 10 m) was manufactured by extrusion molding. The cross section perpendicular to the longitudinal direction was elliptical, with a major axis of 2.0 mm and a minor axis of 0.8 mm. The shape of the cross section and the range of each region were approximately the same as those illustrated in FIG. 1.

[0028] When the manufactured surgical tape 10 was pinched and held 10 cm from one end with one hand and manipulated toward the other end with the other hand, one end b of the surgical tape 10 curled up and maintained its shape as shown in Figures 2 and 3. It was easy to manipulate the tip of the tape, which was about 10 cm away, to the intended position using the other hand. In this way, it was confirmed that the surgical tape 10 has high maneuverability. [Explanation of symbols]

[0029] 10...surgical tape, 1...first region, 2...second region

Claims

1. A surgical tape made of silicone strings used in surgery, The cross section perpendicular to the longitudinal direction has an elliptical shape. the cross-section comprises a first region and a second region having different material compositions; the first region and the second region each define a perimeter of the ellipse, A content c1 of the X-ray contrast agent contained in the first region; and A content c2 of the X-ray contrast agent contained in the second region; and A surgical tape, wherein c1<c2.

2. A first sheet having a thickness of 2 mm and made of a first material constituting the first region; a second sheet having a thickness of 2 mm and made of a second material constituting the second region; 2. The surgical tape according to claim 1, wherein when the storage modulus, loss modulus, and tan δ are measured under conditions of 30° C. and 40 Hz, the following relationships (1) to (3) are satisfied: (1) The storage modulus of the first sheet is greater than the storage modulus of the second sheet (2) The loss modulus of the first sheet is greater than the loss modulus of the second sheet (3) tan δ of the first sheet < tan δ of the second sheet

3. Of the circumference of the ellipse, A circumferential length L1 belonging to the first region and a circumferential length L2 belonging to the second region, The surgical tape of claim 1 or 2, wherein L1 > L2 satisfies the relationship:

4. The surgical tape of claim 3 , wherein the boundary line between the first region and the second region is a curve that follows a straight line connecting the two foci of the ellipse and does not intersect with the straight line.

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