WO2023022202A1 - Bande médicale - Google Patents

Bande médicale Download PDF

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Publication number
WO2023022202A1
WO2023022202A1 PCT/JP2022/031245 JP2022031245W WO2023022202A1 WO 2023022202 A1 WO2023022202 A1 WO 2023022202A1 JP 2022031245 W JP2022031245 W JP 2022031245W WO 2023022202 A1 WO2023022202 A1 WO 2023022202A1
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Prior art keywords
nonwoven fabric
thickness
medical tape
tubular organ
hemostasis
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PCT/JP2022/031245
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English (en)
Japanese (ja)
Inventor
明郎 萩原
洋作 萩原
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株式会社彩
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Publication of WO2023022202A1 publication Critical patent/WO2023022202A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/64—Use of materials characterised by their function or physical properties specially adapted to be resorbable inside the body

Definitions

  • the present invention relates to a medical tape, and more particularly to a medical tape that is used by being wrapped around the outer circumference of a tubular organ.
  • Patent Document 1 describes a biological tissue reinforcing material kit that can reinforce fragile tissues without using blood products, has high pressure resistance, and has adhesion-preventing ability that does not cause adhesions. Disclosed is a nonwoven fabric and an amount of sodium alginate.
  • Patent document 2 describes an effective anticoagulant for the purpose of adhering to the vascular wall for a long period of time, covering the aneurysm with connective tissue induced around it, reinforcing the vascular wall, and preventing the aneurysm from increasing, rupturing, and recurring.
  • a coating material for treatment of aneurysms is disclosed which is composed of a fibrinogen component and a thrombin component as components and a nonwoven fabric made of bioabsorbable synthetic fibers as a substrate.
  • Patent Document 3 discloses no-crimp staple fibers and/or low-crimp staples for the purpose of providing a non-woven fabric for coating film waterproofing that does not impair the aesthetic appearance without causing a step in the overlapped portion.
  • a synthetic fiber nonwoven fabric that uses fiber as the main constituent fiber and can be easily cut by hand, the thickness of portions with a width (V) of 50 to 100 mm from both side ends is gradually reduced toward the ends as an overlap margin. discloses an extremely thin non-woven fabric reinforcement for coating waterproofing and/or corrosion protection.
  • Patent Documents 1 and 2 do not particularly mention wrapping the nonwoven fabric around the outer periphery of the tubular organ or the thickness of the nonwoven fabric.
  • a nonwoven fabric having a portion that gradually decreases toward the end is adopted, but the application is completely different from that of a medical device, and the purpose of adopting the configuration is to reduce the end portion of the nonwoven fabric. To maintain a beautiful appearance without causing a step when superimposed on each other.
  • the tubular organ is, for example, a blood vessel
  • the blood vessel wall is sutured when replacing a part of the own blood vessel (especially artery) with a blood vessel component such as an artificial blood vessel and transplanting it. Bleeding from a needle puncture (needle hole) of a seam of a blood vessel wall or a suture of a blood vessel wall in an operation such as (b) simply repairing blood vessel (e.g., artery) wall damage or bleeding and bleeding. sometimes.
  • Compression hemostasis is a method of artificially compressing the bleeding site to promote the natural hemostatic action of blood, in which blood clots solidify the bleeding site around the bleeding site to stop bleeding. It is an effective hemostasis method for relatively weak bleeding.
  • Suture hemostasis is an operation to stop bleeding by artificially closing the bleeding site by suturing or ligating the bleeding site such as a blood vessel with a surgical needle and thread, and it is also effective for bleeding with strong bleeding. It is an effective hemostasis method.
  • the tubular organ is, for example, the ureter
  • the ureter is a tubular organ that delivers urine from the kidneys to the bladder, where the pulsatile intraureteral pressure produced by the peristaltic movement of the muscles that make up the walls of the ureter drives the urine toward the bladder. Since the urine is subject to pulsating internal pressure in this manner, when the ureteral walls are sutured together, there is an unavoidable risk of leakage of urine from the seams of the sutures.
  • an anastomosis method is selected in which the number of sutures is reduced as much as possible and the sutures are performed sparsely.
  • a drainage tube is placed from the vicinity of the ureteral anastomosis to the outside of the body through the skin to guide the leaking urine out of the body.
  • Drainage therapy is used in combination.
  • the drainage tube is removed from the body only when the anastomotic site has healed enough to stop leakage of urine from the ureteral anastomotic site. Until the drainage tube can be removed, the patient spends a long hospital stay connected to the tube outside the body by the drainage tube from the body. Patients can also suffer from retrograde infections (drain infections) through the drainage ducts.
  • treatment strategies differ greatly between blood vessels and ureters.
  • a treatment capable of preventing stenosis and occlusion caused by the invasion, while preventing the vascular wall from becoming invasive and minimizing the invasiveness.
  • an object of the present invention is to prevent short-term leakage of contents without invading the tubular organ when treating a damaged site of the tubular organ, and to prevent long-term leakage of contents.
  • the inventor of the present invention has made intensive studies to solve the above-mentioned problems.
  • a nonwoven fabric having a gradually increasing portion whose thickness in the longitudinal direction gradually increases from one end to the other end is used, and it is configured so that it can be wrapped around the outer circumference of the tubular organ in layers. found that the above-mentioned problems can be solved.
  • the gist of the present invention is as follows.
  • (1) It is composed of a nonwoven fabric having a gradually increasing portion whose thickness in the longitudinal direction gradually increases from one end to the other end, and the nonwoven fabric can be overlapped and wrapped around the outer circumference of the tubular organ.
  • a medical tape wherein, in the wrapped state, body fluids containing tissue cells of said tubular organ are permeable to said nonwoven fabric.
  • the nonwoven fabric is composed of fibers made of a bioabsorbable material.
  • the gradually increasing portion has a minimum thickness of 40 ⁇ m or less and a maximum thickness greater than the minimum thickness and 150 ⁇ m or less.
  • the weight of the portion from the end of the minimum thickness side to 28 to 35% of the length is 20 g / m 2 or less, and 8 from the end of the maximum thickness side.
  • the medical tape according to any one of items (1) to (3) which has a basis weight of 50 g/m 2 or less up to 13% of the length.
  • the medical tape according to any one of items (1) to (6) which is for hemostasis and can be wrapped around the circumference of a blood vessel.
  • a treatment kit comprising a combination of the medical tape according to any one of items (1) to (7) and an adhesive.
  • a medical tape can be provided that is capable of promoting repair.
  • FIG. 2 is a diagram showing a state in which the medical tape of Example 1 wrapped around the ureteral anastomosis of an experimental animal is left standing after being sprayed with an adhesive.
  • FIG. 1 is a macroscopic photograph of a specimen, such as a ureter, including an anastomosis wound with the medical tape of Example 1, extracted from an experimental animal.
  • FIG. FIG. 5 is a light microscope image of a cross-section of an HE-stained histological specimen of the anastomosis indicated by the arrow in FIG. 4;
  • FIG. 10 is a macroscopic photograph of a specimen such as a ureter including an anastomosis wound with the medical tape of Comparative Example 3, which was excised from an experimental animal.
  • FIG. 7 shows a light microscope image of a cross-section of an HE-stained histological specimen of the anastomosis indicated by the arrow in FIG.
  • a medical tape according to an embodiment of the present invention is composed of a nonwoven fabric having a gradually increasing portion in which the thickness in the length direction gradually increases from one end to the other end. Then, the nonwoven fabrics can be overlapped and wrapped around the outer periphery of the tubular organ, and body fluid containing tissue cells of the tubular organ can permeate the nonwoven fabric in the wound state.
  • “gradually increasing” includes cases where the thickness increases from one longitudinal end side to the other longitudinal end side, as well as cases where the thickness is partially the same. Confirmation of the gradual increase can be performed, for example, by measuring the thickness by the method shown in the section of Examples described later.
  • the "thickness in the length direction” means that the angle at which the imaginary straight line in the length direction of the nonwoven fabric and the imaginary straight line in the direction in which the thickness is constant intersects is a right angle or an acute angle. including.
  • the nonwoven fabrics By having the gradually increasing portion in this way, it is possible to tightly wrap the nonwoven fabrics together without causing slack when the medical tape is wrapped around the tubular organ.
  • body fluids such as blood may permeate the nonwoven fabric in a wound state, or may adhere to the nonwoven fabric during winding.
  • the non-woven fabric In such a wet state, the non-woven fabric has increased frictional force between fibers, and can resist shear stress caused by changes in the outer diameter of the tubular organ when the contents pass through the tubular organ. A frictional force can be easily generated between the wound nonwoven fabrics, and a damaged site of a tubular organ can be tightly pressed.
  • medical tapes can have fundamental therapeutic effects such as prevention of leakage of the contents of tubular organs and promotion of tissue regeneration and repair at damaged sites. It is possible to treat the so-called severely damaged areas.
  • the fibers that make up the nonwoven fabric are not particularly limited, and various organic fibers that are acceptable for medical applications can be used.
  • Such fibers may be either fibers made of a bioabsorbable material or fibers made of a non-bioabsorbable material, and can be appropriately selected according to the purpose.
  • the bioabsorbable material for example, those described in Patent Document 1 can be used.
  • polyglycolide polyglycolic acid
  • polylactide polylactic acid
  • D, L, DL form glycolide (cyclic dimer of glycolic acid)-lactide (cyclic dimer of lactic acid) ( D, L, DL form) copolymer
  • glycolide- ⁇ -caprolactone copolymer glycolide- ⁇ -caprolactone copolymer
  • lactide D, L, DL form
  • glycolide-lactide D, L, DL form)- ⁇ -caprolactone copolymer
  • synthetic polymers such as poly- ⁇ -caprolactone, and materials derived from natural products such as collagen, gelatin, chitosan, and chitin.
  • bioabsorbable materials may be used singly or in combination of two or more, but those derived from natural products are preferably used in combination with synthetic polymers.
  • the copolymer may be a random copolymer or a block copolymer.
  • bioabsorbable materials polyglycolide and lactide (D, L, DL form)- ⁇ -caprolactone copolymer are preferred.
  • the lactide (D, L, DL form)- ⁇ -caprolactone copolymer may be a random copolymer or a block copolymer, but is preferably a block copolymer.
  • Non-bioabsorbable materials include, for example, synthetic polymers such as polyester, polyamide, polyethylene, polypropylene, and polyurethane, and materials derived from natural products such as cotton, silk thread, and spider silk.
  • the gradually increasing portion gradually increases in thickness in the length direction from one end side to the other end side.
  • the minimum thickness and maximum thickness of the gradually increasing portion can be determined in consideration of the size of the outer diameter of the tubular organ to be wound, the number of windings, and the like.
  • the minimum thickness is preferably 40 ⁇ m or less from the viewpoint of more effectively preventing leakage of contents. From the viewpoint of operability, etc., the minimum thickness is preferably 3 ⁇ m or more.
  • the maximum thickness is preferably 150 ⁇ m or less from the viewpoints of adhesiveness between nonwoven fabrics when wound, operability, permeability of body fluids such as blood, and the like. In order to form a tapered structure, the maximum thickness may be greater than the minimum thickness, preferably 50 ⁇ m or more.
  • the thickness at the desired position of the gradually increasing portion can be obtained by measuring the thickness at the desired position, for example, by the method described in the Examples section. Moreover, it can be confirmed that the gradual increase is performed at the gradual increase portion based on the measurement result.
  • the length direction of the nonwoven fabric is equally divided into a plurality of sections, the thickness at the center position is measured to be the representative thickness of the section, and the gradually increasing portion is specified by this representative thickness.
  • the size (length) of one section in the longitudinal direction is not particularly limited, and can be determined according to the total length of the nonwoven fabric. For example, the length of one section is 8 to 25% of the total length of the nonwoven fabric. is preferred.
  • the length of the gradually increasing portion can be determined by considering the size of the outer diameter of the tubular organ and the number of turns.
  • the lumen of the tubular organ can be 1.5 to 10 times the length of the empty circumference.
  • the tubular organ is an artery, for example, 3 to 8 times
  • the tubular organ is a vein, for example, 1.5 to 10 times
  • the ureter is, for example, 2.5 to It can be 5 times.
  • the weight of the gradually increasing portion is 20 g/m 2 or less for the portion from the end of the minimum thickness to 28 to 35% of the length. is preferred.
  • the lower limit of the basis weight of the same part can be, for example, 1 g/m 2 or more.
  • the fabric weight of the portion of 8 to 13% of the length from the end of the maximum thickness is 50 g/m 2 or less.
  • the lower limit of the basis weight of the same portion can be, for example, 10 g/m 2 or more.
  • the basis weight of the gradually increasing portion can be obtained by measuring, for example, by the method described in the Examples section.
  • the basis weight of a predetermined section is taken as the representative basis weight of a predetermined position in the length direction.
  • the end of the minimum thickness is the end opposite to the thick side in the length direction of the section with the minimum thickness
  • the end of the maximum thickness is the maximum thickness. The end of the section opposite the thin side in the longitudinal direction.
  • the fiber diameter of the fibers that make up the nonwoven fabric preferably has a median value of 32 ⁇ m or less from the viewpoints of more effectively preventing leakage of contents and promoting the process of repairing and healing damaged areas.
  • the thickness is preferably 0.6 ⁇ m or more.
  • the fiber diameter can be measured by the method described in the Examples section below, and the median value can be obtained.
  • the fiber diameter can be measured for each part in the same manner as in the case where the fiber diameter is generally uniform, and the median value can be obtained.
  • the median is synonymous with the statistical median.
  • the nonwoven fabric may have any structure as long as it has the gradually increasing portion described above. Therefore, for example, a part that gradually decreases in the length direction from the end where the thickness of the gradually increasing part is the maximum, or a part that repeats increase and decrease may be continuously provided, but the medical tape is tightly wound and the nonwoven fabrics are tightly attached to each other. From the standpoint of facilitating the expansion, it is preferable that the end where the thickness of the gradually increasing portion is the smallest is not connected to the gradually increasing portion in the length direction.
  • the shape of the nonwoven fabric is not particularly limited, and examples thereof include rectangles, parallelograms, trapezoids, rhombuses, ovals, and the like.
  • the angle formed by the virtual straight line in the direction of the same thickness and the virtual straight line in the length direction may be a right angle or an acute angle.
  • a member having a protrusion that can be physically engaged with the wound nonwoven fabric may be provided in a portion extending from the end of the gradually increasing portion of the nonwoven fabric on the side where the thickness in the length direction is greatest. .
  • the nonwoven fabric is configured so that body fluids containing tissue cells of the tubular organ can permeate the nonwoven fabric in a state in which the nonwoven fabrics are wrapped around the outer periphery of the tubular organ.
  • body fluid permeates the nonwoven fabric, increasing the frictional force between the nonwoven fabrics and increasing the diameter of the tubular organ.
  • a resistance to shear stress is obtained.
  • the repair and healing process of the injured site is promoted.
  • Factors that impart such a configuration include the thickness of the nonwoven fabric, basis weight, fiber diameter, fiber material, and the like. Desired permeability can be adjusted by adjusting these in a composite manner.
  • the method for measuring the inter-fiber spacing is changed according to the manufacturing method of the nonwoven fabric.
  • the melt blow method and the electrospinning method generally, when the through holes are not clearly formed by the fibers
  • the needle punch method in which a plurality of knitted fabrics are stacked and entangled generally, the through holes are formed by the fibers. If it is clearly formed), a different measurement method is adopted.
  • the nonwoven fabric described above can be manufactured using a conventionally known method. Examples thereof include melt blowing, electrospinning, and needle punching.
  • melt blowing method for example, a desired gradual increase portion is obtained by changing the discharge amount of synthetic resin using a general device or adjusting the arrangement of the nozzle holes of a general device. It is possible to obtain a nonwoven fabric having
  • electrospinning method for example, a synthetic resin liquid is spun linearly in an electric field, and the target is shifted left and right when laminating it on the target, thereby obtaining a nonwoven fabric having a desired gradually increasing portion. be able to.
  • the above-described interfiber spacing can be adjusted by forming a nonwoven fabric using water-soluble spacers and then washing the nonwoven fabric with water to remove the spacers.
  • the method of superimposing the fabrics is adjusted to obtain a nonwoven fabric having a desired gradually increasing portion. be able to.
  • the melt blowing method is preferable because it is easy to obtain the desired nonwoven fabric. That is, a meltblown nonwoven fabric is preferred.
  • the nonwoven fabric can be permeated by body fluid containing tissue cells of the tubular organ in a state of being wrapped around the tubular organ.
  • a fixing agent other than the patient's own blood may be applied to the nonwoven fabric.
  • an adhesive include fibrin glue, alginic acid, or a mixture of pharmacologically acceptable alginic acid, monovalent cation salts and polyvalent cations (the product after mixing is also referred to as crosslinked alginic acid). , silicone adhesives, anaerobic adhesives, cyanoacrylate adhesives, photocurable adhesives, and the like.
  • Examples of the monovalent cation in the pharmacologically acceptable monovalent cation salt of alginic acid include sodium ion, potassium ion, ammonium ion and the like.
  • Examples of multivalent cations include inorganic multivalent ions such as calcium ions, magnesium ions and iron ions, and multivalent cations such as organic multivalent ions such as polylysine.
  • the polyvalent cation may be in the form of various salts containing such polyvalent cations. Examples of such salts include calcium gluconate, calcium chloride, calcium carbonate, magnesium chloride, ferrous citrate and the like.
  • the fixing agent may be applied to the whole or part of the surface of the nonwoven fabric immediately before winding, may be applied while winding, or may be applied after winding.
  • the medical tape and adhesive described above can be combined and used as a treatment kit for treatment of various tubular organs.
  • the medical tape described above can be used to treat various tubular organs. It is suitable for preventing leakage of urine that can be wrapped around the body, prevention of bile leakage from the biliary tract, prevention of air leakage from the respiratory tract, restoration of reproductive organ walls, prevention of leakage of cerebrospinal fluid from the nervous system, and the like.
  • LA-CL Block copolymer of lactic acid and ⁇ -caprolactam
  • a non-woven fabric (meltblown non-woven fabric) was produced with a tapering portion.
  • the obtained nonwoven fabric was cut into a rectangle with a width of 10 mm and a length of 100 mm. .
  • the nonwoven fabric 1 has substantially the same thickness in the direction orthogonal to the length direction.
  • the thickness of the predetermined position of a length direction was measured and calculated as follows. Measurement sites were determined at intervals of 10 mm starting from a position 5 mm from the end of the thin side toward the thick side, and the thickness at each site was measured. When measuring, the thickness of the five nonwoven fabrics was measured three times with a dial-type precision thickness measuring instrument (manufactured by Ozaki Seisakusho, G-7C), and the thickness of the five nonwoven fabrics was measured three times. Arithmetic mean value of the thickness of 5 non-woven fabrics. In addition, 1 set of 5 nonwoven fabrics is prepared separately, and the thickness is measured as described above. Calculated. Table 1 shows the results.
  • the basis weight (area density) at a predetermined position in the length direction was measured and calculated as follows. In the same way as in the case of measuring the thickness, start from a position 5 mm from the end of the thin side, determine the center position of the measurement site at intervals of 10 mm toward the thick side, cut at the midpoint between adjacent center positions, Ten cut pieces (size: 10 mm ⁇ 10 mm) with a width of 10 mm in the vertical direction were produced. A set of 10 cut pieces having the same central position was prepared in the same manner.
  • the measurement method was according to Horii's method (Horii T., The effects of fiber diameter and spacing-size of an artificial scaffold on the in vivo cellular response and tissue remodeling, ACS Applied Bio Materials 2021, in press).
  • a preliminary scanning electron microscope (scanning electron microscope) inspection cut the nonwoven fabric 1 with a sharp cutter, wrap it around a stainless steel hexagonal jig and pull it to open the inside of the stump of the nonwoven fabric 1 and fix it, The fibers inside the nonwoven fabric near the stump were imaged with a scanning electron microscope. From this image, it was confirmed that all the fibers inside the nonwoven fabric were almost circular, and that there were no beaded, club-shaped, or branched fibers.
  • the median value is determined for each, and the median value is taken as the median value of the fiber diameters at positions in the longitudinal direction of the photographed cross section.
  • the above measurements are taken at three cut surfaces within 15 mm from both ends and the center in the length direction of the nonwoven fabric. median value.
  • the median fiber diameter of nonwoven fabric 1 was 15 ⁇ m.
  • the measurement method was according to Horii's method (Horii T., The effects of fiber diameter and spacing-size of an artificial scaffold on the in vivo cellular response and tissue remodeling, ACS Applied Bio Materials 2021, in press). That is, after freezing and hardening the nonwoven fabric 1 with liquid nitrogen, the freeze-hardened nonwoven fabric 1 was broken by hitting with a small hammer. Next, a cross section of the nonwoven fabric 1 was photographed with a scanning electron microscope (manufactured by Hitachi, Ltd., product name: S-570).
  • one fiber was selected at random from among the fiber cross sections exposed on the cut surface, and a concentric circle was drawn with the center of the selected fiber cross section as the center. The radius of the concentric circle was gradually increased and other fiber stumps falling within this concentric circle were marked. Select 30 fiber stumps marked with this mark in order of distance from the center of the concentric circle, and select the center of the fiber stump selected using distance measurement software (developer Wayne Rasband (NIH), product name ImageJ). The distance between each fiber stump marked with , that is, the distance between the center of the selected fiber stump and the other 30 fiber stumps was measured, and this was measured as the fiber spacing. The median value (synonymous with the median value in statistics) of the 30 measured fiber spacings was determined.
  • the nonwoven fabric 1 had a fiber spacing of 54 ⁇ m.
  • Example 2 Polyglycolic acid (hereinafter referred to as “PGA”) (BMG Co., Ltd., Biodegmar (registered trademark) PGA, average molecular weight 350,000, melting point: 225 to 232 ° C.) was used instead of LA-CL.
  • PGA Polyglycolic acid
  • Example 2 Polyglycolic acid (hereinafter referred to as “PGA”) (BMG Co., Ltd., Biodegmar (registered trademark) PGA, average molecular weight 350,000, melting point: 225 to 232 ° C.) was used instead of LA-CL.
  • PGA Polyglycolic acid
  • a nonwoven fabric 1A having a uniform thickness was produced by a melt-blowing method.
  • the thickness was set to be approximately the same as the thickness (15 ⁇ m) and basis weight (0.30 mg/cm 2 ) of the section containing the thinnest portion of the nonwoven fabric 1 obtained in Example 1.
  • the thickness and weight per unit area were measured and calculated in the same manner as in Example 1 at positions where the distance from one end in the length direction was 95 mm and 5 mm.
  • the median value of the fiber diameter and the fiber spacing were obtained in the same manner as in Example 1. Table 3 shows the results.
  • Example 2 (Comparative example 2) Using LA-CA, a nonwoven fabric 1B having a uniform thickness was produced by a meltblowing method. The thickness of the nonwoven fabric 1 obtained in Example 1 was adjusted to have an intermediate thickness and basis weight. About the obtained nonwoven fabric 1B, the thickness and weight per unit area were measured and calculated in the same manner as in Example 1 at positions where the distance from one end in the length direction was 95 mm and 5 mm. In addition, the median value of the fiber diameter and the fiber spacing were obtained in the same manner as in Example 1. Table 3 shows the results.
  • Example 3 (Comparative Example 3) Using LA-CA, a nonwoven fabric 1C having a uniform thickness was produced by a melt-blowing method. The thickness was set to the same thickness and basis weight as the thickness and basis weight of the section containing the thickest portion of the nonwoven fabric 1 obtained in Example 1. About the obtained nonwoven fabric 1C, the thickness and weight per unit area were measured and calculated in the same manner as in Example 1 at positions where the distance from one end in the length direction was 95 mm and 5 mm. In addition, the median value of the fiber diameter and the fiber spacing were obtained in the same manner as in Example 1. Table 3 shows the results.
  • Example 4 Using a 15% by weight resin solution obtained by dissolving LA-CA in 1,3-dioxolane, a nonwoven fabric 1D having a uniform thickness was produced by an electrospinning method. The thickness was set to be even smaller than the thickness (15 ⁇ m) and basis weight (0.30 mg/cm 2 ) of the section containing the thinnest portion of the nonwoven fabric 1 obtained in Example 1. About the obtained nonwoven fabric 1D, the thickness and weight per unit area were measured and calculated in the same manner as in Example 1 at positions where the distance from one end in the length direction was 95 mm and 5 mm. In addition, the median value of the fiber diameter and the fiber spacing were obtained in the same manner as in Example 1. Table 3 shows the results.
  • a nonwoven fabric 2A having a uniform thickness was produced by a meltblowing method.
  • the thickness was set to be approximately the same as the thickness (40 ⁇ m) and basis weight (0.50 mg/cm 2 ) of the section containing the thinnest portion of the nonwoven fabric 2 obtained in Example 2.
  • the thickness and weight per unit area were measured and calculated in the same manner as in Example 1 at positions where the distance from one end in the length direction was 95 mm and 5 mm.
  • the median value of the fiber diameter and the fiber spacing were obtained in the same manner as in Example 1. Table 3 shows the results.
  • Example 6 (Comparative Example 6) Using a commercially available non-woven fabric (Gunze Co., Ltd., Neovel Nano (registered trademark) D5, material: PGA fiber, manufacturing method: meltblown method, thickness: uniform), it is cut to a width of 10 mm and a length of 100 mm. A nonwoven fabric 2C having a uniform thickness in the direction was produced. Regarding the nonwoven fabric 2C, the thickness and weight per unit area were measured and calculated in the same manner as in Example 1 at positions at distances of 95 mm and 5 mm from one end in the length direction. In addition, the median value of the fiber diameter and the fiber spacing were obtained in the same manner as in Example 1. Table 3 shows the results.
  • Example 7 Commercially available nonwoven fabric (Gunze Co., Ltd., Neoveil (registered trademark) sheet 015G, material: PGA fiber, manufacturing method: 10 to 12 monofilaments with an average fiber diameter of 16 ⁇ m are bundled, and a plurality of multifilament knitted fabrics are piled up and needle punched. (thickness: uniform) was cut into a width of 10 mm and a length of 100 mm to produce a nonwoven fabric 2B having a uniform thickness in the longitudinal direction. Regarding the nonwoven fabric 2B, the thickness and weight per unit area of the nonwoven fabric 2B were measured and calculated in the same manner as in Example 1 at positions where the distance from one end in the length direction was 95 mm and 5 mm. Also, the median value of the fiber diameter was obtained in the same manner as in Example 1. The fiber spacing was obtained as follows. Table 3 shows the results.
  • the surface of the nonwoven fabric is photographed with a stereoscopic microscope (manufactured by Carl Zeiss, product name: Stemi 2000-C, light source: KL1500 LCD, magnification of 10 times or less, light source irradiation from both the front and back sides), and the obtained images are computer images.
  • a stereoscopic microscope manufactured by Carl Zeiss, product name: Stemi 2000-C, light source: KL1500 LCD, magnification of 10 times or less, light source irradiation from both the front and back sides
  • the obtained images are computer images.
  • distance measurement software developer: Wayne Rasband (NIH)
  • product name: ImageJ capable of measuring up to 0.01 ⁇ m
  • the pore diameter was obtained by dividing the sum of the longest diagonal line of the shape or polygon and the longest pore transverse line perpendicular to it divided by two.
  • the median value (synonymous with the median value in statistics) of the 30 values obtained as the diameter was taken as the fiber spacing.
  • Example 8 Using a 15% by weight resin solution obtained by dissolving PGA (the same as in Example 2) in 1,3-dioxolane, a nonwoven fabric 2D having a uniform thickness was produced by an electrospinning method. The thickness was set to be even smaller than the thickness (40 ⁇ m) and basis weight (0.50 mg/cm 2 ) of the section containing the thinnest portion of the nonwoven fabric 2 obtained in Example 2. About the obtained nonwoven fabric 2D, the thickness and weight per unit area were measured and calculated in the same manner as in Example 1 at positions where the distance from one end in the length direction was 95 mm and 5 mm. In addition, the median value of the fiber diameter and the fiber spacing were obtained in the same manner as in Example 1. Table 3 shows the results.
  • the nonwoven fabrics used as medical tapes were 10 mm wide and 60 mm long for the common carotid artery, 10 mm wide and 80 mm long for the common iliac artery, and 10 mm wide and 80 mm long for the common iliac artery.
  • the aorta was 10 mm wide and 100 mm long.
  • the thicker side is excised and discarded.
  • a portion of the nonwoven fabric with a length of 60 mm or 80 mm including the thin side of the remaining thickness was used as a medical tape with a length of 60 mm for the common carotid artery or a medical tape with a length of 80 mm for the common iliac artery.
  • a portion of 20 mm or 40 mm in length at one end was excised and discarded, and the remaining portion of 60 mm or 80 mm in length was used for the common carotid artery. It was used as a 60 mm long medical tape or an 80 mm long medical tape for the common iliac artery.
  • Each medical tape was wrapped around the entire circumference of the artery around the damaged site of the arterial wall that had been damaged across the arterial wall as described above, so that the nonwoven fabrics overlapped with each other to stop bleeding.
  • there is a gradual increase in thickness so that the winding is performed from the thinnest end first (i.e., as the innermost layer in the winding), and then the nonwoven is wrapped over this.
  • the medical tape was wrapped in layers so that the thickest end was wrapped last (ie, the outermost layer).
  • the medical tape was wound while lightly pulling the medical tape, taking care that the first artery wall and the nonwoven fabrics constituting the medical tape to be wound were in close contact with each other without slack.
  • since the thickness of the nonwoven fabric was uniform, it did not matter which end was wound first, but the medical tape was wound in the same manner as in the example.
  • a time limit was set for the wrapping so that it could be wrapped completely within 3 minutes each time. The reason is that the operability of the tape is also evaluated.
  • each operator individually, for each medical tape of each example and comparative example (i) medical tape that is considered to have good overall operability in practical use The operator was asked to write a comment (within 100 characters) about the evaluation of medical tapes that were considered to have problems in operability with an "x" mark, and (ii) the feeling of use in operation felt by the operator.
  • the surgical technique including hemostasis, was performed independently by two surgeons in exactly the same manner.
  • the homonymous artery hemostasis experiment was performed once per animal.
  • a single surgeon used one type of medical tape to stop bleeding at a total of 6 sites: 2 abdominal aortas, 2 common iliac arteries, and 2 common carotid arteries. 12 hemostasis operations were performed by two surgeons.
  • Example 1 and Comparative Examples 1-4 In the hemostasis operation of the medical tapes composed of the nonwoven fabrics of Example 1 and Comparative Examples 1 to 4, the wrapping of the medical tapes around blood vessels was completed within 3 minutes. Complete hemostasis was achieved in all 12 hemostasis operations when the medical tape composed of 1 nonwoven fabric 1 was used. On the other hand, when the medical tapes of nonwoven fabrics 1A to 1D of Comparative Examples 1 to 4 were used, there were cases where complete hemostasis could not be achieved. With regard to operability, both of the two surgeons evaluated the operability of Example 1 as good ( ⁇ ), but all of Comparative Examples 1 to 4 had better operability than those of the Examples. It was evaluated as being inferior and having issues. Moreover, the content of the task was almost the same between the two surgeons.
  • Example 2 and Comparative Examples 5-8 Even in the hemostasis operation of the medical tape composed of the nonwoven fabrics of Example 2 and Comparative Examples 5 to 8, the wrapping of the medical tape around the blood vessel was completed within 3 minutes. 2, complete hemostasis was achieved in all 12 hemostasis operations. On the other hand, when the medical tapes of nonwoven fabrics 2A to 2D of Comparative Examples 5 to 8 were used, there were cases where complete hemostasis could not be achieved. With regard to operability, both of the two surgeons rated the operability of Example 2 as good ( ⁇ ), but all of Comparative Examples 5 to 8 had better operability than those of the Examples. It was evaluated as being inferior and having issues. Moreover, the content of the task was almost the same between the two surgeons.
  • FIG. 2(a) is a stereomicroscopic image of the common carotid artery extracted from the experimental animal including the injured site wrapped with the medical tape of Example 1
  • FIG. Fig. 2(c) is a stereomicroscopic image of the iliac artery, Fig.
  • FIG. 2(c) is an optical microscopic image of a cross section of the HE-stained histological specimen of the excised common carotid artery shown in Fig. 2(a).
  • FIG. 2(d) is a light microscope image of a cross-section of the HE stained histological specimen of the common iliac artery shown in FIG. 2(b). Similar images were obtained when other arteries and the medical tape of Example 2 were used.
  • the medical tapes of Examples 1 and 2 are not only capable of complete hemostasis with early hemostatic effect, but also help regenerate and repair excellent vascular wall in repairing long-term vascular injury sites. It was thought that the effect could be expected.
  • Example 2 Each of the nonwoven fabrics of Example 1 and Comparative Examples 1 to 3 was used as a medical tape (also a ureter tape; the same applies hereinafter in Evaluation 2) to prevent urine leakage and repair ureters that underwent repair and reconstruction surgery in experimental animals. evaluated for facilitation.
  • the experimental method and results are as follows.
  • kidney-side and bladder-side ureteral stumps remaining after this ureterectomy were anastomosed to the ends by the following operation. That is, both stumps of the ureter were brought together while the catheter was passed through, and both stumps were ligated loosely with a full-thickness single nodule using a 7-0 vascular suture. Single knot suture ligations were made at even intervals and were kept to 3 stitches.
  • the tip of the catheter in the ureter was moved to 10 mm from the ureteral anastomosis on the kidney side.
  • a syringe containing colored saline and a water pressure gauge were connected in parallel to the bladder-side tube port of the catheter. It was confirmed that the colored saline smoothly leaked into the abdominal cavity from the sutured portion of the ureteral anastomosis.
  • a nonwoven fabric with a width of 10 mm and a length of 60 mm was used as a medical tape.
  • 40 mm from the end of the thin side was cut and discarded, and the remaining 60 mm long portion of the nonwoven fabric including the thick side was used as a medical tape.
  • a 40 mm long portion was cut off from one end and discarded, and the remaining 60 mm long portion was used as a medical tape.
  • Each medical tape composed of the nonwoven fabric described above was tightly wrapped around the ureteral anastomosis of each experimental animal within 3 minutes from the thin end to the end of the winding.
  • 1 ml of a 20 mg/ml sodium alginate aqueous solution (manufactured by Fuji Kagaku Kogyo Co., Ltd., Snow Algin SSL) and a 10% calcium gluconate aqueous solution were sprayed on top of this state in two batches, and then on the nonwoven fabric. It was allowed to stand for 5 minutes for sufficient permeation (see Figure 3).
  • FIG. 4 is a macroscopic photograph of a specimen such as a ureter including an excised anastomosis. The portion indicated by the arrow is the ureteral anastomosis. As shown in FIG. 4, the ureter was smooth as a whole, and the ureter including the anastomosis was in a healthy state.
  • FIG. 4 is a macroscopic photograph of a specimen such as a ureter including an excised anastomosis. The portion indicated by the arrow is the ureteral anastomosis. As shown in FIG. 4, the ureter was smooth as a whole, and the ureter including the anastomosis was in a healthy state.
  • FIG. 4 is a macroscopic photograph of a specimen such as a ureter including an excised anastomosis. The portion indicated by the arrow is the ureteral anastomosis. As shown in FIG. 4, the ureter was smooth as a whole, and the
  • FIG. 5 is a light microscope image of a cross-section of an HE-stained histological specimen of the anastomosis indicated by the arrow in FIG. As shown in FIG. 5, it can be seen that no space due to leakage of urine is observed between the ureter (symbol A) and its surrounding loose connective tissue (symbol B). A small amount of nonwoven fabric remains in the surrounding tissue, indicated by the dotted line, indicating good healing of the anastomosis.
  • FIG. 6 is a macroscopic photograph of a specimen such as a ureter including an anastomosis excised after three months of observation. The portion indicated by the arrow is the ureteral anastomosis. As shown in FIG. 6, the ureter is edematous as a whole, suggesting the continuation of chronic inflammation throughout the ureter.
  • FIG. 6 is a macroscopic photograph of a specimen such as a ureter including an anastomosis excised after three months of observation. The portion indicated by the arrow is the ureteral anastomosis. As shown in FIG. 6, the ureter is edematous as a whole, suggesting the continuation of chronic inflammation throughout the ureter.
  • FIG. 6 is a macroscopic photograph of a specimen such as a ureter including an anastomosis excised after three months of observation. The portion indicated by the arrow is the ureteral anastomosis. As shown in FIG. 6, the ureter is e
  • FIG. 7 shows a light microscope image of a cross-section of an HE-stained histological specimen of the anastomosis indicated by the arrow in FIG.
  • a large space symbol C formed by leakage of urine is recognized.
  • a large amount of non-woven fabric remains in the surrounding tissue, as indicated by the dotted line, indicating that the anastomosis is not well healed.
  • the medical tape of Example 1 As described above, when the medical tape of Example 1 was used, no findings indicating ureteral stenosis or urine leakage were observed, and the ureteral epithelium was continuously regenerated smoothly. Turns out I was going through a healing process. On the other hand, for example, in the case of the medical tape of Comparative Example 3, at the time of surgery, urine leakage occurred even in individuals who were considered to have completely prevented urine leakage at the time of surgery, and the anastomosis was not complete. . Therefore, the medical tape of Example 1 not only enables complete prevention of urinary leakage due to its early urinary leakage prevention effect, but also helps regenerate and repair the ureter wall excellently in long-term anastomosis repair. It was thought that the effect could be expected.
  • a Ureter B Loose connective tissue around the ureter C Space formed by urinary leakage

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Abstract

La présente invention peut fournir une bande médicale qui: est formée d'un tissu non tissé ayant une partie d'augmentation progressive dans laquelle l'épaisseur dans la direction longitudinale augmente progressivement depuis un côté d'extrémité vers l'autre côté d'extrémité ; peut être enroulée autour de la périphérie externe d'un organe tubulaire dans un état dans lequel le tissu non tissé se chevauche lui-même ; lorsqu'elle est enroulée, permet la perméation de fluides corporels contenant des cellules tissulaires de l'organe tubulaire dans le tissu non tissé ; et est, lorsque le traitement d'un site blessé ou similaire d'un organe tubulaire doit être conduit, capable d'empêcher une fuite de contenu pendant un court terme sans être invasif par rapport à l'organe tubulaire et capable de faciliter la cicatrisation à long terme du site blessé.
PCT/JP2022/031245 2021-08-18 2022-08-18 Bande médicale WO2023022202A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5074944A (en) * 1988-05-27 1991-12-24 Smith & Nephew United, Inc. Method for manufacturing a layered article having a beveled edge
JP2006512176A (ja) * 2002-12-31 2006-04-13 オスール・エイチエフ 創傷包帯
JP2012516703A (ja) * 2009-02-02 2012-07-26 ベーエスエヌ・メディカル・ゲーエムベーハー 創傷手当用品、その製造方法および創傷治療におけるその使用

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5074944A (en) * 1988-05-27 1991-12-24 Smith & Nephew United, Inc. Method for manufacturing a layered article having a beveled edge
JP2006512176A (ja) * 2002-12-31 2006-04-13 オスール・エイチエフ 創傷包帯
JP2012516703A (ja) * 2009-02-02 2012-07-26 ベーエスエヌ・メディカル・ゲーエムベーハー 創傷手当用品、その製造方法および創傷治療におけるその使用

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