WO2019189835A1 - Matériau auxiliaire de suture - Google Patents

Matériau auxiliaire de suture Download PDF

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Publication number
WO2019189835A1
WO2019189835A1 PCT/JP2019/014204 JP2019014204W WO2019189835A1 WO 2019189835 A1 WO2019189835 A1 WO 2019189835A1 JP 2019014204 W JP2019014204 W JP 2019014204W WO 2019189835 A1 WO2019189835 A1 WO 2019189835A1
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WO
WIPO (PCT)
Prior art keywords
collagen
nerve
suture
cylindrical body
assisting material
Prior art date
Application number
PCT/JP2019/014204
Other languages
English (en)
Japanese (ja)
Inventor
琢也 中越
文彦 梶井
西田　光生
Original Assignee
東洋紡株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 東洋紡株式会社 filed Critical 東洋紡株式会社
Priority to JP2020511135A priority Critical patent/JPWO2019189835A1/ja
Publication of WO2019189835A1 publication Critical patent/WO2019189835A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • 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
    • A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/06—At least partially resorbable materials
    • A61L17/08—At least partially resorbable materials of animal origin, e.g. catgut, collagen
    • 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
    • A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/06—At least partially resorbable materials
    • A61L17/10—At least partially resorbable materials containing macromolecular materials
    • A61L17/12—Homopolymers or copolymers of glycolic acid or lactic acid
    • 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
    • A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/14—Post-treatment to improve physical properties
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24—Collagen
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body

Definitions

  • the present invention relates to a suture assisting material made of a bioabsorbable polymer material used for reconstruction of a torn or deficient nerve.
  • a direct suturing method has been used when a suture between the nerve stumps is possible.
  • the length of a nerve defect is 10 mm or less
  • direct suturing is often used.
  • the percentage of direct sutures accounted for about 80% of the cases of nerve reconstruction surgery.
  • Autologous nerve transplantation has been used when the defect is large.
  • a nerve reconstruction technique has been performed in which a cylindrical nerve regeneration tube made of a bioabsorbable polymer material is introduced into a ruptured / defected portion of a peripheral nerve to promote regeneration of the ruptured / defected nerve.
  • Patent Document 1 describes a nerve regeneration tube in which a collagen solution is applied to the outer surface of a cylindrical body made of ultrafine fibers of a biodegradable polymer, and the inside is filled with collagen.
  • Patent Document 2 describes a nerve regeneration tube having a collagen sponge layer and a linear nerve guide path in a cylindrical body made of a fibrous bioabsorbable material. These nerve regeneration tubes have been used as an alternative to autologous nerve transplantation where direct nerve stitching is not possible.
  • the present invention mainly reduces the inhibition of functional recovery due to improper suturing in direct suturing, and further enables suturing assistance to enable nerve reconstruction without renewing the cleaved and destroyed nerves.
  • the purpose is to provide materials.
  • the present inventors have found that a cylindrical body made of a bioabsorbable polymer material can be used as a suture material for direct stitching in a case where direct suture is generally performed, and the present invention has been completed.
  • the present invention provides inventions represented by the following. [1] A cylindrical body made of a bioabsorbable polymer material, having an inner diameter of 0.1 mm or more and 15 mm or less, a length of 1 mm or more and 25 mm or less, and used for a nerve rupture site having a rupture interval of 10 mm or less. For suturing aids. [2] The suture assisting material according to [1], wherein the bioabsorbable polymer material is collagen or polyglycolic acid.
  • the nerve stump on both the central side and the peripheral side is sutured via the suture assisting material of the present invention. It is possible to prevent poor blood flow and to expect good nerve regeneration. In addition, it is possible to suppress twisting of the perineurium and erroneous control of regeneration axons. Furthermore, it is possible to suppress the formation of scars and neuromas that tend to occur at the suture site, and to suppress the pain and numbness associated therewith.
  • suture assisting material of the present invention it is possible to perform a treatment in which the nerve stump that has been damaged is not refreshed, and nerve reconstruction can be performed while preserving the nerve tissue.
  • the suture assisting material of the present invention is also effective for sites where blood circulation is poor or where external pressure is applied from surrounding tissues.
  • the suture assisting material secures a space for nerve axon regeneration, and better nerve reconstruction can be expected as compared with the case where the suture assisting material is not used.
  • the suturing auxiliary material of the present invention is a cylindrical body having an inner diameter of 0.1 mm to 15 mm and a length of 1 mm to 25 mm.
  • the inner diameter can be appropriately selected according to the outer diameter of the nerve.
  • the inner diameter is more preferably 0.5 mm or more, and more preferably 10 mm or less.
  • the length can be appropriately selected depending on the size of the nerve rupture or damaged site.
  • the length is more preferably 2 mm or more.
  • the upper limit of the length is not particularly limited, but generally may be 25 mm or less, or 20 mm or less.
  • the thickness of the neuroprotective material of the present invention is preferably in the range of 150 ⁇ m to 1000 ⁇ m. If the thickness is within the above range, the shape can be maintained against the external pressure from the tissue around the nerve, and the kink resistance, which is an index of difficulty in buckling, is also excellent.
  • the neuroprotective material may be used after being immersed in a physiological saline solution or the like immediately before use during surgery. Said thickness is measured using the neuroprotective material in the dry state before being immersed in physiological saline.
  • said thickness is a thickness including the said collagen layer.
  • bioabsorbable polymer material in the present invention either a synthetic bioabsorbable polymer or a natural bioabsorbable polymer can be used.
  • examples thereof include polyglycolic acid, D-polylactic acid, L-polylactic acid, DL-polylactic acid, polycaprolactone, lactic acid-caprolactone copolymer, lactic acid-glycolic acid copolymer, collagen, and gelatin.
  • polyglycolic acid, polylactic acid, lactic acid-glycolic acid copolymer and / or collagen are preferable, and collagen and / or polyglycolic acid are more preferable.
  • fibrous collagen and / or fibrous polyglycolic acid are particularly preferable.
  • Examples of a method for producing a cylindrical body made of a bioabsorbable polymer material include the following methods.
  • (1) Method for producing cylindrical body from sheet-shaped bioabsorbable polymer material As a method for producing sheet-shaped bioabsorbable polymer material, molten synthetic bioabsorbable polymer material is formed into a sheet. It can be produced by pressing or extruding into a sheet. Further, taking collagen as an example, a collagen sheet can be produced by pouring a collagen solution into a mold so as to form a sheet and freeze-drying it.
  • a sheet-like bioabsorbable polymer material can be produced by producing a nonwoven fabric, a woven fabric, or a knitted fabric from a bioabsorbable polymer material formed into a fiber shape.
  • the produced sheet is wound around a core rod corresponding to a desired inner diameter, and fixed by heating and cooling to obtain a cylindrical body.
  • a cylindrical body can be obtained by extrusion molding (tube molding) of a molten bioabsorbable polymer material. .
  • a cylindrical body can also be produced by melt spinning using a hollow fiber nozzle.
  • a cylindrical body can be produced by producing a hollow braid using a machine.
  • a cylindrical body can be produced by winding a fibrous bioabsorbable polymer material around a core rod or a plate-like substrate.
  • the fibrous form include short fibers, long fibers, nanofibers, thread bodies, and cotton bodies.
  • the fiber may be monofilament or multifilament.
  • the fiber diameter of the fibrous material is usually about 1-1000 ⁇ m, preferably about 3-100 ⁇ m.
  • the suturing auxiliary material of the present invention may further have a collagen layer on the lumen surface or outer surface of the cylindrical body or both surfaces thereof for reinforcement.
  • the collagen layer can be formed by applying a collagen solution to the inner surface and / or outer surface, or immersing a suture assisting material in the collagen solution and further drying by air drying or freeze drying.
  • the collagen layer may be a single layer or a multilayer. In the case of multiple layers, the collagen solution with the same concentration may be applied or immersed multiple times, or the collagen solution with different concentrations may be applied or immersed multiple times.
  • a collagen layer can be formed by laminating fibrous collagen non-woven fabrics in layers or by winding fibrous collagen. In this case, it may be further heated and thermally welded. By providing the collagen layer in this manner, the shape retention force and kink resistance can be further improved.
  • the suture assisting material of the present invention can further contain collagen having a sponge structure, linear collagen fibers, or both in the lumen surface.
  • collagen having a sponge structure can be filled by filling the lumen of the cylindrical body with a collagen solution and freeze-drying.
  • a collagen solution is extruded or spun into a fiber shape to prepare linear collagen fibers having a length equal to or shorter than that of the cylindrical body, and then the linear collagen fibers are formed into the cylindrical body.
  • One or more can be inserted into the lumen.
  • Examples of the collagen used for filling the inner surface of the tubular body and / or the outer surface of the tubular body include type I collagen, type III collagen, type IV collagen, and the like. You may use, and you may use in mixture.
  • As the collagen those having a sodium chloride content of 2.0% by weight or less, preferably 0.1 to 1.5% by weight in a dry state can be used. By using collagen with a reduced concentration of sodium chloride, improvement in cell adhesion, cell proliferation, and cell differentiation inducing ability can be expected.
  • the collagen body When the collagen body has a collagen layer on the inner surface and / or outer surface of the cylindrical body, and when the inner cavity of the cylindrical body is filled with collagen or contains linear collagen fibers, the collagen may be crosslinked by performing a crosslinking treatment.
  • a crosslinking treatment include ⁇ -ray crosslinking, ultraviolet crosslinking, electron beam crosslinking, thermal dehydration crosslinking, glutaraldehyde crosslinking, epoxy crosslinking, and water-soluble carbodiimide crosslinking, but it is easy to control the degree of crosslinking and perform crosslinking treatment. Thermal dehydration crosslinking that does not affect the living body is preferred.
  • the thermal dehydration crosslinking treatment is performed under a vacuum, for example, at a temperature of about 105 to 150 ° C., more preferably at a temperature of about 120 to 150 ° C., and even more preferably at a temperature of about 140 ° C. More preferably, it is performed for about 12 hours. If the crosslinking temperature is too high, the strength of the biodegradable absorbent material may be reduced. Further, if the crosslinking temperature is too low, there is a possibility that sufficient crosslinking reaction does not occur.
  • the suture assisting material of the present invention is preferably immersed in a physiological saline before use.
  • the suturing auxiliary material can be swollen in advance to have flexibility.
  • the suture assisting material can be used after being cut to an appropriate length according to the size of the damaged site of the tearing nerve.
  • the suture assisting material according to the present invention can be used mainly by the following method. First, (1) each of the central nerve stump and the suturing auxiliary material and the peripheral nerve stump and the suturing auxiliary material are joined to each other through a suture, and (2) in the cylindrical body cavity. The nerve stump is pulled in and sutured and fixed.
  • the number of sutures can be appropriately selected depending on the size of the nerve and the degree of damage. For example, 2-3 stitches on one side may be used.
  • sutures via suture aids do not apply pressure to the nerve stumps and require fewer sutures, so they are extremely effective in suppressing nerve regeneration and scarring and neuromas. It is.
  • the suture assisting material of the present invention is made of a bioabsorbable polymer material, it is absorbed into the body and disappears in about several months to one year. In the meantime, the regenerated axon of the nerve that has been torn and lost extends the lumen of the suture assisting material, and the nerve regenerates.
  • the collagen solution was uniformly applied once to the outer surface of the cylindrical body using a brush, air-dried and confirmed to be completely dried, and then the next application was performed in order.
  • the concentration and frequency of the collagen solution applied were 0.2 wt% twice, 0.5 wt% once, 1.0 wt% 17 times, and the collagen solution was applied in order from the lowest collagen concentration.
  • the above-mentioned 1.0 wt% collagen solution was filled in the lumen of the cylindrical body after the application was completed. After filling, freezing and freeze-drying treatments were performed in order to sponge the collagen molecules. After lyophilization, in order to crosslink collagen molecules, thermal crosslinking was performed at 140 ° C. for 24 hours under a reduced pressure of 1 Pa or less to prepare a suture assisting material having a length of 10 mm.
  • Example 1 Using the suture assisting material produced in Production Example 1, the effect of suppressing pain and numbness by protecting the nerve damage site was confirmed by animal experiments.
  • a control group a group in which sutures were directly sutured with 9-0 nylon thread without using a suture assisting material was provided.
  • SD 7-week-old CD
  • the suture assisting material produced in Production Example 1 was immersed in physiological saline for 20 minutes before use.
  • the test animals were anesthetized with isoflurane and fixed in the prone position.
  • the skin on the outer side of the femur of the left hind limb was incised, the fascia was peeled off, and the sciatic nerve was exposed.
  • the sciatic nerve was exfoliated from surrounding tissues, and a sciatic nerve defect was created under a microscope.
  • the sciatic nerve was cut sharply using a direct scissors under a microscope.
  • the sciatic nerve was 5 mm long and sandwiched with Pean hemostats for 10 seconds, and the center was cut using a direct scissors.
  • the suture assisting material produced in Production Example 1 was applied to the defect part, and both ends of the supraneural membrane of the nerve stump on both sides and the suture assisting material were sutured using 9-0 nylon thread. Suture was performed for two stitches at both ends.
  • the control group sciatic nerve defects of the clean cut group and the crush fracture group were created, and then the nerve stumps were sutured together with 6 needles using 9-0 nylon thread.
  • the muscles and skin were sutured with 4-0 nylon thread and the animals were awakened.
  • ampicillin sodium (1 g for injection of Vicillin (registered trademark), manufactured by Meiji Seika Pharma Co., Ltd.) (dose: 50 mg / 0.25 mL / body) was subcutaneously administered to the back.
  • the test animals were observed once daily after the operation and reared for 10 weeks.
  • the suture assisting material according to the present invention can be used as a suture material for direct stitching in a case where direct stitching is generally performed.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Materials Engineering (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Composite Materials (AREA)
  • Dispersion Chemistry (AREA)
  • Zoology (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

Le problème décrit par la présente invention est de pourvoir à un matériau auxiliaire de suture visant à éviter qu'une récupération de fonction soit empêchée à cause de l'utilisation d'une suture inadéquate dans une technique de suture directe, et en outre, à permettre à des nerfs, qui ont été sectionnés et détruits, d'être reconstruits sans régénérer les nerfs. La solution selon l'invention porte sur un matériau auxiliaire de suture qui est un corps cylindrique composé d'un matériau polymère bioabsorbable et ayant un diamètre interne compris entre 0,1 et 15 mm et une longueur comprise entre 1 et 25 mm, le matériau auxiliaire de suture étant destiné à être utilisé dans une région de rupture de nerf ayant un espace de rupture inférieur ou égal à 10 mm.
PCT/JP2019/014204 2018-03-30 2019-03-29 Matériau auxiliaire de suture WO2019189835A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2020511135A JPWO2019189835A1 (ja) 2018-03-30 2019-03-29 縫合補助材

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2018068394 2018-03-30
JP2018-068394 2018-03-30

Publications (1)

Publication Number Publication Date
WO2019189835A1 true WO2019189835A1 (fr) 2019-10-03

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PCT/JP2019/014204 WO2019189835A1 (fr) 2018-03-30 2019-03-29 Matériau auxiliaire de suture

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JP (1) JPWO2019189835A1 (fr)
WO (1) WO2019189835A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002320630A (ja) * 2001-04-26 2002-11-05 Nipro Corp 生体組織または器官再生用器具
JP2003019196A (ja) * 2001-07-09 2003-01-21 Gunze Ltd 神経再生チューブ
JP2009136575A (ja) * 2007-12-07 2009-06-25 Toyobo Co Ltd 神経再生誘導管の製造方法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002320630A (ja) * 2001-04-26 2002-11-05 Nipro Corp 生体組織または器官再生用器具
JP2003019196A (ja) * 2001-07-09 2003-01-21 Gunze Ltd 神経再生チューブ
JP2009136575A (ja) * 2007-12-07 2009-06-25 Toyobo Co Ltd 神経再生誘導管の製造方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
NAKASHIMA, HIDECHIKA: "Regeneration of peripheral nerve gaps with a nerbridge", IGAKU NO AYUMI, vol. 255, no. 4, 2015, pages 291 - 296 *

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