WO2023199794A1 - 子宮頸部狭窄予防デバイス及びその製造方法 - Google Patents

子宮頸部狭窄予防デバイス及びその製造方法 Download PDF

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Publication number
WO2023199794A1
WO2023199794A1 PCT/JP2023/013925 JP2023013925W WO2023199794A1 WO 2023199794 A1 WO2023199794 A1 WO 2023199794A1 JP 2023013925 W JP2023013925 W JP 2023013925W WO 2023199794 A1 WO2023199794 A1 WO 2023199794A1
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WO
WIPO (PCT)
Prior art keywords
vitrigel
dried
cervical stenosis
filamentous
membranous
Prior art date
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Ceased
Application number
PCT/JP2023/013925
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English (en)
French (fr)
Japanese (ja)
Inventor
茂久 青木
俊明 竹澤
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Saga University NUC
National Agriculture and Food Research Organization
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Saga University NUC
National Agriculture and Food Research Organization
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Priority to JP2024514906A priority Critical patent/JP7733373B2/ja
Publication of WO2023199794A1 publication Critical patent/WO2023199794A1/ja
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    • 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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • 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
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials

Definitions

  • the present invention relates to a device for preventing cervical stenosis and a method for manufacturing the same.
  • the present inventor has previously developed a new tissue regeneration technique for the skin, esophagus, and eardrum using membranous atelocollagen vitrigel, and a new tissue regeneration technique for the peritoneum using filamentous atelocollagen vitrigel.
  • These new therapeutic techniques for tissue regeneration are techniques for suppressing pathological contraction and fibrosis (see, for example, Patent Documents 1 to 3).
  • the present invention has been made in view of the above circumstances, and provides a highly practical device for preventing cervical stenosis.
  • the present invention includes the following aspects.
  • a device for preventing cervical stenosis [2] The device for preventing cervical stenosis according to [1], wherein the fixing part has a main part extending in the middle and a plurality of branch parts extending from the main part.
  • [4] The device for preventing cervical stenosis according to [1], wherein the dried membranous vitrigel has a sewn portion of the filamentous core material.
  • [5] The device for preventing cervical stenosis according to [1], wherein the dried membranous vitrigel is a dried membranous atelocollagen vitrigel.
  • [6] The method for manufacturing the device for preventing cervical stenosis according to any one of [1] to [5], which includes step 1 of fixing a filamentous core material in the longitudinal direction of the membranous vitrigel and then drying it.
  • the method for manufacturing a device for preventing cervical stenosis according to [6] which comprises a step 3 of drying the filamentous vitrigel composite to obtain a dried filamentous vitrigel composite after step 2.
  • the method for producing a device for preventing cervical stenosis according to [8] which includes a step 4 of irradiating the dried filamentous vitrigel composite with ultraviolet rays, rehydrating it, and further drying it. .
  • a method for treating the cervix comprising the steps of:
  • FIG. 1 is a plan view of the cervical stenosis prevention device 1.
  • FIG. 1 is a plan view of the cervical stenosis prevention device 1.
  • FIG. It is a photograph of the process of forming through holes in an atelocollagen vitrigel membrane. It is a photograph of an atelocollagen vitrigel membrane having through-holes. This is a photo of FD-1 P70 (Fuji Latex Co., Ltd.). This is a photograph of the tail (nylon thread) of FD-1 passed through a vitrigel membrane.
  • FIG. 3 is a diagram showing the progress of irradiating a dried filamentous atelocollagen vitrigel complex with ultraviolet rays. This is a photograph showing the process in which UV-irradiated FD-1 with a dried vitrigel membrane was placed in PBS, washed, and hung again to dry. This is a photograph of dried atelocollagen vitrigel membrane-covered FD-1.
  • FIG. 2 is a photograph of a device for preventing cervical stenosis coated with a dried atelocollagen vitrigel membrane produced in Production Example 2. This is a photograph showing cone resection performed on the cervix of a mini pig crown type using an electric scalpel.
  • A This is a photograph of the uterine cervix of a mini pig crown type after conization was performed using an electric scalpel.
  • B A photograph showing that a device for preventing cervical stenosis is placed in the cervix. This is a photograph taken 30 days after the cervical stenosis prevention device was placed. This is a photograph of an untreated cervix 2 weeks after conization.
  • the present invention comprises a composite thread portion having a filamentous core material fixed to be covered with a membranous dried vitrigel, and a fixing portion for indwelling the composite thread portion in the cervix.
  • a device for preventing cervical stenosis is provided.
  • the device for preventing cervical stenosis of this embodiment is suitably used as a device for preventing cervical stenosis after cervical conization.
  • FIG. 1 is a plan view of a device 1 for preventing cervical stenosis.
  • the cervical stenosis prevention device 1 has a composite thread part 2 and a fixing part 3.
  • the composite thread part 2 prevents cervical canal stenosis after cervical conization by being located within the cervix.
  • the composite yarn portion 2 has a filamentous core material covered with a membranous dried vitrigel.
  • the dried membrane-like vitrigel covering the filamentous core material is biocompatible, and therefore does not cause foreign body reactions or rejection reactions even if it is located within the cervix.
  • the sol serving as the raw material for the hydrogel for producing the membranous vitrigel may be any material that is biocompatible, such as extracellular matrix-derived components that gel, fibrin, agar, agarose, cellulose, etc.
  • examples include natural polymer compounds and synthetic polymer compounds such as polyacrylamide, polyvinyl alcohol, polyethylene oxide, poly(II-hydroxyethylmethacrylate)/polycaprolactone.
  • the term "sol” refers to a dispersoid colloidal particle (size: about 1 to several hundred nm) using a liquid as a dispersion medium, especially one composed of a polymer compound. More specifically, the sol includes an aqueous solution of a natural polymer compound or a synthetic polymer compound.
  • hydrogel is a semi-solid substance that retains a large amount of water in the network. That is, "hydrogel” means a sol that has been turned into a gel.
  • Extracellular matrix-derived components to be gelled include, for example, collagen (type I, type II, type III, type V, type XI, etc.), mouse EHS tumor extract (type IV collagen, laminin, heparan sulfate proteoglycan, etc.) ) reconstituted basement membrane components (trade name: Matrigel), glycosaminoglycans, hyaluronic acid, proteoglycans, gelatin, etc., but are not limited to these. It is possible to manufacture a desired hydrogel by selecting components such as salts, their concentrations, pH, etc. that are optimal for gelation. Furthermore, by combining raw materials, it is possible to obtain hydrogels that mimic various in-vivo tissues.
  • collagen type I, type II, type III, type V, type XI, etc.
  • mouse EHS tumor extract type IV collagen, laminin, heparan sulfate proteoglycan, etc.
  • basement membrane components trade name: Matrigel
  • an extracellular matrix-derived component that turns into a gel is preferable, and collagen is more preferable.
  • more preferable raw materials include native collagen and atelocollagen, and atelocollagen from which antigenic telopeptides have been deleted is more preferable when transplanted into a living body.
  • vitrigel refers to a gel in a stable state obtained by rehydrating a conventional hydrogel after vitrification. Trademark). Moreover, in this specification, when using the term “vitrigel”, the term “(registered trademark)" may be omitted.
  • the composite yarn portion 2 can improve its breaking strength by having a filamentous core material. Furthermore, by using a filamentous core material that is not bioabsorbable, even if the vitrigel is digested within the cervix, the site where the composite thread portion 2 is placed can be confirmed over time.
  • the filamentous core material is not particularly limited as long as it imparts breaking strength to the composite yarn portion 2, and is appropriately selected depending on the application. Examples of the thread-like core material include chemical fibers such as nylon thread, polyester thread, rayon thread, and polyglactin thread; threads of natural materials such as silk thread, cotton thread, hemp thread, and wool thread; nylon thread is preferred.
  • the filamentous core material may be a single yarn, a double yarn made by twisting the same or two types of yarns together, or a yarn made by twisting three or more yarns together.
  • the length of the composite yarn portion 2 is adjusted as appropriate depending on the application.
  • the length is preferably 1 cm to 100 cm, more preferably 2 cm to 50 cm, and even more preferably 3 cm to 10 cm.
  • the diameter of the composite yarn portion 2 is adjusted as appropriate depending on the application.
  • it is preferably 0.1 mm to 10 mm, more preferably 0.2 mm to 4 mm, and particularly preferably 0.5 mm to 2 mm.
  • the membranous dried vitrigel preferably has a sewn portion of the filamentous core material. It is more preferable that the dried membranous vitrigel has a plurality of sewn parts. It is preferable that the pitch between the sewn parts is constant. The length of the pitch between the sewn parts is preferably 0.5 mm to 10 mm, more preferably 1 mm to 4 mm, and particularly preferably 1 mm to 3 mm.
  • the composite yarn portion of this embodiment has a helical structure by being twisted.
  • the sol serving as the raw material for the dried membranous vitrigel is as described above.
  • dried vitrigel constituting the composite thread portion of this embodiment dried atelocollagen vitrigel is preferable because it is a biocompatible material.
  • the fixing part 3 is for indwelling the composite thread part 2 in the cervix. It is preferable that the fixing part 3 be fixed in the cervix by being caught in the uterine cervix. Therefore, it is preferable that the fixed part 3 has a main part 4 extending in the middle and a plurality of branch parts 5 extending from the main part 4. It is more preferable that the fixing portion 3 extends semi-radially from the point 4 as a starting point, and that the fixing portion 3 is formed in a fishbone shape.
  • the material of the fixing part 3 is preferably one having flexibility and elasticity, such as urethane rubber, nitrile rubber, silicone rubber, silicone resin (for example, polydimethylsiloxane), fluororubber, acrylic rubber, isoprene rubber, ethylene propylene rubber, chlorosulfone.
  • urethane rubber nitrile rubber
  • silicone rubber silicone resin (for example, polydimethylsiloxane), fluororubber, acrylic rubber, isoprene rubber, ethylene propylene rubber, chlorosulfone.
  • Elastomer materials such as polyethylene rubber, epichlorohydrin rubber, chloroprene rubber, styrene-butadiene rubber, butadiene rubber, polyisobutylene rubber; poly(vinyl chloride), poly(vinyl alcohol), poly(methyl methacrylate), poly(vinyl acetate) Plastics containing polymers such as co-maleic anhydride), poly(dimethylsiloxane) monomethacrylate, cyclic olefin polymers, fluorocarbon polymers, polystyrene, polypropylene, polyethylene imine, polyethylene terephthalate (PET); ethylene vinyl acetate, poly(vinyl acetate) Examples include copolymers such as co-maleic anhydride), poly(styrene-co-maleic anhydride), poly(ethylene-co-acrylic acid), and derivatives thereof, with ethylene vinyl acetate being preferred. From the viewpoint of biocompatibility, similarly to the composite thread section 2, the
  • the device 1 for preventing cervical stenosis preferably has a removable uterine insertion part 6 for covering the composite thread part 2 and guiding the composite thread part 2 to the cervix.
  • the uterine insertion section 6 has a thread guide groove that guides the composite thread section 2 in its longitudinal direction.
  • the material of the uterus insertion part 6 may be the same as that of the fixing part 3, and ethylene vinyl acetate is preferable.
  • the present invention provides a method for manufacturing the device for preventing cervical stenosis of the present invention, which comprises a step 1 of fixing a filamentous core material in the longitudinal direction of the membranous vitrigel and then drying it;
  • a method for manufacturing a device for preventing cervical stenosis which comprises step 2 of obtaining a filamentous vitrigel composite by twisting a dried membranous vitrigel to which a filamentous core material is fixed while moistening it with an aqueous solution to form a filament.
  • the method for producing a hydrogel includes a step A in which a sol is injected into a mold, the sol is gelled, and then the mold is removed to obtain a plate-like hydrogel. Further, there is a step B of vitrifying the plate-like hydrogel and then rehydrating it to obtain a membranous vitrigel.
  • the plate-shaped hydrogel may have a protrusion at the end in view of the ease of twisting of the vitrigel membrane to be produced.
  • the plate-like hydrogel may have a rectangular shape and the width may be narrow, but the width is not limited to this and can be adjusted as appropriate. The wider the width of the plate-shaped hydrogel is, the thicker the threads are produced, and the narrower the width of the plate-shaped hydrogel, the thinner the threads are produced. In this way, by adjusting the width of the plate-like hydrogel, the thickness of the thread can be controlled.
  • the width of the plate-shaped hydrogel does not need to be uniform; the width may vary depending on the length as in a gourd shape, or the width may gradually vary as in a triangular shape. It's okay.
  • Step A is a step of injecting a sol into a mold, allowing the sol to gel, and then removing the mold to obtain a plate-like hydrogel.
  • the mold is not particularly limited as long as it has the shape of a desired plate-like hydrogel hollowed out, and examples thereof include PET film.
  • the sol that is the raw material for the plate-shaped hydrogel includes the same materials as those described in ⁇ Cervical stenosis prevention device>, and any biocompatible material may be used, such as native collagen or atelocollagen. From the viewpoint of transplantation into a living body, atelocollagen from which antigenic telopeptide has been deleted is more preferred.
  • step A if the amount of sol is increased when injecting the sol into the mold, a thick plate-like hydrogel can be obtained, and as a result, a thick thread can be obtained. Moreover, if the amount of sol is reduced, a thin plate-like hydrogel can be obtained, and as a result, a thin thread can be obtained. In this way, the thickness of the thread can be controlled by adjusting the amount of sol to be injected.
  • the thickness of the plate-like hydrogel is preferably 0.1 mm to 20 mm, more preferably 0.5 mm to 20 mm, and even more preferably 1 mm to 20 mm.
  • the length of the long side of the plate-like hydrogel is adjusted as appropriate depending on the length of the composite thread used.
  • the length is preferably 1 cm to 100 cm, more preferably 2 cm to 50 cm, and even more preferably 3 cm to 10 cm.
  • the length of the short side of the plate-shaped hydrogel is, for example, preferably 0.5 mm to 20 mm, more preferably 1 mm to 10 mm, and even more preferably 2 mm to 5 mm.
  • the temperature at which the sol is kept warm during gelation may be adjusted as appropriate depending on the type of sol used. For example, if the sol is a collagen sol, the temperature during gelation may be lower than the denaturation temperature of collagen, which depends on the animal species of the collagen used, and is generally at a temperature of 20°C or higher and 37°C or lower. By keeping it warm, gelation can be achieved in a few minutes to a few hours.
  • the plate-shaped hydrogel obtained in step A may be cut out to obtain a strip-shaped hydrogel having a desired width.
  • Step B is a step in which the strip-shaped hydrogel having the desired width obtained in Step A is vitrified and then rehydrated to obtain a membranous vitrigel.
  • thread-like core material examples include those similar to those described in ⁇ Cervical stenosis prevention device>, and particularly those that impart breaking strength to the composite thread obtained using the manufacturing method of this embodiment.
  • nylon yarn is preferred.
  • the filamentous core material may be a single yarn, a double yarn made by twisting the same or two types of yarns together, or a yarn made by twisting three or more yarns together.
  • a filamentous core material is fixed in the longitudinal direction of the membrane-like vitrigel.
  • the fixing method is not particularly limited, and may be fixed with an adhesive, or may be physically fixed when twisting the dried membranous vitrigel in step 2.
  • the filamentous core material it is preferable to pass the filamentous core material alternately through the front and back sides of the membranous vitrigel and to fix them. That is, it is preferable that the membrane-like vitrigel be fixed by being passed through the thread-like core material in a manner such that the thread-like core material is threaded through the film-like vitrigel. Through such an operation, the membrane-like vitrigel and the filamentous core material can be brought into close contact with each other.
  • the preferred position for fixing the thread-like core material is on the central axis that bisects the short side of the membrane-like vitrigel, and the thread-like core material can be penetrated at equal intervals along the axis to form sewn parts.
  • the length of the pitch between the sewn parts is preferably 0.5 mm to 10 mm, more preferably 1 mm to 4 mm, and particularly preferably 1 mm to 3 mm.
  • a method for penetrating the thread-like core material it is possible to sew the thread-like core material through a needle, or to make through holes at regular intervals in the membrane-like vitrigel using a cylindrical or conical knife, etc., and then insert the thread-like core material.
  • the diameter of the through hole is, for example, preferably 0.01 mm to 5 mm, more preferably 0.1 mm to 3 mm, and particularly preferably 0.3 mm to 1 mm.
  • the cylindrical cutter include medical instruments such as biopsy trepanes and injection needles.
  • step 1 the membrane-like vitrigel to which the filamentous core material is fixed is dried.
  • Various methods can be used for drying, such as air drying, drying in a closed container (circulating air in the container and constantly supplying dry air), drying in an environment with silica gel, etc. .
  • air drying methods include drying in an incubator kept aseptic at 10°C and 40% humidity for two days, or drying in a sterile clean bench overnight at room temperature. can.
  • Step 2 the dried membranous vitrigel to which the filamentous core material is fixed is twisted into a filament while being moistened with an aqueous solution to obtain a filamentous vitrigel composite.
  • the aqueous solution is not particularly limited and includes sterile water, physiological saline, PBS, atelocollagen sol, native collagen sol, etc.
  • Atelocollagen sol from which antigenic telopeptide has been deleted is preferred when transplanting into a living body.
  • the strength of the thread can be increased by coating it with atelocollagen sol or native collagen sol. Further, by such an operation, the membrane-like vitrigel and the filamentous core material can be brought into close contact with each other.
  • a preferred drying method is the same as in step 1.
  • the dried filamentous vitrigel composite is irradiated with ultraviolet rays, rehydrated, and further dried.
  • a crosslinked structure is formed between and within the molecules of the collagen constituting the vitrigel and the coated collagen, thereby increasing the strength of the composite thread.
  • the membrane-like vitrigel and the filamentous core material can be brought into close contact with each other.
  • the irradiation energy of the ultraviolet rays described above may be adjusted as appropriate depending on the composition and content of the dried film-like vitrigel.
  • the irradiation energy of ultraviolet rays may be, for example, 0.1 mJ/cm 2 or more and 6000 mJ/cm 2 or less, for example, 10 mJ/cm 2 or more and 4000 mJ/cm 2 or less, for example, 20 mJ/cm 2 or more and 2000 mJ/cm 2 or less .
  • the following is sufficient.
  • Examples of the aqueous solution used for rehydration include sterile water, physiological saline, and PBS. After rehydration, the filamentous vitrigel composite is dried and revitrified.
  • the breaking strength of the filamentous atelocollagen vitrigel can be improved, so that the obtained composite filament is also suitable for the hard tissue of the cervix. It can be used for.
  • the obtained composite thread is inserted into tissue and left in place, even though the membranous dried vitrigel is gradually digested in vivo, the filamentous core material remains undigested, or atelocollagen vitrigel remains undigested. Since it is a filamentous core material that digests more slowly, the site where the composite filament is placed can be confirmed over time. Furthermore, by using the filamentous core material, vitrigel can be used only in the necessary areas of the filamentous core material, and expensive vitrigel can be saved.
  • the method for treating the cervix of this embodiment includes the steps of removing the cervical cone and inserting and placing the cervical stenosis prevention device of this embodiment into the remaining uterus after the cervical cone has been removed. has.
  • post-operative cervical stenosis can be easily prevented by indwelling the region to which the vitrigel is in close contact within the residual cervix to be treated.
  • the cervical stenosis prevention device can be easily removed after healing.
  • a vitrigel membrane measuring approximately 3 mm x approximately 55 mm with approximately 27 needle marks was obtained (see Figure 4), and this was placed in PBS.
  • the inserter of FD-1 P70 (Fuji Latex Co., Ltd.) was removed (see Figure 5), and the tail (nylon thread portion) of FD-1 was passed through the holed vitrigel membrane in PBS. At this time, I sewed it, alternating the stitches from the top and the bottom, creating a zigzag pattern.
  • the vitrigel membrane was passed through until it contacted the main body of FD-1, spread out and placed on vinyl to dry (see Figure 6).
  • the dried atelocollagen vitrigel membrane-covered FD-1 (see FIG. 10) was set in the inserter, placed in a container, and then stored in a bag.
  • Five devices for preventing cervical stenosis (collagen density: 10 mg/cm 2 ) coated with dried atelocollagen vitrigel membrane could be produced (see FIG. 11).
  • Example 1 Treatment method after cervical conization Day of surgery: 10 months old, weighing 19.3 kg to 22.4 kg mini-crown type pigs. An electric scalpel was used on the left and right sides of the cervix (bicornuate uterus), respectively. After performing conization (see FIGS. 12 and 13(A)), the atelocollagen vitrigel membrane-coated cervical stenosis prevention device manufactured in Production Example 2 was inserted into the cervix and fixed ( (See Figure 13(B).)
  • Example 2 Treatment method after cervical conization
  • the results are shown in FIG.
  • 4 dogs showed cervical blindness and 1 dog showed cervical stenosis.
  • the treatment group none of the six animals had blindness or stenosis.
  • the effectiveness of the atelocollagen vitrigel membrane-covered cervical stenosis prevention device in preventing cervical stenosis and closure after uterine conization was confirmed.

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PCT/JP2023/013925 2022-04-11 2023-04-04 子宮頸部狭窄予防デバイス及びその製造方法 Ceased WO2023199794A1 (ja)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS54108595U (https=) * 1978-01-19 1979-07-31
JP2020186487A (ja) * 2019-05-13 2020-11-19 国立研究開発法人農業・食品産業技術総合研究機構 糸及びその製造方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS54108595U (https=) * 1978-01-19 1979-07-31
JP2020186487A (ja) * 2019-05-13 2020-11-19 国立研究開発法人農業・食品産業技術総合研究機構 糸及びその製造方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HASHIGUCHI, MARIKO ET AL.: "Collagen vitrigel membrane-coated nylon line prevents stenosis after conization of the cervix uteri", PROCEEDINGS OF THE JAPANESE SOCIETY OF PATHOLOGY, JP, vol. 111, no. 1, 14 March 2022 (2022-03-14), JP , pages 249, XP009550299, ISSN: 0300-9181 *

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