JP4765602B2 - Package for regenerative medical instrument and processing method for regenerative medical instrument - Google Patents

Description

The present invention relates to a package for a regenerative medical instrument. More specifically, a regenerative medical instrument including a dry molded body of biodegradable absorbable polymer, a tray including a liquid tank for storing a liquid, and
The present invention relates to a regenerative medical instrument package including the regenerative medical instrument and a packaging material in which the tray is sealed, wherein the regenerative medical instrument, the tray, and the packaging material are sterilized. Furthermore, the present invention extends to a method for treating a regenerative medical instrument.

  In recent years, a treatment that restores the function by implanting a device having a scaffold for the cells of the tissue to proliferate in a tissue that has been deficient or excised due to an accident or surgery, and the cells grow along the scaffold. Various studies have been conducted on the law. This is so-called regenerative medicine research.

  However, in the development of these instruments used for regenerative medicine, researchers have considered easily incorporating drugs and / or cells into the instruments. Certainly, a high therapeutic effect can be expected if drugs and / or cells are incorporated into the device, but this places an extra burden on the physician in terms of device storage and safety management. In addition, doctors may be required to have knowledge of drug and / or cell handling. In particular, cell culture techniques are required for instruments incorporating cells.

  In view of the above-described present state of regenerative medicine, the present inventors have intensively studied the development of a regenerative medical instrument that does not handle cells, and have invented a tissue regenerative medical instrument made of collagen (Patent Documents 1 to 3). 6). Such devices are all made of collagen, a biodegradable material. In addition, since no chemical compound such as a crosslinking agent is used, it can be safely decomposed and absorbed in vivo. Moreover, surprisingly, these devices have been demonstrated to regenerate tissue without the incorporation of special cells. In other words, if these instruments are used, it is not necessary to handle cells, so that the manufacturer can manufacture these instruments at a low cost. Furthermore, the manufactured device does not deteriorate over a long period of time and can be stored well. In addition, since a doctor does not need to acquire a technique for handling cells, treatment can be easily performed using this instrument.

  By the way, the regenerative medical instrument described above is generally immersed in a solution such as physiological saline to swell the regenerative medical instrument in order to adjust the osmotic pressure in the body at the time of implantation. Has been done. At present, this operation is performed by preparing a separate container. However, since the prepared container is not sterilized, there is a problem of hygiene and bacterial or virus infection. Further, when the regenerative medical instrument is transferred to the container prepared by the operator, there is a problem that the regenerative medical instrument is dropped on the floor or the like and the instrument is contaminated.

JP 2002-320630 A JP 2004-073221 A JP 2003-235955 A JP 2003-245341 A JP 2004-188037 A International Publication 2005/070340 Pamphlet

  There is a need to provide a package for a regenerative medical instrument and a method for treating the regenerative medical instrument that allows a regenerative medical operator to prepare hygienically and easily for a regenerative medical operation.

The present invention
[1] A package for transporting a regenerative medical instrument,
A regenerative medical device comprising a dry molded body of biodegradable absorbable polymer;
A tray with a liquid reservoir for storing liquid; and
Including a packaging material for sealing the regenerative medical instrument and the tray,
The regenerative medical instrument packaging, the tray and the packaging material are sterilized,
[2] The package according to [1], wherein the regenerative medical instrument is disposed on a bottom surface or a side wall in the liquid tank,
[3] Furthermore, a fixing means for fixing the regenerative medical instrument is provided,
The package according to [2], wherein the regenerative medical instrument is fixed by the fixing means,
[4] The liquid tank includes a first liquid tank and a second liquid tank provided on the bottom surface of the first liquid tank,
The fixing means consists of a concave groove and a convex part,
The concave groove is provided on the bottom surface of the first liquid tank so as to extend from the opposite side wall of the second liquid tank,
The package according to [3], wherein the convex portion is provided on the upper wall portion of the concave groove so as to fix the regenerative medical instrument,
[5] The package according to [1], wherein the biodegradable polymer is collagen.
[6] The package according to [1], wherein the molded body is a structure composed of yarn.
[7] The package according to [6], wherein the structure is a coil body,
[8] The package according to [1], further including a container containing a liquid,
[9] The package according to [8], wherein the container containing the liquid is disposed in the liquid tank,
[10] Further, an oxygen scavenger and / or a hygroscopic agent are provided,
The package according to [1], wherein the oxygen scavenger and / or hygroscopic agent is sealed with a packaging material together with a regenerative medical instrument and a tray.
[11] The tray further includes a leg wall part that supports the liquid tank, and the bottom surface of the liquid tank is made higher than the lower end of the leg wall part, thereby being surrounded by the leg wall part and the bottom surface of the liquid tank. Formed a space,
The package according to [10], wherein an oxygen scavenger and / or a hygroscopic agent is disposed in the space.
And [12] a regenerative medical instrument comprising a dried molded body of biodegradable absorbable polymer;
A tray with a liquid reservoir for storing liquid; and
A packaging material in which the regenerative medical instrument and the tray are sealed;
The regenerative medical instrument, the tray, and the packaging material are sterilized regenerative medical instrument packaging using a regenerative medical instrument package,
(i) removing the packaging material; and
(ii) The present invention relates to a method for treating a regenerative medical instrument including a step of pouring a liquid into a liquid tank of the tray and immersing the regenerative medical instrument in the liquid.

  According to the package of the present invention, it is not necessary to prepare a separate container when the regenerative medical instrument is immersed in a solution such as physiological saline. Therefore, a series of operations in regenerative medical surgery can be performed hygienically and easily, infection by bacteria or viruses can be prevented, and the possibility that the surgeon is charged with medical responsibility is greatly reduced.

  The “packaging body” of the present invention refers to a packaging structure for transporting a regenerative medical instrument, and includes a regenerative medical instrument, a tray, and a packaging material. The regenerative medical instrument and tray are sealed with a packaging material. Here, “sealing” refers to a state in which the inside and the outside are blocked by the packaging material, and refers to a state in which various bacteria, viruses, and the like have entered the inside and so-called contamination is suppressed.

  Here, the “regenerative medical device” refers to a device that can be implanted in a living body and regenerate a damaged or missing tissue, and refers to a device that includes at least a dry molded body of a biodegradable absorbable polymer. . Examples of the “tissue” include kidney, pancreas, liver, stomach, heart, gallbladder, cerebral dura mater, diaphragm, pericardium, serosa, nerve, ligament, tendon, blood vessel, digestive organ, alveolar bone and bone. .

  The above-mentioned “dried molded product” refers to those having a moisture content of about 0 to 60%, preferably about 0 to 40%, particularly preferably about 0 to 20%. In addition, when immersed in a liquid, the physical properties such as swelling, softening, curing, wetting or weight increase can change. In other words, cells or tissues that retain moisture are not included. Such changes in physical properties can be attributed to molecular factors such as covalent bonds, hydrophobic interactions, ionic bonds and disulfide bonds, etc. of biodegradable absorbable polymers, biodegradable absorbable polymers. There is no particular limitation as long as it is caused by a physicochemical element due to compatibility with a liquid and structural elements such as a porous structure, a cotton-like structure, and a fine fiber structure. The dried molded body is selected from the group consisting of a film shape, a linear shape, and a cylindrical shape, for example, including at least one selected from the group consisting of yarn, film, woven fabric, knitted fabric, woven fabric, non-woven fabric, and sponge. And at least one shape.

  The above-mentioned “liquid” is not particularly limited as long as the regenerative medical instrument changes its physical properties such as swelling, softening, curing, wetting or weight increase by immersion of the regenerative medical instrument. However, from the viewpoint of adjusting the osmotic pressure when a regenerative medical instrument is implanted in a living body, physiological saline is generally used. Furthermore, the chemical | medical solution etc. for improving the therapeutic effect of the regenerative medical instrument of this invention can also be selected.

  The shape of the molded body can be appropriately selected by those skilled in the art depending on the organ, tissue and organ type to be regenerated. For example, in order to regenerate membranous tissue such as cerebral dura mater, diaphragm, pericardium and serosa Can select a film-like material composed of a film, a woven fabric, a knitted fabric, a woven fabric or a non-woven fabric. In addition, for example, as a molded body for regenerating tubular or linear tissue such as nerves, ligaments, tendons, blood vessels and digestive organs, linear structures composed of threads, films, woven fabrics, knitted fabrics, woven fabrics or non-woven fabrics are used. Or selecting a cylindrical thing is mentioned.

  Since the molded body is used for regenerative medicine, it is made of a biodegradable absorbable polymer. “Biodegradable absorbable polymer” refers to a polymer that can be decomposed or absorbed after implantation in a living body. Examples thereof include polylactic acid, polyglycolic acid, ε-aminocaproic acid, collagen, and glycosaminoglycans such as chitosan, alginic acid and hyaluronic acid. Among these biodegradable and absorbable polymers, collagen is preferable from the viewpoint that an inflammatory reaction after implantation does not occur and that the absorbability can be easily controlled by a crosslinking treatment or the like.

  The above-mentioned “collagen” refers to a main protein component constituting an animal connective tissue, and the main chain structure of the molecule is (Gly-XY), (Gly-Pro-X) and (Gly-Pro-Hyp). It is composed of Here, X and Y are natural and non-natural amino acids other than glycine, proline and hydroxyproline.

  Examples of collagen types include type I, type II, and type III. Among these, from the viewpoint of easy handling, type I and type III are preferable, but are not limited thereto. The collagen of the present invention may be gelatin which is heat-denatured collagen, but collagen is preferred from the viewpoint of cell adhesion.

  Collagen is produced by extraction from living tissue, chemical polypeptide synthesis, recombinant DNA method, and the like. At the present time, those obtained by extraction from living tissue are preferred from the viewpoint of manufacturing cost. Examples of the origin of biological tissues include cattle, pigs, rabbits, sheep, mice, birds, fish and humans. Examples of the living tissue include skin, tendon, bone, cartilage, and organ. These selections can be appropriately made by those skilled in the art, and the present invention is not limited to these.

  Furthermore, from the viewpoint of facilitating industrial production, it is preferable to select collagen that has been treated so that it can be dissolved in a solvent. Examples thereof include solubilized collagen such as enzyme-solubilized collagen, acid-solubilized collagen, alkali-solubilized collagen, and neutral-solubilized collagen. Among these, acid-solubilized collagen is preferable from the viewpoint of easy handling. Furthermore, it is preferable that it is atelocollagen from which the removal process of the telopeptide which is an antigenic determinant is performed from a viewpoint of the safety | security at the time of in-vivo implantation.

  As an example of the regenerative medical instrument including the dried molded body described above, the nerves disclosed in Japanese Patent Application Laid-Open No. 2002-320630 (Patent Document 1) and Japanese Patent Application Laid-Open No. 2004-073221 (Patent Document 2) are used. A device for regenerating, a device for regenerating serosa or pericardium disclosed in Japanese Patent Application Laid-Open No. 2003-235955 (Patent Document 3) and Japanese Patent Application Laid-Open No. 2003-245341 (Patent Document 4), Japanese Patent Application Laid-Open No. 2004-188037 ( Examples include a device for regenerating a blood vessel disclosed in Patent Document 5) and a device for regenerating a tendon or a ligament disclosed in International Publication No. 2005/070340 (Patent Document 6).

  On the other hand, the “tray” refers to a container that can be a container for performing an operation of immersing a regenerative medical instrument in a liquid. Examples of the shape of the tray include a rectangular parallelepiped shape, a cylindrical shape, a triangular prism shape, and a hemispherical shape. Among these shapes, a rectangular parallelepiped shape is preferable from the viewpoint of being able to be stacked during transportation, but the present invention is not limited to this. The size depends on the size of the regenerative medical device and cannot be described generally. For example, when the shape of the tray is a rectangular parallelepiped, the size is about 100 to 100,000,000 mm3, preferably about 1000. What is necessary is just about 1,000,000 mm3.

  The tray of the present invention includes a liquid tank into which liquid can be injected. “Liquid tank” means a general container for injecting a liquid. Examples of the shape include a rectangular parallelepiped shape, a cylindrical shape, a triangular prism shape, and a hemispherical shape. Among these shapes, a rectangular parallelepiped shape is preferable from the viewpoint that the restraining means described later can be easily provided, but the present invention is not limited to this. Since the volume of the liquid tank depends on the amount of liquid absorbed by the regenerative medical instrument, it cannot be generally described, but is, for example, about 0.1 to 100,000 ml, preferably about 1 to 1,000 ml.

  The material of the tray is generally only required to be easily molded, for example, polymer materials such as polypropylene, polyethylene terephthalate, polyamide, polycarbonate, polystyrene, polyacrylamide, polymethyl methacrylate, polyester and epoxy resin, Examples include inorganic materials such as glass and ceramics, and metal materials such as iron, copper, and stainless steel. Among these materials, polypropylene and polyethylene terephthalate are preferable from the viewpoint of light weight, easy molding, and low manufacturing cost, but are not particularly limited.

  Moreover, what is necessary is just to select a general manufacturing method also as the manufacturing method of a tray, For example, when the raw material of a tray is a polymer material, extrusion molding, melt molding, injection molding, vacuum molding, compression molding, etc. are mentioned. Among these production methods, extrusion molding, injection molding and vacuum molding are preferred from the viewpoint of easy production and low cost, but the present invention is not limited to these.

  Furthermore, the “wrapping material” refers to a flexible sheet capable of packaging the regenerative medical instrument and the tray. The packaging material is not particularly limited as long as it is a flexible sheet, but is preferably a non-breathable material from the viewpoint that the regenerative medical instrument to be sealed can be stored well.

Here, the “non-breathable material” refers to a material that is difficult for gas, particularly oxygen and water vapor to pass therethrough. The oxygen permeability is, for example, an oxygen permeability coefficient of about 5.0 × 10 ² cc / m ² · atm · hour or less, preferably 1.0 × 10 ³ cc / ^{2 at} a temperature of about 25 ° C. and a humidity of about 50%.・ Atm ・ hour. The water vapor permeability is about 1,000 g / m ² · atm · 24 hr or less, preferably about 100 g / m ² · atm · 24 hr or less, more preferably about 10 g / m ² · atm · 24 hr or less. is there.

  Non-breathable materials satisfying the above conditions include, for example, stretched nylon, polyester, polyvinylidene chloride, polyvinylidene chloride-coated stretched nylon, polyvinylidene chloride-coated polyester, polyvinyl chloride-coated polypropylene, polyvinyl alcohol, poly (ethylene -Vinyl alcohol) copolymer, aluminum vapor deposition polyethylene, aluminum vapor deposition polyester, silica coat polyester, etc. are mentioned. Among these non-breathable materials, the outer layer is made of polyethylene, the intermediate layer is made of aluminum, and the inner layer is made of polyethylene from the viewpoint of easy molding processability, resistance to radiation sterilization, and shielding of external light. A laminate sheet is most preferable, but the present invention is not limited to this.

  The package of the present invention is sterilized while the regenerative medical instrument and tray are sealed with a packaging material. Sterilization is performed by a sterilization method that is achieved in a dry state because the regenerative medical material includes a dried molded body. Specific examples include α-rays, β-rays, γ-rays, X-rays, and electron beam sterilization. Among these sterilization methods, γ-ray sterilization is preferred from the viewpoint of providing a sufficiently clean medical instrument, but the present invention is not limited to this.

  As a preferable aspect in the package of this invention, the aspect which has arrange | positioned the regenerative medical instrument in the bottom face or side wall in the liquid tank of a tray is mentioned. By this, the operator can immerse the regenerative medical instrument in the liquid as it is by simply injecting the liquid into the liquid tank after removing the packaging material in the package of the present invention conveyed to the hand. .

  At this time, if the regenerative medical instrument is provided with a fixing means for fixing the regenerative medical instrument to the liquid tank, and the regenerative medical instrument is fixed by the fixing means, the regenerative medical instrument will not collide with the inner wall of the liquid tank or the like during the transportation and be damaged. Therefore, it is preferable. The “fixing means” refers to a means for restricting the movement of the regenerative medical instrument by holding, restraining, restraining, fitting and locking the dry regenerative medical instrument on the tray. In particular, it is preferable that the tray is restrained to the extent that there is no play from the viewpoint of making it difficult to release the fixation during conveyance.

  The structure of the fixing means may be any structure that fixes the regenerative medical instrument. For example, the fixing means includes a fitting structure as shown in FIG. 1 and a groove and a convex as shown in FIG. Examples include combinations. Among these, the combination of the concave groove and the convex portion as shown in FIG. 2 is preferable from the viewpoint of easy manufacture of the tray and suppression of breakage of the regenerative medical instrument during fixation.

  Here, if the regenerative medical instrument has a characteristic of being softened or deformed by immersion of the liquid, the fixation by the fixing means can be released. That is, the regenerative medical instrument is tightly fixed to the tray at the time of transportation, but can be easily detached from the tray at the time of surgery by being softened or deformed by immersion of the liquid.

  Examples of the regenerative medical instrument that softens or deforms by immersion of the liquid include regenerative medical instruments that include the above-described collagen molded bodies. In particular, if the molded body is a structure composed of biodegradable absorbable polymer yarns, it is easily softened by immersion in the liquid.

  The “yarn” includes single yarn and kite yarn. Examples of the single yarn include those produced by a wet spinning method, a dry spinning method, a melt spinning method, and the like. Among these production methods, a preferred method is a wet spinning method from the viewpoint of easy production and low production cost when the raw material is collagen.

  Specific examples of the wet spinning method include a method in which an aqueous solution of a biodegradable polymer is discharged into a coagulation bath using a gear pump, a dispenser, various extrusion devices, and the like. The dispenser is preferably a dispenser from the viewpoint of stably dispensing a solution with a small amount of pulsation. Moreover, the diameter of the nozzle to discharge is about 10-200 micrometers from a viewpoint of the intensity | strength of a single yarn, Preferably it is about 50-150 micrometers. Further, the concentration of the aqueous solution is about 0.1 to 20% by weight, preferably about 1 to 10% by weight, from the viewpoint of the strength of the single yarn.

  The solvent for the coagulation bath used in wet spinning may be any solvent, suspension, emulsion, or solution that can coagulate the biodegradable absorbent polymer. For example, when collagen is used as the raw material of the filamentous material, examples of the solvent for the coagulation bath include inorganic salt aqueous solutions, inorganic salt-containing organic solvents, alcohols, and ketones. Examples of the inorganic salt aqueous solution include aqueous solutions such as sodium sulfate, sodium chloride, ammonium sulfate, calcium chloride, and magnesium chloride, and particularly aqueous solutions such as sodium chloride, sodium sulfate, and ammonium sulfate. A solvent in which these inorganic salts are dissolved or dispersed in alcohols or acetones may be used. Examples of alcohols include methanol, ethanol, isopropanol, amyl alcohol, pentanol, hexanol, and ethylene glycol. Examples of ketones include acetone and methyl ethyl ketone. Among these, it is preferable to use ethanol, an ethanol solution of sodium chloride, and an ethanol dispersion solution of sodium chloride from the viewpoint of the strength of the single yarn.

  The yarn of the biodegradable material discharged to the coagulation bath is pulled up from the coagulation bath and then manufactured as a single yarn through a drying process. In the drying step, collagen is not thermally denatured, the droplets in the coagulation bath attached to the periphery of the single yarn are removed, and the single yarn is dried under the conditions that do not break. It is preferable that it remains. As specific conditions in the drying step, for example, when the aqueous collagen solution is spun into an ethanol coagulation bath, the spinning speed is about 1 to 100 m / min, the humidity is about 50% or less, and the temperature is 43 ° C. or less. For example, air drying by air.

  Furthermore, a kite yarn may be manufactured by preparing a plurality of the single yarns manufactured as described above and winding the plurality of single yarns. The type of single yarn constituting the kite yarn may be the same or plural. For example, a cocoon yarn composed of a collagen single yarn and a polylactic acid single yarn has both characteristics of cell adhesion by collagen and resistance to decomposition and absorption by polylactic acid. The above-described kite yarn can be produced by a commercially available kite machine or the like.

  The yarn described above swells and softens when immersed in a liquid. Moreover, it may be deformed depending on the type of biodegradable absorbable polymer. The deformation of the yarn depends on the type of biodegradable absorbable polymer material constituting the yarn and the method for producing the yarn, and therefore cannot be described in general. For example, wet spinning using an ethanol coagulation bath was performed. Thereafter, when the collagen single yarn that has been thermally dehydrated and cross-linked for about 12 to 60 hours is swollen in physiological saline at about 30 to 40 degrees, the length of the single yarn is about 99 to 70% and the thickness is about 101 -400%.

  Furthermore, if the molded body is a coil body made of the above-described biodegradable absorbable polymer yarn, it is possible to provide one that deforms more significantly when immersed in a liquid. Here, the “coil body” is a structure having a lumen and having a biodegradable and absorbable polymer yarn as a constituent unit, and the yarn is arranged at least 45 degrees, preferably 60 degrees or more with respect to the longitudinal direction. Say. Preferably, it refers to a structure that prevents the cells of the tissue from growing into the surrounding tissue and that the cells of the tissue can induce regeneration in the longitudinal direction. Examples of the shape of the coil body include a cylindrical shape (tube shape) and a rectangular tube shape (triangle, square, pentagon, and hexagon). Among these shapes, a cylindrical shape (tube shape) is preferable from the viewpoint of easy production, but the present invention is not limited thereto.

  The length of the coil body in the longitudinal direction is not particularly limited because it depends on the biological classification of the patient or animal, the body type, and the type of tissue, but the length of the excised tissue that can be assumed by those skilled in the art It is preferable that the length is sufficiently longer than that. The length of excised tissue that can be envisioned by those skilled in the art is, for example, about 1 to 300 mm when the tissue is a human median nerve. When the tissue is a human sciatic nerve, it is about 1 to 500 mm.

  Therefore, for example, when the tissue is a human nerve, the length of the coil body in the longitudinal direction may be about 5 mm or more from the viewpoint of being applicable to regeneration of any human nerve, but preferably about 10 to 100 mm. It is. For example, when the tissue is a human tendon, the length of the coil body in the longitudinal direction may be about 5 mm or more, but is preferably about 10 to 200 mm. Furthermore, for example, when the tissue is a human ligament, the length of the coil body in the longitudinal direction may be about 5 mm or more, but is preferably about 10 to 100 mm.

  On the other hand, the inner diameter of the coil body can be appropriately set by those skilled in the art depending on the tissue to be regenerated, and is not particularly limited. For example, when the tissue is a nerve, it is about 1 to 20 mm, preferably about 1 to 10 mm from the viewpoint that the handling frequency may be the highest. For example, when the tissue is a human tendon, the thickness is about 1 to 30 mm, preferably about 1 to 20 mm. Furthermore, for example, when the tissue is a human ligament, it is about 1 to 20 mm, preferably about 1 to 10 mm.

  The coil body can be manufactured by laminating a plurality of layers by winding the yarn around the rod-shaped body several times. At this time, it is preferable that the winding density of at least one layer of yarn is different from the winding density of single yarns of other layers, whereby the strength is further improved. The winding density in the present invention refers to the number of windings per unit length in the longitudinal direction of the coil body. For example, the winding density of the single yarn of at least one layer is preferably less than 10 turns / cm, and the winding density of the single yarn of the other layers is preferably about 10 to 30 turns / cm. For details, refer to Japanese Unexamined Patent Application Publication No. 2004-072221.

  Moreover, it is preferable to perform the process of forming a coil body continuously after drying the single yarn described above, because the number of manufacturing steps is reduced and the cost is suppressed. At this time, from the viewpoint of improving the strength of the coil body, it is preferable to darely dry the single yarn. This insufficient drying leaves some solvent in the single yarn. This remaining solvent has an effect of adhering adjacent single yarns in the coil body. Thereafter, by drying the coil body, a coil body with further improved strength can be formed.

  Moreover, since a strength improves by apply | coating and drying a biodegradable material solution to the side wall of the obtained coil body, it is preferable. The biodegradable material used for this treatment is preferably the same material as the coil body material from the viewpoint of affinity with the coil body material. The concentration thereof is, for example, about 0.1 to 20% by weight, preferably about 1 to 10% by weight from the viewpoint of easy handling of the solution when the biodegradable polymer is collagen.

  The coil body is preferably further subjected to a crosslinking treatment after drying. By this crosslinking treatment, it is possible to control the degradation time of the tissue regenerative medical instrument in the living body. Examples of the crosslinking method include chemical crosslinking using a crosslinking agent, and physicochemical crosslinking using γ-ray irradiation, ultraviolet irradiation, electron beam irradiation, plasma irradiation, thermal dehydration crosslinking, and the like. Among these crosslinking methods, thermal dehydration crosslinking is preferable from the viewpoint of safety after in vivo implantation. As conditions for thermal dehydration crosslinking, for example, the crosslinking temperature is about 100 to 140 degrees, preferably about 110 to 130 degrees, and the crosslinking time is about 6 to 72 hours, preferably about 12 to 48 hours.

  Selection of the manufacturing method and manufacturing conditions in the above coil body manufacturing method can be appropriately set by those skilled in the art and are not particularly limited.

  When the coil body described above is immersed in a liquid, it becomes elongated in the longitudinal direction as shown in FIG. This is because when the yarn arranged at an angle of at least 45 degrees with respect to the longitudinal direction swells with a solution such as physiological saline, the width becomes thick and the length becomes short. The deformation of the coil body depends on the size of the coil body, the winding density and arrangement of the yarn in addition to the types of yarns described above, and is more difficult to describe in general. For example, the outer diameter is about 1 A coil body having a length of about 5 mm and a length of about 10 to 100 mm, wherein the collagen single yarn is wound at a winding density of about 10 to 100 times / cm and about 60 to 90 degrees with respect to the length of the coil body. When the coil bodies arranged in the above range are immersed in physiological saline at about 30 to 40 degrees, the thickness is about 70 to 99% and the length in the longitudinal direction is about 101 to 150%.

  The obtained coil body is handled as a part of the regenerative medical instrument of the present invention. Here, although only the coil body may be handled as a regenerative medical instrument as it is, a guiding means for promoting regeneration of a tissue or an organ, cells, medicines, and the like may be combined with the lumen of the coil body.

  For example, when the regenerative medical instrument of the present invention is used for nerve regeneration, it is possible to provide guidance means for growing nerve cells in the lumen of the coil body. Here, the “inducing means” refers to a portion that becomes a scaffold for allowing cells of damaged tissue or organ to grow in the longitudinal direction of the coil body. As for the form, what deform | transformed or shredded film | membrane-like materials, such as sponge, a fiber bundle, a woven fabric, a nonwoven fabric, and a sheet | seat, is mentioned, for example.

  The “sponge” refers to a porous body in which pores of uniform or non-uniform size are dispersed continuously or discontinuously. The porosity of the sponge is about 10 to 99%, preferably about 50 to 99.9%, from the viewpoint of maintaining a scaffold in which cells can grow and a space.

  Examples of the method for producing the sponge include a method in which a solution of a biodegradable material is poured into a mold produced in accordance with a target shape and formed by a method such as natural drying, vacuum drying, freeze thawing, and vacuum freeze drying. It is done. Among these drying methods, the vacuum freeze-drying method is preferable from the viewpoint of uniformly forming pores. As a condition of the vacuum freeze-drying method, for example, from the viewpoint of ease of production, a solution of about 0.05 to 30% by weight of a biodegradable material is about 0.08 Torr.

  On the other hand, the above-mentioned “fiber bundle” refers to one composed of at least two filaments, and each filament is about 85 degrees or less, preferably about 45 degrees with respect to the longitudinal direction of the cylindrical body. Hereinafter, it is particularly preferably one arranged at an angle of about 30 degrees or less. Each filamentous material may be parallel or non-parallel.

  The filamentous material constituting the fiber bundle may be substantially the same as the yarn constituting the coil body of the present invention, and examples thereof include single yarn and kite yarn. Among these, single yarn is preferable from the viewpoint of production cost. A single yarn may be manufactured by the same manufacturing method as described above.

  In addition, the filaments of the fiber bundle are made of filaments having an outer diameter of about 1 to 10,000 μm at a filling rate of about 1 to 99%, preferably about 10 to 30%, from the viewpoint of maintaining a scaffold in which cells can grow and a space. What is necessary is just to fill the lumen | bore of a coil body. Here, the “filling rate” refers to the ratio of the occupied volume of the fiber bundle to the volume of the coil body lumen.

  As a method of forming a fiber bundle, for example, after manufacturing a filamentous material, at least two opposite sides are parallelly wound on a rectangular plate or frame a plurality of times so that the filamentous material is substantially perpendicular to the two sides. There is a method obtained by cutting the obtained filamentous material in the vicinity of two sides. The winding speed of the plate and the frame may be the same as the conditions for manufacturing the cylindrical body from the yarn described above.

  The shape, material, manufacturing conditions, etc. in the above guiding means can be appropriately selected by those skilled in the art, and the present invention is not limited to these.

  Moreover, it is preferable that it is a kit further provided with the container which accommodated the liquid as another aspect of the package of this invention. This is convenient because it is not necessary to separately prepare a liquid for immersing the regenerative medical instrument. The container containing the liquid may be sealed together with the regenerative medical base material and the tray by a packaging material, or may be provided separately. The container is not particularly limited as long as the contained liquid does not leak, but when the container is sealed together with the regenerative medical base material and the tray by the packaging material, the regenerative medical instrument is kept in a dry state. Therefore, it is necessary to be a non-breathable material with low water vapor permeability. As the non-breathable material, the same material as the above-described packaging material is preferably selected.

  Furthermore, it is preferable that the package of the present invention further includes an oxygen scavenger and / or a hygroscopic agent, and is sealed together with the regenerative medical base material and the tray by the packaging material. With the oxygen scavenger, generation of active oxygen during γ-ray sterilization can be suppressed, and a decrease in physical strength of the regenerative medical instrument can be suppressed. That is, it is possible to maintain a strength that can withstand suturing during surgery. In addition, the hygroscopic agent keeps the regenerative medical instrument in a dry state and can be stored well.

  Here, the “deoxygenating agent” refers to an agent that can adsorb or absorb oxygen present in the atmosphere. For example, oxides such as iron, zinc, copper and tin, saccharides, polysaccharides, vitamin C, L-ascorbic acid, erythorbic acid, activated carbon, chitin activated carbon, chitosan activated carbon, cellulose activated carbon, zeolite, carbon molecular sieve, Examples include silica gel and activated alumina. Examples of commercially available products include Sanso-Cut (trade name, manufactured by Nittetsu Fine Products), Ageless (trade name, manufactured by Mitsubishi Gas Chemical Company), Tamotsu (trade name, manufactured by Oji Duck), Well Pack ( Trade name, manufactured by Taisei Corporation), and A500-HS oxygen absorbent (trade name, manufactured by I.S. O.).

  The “humectant” means an agent that can adsorb or absorb water vapor present in the atmosphere. For example, silica gel, crystalline zeolite, calcium chloride and the like can be mentioned. Examples of commercially available products include molecular sieve (trade name, manufactured by Cosmo Bio), ID sheet (trade name, manufactured by ID Corporation), and dry keep (trade name, manufactured by Sasaki Chemical Co., Ltd.).

  In the aspect including the oxygen scavenger and / or the hygroscopic agent described above, the tray of the present invention preferably includes a space where the oxygen scavenger and / or the hygroscopic agent can be arranged on the tray as shown in FIG. For example, the tray wall further includes a leg wall part that supports the liquid tank, and the bottom surface of the liquid tank is made higher than the lower end of the leg wall part, so that the space surrounded by the leg wall part and the bottom surface of the liquid tank. Can be formed. If an oxygen absorber and / or a hygroscopic agent are arranged in this space, the oxygen absorber and / or the hygroscopic agent will not get wet with the liquid injected into the liquid tank. Furthermore, since the oxygen scavenger and / or the hygroscopic agent is not mixed in the living body, it is safe. The height of the space is about 3 mm to 20 mm, preferably 5 to 10 mm, considering the size of commercially available oxygen scavengers and hygroscopic agents, but the present invention is not limited to this.

  Moreover, you may further provide the container which accommodated the cell and / or the structure | tissue as another aspect of the package of this invention. A container for storing cells and / or tissues may be sealed together with a regenerative medical substrate and a tray by a packaging material, or may be provided separately. The container is not particularly limited as long as the contained liquid does not leak, but when the container is sealed together with the regenerative medical base material and the tray by the packaging material, the regenerative medical instrument is kept in a dry state. Therefore, it is necessary to be a non-breathable material with low water vapor permeability. As the non-breathable material, the same material as the above-described packaging material is preferably selected.

  Furthermore, the present invention extends to a method for treating a regenerative medical instrument. The treatment method of the present invention refers to a method including a step of pouring a liquid into the tray of the regenerative medical instrument package described above and immersing the regenerative medical instrument in the liquid. Here, the “liquid” is not particularly limited as long as it changes the physical properties of the regenerative medical device such as swelling, softening, curing, wetting or weight increase as described above. In general, physiological saline is mainly mentioned from the viewpoint of adjusting the osmotic pressure when a regenerative medical instrument is implanted in a living body. Furthermore, the chemical | medical solution for improving the therapeutic effect of the regenerative medical instrument of this invention can also be selected.

  The doctor immerses the regenerative medical instrument by injecting a liquid into the liquid tank. The physical characteristics of regenerative medical devices change depending on the liquid. For example, when the coil body made of the collagen yarn described above is immersed in physiological saline, the coil body extends in the longitudinal direction as shown in FIG. This is because the yarns in the coil body are arranged at an angle of at least 45 degrees, preferably 60 degrees or more with respect to the longitudinal axis direction. This is because it is short in the circumferential direction and thick in the longitudinal direction.

  Furthermore, when the regenerative medical instrument is fixed by the fixing means, the fixing is released by softening or deformation. Thereby, the regenerative medical instrument can be easily taken out from the fixing means and can be used as it is for the operation.

  Examples of the present invention will be described below with reference to the drawings. However, the present invention is not limited to the following examples.

Example 1
FIG. 1 is an embodiment of the present invention. The tray includes a rectangular parallelepiped liquid tank 21 and claw-shaped fixing means 22 for fixing the regenerative medical instrument 1 to the bottom surface of the liquid tank. With this fixing means 22, the regenerative medical instrument 1 can be fixed by being held. Although the packaging material is omitted to make the drawing easy to see, the regenerative medical instrument 1 and the tray 2 are sealed with the packaging material.

Example 2
FIG. 2 shows another embodiment of the present invention different from FIG. The tray 2 includes a liquid tank 21, fixing means 22 for fixing the regenerative medical instrument 1, and leg wall portions 23. The liquid tank 21 includes a first liquid tank 211 and a second liquid tank 212 having a bottom surface deeper than the bottom surface of the first liquid tank 211. The fixing means 22 is configured by a combination of a concave groove 221 and a convex portion 222. The concave groove 221 is provided on the bottom surface of the first liquid tank 211 so as to extend outward from the opposing wall surface in the second liquid tank 212. Further, the convex portion 222 is provided on the upper wall portion of the concave groove 221. The regenerative medical instrument 1 can be fixed by being locked by the concave groove 221 and the convex portion 222. Although the packaging material is omitted to make the drawing easy to see, the regenerative medical instrument 1 and the tray 2 are sealed with the packaging material.

  FIG. 3 is a cross-sectional view of a plane that passes through the broken line X in FIG. 2 and is parallel to the normal direction. The bottom surface of the second liquid tank 212 is located higher than the lower end of the leg wall portion 23, and 24 spaces are formed by the inner wall of the leg wall portion 23 and the bottom surface of the second liquid tank 212. In this space 24, the oxygen scavenger 4 and the hygroscopic agent 5 are arranged. Although the packaging material is omitted to make the drawing easy to see, the regenerative medical instrument 1, the tray 2, the oxygen scavenger 4 and the hygroscopic agent 5 are sealed with the packaging material.

  According to the package of the present invention, it is not necessary to prepare a separate container when the regenerative medical instrument is immersed in a solution such as physiological saline. Therefore, a series of operations in regenerative medical surgery can be performed hygienically and easily, infection by bacteria and viruses can be prevented, and the possibility that the surgeon is charged with medical responsibility is greatly reduced. Many doctors can safely perform regenerative medical treatment.

FIG. 1 is a view showing an embodiment of the package of the present invention. FIG. 2 is a view showing another embodiment different from FIG. 1 of the package of the present invention. FIG. 3 is a cross-sectional view in the normal direction passing through the broken line X in FIG. FIG. 4 is an image diagram showing the swelling behavior of the single strand and coil body of the biodegradable and absorbable polymer of the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Regenerative medical instrument 111 Coil body 112 Swelled coil body 121 Yarn 122 Swollen thread 2 Tray 21 Liquid tank 211 First liquid tank 212 Second liquid tank 22 Fixing means 221 Concave groove 222 Convex part 23 Leg wall part 24 Space 4 Oxygen absorber 5 Hygroscopic agent

Claims (11)

A package for transporting a regenerative medical instrument,
A regenerative medical device comprising a dry molded body of biodegradable absorbable polymer;
A liquid tank for storing liquid, and a tray provided with fixing means which is a structure sandwiched between the liquid tanks or a combination of concave grooves and convex parts ; and
Including a packaging material for sealing the regenerative medical instrument and the tray,
The regenerative medical instrument, tray and packaging material are sterilized,
The regenerative medical instrument is fixed by the fixing means;
A package for a regenerative medical instrument, wherein the regenerative medical instrument is softened by immersion in a liquid and can be removed from the fixing means .   The package according to claim 1, wherein the regenerative medical instrument is disposed on a bottom surface or a side wall in the liquid tank. The liquid tank includes a first liquid tank and a second liquid tank provided on the bottom surface of the first liquid tank,
The fixing means consists of a concave groove and a convex part,
The concave groove is provided on the bottom surface of the first liquid tank so as to extend from the opposite side wall of the second liquid tank,
The package according to claim 2 , wherein the convex portion is provided on the upper wall portion of the concave groove so as to fix the regenerative medical instrument.   The package according to claim 1, wherein the biodegradable absorbable polymer is collagen.   The package according to claim 1, wherein the molded body is a structure composed of yarn. The package according to claim 5 , wherein the structure is a coil body.   Furthermore, the package body of Claim 1 provided with the container which accommodated the liquid. The package according to claim 7 , wherein the container containing the liquid is disposed in the liquid tank. Furthermore, an oxygen scavenger and / or a hygroscopic agent are provided,
The package according to claim 1, wherein the oxygen scavenger and / or hygroscopic agent is sealed with a packaging material together with a regenerative medical instrument and a tray. The tray further comprises a leg wall that supports the liquid tank,
By making the bottom surface of the liquid tank higher than the lower end of the leg wall part, a space surrounded by the leg wall part and the bottom surface of the liquid tank is formed,
The package according to claim 9 , wherein an oxygen scavenger and / or a hygroscopic agent is disposed in the space. A regenerative medical device comprising a dry molded body of biodegradable absorbable polymer;
A liquid tank for storing liquid, and a tray provided with fixing means which is a structure sandwiched between the liquid tanks or a combination of concave grooves and convex parts ; and
A packaging material in which the regenerative medical instrument and the tray are sealed;
The regenerative medical instrument, the tray, and the packaging material are sterilized regenerative medical instrument packaging using a regenerative medical instrument package,
(i) removing the packaging material; and
(ii) For regenerative medicine, including a step of pouring a liquid into the liquid tank of the tray and removing the regenerative medical instrument fixed by the fixing means from the fixing means by softening by immersion in the liquid. Instrument processing method.

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