JP2012120625A - Storage container for bone prosthetic material - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a storage container for a bone prosthetic material, cutting out the bone prosthetic material to optional size with easy operation without impairing sterilization properties.SOLUTION: The storage container for the bone prosthetic material 2 includes: a mechanism (a delivery mechanism part 3) delivering the columnar bone prosthetic material 2; and a mechanism (a first cutting mechanism part 4) fixed to the delivery mechanism part 3, and cutting the delivered bone prosthetic material 2. The first cutting mechanism part 4 cuts the bone prosthetic material 2 delivered in any length by the delivery mechanism part 3, so that a block of the bone prosthetic material 2 of a desired length can be easily obtained. Preferably, an opening part of the delivery mechanism part 3 for passage of the delivered bone prosthetic material 2 is provided with a lid 5.

Description

  The present invention relates to a container for storing a bone prosthetic material, and more particularly to a container for storing a bone prosthetic material capable of cutting the bone prosthetic material into an arbitrary size by a simple operation.

  As the bone prosthetic material, a block-shaped material is often used. However, when the size of the bone prosthetic material is too large compared to the bone defect portion, processing such as cutting must be performed. In that case, the bone filling material taken out from the sterilization bag or container must be taken out and processed once without filling the affected area as it is. Incurs a decline. Further, the remaining bone prosthetic material is discarded without being used, and there is a risk that waste is increased.

  Japanese Patent Laid-Open No. 2009-133641 (Patent Document 1) discloses an inner wall slightly larger than a sample as a container for storing a sample such as a HAp / col composite porous body that can safely transport a sample and easily take out the sample. A sample container having a sample mounting portion and a groove provided on a side surface portion of the inner wall of the sample mounting portion facing each other and into which tweezers for taking out the sample can be inserted is disclosed. However, the sample container described in Patent Document 1 does not solve the above-described problems relating to ease of processing and workability.

JP 2009-133641

  Accordingly, an object of the present invention is to provide a storage container for a bone grafting material that can cut out the bone grafting material into an arbitrary size by a simple operation without impairing sterility.

  As a result of diligent research in view of the above object, the present inventors have made it possible to perform a simple operation without impairing sterility by using a storage container having a mechanism for feeding out a bone grafting material and a mechanism for cutting the bone grafting material that has been fed out. The present inventors have found that a bone prosthetic material can be cut into an arbitrary size, and have arrived at the present invention.

  That is, the storage container for bone prosthetic material of the present invention is characterized by having a mechanism for feeding out the bone prosthetic material and a mechanism for cutting the delivered bone prosthetic material.

  The feeding mechanism includes a cylindrical case for storing the bone prosthetic material, an axial rack fixed to an inner peripheral surface of the cylindrical case, and one end of the bone prosthetic material. And a guide sleeve that guides the slider, a knob cylinder that is rotatably fitted to the front outer peripheral surface of the cylindrical case, and the cylindrical It is preferable to provide a tail plug attached to the rear end of the case.

  After the cutting mechanism includes a thread-like or sheet-like blade for cutting the bone prosthetic material, a support slider for supporting both ends of the blade and moving the blade, and after cutting the bone prosthetic material Urging means provided on the support slider to return the blade to its original position, and the blade connected to the support slider and supported by the support slider together with the support slider to move the bone replacement It is preferable to provide a lever for cutting the material.

  The thread-like or sheet-like blade is preferably not exposed.

  The cutting mechanism includes a cutting knob tube rotatably fitted on the front outer peripheral surface of the storage container, and one end attached to the inner peripheral surface of the cutting knob cylinder, and provided on the cutting knob cylinder. A thread or a wire that is inserted into the inside of the knob tube from the open hole and wound around the bone prosthetic material, and the other end is attached to a portion of the inner peripheral surface of the knob cylinder adjacent to the hole. It is preferable that the cutting mechanism is configured such that the thread or wire is pulled and the bone prosthetic material is tightened by rotating the cutting knob.

  The cutting mechanism includes a thread or a wire attached to the front end of the storage container, and is a mechanism for cutting the bone prosthetic material by winding and pulling the thread or wire around the bone prosthetic material. Is preferred.

  Preferably, the tail plug mounted on the rear end of the cylindrical case is provided with a hole for allowing the liquid agent to penetrate into the bone filling material.

  The bone grafting material is preferably an apatite / collagen composite.

  By using the storage container of the present invention, the bone prosthetic material can be processed into a desired size without losing sterility by a simple operation. Also, bone replacement surgery can be performed quickly.

  Since the sterilized material itself can be aseptically processed and supplemented for as much bone substitute as is desired, it is more hygienic.

  Using a syringe or the like, blood or a drug can be soaked into the material simply and aseptically.

  Since the container is made of plastic or metal, the container and the bone grafting material can be sterilized and re-sterilized together.

It is the schematic diagram seen from the axial direction which shows an example of the storage container of the bone grafting material of this invention. It is the schematic diagram seen from the direction orthogonal to the axial direction which shows an example of the storage container of the bone grafting material of this invention. It is AA sectional drawing of FIG. It is BB sectional drawing of FIG. It is a disassembled perspective view which shows an example of the storage container of the bone grafting material of this invention. It is a disassembled perspective view which shows an example of the cutting mechanism of the storage container of the bone grafting material of this invention. It is a schematic diagram for demonstrating the operation procedure of the storage container of the bone grafting material of this invention. It is a schematic diagram for demonstrating the movement of the lever of the 1st cutting mechanism of the storage container of the bone grafting material of this invention. It is sectional drawing which shows another example of the storage container of the bone grafting material of this invention. FIG. 10 is a cross-sectional view taken along the line C-C in FIG. 9. It is a schematic diagram which shows the attachment part of the thread | yarn or wire in the 2nd cutting mechanism of the storage container of the bone grafting material of this invention. It is sectional drawing which shows another example of the storage container of the bone grafting material of this invention.

[1] Bone filling container
(1) First Embodiment FIG. 1, FIG. 2, FIG. 3 and FIG. 4 show a preferred first embodiment of the bone filling material storage container 1 of the present invention. As shown in FIG. 4, the storage container 1 for the bone prosthetic material includes a mechanism (feeding mechanism part 3) for feeding a columnar bone filling material 2 and a bone feeding material 2 that is fixed to the feeding mechanism part 3 and is fed out. And a mechanism (first cutting mechanism unit 4). By cutting the bone grafting material 2 fed to an arbitrary length by the feeding mechanism unit 3 by the first cutting mechanism unit 4, a block of the bone grafting material 2 having a desired length can be easily obtained. Can do. It is preferable to provide a lid 5 in the opening 41a of the feeding mechanism portion 3 through which the delivered bone prosthetic material 2 passes.

(a) Feeding mechanism part As shown in FIGS. 4 and 5, the feeding mechanism part 3 includes a cylindrical case 31 for housing the bone grafting material 2, and an inner peripheral surface of the cylindrical case 31. The racks 32a and 32b in the axial direction fixed to the slider, the slider 33 which is attached to one end of the bone grafting material 2 and meshes with the racks 32a and 32b and is movable in the axial direction in the case 31; A guide sleeve 34 for guiding, a knob cylinder 35 rotatably fitted on an outer peripheral surface of the front portion (the end portion on the side where the bone prosthetic material is fed) of the cylindrical case 31, and the cylindrical case 31 A tail plug 36 attached to the rear end, and a main body case 30 fixed to the knob cylinder 35 and housing the cylindrical case 31, the racks 32a and 32b, the slider 33, and the guide sleeve 34 are provided. The body case 30 is provided with an opening 30a through which the delivered bone prosthetic material 2 passes. The main body case 30 is not necessarily an essential structure and may be omitted. In that case, the tail plug 36 is also preferably omitted in a compact shape (the fringe portion is omitted).

  The racks 32a and 32b are cylindrical bodies provided with a spiral recess 321 on the inner peripheral surface, while a spiral protrusion 331 is provided on the outer peripheral surface of the slider 33, The racks 32a and 32b and the slider 33 are assembled with each other so that the spiral recess 321 and the spiral protrusion 331 can be engaged with each other, thereby engaging the guide groove 341 of the guide sleeve 34. The combined slider 33 can move in the axial direction in the case 31 by the relative rotation of the racks 32a and 32b and the guide sleeve 34, and is provided in the main body case 30. The bone filling material 2 can be made to appear and disappear through the opening 30a.

  The tail plug 36 is engaged with a notch 31b formed at the rear end of the cylindrical case 31 by a projection 36a provided on the tail plug 36. The cylindrical case 31 and the racks 32a and 32b are assembled so that they can rotate synchronously with each other by the rotation of the tail plug 36. The guide sleeve 34 and the knob cylinder 35 are assembled so as to be able to rotate in synchronization with each other relative to the cylindrical case 31 and the racks 32a and 32b.

  As shown by an imaginary line in FIG. 5, the slider 33 is provided with a rear end portion 2 a of the columnar bone filling material 2. The slider 33 is moved along the guide groove 341 of the guide sleeve 34 by relative rotation of the case 31, the racks 32a and 32b, the tail plug 36, the guide sleeve 34, and the knob cylinder 35. The front end 2b of the bone prosthetic material 2 that is moved in the axial direction and has the rear end 2a attached to the slider 33 is configured to be able to protrude and retract from the opening 31a.

(b) First cutting mechanism section As shown in FIGS. 3 and 6, the first cutting mechanism section 4 is fixed to the knob cylinder 35 of the feeding mechanism section 3 and has a substantially square shape when viewed in the axial direction. A part container 41, a thread-like or sheet-like blade 42 for cutting the bone prosthetic material 2 stored in the cutting part container 41, and both ends of the blade 42 are supported, and the blade 42 is moved. Support sliders 43a, 43b, urging means 44a, 44b provided on the support sliders 43a, 43b to return the blade 42 to its original position after cutting the bone filling material 2, and the support slider 43a , 43b, and a lever 45 for moving the blade 42 supported by the support sliders 43a, 43b together with the support sliders 43a, 43b to cut the bone prosthetic material 2. The cutting portion container 41 is provided with an opening 41a through which the fed bone prosthetic material 2 passes. The support sliders 43a and 43b are supported by support shafts 47a and 47b supported by support members 46a, 46b, 46c and 46d fixed to the main body case 30 so as to be linearly movable. The lever 45 is rotatably supported by the support sliders 43a and 43b by pins 49a and 49b together with ring-shaped members 48a and 48b for holding the lever 45 in a cut or stored state.

  As the blade 42, a thread-like one such as a thread, a wire or a piano wire, or a thin sheet-like one made of metal, ceramics, plastic or the like can be preferably used. It is preferable that the blade 42 is accommodated in the case and not exposed so that a fingertip or the like is not accidentally damaged during use.

  The lever 45 is folded to the storage container 1 side so as not to accidentally cut the bone prosthetic material 2 when the blade 42 is not used, as indicated by a two-dot chain line in FIG. I can leave. On the other hand, when cutting the bone prosthetic material 2, as shown by solid lines in FIG. 7, the blades 42 are pushed in by rotating the pins 49a and 49b around the pins 49a to support the bone prosthesis. The material 2 can be cut. As shown in FIG. 8, the lever 45 has grooves 45a and 45b (groove 45a not shown) provided in the lever 45 when the bone prosthetic material 2 is cut, and the ring shape. The pressing force applied to the lever 45 when the bone prosthetic material 2 is cut by engaging the projections 481a and 481b (the ring-shaped member 48a and the projection 481a not shown) provided on the members 48a and 48b. Thus, the lever 45 is fixed so as not to return to the folded state, and the cut state is maintained.

(c) Lid It is preferable to provide the lid 5 in the opening 41a through which the fed bone prosthetic material 2 passes through the first cutting mechanism 4. The lid 5 may be of a sliding type as shown in FIG. 1 (closed state) and FIG. 7 (opened state), or may be a cap type (not shown). In the case of providing a cap-type lid, by providing a fringe in the opening 41a of the cutting portion container 41 of the first cutting mechanism portion 4, the cap-type lid is engaged with the fringe portion and the lid is closed. Can do.

(d) Operational Procedure It is preferable that the bone filling material storage container 1 is sterilized and provided with the bone filling material 2 inserted therein. Or, if necessary, it may be sterilized by an autoclave or the like immediately before use.

  As shown in FIG. 7, the lid 5 provided on the cutting portion container 41 is opened, the main body case 30 is picked with one hand, and the tail plug 36 is picked with the finger of the other hand, and the main body case 30 is picked. The tail plug 36 is rotated clockwise. As a result, the slider 33 engaged with the racks 32a and 32b moves forward in the cylindrical case 31, and the front end portion of the bone grafting material 2 having the rear end portion 2a attached to the slider 33. 2b is fed out from the opening 41a of the cutting section container 41. When the bone prosthetic material 2 is drawn out to a desired length, the rotation of the tail plug 36 is stopped.

  When the main body case 30 and a part of the tail plug 36 (fringe portion) are omitted, the feeding operation of the bone prosthetic material 2 can be performed by moving the cylindrical case 31 with one hand and the other hand. The knobs 35 are respectively picked with fingers, and the cylindrical case 31 is rotated clockwise with respect to the knob 35.

  On the other hand, as shown by a two-dot chain line in FIG. 7, the lever 45 folded to the storage container 1 side is rotated 180 ° with the pins 49a and 49b as fulcrums as shown by a solid line in FIG. Leave it in the state. By pressing the lever 45 in this state with a thumb or the like, the blade 42 supported by the support sliders 43a and 43b cuts the bone filling material 2 without touching the bone filling material 2 directly by hand, A piece of the bone grafting material 2 cut to a desired length can be obtained. When the pressing of the lever 45 is released, the supporting sliders 43a and 43b are returned to their original positions together with the blades 42 by the urging means 44a and 44b provided on the supporting sliders 43a and 43b.

  When a piece of the bone prosthetic material 2 having a desired length is further added and manufactured, the rotation of the tail plug 36 and the pressing of the lever 45 are repeated as described above.

  After all the necessary pieces of bone grafting material 2 are produced, as shown by a two-dot chain line in FIG. 7 so as not to accidentally damage or cut the bone grafting material 2 in the middle of feeding, The lever 45 is returned to the folded state on the storage container 1 side, and the lid 5 is closed.

  When the bone prosthetic material 2 becomes too small to be used, it can be replaced with a new bone prosthetic material 2. At this time, it is preferable to sterilize by an autoclave if necessary.

  In the case where a liquid agent such as blood is wetted in advance on the bone filling material 2, the lid 5 may be opened to wet the liquid agent directly on the bone filling material 2, but a hole provided in the tail plug 36 may be used. The liquid agent can be injected from the 36b with an injection needle or the like, and the liquid agent can be wetted in the bone filling material 2.

(2) Second Embodiment The second embodiment of the bone grafting material storage container 10 is that the first cutting mechanism 4 is changed to the second cutting mechanism 6 shown in FIGS. 9 and 10. Is the same as in the first embodiment. However, in the second embodiment shown in FIG. 9, a part of the main body case 30 and the tail plug 36 in the first embodiment is omitted. These parts are not essential in the second embodiment, including the first embodiment.

(a) Second cutting mechanism portion The second cutting mechanism portion 6 includes a cutting knob 62 that is rotatably fitted to the outer peripheral surface of the front portion 61a of the knob 61 of the storage container 10, and one end of the cutting mechanism 62 is It is attached to the inner peripheral surface of the cutting knob 62, inserted into the knob 61 through a hole 61b provided in the knob 61, wound around the bone prosthetic material 2, and the other end thereof A thread or wire 63 attached to a notch 61c provided in a portion adjacent to the hole 61b on the inner peripheral surface of the knob 61, and by rotating the cutting knob 62, the thread or wire 63 Is pulled and can be cut by tightening the bone filling material 2.

  It is preferable that a recess 61 d for accommodating the thread or wire 63 is formed on the inner peripheral surface of the knob cylinder 61. By storing the thread or wire 63 in the recess 61d, when the bone prosthetic material 2 is to be fed out, the bone prosthetic material 2 is caught by the thread or wire 63 and the bone prosthetic material 2 is fed out successfully. It is possible to prevent the bone filling material 2 from being lost or not being able to be cut well.

  The thread or wire 63 is strong enough to cut the bone grafting material 2 and is preferably as thin as possible to obtain a sharp sharpness. Further, in order to allow the thread or wire 63 to be stored in the recess 61d provided on the inner peripheral surface of the knob cylinder 61 after the bone prosthetic material 2 is cut, a material having a strong waist is preferable. . Specifically, a plastic thread such as nylon (registered trademark) or a wire such as a piano wire is preferable.

  As shown in FIG. 11, the thread or wire 63 is preferably attached to a notch 61c provided in the knob cylinder 61 with a fixing jig 63a provided at the end thereof. Similarly, when attaching the thread or wire 63 to the cutting knob 62, it is preferable to similarly attach a fixing jig to the end of the thread or wire 63 and attach it to the cutting knob 62. By attaching the thread or wire 63 to the knob cylinder 61 and the cutting knob 62 in this manner, the thread or wire 63 can be easily exchanged.

  When a lid is provided in the second embodiment of the bone grafting material storage container 10, it is preferable to use a cap-type lid that covers the cutting knob 62.

(b) Operation procedure Since the operations other than the mechanism for cutting the bone grafting material 2 are the same as those in the first embodiment, the operation procedure of the second cutting mechanism unit 6 will be described in detail. In the second embodiment, the feeding operation of the bone prosthetic material 2 is performed by picking the cylindrical case 60 with one hand and the picking tube 61 with the finger of the other hand. Then, the cylindrical case 60 is rotated in the clockwise direction.

  When the bone prosthetic material 2 is unwound, the second cutting mechanism 6 stores the thread or wire 63 in a recess 61d provided on the inner peripheral surface of the knob 61 as shown in FIG. 10 (a). It is in the state that was done. After the bone prosthetic material 2 is drawn out to a desired length, the cutting knob 62 is rotated clockwise as shown in FIG. 10 (b) so that the thread or wire 63 is turned into the knob. While being pulled out from the hole 61b provided in 61, the bone prosthetic material 2 located inside the thread or wire 63 can be cut so as to be tightened. After the bone prosthetic material 2 has been cut, by rotating the cutting knob 62 in a counterclockwise direction, the thread or wire 63 is returned into the knob 61 and the inside of the knob 61 It is stored again in the recess 61d provided on the peripheral surface.

(3) Third Embodiment A third embodiment of the bone filling material storage container 11 is the same as the third embodiment except that the first cutting mechanism 4 is changed to the third cutting mechanism 7 shown in FIG. It is the same as that of one embodiment. However, in the second embodiment shown in FIG. 12, a part of the main body case 30 and the tail plug 36 in the first embodiment is omitted. These parts are not essential in the third embodiment, including the first embodiment.

  The third cutting mechanism 7 includes a thread or wire 72 attached to the front end 71a of the knob cylinder 71 of the storage container 11, and the thread or wire 72 is moved along the front end 71a of the knob cylinder 71. By wrapping around the bone grafting material 2 and pulling the other end of the thread or wire 72, the bone grafting material 2 can be cut. A handle 72a is preferably provided at the other end of the thread or wire 72 to facilitate pulling the thread or wire 72.

  The thread or wire 72 has a strength sufficient to cut the bone filling material 2 and is preferably as thin as possible in order to obtain a sharp sharpness. Specifically, a plastic thread such as nylon and a wire such as a piano wire are preferable.

  In the third embodiment, the feeding operation of the bone grafting material 2 is performed by picking the cylindrical case 70 with one hand and the picking tube 71 with the finger of the other hand. The cylindrical case 70 is rotated in the clockwise direction.

  When a lid is provided in the third embodiment of the storage container 11 for bone grafting material, it is preferable to use a cap-type lid that covers the knob tube 71.

  Since the third cutting mechanism portion 7 has a simple configuration as compared with the first cutting mechanism portion 4 or the second cutting mechanism portion 6, it can be provided at a low cost.

[2] Bone prosthetic material The bone prosthetic material used in the present invention is preferably an apatite / collagen porous material. The apatite / collagen porous body is preferably composed of apatite / collagen composite fibers, and preferably has a porosity of 90 to 95% and an average pore diameter of about 10 to 500 μm.

  The apatite / collagen porous body is columnar, and preferably has a size of, for example, about 5 mm × 5 mm × 50 mm to about 20 mm × 20 mm × 150 mm. The columnar shape may be a column, a square column, a hexagonal column or the like, but a column is preferable.

[3] Method for producing apatite / collagen porous material
(1) Apatite / collagen composite fiber
(a) Raw material The apatite / collagen composite fiber is made from collagen, phosphoric acid or a salt thereof, and a calcium salt. It does not specifically limit as collagen, What was extracted from the animal etc. can be used. The species, tissue site, age, etc. of the derived animal are not particularly limited. Generally, collagen obtained from the skin, bone, cartilage, tendon, organ, etc. of mammals (eg, cows, pigs, horses, rabbits and mice) and birds (eg, chickens) can be used. Collagen-like proteins obtained from the skin, bones, cartilage, fins, scales, organs, etc. of fish (eg, cod, flounder, flounder, salmon, trout, tuna, mackerel, Thailand, sardine and shark) may also be used. The method for extracting collagen is not particularly limited, and can be based on a general extraction method. In addition, collagen obtained by gene recombination techniques may be used instead of those extracted from animal tissues.

  The apatite / collagen composite fiber is preferably prepared by mixing phosphoric acid or a salt thereof (hereinafter simply referred to as “phosphoric acid (salt)”) and a calcium salt in the presence of collagen. As phosphoric acid (salt), phosphoric acid, disodium hydrogen phosphate, sodium dihydrogen phosphate, dipotassium hydrogen phosphate and potassium dihydrogen phosphate can be used, and calcium salts include calcium carbonate, calcium acetate and water. Calcium oxide can be used. The phosphate and calcium salt are added in the form of a uniform aqueous solution or suspension, respectively.

  The ratio of apatite / collagen in the apatite / collagen composite fiber can be appropriately determined depending on the composition ratio of the target apatite / collagen composite fiber, but is usually 9/1 to 6/4 (mass ratio). And is particularly preferably about 8/2 (mass ratio). The mass ratio of apatite / collagen can be controlled by adjusting the amount of apatite raw material [phosphoric acid (salt) and calcium salt] and collagen used.

(b) Preparation of solution Prepare collagen / phosphoric acid (salt) aqueous solution and calcium salt aqueous solution (or suspension). The collagen / phosphoric acid (salt) aqueous solution is an aqueous solution in which collagen and phosphoric acid (salt) are dissolved, and the concentration of collagen is preferably 0.5 to 1% by mass, more preferably 0.5 to 0.9% by mass. Moreover, 10-240 mmol / L is preferable and the density | concentration of phosphoric acid (salt) has more preferable 100-120 mmol / L. The concentration of the aqueous calcium salt solution (or suspension) is preferably 50 to 800 mmol / L, particularly preferably 200 to 400 mmol / L. The fiber length of the apatite / collagen complex can be adjusted by adjusting the concentration of each solution. Specifically, when the concentration of each solution is increased, the fiber length is shortened, and when the concentration of each solution is decreased, the fiber length is increased. Collagen is preferably added to the aforementioned phosphoric acid (salt) aqueous solution in a state of being previously dissolved in a phosphoric acid aqueous solution having a low concentration. The collagen + phosphoric acid aqueous solution in which collagen is dissolved in advance preferably has a collagen concentration of 0.5 to 1% by mass and a phosphoric acid concentration of 10 to 30 mmol / L.

(c) Production of apatite / collagen composite fiber Almost the same amount of calcium salt aqueous solution to be added (preferably 0.5 to 2 times, more preferably 0.8 to 1.2 times that of the calcium salt aqueous solution to be added) At about 40 ° C., a phosphoric acid (salt) aqueous solution and a calcium salt aqueous solution containing collagen are simultaneously added dropwise. The length of the apatite / collagen composite fiber to be synthesized can be controlled by the dripping conditions. The dropping speed is preferably about 10 to 50 ml / min, and the reaction solution is preferably stirred at about 50 to 300 rpm. During the dropping, it is preferable to maintain the calcium ion concentration in the reaction solution at 3.75 mM or less and the phosphate ion concentration at 2.25 mM or less. Thereby, the pH of the reaction solution is maintained at 8.9 to 9.1. When the concentration of calcium ions and / or phosphate ions exceeds the above range, self-assembly of the complex is prevented. In this specification, “self-organization” means that hydroxyapatite (calcium phosphate having an apatite structure) is oriented along the collagen fiber, that is, the C axis of hydroxyapatite is along the collagen fiber. It means that it is oriented. By the above dropping conditions, the apatite / collagen composite fiber becomes self-organized with a length of 1 mm or less suitable as a raw material for the porous body.

  After completion of the dropwise addition, the slurry-like apatite / collagen composite fiber dispersion is freeze-dried. Freeze-drying is carried out by drawing a vacuum in a state of being frozen at −10 ° C. or lower and drying rapidly.

(2) Preparation of dispersion containing apatite / collagen composite fiber Water, phosphoric acid aqueous solution or the like is added to the apatite / collagen composite fiber and stirred to prepare a paste-like dispersion. The content of the liquid contained in the dispersion is preferably 80 to 99% by volume, and more preferably 90 to 97% by volume. That is, the content of the composite fiber is preferably 1 to 20% by volume, and more preferably 3 to 10% by volume. It is preferable that water vapor is attached to the apatite / collagen composite fiber in advance. In this case, it is necessary to subtract the amount of water vapor attached to the apatite / collagen composite fiber to determine the amount of water to be added.

The porosity P (%) of the porous material to be produced depends on the volume ratio of the apatite / collagen composite fiber and the liquid in the dispersion, and the following formula (1):
P = Y / (X + Y) × 100 (1)
[Wherein X represents the volume of the apatite / collagen composite fiber in the dispersion, and Y represents the volume of the liquid in the dispersion. ]. Therefore, the porosity P of the porous body can be controlled by the amount of liquid added. By stirring the dispersion after adding the liquid, the apatite / collagen composite fiber is cut and the fiber length distribution width is increased, so that the strength of the porous body to be produced is improved.

  Collagen is added to the composite dispersion as a binder and further stirred. The amount of collagen added is preferably 1 to 10% by mass and more preferably 3 to 6% by mass with respect to 100% by mass of the apatite / collagen composite fiber. As in the case of the complex, collagen is preferably added in a state dissolved in an aqueous phosphoric acid solution. The concentration of collagen and phosphoric acid in the phosphoric acid aqueous solution containing collagen is not particularly limited, but practically, the concentration of collagen is 0.8 to 0.9% by mass (for example, 0.85% by mass), and the concentration of phosphoric acid is 15 to 25 mM (for example, 20 mM).

(3) Gelation of dispersion A sodium hydroxide solution is added to neutralize the dispersion that has become acidic by the addition of an aqueous phosphoric acid (salt) solution containing collagen. The pH of the dispersion is preferably adjusted to 6.8 to 7.6, more preferably 7.0 to 7.4. By adjusting the pH of the dispersion to 6.8 to 7.6, the fiberization of collagen added as a binder can be promoted.

  A concentrated solution of about 2.5 to 10 times the phosphate buffer solution (PBS) is added to the dispersion and stirred to adjust the ionic strength to 0.2 to 0.8. A more preferable ionic strength is the same ionic strength as PBS (about 0.2 to 0.8). By increasing the ionic strength of the dispersion, it is possible to promote the fiberization of collagen added as a binder.

  After putting the dispersion in a mold, the dispersion is gelled by maintaining the temperature at 35 to 43 ° C. The holding temperature is more preferably 35 to 40 ° C. In order to sufficiently gel the dispersion, the holding time is preferably 0.5 to 3.5 hours, and more preferably 1 to 3 hours. By maintaining the temperature of the dispersion at 35 to 43 ° C., collagen added as a binder is fibrillated, and the dispersion becomes a gel. By gelling the dispersion, it is possible to prevent the apatite / collagen composite fibers from being settled in the dispersion, and it is possible to produce a uniform porous body.

(4) Freezing and drying of the gel body The gel body containing the apatite / collagen composite fiber is frozen. The average pore size of the target apatite / collagen porous body depends on the time required for freezing the gel body. The freezing temperature is preferably −100 to 0 ° C., more preferably −100 to −10 ° C., and particularly preferably −80 to −20 ° C. Below −100 ° C., the average pore size of the resulting apatite / collagen porous body is too small. If it exceeds 0 ° C., it does not freeze or it takes a long time to freeze, and the average pore diameter of the porous body is too large.

  The frozen gel body is dried by freeze-drying to make a porous body. That is, as in the case of the apatite / collagen composite fiber, it is evacuated in a state of being frozen at −10 ° C. or lower and rapidly dried. Freeze-drying may be performed until the dispersion is sufficiently dried, and the time is not particularly limited, but is generally about 24 to 72 hours.

(5) Collagen cross-linking The apatite / collagen complex is preferably cross-linked with collagen in order to maintain its shape for a certain period in vivo. Collagen can be crosslinked by a physical crosslinking method (a method using γ rays, ultraviolet rays, thermal dehydration, electron beam, etc.) or a chemical crosslinking method (a method using a crosslinking agent or a condensing agent).

  The chemical crosslinking method is carried out by immersing collagen and / or apatite / collagen complex in a solution of a crosslinking agent. Examples of crosslinking agents include aldehyde-based crosslinking agents (such as glutaraldehyde and formaldehyde), isocyanate-based crosslinking agents (such as hexamethylene diisocyanate), and carbodide-based crosslinking agents (1-ethyl-3- (3-dimethylaminopropyl) carbodiimide hydrochloride. Etc.), polyepoxy crosslinking agents (ethylene glycol diethyl ether, etc.), transglutaminase and the like. Of these cross-linking agents, glutaraldehyde is particularly preferable from the viewpoint of easy control of the degree of cross-linking and the biocompatibility of the resulting cage-like bone prosthetic material.

  When crosslinking is performed using glutaraldehyde, the concentration of the glutaraldehyde solution is preferably 0.005 to 0.015% by mass, and more preferably 0.005 to 0.01% by mass. When an alcohol such as ethanol is used as a solvent for the glutaraldehyde solution, dehydration can be performed simultaneously with the crosslinking of collagen. After the crosslinking treatment, collagen and / or apatite / collagen complex is immersed in an aqueous solution of about 2% by mass of glycine to remove unreacted glutaraldehyde, and then washed with water. Further, the collagen and / or apatite / collagen complex is dehydrated by immersing in ethanol and then dried at room temperature.

  Thermal dehydration crosslinking is performed by holding the collagen and / or apatite / collagen complex in a vacuum oven at 100 to 160 ° C. and 0 to 100 hPa for 10 to 12 hours.

  Thermal dehydration crosslinking is performed by holding the lyophilized porous body in a vacuum oven at 100 to 160 ° C. and 0 to 100 hPa for 10 to 12 hours.

(6) Gamma ray treatment Since apatite collagen porous bodies using animal-derived collagen may contain endotoxin, the cross-linked porous body has a dose of 16 to 35 kGy [unit is Gy (gray)]. Irradiation with gamma rays is preferred. Endotoxin activity can be reduced by gamma irradiation. The higher the gamma ray dose, the lower the endotoxin activity, but the elasticity of the apatite / collagen porous body is lost and the shape cannot be maintained. Therefore, the irradiation dose is preferably 35 kGy or less. If it is less than 16 kGy, inactivation of endotoxin is insufficient. The irradiation dose of gamma rays is more preferably 20 to 30 kGy, and further preferably 22 to 25 kGy. Cobalt 60 is generally used as the radiation source. As an irradiation method, enter the irradiation chamber with a belt conveyor, go out after a certain period of time, and then enter the irradiation chamber again until it reaches the fixed absorbed dose. There is static irradiation.

1,10,100 ... Bone prosthesis storage container 2 ... Bone prosthesis
2a ・ ・ ・ Rear end
2b: Front end 3 ... Feeding mechanism
30 ... Body case
30a ... Opening
31 ... Cylindrical case
31a ・ ・ ・ Opening
31b ・ ・ ・ Notch
32a, 32b ... Rack
321 ... spiral groove
33 ・ ・ ・ Slurder
331 ・ ・ ・ Spiral ridge
34 ... Guide sleeve
341 ... Guide groove
35 ... Picking tube
36 ・ ・ ・ Tail plug
36a ・ ・ ・ Protrusions
36b ... hole 4 ... first cutting mechanism
41 ... Container
41a ・ ・ ・ Opening
42 ... blade
43a, 43b ... support slider
44a, 44b ... biasing means
45 ... Lever
46a, 46b, 46c, 46d ... support member
47a, 47b ... support shaft
48a, 48b ・ ・ ・ Ring-shaped member
481a, 481b ・ ・ ・ Protrusions
49a, 49b ... Pin 5 ... Lid 6 ... Second cutting mechanism
61 ... Picking cylinder
61a ・ ・ ・ Front
61b ... hole
61c ・ ・ ・ Incision
61d ・ ・ ・ Recess
62 ... Cut picking cylinder
62a ・ ・ ・ Incision
63 ... Yarn or wire
63a: Fixing jig 7: Third cutting mechanism
71 ・ ・ ・ Picking cylinder
71a ・ ・ ・ Front end
72 ... Yarn or wire
72a ・ ・ ・ Handle

Claims (8)

  A storage container for a bone grafting material, comprising: a mechanism for feeding a columnar bone grafting material; and a mechanism for cutting the fed bone grafting material.   2. The storage container for a bone prosthetic material according to claim 1, wherein the feeding mechanism includes a cylindrical case for storing the bone prosthetic material, and an axial rack fixed to an inner peripheral surface of the cylindrical case. And a slider that is attached to one end of the bone prosthetic material, meshes with the rack and is movable in the axial direction in the case, a guide sleeve for guiding the slider, and a front outer peripheral surface of the cylindrical case. A bone-retaining material storage container, comprising: a picking tube fitted rotatably, and a tail plug attached to a rear end of the cylindrical case.   The bone grafting material storage container according to claim 2, wherein the cutting mechanism supports a thread-like or sheet-like blade for cutting the bone grafting material, both ends of the blade, and moves the blade. A support slider, and an urging means provided on the support slider to return the blade to its original position after cutting the bone filling material, and connected to the support slider, the support slider together with the support A bone filling material storage container, comprising: a lever for moving the blade supported by a slider and cutting the bone filling material.   The storage container for bone filling material according to claim 3, wherein the thread-like or sheet-like blade is not exposed.   The storage container for a bone grafting material according to claim 2, wherein the cutting mechanism includes a cutting knob that is rotatably fitted to the outer peripheral surface of the front portion of the storage container, and one end of the cutting knob. It is attached to the peripheral surface, inserted into the inside of the knob cylinder from a hole provided in the cutting knob cylinder, wound around the bone filling material, and the other end of the hole on the inner peripheral surface of the knob cylinder A thread or wire attached to a portion adjacent to the wire, and by rotating the cutting knob, the thread or wire is pulled to cut the bone prosthetic material so as to be tightened. Bone filling material storage container.   The storage container for a bone grafting material according to claim 2, wherein the cutting mechanism comprises a thread or wire attached to the front end of the packaging container, and the thread or wire is wound around the bone grafting material. A storage container for a bone grafting material, which is a mechanism for cutting the bone grafting material by pulling.   The bone filling material storage container according to any one of claims 1 to 6, wherein the tail plug mounted on the rear end of the cylindrical case has a liquid soaked in the bone filling material. A storage container for bone prosthetic material, wherein:   The storage container for bone filling materials according to any one of claims 1 to 6, wherein the bone filling material is an apatite / collagen composite.

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