JP2014226527A - Package of granular artificial bone - Google Patents

Package of granular artificial bone Download PDF

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JP2014226527A
JP2014226527A JP2013120216A JP2013120216A JP2014226527A JP 2014226527 A JP2014226527 A JP 2014226527A JP 2013120216 A JP2013120216 A JP 2013120216A JP 2013120216 A JP2013120216 A JP 2013120216A JP 2014226527 A JP2014226527 A JP 2014226527A
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package
artificial bone
bone material
spout
granular
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達鋭 橋本
Tatsutoshi Hashimoto
達鋭 橋本
秀行 河津
Hideyuki Kawazu
秀行 河津
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CATALYMEDIC Inc
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CATALYMEDIC Inc
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Abstract

PROBLEM TO BE SOLVED: To provide a package in which an artificial bone material is prepackaged so that, when having a bone defective part filled with the artificial bone material in a powder or granular form, even a deep or narrow local part of an operating field can be filled with a controlled amount of the material, directly from the package without scattering or falling of the material.SOLUTION: An approximately cylindrical straw-shaped package filled with an artificial bone material in a granular form is provided. An end seal is cut with scissors or the like so as to make a spout for using the material. While a part adjacent to the spout is deformed by compression with fingers in order to prevent the artificial bone material from passing, the spout is applied to an affected part to be injected. The deformed part is then loosened with fingers such that the granular artificial bone material falls to fill the affected part.

Description

本発明は、粉体(粉末状)や顆粒状の人工骨材料の包装体に関するものである。The present invention relates to a powder (powder) or granular artificial bone material package.

事故や病気などの疾患により骨に欠損部が生じたときの治療として、欠損した骨を修復するためにHA(ハイドロキシアパタイト)やβ−TCP(β−リン酸三カルシウム)などの人工骨材料が治療材料として手術に使用されている。Artificial bone materials such as HA (hydroxyapatite) and β-TCP (β-tricalcium phosphate) are used to repair the missing bone as a treatment when a defect occurs in the bone due to an accident or illness. It is used in surgery as a therapeutic material.

これらの手術は主に整形外科医によって行われ、疾患部分の状況により粉体あるいは顆粒状の人工骨材料の小片を、鋭匙又は医療用のさじ、あるいはスプーン等を用いて、欠損により生じた骨の空隙部へ補填することが行われている。These surgeries are mainly performed by orthopedic surgeons. Depending on the condition of the diseased part, a bone or bone caused by a defect can be obtained using a small piece of artificial bone material in the form of powder or granules, a sharp spoon, a medical spoon or spoon It is performed to fill in the voids.

しかし、この鋭匙などを用いた補填作業は粉体や顆粒が周辺の軟部組織へこぼれ落ち、あるいは散らばり、目的とする部位へ十分に充填されないことで作業性が悪く、円滑な手術の妨げとなっていた。However, this supplementary work using sharps or the like is inferior in workability because powder and granules spill or scatter into the surrounding soft tissue and are not sufficiently filled into the target site, which hinders smooth surgery. It was.

手術中に人工骨材料の粉体や顆粒が、補填を避けたい周辺の軟部組織にこぼれ落ちて付着してしまうと、これを取り除くために生理食塩水を用いて流し取るか、あるいは軟部組織に付着した1粒1粒をピンセットを用いて除去する必要があり、手術時間の増大となっていた。During the operation, if artificial bone powder or granules spill and adhere to the surrounding soft tissue where you want to avoid supplementation, remove it with saline to remove it, or adhere to the soft tissue. Therefore, it was necessary to remove each of the grains using tweezers, which increased the operation time.

上記の不具合の改善策としてロート状の治具を用いる事があるが、ロートの内部で粉体や顆粒がひっかかり詰まりが生じやすく作業性が悪かった。HA製やβ−TCP製の人工骨は硬度が高く、表面に角があるためロート内面に詰まり易く、無理に押し込むとロート内面を削る事となり、削られたロートの素材が人工骨材料に混ざり問題となるところである。Although a funnel-shaped jig may be used as a measure for improving the above problems, powder and granules are caught inside the funnel and clogging is likely to occur, resulting in poor workability. HA and β-TCP artificial bones have high hardness and have chamfered surfaces, so they can easily clog the inner surface of the funnel. If you push it forcibly, the inner surface of the funnel will be cut, and the material of the cut funnel will be mixed with the artificial bone material. It is a problem.

また、股関節手術などのように術野の深い位置に人工骨材料の補填が必要となった場合、必然的に先端部の長いロートを使用するが、ロートの口元から粉体や顆粒を充填する作業とロートの先端部から排出されるタイミングに時間差があるため、手術者が必要とする補填量を正確に制御することが困難であった。Also, when artificial bone material needs to be replenished deep in the surgical field, such as in hip joint surgery, a funnel with a long tip is inevitably used, but powder or granules are filled from the mouth of the funnel. Since there is a time difference between the work and the discharge timing from the tip of the funnel, it has been difficult to accurately control the amount of compensation required by the operator.

また、歯科においても、歯根部に顆粒の人工骨を充填する場合があるが、充填部が極端に狭かったり、奥まっていることがある。このような場合、手術前に予め、粉や顆粒状の人工骨と、水や生理食塩水等に混ぜてスラリー状にして、シリンジ等で補充するようにしている。このための手間がかかる。また、水分を混ぜるので、充填率が落ちるなどの不都合があった。Also, in dentistry, there are cases where an artificial bone of granules is filled in the root portion, but the filling portion may be extremely narrow or recessed. In such a case, before surgery, it is mixed in advance with powder or granular artificial bone, water, physiological saline or the like to form a slurry and replenished with a syringe or the like. This takes time. Further, since water is mixed, there is a disadvantage that the filling rate is lowered.

なし  None

解決しようとする課題は、人工骨の補填が必要な手術において、粉体や顆粒状の人工骨材料を骨欠損部に補填する時に、周辺の組織部への散らばりや脱落なしに速やかに狙った場所へ補填することができないことである。  The problem to be solved was aimed at promptly without scattering or dropping off to the surrounding tissue part when filling the bone defect with powder or granular artificial bone material in surgery requiring artificial bone supplementation. It is impossible to make up for the place.

また、粉体や顆粒状の人工骨材料を補填する時、手術者が適量と考える補填量にするための補填操作が行えないことである。  In addition, when supplementing powder or granular artificial bone material, it is impossible to perform a supplementing operation to obtain a supplement amount that the surgeon considers to be an appropriate amount.

本発明は、粉体や顆粒状の人工骨材料を骨欠損部へ補填する時に、人工骨包装体から直接、狙った部位に、正確に、速やかに、補填量を制御しながら補填することを可能とすることを主要な特徴とする。  In the present invention, when powdered or granulated artificial bone material is to be filled in a bone defect part, it is possible to directly and directly fill the target site from the artificial bone package while controlling the amount of filling. The main feature is to make it possible.

本発明による人工骨包装体は、人工骨包装体から直接、粉体や顆粒状の人工骨材料を周辺の組織への散らばりや脱落をしないで、狙った部位へ、補填量を制御しながら適量な供給ができるため、これらの正確な補填作業により手術時間の短縮が図られる利点がある。  The artificial bone package according to the present invention is suitable for controlling the amount of supplementation to the target site without scattering or dropping powdered or granular artificial bone material directly into the surrounding tissue directly from the artificial bone package. Therefore, there is an advantage that the operation time can be shortened by these accurate compensation operations.

図1は、本発明装置の1実施例である。1は人工骨材料を内包した包装体全体を示す。内部に人工骨材料を収納するための空腔があり、本体はほぼ透明な材質で作られ、透明であることにより外部から本体に収納された量を知ることができる。  FIG. 1 shows an embodiment of the apparatus of the present invention. Reference numeral 1 denotes an entire package including an artificial bone material. There is a cavity for accommodating artificial bone material inside, the main body is made of a substantially transparent material, and the amount stored in the main body can be known from the outside by being transparent.

はじめに構成を説明する。2はストロー状態の円筒部を示す。22はシール部である。4は内包された顆粒状の人工骨材料である。  First, the configuration will be described. 2 shows the cylindrical part of a straw state. Reference numeral 22 denotes a seal portion. 4 is an encapsulated granular artificial bone material.

両端部のシール部22は熱により、溶着されている。このシール部22とその近傍をのぞき、一般のストローと同じ断面積がほぼ一定のストレート状の円筒体である。  The seal portions 22 at both ends are welded by heat. Except this seal part 22 and its vicinity, it is a straight cylindrical body with the substantially same cross-sectional area as a general straw.

次に、使用方法を説明する。図2はこの包装体を立てて、先端をはさみで斜めに切る状態を示す。包装体を立てると、顆粒状の人工骨材料4が下に移動する。この状態で先端をカットして、21の前方付近を指でつまみ、変形させる。そうすることで、カットした注ぎ口24を下に向けても、顆粒状の人工骨材料4は注ぎ口24から落ちづに蓋としての作用が働く。この状態で、図3のように、注ぎ口24を充填したい患部の上に配置し、つまんで変形していた部分をゆるめ、変形を戻すと、顆粒状の人工骨材料4は注ぎ口24から落ちる。落下しにくい場合は、指でもみほぐせば良い。  Next, the usage method will be described. FIG. 2 shows a state in which this package is erected and the tip is cut obliquely with scissors. When the packaging body is raised, the granular artificial bone material 4 moves downward. In this state, the tip is cut, and the vicinity of the front of 21 is pinched with a finger and deformed. By doing so, even if the cut spout 24 is directed downward, the granular artificial bone material 4 acts as a lid as it falls from the spout 24. In this state, as shown in FIG. 3, when the spout 24 is placed on the affected part to be filled, the part that has been pinched and deformed is loosened, and the deformation is restored, the granular artificial bone material 4 is removed from the spout 24. drop down. If it is difficult to drop, you can just use your finger to loosen it.

他の実施例Other examples

図4は、本発明装置の他の実施例である。1は人工骨材料を内包した包装体全体を示す。内部に人工骨材料を収納するための空腔があり、本体はほぼ透明な材質で作られ、透明であることにより外部から本体に収納された量を知ることができる。  FIG. 4 shows another embodiment of the apparatus of the present invention. Reference numeral 1 denotes an entire package including an artificial bone material. There is a cavity for storing artificial bone material inside, the main body is made of a substantially transparent material, and the amount stored in the main body can be known from the outside by being transparent.

はじめに構成を説明する。2はストロー状態の大きな径の大円筒部を示す。21は大円筒部に作られた蛇腹である。22はシール部である。23は固定部である。3は小円筒部である。小円筒部3は大円筒部2にスライド自在に収納されている。31は小円筒部3のシール部、32は絞り部である。4は内包された顆粒状の人工骨材料である。  First, the configuration will be described. Reference numeral 2 denotes a large cylindrical portion having a large diameter in a straw state. 21 is a bellows made in the large cylindrical portion. Reference numeral 22 denotes a seal portion. Reference numeral 23 denotes a fixed portion. 3 is a small cylindrical part. The small cylindrical portion 3 is slidably accommodated in the large cylindrical portion 2. 31 is a seal part of the small cylindrical part 3, and 32 is a throttle part. 4 is an encapsulated granular artificial bone material.

シール部22及び、31は熱により、溶着されている。このシール部22,31をのぞき、伸縮と湾曲の可能な構造のストローと同じ構成である。よって、使用時には状況に応じて、小円筒部3を引き出して伸ばし、絞り部32を固定部23に無理に入れて、固定したり、蛇腹21で曲げたりすることができる。  The seal portions 22 and 31 are welded by heat. Except for the seal portions 22 and 31, it has the same structure as a straw having a structure that can be expanded and contracted. Therefore, depending on the situation, the small cylindrical part 3 can be pulled out and extended, and the throttle part 32 can be forced into the fixing part 23 and fixed or bent by the bellows 21 depending on the situation.

次に、使用方法を説明する。図5はこの包装体を立てて、先端をはさみで斜めに切る状態を示す。包装体を立てると、小円筒部3に顆粒状の人工骨材料4がすべて移動する。この状態で先端をカットして、小円筒部3を引き出して、蛇腹21の前方付近を指でつまみ、変形させる。そうすることで、カットした注ぎ口24を下に向けても、顆粒状の人工骨材料4は注ぎ口24から落ちない。図5ではカットするのは大円筒部2のシール部23としたが、より狭い充填部に充填する場合は、小円筒部3のシール部23を上に向けてカットして使用しても問題ない。若干落下しにくくなるが、指でもみほぐせば良い。  Next, the usage method will be described. FIG. 5 shows a state in which this package is erected and the tip is cut obliquely with scissors. When the packaging body is erected, all of the granular artificial bone material 4 moves to the small cylindrical portion 3. In this state, the tip is cut, the small cylindrical portion 3 is pulled out, and the vicinity of the front of the bellows 21 is pinched with a finger and deformed. By doing so, the granular artificial bone material 4 does not fall from the spout 24 even if the cut spout 24 is directed downward. In FIG. 5, the cut portion is the seal portion 23 of the large cylindrical portion 2, but when filling a narrower filling portion, there is a problem even if the seal portion 23 of the small cylindrical portion 3 is cut upward and used. Absent. It will be a little difficult to drop, but you can just use your finger to loosen it.

図6は充填する状態を示す。指で包装体をつまむことで蓋をして、蛇腹21で湾曲させて、小円筒部3を親指と人差し指の指間にあてがい、安定させて、包装体をもみほぐすことで、顆粒状の人工骨材4を確実に、カットした注ぎ口24から、狙った充填部に落下させることができる。また、包装体の少なくとも一部が湾曲できるように蛇腹形状を持つことで、曲げることが可能になり、充填部へのアプローチがやりやすくなる。また、包装体で少なくとも2段に伸縮出来、伸ばした状態をホールドできる構造にすることで、充填部からより離れても、保持が可能となる。  FIG. 6 shows the state of filling. By pinching the package with fingers, curving it with the bellows 21, placing the small cylindrical part 3 between the thumb and forefinger, stabilizing it, and loosening the package, granulated artificial The aggregate 4 can be reliably dropped from the cut spout 24 to the targeted filling portion. Moreover, by having an accordion shape so that at least a part of the package can be bent, it can be bent, and the approach to the filling portion is facilitated. Moreover, it can hold | maintain even if it leaves | separates further from a filling part by making it the structure which can be expanded-contracted at least 2 steps | paragraphs with a package, and can hold the extended state.

このように、円筒形状の包装体で、指で押さえて断面形状を変えることができるので、内包された人工骨材を落下させたり、押さえて、止めたり、の蓋の役目ができるとともに、包装体を指でもみほぐすなどの変形をさせることで、包装体の内側に引っかかって落ちない顆粒状人工骨材4を落とすことができる。  In this way, it is possible to change the cross-sectional shape by pressing with a finger with a cylindrical packaging body, so that it can serve as a lid for dropping, pressing and stopping the enclosed artificial aggregate, and packaging By deforming the body with a finger or the like, the granular artificial bone material 4 that is caught inside the package and does not fall can be dropped.

指で押さえて断面形状を変えるのは蛇腹21の手前であってもよいが、蛇腹21に顆粒状人工骨材4が引っかかりやすいので、引っかかった場合も透明であれば、目視確認できるので、この部分を指でもみほぐすことで、顆粒状人工骨材4を落とすことができる。
また、この蛇腹をまっすぐの状態にして、前後を持って蛇腹部を伸縮させると、蛇腹部に詰まった骨材で、ストレート部の骨材を押し出すことも可能である。
It may be in front of the bellows 21 that the cross-sectional shape is changed by pressing with a finger, but since the granular artificial bone material 4 is easily caught on the bellows 21, if it is transparent, it can be visually confirmed. The granular artificial bone 4 can be dropped by unraveling the part with a finger.
Further, when this bellows is straightened and the bellows part is expanded and contracted with the front and back, the aggregate in the straight part can be pushed out by the aggregate packed in the bellows part.

供給される顆粒の人工骨材の最大径を包括できる大きさの包装体の内接円径は、紛体状人工骨材でも最少内接円径は2mm以上あった方がよい。それ以下では、内壁面への付着が強く、なかなか落下しにくい。その場合に指で変形可能な厚みを考慮すると、内接円径が小さい場合は肉厚はできるだけ薄くする方がよい。結果、略円筒の内接円径が2mm以上、肉厚0.015mm以上が適切である。  The inscribed circle diameter of the package that can accommodate the maximum diameter of the supplied artificial aggregate of granules is preferably 2 mm or more even in the case of powdered artificial aggregate. Below that, the adhesion to the inner wall surface is strong and it is difficult to fall. In this case, considering the thickness that can be deformed with a finger, it is better to make the wall thickness as thin as possible when the inscribed circle diameter is small. As a result, it is appropriate that the inscribed circle diameter of the substantially cylinder is 2 mm or more and the wall thickness is 0.015 mm or more.

使用頻度の高い顆粒状人工骨材は最大粒径が8mm以下のものが多く使われている。この場合は、指で変形可能な厚みを考慮し、略円筒の内接円径が最大粒径より若干大きい8.1mm程度で、肉厚0.03mm以上で1.5mm以下のプラスチックからなることが、より適切になる。  The most frequently used granular artificial bones have a maximum particle size of 8 mm or less. In this case, in consideration of the thickness that can be deformed by a finger, the inscribed circle diameter of the substantially cylinder is about 8.1 mm, which is slightly larger than the maximum particle diameter, and the wall thickness is 0.03 mm or more and 1.5 mm or less. Is more appropriate.

実施例のストロー状包装体は全体にレーザーエネルギーで微細な穴を多数開ける処理を施している。包装体の少なくともその一部が通気性のある構造または材質からなることで、ガス滅菌あるいは蒸気滅菌について、包装体の内部まで滅菌作用が働くため、滅菌手段を選択できることが可能となる。
ここでいう包装体の材質は紙、合成紙、プラスチックや金属箔をラミネートした紙、等がある。プラスチックの場合はABS、ポリカーボネート、ポリプロピレン、ポリエチレン、ポリエチレンテレフタレート、ポリスチレン、ポリアミド、ポリ乳酸、塩ビ、等でもよい。
The straw-shaped package of the example is subjected to a process of making a large number of fine holes with laser energy. Since at least a part of the package is made of a breathable structure or material, gas sterilization or sterilization works to the inside of the package, so that a sterilization means can be selected.
Examples of the material of the package include paper, synthetic paper, paper laminated with plastic and metal foil, and the like. In the case of plastic, ABS, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polystyrene, polyamide, polylactic acid, vinyl chloride, etc. may be used.

使用するとき、まず、注ぎ口になる側の端部を上に向け、鋏で斜めにカットするが、包装体への顆粒状人工骨材料の充填率があまり高いと、注ぎ口を下に向けたとき
顆粒状人工骨材料が落下しないために、指で押さえる位置を注ぎ口近くにしないといけなくなる。そうすると、落下をおさえている指が邪魔になって、充填部へのアプローチが難しくなる。そこで、充填率は70%以下に抑えることで、注ぎ口と指との間に包装体のガイド部ができ、充填部へのアプローチが容易になり、充填しやすくなる。
When using, first turn the end to become the spout upward and cut diagonally with scissors, but if the packing rate of the granular artificial bone material in the package is too high, turn the spout downward When the granulated artificial bone material does not fall, the finger must be placed close to the spout. If it does so, the finger which is holding down will get in the way, and approach to a filling part will become difficult. Therefore, by suppressing the filling rate to 70% or less, a guide part of the package is formed between the spout and the finger, and the approach to the filling part is facilitated and the filling becomes easy.

顆粒状人工骨の粒度が小さいものを包装する略円筒状の包装体は、静電気で円筒内面に顆粒状人工骨が付着して、うまく落下しなかったり、内部が見えなくなるなどの不具合が生じることがある。この場合は、包装体を静電気が発生しにくい材質にしたり、顆粒状人工骨材と同じ極性の帯電しやすい材質にしたり、静電防止処理を施すとよい。  The substantially cylindrical package that wraps the granular artificial bone with a small particle size may cause problems such as static adhesion of the granular artificial bone to the inner surface of the cylinder due to static electricity, and it will not fall well or the inside will not be visible. There is. In this case, the packaging body may be made of a material that hardly generates static electricity, or made of a material that is easily charged with the same polarity as that of the granular artificial bone, or subjected to antistatic treatment.

実施例では、包装体の両端のシールは熱融着しているが、折り曲げたり、別部材のシール材を貼ったり、あるいは別部材のシール材で穴を詰めたりしてもよい。  In the embodiment, the seals at both ends of the package are heat-sealed. However, the seals may be bent, a separate sealing material may be attached, or the holes may be filled with a separate sealing material.

図1は人工骨材料を内包した包装体全体の説明図である。FIG. 1 is an explanatory view of the entire package including an artificial bone material. 図2は注ぎ口を鋏で切って作るのを示した図。FIG. 2 is a diagram illustrating making a spout by cutting with a scissors. 図3は指で包装体をつまみ、蓋をした状態で、患部に充填する状態を示した図。FIG. 3 is a view showing a state in which the affected area is filled with a finger gripping the package and covering the package. 図4は他の実施例で人工骨材料を内包した包装体全体の説明図である。FIG. 4 is an explanatory view of the entire package including an artificial bone material in another embodiment. 図5は注ぎ口を鋏で切って作るのを示した図。FIG. 5 is a diagram showing making a spout with a scissors. 図6は指で包装体をつまみ、蓋をした状態で、かつ、向きを安定させるために、後端を伸ばして患部に充填する状態を示した図。FIG. 6 is a view showing a state in which the package is pinched with a finger and covered, and the rear end is extended and the affected part is filled in order to stabilize the orientation.

Claims (7)

断面形状が円または多角形の略円筒の筒形状であって、指でおさえて、断面形状を変化させることができる厚みと剛性との組み合わせをもつ材質からなることを特徴とする人工骨材料の包装体。  An artificial bone material comprising a material having a combination of thickness and rigidity that can be changed with a finger and having a cross-sectional shape that is a circle or polygonal substantially cylindrical tube Packaging body. 請求項1の包装体であって、少なくとも一部が透明のプラスチックからなることを特徴とする人工骨材料の包装体。  2. The package of artificial bone material according to claim 1, wherein at least a part is made of a transparent plastic. 請求項1の包装体であって、略円筒の内接円径が2mm以上、かつ肉厚0.015mm以上のプラスチックからなることを特徴とする人工骨材料の包装体。  2. The package of artificial bone material according to claim 1, wherein the package is made of a plastic having a substantially cylindrical inscribed circle diameter of 2 mm or more and a wall thickness of 0.015 mm or more. 請求項1の包装体であって、少なくともその一部が通気性のある構造または材質からなるとを特徴とする人工骨材料の包装体。  The package of artificial bone material according to claim 1, wherein at least part of the package is made of a breathable structure or material. 請求項1の包装体であって、少なくとも一部が湾曲できるような構造を持つことを特徴とする人工骨材料の包装体。  It is a package of Claim 1, Comprising: At least one part has a structure which can curve, The package of the artificial bone material characterized by the above-mentioned. 請求項1の包装体であって、少なくとも2段に伸縮出来、伸ばした状態をホールドできる構造からなることを特徴とする人工骨材料の包装体。  It is a package of Claim 1, Comprising: It has a structure which can be expanded-contracted at least 2 steps | paragraphs and can hold | maintain the extended state, The package of the artificial bone material characterized by the above-mentioned. 請求項1の包装体であって、包装体の内容積に対し、内包される人工骨の嵩が70%以下であることを特徴とする人工骨材料の包装体。  The package of artificial bone material according to claim 1, wherein the volume of the artificial bone to be contained is 70% or less with respect to the internal volume of the package.
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