JP3877982B2

JP3877982B2 - Biomedical cement injection device with tissue collection function

Info

Publication number: JP3877982B2
Application number: JP2001216073A
Authority: JP
Inventors: 晃内藤; 勝丸山; 亨彦玉井; 英彦西澤
Original assignee: Hakko Co Ltd
Current assignee: Hakko Co Ltd
Priority date: 2001-07-17
Filing date: 2001-07-17
Publication date: 2007-02-07
Anticipated expiration: 2021-07-17
Also published as: JP2003024339A

Description

【０００１】
【産業上の利用分野】
本発明は、骨腫瘍や骨粗鬆症による圧迫骨折等の骨疾患部位に穿刺して、骨組織の採取と共に骨内に生体用セメントを注入するのに用いる組織採取機能を有する生体用セメント注入器具に関する。
【０００２】
【従来の技術】
近年、骨腫瘍の良悪判定等を目的として、骨組織を採取する骨生検においては、ＣＴガイド下等で経皮的に施術する手技が行われており、そのための器具としていくつか骨生検針が知られている。これらの針は、金属棒状体の内針の先端を三角錐ポイント（トラカールポイント）、あるいは斜めカットポイントの鋭利な刃先とし、一方、金属中空管の外針は先端を斜めカットし、カット面をテーパー状に研磨した刃面として、内針を外針内腔に外針先端部より突出するように挿着した同心状の２重針構造として形成され、各々の基端部に設けた針基を係合して基本構成しており、内臓組織等を適用とする生検針と比較して硬い骨組織への穿刺を考慮し、押圧に加え、回動させながらの穿刺が容易に可能なように、針基（操作部）を大きく形成したものや、特許２５６３９８０に開示されるような外針の先端部位に上面研磨したおねじを形成するなどの工夫をしたものがある。
【０００３】
一方、骨粗鬆症や骨腫瘍等により圧迫骨折をきたした症例に対する整復や骨の補強の目的、あるいは、最近報告されている悪性骨腫瘍の疼痛除去の目的で、ＣＴガイド下等により経皮的に患部へ、リン酸カルシウムやアクリル系材料等よりなる骨セメントのペーストを注入する手技（経皮的骨セメント局注療法、あるいは経皮的骨形成術）がおこなわれている。この骨セメント注入の一般的な手段としては、例えば椎体が圧迫骨折を起こした場合についてみると、背部を切開し、椎弓部をドリルで開孔して、注射器形状の器具を該開孔部より挿入して骨セメントを注入するといった方法が採られており、そのための器具として、例えば特開平７−３１３５８６に開示されているような、先端部を閉塞し、側面に複数の開孔部を設けた生体挿入管と、該挿入管の基端部に押し出し手段を設けたセメント収容部とにより構成される生体セメント用充填装置などがある。また、特に専用器具を用いず、前段の生検針を代用している場合などもある。
【０００４】
【発明が解決しようとする課題】
しかし、臨床において、例えば悪性骨腫瘍が疑われる圧迫骨折などの症例では、骨組織の採取と、セメント注入による骨整復や除痛処置を一度の連続した手技で施術したいとする場合があり、それに適する器具が求められているが、前述した従来の骨生検針や骨セメント注入器具では、本来前記手技を想定したものではないため、どれも単独で適用することはできない。
【０００５】
また、骨セメント注入器具として骨生検針を代用したとする報告もあるが、骨セメントは、粘度の高いペースト状で乾燥も早いため、低粘度のものを少量注入するのであれば問題はないと想像されるが、比較的粘度の高いものを用いる場合や、ある程度の注入量を必要とする症例では、従来の骨生検針の針管の内径では小さく、一度の手技で十分な充填量を注入するのは難しい。また、生検と連続してセメント注入を行うといったことは、生検手技の後に針管内の採取組織を取り出すため一度針を抜去する必要があるため適用できない。
【０００６】
また、従来の器具を利用して、骨生検と骨セメント注入を一度の連続した手技で行うことが可能な想像される手段としては、従来の生体セメント注入器具の中で先端部が開放された管状の針管、あるいは、比較的内径の大きな金属中空状の針管の外針と、金属棒状体よりなる適当な刃先を有する内針とによりなる二重針をセメント注入針として、一方、従来の骨生検針を生検針として、生体のセメント注入部位（患部）に、前記セメント注入針を穿設し、注入針の内針を抜去するなどして生検針挿入のための通路を確保した後、前記骨生検針を該通路に挿通して生検を行うといった手技が考えられるが、注入器具、生検針の他にもドリル等の複数の器具を必要としたり、針管の入れ替え等により手技が面倒となるといった問題があり、また、各々の器具の相互的な適合性等による制約も懸念される。
【０００７】
上述のように、従来では骨組織の採取（骨生検）と骨セメント注入を一つの器具で連続して行うための器具がないことに鑑み、本発明は、経皮的にＣＴガイド下等で、骨組織の採取と骨セメントの注入を一つの器具で一度の連続した手技として施術でき、また、十分な量のセメント注入が可能で、更に、一連の手技（針の穿刺、組織採取、及びセメント注入）が容易で、いずれの段階も満足させることのできる組織採取機能を有する生体セメント注入器具を提供することを課題とした。
【０００８】
【課題を解決するための手段】
本発明の組織採取機能を有する生体セメント注入器具は、生体用セメントの注入通路となる、先端部に刃面と、基端部に針基を設け、先端側に骨穿刺を確実にするためのラセン状の溝を施した金属中空管よりなる注入管、および、組織採取のための、先端部に刃面と、基端部に針基を有する金属中空管よりなる外針と、該外針の内腔に摺動可能に挿着する先端に鋭利な刃先と基端部に針基を有する金属棒状体よりなる内針とを、内針の先端を外針の先端より突出させて、また、内針先端の刃先及び外針先端の刃面部を、あたかも１本の針のように一体として三角錐形状（トラカールポイント）に形成し、各々の基端部に設けた針基により係合させた生検針とにより構成し、前記注入管の内腔に前記生検針を、生検針の先端が注入管の先端より突出するように、かつ摺動可能に挿着し３重針とし、前記注入管の針基と生検針外針の針基、及び生検針外針の針基及び内針の針基は脱着可能で、かつ、穿刺機能を考慮して、注入管と生検針外針及び生検針内外針を挿着した状態では、引き抜き動作及び回動動作（ねじ込み動作）により針基間の脱離あるいは針管相互の位置ズレを生じない固定機構を備えて構成する。
【０００９】
前記注入管より生検針を抜去し、生体用セメントを注入した後、該注入管管内に残存する生体セメントを押し出すための、前記注入管の内腔に摺動可能に挿着される基端部に針基を有する金属棒状体のスタイレットを備えて構成する。
【００１０】
前述した注入管は、生体セメント注入機能及び生体への侵襲性を考慮して、内径を１．６ｍｍ以上、３．８ｍｍ以下に形成することが好ましい。
【００１１】
前記針基間の固定機能として、注入管、生検針外針及び内針の各々の針基を翼形状とし、注入管と生検針外針の針基の固定においては、注入管の翼形状の針基の両側辺部に係止孔を設け、生検針外針の針基には、装着のさい該係止孔と嵌合する位置に係止突起部を設けて、一方、生検針外針と内針の針基の固定においては、外針の針基の両側辺部に係止孔を設け、内針の針基には、装着のさい該係止孔と嵌合する位置に係止突起部を設けて、各々の係止孔に係止突起部を填め込み係合することにより係止固定する機構とする。
【００１２】
また、前記注入管、生検針外針及び内針の翼形状の針基は、各々の管及び針の軸を挟み左右非対称形状とすることが好ましい。
【００１３】
【作用】
本発明の手段によれば、生体セメント注入のための注入管と組織採取のための生検針が一体に構成されているため、ＣＴガイド下等における、経皮的な組織採取とセメント注入を一つの器具により、一度の針穿刺で連続して施術することができる。また、生検針の先端が鋭利な刃先及び刃面を有し、注入針の先端部は刃面及びラセン溝を形成していることにより硬い骨組織への穿刺も器具を回動させながらアプローチすることにより、より容易、確実に穿設することができる。
【００１４】
生体セメント注入終了後、注入管管内に残存する生体セメントを押し出すためのスタイレットを備えることにより、注入管管内に生体セメントを残したままにしておくことにより生じる管内部でのセメント剤の固まりを防止し、同一注入管による複数回のセメント注入を可能とし、またセメント剤硬化により注入管の抜去が困難になるといった不都合を防止することができる。
【００１５】
また、生検針の内外針を一体化して、あたかも一本の針のようにして三角錐形状の刃先を形成していることにより、比較的細い内針の先端部のみに設ける刃先と比較して、穿刺のための最先端部となる刃先部を大きく、長く形成できるため、刃先の強度が向上し穿刺性能を向上させることができ、硬い骨組織への穿刺を考慮すると大きな作用となる。更に、硬い骨組織への穿刺となることで生検針外針が肉薄の金属中空管であると、刃面が刃こぼれを起こす懸念があるため、対応策として生検針外針には比較的肉厚の金属中空管を用いることが想定されるが、このような場合、当然相対的に内針が細くなるため、一層この作用が大きなものとなる。
【００１６】
また、注入管の内径を１．６ｍｍ以上、３．８ｍｍ以下に設定したことは、粘度が高く乾燥しやすい生体用セメントの注入に必要十分な内径を確保すると同時に、生体に対する侵襲性を必要最小限にとどめるよう考慮したものであり、注入量や使用する骨セメントの粘度により十分な内径を確保した上で、極力細いものを選択するよう配慮される。
【００１７】
更に、注入管の針基と生検針外針の針基、及び生検針外針の針基と内針の針基の係合を、各々を挿着した状態で、引き抜き動作及び回動動作により、針基間の脱離や針管相互の位置ズレを生じない前述したような固定機構を備える構成にしたことにより、硬い骨組織へ本器具を穿刺するさいに必要な、比較的強い押圧による穿刺や回動しながらの穿刺による、針基間の係合の抜け、緩み、回動を防ぎ、針管相互の刃先位置ズレを防止することができ、確実な穿刺が可能となる。
【００１８】
また、翼形状とした注入管、生検針外針及び内針の針基を、管あるいは針の軸を挟んで左右非対称形状としたことにより、誤って１８０°逆に装着しようとしても針基が係合されないため、針先が装着段階でズレることを未然に防止することができる。
【００１９】
【実施例】
本発明の組織採取機能を有する生体セメント注入器具の実施例を図面を参考にして詳細に説明する。
【００２０】
図１は、本発明の組織採取機能を有する生体セメント注入器具の一例を示す全体構成図で、１Ａが注入管に生検針を装着したさいの正面図、１Ｂが前記の側面図、１Ｃがスタイレットを示す。患部に生体セメントを注入する注入管１と、該注入管１の内腔に挿通し患部の組織を採取する生検針２と、生体セメント注入後、注入管１の内腔に挿通し管内に残存するセメント剤を押し出すスタイレット５により基本構成され、生検針２は、外針３及び内針４の二重針で構成される。
【００２１】
図２は、本発明の一例の注入管を示す構成図で、注入管１は、注入針１１及び注入針基１２より構成される。注入針１１は、ステンレスパイプよりなり先端部を斜めに切断し、該切断面をテーパー状に研磨して刃面１３とし、先端部より約１０ｍｍの位置までラセン溝１４を設けてなり、注入針基１２は翼形状とし、注入針１１の基端部と接着され、生検針２の外針針基と係合する接続部位となる後端部に、雌ルアーテーパー１２１を形成し、更に後記する固定機構を設けた樹脂成型品よりなる。尚、注入針１１の外径、内径及び長さは特定するものではないが、前述した作用を得るためには、内径を１．６〜３．８ｍｍの範囲とすることが特に好ましく、また注入管外表面には、穿刺の深さの指標となる目盛り１５を例えば１０ｍｍ間隔で設けることが好ましい。
【００２２】
図３は、本発明の一例の生検針を示す構成図で、３Ａが外針、３Ｂが内針、３Ｃが内外針を挿着した生検針２を示す。外針３及び該外針３の内腔に挿着する内針４からなり、外針３は、前記注入管１１の内径と適合してほぼ同じ外径のステンレスパイプよりなり、一方、内針４は、前記外針３の内径と適合してほぼ同じ外径のステンレス棒状体よりなり、外針３の内腔に内針４を挿着したさい、内針４の先端が外針３の先端より突出しており、該先端部は、内外針４、３が一体として三角錐形状（トラカールポイント）を形成するような内針への刃先４１及び外針への刃面３１を設ける。一方、各々の針管端部は、翼形状とした樹脂成型品よりなる外針基３２及び内針基４２と接着され、該外針基３２と内針基４２を着脱自在に係合固定した同心状の二重針として構成している。尚、該外針基３２は、前記した注入針基１２との接続部位となる前端側を雄ルアーテーパー３２２として、更に後記する固定機構を設け、内針基４２との接続部位となる後端側を雌ルアーテーパー３２１として、更に後記する固定機構を設け、内針基４２は、前記外針基３２との接続部位を雄テーパー４２２として、更に後記する固定機構を設けて構成する。
【００２３】
図４は、本発明の一例のスタイレットを示す構成図で、スタイレット５は、押し出し棒５１及びスタイレット基５２より構成される。押し出し棒５１はステンレス棒状体よりなり、先端は半球面形状とし形成され、基端部は樹脂成型品のスタイレット基５２に接着される。注入管１より生検針２を抜去し、生体セメントの注入が一度終了する毎に、該注入管１内腔に挿入し管内に残ったセメント剤を骨内に押し出す目的で使用され、非常に短時間で硬化するセメント剤が手技の中途で管内で硬化して手技を妨げたり、手技終了後セメント剤の硬化により注入管１の抜去が困難になるのを防止するために備えられる。
【００２４】
図５は、本発明の前記一例の先端部の構成図で、５Ａが注入針１、５Ｂが生検針外針３、５Ｃが生検針内針４、５Ｄが各々を係合した状態を示す。尚、図面においては理解を容易とするため、５Ａ、５Ｂ、５Ｃにおいては正面図を、５Ｄにおいては側面図を示した。前記した通り注入針１１の先端刃面１３は、斜め切断面をテーパー状に研磨した形状となり、生検針２先端は、内外針４、３一体として三角錐形状とした刃先４１、刃面３１となっている。詳しくは、生検針内針４は三角錐形状の刃先４１となり、外針３は、斜辺部に３つの鋭い尖塔部を有する先端部を欠いた三角錐台形のような形状の刃面３１となり、内外針各々を係合して一体とすると、トラカールポイントと呼称される三角錐形状の先端部を形成している。
【００２５】
図６は、本発明の前記一例の針基の構成図で、６Ａが注入針基１２、６Ｂが生検針外針基３２、６Ｃが生検針内針基４２、６Ｄが各々を係合して一体化した状態を示す。注入針基１２の後端側と生検針外針基３２の前端側、及び、生検針外針基３２の後端側と生検針内針基４２の前端側が各々次の手段により着脱自在に係合固定される。係合手段となる第１の手段は、注入針基１２の後端側に雌ルアーテーパー１２１を形成し、生検針外針基３２の前端側に雄ルアーテーパー３２２を形成して、一方、生検針外針基３２の後端側に雌ルアーテーパー３２１、生検針内針基４２の前端側に雄ルアーテーパー４２２を形成して、各々を係合させ係止する手段となっている。また、硬い骨組織への針穿刺のさいの強い力による押圧やねじ込みといった操作による、針基間の離脱や刃面の位置ズレなどを生じさせないため固定機構となる第２の手段として各々の針基を翼形状に形成して、注入針基１２は、前記雌ルアーテーパー１２１の両側部に各々係止孔１２３を設けた翼状部１２４を連設した形状として、生検針外針基３２は、前端側の前記雄ルアーテーパー３２２の両側部に、各々、挿入方向は緩やかなテーパー形状３２３をなし、抜去方向には凸形状３２４のストッパーとなる係止突起部３２５、及び該係止突起部３２５に連設して係止突起部間を拡縮方向に可動する張出部３２６を設けた可撓性のアーム部３２７を連設した形状として、後端側は、前記した注入針基１２と同様な係止孔３２８を設けた翼状部３２９を連接した形状とし、生検針内針基４２は、前記した生検針外針基３２の先端側と同様に、係止突起部４２３及び張出部４２４を設けた可撓性のアーム部４２５を連設した形状となっている。各々の連結は、注入針基１２の雌ルアーテーパー部１２１に生検針の外針基３２の雄ルアーテーパー部３２２を係合させるのと同時に、生検針外針３２のアーム部３２７の可撓性による係止突起部３２５間の縮小、及び係止突起部３２５の挿入方向のテーパー形状３２３を利用して、注入針基１２の翼状部１２４の係止孔１２３に、生検針外針基３２のアーム部３２７の係止突起部３２５がはめ込まれるようになっており、係合手段としては差し込むのみで、係止突起部３２５は抜去方向には凸形状３２４をなすためロックされ容易に抜けない固定機構となる。この係止手段は、生検針外針基３２と生検針内針基４２を係合固定する場合も同様であるため説明を省略する。また、取り外す場合は、可撓性のアーム部３２７（あるいは、４２５）の張出部３２６（あるいは、４２４）を両側から押して、係止突起部３２５（あるいは、４２３）間を縮小させることにより係止孔１２３（あるいは、３２８）より係止突起部３２５（あるいは、４２３）を外し、係合を解除して引き抜くことで離脱することができる。
【００２６】
また、各々の針基（１２、３２、４２）は、各々の針管（１１、３、４）の軸を挟み両側部を左右非対称形状としており、詳細には、翼形状とした各々の針基（１２、３２、４２）で両翼左右の針管軸中心からの幅方向への長さに差異を設けており、一方、前記第２の固定機構となる係止孔（１２３、３２８）や係止突起部（３２５、４２３）等を該針基（１２、３２、４２）の両翼辺部に設けているため、該第２の固定機構は、正しい方向には係合するが、逆方向には係合することができず、これにより、係合時に誤って１８０°逆に取り付けることを未然に防いでおり、各々の針基（１２、３２、４２）を係合した場合に刃先及び刃面（１３、２１（３１、４１））の位置を確実に一致させることができる。
【００２７】
本発明の実施例を用いた臨床における使用方法を簡単に説明すると、
１．（穿刺）ＣＴ透視下で穿刺位置及び穿刺目標を定めたら、ＣＴ画像をガイドとして本品の針先を目標部まで穿刺する。この時、骨組織は硬いため押圧穿刺動作に加え、回動動作によりねじ込むことにより確実に穿刺することができる。
２．（組織採取）目標部位に穿刺できたら、生検針の内針を、基部の固定を解除して抜去し、吸引筒を生検針の外針基に装着して吸引する等により組織の採取を行う。
３．（セメント注入）生検が終了したら、生検針の外針を、基部の固定を解除して抜去し、予め調製しておいた生体セメントを入れたシリンジを注入基に装着して、ＣＴ透視下に広がり状態等を確認しながら注入を行う。
４．一度のセメント注入が終了したら、シリンジを取り去り、スタイレットを注入管に挿入して注入管内部に残るセメントを残らず押し出し、必要量が注入できるまで、３．のセメント注入及び４．の残存するセメントを押し出す操作を繰り返えす。
【００２８】
【発明の効果】
本発明によれば、前述された作用により組織採取と生体セメント注入を同時に施術したい症例に対して、一つの器具により、器具の穿刺、組織採取、及び生体セメント注入の一連の手技を連続して効率的にかつ容易に行うことができ、また、生体への低侵襲性や安全性も考慮していることにより、術者にとって、また患者にとっても負担のすくない組織採取機能を有する生体セメント注入器具を提供することができる。
【図面の簡単な説明】
【図１】本発明の実施例の組織採取機能を有する生体セメント注入針を示す全体構成図
【図２】本発明の実施例の注入管を示す構成図
【図３】本発明の実施例の生検針を示す構成図
【図４】本発明の実施例のスタイレットを示す構成図
【図５】本発明の実施例の注入管及び生検針の先端部を示す拡大構成図
【図６】本発明の実施例の注入管及び生検針の基部を示す構成図
【符号の説明】
１．注入管
１１．注入針
１２．注入針針基
１２１．雌ルアーテーパー
１２３．係止孔
１２４．翼状部
１３．刃面
１４．ラセン溝
１５．目盛り
２．生検針
２１．刃先（刃面）部
３．（生検針）外針
３１．刃面
３２．外針基
３２１．雌ルアーテーパー
３２２．雄ルアーテーパー
３２３．係止突起部のテーパー形状
３２４．係止突起部の凸形状
３２５．係止突起部
３２６．張出部
３２７．アーム部
３２８．係止孔
３２９．翼状部
４．（生検針）内針
４１．刃先
４２．内針基
４２２．雄ルアーテーパー
４２３．係止突起部
４２４．張出部
４２５．アーム部
５．スタイレット
５１．押し出し棒
５２．スタイレット基[0001]
[Industrial application fields]
The present invention relates to a biomedical cement injection device having a tissue collection function that is used to puncture a bone disease site such as a compression fracture due to a bone tumor or osteoporosis, and to inject the biomedical cement into the bone together with the collection of the bone tissue.
[0002]
[Prior art]
In recent years, bone biopsy for collecting bone tissue has been performed percutaneously under CT guides for the purpose of determining the quality of bone tumors. Meter reading is known. In these needles, the tip of the inner needle of the metal rod-shaped body has a triangular pyramid point (tracar point) or a sharp cutting edge at an oblique cut point, while the outer needle of the metal hollow tube cuts the tip obliquely and cuts the cut surface. Are formed as a concentric double needle structure in which the inner needle is inserted into the outer needle lumen so as to protrude from the distal end portion of the outer needle as a blade surface polished in a tapered shape. The basic structure is engaged by engaging the base, and it is easy to puncture while rotating, in addition to pressing, considering puncture to hard bone tissue compared to biopsy needles that apply visceral tissue etc. As described above, there are ones in which the needle base (operation part) is formed large, and ones that have been devised such as forming an externally threaded external thread at the tip of the outer needle as disclosed in Japanese Patent No. 2563980.
[0003]
On the other hand, in order to reduce or reinforce bone for patients with compression fractures due to osteoporosis, bone tumors, etc., or for the purpose of removing pain of recently reported malignant bone tumors, the affected area is percutaneously under CT guidance. A technique (percutaneous bone cement local injection therapy or percutaneous osteoplasty) for injecting a bone cement paste made of calcium phosphate, an acrylic material or the like has been performed. As a general means for injecting bone cement, for example, when the vertebral body has a compression fracture, the back is incised, the vertebral arch is opened with a drill, and a syringe-shaped device is opened. For example, as disclosed in Japanese Patent Application Laid-Open No. 7-313586, the distal end is closed and a plurality of apertures are formed on the side surface. There is a bio-cement filling device composed of a bio-insertion tube provided with a slab and a cement storage unit provided with a pushing means at the base end of the insert tube. In some cases, a special biopsy needle is used instead of a special instrument.
[0004]
[Problems to be solved by the invention]
However, in clinical cases, for example, in cases such as compression fractures where a malignant bone tumor is suspected, it may be desired to perform bone tissue collection and bone reduction or pain relief treatment by cement injection in one continuous procedure. Although a suitable instrument is required, none of the conventional bone biopsy needles and bone cement injection instruments described above are originally intended for the above procedure, and therefore cannot be applied alone.
[0005]
There is also a report that a bone biopsy needle was used as a bone cement injection device, but bone cement is a paste with high viscosity and quick drying, so there is no problem if a small amount of low viscosity is injected. As imagined, in cases where a relatively high viscosity is used or a case where a certain amount of injection is required, the inner diameter of the needle tube of a conventional bone biopsy needle is small, and a sufficient filling amount is injected by one procedure. Is difficult. In addition, cement injection continuously with a biopsy is not applicable because it is necessary to remove the needle once in order to take out the collected tissue in the needle tube after the biopsy procedure.
[0006]
In addition, as a conceivable means capable of performing bone biopsy and bone cement injection by one continuous procedure using a conventional instrument, the tip portion is opened in the conventional biological cement injection instrument. A double needle consisting of a tubular needle tube or an outer needle of a metal hollow needle tube having a relatively large inner diameter and an inner needle having an appropriate cutting edge made of a metal rod-shaped body is used as a cement injection needle. Using a bone biopsy needle as a biopsy needle, drilling the cement injection needle in the cement injection site (affected part) of the living body, and removing the inner needle of the injection needle, etc., to secure a passage for biopsy needle insertion, A technique such as inserting a bone biopsy needle into the passage and performing a biopsy can be considered, but in addition to an injection instrument and a biopsy needle, a plurality of instruments such as a drill are required, and the procedure is troublesome by replacing the needle tube. And there is a problem that Limited by mutual compatibility, and the like of people of the instrument is also a concern.
[0007]
As described above, in view of the fact that there is no instrument for continuously performing bone tissue collection (bone biopsy) and bone cement injection with a single instrument, the present invention is percutaneously CT-guided or the like. Therefore, the collection of bone tissue and the injection of bone cement can be performed as a single continuous procedure with one instrument, and a sufficient amount of cement can be injected. Furthermore, a series of procedures (needle puncture, tissue sampling, It was an object of the present invention to provide a bio-cement injection device having a tissue sampling function that can be satisfied at any stage.
[0008]
[Means for Solving the Problems]
The bio-cement injection device having a tissue sampling function of the present invention is a bio-cement injecting passage, provided with a blade surface at the distal end portion and a needle base at the proximal end portion to ensure bone puncture at the distal end side. An injection tube made of a metal hollow tube with a spiral groove, and an outer needle made of a metal hollow tube having a blade surface at the distal end and a needle base at the proximal end for tissue collection, Insert the tip of the inner needle into the tip of the outer needle with a sharp cutting edge at the tip of the outer needle that is slidably inserted into the lumen of the outer needle and the inner needle made of a metal rod with a needle base at the base end. In addition, the tip of the inner needle and the blade surface of the outer needle tip are formed into a triangular pyramid shape (trocar point) as if they were one needle, and are engaged by a needle base provided at each base end. A biopsy needle combined with the biopsy needle in the lumen of the injection tube, the tip of the biopsy needle from the tip of the injection tube As output, and slidably and inserted to triple needle, the needle hub and the biopsy needle outside the needle hub of the injection tube, and a needle base and the inner needle hub of the biopsy needle outer needle is removable In addition, in consideration of the puncture function, when the injection tube, the biopsy needle outer needle, and the biopsy needle inner / outer needle are inserted, the needle base is detached or the needle tube is mutually removed by the pulling operation and the rotating operation (screwing operation). And a fixing mechanism that does not cause the positional deviation .
[0009]
A base end portion slidably inserted into the lumen of the injection tube for extruding the biological cement remaining in the injection tube after extracting the biopsy needle from the injection tube and injecting the biological cement A metal rod-like stylet having a needle base is provided.
[0010]
The above-mentioned injection tube is preferably formed with an inner diameter of 1.6 mm or more and 3.8 mm or less in consideration of a living cement injection function and invasiveness to the living body.
[0011]
As the fixing function between the needle bases, the needle base of each of the injection tube, the biopsy needle outer needle and the inner needle has a wing shape, and in fixing the needle base of the injection tube and the biopsy needle outer needle, the wing shape of the injection tube Locking holes are provided on both sides of the needle base, and the needle base of the biopsy needle outer needle is provided with a locking projection at a position where it is fitted with the locking hole, while the biopsy needle outer needle When securing the needle base of the inner needle, locking holes are provided on both sides of the needle base of the outer needle, and the needle base of the inner needle is locked at a position where it fits into the locking hole during mounting. Protrusions are provided, and the locking projections are inserted into the respective locking holes and engaged with each other to engage and fix.
[0012]
In addition, it is preferable that the wing-shaped needle bases of the injection tube, the biopsy needle outer needle, and the inner needle have a left-right asymmetric shape with the axis of each tube and needle interposed therebetween.
[0013]
[Action]
According to the means of the present invention, since the injection tube for bio-cement injection and the biopsy needle for tissue collection are configured integrally, percutaneous tissue collection and cement injection under a CT guide or the like are integrated. With one instrument, a single needle puncture can be performed continuously. In addition, the tip of the biopsy needle has a sharp blade edge and blade surface, and the tip of the injection needle forms a blade surface and a helical groove, so that puncture to hard bone tissue is approached while rotating the instrument. Therefore, it can be drilled more easily and reliably.
[0014]
After completion of bio-cement injection, by providing a stylet for extruding the bio-cement remaining in the injection tube, it is possible to reduce the amount of cement in the tube caused by leaving bio-cement in the injection tube. It is possible to prevent the inconvenience that the cement injection can be performed a plurality of times by the same injection pipe, and that it becomes difficult to remove the injection pipe due to the hardening of the cement agent.
[0015]
In addition, the inner and outer needles of the biopsy needle are integrated to form a triangular pyramid-shaped cutting edge as if it were a single needle, compared to a cutting edge provided only at the tip of a relatively thin inner needle. Since the cutting edge portion that is the most advanced portion for puncturing can be formed large and long, the strength of the cutting edge can be improved and the puncturing performance can be improved, which is a great effect when considering puncturing to hard bone tissue. Furthermore, if the biopsy needle outer needle is a thin metal hollow tube due to puncture to hard bone tissue, there is a concern that the blade surface may spill out. Although it is assumed that a thick metal hollow tube is used, in such a case, the inner needle is naturally relatively thin, and this action is further increased.
[0016]
In addition, setting the inner diameter of the injection tube to 1.6 mm or more and 3.8 mm or less ensures the necessary and sufficient inner diameter for injection of biological cement that is highly viscous and easy to dry, and at the same time minimizes invasiveness to the living body. It is considered to be limited, and it is considered to select a thin one as much as possible after securing a sufficient inner diameter depending on the injection amount and the viscosity of the bone cement to be used.
[0017]
Furthermore, with the needle base of the injection tube and the needle base of the outer needle of the biopsy needle, and the engagement of the needle base of the biopsy needle outer needle and the needle base of the inner needle being inserted and attached, Puncturing with a relatively strong pressure required for puncturing the instrument into hard bone tissue by employing the above-described fixing mechanism that does not cause detachment between needle bases or misalignment between needle tubes. Further, it is possible to prevent disengagement, loosening, and rotation between the needle bases due to puncturing while rotating, and to prevent the edge positions of the needle tubes from being displaced, thereby enabling reliable puncturing.
[0018]
In addition, the needle base of the wing-shaped injection tube, biopsy needle outer needle and inner needle is asymmetrical with the tube or needle shaft in between, so that the needle base will not be attached even if it is erroneously mounted 180 ° Since they are not engaged, it is possible to prevent the needle tip from shifting at the mounting stage.
[0019]
【Example】
An embodiment of a bio-cement injection device having a tissue sampling function of the present invention will be described in detail with reference to the drawings.
[0020]
FIG. 1 is an overall configuration diagram showing an example of a biocement injection device having a tissue sampling function according to the present invention. 1A is a front view when a biopsy needle is attached to an injection tube, 1B is the side view, and 1C is a stylus. Indicates a let. An injection tube 1 for injecting biological cement into the affected part, a biopsy needle 2 for taking the tissue of the affected part through the lumen of the injection tube 1, and inserting into the lumen of the injection pipe 1 after injection of the biological cement and remaining in the pipe The biopsy needle 2 is composed of a double needle of an outer needle 3 and an inner needle 4.
[0021]
FIG. 2 is a block diagram showing an injection tube according to an example of the present invention. The injection tube 1 is composed of an injection needle 11 and an injection needle base 12. The injection needle 11 is made of a stainless steel pipe, the tip portion is cut obliquely, the cut surface is polished into a taper shape, and a helical groove 14 is provided to a position about 10 mm from the tip portion. The base 12 has a wing shape and is bonded to the base end portion of the injection needle 11, and a female luer taper 121 is formed at the rear end portion that becomes a connection portion that engages with the outer needle base of the biopsy needle 2, which will be described later. It consists of a resin molded product provided with a fixing mechanism. Although the outer diameter, inner diameter, and length of the injection needle 11 are not specified, it is particularly preferable that the inner diameter be in the range of 1.6 to 3.8 mm in order to obtain the above-described action. On the outer surface of the tube, it is preferable to provide a scale 15 that is an index of puncture depth, for example, at intervals of 10 mm.
[0022]
FIG. 3 is a block diagram showing a biopsy needle according to an example of the present invention. 3A shows an outer needle, 3B shows an inner needle, and 3C shows a biopsy needle 2 with an inner and outer needle inserted therein. The outer needle 3 is composed of an outer needle 3 and an inner needle 4 which is inserted into the inner cavity of the outer needle 3. The outer needle 3 is made of a stainless steel pipe having substantially the same outer diameter that matches the inner diameter of the injection tube 11, while the inner needle 4 is made of a stainless rod-like body having the same outer diameter that matches the inner diameter of the outer needle 3, and when the inner needle 4 is inserted into the lumen of the outer needle 3, the tip of the inner needle 4 is the outer needle 3. The tip protrudes from the tip, and the tip portion is provided with a blade tip 41 to the inner needle and a blade surface 31 to the outer needle so that the inner and outer needles 4 and 3 integrally form a triangular pyramid shape (trocar point). On the other hand, each end of the needle tube is bonded to an outer needle base 32 and an inner needle base 42 made of a wing-shaped resin molded product, and the outer needle base 32 and the inner needle base 42 are detachably engaged and fixed. It is configured as a double needle. The outer needle base 32 has a male luer taper 322 on the front end side which is a connection site with the injection needle base 12 and a fixing mechanism which will be described later, and a rear end which becomes a connection site with the inner needle base 42. The inner needle base 42 is configured with a male taper 422 as a connecting portion with the outer needle base 32 and further provided with a fixing mechanism described later.
[0023]
FIG. 4 is a block diagram showing a stylet according to an example of the present invention. The stylet 5 includes an extrusion bar 51 and a stylet base 52. The extrusion rod 51 is made of a stainless rod-like body, the tip is formed in a hemispherical shape, and the base end is bonded to a stylet base 52 of a resin molded product. The biopsy needle 2 is removed from the injection tube 1 and is used for the purpose of pushing out the cement agent inserted into the lumen of the injection tube 1 and remaining in the tube every time bioinjection of the biological cement is completed. It is provided to prevent the cement agent that hardens in time from being hardened in the tube in the middle of the procedure and hindering the procedure, or to make it difficult to remove the injection tube 1 due to the hardening of the cement agent after the procedure is completed.
[0024]
FIG. 5 is a configuration diagram of the distal end portion of the example of the present invention, in which 5A shows an injection needle 1, 5B a biopsy needle outer needle 3, 5C and a biopsy needle inner needle 4, 5D engaged with each other. In the drawings, for easy understanding, a front view is shown in 5A, 5B, and 5C, and a side view is shown in 5D. As described above, the distal end blade surface 13 of the injection needle 11 has a shape obtained by polishing an oblique cut surface into a taper shape, and the distal end of the biopsy needle 2 has a blade tip 41, a blade surface 31 and an inner and outer needles 4 and 3 integrally formed with a triangular pyramid shape. It has become. Specifically, the biopsy needle inner needle 4 is a triangular pyramid-shaped cutting edge 41, and the outer needle 3 is a triangular frustum-shaped blade surface 31 lacking a tip having three sharp spire portions on the hypotenuse, When the inner and outer needles are engaged and integrated, a triangular pyramid-shaped tip called a trocar point is formed.
[0025]
FIG. 6 is a configuration diagram of the needle base of the above-described example of the present invention. 6A is an injection needle base 12, 6B is a biopsy needle outer needle base 32, 6C is a biopsy needle inner needle base 42, 6D is engaged with each other. An integrated state is shown. The rear end side of the injection needle base 12 and the front end side of the biopsy needle outer needle base 32 and the rear end side of the biopsy needle outer needle base 32 and the front end side of the biopsy needle inner needle base 42 are detachably engaged by the following means, respectively. Fixed. The first means as the engaging means is formed with a female luer taper 121 on the rear end side of the injection needle base 12 and a male luer taper 322 on the front end side of the biopsy needle outer needle base 32, A female luer taper 321 is formed at the rear end side of the meter reading outer needle base 32 and a male luer taper 422 is formed at the front end side of the biopsy needle inner needle base 42, which serve as means for engaging and locking each. In addition, each needle is used as a second mechanism that serves as a fixing mechanism so as not to cause disengagement between needle bases or displacement of the blade surface due to operations such as pressing or screwing with a strong force when needle punctures hard bone tissue. The base is formed in a wing shape, and the injection needle base 12 has a shape in which wing-like portions 124 provided with locking holes 123 on both sides of the female luer taper 121 are connected to each other. On both sides of the male luer taper 322 on the front end side, there are formed a tapered shape 323 with a gentle insertion direction, a locking projection 325 serving as a stopper with a convex shape 324 in the removal direction, and the locking projection 325. The rear end side is the same as that of the injection needle base 12 described above, with a flexible arm portion 327 provided continuously with the protruding portion 326 that is movable in the expansion / contraction direction between the locking projections. Wing shape with a simple locking hole 328 329 is formed in a connected shape, and the biopsy needle inner needle base 42 is a flexible arm portion 425 provided with a locking projection 423 and an overhanging portion 424 in the same manner as the distal end side of the biopsy needle outer needle base 32 described above. It has a shape that is connected continuously. Each connection is made by engaging the male luer tapered portion 322 of the outer needle base 32 of the biopsy needle with the female luer tapered portion 121 of the injection needle base 12 and at the same time, the flexibility of the arm portion 327 of the biopsy needle outer needle 32. By utilizing the reduction between the locking projections 325 and the taper shape 323 in the insertion direction of the locking projection 325, the biopsy needle outer needle base 32 is inserted into the locking hole 123 of the wing-shaped portion 124 of the injection needle base 12. The locking projection 325 of the arm portion 327 is fitted, and the locking projection 325 is locked because it has a convex shape 324 in the removal direction only by being inserted as an engaging means. It becomes a mechanism. This locking means is the same when the biopsy needle outer needle base 32 and the biopsy needle inner needle base 42 are engaged and fixed, and the description thereof will be omitted. Also, when removing, the overhanging portion 326 (or 424) of the flexible arm portion 327 (or 425) is pushed from both sides to reduce the space between the locking projections 325 (or 423). It can be detached by removing the locking projection 325 (or 423) from the stop hole 123 (or 328), releasing the engagement and pulling it out.
[0026]
Each needle base (12, 32, 42) has an asymmetrical shape on both sides sandwiching the axis of each needle tube (11, 3, 4), and more specifically, each needle base having a wing shape. (12, 32, 42), there is a difference in length in the width direction from the center of the needle tube shaft on the left and right sides of both wings. On the other hand, the locking holes (123, 328) and the locking that serve as the second fixing mechanism Since the projections (325, 423) and the like are provided on both wing sides of the needle base (12, 32, 42), the second fixing mechanism is engaged in the correct direction, but in the opposite direction. It is impossible to engage with each other, thereby preventing an erroneous 180 ° reverse mounting at the time of engagement, and the blade edge and the blade surface when each needle base (12, 32, 42) is engaged. The positions of (13, 21 (31, 41)) can be reliably matched.
[0027]
Briefly describing the clinical use method using an embodiment of the present invention,
1. (Puncture) When the puncture position and puncture target are determined under CT fluoroscopy, the needle tip of this product is punctured to the target portion using the CT image as a guide. At this time, since the bone tissue is hard, in addition to the pressing puncturing operation, it can be reliably punctured by being screwed by a rotating operation.
2. (Tissue sampling) Once the target site has been punctured, the inner needle of the biopsy needle is removed with the base fixed, and the tissue is collected by attaching a suction cylinder to the outer needle base of the biopsy needle and performing suction, etc. .
3. (Cement injection) When the biopsy is completed, the outer needle of the biopsy needle is removed with the base fixed, and a syringe containing biological cement prepared in advance is attached to the injection base. The injection is performed while confirming the spread state.
4). 2. Once cement injection is complete, remove the syringe, insert the stylet into the injection tube and push out all of the cement remaining inside the injection tube until the required amount can be injected. 3. cement injection and Repeat the operation of extruding the remaining cement.
[0028]
【The invention's effect】
According to the present invention, for a case where tissue sampling and bio-cement injection are simultaneously performed by the above-described action, a series of procedures of instrument puncture, tissue sampling, and bio-cement injection are continuously performed with one instrument. A bio-cement injection device that can be performed efficiently and easily, and has a tissue collection function that is less burdensome for the operator and patient by considering the minimally invasiveness and safety of the living body. Can be provided.
[Brief description of the drawings]
FIG. 1 is an overall configuration diagram showing a bio-cement injection needle having a tissue sampling function according to an embodiment of the present invention. FIG. 2 is a configuration diagram showing an injection tube according to an embodiment of the present invention. FIG. 4 is a block diagram showing a stylet according to an embodiment of the present invention. FIG. 5 is an enlarged block diagram showing an injection tube and a tip of a biopsy needle according to an embodiment of the present invention. Schematic diagram showing the base of the injection tube and biopsy needle of the embodiment of the invention
1. Injection tube 11. Injection needle 12. Injection needle needle base 121. Female luer taper 123. Locking hole 124. Wing 13. Blade surface 14. Helical groove 15. Scale 2 Biopsy needle 21. 2. Blade edge (blade surface) part (Biopsy needle) Outer needle 31. Blade surface 32. Outer needle base 321. Female luer taper 322. Male luer taper 323. Tapered shape of locking projection 324. Convex shape of locking projection 325. Locking protrusion 326. Overhang part 327. Arm portion 328. Locking hole 329. Wings 4. (Biopsy needle) Inner needle 41. Cutting edge 42. Inner needle base 422. Male luer taper 423. Locking protrusion 424. Overhang portion 425. 4. Arm part Stylet 51. Push bar 52. Stylet group

Claims

An injection tube that has a blade surface at the distal end portion, a needle base at the proximal end portion, and a metal hollow tube having a spiral groove on the distal end side, which serves as an injection passage for biological cement,
An outer needle made of a metal hollow tube having a blade surface at the distal end portion and a needle base at the proximal end portion, a sharp blade tip slidably inserted into the lumen of the outer needle, and a proximal end portion The tip of the inner needle is projected from the tip of the outer needle, and the tip (blade surface) of the tip is triangular with the inner needle and outer needle integrated. It is formed with a cone shape (trocar point) and is composed of a biopsy needle for tissue collection engaged by a needle base provided at each proximal end,
The biopsy needle is inserted into the lumen of the injection tube so that the tip of the biopsy needle protrudes from the tip of the injection tube and is slidable to form a triple needle. The needle base of the injection tube and the outside of the biopsy needle The engagement between the needle base of the needle and the needle base of the biopsy needle outer needle and the needle base of the biopsy needle is detachable, and in the inserted state, the needle base is detached by the pulling or rotating operation. A cement injection needle for living body having a tissue sampling function, characterized by comprising a fixing mechanism that is not provided .

A stylet for extruding the living cement remaining in the injection tube after the biocement injection, comprising a metal rod-like body slidably inserted into the lumen of the injection tube and having a needle base at the base end. A biological cement injection needle having a tissue sampling function.

The living body cement injection device having a tissue sampling function according to claim 1 or 2 , wherein the injection tube has an inner diameter of 1.6 mm or more and 3.8 mm or less.

The fixing mechanism between the needle bases has a needle shape of each of the injection tube, the outer needle of the biopsy needle and the inner needle, and in fixing the needle base of the injection tube and the outer needle of the biopsy needle, Locking holes are provided on both sides of the needle base, while the needle base of the biopsy needle outer needle is provided with a locking projection at a position where it fits into the locking hole when mounted,
When fixing the outer base of the biopsy needle and the needle base of the inner needle, locking holes are provided on both sides of the needle base of the outer needle, while the needle base of the inner needle is fitted with the locking hole when mounted. Provide a locking projection at the mating position,
Biological cement injection instrument having a tissue sampling function according to claim 1 to 3, locked and fixed by insert engaging the locking projections in locking holes each.

The living cement injection device having a tissue sampling function according to claim 4 , wherein the wing-shaped needle bases of the injection tube, the outer needle of the biopsy needle and the inner needle have a bilaterally asymmetric shape sandwiching the axis of each tube and needle.