JP2009538684A - Surgical stapler with timer and feedback display - Google Patents
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- A61B17/00—Surgical instruments, devices or methods
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00115—Electrical control of surgical instruments with audible or visual output
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00115—Electrical control of surgical instruments with audible or visual output
- A61B2017/00119—Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00115—Electrical control of surgical instruments with audible or visual output
- A61B2017/00128—Electrical control of surgical instruments with audible or visual output related to intensity or progress of surgical action
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00132—Setting operation time of a device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0807—Indication means
- A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
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Abstract
外科装置は、クランプとステープリングメカニズムとを有する。クランプは、第1の顎部と第2の顎部とを有しており、ステープリング動作のために、所望の位置で身体組織をクランピングする。ステープリングメカニズムは、トリガハンドルまたはスイッチアセンブリによって制御される。外科装置は、クランピングとステープリングメカニズムの発射メカニズムの作動との間に遅延を提供するコントローラを有する。遅延はより均一なステープルの形成を生成する組織の圧縮のための所望の時間を提供する。外科器具はまたインジケータを有する。インジケータはステープリングメカニズムの状態に関するフィードバックを提供し、クランプによる組織の圧縮時間の表示も行う。The surgical device has a clamp and a stapling mechanism. The clamp has a first jaw and a second jaw and clamps body tissue at a desired location for stapling action. The stapling mechanism is controlled by a trigger handle or switch assembly. The surgical device has a controller that provides a delay between clamping and actuation of the firing mechanism of the stapling mechanism. The delay provides the desired time for tissue compression to produce a more uniform staple formation. The surgical instrument also has an indicator. The indicator provides feedback on the status of the stapling mechanism and also displays the time of tissue compression by the clamp.
Description
(関連出願の引用)
本特許出願は、Violaらによる2005年6月3日出願の米国特許仮出願第60/687,406号に対する優先権を主張し、該仮出願は本明細書においてその全体が参考として援用される。本特許出願はまた、Violaらによる2005年6月3日出願の米国特許仮出願第60/687,244号に対する優先権を主張し、該仮出願は本明細書においてその全体が参考として援用される。本特許出願はまた、本明細書においてその全体が参考として援用される当該特許出願と同時に出願されているViolaらによる米国特許出願第 号(代理人整理番号第H−US−00377(203−4730))と関連する。
(Citation of related application)
This patent application claims priority to US Provisional Application No. 60 / 687,406, filed June 3, 2005, by Viola et al., Which is hereby incorporated by reference in its entirety. . This patent application also claims priority to US Provisional Application No. 60 / 687,244, filed June 3, 2005, by Viola et al., Which is incorporated herein by reference in its entirety. The This patent application is also a U.S. patent application filed by Viola et al. Filed concurrently with that patent application incorporated herein by reference in its entirety. (Attorney Docket No. H-US-00377 (203-4730)).
(技術分野)
本開示は外科器具に関する。さらに詳細には、本開示はフィードバックおよびタイマーのデバイスを有する外科用ステープリングデバイスに関する。さらにより詳細には、本開示は、外科用ステープリングデバイスの1つ以上のパラメータを調節し、組織の圧縮を提供するコントローラを有する外科用ステープリングデバイスに関する。またさらにより詳細には、本開示は、位置、時間、または他の貴重なユーザのフィードバックを決定する感覚(すなわち、視覚的、聴覚的、触覚的)インジケータをも含み得る外科用ステープリングデバイスに関する。
(Technical field)
The present disclosure relates to surgical instruments. More particularly, the present disclosure relates to a surgical stapling device having a feedback and timer device. Even more particularly, the present disclosure relates to a surgical stapling device having a controller that adjusts one or more parameters of the surgical stapling device and provides tissue compression. Even more particularly, the present disclosure relates to a surgical stapling device that may also include a sensory (ie, visual, audible, tactile) indicator that determines position, time, or other valuable user feedback. .
いったんクランプデバイスのような外科用ステープラの顎部構造からの圧力の下に置かれると、身体組織はゆっくりと圧縮する。クランプデバイスによる圧縮は、クランピングされた組織への血液および体液の量を減少させる。このような圧縮を用いなければ、圧縮されていない身体組織は、より厚いままであるが、圧縮された身体組織は、より薄くなり、よりコンパクトになる。組織を圧縮することはまた、概ね、高圧のまたは圧縮されたエリアから別の低圧のまたは隣接するエリアに血液および他の体液を横切らせる。 Once placed under pressure from the surgical stapler jaw structure, such as a clamping device, the body tissue slowly compresses. Compression by the clamping device reduces the amount of blood and fluid to the clamped tissue. Without such compression, uncompressed body tissue remains thicker, but compressed body tissue becomes thinner and more compact. Compressing tissue also generally causes blood and other bodily fluids to cross from a high pressure or compressed area to another low pressure or adjacent area.
いったん解放されると、体液は、組織の粘弾特性により、隣接するエリアから、先に圧縮されていた組織に戻る。一部の現在の外科用ステープリングデバイスは、身体組織の中へのステープルの導入に先立ち、最初に組織を圧縮する。組織が圧縮される時間は、現在では、外科医の裁量に任されている。外科医は、ステープルを組織の中に発射することに先立ち、組織が圧縮される時間を手動で制御する。従って、所定の圧縮量の後に常にステープルを発射する外科用ステープリングデバイスを有することが望ましい。 Once released, body fluid returns from the adjacent area to the previously compressed tissue due to the viscoelastic properties of the tissue. Some current surgical stapling devices initially compress tissue prior to the introduction of staples into body tissue. The time at which the tissue is compressed is now left to the surgeon's discretion. The surgeon manually controls the time that the tissue is compressed prior to firing the staples into the tissue. Accordingly, it is desirable to have a surgical stapling device that always fires staples after a predetermined amount of compression.
本開示の第1の実施形態に従って、固定のハンドルと、作動ストロークを介した操作のために設置されている旋回可能なハンドルとを含むハンドルアセンブリを有する外科用ステープラが提供される。別の実施形態において、ステープラは作動ストロークを介してカム部材を操作するように動作可能であるトリガを有し得る。ステープラはまたハンドルアセンブリから遠位方向に伸び、長手方向軸を規定する細長い本体と、細長い本体の遠位端付近で支持され、複数のステープルを含むステープルカートリッジとを有する。 In accordance with a first embodiment of the present disclosure, a surgical stapler is provided having a handle assembly that includes a fixed handle and a pivotable handle that is installed for operation via an actuation stroke. In another embodiment, the stapler may have a trigger that is operable to manipulate the cam member via an actuation stroke. The stapler also has an elongate body extending distally from the handle assembly and defining a longitudinal axis, and a staple cartridge supported near the distal end of the elongate body and including a plurality of staples.
ステープラはさらに細長い本体の遠位端付近にカートリッジに対して旋回するように設置されているアンビルを有し、該アンビルはその上にファスナ形成面を有し、ステープルカートリッジから間隔が空けられた遠位端を有する開位置と、ステープルカートリッジに密着し協働する配置にある閉位置との間でのカートリッジに対する旋回的な動きのために設置されている。ステープラはまた、カートリッジ内で支持されている作動スレッドを有する。作動スレッドは、該カートリッジから複数のステープルを押し出すように動く。 The stapler further has an anvil positioned to pivot relative to the cartridge near the distal end of the elongate body, the anvil having a fastener-forming surface thereon and spaced far from the staple cartridge. Installed for pivotal movement relative to the cartridge between an open position having a leading edge and a closed position in close contact with and cooperating with the staple cartridge. The stapler also has an actuation sled that is supported in the cartridge. The actuation sled moves to push a plurality of staples from the cartridge.
ステープラはさらに、作業端と該作業端の上で支持されているカム部材とを有する本体を含む駆動アセンブリを有する。カム部材は、ステープラの発射の間にアンビルを閉位置に維持するように、アンビルに対して移動するように配置される。トリガまたは旋回可能なハンドルは駆動アセンブリに動作可能に接続され、作動ストロークを介した旋回可能なハンドルの操作が、該アンビルに対する該カム部材の移動をもたらす。ステープラはまたステープルカートリッジを支持するためのチャネルと、ステープルカートリッジ内で支持される作動スレッドを制御するように構成されているコントローラとを有する。アンビルが閉位置にあり、ステープルカートリッジと協働する配置にあるときには、コントローラは、所定の期間、ステープルカートリッジから複数のステープルを押し出すための作動スレッドの動きを遅延させる。 The stapler further includes a drive assembly that includes a body having a working end and a cam member supported on the working end. The cam member is arranged to move relative to the anvil so as to maintain the anvil in the closed position during stapler firing. A trigger or pivotable handle is operably connected to the drive assembly, and manipulation of the pivotable handle via the actuation stroke results in movement of the cam member relative to the anvil. The stapler also has a channel for supporting the staple cartridge and a controller configured to control the actuation sled supported within the staple cartridge. When the anvil is in the closed position and in an arrangement for cooperating with the staple cartridge, the controller delays movement of the actuation sled to push the plurality of staples out of the staple cartridge for a predetermined period of time.
本開示の別の局面に従って、外科用ステープラは固定のハンドルと、作動ストロークを介してカム部材を操作するように構成されているトリガとを含むハンドルアセンブリを有する。ステープラはまた、ハンドルアセンブリから遠位方向に伸び、長手方向軸を規定する細長い本体と、細長い本体の遠位端付近で支持され、ステープルを有するステープルカートリッジとを有する。ステープラはさらに、細長い本体の遠位端付近に該カートリッジに対して旋回するように設置されているアンビルを有する。アンビルはその上にファスナ形成面を有し、ステープルカートリッジから間隔が空けられた遠位端を有する開位置と、ステープルカートリッジに密着し協働する配置にある閉位置との間でのカートリッジに対する旋回的な動きのために設置されている。 In accordance with another aspect of the present disclosure, a surgical stapler has a handle assembly that includes a fixed handle and a trigger configured to manipulate a cam member via an actuation stroke. The stapler also has an elongate body extending distally from the handle assembly and defining a longitudinal axis, and a staple cartridge supported near the distal end of the elongate body and having staples. The stapler further has an anvil positioned to pivot relative to the cartridge near the distal end of the elongated body. The anvil has a fastener-forming surface thereon and pivots with respect to the cartridge between an open position having a distal end spaced from the staple cartridge and a closed position in close contact with and cooperating with the staple cartridge. It is installed for dynamic movement.
ステープラはまたカートリッジ内で支持されている作動スレッドを有する。作動スレッドは、カートリッジからステープルを押し出すように動く。駆動アセンブリは作業端と該作業端の上で支持されている該カム部材とを有する本体を含む。カム部材はステープラの発射の間にアンビルを閉位置に維持するように、アンビルに対して移動するように配置される。 The stapler also has a working sled supported within the cartridge. The actuation sled moves to push the staples from the cartridge. The drive assembly includes a body having a working end and the cam member supported on the working end. The cam member is arranged to move relative to the anvil so as to maintain the anvil in the closed position during firing of the stapler.
トリガは該駆動アセンブリに接続されることにより、作動ストロークを介したトリガの操作が、アンビルに対するカム部材の移動をもたらす。ステープラはまたステープルカートリッジを支持するためのチャネルを有する。ステープラはまたコントローラを有する。コントローラはステープルカートリッジ内で支持される作動スレッドを制御するように構成されている。アンビルが閉位置にあり、ステープルカートリッジと協働する配置にあるときに、コントローラは、所定の期間、カートリッジから複数のステープルを押し出すための作動スレッドの動きを遅延させる。外科用ステープラはまた、コントローラに接続されているインジケータを有する。所定の期間に到達したときに、コントローラはインジケータを制御することにより、指示を提供する。 A trigger is connected to the drive assembly so that manipulation of the trigger via the actuation stroke results in movement of the cam member relative to the anvil. The stapler also has a channel for supporting the staple cartridge. The stapler also has a controller. The controller is configured to control the working sled supported within the staple cartridge. When the anvil is in the closed position and in an arrangement for cooperating with the staple cartridge, the controller delays movement of the actuation sled to push the plurality of staples out of the cartridge for a predetermined period of time. The surgical stapler also has an indicator connected to the controller. When the predetermined period is reached, the controller provides an indication by controlling the indicator.
本開示の別の実施形態に従って、組織をステープリングする方法が提供される。方法は、ステープルカートリッジとアンビルとの間で組織の位置を決めるステップと、ステープルカートリッジとアンビルとの間で組織を圧縮するステップとを含む。方法はまた、作動器を操作し、ステープルカートリッジからステープルを発射するステップを有する。作動器は、所定の期間、ステープルを発射することを自動的に遅延させるように構成されている。所定の期間は、該所定の期間に組織の圧縮を可能にし、組織が第1の初期の状態から第2の圧縮された状態に移ることを可能にするのに適した長さである。方法はまた、組織が第2の圧縮状態にあるときには、所定の期間の経過時にステープルカートリッジから組織を通してステープルを押し出すステップを有する。 In accordance with another embodiment of the present disclosure, a method for stapling tissue is provided. The method includes positioning tissue between the staple cartridge and the anvil and compressing tissue between the staple cartridge and the anvil. The method also includes manipulating the actuator and firing staples from the staple cartridge. The actuator is configured to automatically delay firing the staple for a predetermined period of time. The predetermined time period is of a length suitable to allow tissue compression during the predetermined time period and to allow the tissue to move from a first initial state to a second compressed state. The method also includes pushing the staples from the staple cartridge through the tissue when the predetermined period has elapsed when the tissue is in the second compressed state.
本開示の別の局面に従って、外科用ステープラは、発射メカニズム構成要素の作動とステープルの実際の発射との間に遅延を置くコントローラを有する。 In accordance with another aspect of the present disclosure, the surgical stapler has a controller that places a delay between actuation of the firing mechanism component and actual firing of the staples.
本開示の別の局面に従って、外科用ステープラは、クランプの組織圧縮時間を増加させるために、発射メカニズム構成要素のストロークパラメータ、距離パラメータ、および/または時間パラメータを制御する制御デバイスを有する。 In accordance with another aspect of the present disclosure, the surgical stapler has a control device that controls the stroke, distance, and / or time parameters of the firing mechanism component to increase the tissue compression time of the clamp.
本開示のまた別の局面に従って、外科ステープルはモータと第1のスイッチとを有する。第1のスイッチはモータに接続され、クランプによる充分な組織の圧縮を達成するために、モータが作動することを遅延させる。外科用ステープラは第2のスイッチを有し得る。第2のスイッチは別の位置の駆動スクリューを感知し、モータの反転機能を作動し、駆動スクリューを最初の位置に戻す。 In accordance with yet another aspect of the present disclosure, the surgical staple has a motor and a first switch. The first switch is connected to the motor and delays operation of the motor to achieve sufficient tissue compression by the clamp. The surgical stapler can have a second switch. The second switch senses another position of the drive screw, activates the reversal function of the motor, and returns the drive screw to the initial position.
本開示のまたさらに別の局面において、外科用ステープラは駆動スクリューの移動距離またはクランプの組織圧縮時間を測定するインジケータを有する。 In yet another aspect of the present disclosure, the surgical stapler has an indicator that measures the travel distance of the drive screw or the tissue compression time of the clamp.
本開示のさらに別の局面において、外科用ステープラは発射メカニズム構成要素の位置を示すか、または外科ステープリングの状態条件を示す視覚的指示を有する。 In yet another aspect of the present disclosure, the surgical stapler has a visual indication that indicates the position of the firing mechanism component or indicates the status condition of the surgical stapling.
本開示の別の実施形態において、外科用ステープラが提供される。ステープラは、トリガを含むハンドルアセンブリと、複数のステープルを含んでいるステープルカートリッジと、その上にファスナ形成面を有するアンビルを有するクランピングデバイスとを有する。ステープラは、アンビルとステープルカートリッジとによるクランピングの発生を判断するように構成されているコントローラを有する。コントローラはステープルカートリッジからの複数のステープルの発射を制御する。トリガが作動されるときには、コントローラがステープルカートリッジからの複数のステープルの発射を遅延させ、アンビルとステープルカートリッジとの間で、組織の所定の組織圧縮期間を提供する。所定の期間に達すると、コントローラが、発射を可能にするための制御信号を出力する。 In another embodiment of the present disclosure, a surgical stapler is provided. The stapler includes a handle assembly including a trigger, a staple cartridge including a plurality of staples, and a clamping device having an anvil having a fastener forming surface thereon. The stapler has a controller configured to determine the occurrence of clamping by the anvil and staple cartridge. The controller controls the firing of a plurality of staples from the staple cartridge. When the trigger is activated, the controller delays the firing of the plurality of staples from the staple cartridge and provides a predetermined tissue compression period of tissue between the anvil and the staple cartridge. When the predetermined period is reached, the controller outputs a control signal to enable firing.
本開示に関する他のおよびさらなる目的、利点および特徴は、添付の図面と共に以下の明細書を参考にすることによって理解され、図面においては、同じ参照番号は構造の同じ要素を示している。 Other and further objects, advantages and features of the present disclosure will be understood by reference to the following specification, taken in conjunction with the accompanying drawings, in which like reference numbers indicate like elements of the structure.
以下の図面および記述において、用語「近位」は、従来のように、オペレータに最も近い装置の端を指し、用語「遠位」は、オペレータから最も遠い装置の端を指す。 In the drawings and description below, the term “proximal” refers to the end of the device that is closest to the operator, as is conventional, and the term “distal” refers to the end of the device that is furthest from the operator.
本開示は、当該分野において公知である任意のステープラと共に使用され得、同じ結果を達成することが意図されており、従来的な処置および装置と内視鏡的な処置および装置との両方の点で述べられることが意図されている。しかしながら、とりわけ、「内視鏡的な」、「内視鏡的に」、および「内視鏡的な部分」などのような用語の本明細書における使用は、内視鏡的なチューブを伴う使用のための装置に本開示を限定するものとして考えられるべきではない。本開示の装置は、関節鏡的および/または腹腔鏡的な処置のような小さい切開、または他の従来的な医療処置にアクセスが制限される場合の使用を含むが、それに限定されない、これらのまたは他の使用における処置において用途を見つけ得る。本メカニズムはまた、クランピング処置および発射処置が独立しているか、または組み合わされている外科ステープリングデバイスと共に使用され得る。本開示はさらに、クランピングおよび発射を同時にまたは別々に行うメカニズムを有する外科ステープリングデバイスに組み込まれ得る。本開示はまた、不連続なクランピング勾配を有するこのような外科ステープリングデバイスと共に使用されることが意図されている。 The present disclosure can be used with any stapler known in the art and is intended to achieve the same results, both in terms of both conventional and endoscopic procedures and devices. It is intended to be stated in However, the use herein of terms such as “endoscopic”, “endoscopically”, “endoscopic portion” and the like, inter alia, involves an endoscopic tube. It should not be considered as limiting the present disclosure to devices for use. The devices of the present disclosure include, but are not limited to, small incisions such as arthroscopic and / or laparoscopic procedures, or use where access is limited to other conventional medical procedures. Or find use in treatment in other uses. The mechanism can also be used with surgical stapling devices where the clamping and firing procedures are independent or combined. The present disclosure may further be incorporated into a surgical stapling device having a mechanism for performing clamping and firing simultaneously or separately. The present disclosure is also intended for use with such surgical stapling devices having discontinuous clamping gradients.
ここで図面を参照すると、同じ参照番号は対象の開示の同じ構成要素を識別しており、図1においては、対象の開示の実施形態に従って構成され、包括的に参照番号10で示されている自蔵型電動外科用ステープラを図示している。外科用ステープラ10は、概ね、使い捨てであることが意図されているが、使い捨ての装置に限定するものではなく、使い捨てではない他の装置が考えられ、本開示の範囲内となり得る。
Referring now to the drawings, wherein like reference numerals identify like elements of the subject disclosure, and in FIG. 1 are configured in accordance with the subject disclosure embodiment and are indicated generally by the
(図1に斜視図で示され、本明細書で記述されている)本開示の外科用ステープラ10は、参照番号12で包括的に表されているフレームと、参照番号14で包括的に表されているハンドルとを含む。フレーム12は、身体組織への適用のための多数のステープルと共に、外科用ステープラ10の様々な相互に協働する機械的な構成要素を支持するための一連の内部チャンバまたはスペースを規定する。
The
フレーム12は部分16すなわち伸びたチューブ状部分を支持する。部分16は回転されることが可能であり、約10ミリメートルの範囲内の比較的に小さい直径を有しており、小さい開口、または体の中、例えば、腹腔または他の同様な体腔に挿入されたチューブの中への挿入を目的としている。部分16は長手方向軸を有し、体の内部における手術部位に到達するために適した長さを有する。外科ステープル10は、内視鏡または体の内部を視覚的に検査する他の光学デバイスのような他の機器と共に使用され、例えば、CCDデバイスによるカメラ、光ファイバー、または他の光学的または記録デバイスと共に使用され得る。
概して、外科ステープル10の部分16は、小さい開口または傷を通して挿入され、手術部位まで動かされる。本開示は、限定するわけではないが、同時のクランピングおよび不連続なクランピングを有する外科用ステープラを含む任意の外科用ステープラと共に使用されることが意図されている。
Generally, the
部分16は、参照番号18で包括的に表されている締め付けアセンブリと、当該分野において公知である切断アセンブリ(図示せず)とを有する。締め付けアセンブリ18と切断アセンブリ(図示せず)とは、筐体20内に位置を決められており、該筐体20は手術部位に対するファスナと選択的な切断具とを保持している。この特定の実施形態における締め付けアセンブリ18は、顎またはステープルカートリッジ21と第2の顎またはアンビル22とを有する。ステープルカートリッジ21とアンビル22とは、顎21、22がその間でクランプを形成するように、互いに近接して協働配置にされ得る。顎21、22は、開閉する第1および第2の顎であり得るか、または当該分野において公知であるような別の異なるクランピングタイプの構造であり得る。ステープルカートリッジ21は、顎21、22自体の中で、筐体20の遠位端に位置を決められ得るか、またはMastriらによる米国特許第7,044,353号に記述されているような他の位置に位置を決められ得、該特許は本明細書においてその全体が参考として援用される。ステープルカートリッジ21は一列以上のステープルを有する。外科用ステープラ10はまた、アンビル(図示せず)を有しており、ステープリングを達成するために、当該分野において公知であるような選択的なナイフ(図示せず)をさらに含み得る。ステープルカートリッジ21とアンビル22を用いた顎21、22の閉鎖は、ステープルカートリッジ21に対してアンビル22を旋回することによって、またはアンビル22に対してステープルカートリッジ21を旋回することによって、またはステープルカートリッジ21とアンビル22との両方を互いに対して旋回することによって達成され得るということが理解される。
概して、締め付けアセンブリ18の動作部分の作動は、狭い長手方向に伸びるチューブ状部分16上またはその中に配置される中間構成要素により達成され得る。非限定的な一例において、円筒形のチューブ状スリーブ部材が部分16を囲繞する。スリーブは外科ステープリングデバイスの長手方向軸方向に動かされ得る。スリーブは顎21、22を閉鎖するためにアンビル22上を滑動し、該顎21、22は、クランピングを達成するために付勢デバイス(図示せず)によって付勢され開いている。本開示の外科ステープル10は3つの基本動作または機能を有するが、本開示は、限定するわけではないが、同時のクランピング(すなわち、同時にクランピングとステープルの発射をする)と、単独のクランピング(すなわち、ステープルの発射に先立ちクランピングをする)とを有する外科用ステープラを含む任意の外科用ステープラと共に使用されることが意図されている。
In general, actuation of the working portion of the clamping
第1に、部分16は人間または動物の体内に導入され、標的組織を受け取るために所望のステープリング部位に並べられた顎21、22と共に配置される。これは、外科ステープル10を全体的に回転させることによるか、もしくは部分16をフレーム12に対して許す限り単に回転させることによるか、または両方の動作の組み合わせによるかのいずれかの、体に対する部分16の回転を含み得る。次に(すなわち、第2に)、外科用ステープラ10は、筐体20の遠位端におけるステープルカートリッジまたは顎21とアンビル22との間に標的の身体組織を固定する。これは、顎21、22のクランピング動作によってか、または代替的に、別の同様なまたは異なるクランピング部材によって達成される。
First, the
顎21、22は、特定の組織に応じて、所望の期間、閉じた位置のままにあることを許可される。顎21、22を所定の期間閉じたままにするように構成することによって、ステープリングカートリッジ21の作動に先立ち、組織内のあらゆる過剰な液体または体液が身体組織から排出されることを可能にする。これは、発射の後に、液体が組織から外方向に流出し、不均一なステープルを形成しないことを確かなものとし、その代わりに、適切で均一なステープルの形成を確かなものとする。
The
標的組織がアンビル22とカートリッジ21との間でクランピングに関し、筐体20とアンビル22とを囲繞しているカム面が、外科ステープル10の顎21、22を閉じ、アンビル22とステープルカートリッジ21の組織接触面との間で組織をクランピングするために使用される。当該分野において公知であるような、顎21、22の反対側にあるレバー24の作動によって、顎21、22はクランピングされる。その後に、外科医は身体組織にステープルを適用する。長手方向に伸びるチャネルは、当該分野において公知であるような軸駆動部材と組織切断ナイフとに、長手方向の動きを提供するために使用される。
With the target tissue clamping between the
軸駆動部材または軸駆動スクリューはプッシャ要素に接触する。プッシャ要素は身体組織を通して、本明細書において述べられているようなファスナまたはアンビルの形成面に向けてステープルを駆動する。一般的には、当該分野において、外科用ステープラ10は、通常、第1のトリガハンドルの作動または代替的にトリガスイッチ26を使用することによって発射する。その後に、顎21、22のクランピング動作が解放され、外科用ステープラ10またはその一部分が体から引き抜かれ得る。
The shaft drive member or shaft drive screw contacts the pusher element. The pusher element drives the staples through the body tissue toward the fastener or anvil forming surface as described herein. In general, in the art,
ここで図2を参照すると、本開示の外科用ステープラ10のブロック図が示されている。本開示の第1の局面に従って、外科用ステープラ10は選択的なコントローラ28を有し得る。コントローラ28は、1つ以上の読み取り可能なプログラム命令を実行するためにメモリに結合されている任意の電子デバイスであるか、または代替的に、適切なアナログ回路であり得る。またさらに、コントローラ28は、外科ステープル10の1つ以上の機能を制御するための適切な機械的部材または連動装置であり得る。
Referring now to FIG. 2, a block diagram of the
コントローラ28は内部または外部の電源とモータとに接続されており、アンビル22とステープルカートリッジ21との間で接続されている。代替的な実施形態において、トリガハンドルもしくは別の作動スイッチまたは構成要素26は機械的または電子的に連結されているか、または当該分野において公知であるように、点線で示されているようにステープルカートリッジ21に接続されているが、本開示はどのような構成にも限定されることを意図されていない。いったん、ステープリングカートリッジ21が、トリガスイッチ26を使用して発射されると、顎21、22は開かれ、発射メカニズムは引っ込められる。外科ステープル10は、概して、身体組織から引き抜かれるか、または示されているように次のあるいは第2のステープリング動作のために動かされ得る。
The
本外科用ステープラ10はコントローラ28を有しており、該コントローラ28は、顎もしくはアンビル21または顎もしくはステープルカートリッジ21のうちの1つとトリガスイッチ26とに接続されるか、または顎21、22の両方とトリガスイッチ26とに接続される。一実施形態において、いったん、所望の部位まで到達すると、外科医は顎21、22を使用し、選択された身体組織を圧縮する。代替的に、外科ステープル10はアンビル22とステープリングカートリッジ21との両方を駆動し得る単一の駆動構成要素を有し得る。
The
その後に、コントローラ28は、クランピングと発射との間(またはクランピングした後であり、発射の前)に必要な量の遅延を提供し得ることにより、組織の圧縮と体液の排出を確実なものにする。所望の圧縮が達成されると、ステープルカートリッジ21は、コントローラ28によって自動的に係合され得ることにより、ステープルカートリッジ21から身体組織の中にステープルを発射するか、または代替的に、コントローラ28は外科医に信号を送信し得ることにより、外科医がステープルを発射すべき提案を外科医に告げる。発射は自動的または手動であり得るということが想定されている。
Thereafter, the
さらに、コントローラ28は、ステープルがステープルカートリッジ21から発射される速度を制御し得る。またさらに、コントローラ28は発射の前の遅延の量を制御し得る。一実施形態におけるコントローラ28は、ステープルカートリッジ21に信号を出力することに先立ち経過する所定の期間を提供し得る。別の電動ステープルの実施形態において、コントローラ28はモータの速度を落とし得ることにより、身体組織の圧縮時間を増加させる。
Further, the
また別の実施形態において、コントローラ28は緩衝デバイス30に係合し得る。緩衝デバイス30は、身体組織の全圧縮時間を増加させるために、ステープルカートリッジ21の作動を遅らせるように構成されている。このような緩衝デバイス30は、外科用ステープラ10の1つ以上の構成要素の動作を緩衝または調節し得る油圧または空気圧タイプの緩衝装置またはその他任意のデバイスであり得る。別の実施形態において、トリガ26は、関連する制御回路網において、所定の期間、発射信号を単に保持し得、かつ、所定の期間の満了に際して、ステープルカートリッジ21に信号を伝え得る。
In yet another embodiment, the
コントローラ28はモータの速度を落とし、ギアを調節し、またさらに、モータの回路網に係合し、モータの動作を遅くするか、または作動、すなわち、軸駆動スクリューの回転率を減少させるように構成され得る。またさらに、外科用ステープラ10はまた制御停止スイッチ32を含み得る。制御停止スイッチ32は自動または手動のデバイス(または他のスイッチ)であり、該自動または手動のデバイス(または他のスイッチ)は、選択的にコントローラ28を離し、外科医の判断によりどのような遅延もなく、トリガスイッチ26によるステープルカートリッジ21の直接的な作動を可能にする。
The
本開示の一局面において、本外科用ステープラ10は顎21、22を含み、該顎21、22は、アンビル130とステープリングカートリッジ21のステープラカートリッジ132との間で組織を圧縮する(図2B)。図2Bにおいて示されているように、ステープルカートリッジ132からのステープル158の押し出しに先立ち、外科医がアンビル130とステープルカートリッジ132との間に組織を動かして、圧縮することを可能にするデバイスであるとして、顎21、22は当該分野において理解されている。顎21、22は、モータまたは空気式デバイスのように電源によって、単独に電力を供給され得るか、またはステープルカートリッジ21と同じ電源によって電力を供給され得る。外科用ステープラ10は顎21、22を使用してステープラカートリッジ132とアンビル130との間で組織をクランピングし(図2b)、ステープラ10が発射されるときに、顎21、22はさらに締められ得、ステープル158がステープリングカートリッジ21から押し出される。
In one aspect of the present disclosure, the
一局面において、外科用ステープラ10は第1の間隔の間に顎21、22を使用し、組織を予備クランピングし得るか、または圧縮し得る。第1の時間間隔は事前に設定され、かつ、固定され得るか、または組織のタイプに従って変化可能であり得る。第1の間隔は数分、数秒、またはその他任意の変化可能であるかもしくは固定の所定の期間であり得る。次に、ステープリングに先立ち、顎21、22はさらにクランピングし得、さらに数秒間の圧縮の時間間隔の間に組織を圧縮し、発射する。第2の時間間隔は第1の時間間隔とは異なり得、第1の時間間隔よりも短くまたは長くなり得る。別の局面において、機器は顎21、22を使用し、組織を予備クランピングし得るか、または圧縮し得、次に、単に自動的にデバイスを発射し、第1の間隔の最後にステープルカートリッジ132からステープル158を押し出す。様々な構成が可能であり、本外科用ステープラ10は、外科医および/または設計者によって所望される任意の数の圧縮間隔のためのプログラム命令を有し得る。外科用ステープラ10は、代替的に、ステープラ10と協働する第2の別個のクランピングデバイスをさらに使用し得る。本明細書においてその全体が参考として援用されるRacenetらによる米国特許第6,817,508号のようなTA外科ステープルのような、発射の前に組織を接合させる機器に、本開示は組み込まれ得るか、または発射の前にこのような接合を必要とすることのない機器と共に使用され得るということが理解される。
In one aspect, the
本開示の別の実施形態において、外科ステープリングデバイス10は、インジケータ36によりフィードバックを外科医に提供し得る。インジケータ36は圧縮時間を表示し得、および/またはステープリングの状態のフィードバックを提供し得るか、または駆動スクリューまたは駆動部材の位置に関する情報を表示し得る。本開示の別の実施形態において、外科用ステープラ10は不連続なクランピングおよび発射の作動装置を有さないことがあり得、クランピング勾配インジケータ36または同時にクランピングおよび発射を指示するメカニズムを含み得る。例えば、外科用ステープラ10は発射速度の制御を可能にするように構成され得、次に、該発射速度の制御がクランピング速度およびタイミングを制御し、それから組織を圧搾し、所望の部位における組織から血液および体液を押し出すために最適な圧縮を提供する。
In another embodiment of the present disclosure, the
図2Aは図1の外科用ステープラ10の多数の構成要素の分解図を示す。ステープラ10はラック100を有し、該ラック100はハンドル部分14内で滑動可能である。ラック100はクランプチューブ102と相互作用する。クランプチューブ102の遠位側にチャネル104が存在する。チャネル104はクランプチューブ102に係合し、チャネルの遠位側で一対のフォーク106、108に係合する。ステープラ10はまた、上側カバー110と、下側カバー112と、延長チューブ114とを有する。延長チューブ114はカラーチューブ116に係合する。ステープラ10はまた、チャネル部分120と共に回転ノブ118を有する。チャネル部分120は遠位端に一対のカム面122を有する。該遠位端はまた、遠位側にクリンプ124を有することにより、アンビル22を受け取る。
FIG. 2A shows an exploded view of a number of components of the
動作において、ラック100はクランピングチューブ102を遠位方向に滑動させ、移動させる。クランピングチューブ102はハンドル部分14と延長チューブ114とを相互接続するために提供される。チャネル104は、往復の長手方向の動きのために滑動するように設置されている。延長チューブ114は外科用ステープラ10に対する支持を提供し、カラーチューブ116と相互作用するスロットを有する。外科用ステープル10はまた、長手方向の動きのために、かつ、図2bに記述されているようなステープリングメカニズムを動作させるためにサポート120を有する。これらの構成要素の動作は周知であり、Greenらに対する米国特許第5,318,221号において開示されており、該特許は本明細書においてその全体が参考として援用される。
In operation, the
有利にも、ラック100は遠位方向に動き、チャネル104を遠位方向に進ませる。図2bに示されているステープラカートリッジ21の動作のために、チャネル104は、当該分野において公知であるようなプッシャカムバーに長手方向の動きを与える。図2aに示されている構成要素は本外科用ステープラ10の一実施形態を図示しているのみであり、ラック100の代わりに、外科用ステープラ10は、長手方向の動きのために、かつ、ステープルカートリッジ21を作動するために駆動スクリュー(図示せず)を有し得るということが理解されるべきである。ここで図2bを参照すると、アンビル22と、作動スレッド169を有するステープラカートリッジ132との分解図が示されている。
Advantageously, the
図2bを参照すると、ステープラカートリッジ21は、図示目的のために分解図で示されているアンビルアセンブリ130とカートリッジアセンブリ132とを含む。アンビルアセンブリ130は、複数のステープル変形くぼみ(図示せず)を有するアンビル部分22と、アンビル部分134の上面に固定され、空洞(図示せず)を規定するカバープレート136とを含む。カバープレート136は、外科用ステープラ10のクランピングおよび発射の間に、組織の締め付けを防止する。空洞は軸駆動アセンブリ138の遠位端を受け取るように大きさを決められている。
Referring to FIG. 2b, the
アンビル130は長手方向スロット140を有し、該長手方向スロット140がアンビル部分130全体を伸びることにより、アンビルスロット140への軸駆動アセンブリ138の保持フランジ142の通過を容易にする。アンビル22上に形成されているカム面144が軸駆動アセンブリ138に係合するように配置されていることにより、組織のクランピングを容易にする。アンビル部材130に形成される一対のピボット部材146は、開いた位置とクランピングされた位置との間にアンビル部分130を導くために、キャリア148に形成されるスロット146’の中に配置される。
The
ステープラ10はキャリア148上に形成されているそれぞれの肩に係合する一対の安定化部材152を有することにより、アンビル部材130のカム面が変形されるにつれ、アンビル部分30がステープルカートリッジ132に対して軸方向に滑動することを防止する。カートリッジアセンブリ132は、細長いサポートチャネル154を規定するキャリア148を含む。細長いサポートチャネル154は、図2bの分解図においてキャリア148の上に示されているステープルカートリッジ132を受け取るように大きさを決められ、構成されている。対応するタブと、ステープルカートリッジ132に沿って形成されるスロットと、細長いサポートチャネル148’は、キャリア148のサポートチャネル154内にステープルカートリッジ132を保持するように機能する。ステープルカートリッジ132に形成される一対のサポート支柱は、キャリア148の側壁にもたれるように配置されることにより、サポートチャネル154内でステープルカートリッジ132をさらに安定させるが、チャネル154上でカートリッジ132を支持する他の配置が使用され得るので、この配置は限定するものではない。
The
ステープルカートリッジ132は、複数のファスナ158とプッシャ160とを受け取るための保持スロット156を含む。長手方向のスロット156は、作動スレッド164の直立カムウェッジ162を収容するように、ステープルカートリッジ132を通って伸びる。中央の長手方向スロット166がステープルカートリッジ132の長軸に沿って伸びることにより、ナイフブレード(図示せず)の通過を容易にする。外科用ステープラ10の動作の間、カムウェッジ162を遠位方向に進め、プッシャ160と順次接触させるように、作動スレッド164が、ステープルカートリッジ132の長手方向スロット156を通って移動するように、遠位方向に駆動されることにより、プッシャ160をスロット156内で垂直に移動させ、ファスナ158をスロット156からアンビルアセンブリ130のステープル変形くぼみに押し出し、組織のステープリングを達成する。
図3を参照すると、外科用ステープラ10はインジケータ36を含み得、該インジケータ36は、外科医に感覚フィードバックを提供するための、当該分野において公知である任意のデバイスであり得る。インジケータ36は、外科用ステープラ10の1つ以上の状態の視覚的、触覚的、または聴覚的な監視を可能にする任意のデバイスであり得る。インジケータ36は、外面34に配置され得、かつ、ハンドル14に配置され得る。代替的に、部分16、トリガスイッチ26、レバー24、または外科医による立つ位置の変更という位置の変更なく、インジケータ36が外科医によって容易に見られ得るその他任意の適切な位置に、インジケータ36は配置され得る。
With reference to FIG. 3, the
示されているような一実施形態において、インジケータ36は多数のライトバルブ38を含む。ライト38は1つのライト、または1つの色または2つ以上の各種の色を有する一連の多数のライトバルブまたはLEDであり得る。ライト38のそれぞれは、外科用ステープラ10の1つ以上の状態を表す色を有し得る。代替的に、ライト36のうちの1つまたは全てが光り得ることにより、外科用ステープラ10の状態を示す。
In one embodiment as shown,
トリガスイッチ26によって作動されると、外科用ステープラ10はステープルの発射前に遅延を伝え得る。しかしながら、外科医に適切なフィードバックを提供するために、例えば、ライト38はステープルカートリッジ21の発射の進行に関する視覚的な指示を提供する。例えば、続けて図3を参照すると、第1のライト40と、第2のライト42と、第3のライト44と、第4のライト46と、第5のライト48とが示されている。軸駆動スクリュー(図示されておらず、ハンドル内に存在する)が所定の駆動経路を移動すると、ライト40、42、46、および48が順次光り、ハンドルの外側に駆動スクリューの相対距離を示す。ライト40、42、44、46、および48が光ると、ステープリングカートリッジ21は発射し、そのことが、ステープルの配置に先立ち、適切な組織の圧縮が生じることを確かなものにする。
When actuated by the
ここで図4を参照すると、本開示の別の例示的な実施形態において、外科用ステープラ10は、複数の不連続なセグメント、つまり、第1のセグメント52と、第2のセグメント54と、第3のセグメント56と、第4のセグメント58と、第5のセグメント60とを有するリニアインジケータ50を含む。やはり、いったん、トリガ26が作動され、ステープルカートリッジ21を発射すると、セグメント52、54、56、58、および60はそれぞれ、所定のパターンで光り、ハンドル14で駆動スクリューの進行状況を外科医に示す。
Referring now to FIG. 4, in another exemplary embodiment of the present disclosure, the
セグメント52、54、56、58、および60の全てが光ると、ステープルカートリッジ21は、身体組織の圧縮期間が終了したということの確証を有し、体の中にステープルを発射する。リニアディスプレイ50は1つ以上の異なる色または色の組み合わせを有し得ることにより、駆動スクリューの位置を示す。例えば、「赤」は発射を示し、「緑」は発射が完了したことを示し、また逆も同様である。またさらに、リニアディスプレイ50は1つ以上の図形表示、画像、写真を表示し得ることにより、外科用ステープラ10の1つ以上の状態または動作パラメータを示す。
When all of the
例えば、リニアディスプレイ50は、外科用ステープラ10が所定の期間に発射することを示すために、「発射(FIRE)」もしくは「完了(COMPLETE)」またはその他任意の図形表示を示し得る。様々な可能な組み合わせが考えられ、全てが本開示の範囲内となる。
For example, the
図5に示されている本開示のまた別の例示的な実施形態において、外科用ステープラ10はデジタルディスプレイ62を含み得る。デジタルディスプレイ62は、トリガ26の作動後のカウントダウンまたはカウントアップ(または他の時間間隔)を示し得る。例えば、デジタルディスプレイ62は、顎21、22による所定の量の組織の圧縮を確実にするために、圧縮後に所望のステープリング時間までカウントダウンし得る。デジタルディスプレイ62は、顎21、22によって作動され、互いに密接に提携されるか、またはクランピングとは別に作動され得る。所望のクランピング間隔が所望の組織に対して事前に設定され得る。
In yet another exemplary embodiment of the present disclosure shown in FIG. 5, the
代替的に、デジタルディスプレイ62は、または入力デバイス(図示せず)もしくはボタンを使用して外科医によって選択的に事前に設定され、入力され得る。外科医はディスプレイ62にクランピングの期間を入力し得る。その後、ディスプレイ62はクランピング期間の経過時に発射を勧めるか、または(例えば、約10〜45秒間のような)所定のクランピング期間が経過した後で、自動的に発射し、適切な組織の圧縮を確かなものにし得る。デジタルディスプレイ62は、所定のクランピングの設定時間からカウントダウンするように構成され、コントローラ28に信号を視覚的に伝え得る。信号を受信した後、コントローラ28は所望の期間のクランピングが経過することを可能にする。設定された期間が終了すると、コントローラ28は第2の信号を伝え、ステープルカートリッジ21を作動し得る。代替的に、コントローラ28は、所望の期間の終了時にステープルカートリッジ21を作動することに適した速度で動作を開始するために、モータの速度を単に調節し得る。またさらに別の実施形態において、デジタルディスプレイ62は組織のクランピングの開始後に数えることを開始するように構成され得、そして、その時点からの先の時間を単に表示することにより、外科医が監視し、所望の期間の終了時にトリガスイッチ26を手動で作動することを可能にする。その後、デジタルディスプレイ62は外科医に対して圧縮時間と正確な経過期間とを単に表示し得るか、または発光し得る。機器は所定の遅延を提供し、それから機器が手動で発射される準備ができているということを示し得るか、または代替的に、機器が遅延し、それから示し、そして自動的に発射し得るということが理解される。
Alternatively, the
ここで図6を参照すると、外科用ステープラ10は、代替的に、ハンドル14の外面に配置されるアナログディスプレイ64を有し得、該アナログディスプレイ64はデジタルディスプレイ62と同様に機能する。アナログディスプレイ64は聴覚的アラームを有し得るか、または代替的に、組織の適切な圧縮期間に到達したか、またはそれを超過したかを示す発光ライトを有し得る。
Referring now to FIG. 6, the
ここで図7を参照すると、図3の切断線7−7に沿った、外科用ステープラのハンドル12の断面図が示されている。この実施形態において、外科用ステープラ10は電動デバイスであり、駆動メカニズムを有するモータ66を有する。駆動メカニズムは駆動出力シャフト68である。シャフト68は第1のギア70に接続する。第1のギア70は第2のギア72に接続されており、該第2のギア72は、次に、軸駆動スクリュー74に係合する。モータ66は外科用ステープラ10の1つ以上の構成要素を駆動するデバイスであり得る。
Referring now to FIG. 7, there is shown a cross-sectional view of the surgical stapler handle 12 taken along section line 7-7 of FIG. In this embodiment, the
駆動スクリュー74は多数の螺旋状の溝を有するねじを切られたロッドであり、圧縮が外科医によってクランプまたは顎21、22を使用して行われると、ステープリングカートリッジ21を外科用ステープラ10の遠位の位置で作動させるように、該螺旋状の溝は回転し、別の部材に接触することが意図されている。軸駆動スクリュー74は、第2のギア72の中央内腔76を通って歯で係合し配置される。軸駆動スクリューはまた、第2のギア72からずれて配置され得るか、またはその他任意の所望のギア配置で配置され得る。当該分野において公知であるように、モータ66の作動の際に、軸駆動スクリュー74は回転し、外科用ステープラ10の部分16を通って遠位方向に移動することにより、ステープラカートリッジ21に係合する。代替的に、外科用ステープラ10は、軸駆動スクリュー74の代わりに、駆動ピストンまたはプランジャを有し得るか、または単一の駆動メカニズムを有し得ることにより、アンビル22とステープリングカートリッジ21との両方を制御する。このようなメカニズムは当該分野において公知であり、Millimanらに対する米国特許第6,330,965号、Greenら対する米国特許第6,250,532号、Millimanらに対する米国特許第6,241,139号、Alliらに対する米国特許第6,109,500号、Geisteらに対する米国特許第6,202,914号、Mastriらに対する米国特許第6,032,849号、およびViolaらに対する米国特許第5,954,259号で見られ得、該特許は本明細書においてその全体が参考として援用される。
The
外科用ステープラ10は第1のスイッチ80を含み得る。スイッチ80は、示されているようなハンドルの固定された位置に位置を決められている。ステープラ10はまた、第1のスイッチ80に対して遠位方向に配置されている第2のスイッチ82を有し、該第2のスイッチは第1の開始位置78における駆動スクリュー74の経路の遠位またはその近くに存在する。同様に、第2の発射位置84における第2のスイッチ82は、第1の開始位置から遠位方向に配置され、かつ、駆動スクリュー74の経路の付近または近くに配置される。第1および第2のスイッチ80、82のそれぞれはリミットスイッチであるが、代替的に、それぞれのリミットスイッチを横切る、またはその付近を通る軸駆動スクリュー74の単純な動きによって第1の位置から第2の位置に切替えまたはトグルする、当該分野において公知である任意のスイッチであり得る。
いったん、軸駆動スクリュー74またはその一部分が第1のスイッチ80を横切って過ぎると、第1のスイッチはリード86によってコントローラ28に信号を伝える。その結果、コントローラ28は、リード88によって、インジケータ36またはその一部分を光らせ、軸駆動スクリュー74の第1の位置を外科医に示す。
Once the
その後、駆動スクリュー74またはその一部分は、第2の発射位置84において第2のスイッチ82を横切るか、またはそれに接触する。第2のスイッチ82はまたリミットスイッチであり、リード90によって、ステープラカートリッジ21の位置または発射に関する第2の信号をコントローラ28に伝える。次に、コントローラ28は、リード88によってインジケータ36(またはその別の部分)を光らせることにより、ステープリングが完了したということを外科医に示す。ステープリングが終了すると、外科医/オペレータは引き抜きを開始し、リード92によってモータ66の方向を反転する。次に、モータ66は動きを反転させ、次のステープリング動作のために最初の位置78に軸駆動スクリュー74を戻す。
Thereafter, the
代替的に、リード86によって第1のスイッチ80から第1の信号を受信すると、コントローラ28は外科用ステープラ10の1つ以上の動作を調節する。例えば、第1の信号を受け取ることに応答して、コントローラ28は、外科用ステープラ10の1つ以上のパラメータを制御し得、該パラメータは、組織のギャップ、モータ66の速度、軸駆動スクリュー74の制御ストローク、軸駆動スクリューの移動距離、軸駆動スクリューの回転率、およびそれら任意の組み合わせを含む。
Alternatively, upon receipt of the first signal from the
ここで図8を参照すると、外科医はステープリングカートリッジ21を作動するために、発射メカニズムを動作/係合し得る。発射メカニズムは図8に示されているモータ66を作動する。軸駆動スクリュー74は回転を開始し、スイッチ80を横切って過ぎることによって、駆動スクリュー74は第1のスイッチ80を作動する。第1のスイッチ80はリード86によって信号をコントローラ28に出力する。コントローラ28は、第1のスイッチ80からの信号に応答して、リード92によって第1のライト40を作動する。外科用ステープラ10は停止機能に係合するために適切な構造をさらに有し得る。停止機能は駆動スクリュー74の過駆動を予防する。
Referring now to FIG. 8, the surgeon may operate / engage the firing mechanism to operate the stapling
その後、軸駆動スクリュー74が所定の距離を横切って過ぎることにより、クランプまたは顎21、22による組織の圧縮を確かなものにする。第2のスイッチ82が作動され、リード90によってコントローラ28に第2の信号を出力する。コントローラ28は、第2の信号に応答して、リード94によって第2のライト42を光らせる。第2のライト42はステープリングカートリッジ21が発射したということを示す。第2のスイッチ82はさらに、モータ66のその方向への動きを反転するか、もしくは停止し、または最初の位置に軸駆動スクリュー74を戻すように、コントローラ28に信号を発し得る。医師/オペレータはまた、モータ66の方向を手動で反転し得る。第3のライト44は、軸駆動スクリュー74が最初の位置78に戻っているということを医師に示すために光り得る。
Thereafter, the
図8Aは本ステープラの別の実施形態を図示している。示されている実施形態において、医師は、ステープリングカートリッジ21を作動するために、発射メカニズムを動作/係合し得る。しかしながら、第1のスイッチ80’は図8に示されている実施形態とは異なる位置にある。この実施形態において、第1のスイッチ80’はハンドル14に対して近位にあるレバー24の真下に位置を決められている。図8Aにおけるスイッチ80’はレバー24に配置されるタブ24’と係合する。レバー24が作動され、ハンドル14に向けて駆動されるときには、タブ24’はスイッチ80’に接触し、スイッチ80’はリード86によってコントローラ28に信号を出力する。次に、コントローラ28は、第1のスイッチ80からの信号に応答して、リード92によって第1のライト40を作動する。
FIG. 8A illustrates another embodiment of the stapler. In the illustrated embodiment, the physician can operate / engage the firing mechanism to actuate the stapling
その後、軸駆動スクリュー74が所定の距離を横切ることにより、クランプまたは顎21、22による組織の圧縮を確かなものにした後、第2のスイッチ82が作動され、リード90によってコントローラ28に第2の信号を出力する。やはり、コントローラ28は、第2の信号に応答して、リード94によって第2のライト42を光らせる。第2のライト42は、ステープリングカートリッジ21が発射したことを示している。第2のスイッチ82はスイッチ80’によって作動され、モータ66のその方向への動きを反転するか、もしくは停止し、または最初の位置に軸駆動スクリュー74を戻すように、コントローラ28に信号をさらに発し得る。第3のインジケータ44は、軸駆動スクリュー74が最初の位置78に戻っているということを外科医に示すために含まれ得る。
Thereafter, after the
図8Bはまた別の実施形態を示し、第1のスイッチ80’’はハンドル14のまた別の位置、かつ、ピボット付近におけるレバー24の反対の遠位側に位置を決められている。様々な構成が可能であり、かつ、本発明の範囲内となり、スイッチ80’’はレバー24に対して様々な構成で配置され得る。
FIG. 8B shows another embodiment, in which the
図9はレバー24を有する外科用ステープラ10を示す。持ち上げられた位置で示されているレバー24は、クランプ21、22を制御するが、この配置は限定的ではなく、別の駆動部材、例えば、モータ66(図7)が、クランプまたは顎21、22を制御し得る。レバー24はクランプの顎21、22を開閉することにより、外科ステープリングに先立ち、身体組織を圧縮する。外科用ステープラ10はさらに導電性の部材の電気的接点96を含むことにより、適切なアナログまたはデジタルの回路を完成する。レバー24が下げられた位置にあるか、またはハンドル14と嵌合するときに、電気的接点96はレバー24の相補的な入れ子の位置にある。レバー24が、持ち上げられた位置または高い位置から下げられた位置に下げられるか、またはハンドル14と接触するときに、レバー24は電気的接点96に係合する。下げられた位置にあるときに、電気的接点はディスプレイ62の適切なタイマー回路を完成し得る。この実施形態において、電気的接点96はディスプレイ62を起動する。ディスプレイ62はゼロから所定の期限まで数え上げ得るか、または理想的な所定の組織圧縮時間間隔からカウントダウンし得る。いったん表示された時間が所定の時間間隔に到達すると、聴覚的アラーム98が音を出し得る。聴覚的アラーム98は、最適な組織の圧縮時間に到達したということと、ステープルカートリッジ21からステープルを発射し、均一なステープルの形成を確かなものとするために、発射メカニズムが作動されるべきであるということとに関する合図を外科医に提供する。
FIG. 9 shows a
図10は、また別の実施形態を図示しており、該実施形態においては、顎21、22によって形成されたクランプがレバー24を下げることによって作動される。同時に、ディスプレイ62のタイマー回路がレバー24上の電気的接点96によって作動される。インジケータ36はリニアディスプレイ50であり得、該ディスプレイ50は、トリガスイッチまたはボタン26によるステープリングメカニズム21の作動を促す第1の色を示す。次に、ディスプレイ50は第2の画像を表示し得るか、または図7に示されているような軸駆動スクリュー74の移動経路に対応するセグメントの数を光らせ得る。作動に際して、第2のスイッチ82はコントローラ28に信号を出力する。次に、コントローラ28はモータ66を停止し、コントローラは制御信号をディスプレイ50に出力することにより、第1の色から別の第2の色へ、または第1の画像から第2の画像へディスプレイを調節し、ステープリングカートリッジ21が発射したということを示す。任意的ではあるが、コントローラ28はさらに聴覚的アラーム28の音を出し得、ステープルカートリッジ21が発射したということを示す。アラームは任意の音または聴覚的パターンであり得、ブザー、歌、チャープ(chirp)、チャイム、またはそれらの任意の組み合わせを含む。様々なインジケータの構成が可能であり、本開示の範囲内となる。
FIG. 10 illustrates yet another embodiment, in which the clamp formed by the
また別の実施形態において、顎21、22はレバー24を下げることによって作動され得る。同時に、ディスプレイ62のタイマー回路はレバー24によって作動される。その後に、インジケータ36は、所望の期間の経過後にスイッチ26を作動することによるステープリングカートリッジ21の作動を促す第1の指示を示す。トリガスイッチ26が作動されると、コントローラ28はモータ30を作動する。次に、モータ30は、図7に示されているように駆動スクリュー74を動かす。
In yet another embodiment, the
軸駆動スクリュー74は軸方向に動くとき、駆動スクリュー(または、図11に示されているような駆動スクリューに接続される別のプランジャ100)は、第2の部材102に接触している。第2の部材102は、プランジャ100の動きに基づいて転調し、かつ、別のデバイスによって検出または感知され得ることにより、外科医に指示を提供する任意の部材であり得る。第2の部材102は抵抗ストリップであり得、プランジャ100または軸駆動スクリュー74が外科用ステープラ10の部分16(または他の適切な移動面の位置)に沿って横切るにつれ、該抵抗ストリップは、プランジャ100の移動面104に沿って抵抗を変更する。抵抗器ストリップ102はインジケータ36に結合されることにより、抵抗器ストリップ102の抵抗に関する変化がライト40〜48のそれぞれを選択的に光らせ、その結果、軸駆動スクリュー74またはプランジャ100もしくは他の適切な駆動部材による移動量を知らせる。
As the
代替的に、抵抗器ストリップ102は、別のインジケータ、例えば、リニアディスプレイ50に結合され得る。軸駆動スクリューがステープラカートリッジ21を作動するまで、ディスプレイ50は軸駆動スクリュー74またはプランジャ100の移動に対応するセグメント52、54、56、58、および60の数を光らせる。作動の際に、抵抗器ストリップ102はコントローラ28に信号を出力し、該コントローラ28はモータ66の動作を調節し、ステープリングカートリッジ21が発射したということを示すために、別の第2の信号をディスプレイ50に送信する。ディスプレイ50は、それに応答して、ステープリングカートリッジ21の発射が完了したということを外科医に示すために、適切な図形画像、別の色、文章メッセージ、またはその他任意の指示を表示し得る。様々なインジケータの構成が可能であり、本開示の範囲内となる。
Alternatively, the
ここで図12を参照すると、本開示のさらに別の実施形態において、外科用ステープラ10はさらに非接触センサ106を含み得る。非接触センサ106は、任意的ではあるが、発見者E.H.Hallにちなんで名付けられたホール効果の物理原理に部分的に依存する所謂「ホール効果非接触センサ」(または代替的に、その他任意の非接触センサ)であり得る。
Referring now to FIG. 12, in still another embodiment of the present disclosure, the
例えば、軸スクリュー74の端108はモータ74に直接的に接続されるか、それと連動されているか、またはそれから偏って置かれており、軸スクリュー74のキャップ状の自由端110がステープラカートリッジ21と接触することにより、先に記述されたようにステープルカートリッジを作動し、ステープルを発射する。駆動スクリュー74の自由端110は磁気部材112を有し、該磁気部材112は自由端に接続しており、駆動スクリュー74の回転によって取り外されない。代替的に、磁気部材112はディスク形状であり得、自由端110に単に接続され得る。ある初期の姿勢において、自由端110と磁気部材112とは非接触センサ106に非常に近接してか、またはその近くに配置される。この初期の姿勢において、磁気部材112は非接触センサ106から第1の距離「d」だけ離される。
For example, the
いったん、トリガスイッチまたはボタン26が作動されると、モータ66が作動され、回転し、上で記述されたように駆動軸スクリュー74が遠位方向に横切ることにより、ステープルカートリッジ21を作動する。第2の姿勢において、モータ66が作動された後に、磁気部材112は動き、非接触センサ106から第2の距離「d」だけ離れている。第2の距離は第1の距離「d」よりも大きい任意の距離である。磁気部材112が非接触センサ106から離れて動くにつれ、磁気部材112の磁界から第2の距離だけ離れて位置を決められている非接触センサは、モータ66の動作を調節する。
Once the trigger switch or
用語「調節」は、動的な方法でモータ66によって受け取られる電圧量を調節すること、所望のストロークでモータを「停止」すること、モータの速度を変更すること、モータの駆動ギアの削減、軸駆動スクリューのピッチの低減、またはモータの電圧もしくは電流投入量に関する変更、または別の発射構成要素に変更すること、モータの構成要素の変更、およびそれらの任意の組み合わせとして定義される。従って、これはモータ66の動作を遅くし、顎21,22の間での身体組織の圧縮期間を増加させ得る。別の代替的な実施形態において、磁気部材112は駆動スクリュー66の代わりに適切な駆動ピストン上に配置され得る。駆動ピストンは非接触センサ106から離れるように移動するので、低減または調節された電力量がモータ66に提供され得る。またさらに、別の代替的な実施形態において、非接触センサ106は駆動スクリュー74の自由端110に配置され、磁気部材112は固定され得る。
The term “adjustment” adjusts the amount of voltage received by the
本開示の別の実施形態において、外科用ステープラは複合駆動メカニズムを有し得る。複合駆動メカニズムはステープリングメカニズムの発射構成要素とクランピングメカニズムとの両方を制御し得る。外科用ステープラ10は、作動されると、駆動メカニズムを進めることにより、クランピングメカニズムを使用してクランピングを開始して保持し、次に、待機するに従って所定の遅延を提供する。次に、いったん所望の量の圧縮に到達すると、外科用ステープラ10は外科医/オペレータに指示を提供する。その後に、外科医/オペレータは時間遅延の後に駆動メカニズムを作動する。駆動メカニズムはステープリングカートリッジ21から圧縮された組織にステープルを発射し、均一なステープルの形成を確かなものにする。このように外科用ステープラ10はステープリングに先立ち時間遅延を提供し、組織の圧縮を確かなものにする。
In another embodiment of the present disclosure, the surgical stapler can have a compound drive mechanism. The compound drive mechanism may control both the firing component and the clamping mechanism of the stapling mechanism. When activated, the
内視鏡的な外科用ステープラとして示されているが、本駆動システムは、当該分野において公知である任意の外科ステープリングデバイスで使用され、例えば、内視鏡的な外科ステープリングデバイス、空気式ステープリングデバイス、GIA外科ステープリングデバイス、内視鏡GIAステープリングデバイス、TA外科ステープリングデバイス、および当該分野において公知である手術のためのその他任意のステープラデバイスで使用され得る。本開示はまた、クランピングおよびステーププリングの両方のデバイスを駆動する単一駆動の外科用ステープラで使用され得る。本開示は、TA外科ステープリングデバイスのような接合してそれから発射するデバイス、またはこのような組織の接合を全く用いることのない外科用ステープラに組み込まれ得る。 Although shown as an endoscopic surgical stapler, the present drive system can be used with any surgical stapling device known in the art, eg, an endoscopic surgical stapling device, pneumatic It can be used in stapling devices, GIA surgical stapling devices, endoscopic GIA stapling devices, TA surgical stapling devices, and any other stapler device for surgery known in the art. The present disclosure may also be used with single drive surgical staplers that drive both clamping and stapling devices. The present disclosure can be incorporated into a device that joins and fires from a TA surgical stapling device, or a surgical stapler that does not use any such tissue joining.
上記の記述は本開示の単なる例示であるということを理解されたい。様々な代替案および改変が本開示を逸脱することなく当業者によって工夫され得る。従って、本開示はこのような全ての代替案、改変および変形を包含することが意図されている。添付の図面を参照に記述されてきた実施形態は本開示の特定の例を示すだけのために提示されている。上で記述されたものおよび/または添付の特許請求の範囲で記述されたものと実質的に異ならない他の要素、ステップ、方法および技術はまた本開示の範囲内となることが意図されている。 It should be understood that the above description is only illustrative of the present disclosure. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variations. The embodiments described with reference to the accompanying drawings are presented only to illustrate certain examples of the disclosure. Other elements, steps, methods and techniques not substantially different from those described above and / or in the appended claims are also intended to be within the scope of this disclosure. .
Claims (41)
a)固定のハンドルと、作動ストロークを介してカム部材を操作するように構成されているトリガとを含むハンドルアセンブリと、
b)該ハンドルアセンブリから遠位方向に伸び、長手方向軸を規定する細長い本体と、
c)該細長い本体の遠位端付近で支持され、複数のステープルを含むステープルカートリッジと、
d)該細長い本体の遠位端付近に該カートリッジに対して旋回するように設置されているアンビルであって、該アンビルはその上にファスナ形成面を有し、該ステープルカートリッジから間隔が空けられた遠位端を有する開位置と該ステープルカートリッジに密着し協働する配置にある閉位置との間での該ステープルカートリッジに対する旋回的な動きのために設置されている、アンビルと、
e)該ステープルカートリッジ内で支持されている作動スレッドであって、該作動スレッドは、該ステープルカートリッジから複数のステープルを押し出すように動くことが可能である、作動スレッドと、
f)作業端と該作業端の上で支持されている該カム部材とを有する本体を含む駆動アセンブリであって、該カム部材は該ステープラの発射の間に該アンビルを該閉位置に維持するように、該アンビルに対して移動するように配置され、該旋回可能なハンドルは該駆動アセンブリに動作可能に接続されることにより、該トリガの操作が、該アンビルに対する該カム部材の移動をもたらす、駆動アセンブリと、
g)該ステープルカートリッジを支持するためのチャネルと、
h)該ステープルカートリッジ内で支持される該作動スレッドを制御するように構成されているコントローラであって、該アンビルが該閉位置にあり、該ステープルカートリッジと協働する配置にあるときには、該コントローラは、所定の期間、該ステープルカートリッジから複数のステープルを押し出すための該作動スレッドの動きを遅延させる、コントローラと
を備えている、外科用ステープラ。 A surgical stapler,
a) a handle assembly including a fixed handle and a trigger configured to operate the cam member via an actuation stroke;
b) an elongated body extending distally from the handle assembly and defining a longitudinal axis;
c) a staple cartridge supported near the distal end of the elongate body and including a plurality of staples;
d) An anvil positioned to pivot relative to the cartridge near the distal end of the elongate body, the anvil having a fastener forming surface thereon and spaced from the staple cartridge. An anvil installed for pivotal movement relative to the staple cartridge between an open position having a distal end and a closed position in close contact with and cooperating with the staple cartridge;
e) an actuation sled supported within the staple cartridge, wherein the actuation sled is movable to extrude a plurality of staples from the staple cartridge;
f) A drive assembly including a body having a working end and the cam member supported on the working end, the cam member maintaining the anvil in the closed position during firing of the stapler. The pivotable handle is operatively connected to the drive assembly such that manipulation of the trigger results in movement of the cam member relative to the anvil. A drive assembly;
g) a channel for supporting the staple cartridge;
h) a controller configured to control the working sled supported within the staple cartridge when the anvil is in the closed position and in a cooperating arrangement with the staple cartridge; And a controller for delaying movement of the actuation sled to extrude a plurality of staples from the staple cartridge for a predetermined period of time.
a)固定のハンドルと、カム部材を操作するように構成されているトリガとを含むハンドルアセンブリと、
b)該ハンドルアセンブリから遠位方向に伸び、長手方向軸を規定する細長い本体と、
c)該細長い本体の遠位端付近で支持され、複数のステープルを含むステープルカートリッジと、
d)該細長い本体の遠位端付近に該カートリッジに対して旋回するように設置されているアンビルであって、該アンビルはその上にファスナ形成面を有し、該ステープルカートリッジから間隔が空けられた遠位端を有する開位置と該ステープルカートリッジに密着し協働する配置にある閉位置との間での該カートリッジに対する旋回的な動きのために設置されている、アンビルと、
e)該カートリッジ内で支持されている作動スレッドであって、該作動スレッドは、該カートリッジから複数のステープルを押し出すように動くことが可能である、作動スレッドと、
f)作業端と該作業端の上で支持されている該カム部材とを有する本体を含む駆動アセンブリであって、該カム部材は該ステープラの発射の間に該アンビルを該閉位置に維持するように該アンビルに対して移動するように配置され、該トリガは該駆動アセンブリに動作可能に接続されることにより、該トリガの操作が、該アンビルに対する該カム部材の移動をもたらす、駆動アセンブリと、
g)該ステープルカートリッジを支持するためのチャネルと、
h)該ステープルカートリッジ内で支持される該作動スレッドを制御するように構成されているコントローラであって、該アンビルが該閉位置にあり、該ステープルカートリッジと協働する配置にあるときには、該コントローラは、所定の期間、該ステープルカートリッジから複数のステープルを押し出すための該作動スレッドの動きを遅延させる、コントローラと、
i)該コントローラに接続されているインジケータであって、該所定の期間に到達したときに、該コントローラは該インジケータを制御することにより、指示を提供する、インジケータと
を備えている、外科用ステープラ。 A surgical stapler,
a) a handle assembly including a fixed handle and a trigger configured to operate the cam member;
b) an elongated body extending distally from the handle assembly and defining a longitudinal axis;
c) a staple cartridge supported near the distal end of the elongate body and including a plurality of staples;
d) An anvil positioned to pivot relative to the cartridge near the distal end of the elongate body, the anvil having a fastener forming surface thereon and spaced from the staple cartridge. An anvil installed for pivotal movement relative to the cartridge between an open position having a distal end and a closed position in close contact with and cooperating with the staple cartridge;
e) an actuation sled supported within the cartridge, the actuation sled being movable to extrude a plurality of staples from the cartridge;
f) A drive assembly including a body having a working end and the cam member supported on the working end, the cam member maintaining the anvil in the closed position during firing of the stapler. A drive assembly, wherein the trigger is operatively connected to the drive assembly such that operation of the trigger results in movement of the cam member relative to the anvil; and ,
g) a channel for supporting the staple cartridge;
h) a controller configured to control the working sled supported within the staple cartridge when the anvil is in the closed position and in a cooperating arrangement with the staple cartridge; A controller that delays movement of the working sled to extrude a plurality of staples from the staple cartridge for a predetermined period of time;
i) an indicator connected to the controller, the controller comprising: an indicator that provides an indication by controlling the indicator when the predetermined period is reached; .
ステープルカートリッジとアンビルとの間で組織の位置を決めることと、
該ステープルカートリッジと該アンビルとの間で組織を圧縮することと、
作動器を操作し、該ステープルカートリッジからステープルを発射することであって、
該作動器は、所定の期間、ステープルを発射することを自動的に遅延させるように構成されており、
該所定の期間は該所定の期間に組織の圧縮を可能にし、組織が第1の初期の状態から第2の圧縮された状態に移ることを可能にするのに適した長さであることと、
該組織が第2の圧縮状態にあるときに、所定の期間の経過時に該ステープルカートリッジから該組織を通してステープルを押し出すことと
を包含する、方法。 A method of stapling tissue,
Positioning the tissue between the staple cartridge and the anvil;
Compressing tissue between the staple cartridge and the anvil;
Manipulating an actuator to fire staples from the staple cartridge,
The actuator is configured to automatically delay firing the staple for a predetermined period of time;
The predetermined period is of a length suitable to permit tissue compression during the predetermined period and to allow the tissue to transition from a first initial state to a second compressed state; ,
Pushing the staples from the staple cartridge through the tissue after a predetermined period of time when the tissue is in a second compressed state.
トリガを含むハンドルアセンブリと、
複数のステープルを含んでいるステープルカートリッジと、その上にファスナ形成面を有するアンビルとを有するクランピングデバイスと、
該アンビルと該ステープルカートリッジとによるクランピングの発生を判断するように構成されているコントローラであって、該コントローラは該ステープルカートリッジからの該複数のステープルの発射を制御する、コントローラと
を備え、
該トリガが作動されるときに、該コントローラは該ステープルカートリッジからの該複数のステープルの発射を遅延させ、該アンビルと該ステープルカートリッジとの間の、組織の所定の組織圧縮期間を提供し、所定の期間に達すると、該コントローラは、発射を可能にするための制御信号を出力する、外科用ステープラ。 A surgical stapler,
A handle assembly including a trigger;
A clamping device having a staple cartridge containing a plurality of staples and an anvil having a fastener-forming surface thereon;
A controller configured to determine the occurrence of clamping by the anvil and the staple cartridge, the controller comprising: a controller for controlling firing of the plurality of staples from the staple cartridge;
When the trigger is activated, the controller delays firing of the plurality of staples from the staple cartridge, provides a predetermined tissue compression period of tissue between the anvil and the staple cartridge, The surgical stapler outputs a control signal to enable firing when the period of time is reached.
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US12144501B2 (en) | 2023-05-31 | 2024-11-19 | Cilag Gmbh International | Monitoring of manufacturing life-cycle |
Also Published As
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AU2006344427A1 (en) | 2007-12-13 |
WO2007142625A3 (en) | 2009-04-16 |
WO2007142625A2 (en) | 2007-12-13 |
CA2608791C (en) | 2013-11-12 |
AU2006344427B2 (en) | 2012-03-01 |
JP5147837B2 (en) | 2013-02-20 |
CA2608791A1 (en) | 2007-12-02 |
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