JP7322047B2 - 電気的パラメータを使用するリアルタイム組織分類 - Google Patents
電気的パラメータを使用するリアルタイム組織分類 Download PDFInfo
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- JP7322047B2 JP7322047B2 JP2020546989A JP2020546989A JP7322047B2 JP 7322047 B2 JP7322047 B2 JP 7322047B2 JP 2020546989 A JP2020546989 A JP 2020546989A JP 2020546989 A JP2020546989 A JP 2020546989A JP 7322047 B2 JP7322047 B2 JP 7322047B2
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Description
本出願は、2018年9月27日出願の「LIVE TIME TISSUE CLASSIFICATION USING ELECTRICAL PARAMETERS」と題する米国特許非仮出願第16/144,486号の利益を主張し、その開示は、全体が参照により本明細書に組み込まれる。
・「METHODS FOR CONTROLLING TEMPERATURE IN ULTRASONIC DEVICE」と題する米国特許仮出願、代理人整理番号END8560USNP1/180106-1M、
・「ULTRASONIC SEALING ALGORITHM WITH TEMPERATURE CONTROL」と題する米国特許仮出願、代理人整理番号END8560USNP3/180106-3、
・「APPLICATION OF SMART ULTRASONIC BLADE TECHNOLOGY」と題する米国特許仮出願、代理人整理番号END8560USNP4/180106-4、
・「ADAPTIVE ADVANCED TISSUE TREATMENT PAD SAVER MODE」と題する米国特許仮出願、代理人整理番号END8560USNP5/180106-5、
・「SMART BLADE TECHNOLOGY TO CONTROL BLADE INSTABILITY」と題する米国特許仮出願、代理人整理番号END8560USNP6/180106-6、及び
・「START TEMPERATURE OF BLADE」と題する米国特許仮出願、代理人整理番号END8560USNP7/180106-7。
・「METHODS FOR ESTIMATING AND CONTROLLING STATE OF ULTRASONIC END EFFECTOR」と題する米国特許仮出願、代理人整理番号END8536USNP1/180107-1M、
・「IN-THE-JAW CLASSIFIER BASED ON MODEL」と題する米国特許出願、代理人整理番号END8536USNP3/180107-3、
・「APPLICATION OF SMART BLADE TECHNOLOGY」と題する米国特許仮出願、代理人整理番号END8536USNP4/180107-4、
・「SMART BLADE AND POWER PULSING」と題する米国特許仮出願、代理人整理番号END8536USNP5/180107-5、
・「ADJUSTMENT OF COMPLEX IMPEDANCE TO COMPENSATE FOR LOST POWER IN AN ARTICULATING ULTRASONIC DEVICE」と題する米国特許仮出願、代理人整理番号END8536USNP6/180107-6、
・「USING SPECTROSCOPY TO DETERMINE DEVICE USE STATE IN COMBO INSTRUMENT」と題する米国特許仮出願、代理人整理番号END8536USNP7/180107-7、
・「VESSEL SENSING FOR ADAPTIVE ADVANCED HEMOSTASIS」と題する米国特許仮出願、代理人整理番号END8536USNP8/180107-8、
・「CALCIFIED VESSEL IDENTIFICATION」と題する米国特許仮出願、代理人整理番号END8536USNP9/180107-9、
・「DETECTION OF LARGE VESSELS DURING PARENCHYMAL DISSECTION USING A SMART BLADE」と題する米国特許仮出願、代理人整理番号END8536USNP10/180107-10、
・「SMART BLADE APPLICATION FOR REUSABLE AND DISPOSABLE DEVICES」と題する米国特許仮出願、代理人整理番号END8536USNP11/180107-11、及び
・「FINE DISSECTION MODE FOR TISSUE CLASSIFICATION」と題する米国特許仮出願、代理人整理番号END8536USNP13/180107-13。
・「AUTOMATED DATA SCALING,ALIGNMENT,AND ORGANIZING BASED ON PREDEFINED PARAMETERS WITHIN A SURGICAL NETWORK BEFORE TRANSMISSION」と題する米国特許仮出願第62/729,177号、
・「SENSING THE PATIENT POSITION AND CONTACT UTILIZING THE MONO POLAR RETURN PAD ELECTRODE TO PROVIDE SITUATIONAL AWARENESS TO THE HUB」と題する米国特許仮出願第62/729,182号、
・「POWERED SURGICAL TOOL WITH A PREDEFINED ADJUSTABLE CONTROL ALGORITHM FOR CONTROLLING AT LEAST ONE END EFFECTOR PARAMETER AND A MEANS FOR LIMITING THE ADJUSTMENT」と題する米国特許仮出願第62/729,184号、
・「SURGICAL NETWORK RECOMMENDATIONS FROM REAL TIME ANALYSIS OF PROCEDURE VARIABLES AGAINST A BASELINE HIGHLIGHTING DIFFERENCES FROM THE OPTIMAL SOLUTION」と題する米国特許仮出願第62/729,183号、
・「A CONTROL FOR A SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE THAT ADJUSTS ITS FUNCTION BASED ON A SENSED SITUATION OR USAGE」と題する米国特許仮出願第62/729,191号、
・「INDIRECT COMMAND AND CONTROL OF A FIRST OPERATING ROOM SYSTEM THROUGH THE USE OF A SECOND OPERATING ROOM SYSTEM WITHIN A STERILE FIELD WHERE THE SECOND OPERATING ROOM SYSTEM HAS PRIMARY AND SECONDARY OPERATING MODES」と題する米国特許仮出願第62/729,176号、
・「WIRELESS PAIRING OF A SURGICAL DEVICE WITH ANOTHER DEVICE WITHIN A STERILE SURGICAL FIELD BASED ON THE USAGE AND SITUATIONAL AWARENESS OF DEVICES」と題する米国特許仮出願第62/729,186号、及び
・「POWERED STAPLING DEVICE THAT IS CAPABLE OF ADJUSTING FORCE,ADVANCEMENT SPEED,AND OVERALL STROKE OF CUTTING MEMBER OF THE DEVICE BASED ON SENSED PARAMETER OF FIRING OR CLAMPING」と題する米国特許仮出願第62/729,185号。
・「ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR」と題する米国特許出願第16/115,214号、
・「TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR」と題する米国特許出願第16/115,205号、
・「RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS」と題する米国特許出願第16/115,233号、
・「CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION」と題する米国特許出願第16/115,208号、
・「CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE」と題する米国特許出願第16/115,220号、
・「DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM」と題する米国特許出願第16/115,232号、
・「DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT」と題する米国特許出願第16/115,239号、
・「DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR」と題する米国特許出願第16/115,247号、
・「SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS」と題する米国特許出願第16/115,211号、
・「MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT」と題する米国特許出願第16/115,226号、
・「DETECTION OF END EFFECTOR EMERSION IN LIQUID」と題する米国特許出願第16/115,240号、
・「INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING」と題する米国特許出願第16/115,249号、
・「INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP」と題する米国特許出願第16/115,256号、
・「BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY」と題する米国特許出願第16/115,223号、及び
・「ACTIVATION OF ENERGY DEVICES」と題する米国特許出願第16/115,238号。
・「CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION」と題する米国特許仮出願第62/721,995号、
・「SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS」と題する米国特許仮出願第62/721,998号、
・「INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING」と題する米国特許仮出願第62/721,999号、
・「BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY」と題する米国特許仮出願第62/721,994号、及び
・「RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS」と題する米国特許仮出願第62/721,996号。
・「SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE」と題する米国特許仮出願第62/692,747号、
・「SMART ENERGY ARCHITECTURE」と題する米国特許仮出願第62/692,748号、及び
・「SMART ENERGY DEVICES」と題する米国特許仮出願第62/692,768号。
・「CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS」と題する米国特許出願第16/024,090号、
・「CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS」と題する米国特許出願第16/024,057号、
・「SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION」と題する米国特許出願第16/024,067号、
・「SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING」と題する米国特許出願第16/024,075号、
・「SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING」と題する米国特許出願第16/024,083号、
・「SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES」と題する米国特許出願第16/024,094号、
・「SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE」と題する米国特許出願第16/024,138号、
・「SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES」と題する米国特許出願第16/024,150号、
・「VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY」と題する米国特許出願第16/024,160号、
・「SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE」と題する米国特許出願第16/024,124号、
・「SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT」と題する米国特許出願第16/024,132号、
・「SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY」と題する米国特許出願第16/024,141号、
・「SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES」と題する米国特許出願第16/024,162号、
・「SURGICAL EVACUATION SENSING AND MOTOR CONTROL」と題する米国特許出願第16/024,066号、
・「SURGICAL EVACUATION SENSOR ARRANGEMENTS」と題する米国特許出願第16/024,096号、
・「SURGICAL EVACUATION FLOW PATHS」と題する米国特許出願第16/024,116号、
・「SURGICAL EVACUATION SENSING AND GENERATOR CONTROL」と題する米国特許出願第16/024,149号、
・「SURGICAL EVACUATION SENSING AND DISPLAY」と題する米国特許出願第16/024,180号、
・「COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM」と題する米国特許出願第16/024,245号、
・「SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM」と題する米国特許出願第16/024,258号、
・「SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE」と題する米国特許出願第16/024,265号、及び
・「DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS」と題する米国特許出願第16/024,273号。
・「A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES」と題する米国特許仮出願第62/691,228号、
・「CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS」と題する米国特許仮出願第62/691,227号、
・「SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE」と題する米国特許仮出願第62/691,230号、
・「SURGICAL EVACUATION SENSING AND MOTOR CONTROL」と題する米国特許仮出願第62/691,219号、
・「COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM」と題する米国特許仮出願第62/691,257号、
・「SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE」と題する米国特許仮出願第62/691,262号、及び
・「DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS」と題する米国特許仮出願第62/691,251号。
・「METHOD OF HUB COMMUNICATION」と題する米国特許仮出願第62/659,900号。
・「CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS」と題する2018年3月30日出願の米国特許仮出願第62/650,898号、
・「SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES」と題する米国特許仮出願第62/650,887号、
・「SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM」と題する米国特許仮出願第62/650,882号、及び
・「SURGICAL SMOKE EVACUATION SENSING AND CONTROLS」と題する米国特許仮出願第62/650,877号。
・「INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES」と題する米国特許出願第15/940,641号、
・「INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES」と題する米国特許出願第15/940,648号、
・「SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES」と題する米国特許出願第15/940,656号、
・「SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS」と題する米国特許出願第15/940,666号、
・「COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS」と題する米国特許出願第15/940,670号、
・「SURGICAL HUB CONTROL ARRANGEMENTS」と題する米国特許出願第15/940,677号、
・「DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD」と題する米国特許出願第15/940,632号、
・「COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS」と題する米国特許出願第15/940,640号、
・「SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT」と題する米国特許出願第15/940,645号、
・「DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME」と題する米国特許出願第15/940,649号、
・「SURGICAL HUB SITUATIONAL AWARENESS」と題する米国特許出願第15/940,654号、
・「SURGICAL SYSTEM DISTRIBUTED PROCESSING」と題する米国特許出願第15/940,663号、
・「AGGREGATION AND REPORTING OF SURGICAL HUB DATA」と題する米国特許出願第15/940,668号、
・「SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER」と題する米国特許出願第15/940,671号、
・「DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE」と題する米国特許出願第15/940,686号、
・「STERILE FIELD INTERACTIVE CONTROL DISPLAYS」と題する米国特許出願第15/940,700号、
・「COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS」と題する米国特許出願第15/940,629号、
・「USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT」と題する米国特許出願第15/940,704号、
・「CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY」と題する米国特許出願第15/940,722号、及び
・「DUAL CMOS ARRAY IMAGING」と題する米国特許出願第15/940,742号。
・「ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES」と題する米国特許出願第15/940,636号、
・「ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS」と題する米国特許出願第15/940,653号、
・「CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER」と題する米国特許出願第15/940,660号、
・「CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET」と題する米国特許出願第15/940,679号、
・「CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION」と題する米国特許出願第15/940,694号、
・「CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES」と題する米国特許出願第15/940,634号、
・「DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK」と題する米国特許出願第15/940,706号、及び
・「CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES」と題する米国特許出願第15/940,675号。
・「DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第15/940,627号、
・「COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第15/940,637号、
・「CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第15/940,642号、
・「AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第15/940,676号、
・「CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第15/940,680号、
・「COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第15/940,683号、
・「DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第15/940,690号、及び
・「SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第15/940,711号。
・「INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES」と題する米国特許仮出願第62/649,302号、
・「DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD」と題する米国特許仮出願第62/649,294号、
・「SURGICAL HUB SITUATIONAL AWARENESS」と題する米国特許仮出願第62/649,300号、
・「SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER」と題する米国特許仮出願第62/649,309号、
・「COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS」と題する米国特許仮出願第62/649,310号、
・「USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT」と題する米国特許仮出願第62/649,291号、
・「ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES」と題する米国特許仮出願第62/649,296号、
・「CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER」と題する米国特許仮出願第62/649,333号、
・「CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES」と題する米国特許仮出願第62/649,327号、
・「DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK」と題する米国特許仮出願第62/649,315号、
・「CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES」と題する米国特許仮出願第62/649,313号、
・「DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許仮出願第62/649,320号、
・「AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許仮出願第62/649,307号、及び
・「SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許仮出願第62/649,323号。
・「INTERACTIVE SURGICAL PLATFORM」と題する米国特許仮出願第62/611,341号、
・「CLOUD-BASED MEDICAL ANALYTICS」と題する米国特許仮出願第62/611,340号、及び
・「ROBOT ASSISTED SURGICAL PLATFORM」と題する米国特許仮出願第62/611,339号。
様々な態様では、スマート超音波エネルギー装置は、超音波ブレードの動作を制御するための適応アルゴリズムを含んでもよい。一態様では、超音波ブレード適応制御アルゴリズムは、組織の種類を特定し、装置パラメータを調整するように構成される。一態様では、超音波ブレード制御アルゴリズムは、組織の種類をパラメータ化するように構成される。超音波ブレードの遠位先端の振幅を調整するために組織のコラーゲン/弾性比を検出するためのアルゴリズムが、本開示の以下の項で説明される。スマート超音波エネルギー装置の様々な態様が、例えば図1及び図2に関連して本明細書で説明される。したがって、適応型超音波ブレード制御アルゴリズムの以下の説明は、図1及び図2並びにこれらに関連する説明と併せて読まれるべきである。
図2は、超音波器具と連結するように構成され、かつ、図1に示すモジュール式通信ハブを備える外科用データネットワーク内で適応型超音波ブレード制御アルゴリズムを実行するように更に構成された発生器の一形態である、発生器900の一例を示す。発生器900は、複数のエネルギーモダリティを外科用器具に送達するように構成されている。発生器900は、エネルギーを外科用器具に送達するためのRF信号及び超音波信号を単独で又は同時にのいずれかで提供する。RF信号及び超音波信号は、単独で又は組み合わせて提供されてもよく、また同時に提供されてもよい。上述したように、少なくとも1つの発生器出力部は、単一のポートを通して複数のエネルギーモダリティ(例えば、とりわけ超音波、双極若しくは単極RF、不可逆及び/若しくは可逆電気穿孔法並びに/又はマイクロ波エネルギー)を送達することができ、これらの信号は、組織を治療するために個別に又は同時にエンドエフェクタに送達することができる。発生器900は、波形発生器904に連結されたプロセッサ902を備える。プロセッサ902及び波形発生器904は、プロセッサ902に連結されたメモリに記憶された情報(開示を明瞭にするために示されず)に基づいて、種々の信号波形を発生するように構成されている。波形に関連するデジタル情報は、デジタル入力をアナログ出力に変換するために1つ又は2つ以上のDAC回路を含む波形発生器904に提供される。アナログ出力は、信号調整及び増幅のために、増幅器906に供給される。増幅器906の、調節され増幅された出力は、電力変圧器908に連結されている。信号は、電力変圧器908を横断して患者絶縁側にある二次側に連結されている。第1のエネルギーモダリティの第1の信号は、外科用器具のENERGY1及びRETURNとラベルされた端子間に提供される。第2のエネルギーモダリティの第2の信号は、コンデンサ910を横断して連結され、外科用器具のENERGY2及びRETURNとラベルされた端子間に提供される。2つを超えるエネルギーモダリティが出力されてもよく、したがって添え字「n」は、最大n個のENERGYn端子が提供され得ることを示すために使用することができ、ここでnは、1超の正の整数であることが理解されよう。最大「n」個のリターンパス(RETURNn)が、本開示の範囲から逸脱することなく提供されてもよいことも理解されよう。
φ=2πft+φ0
式中、φは位相角であり、fは周波数であり、tは時間であり、φ0は、t=0における位相である。
と等しいことに留意されたい。n=32では、分解能は40億における一部よりも高い。DDS回路4200の一態様では、位相アキュムレータ4206外の全てのビットがルックアップテーブル4210に伝えられるわけではなく、切り捨てられて、例えば、最初の13~15個の最上位ビット(most significant bit、MSB)のみが残される。これはルックアップテーブル4210のサイズを低減し、かつ周波数分解能に影響を及ぼさない。位相の切り捨ては、少量であるが許容可能な位相雑音の量のみを最終出力に追加する。
超音波エネルギー送達に伴う課題は、超音波音響が誤った材料又は誤った組織に適用されることにより、装置故障、例えば、クランプアームパッドの溶落ち又は超音波ブレードの破損が生じ得ることである。また、ジョー内に追加のセンサを追加することなく、超音波装置のエンドエフェクタのジョー内に何が位置するのか、及びジョーの状態を検出することも望ましい。超音波エンドエフェクタのジョー内にセンサを位置決めすることは、信頼性、コスト、及び複雑性の課題を提起する。
に基づいて、ジョーの状態(クランプアームパッドの溶落ち、ステープル、壊れたブレード、ジョー内の骨、ジョー内の組織、ジョーが閉じた状態でのバックカット)を推定するために、超音波分光スマートブレードアルゴリズム技術を用いてもよい。インピーダンスZg(t)、大きさ|Z|、及び位相φは、周波数fの関数としてプロットされる。
各特性パターンに関して、パラメトリックラインは、便宜により決定され得るように、多項式、フーリエ級数、又は任意の他の形態のパラメトリック方程式を使用して、訓練に使用されるデータに適合させることができる。新しいデータ点が受信され、これを、新たなデータ点から特性パターン訓練データに適合された軌跡までのユークリッド垂直距離を使用することによって分類する。新たなデータ点の軌跡の各々(各軌跡は異なる状態又はコンディションを表す)までの垂直距離を使用して、点を状態又はコンディションに割り当てる。
超音波トランスデューサ/超音波ブレードの起動前、起動中、又は起動後に測定されたデータの分類に基づいて、種々の自動タスク及び安全対策を実装することができる。同様に、エンドエフェクタ内に位置する組織の状態及び超音波ブレードの温度もある程度推定され、ユーザに超音波装置の状態をよりよく知らせるか、又は重要な構造を保護するためなどに使用することもできる。超音波ブレードの温度制御は、その全体が参照により本明細書に組み込まれる、2018年3月8日に出願された共同所有の米国特許仮出願第62/640,417号、題「TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR」に記載されている。
このシステムは、確率関数及びカルマンフィルタを使用して、このプロセスからのデータを前述のデータと組み合わせることによって、センサ、ユーザ、患者の測定基準、環境要因などによって提供される他の情報と併用することができる。カルマンフィルタは、様々な信頼性の不確かな測定値をふんだんに考慮して、生じる状態又はコンディションの最大尤度を決定する。この方法により、新たに分類されたデータ点への確率の割り当てが可能となるため、このアルゴリズムの情報は、カルマンフィルタ内の他の測定又は推定を用いて実装することができる。
として定義される。制御回路は、複素インピーダンス測定データ点を受信し(132048)、複素インピーダンス測定データ点を基準複素インピーダンス特性パターンのデータ点と比較する(132050)。制御回路は、比較分析の結果に基づいて複素インピーダンス測定データ点を分類し(132052)、比較分析の結果に基づいてエンドエフェクタの状態又はコンディションを割り当てる(132054)。
組織の種類及びコンディションを含む超音波装置のジョー内に位置する物質を分類することに対する関心は既存である。様々な態様において、高度なデータサンプリング及び精緻なパターン認識を用いると、この分類が可能であることが示され得る。このアプローチは、周波数の関数としてのインピーダンスに基づくものであり、ここでは、大きさ、位相、及び周波数が3Dでプロットされ、パターンは、図19及び図20、並びに図21の論理フロー図に示されるように、リボン様に見える。本開示は、圧電トランスデューサの十分に確立されたモデルに基づく代替的なスマートブレードアルゴリズムのアプローチを提供する。
Co=3.0nF
Cs=8.22pF
Ls=1.0H
Rs=450Ω
r=1.012*103
a=1.013*103
b=-954.585
r2=(x-a)2+(y-b)2
Z1,iは、コンダクタンスと称される実数成分の第1のベクトルであり、
Z2,iは、サセプタンスと称される虚数成分の第2であり、
Z3,iは、アドミッタンスが計算される周波数を表す第3のベクトルである。
Ls=L1=1.1068H
Rs=R1=311.352Ω
Cs=C1=7.43265pF
C0=C0=3.64026nF
図25は、本開示の少なくとも1つの態様による、ジョーが開放しており、負荷がない超音波装置の複素インピーダンス(Z)/アドミッタンス(Y)円プロット132068、132070を示すインピーダンス分析器のグラフ表示132066であり、実線の円プロット132068は複素インピーダンスを示し、破線の円プロット132070は複素アドミッタンスを示す。超音波トランスデューサに印加される発振器電圧は500mVであり、周波数は55kHz~56kHzにスイープされる。インピーダンス(Z)スケールは200Ω/divであり、アドミッタンス(Y)スケールは500μS/divである。複素インピーダンス(Z)及びアドミッタンス(Y)円プロット132068、132070を特徴付け得る値の測定は、インピーダンスカーソル132072及びアドミッタンスカーソル132074によって示される円プロット132068、132070上の位置で取得されてもよい。したがって、インピーダンスカーソル132072は、約55.55kHzに等しいインピーダンス円プロット132068の一部分に位置し、アドミッタンスカーソル132074は、約55.29kHzに等しいアドミッタンス円プロット132070の一部分に位置する。図25に示されるように、インピーダンスカーソル132072の位置は、以下の値に対応する:
R=1.66026Ω
X=-697.309Ω
式中、Rは抵抗(実数値)であり、Xはリアクタンス(虚数値)である。同様に、アドミッタンスカーソル132074の位置は、以下の値に対応する。
G=64.0322μS
B=1.63007mS
式中、Gはコンダクタンス(実数値)であり、Bはサセプタンス(虚数値)である。
図26は、本開示の少なくとも1つの態様による、エンドエフェクタのジョーが乾燥したセームを挟んでクランプされている超音波装置の複素インピーダンス(Z)/アドミッタンス(Y)円プロット132078、132080を示すインピーダンス分析器のグラフ表示132076であり、インピーダンス円プロット132078は実線で示され、アドミッタンス円プロット132080は破線で示されている。超音波トランスデューサに印加される電圧は500mVであり、周波数は55kHz~56kHzにスイープされる。インピーダンス(Z)スケールは200Ω/divであり、アドミッタンス(Y)スケールは500μS/divである。
R=434.577Ω
X=-758.772Ω
式中、Rは抵抗(実数値)であり、Xはリアクタンス(虚数値)である。
G=85.1712μS
B=1.49569mS
式中、Gはコンダクタンス(実数値)であり、Bはサセプタンス(虚数値)である。
図27は、本開示の少なくとも1つの態様による、ジョーの先端が湿ったセームを挟んでクランプされている超音波装置の複素インピーダンス(Z)/アドミッタンス(Y)円プロット132098、132090を示すインピーダンス分析器のグラフ表示132086であり、インピーダンス円プロット132088は実線で示され、アドミッタンス円プロット132090は破線で示されている。超音波トランスデューサに印加される電圧は500mVであり、周波数は55kHz~56kHzにスイープされる。インピーダンス(Z)スケールは200Ω/divであり、アドミッタンス(Y)スケールは500μS/divである。
R=445.259Ω
X=-750.082Ω
式中、Rは抵抗(実数値)であり、Xはリアクタンス(虚数値)である。同様に、アドミッタンスカーソル132094は、以下の値に対応する。
G=96.2179μS
B=1.50236mS
式中、Gはコンダクタンス(実数値)であり、Bはサセプタンス(虚数値)である。
図28は、本開示の少なくとも1つの態様による、ジョーが湿ったセームを挟んで完全にクランプされている超音波装置の複素インピーダンス(Z)/アドミッタンス(Y)円プロット132098、132100を示すインピーダンス分析器のグラフ表示132096であり、インピーダンス円プロット132098は実線で示され、アドミッタンス円プロット132100は破線で示されている。超音波トランスデューサに印加される電圧は500mVであり、周波数は55kHz~56kHzにスイープされる。インピーダンス(Z)スケールは200Ω/divであり、アドミッタンス(Y)スケールは500μS/divである。
G=137.272μS
B=1.48481mS
式中、Gはコンダクタンス(実数値)であり、Bはサセプタンス(虚数値)である。
図29は、本開示の少なくとも1つの態様による、インピーダンス(Z)/アドミッタンス(Y)円プロットを示すインピーダンス分析器のグラフ表示132106であり、周波数は、ジョーが開放しており、負荷がない超音波装置の複数の共振を捕捉するために、48kHz~62kHzにスイープされ、破線で示される矩形132108によって指定された領域は、実線で示されるインピーダンス円プロット132110a、132110b、132110c、及びアドミッタンス円プロット132112a、132112b、132112cを見やすくするためのものである。超音波トランスデューサに印加される電圧は500mVであり、周波数は48kHz~62kHzにスイープされる。インピーダンス(Z)スケールは500Ω/divであり、アドミッタンス(Y)スケールは500μS/divである。
R=1.86163kΩ
X=-536.229Ω
式中、Rは抵抗(実数値)であり、Xはリアクタンス(虚数値)である。同様に、アドミッタンスカーソル132116は、以下の値に対応する:
G=649.956μS
B=2.51975mS
式中、Gはコンダクタンス(実数値)であり、Bはサセプタンス(虚数値)である。
Ls=L1=1.1068H
Rs=R1=311.352Ω
Cs=C1=7.43265pF、及び
C0=C0=3.64026nF
一態様では、本開示は、組織をグループに分類するためのアルゴリズムを提供する。組織の種類は、「ジョーの状態の予測(パッドの溶落ち、ステープル、壊れたブレード、ジョー内の骨、ジョー内の組織」の見出しで図19~図21に、及び/若しくは「モデルに基づくジョーの状態の分類子」の見出しで図22~図30に説明される技術を使用して決定され得(132152)、並びに/又は超音波ブレードの温度を推定するための技術は、「TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR」と題する、Nottらに対する米国特許仮出願第62/640,417号に関連して説明され、該米国特許仮出願の全体は、参照により本明細書に組み込まれる。ライブタイムで組織を分類する能力は、特定の組織グループにアルゴリズムを調整することを可能にする。調整されたアルゴリズムは、全ての組織の種類にわたって封止時間及び止血を最適化し得る。一態様では、本開示は、大きい血管に必要とされる止血を提供し、延長されたエネルギー起動を必要としないより小さい構造を迅速に封止するための封止アルゴリズムを提供する。これらの別個の組織の種類を分類する能力は、ライブタイムで各グループ用の最適化されたアルゴリズムを可能にする。
実施例1.ライブタイムで組織を分類する方法であって、方法は、
プロセッサ又は制御回路によって、第1の期間T1の間、高周波(RF)器具を起動することであって、RF器具が、組織に接触する、起動することと、
プロセッサ又は制御回路によって、RF器具と接触している組織と関連付けられた少なくとも3つの電気的パラメータをプロットして、組織を別個のグループに分類することと、
プロセッサ又は制御回路によって、分類アルゴリズムを適用して、ライブタイムで組織を別個のグループに分類することと、を含む、方法。
エンドエフェクタを含む高周波(RF)器具と、
エンドエフェクタに電力を供給するように構成された発生器と、を備え、発生器が、制御回路を含み、制御回路は、
第1の期間T1の間、高周波(RF)器具を起動することであって、RF器具が、組織に接触する、起動することと、
RF器具と接触している組織と関連付けられた少なくとも3つの電気的パラメータをプロットして、組織を別個のグループに分類することと、
分類アルゴリズムを適用して、ライブタイムで組織を別個のグループに分類することと、を行うように構成されている、外科用器具。
制御回路、を備え、制御回路は、
第1の期間T1の間、高周波(RF)器具を起動することであって、RF器具が、組織に接触する、起動することと、
RF器具と接触している組織と関連付けられた少なくとも3つの電気的パラメータをプロットして、組織を別個のグループに分類することと、
分類アルゴリズムを適用して、ライブタイムで組織を別個のグループに分類することと、を行うように構成されている、外科用器具用の発生器。
(1) ライブタイムで(in live time)組織を分類する方法であって、前記方法は、
プロセッサ又は制御回路によって、第1の期間T1の間、高周波(RF)器具を起動することであって、前記RF器具が、前記組織に接触する、起動することと、
前記プロセッサ又は前記制御回路によって、前記RF器具と接触している前記組織と関連付けられた少なくとも3つの電気的パラメータをプロットして、前記組織を別個のグループに分類することと、
前記プロセッサ又は前記制御回路によって、分類アルゴリズムを適用して、ライブタイムで前記組織を別個のグループに分類することと、を含む、方法。
(2) 前記プロセッサ又は前記制御回路によって、前記RF器具と接触している前記組織と関連付けられた少なくとも3つの電気的パラメータをプロットすることは、前記プロセッサ又は前記制御回路によって、前記組織の初期RFインピーダンス、前記組織の最小RFインピーダンス、及び前記RFインピーダンス勾配が~0であるミリ秒単位の時間量をプロットすることを含む、実施態様1に記載の方法。
(3) 前記プロセッサ又は前記制御回路によって、所定の時間量で前記少なくとも3つの電気的パラメータと関連付けられたデータを収集することを更に含む、実施態様1に記載の方法。
(4) 前記プロセッサ又は前記制御回路によって、所定の時間量で前記少なくとも3つの電気的パラメータと関連付けられたデータを収集することが、前記プロセッサ又は前記制御回路によって、前記高周波(RF)器具の起動後の最初の0.75秒以内に、前記少なくとも3つの電気的パラメータと関連付けられたデータを収集することを含む、実施態様3に記載の方法。
(5) 前記プロセッサ又は前記制御回路によって、分類アルゴリズムを適用して、ライブタイムで前記組織を別個のグループに分類することが、前記プロセッサ又は前記制御回路によって、分類アルゴリズムを適用して、サポートベクターマシンアルゴリズムを使用してライブタイムで前記組織を別個のグループに分類することを含む、実施態様1に記載の方法。
(7) 前記プロセッサ又は前記制御回路によって、前記第1の期間T1の後に各組織グループに固有の起動アルゴリズムを適用することを更に含む、実施態様1に記載の方法。
(8) 外科用器具であって、
エンドエフェクタを含む高周波(RF)器具と、
前記エンドエフェクタに電力を供給するように構成された発生器と、を備え、前記発生器が、制御回路を含み、前記制御回路は、
第1の期間T1の間、前記高周波(RF)器具を起動することであって、前記RF器具が、前記組織に接触する、起動することと、
前記RF器具と接触している前記組織と関連付けられた少なくとも3つの電気的パラメータをプロットして、前記組織を別個のグループに分類することと、
分類アルゴリズムを適用して、ライブタイムで前記組織を別個のグループに分類することと、を行うように構成されている、外科用器具。
(9) 前記RF器具と接触している前記組織と関連付けられた前記少なくとも3つの電気的パラメータは、前記組織の初期RFインピーダンス、前記組織の最小RFインピーダンス、及び前記RFインピーダンス勾配が~0であるミリ秒単位の時間量を含む、実施態様8に記載の外科用器具。
(10) 前記制御回路が、所定の時間量で前記少なくとも3つの電気的パラメータと関連付けられたデータを収集するように更に構成されている、実施態様8に記載の外科用器具。
(12) 前記制御回路が、サポートベクターマシンアルゴリズムを使用してライブタイムで前記組織を別個のグループに分類するように更に構成されている、実施態様8に記載の外科用器具。
(13) 前記サポートベクターマシンアルゴリズムが、線形基底関数、多項式基底関数、又は放射基底関数を含む、実施態様12に記載の外科用器具。
(14) 前記制御回路が、前記第1の期間T1の後に各組織グループに固有の起動アルゴリズムを適用するように更に構成されている、実施態様8に記載の外科用器具。
(15) 外科用器具用の発生器であって、前記外科用器具が、エンドエフェクタを含む高周波(RF)器具を含み、前記発生器は、
制御回路、を備え、前記制御回路は、
第1の期間T1の間、前記高周波(RF)器具を起動することであって、前記RF器具が、組織に接触する、起動することと、
前記RF器具と接触している前記組織と関連付けられた少なくとも3つの電気的パラメータをプロットして、前記組織を別個のグループに分類することと、
分類アルゴリズムを適用して、ライブタイムで前記組織を別個のグループに分類することと、を行うように構成されている、外科用器具用の発生器。
(17) 前記制御回路が、所定の時間量で前記少なくとも3つの電気的パラメータと関連付けられたデータを収集するように更に構成されている、実施態様15に記載の外科用器具用の発生器。
(18) 前記所定の時間量が、前記高周波(RF)器具の起動後の最初の0.75秒を含む、実施態様17に記載の外科用器具用の発生器。
(19) 前記制御回路が、サポートベクターマシンアルゴリズムを使用してライブタイムで前記組織を別個のグループに分類するように更に構成されている、実施態様15に記載の外科用器具用の発生器。
(20) 前記サポートベクターマシンアルゴリズムが、線形基底関数、多項式基底関数、又は放射基底関数を含む、実施態様19に記載の外科用器具用の発生器。
Claims (10)
- 外科用器具であって、
エンドエフェクタを含む高周波(RF)器具と、
前記エンドエフェクタに電力を供給するように構成された発生器と、を備え、前記発生器が、制御回路を含み、前記制御回路は、
前記高周波(RF)器具が組織に接触している間に、第1の期間T1の間、前記高周波(RF)器具を起動することと、
前記組織の初期RFインピーダンス、前記組織の最小RFインピーダンス、及びRFインピーダンスの時間に対する勾配が~0であるミリ秒単位の時間量を含む、前記高周波(RF)器具と接触している前記組織と関連付けられた少なくとも3つの電気的パラメータをプロットして、前記組織を別個のグループに分類することと、
分類アルゴリズムを適用して、ライブタイムで前記組織を別個のグループに分類することと、を行うように構成されている、外科用器具。 - 前記制御回路が、所定の時間量で前記少なくとも3つの電気的パラメータと関連付けられたデータを収集するように更に構成されている、請求項1に記載の外科用器具。
- 前記所定の時間量が、前記高周波(RF)器具の起動後の最初の0.75秒を含む、請求項2に記載の外科用器具。
- 前記制御回路が、サポートベクターマシンアルゴリズムを使用してライブタイムで前記組織を別個のグループに分類するように更に構成されている、請求項1に記載の外科用器具。
- 前記サポートベクターマシンアルゴリズムが、線形基底関数、多項式基底関数、又は放射基底関数を含む、請求項4に記載の外科用器具。
- 外科用器具用の発生器であって、前記外科用器具が、エンドエフェクタを含む高周波(RF)器具を含み、前記発生器は、
制御回路、を備え、前記制御回路は、
前記高周波(RF)器具が組織に接触している間に、第1の期間T1の間、前記高周波(RF)器具を起動することと、
前記組織の初期RFインピーダンス、前記組織の最小RFインピーダンス、及びRFインピーダンスの時間に対する勾配が~0であるミリ秒単位の時間量を含む、前記高周波(RF)器具と接触している前記組織と関連付けられた少なくとも3つの電気的パラメータをプロットして、前記組織を別個のグループに分類することと、
分類アルゴリズムを適用して、ライブタイムで前記組織を別個のグループに分類することと、を行うように構成されている、外科用器具用の発生器。 - 前記制御回路が、所定の時間量で前記少なくとも3つの電気的パラメータと関連付けられたデータを収集するように更に構成されている、請求項6に記載の外科用器具用の発生器。
- 前記所定の時間量が、前記高周波(RF)器具の起動後の最初の0.75秒を含む、請求項7に記載の外科用器具用の発生器。
- 前記制御回路が、サポートベクターマシンアルゴリズムを使用してライブタイムで前記組織を別個のグループに分類するように更に構成されている、請求項6に記載の外科用器具用の発生器。
- 前記サポートベクターマシンアルゴリズムが、線形基底関数、多項式基底関数、又は放射基底関数を含む、請求項9に記載の外科用器具用の発生器。
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