JP6702966B2 - 解放可能な補助材を含むステープルカートリッジ - Google Patents

解放可能な補助材を含むステープルカートリッジ Download PDF

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JP6702966B2
JP6702966B2 JP2017524013A JP2017524013A JP6702966B2 JP 6702966 B2 JP6702966 B2 JP 6702966B2 JP 2017524013 A JP2017524013 A JP 2017524013A JP 2017524013 A JP2017524013 A JP 2017524013A JP 6702966 B2 JP6702966 B2 JP 6702966B2
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バクスター・ザ・サード・チェスター・オー
モルガン・ジェローム・アール
シェルトン・ザ・フォース・フレデリック・イー
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B17/07292Reinforcements for staple line, e.g. pledgets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B17/07207Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • A61B17/0686Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying below the tissue during stapling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/10Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
    • A61B17/105Wound clamp magazines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115Staplers for performing anastomosis in a single operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07257Stapler heads characterised by its anvil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07271Stapler heads characterised by its cartridge
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07285Stapler heads characterised by its cutter

Description

本発明はステープル留め器具に関し、様々な実施形態において、1以上のステープルの列を生成するための外科用ステープル留め器具に関する。
ステープル留め器具は、一対の協働する細長い顎部材を含むことができ、各顎部材が患者の中に挿入され、ステープル留め及び切開される組織に対して位置付けられるように適合させることができる。様々な実施形態において、顎部材のうちの一方は、少なくとも2列の横方向に間隔をおいたステープルをその中に収容するステープルカートリッジを支持し、他方の顎部材は、ステープルカートリッジ内のステープル列と整列されたステープル形成ポケットを有するアンビルを支持することができる。概して、ステープル留め器具は更に、顎部材に対して摺動自在な押し込みバー及びナイフブレードを含んで、押し込みバー上のカム面及び/又は押し込みバーによって押し込まれるウェッジスレッド上のカム面を介してステープルカートリッジからステープルを連続的に放出することができる。少なくとも1つの実施形態において、カム面を、カートリッジが有する、ステープルに付随した複数のステープル駆動要素を作動させて、ステープルをアンビルに対して押し込み、顎部材の間に把持された組織に、横方向に間隔をおいた変形したステープルの列を形成するように構成することができる。少なくとも1つの実施形態において、ナイフブレードはカム面に追従して、ステープル列間の線に沿って組織を切開することができる。かかるステープル留め器具の例は、「SURGICAL STAPLES HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FOR DEPLOYING THE SAME」と題する米国特許第7,794,475号に開示されており、その全体の開示は、参照のために本明細書に組み込まれる。
上述の議論は、当時の本発明の分野における関連技術の様々な態様を説明することのみを意図したものであり、特許請求の範囲を否定するものとみなされるべきではない。
本明細書に記載される実施形態の様々な特徴が、特許請求の範囲で詳細に示される。ただし、機構及び作動方法の両方に関する様々な実施形態は、それらの利点と共に、以下の添付図面を伴う以下の説明により理解することができる。
カートリッジ本体と、引込式保持部材によってカートリッジ本体に解放可能に取り付けられた層とを備える、少なくとも1つの実施形態によるステープルカートリッジの斜視図である。 延出位置にある保持部材を示す、図1のステープルカートリッジの部分断面図である。 引込位置にある保持部材を示す、図1のステープルカートリッジの部分断面図である。 カートリッジ本体と、昇降式保持部材によってカートリッジ本体に解放可能に取り付けられた層とを備える、少なくとも1つの実施形態によるステープルカートリッジの部分斜視図である。 把持位置にある保持部材を示す、図4のステープルカートリッジの部分断面図である。 上昇位置にある保持部材を示す、図4のステープルカートリッジの部分断面図である。 カートリッジ本体と、カートリッジ本体に解放可能に取り付けられたカートリッジ層と、更にカートリッジ本体に解放可能に取り付けられたアンビル層とを備える、ステープルカートリッジを含む、エンドエフェクタアセンブリの部分斜視図である。 図7のエンドエフェクタアセンブリの断面立面図である。 カートリッジ本体に解放可能に取り付けられたカートリッジ層及びアンビル層の近位端を示す、図7のエンドエフェクタアセンブリの部分断面平面図である。 カートリッジ本体から解放されたカートリッジ層及びアンビル層の近位端を示す、図7のエンドエフェクタアセンブリの部分断面平面図である。
対応する参照符合は、複数の図を通じて対応する部材を示す。本明細書に記載される例示は、本発明の様々な実施形態を1つの形態で例示するものであり、かかる例示は、いかなる方法によっても本発明の範囲を限定するものとして解釈されるべきではない。
本出願の出願人は、それぞれの内容全体が参照により本明細書に組み込まれる以下に示す米国特許出願について出願した権利も所有する。
米国特許出願第12/894,311号、発明の名称「SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS」(現在は、米国特許第8,763,877号)、
米国特許出願第12/894,340号、発明の名称「SURGICAL STAPLE CARTRIDGES SUPPORTING NON−LINEARLY ARRANGED STAPLES AND SURGICAL STAPLING INSTRUMENTS WITH COMMON STAPLE−FORMING POCKETS」(現在は、米国特許出願公開第2012/0080482号)、
米国特許出願第12/894,327号、発明の名称「JAW CLOSURE ARRANGEMENTS FOR SURGICAL INSTRUMENTS」(現在は、米国特許出願公開第2012/0080499号)、
米国特許出願第12/894,351号、発明の名称「SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE AND DISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS」(現在は、米国特許出願公開第2012/0080502号)、
米国特許出願第12/894,338号、発明の名称「IMPLANTABLE FASTENER CARTRIDGE HAVING A NON−UNIFORM ARRANGEMENT」(現在は、米国特許第8,864,007号)、
米国特許出願第12/894,369号、発明の名称「IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER」(現在は、米国特許出願公開第2012/0080344号)、
米国特許出願第12/894,312号、発明の名称「IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS」(現在は、米国特許出願公開第2012/0080479号)、
米国特許出願第12/894,377号、発明の名称「SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE」(現在は、米国特許第8,393,514号)、
米国特許出願第12/894,339号、発明の名称「SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROL ARRANGEMENT」(現在は、米国特許第8,840,003号)、
米国特許出願第12/894,360号、発明の名称「SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM」(現在は、米国特許出願公開第2012/0080484号)、
米国特許出願第12/894,322号、発明の名称「SURGICAL STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLE CARTRIDGE ARRANGEMENTS」(現在は、米国特許第8,740,034号)、
米国特許出願第12/894,350号、発明の名称「SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES」(現在は、米国特許出願公開第2012/0080478号)、
米国特許出願第12/894,383号、発明の名称「IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIOABSORBABLE LAYERS」(現在は、米国特許第8,752,699号)、
米国特許出願第12/894,389号、発明の名称「COMPRESSIBLE FASTENER CARTRIDGE」(現在は、米国特許第8,740,037号)、
米国特許出願第12/894,345号、発明の名称「FASTENERS SUPPORTED BY A FASTENER CARTRIDGE SUPPORT」(現在は、米国特許第8,783,542号)、
米国特許出願第12/894,306号、発明の名称「COLLAPSIBLE FASTENER CARTRIDGE」(現在は、米国特許出願公開第2012/0080332号)、
米国特許出願第12/894,318号、発明の名称「FASTENER SYSTEM COMPRISING A PLURALITY OF CONNECTED RETENTION MATRIX ELEMENTS」(現在は、米国特許第8,814,024号)、
米国特許出願第12/894,330号、発明の名称「FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENT MATRIX」(現在は、米国特許第8,757,465号)、
米国特許出願第12/894,361号、発明の名称「FASTENER SYSTEM COMPRISING A RETENTION MATRIX」(現在は、米国特許第8,529,600号)、
米国特許出願第12/894,367号、発明の名称「FASTENING INSTRUMENT FOR DEPLOYING A FASTENER SYSTEM COMPRISING A RETENTION MATRIX」(現在は、米国特許出願公開第2012/0080485号)、
米国特許出願第12/894,388号、発明の名称「FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER」(現在は、米国特許第8,474,677号)、
米国特許出願第12/894,376号、発明の名称「FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES」(現在は、米国特許出願公開第2012/0080486号)、
米国特許出願第13/097,865号、発明の名称「SURGICAL STAPLER ANVIL COMPRISING A PLURALITY OF FORMING POCKETS」(現在は、米国特許出願公開第2012/0080488号)、
米国特許出願第13/097,936号、発明の名称「TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER」(現在は、米国特許第8,657,176号)、
米国特許出願第13/097,954号、発明の名称「STAPLE CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIBLE PORTION」(現在は、米国特許出願公開第2012/0080340号)、
米国特許出願第13/097,856号、発明の名称「STAPLE CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN A COMPRESSIBLE PORTION THEREOF」(現在は、米国特許出願公開第2012/0080336号)、
米国特許出願第13/097,928号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING DETACHABLE PORTIONS」(現在は、米国特許第8,746,535号)、
米国特許出願第13/097,891号、発明の名称「TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER COMPRISING AN ADJUSTABLE ANVIL」(現在は、米国特許第8,864,009号)、
米国特許出願第13/097,948号、発明の名称「STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION」(現在は、米国特許出願公開第2012/0083836号)、
米国特許出願第13/097,907号、発明の名称「COMPRESSIBLE STAPLE CARTRIDGE ASSEMBLY」(現在は、米国特許出願公開第2012/0080338号)、
米国特許出願第13/097,861号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING PORTIONS HAVING DIFFERENT PROPERTIES」(現在は、米国特許出願公開第2012/0080337号)、
米国特許出願第13/097,869号、発明の名称「STAPLE CARTRIDGE LOADING ASSEMBLY」(現在は、米国特許第8,857,694号)、
米国特許出願第13/097,917号、発明の名称「COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS」(現在は、米国特許第8,777,004号)、
米国特許出願第13/097,873号、発明の名称「STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION」(現在は、米国特許第8,740,038号)、
米国特許出願第13/097,938号、発明の名称「STAPLE CARTRIDGE COMPRISING COMPRESSIBLE DISTORTION RESISTANT COMPONENTS」(現在は、米国特許出願公開第2012/0080491号)、
米国特許出願第13/097,924号、発明の名称「STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR」(現在は、米国特許出願公開第2012/0083835号)、
米国特許出願第13/242,029号、発明の名称「SURGICAL STAPLER WITH FLOATING ANVIL」(現在は、米国特許出願公開第2012/0080493号)、
米国特許出願第13/242,066号、発明の名称「CURVED END EFFECTOR FOR A STAPLING INSTRUMENT」(現在は、米国特許出願公開第2012/0080498号)、
米国特許出願第13/242,086号、発明の名称「STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK」(現在は、米国特許出願公開第2013/0075450号)、
米国特許出願第13/241,912号、発明の名称「STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT」(現在は、米国特許出願公開第2013/0075448号)、
米国特許出願第13/241,922号、発明の名称「SURGICAL STAPLER WITH STATIONARY STAPLE DRIVERS」(現在は、米国特許出願公開第2013/0075449号)、
米国特許出願第13/241,637号、発明の名称「SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATING MULTIPLE ACTUATION MOTIONS」(現在は、米国特許第8,789,741号)、
米国特許出願第13/241,629号、発明の名称「SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE END EFFECTOR」(現在は、米国特許出願公開第2012/0074200号)、
米国特許出願第13/433,096号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF CAPSULES」(現在は、米国特許出願公開第2012/0241496号)、
米国特許出願第13/433,103号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF LAYERS」(現在は、米国特許出願公開第2012/0241498号)、
米国特許出願第13/433,098号、発明の名称「EXPANDABLE TISSUE THICKNESS COMPENSATOR」(現在は、米国特許出願公開第2012/0241491号)、
米国特許出願第13/433,102号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR」(現在は、米国特許出願公開第2012/0241497号)、
米国特許出願第13/433,114号、発明の名称「RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR」(現在は、米国特許出願公開第2012/0241499号)、
米国特許出願第13/433,136号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING AT LEAST ONE MEDICAMENT」(現在は、米国特許出願公開第2012/0241492号)、
米国特許出願第13/433,141号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING CONTROLLED RELEASE AND EXPANSION」(現在は、米国特許出願公開第2012/0241493号)、
米国特許出願第13/433,144号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING FIBERS TO PRODUCE A RESILIENT LOAD」(現在は、米国特許出願公開第2012/0241500号)、
米国特許出願第13/433,148号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING STRUCTURE TO PRODUCE A RESILIENT LOAD」(現在は、米国特許出願公開第2012/0241501号)、
米国特許出願第13/433,155号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING RESILIENT MEMBERS」(現在は、米国特許出願公開第2012/0241502号)、
米国特許出願第13/433,163号、発明の名称「METHODS FOR FORMING TISSUE THICKNESS COMPENSATOR ARRANGEMENTS FOR SURGICAL STAPLERS」(現在は、米国特許出願公開第2012/0248169号)、
米国特許出願第13/433,167号、発明の名称「TISSUE THICKNESS COMPENSATORS」(現在は、米国特許出願公開第2012/0241503号)、
米国特許出願第13/433,175号、発明の名称「LAYERED TISSUE THICKNESS COMPENSATOR」(現在は、米国特許出願公開第2012/0253298号)、
米国特許出願第13/433,179号、発明の名称「TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS」(現在は、米国特許出願公開第2012/0241505号)、
米国特許出願第13/763,028号、発明の名称「ADHESIVE FILM LAMINATE」(現在は、米国特許出願公開第2013/0146643号)、
米国特許出願第13/433,115号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING CAPSULES DEFINING A LOW PRESSURE ENVIRONMENT」(現在は、米国特許出願公開第2013/0256372号)、
米国特許出願第13/433,118号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISED OF A PLURALITY OF MATERIALS」(現在は、米国特許出願公開第2013/0256365号)、
米国特許出願第13/433,135号、発明の名称「MOVABLE MEMBER FOR USE WITH A TISSUE THICKNESS COMPENSATOR」(現在は、米国特許出願公開第2013/0256382号)、
米国特許出願第13/433,140号、発明の名称「TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME」(現在は、米国特許出願公開第2013/0256368号)、
米国特許出願第13/433,129号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF MEDICAMENTS」(現在は、米国特許出願公開第2013/0256367号)、
米国特許出願第11/216,562号、発明の名称「STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS」(現在は、米国特許番号第7,669,746号)、
米国特許出願第11/714,049号、発明の名称「SURGICAL STAPLING DEVICE WITH ANVIL HAVING STAPLE FORMING POCKETS OF VARYING DEPTHS」(現在は、米国特許出願公開第2007/0194082号)、
米国特許出願第11/711,979号、発明の名称「SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS」、米国特許出願公開第8,317,070号、
米国特許出願第11/711,975号、発明の名称「SURGICAL STAPLING DEVICE WITH STAPLE DRIVERS OF DIFFERENT HEIGHT」(現在は、米国特許出願公開第2007/0194079号)、
米国特許出願第11/711,977号、発明の名称「SURGICAL STAPLING DEVICE WITH STAPLE DRIVER THAT SUPPORTS MULTIPLE WIRE DIAMETER STAPLES」(現在は、米国特許番号第7,673,781号)、
米国特許出願第11/712,315号、発明の名称「SURGICAL STAPLING DEVICE WITH MULTIPLE STACKED ACTUATOR WEDGE CAMS FOR DRIVING STAPLE DRIVERS」(現在、米国特許出願公報第7,500,979号)、
米国特許出願第12/038,939号、発明の名称「STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS」(現在、米国特許第7,934,630号)、
米国特許出願第13/020,263号、発明の名称「SURGICAL STAPLING SYSTEMS THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS」(現在は、米国特許第8,636,187号)、
米国特許出願第13/118,278号、発明の名称「ROBOTICALLY−CONTROLLED SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS」(現在は、米国特許出願公開第2011/0290851号)、
米国特許出願第13/369,629号、発明の名称「ROBOTICALLY−CONTROLLED CABLE−BASED SURGICAL END EFFECTORS」(現在は、米国特許第8,800,838号)、
米国特許出願第12/695,359号、発明の名称「SURGICAL STAPLING DEVICES FOR FORMING STAPLES WITH DIFFERENT FORMED HEIGHTS」(現在は、米国特許第8,464,923号)、
米国特許出願第13/072,923号、発明の名称「STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS」(現在は、米国特許第8,567,656号)、
米国特許出願第13/766,325号、発明の名称「LAYER OF MATERIAL FOR A SURGICAL END EFFECTOR」(現在は、米国特許出願公開第2013/0256380号)、
米国特許出願第13/763,078号、発明の名称「ANVIL LAYER ATTACHED TO A PROXIMAL END OF AN END EFFECTOR」(現在は、米国特許出願公開第2013/0256383号)、
米国特許出願第13/763,094号、発明の名称「LAYER COMPRISING DEPLOYABLE ATTACHMENT MEMBERS」(現在は、米国特許出願公開第2013/0256377号)、
米国特許出願第13/763,106号、発明の名称「END EFFECTOR COMPRISING A DISTAL TISSUE ABUTMENT MEMBER」(現在は、米国特許出願公開第2013/0256378号)、
米国特許出願第13/433,147号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS」(現在は、米国特許出願公開第2013/0256369号)、
米国特許出願第13/763,112号、発明の名称「SURGICAL STAPLING CARTRIDGE WITH LAYER RETENTION FEATURES」(現在は、米国特許出願公開第2013/0256379号)、
米国特許出願第13/763,035号、発明の名称「ACTUATOR FOR RELEASING A TISSUE THICKNESS COMPENSATOR FROM A FASTENER CARTRIDGE」(現在は、米国特許出願公開第2013/0214030号)、
米国特許出願第13/763,042号、発明の名称「RELEASABLE TISSUE THICKNESS COMPENSATOR AND FASTENER CARTRIDGE HAVING THE SAME」(現在は、米国特許出願公開第2013/0221063号)、
米国特許出願第13/763,048号、発明の名称「FASTENER CARTRIDGE COMPRISING A RELEASABLE TISSUE THICKNESS COMPENSATOR」(現在は、米国特許出願公開第2013/0221064号)、
米国特許出願第13/763,054号、発明の名称「FASTENER CARTRIDGE COMPRISING A CUTTING MEMBER FOR RELEASING A TISSUE THICKNESS COMPENSATOR」(現在は、米国特許出願公開第2014/0097227号)、
米国特許出願第13/763,065号、発明の名称「FASTENER CARTRIDGE COMPRISING A RELEASABLY ATTACHED TISSUE THICKNESS COMPENSATOR」(現在は、米国特許出願公開第2013/0221065号)、
米国特許出願第13/763,021号、発明の名称「STAPLE CARTRIDGE COMPRISING A RELEASABLE COVER」(現在は、米国特許出願公開第2014/0224686号)、
米国特許出願第13/763,078号、発明の名称「ANVIL LAYER ATTACHED TO A PROXIMAL END OF AN END EFFECTOR」(現在は、米国特許出願公開第2013/0256383号)、
米国特許出願第13/763,095号、発明の名称「LAYER ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES」(現在は、米国特許出願公開第2013/0161374号)、
米国特許出願第13/463,147号、発明の名称「IMPLANTABLE ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES」(現在は、米国特許出願公開第2013/0292398号)、
米国特許出願第13/763,192号、発明の名称「MULTIPLE THICKNESS IMPLANTABLE LAYERS FOR SURGICAL STAPLING DEVICES」(現在は、米国特許出願公開第2013/0146642号)、
米国特許出願第13/763,161号、発明の名称「RELEASABLE LAYER OF MATERIAL AND SURGICAL END EFFECTOR HAVING THE SAME」(現在は、米国特許出願公開第2013/0153641号)、
米国特許出願第13/763,177号、発明の名称「ACTUATOR FOR RELEASING A LAYER OF MATERIAL FROM A SURGICAL END EFFECTOR」(現在は、米国特許出願公開第2013/0146641号)、
米国特許出願第13/763,037号、発明の名称「STAPLE CARTRIDGE COMPRISING A COMPRESSIBLE PORTION」(現在は、米国特許出願公開第2014/0224857号)、
米国特許出願第13/433,126号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTH FEATURES」(現在は、米国特許出願公開第2013/0256366号)、
米国特許出願第13/433,132号、発明の名称「DEVICES AND METHODS FOR ATTACHING TISSUE THICKNESS COMPENSATING MATERIALS TO SURGICAL STAPLING INSTRUMENTS」(現在は、米国特許出願公開第2013/0256373号)、
米国特許出願第13/851,703号、発明の名称「FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR INCLUDING OPENINGS THEREIN」(現在は、米国特許出願公開第2014/0291382号)、
米国特許出願第13/851,676号、発明の名称「TISSUE THICKNESS COMPENSATOR COMPRISING A CUTTING MEMBER PATH」(現在は、米国特許出願公開第2014/0291379号)、
米国特許出願第13/851,693号、発明の名称「FASTENER CARTRIDGE ASSEMBLIES」(現在は、米国特許出願公開第2014/0291381号)、
米国特許出願第13/851,684号、発明の名称「FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR AND A GAP SETTING ELEMENT」(現在は、米国特許出願公開第2014/0291380号)、
米国特許出願第14/187,383号、発明の名称「IMPLANTABLE LAYERS AND METHODS FOR ALTERING IMPLANTABLE LAYERS FOR USE WITH SURGICAL FASTENING INSTRUMENTS」、
米国特許出願第14/187,386号、発明の名称「IMPLANTABLE LAYERS AND METHODS FOR ALTERING ONE OR MORE PROPERTIES OF IMPLANTABLE LAYERS FOR USE WITH FASTENING INSTRUMENTS」、
米国特許出願第14/187,390号、発明の名称「IMPLANTABLE LAYERS AND METHODS FOR MODIFYING THE SHAPE OF THE IMPLANTABLE LAYERS FOR USE WITH A SURGICAL FASTENING INSTRUMENT」、
米国特許出願第14/187,389号、発明の名称「IMPLANTABLE LAYER ASSEMBLIES」、
米国特許出願第14/187,385号、発明の名称「IMPLANTABLE LAYERS COMPRISING A PRESSED REGION」、
米国特許出願第14/187,384号、発明の名称「FASTENING SYSTEM COMPRISING A FIRING MEMBER LOCKOUT」、及び
米国特許出願第14/516,277号、発明の名称「STAPLE CARTRIDGE COMPRISING AN ADJUNCT MATERIAL」。
明細書に記載され添付の図面に示される実施形態の全体的な構造、機能、製造及び使用の完全な理解をもたらすように、多くの具体的詳細が示される。しかしながら、実施形態はそのような具体的詳細なくして実施され得ることが、当業者には理解されるであろう。他の例においては、周知の動作、構成要素、及び要素は、本明細書に記載される実施形態を不明瞭にしないようにするため詳細に記載されていない。本明細書に記載及び図示される実施形態は非限定例であることが当業者には理解され、それ故、本明細書に開示される特定の構造及び機能の詳細は典型及び例示であり得ることが理解されるであろう。これに対する変形及び変更は、特許請求の範囲を逸脱することなく行なわれ得る。
用語「備える(comprise、並びにcomprises及びcomprisingなど、compriseの任意の語形)」、「有する(have、並びにhas及びhavingなど、haveの任意の語形)」、「含む(include、並びにincludes及びincludingなど、includeの任意の語形)」、「含有する(contain、並びにcontains及びcontainingなど、containの任意の語形)」は、開放型の連結動詞である。結果として、1つ以上の要素を「備える」か、「有する」か、「含む」か、若しくは「含有する」外科用システム、デバイス、又は装置は、それら1つ以上の要素を有しているが、それら1つ以上の要素のみを有することに限定されない。同様に、1つ以上の特徴を「備える」か、「有する」か、「含む」か、若しくは「含有する」、システム、デバイス、又は装置の要素は、それら1つ以上の特徴を有しているが、それら1つ以上の特徴のみを有することに限定されない。
「近位」及び「遠位」という用語は、本明細書において、外科用器具のハンドル部分を操作する臨床医を基準として使用される。「近位」という用語は、臨床医に最も近い部分を指し、「遠位」という用語は、臨床医から遠くに位置する部分を指す。便宜上及び明確性のために、「垂直」、「水平」、「上」、及び「下」などの空間的用語が、本明細書において図面に対して使用され得ることが更に理解されるであろう。しかしながら、外科用器具は多くの配向及び位置で使用されるものであり、これらの用語は、限定的及び/又は絶対的であることを意図しない。
腹腔鏡下及び低侵襲性の外科的処置を行うための、様々な代表的な装置及び方法が提供される。しかしながら、本明細書に開示する様々な方法及びデバイスは、例えば、開放的外科処置と関連するものを含む多数の外科的処置及び用途で使用することができることが、当業者には容易に理解されるであろう。この発明を実施するための形態を読み進めると、本明細書で開示する様々な器具が、自然開口部を通って、組織内に形成された切込み又は穿刺孔を通ってなど、任意の方式で体の内部に挿入され得ることが、当業者には更に明らかとなろう。器具の作動部分又はエンドエフェクタ部分は、直接患者の体の内部に挿入されてもよく、あるいは、外科用器具のエンドエフェクタ及び細長シャフトが前進され得る作動チャネルを有するアクセス装置を通って挿入されてもよい。
上記で一覧表示した特許出願の多くは、ステープルカートリッジに接続して使用される様々な層を開示している。ステープルカートリッジからステープルが配備されると、ステープルは、少なくとも1つの層を捕捉して組織に層を植え込むことができる。以下に外科用ステープリングシステムの簡単な説明を記載する。本明細書で開示するステープルカートリッジ及び層は、この外科用ステープリングシステム及び/又はいずれか好適なステープリングシステムで使用することができる。
外科用ステープリングシステムは、シャフトと、シャフトから延びるエンドエフェクタとを備え得る。エンドエフェクタは、第1顎部と第2顎部とを備える。第1顎部は、ステープルカートリッジを備える。ステープルカートリッジは、第1顎部に挿入可能かつ取り外し可能であるが、ステープルカートリッジが第1顎部から取り外しできない、又は少なくとも容易に取り換えできない、他の実施形態も想定される。第2顎部は、ステープルカートリッジから射出されたステープルを変形させるように構成されたアンビルを備える。第2顎部は、第1顎部に対して閉鎖軸を中心に枢動可能であるが、第1顎部が第2顎部に対して枢動可能である他の実施形態も想定される。外科用ステープリングシステムは、エンドエフェクタがシャフトに対して回転する(即ち、関節式に連結される)ことができるように構成された関節継手を更に備える。エンドエフェクタは、関節継手を通って延びる関節軸を中心に回転可能である。関節継手を含まない他の実施形態も想定される。
ステープルカートリッジは、カートリッジ本体を備える。カートリッジ本体は、近位端、遠位端、及び近位端と遠位端との間に延びるデッキを含む。使用時に、ステープルカートリッジは、ステープル留めされる組織の第1側部に配置され、アンビルは、組織の第2側部に配置される。アンビルは、ステープルカートリッジに向かって移動され、デッキに組織を押し付けてクランプする。その後、カートリッジ本体に取り外し可能に格納されたステープルが組織内に配備され得る。カートリッジ本体は、カートリッジ本体に画定されたステープル空洞を含み、ステープルは、ステープル空洞に取り外し可能に格納される。ステープル空洞は、縦6列に配置される。ステープル空洞の3列は縦スロットの第1側部に配置され、ステープル空洞の3列は縦スロットの第2側部に配置される。ステープル空洞及びステープルの他の配置も可能であり得る。
ステープルは、カートリッジ本体内でステープルドライバによって支持される。ドライバは、第1(即ち、未発射)位置と第2(即ち、発射)位置との間で移動可能であり、ステープルをステープルカートリッジから射出する。ドライバは、カートリッジ本体の底部周辺に延びる保持体によってカートリッジ本体に保持され、カートリッジ本体を把持して保持体をカートリッジ本体に保持するように構成された弾性部材を含む。ドライバは、スレッドによってその未発射位置とその発射位置との間で移動可能である。スレッドは、近位端に隣接する近位位置と遠位端に隣接する遠位位置との間で移動可能である。スレッドは、ドライバの下に摺動してドライバ(及びその上に支持されたステープル)をアンビルに向かって持ち上げるように構成された複数の傾斜面を備える。
上記に付け加えて、スレッドは発射部材によって遠位側に移動される。発射部材は、スレッドに接触してスレッドを遠位端に向かって押すように構成される。カートリッジ本体に画定された縦スロットは、発射部材を受容するように構成される。アンビルもまた、発射部材を受容するように構成されたスロットを含む。発射部材は、第1顎部に係合する第1カムと、第2顎部に係合する第2カムとを更に備える。発射部材が遠位側に進むとき、第1カム及び第2カムは、ステープルカートリッジのデッキとアンビルとの間で距離(即ち、組織ギャップ)を制御することができる。発射部材はまた、ステープルカートリッジとアンビルとの間に捕捉された組織を切開するように構成されたナイフを備える。ステープルがナイフの前方で射出されるように、ナイフは傾斜面に対して少なくとも部分的に近位側に配置されることが望ましい。
エンドエフェクタアセンブリ1000を図1〜図3に示す。エンドエフェクタアセンブリ1000は、第1顎部1001及び第2顎部1002を備える。第1顎部1001は、ステープルカートリッジ1005を備える。ステープルカートリッジ1005は、第1顎部1001から容易に取り外し可能であり、別のステープルカートリッジに置き換えることができる。ステープルカートリッジ1005が第1顎部1001から容易に取り外しできない、他の実施形態も想定される。ステープルカートリッジ1005は、カートリッジ本体1010と植え込み可能な層1020とを備える。カートリッジ本体1010は、近位端1011と、遠位端1012と、組織を支持するように構成されたデッキ1013とを備える。以下でより詳細に説明するように、層1020はデッキ1013に解放可能に保持される。カートリッジ本体1010は、縦スロット1014と、デッキ1013に画定された複数のステープル空洞1015とを更に備える。ステープルカートリッジ1005は、ステープル1040、及び/又はステープル空洞1015に取り外し可能に格納される任意の他の好適なファスナ、及びステープル1040をデッキ1013に向かって持ち上げるように構成されたステープルドライバ1050を更に備える。ドライバ1050、及びその上に支持されるステープル1040は、発射部材(例えば、スレッド1060など)によって未発射位置(図2)と発射位置(図3)との間で移動可能である。スレッド1060は、発射バー1061(図8)によって前方に押されてもよく、又は別の方法としては、スレッド1060は、発射バーと一体形成されてもよい。いずれにしても、スレッド1060は、スレッド1060が近位位置(図8及び図9)から遠位位置(図3)に向かって進むとき、ステープルドライバ1050の下に摺動してステープルドライバ1050を上方に持ち上げるように構成された傾斜面1063(図3)を備える。
第2顎部1002は、ステープル1040を変形させるように構成されたアンビル1030を備える。第2顎部1002は、第1顎部1001に対して回転可能であり、したがってアンビル1030は、ステープルカートリッジ1005に対して回転可能であるが、ステープルカートリッジ1005がアンビル1030に対して回転可能である特定の実施形態も想定される。スレッド1060及び/又は発射バー1061は、スレッド1060及び発射バー1061が遠位側に進むとき、第1顎部1001に係合するように構成された第1カム1067(図8)と、第2顎部1002に係合するように構成された第2カム1069(図8)とを含み得る。第1カム1067及び第2カム1069は、ステープルカートリッジ1005に対してアンビル1030を配置し、それらの間に組織ギャップを画定するために協働することができる。第1顎部1001は、第1カム1067を受容するように構成された、第1顎部1001に画定された第1カムスロット1007を備え、第2顎部1002は、第2カム1069を受容するように構成された、第2顎部1002に画定された第2カムスロット1009を備える。スレッド1060及び/又は発射バー1061は、アンビル1030とステープルカートリッジ1005との間に捕捉された組織及び層1020を切開するように構成された切断面(例えば、ナイフエッジ1062(図8)など)を備え得る。
再び図1〜図3を参照すると、層1020は、カートリッジ本体1010に解放可能に保持される。層1020は、カートリッジ本体1010の近位端1011の上に配置された近位端1021と、遠位端1012の上に配置された遠位端1022とを備える。ステープルカートリッジ1005は、層保持体1070を更に備え、層保持体1070は、層保持体1070が層1020の遠位端1022をカートリッジ本体1010の遠位端1012に解放可能に保持する第1位置(図2)と、層1020の遠位端1022が遠位端1012から解放される第2位置(図3)との間で移動可能である。ステープルカートリッジ1005は、実際には2つの層保持体1070を備えており、第1層保持体1070は縦スロット1014の第1側部に配置され、第2層保持体1070は縦スロット1014の第2側部に配置されるが、ステープルカートリッジは、いずれか好適な数の層保持体を備えていてもよい。第1層保持体1070は、カートリッジ本体1010内のステープル空洞1015及び/又はステープルドライバ1050の第1列と整列され、第2層保持体1070は、ステープル空洞1015及び/又はステープルドライバ1050の第2列と整列される。各層保持体1070は、層保持体1070がその第1位置(図2)にあるとき、層1020に画定されたピン開口部1023内に受容される、少なくとも1本のピン1073を備える。様々な例では、ピン1073及びピン開口部1023は、層1020の遠位端1022をカートリッジ本体1010の遠位端1012に保持できる締り嵌めがそれらの間に存在するように寸法決め及び構成され得る。層保持体1070がその第2位置(図3)に移動するとき、ピン1073は、ピン開口部1023から外されるか又は少なくとも実質的に外され、その結果、層1020又は少なくとも層1020の遠位端1022は、以下でより詳細に説明するように、もはやカートリッジ本体1010に接続されていない。
各層保持体1070は、ステープルドライバ1050によってその第1位置(層1020に係合される)からその第2位置(層1020から係合解除される)まで移動可能である。ステープルドライバ1050は、カートリッジ本体1010の近位端1011と遠位端1012との間で近位から遠位まで配置され、最も遠位にあるステープルドライバ(即ち、ステープルドライバ1050d)は、スレッド1060がステープルドライバ1050dをデッキ1013に向かって持ち上げるとき、層保持体1070を無効にする。それぞれの遠位のステープルドライバ1050dは、ステープルドライバ1050dがその未発射位置(図2)とその発射位置(図3)との間で移動するとき、層保持体1070から近位側に延びるスイッチアーム1071と接触するように構成された、ステープルドライバ1050dから遠位側に延びるアクチュエータ1051を備える。スイッチアーム1071は、層保持体1070の支点1078から延びており、支点1078は、カートリッジ本体1010に画定されたピボット面1018に対して配置されるか又は配置可能であり、スイッチアーム1071がステープルドライバ1050dによって上方に動かされるとき、層保持体1070をその第1位置(図2)とその第2位置(図3)との間で回転させるように構成される。層保持体1070は、その第1位置とその第2位置との間で回転してもよいが、層保持体1070のピン1073は、縦経路に沿って平行移動するように強制され得る。少なくとも1つの例では、カートリッジ本体1010は、例えば、ピン1073の動きを垂直軸に沿った動きに制限することができる、ピン1073を密接して受容するように構成されたピンスロット1074を更に備える。遠位のドライバ1050dは、スイッチアーム1071がピボット面1078に接するまでスイッチアーム1071を上方に回転させることができる。このような時点で、遠位のドライバ1050dはその完全な発射位置になる。
上記のように、層保持体1070は、層1020をカートリッジ本体1010に保持する第1位置と、層1020がカートリッジ本体1010から解放される第2位置との間で移動可能である。層保持体1070がその第1位置にあるとき、ピン1073は、カートリッジ本体1010のデッキ1013の上に延びている。層保持体1070がその第2位置に移動するとき、ピン1073は、デッキ1013に対して下に下げられ、デッキ1013と同一平面又はその下に配置される。このような状況では、ピン1073は、層1020に画定されたピン開口部1023から完全に外され得る。層保持体1070がその第2位置にあるとき、ピン1073がデッキ1013の上に延びている、他の実施形態も想定される。このような位置では、ピン1073は、層1020に画定されたピン開口部1023内に部分的に配置されてもよく、又は配置されなくてもよい。層保持体1070がその第2位置にあるとき、ピン1073が依然としてピン開口部1020内に部分的に配置されている場合、層1020はそれでもなおピン1073から外れることができ、層1020をカートリッジ本体1010から取り外すことができる。様々な例では、ピン1073と層開口部1023との間に隙間嵌めが存在してもよい。
ステープルカートリッジ1005は、層保持体1070をその第1位置へと付勢するように構成された付勢部材(例えば、バネなど)を含み得る。いくつかの例では、ステープルカートリッジ1005は、第1層保持体1070をその第1位置に付勢する第1付勢部材と、第2層保持体1070をその第1位置に付勢する第2付勢部材とを備え得る。遠位のドライバ1050dが層保持体1070をその第2位置へ押すとき、遠位のドライバ1050dは、付勢部材によって加えられた付勢力に打ち勝つことができる。
層保持体1070は、発射ストローク時にスレッド1060及び発射バー1061が遠位側に進むまで、層1020をカートリッジ本体1010に保持する。この配置は、ステープル留めされる組織に対してステープルカートリッジ1005を配置する間、層1020を適所に保持するのに有用であり得る。一旦、ステープルカートリッジ1005が組織に対して好適に配置されると、アンビル1030は、閉鎖位置に移動されて層1020に対して組織をクランプし得る。このような時点で、スレッド1060及び発射バー1061は、その発射ストロークによって遠位側に進むことができる。層保持体1070は、発射ストロークの全体の間、又は別の方法としては発射ストロークの一部の間、層1020をカートリッジ本体1010に保持することができる。様々な例では、層保持体1070は、全てのステープル1040が完全に発射されるまで、又は発射後も、層1020をカートリッジ本体1010から解放しなくてもよい。いくつかの例では、層保持体1070は、発射ストロークの完了前に、又はその直前に、層1020を解放してもよい。いずれにしても、層保持体1070は、ナイフエッジ1062が遠位側に移動して層1020を切断するとき、層1020がナイフエッジ1062によって遠位側に押されるのを防止又は阻止することができる。スレッド1060及び発射バー1061がその完全な発射ストロークによって前進しない場合、層保持体1070は、遠位のドライバ1050dによって無効にされないことがあり、その場合、層保持体1070は、層1020をカートリッジ本体1010に保持し続けることがある。層保持体1070のピン1073及び層1020のピン開口部1023は、発射ストローク前及び発射ストローク中の層1020の動きに耐えられるが、発射ストロークが完了されない場合に層1020をカートリッジ本体1010から引き離すことができる、特定量の保持力をそれらの間に与えるように寸法決め及び構成され得る。
ここで図4〜図6を参照すると、エンドエフェクタアセンブリ1100は、第1顎部1001と第2顎部1002とを備える。第1顎部1001は、ステープルカートリッジ1105を備える。ステープルカートリッジ1105は、第1顎部1001から容易に取り外し可能であり、別のステープルカートリッジに置き換えることができる。ステープルカートリッジ1105が第1顎部1001から容易に取り外しできない、他の実施形態も想定される。ステープルカートリッジ1105は、カートリッジ本体1110と植え込み可能な層1120とを備える。カートリッジ本体1110は、近位端1111(図9及び図10)と、遠位端1112と、組織を支持するように構成されたデッキ1113とを備える。以下でより詳細に説明するように、層1120はデッキ1113に解放可能に保持される。カートリッジ本体1110は、縦スロット1114と、デッキ1113に画定された複数のステープル空洞1015とを更に備える。ステープルカートリッジ1105は、ステープル1040、及び/又はステープル空洞1015に取り外し可能に格納される任意の他の好適なファスナ、及びステープル1040をデッキ1113に向かって持ち上げるように構成されたステープルドライバ1150を更に備える。ドライバ1150、及びその上に支持されるステープル1040は、発射部材(例えば、スレッド1060など)によって未発射位置(図8)と発射位置(図5及び図6)との間で移動可能である。スレッド1060は、発射バー1061(図8)によって前方に押されてもよく、又は別の方法としては、スレッド1060は、発射バーと一体形成されてもよい。いずれにしても、スレッド1060は、スレッド1060が近位位置(図8及び図9)から遠位位置(図3)に向かって進むとき、ステープルドライバ1150の下に摺動してステープルドライバ1150を上方に持ち上げるように構成された傾斜面1063(図5及び図6)を備える。
第2顎部1002は、ステープル1040を変形させるように構成されたアンビル1030を備える。第2顎部1002は、第1顎部1001に対して回転可能であり、したがってアンビル1030は、ステープルカートリッジ1105に対して回転可能であるが、ステープルカートリッジ1105がアンビル1030に対して回転可能である特定の実施形態も想定される。スレッド1060及び/又は発射バー1061は、スレッド1060及び発射バー1061が遠位側に進むとき、第1顎部1001に係合するように構成された第1カム1067(図8)と、第2顎部1002に係合するように構成された第2カム1069(図8)とを含み得る。第1カム1067及び第2カム1069は、ステープルカートリッジ1105に対してアンビル1030を配置し、それらの間に組織ギャップを画定するために協働することができる。第1顎部1001は、第1カム1067を受容するように構成された、第1顎部1001に画定された第1カムスロット1007(図2及び図3)を備え、第2顎部1002は、第2カム1069を受容するように構成された、第2顎部1002に画定された第2カムスロット1009(図2及び図3)を備える。スレッド1060及び/又は発射バー1061は、アンビル1030とステープルカートリッジ1105との間に捕捉された組織及び層1120を切開するように構成された切断面(例えば、ナイフエッジ1062(図8)など)を備え得る。
再び図4〜図6を参照すると、層1120は、カートリッジ本体1110に解放可能に保持される。層1120は、カートリッジ本体1110の近位端1111(図8〜図10)の上に配置された近位端と、遠位端1112の上に配置された遠位端1122とを備える。ステープルカートリッジ1105は、層保持体1170を更に備え、層保持体1170は、層保持体1170が層1120の遠位端1122をカートリッジ本体1110の遠位端1112に解放可能に保持する第1位置(図4及び図5)と、層1120の遠位端1122が遠位端1112から解放される第2位置(図6)との間で移動可能である。層保持体1170は、カートリッジ本体1110に画定された縦スロット1114と整列される。層保持体1170は、層保持体1170がその第1位置(図5)にあるとき、カートリッジ本体1110に画定されたクリップスロット1123内に受容されるクリップ1173を備える。様々な例では、クリップ1173及びクリップスロット1123は、それらの間に層1120の遠位端1122が挟まれ、その結果、層1120がカートリッジ本体1110の遠位端1112に解放可能に保持されるように寸法決め及び構成され得る。層保持体1170がその第2位置(図6)に移動するとき、クリップ1173は、クリップスロット1123から外されるか又は少なくとも実質的に外され、その結果、層1120又は少なくとも層1120の遠位端1122は、以下でより詳細に説明するように、もはやカートリッジ本体1110に接続されていない。
層保持体1170は、スレッド1060によってその第1位置(層1120に係合される)からその第2位置(層1120から係合解除される)まで移動可能である。スレッド1060は、縦スロット1114内で平行移動し、かつ層保持体1170に係合して層保持体1170をその第1位置からその第2位置に向かって持ち上げるように構成されたカム面を含む、中心部分1064を備える。層保持体1170は、中心部分1064によって接触されて上方に押される、近位側に延びるスイッチアーム1171を含む。カートリッジ本体1110は、層保持体1170を密接して受容し、かつ層保持体1170を縦経路に沿って誘導するように構成された、カートリッジ本体1110に画定されたガイドスロット1172を備え、その結果、スイッチアーム1171がスレッド1060によって上方に押されると、層保持体1170のクリップ1173も上方に押される。様々な別の実施形態では、層保持体1170は、スレッド1060上に画定された傾斜面1063によって上方に押されてもよい。
上記のように、層保持体1170は、層1120をカートリッジ本体1110に保持する第1位置と、層1120がカートリッジ本体1110から解放される第2位置との間で移動可能である。層保持体1170がその第1位置にあるとき、クリップ1173のクリップ縁1174は、カートリッジ本体1110に画定されたクリップスロット1123内に延びている。このような位置では、層1120は、クリップ縁1174とクリップスロット縁1124との間に捕捉されている。このような位置では、クリップ1173は、カートリッジ本体1110のデッキ1113の上に延びていても、下に引っ込んでいても、又は同一平面にあってもよい。層保持体1170がその第2位置に移動するとき、クリップ縁1174は、デッキ1113に対して及び/又はデッキ1113の上に持ち上げられ、クリップスロット縁1124から離れる。このような位置では、層1120は、クリップ縁1174とクリップスロット縁1124との間から容易に滑り出ることができる。様々な例では、層1120の遠位端1121は、例えば、その内部に画定された開口部のない連続材を備え得る。このような配置は、組織に対する潜在的な刺激を低減し得る。
上記のように、層保持体1170は、発射ストローク時にスレッド1060及び発射バー1061が遠位側に進むまで、層1120をカートリッジ本体1110に保持する。この配置は、ステープル留めされる組織に対してステープルカートリッジ1105を配置する間、層1120を適所に保持するのに有用であり得る。一旦、ステープルカートリッジ1105が組織に対して好適に配置されると、アンビル1030は、閉鎖位置に移動されて層1120に対して組織をクランプし得る。このような時点で、スレッド1060及び発射バー1061は、その発射ストロークによって遠位側に進むことができる。層保持体1170は、発射ストロークの全体の間、又は別の方法としては発射ストロークの一部の間、層1120をカートリッジ本体1110に保持することができる。様々な例では、層保持体1170は、全てのステープル1040が完全に発射されるまで、又は発射後も、層1120をカートリッジ本体1110から解放しなくてもよい。いくつかの例では、層保持体1170は、発射ストロークの完了前に、又はその直前に、層1120を解放してもよい。いずれにしても、層保持体1170は、ナイフエッジ1062が遠位側に移動して層1120を切断するとき、層1120がナイフエッジ1062によって遠位側に押されるのを防止又は阻止することができる。スレッド1060及び発射バー1061がその完全な発射ストロークによって進まない場合、層保持体1170は、スレッド1060によって無効にされないことがあり、その場合、層保持体1170は、層1120をカートリッジ本体1110に保持し続けることがある。層保持体1170のクリップ1173及び層1120のクリップスロット1123は、発射ストローク前及び発射ストローク中の層1120の動きに耐えられるが、発射ストロークが完了されない場合に層1120をカートリッジ本体1110から引き離すことができる、特定量の保持力をそれらの間に与えるように寸法決め及び構成され得る。
上記のように、ステープルカートリッジは、層をステープルカートリッジに解放可能に保持するために、その遠位端に配置された層保持体を含み得る。遠位の層保持体に加えて、又はその代わりに、ステープルカートリッジは、その近位端に配置された層保持体を含み得る。ここで図7〜図10を参照すると、エンドエフェクタアセンブリ1200は、第1顎部1001と第2顎部1002とを備える。第1顎部1001は、ステープルカートリッジ1205を備える。ステープルカートリッジ1205は、第1顎部1001から容易に取り外し可能であり、別のステープルカートリッジに置き換えることができる。ステープルカートリッジ1205が第1顎部1001から容易に取り外しできない、他の実施形態も想定される。ステープルカートリッジ1205は、カートリッジ本体1110と植え込み可能な層1220とを備える。以下でより詳細に説明するように、層1220は、カートリッジ本体1110のデッキ1113に解放可能に保持される。
第2顎部1002は、第1顎部1001に対して回転可能であり、したがってアンビル1030は、ステープルカートリッジ1205に対して回転可能であるが、ステープルカートリッジ1205がアンビル1030に対して回転可能である特定の実施形態も想定される。スレッド1060及び/又は発射バー1061は、スレッド1060及び発射バー1061が遠位側に進むとき、第1顎部1001に係合するように構成された第1カム1067(図8)と、第2顎部1002に係合するように構成された第2カム1069(図8)とを含み得る。第1カム1067及び第2カム1069は、ステープルカートリッジ1205に対してアンビル1030を配置し、それらの間に組織ギャップを画定するために協働することができる。スレッド1060及び/又は発射バー1061は、アンビル1030とステープルカートリッジ1205との間に捕捉された組織及び層1220を切開するように構成された切断面(例えば、ナイフエッジ1062(図8)など)を備え得る。
再び図7〜図10を参照すると、層1220は、カートリッジ本体1110に解放可能に保持される。層1220は、カートリッジ本体1110の近位端1111の上に配置された近位端1221と、遠位端1112の上に配置された遠位端1222とを備える。層1220の近位端1221は、ステープルカートリッジ1205に解放可能に保持される層保持体1225を備える。層保持体1225は、図7〜図9に示すように、カートリッジ本体1060がその近位未発射位置にあるとき、スレッド1060とカートリッジ本体1110との間に挟まれるか又は捕捉される尾部を備える。主に図9を参照すると、層保持体1225の尾部は、スレッド1060の中心部分1064とスロット1114の第1縦側壁1114aとの間に配置され、それらの間の締り嵌めのおかげで、層1220の近位端1221は、カートリッジ本体1110の近位端1111に解放可能に保持される。第1側壁1114aは、層保持体の尾部1225の末端部に画定された拡大タブ1227を受容するように構成された、第1側壁1114aに画定された第1凹部1226を備える。拡大タブ1227は、スレッド1060が遠位側に進む前に、第1凹部1226から引き出されるのを防止又は少なくとも阻止するように寸法決め及び構成され得る。上記に加えて、又は上記の代わりに、スレッド1060は、層保持体1225を縦スロット1114の第1側壁1114aにピン留めするように構成された、スレッド1060から延びるディンプルを含み得る。また、上記に加えて、又は上記の代わりに、縦スロット1114の第1側壁1114aは、層保持体1225をスレッド1060にピン留めするように構成された、第1側壁1114aから延びるディンプルを含み得る。いずれにしても、主に図7及び図9を参照すると、スレッド1060の中心部分1064は、スレッド1060がその近位未発射位置にあるとき、層保持体1225が通過して延びることができる、中心部分1064に画定された凹部1065を含む。
スレッド1060がその近位位置から遠位側に進むとき、主に図10を参照すると、層保持体1225は、スレッド1060と第1側壁1114aとの間にもはや捕捉されておらず、その結果、拡大タブ1227は、第1凹部1226及び縦スロット1114から容易に滑り出ることができる。近位の層保持体1225が層1220をカートリッジ本体に保持する唯一の層保持体である実施形態では、近位の層保持体1225の解放により、層1220をカートリッジ本体1110から解放することができる。このような例では、スレッド1060及び発射バー1061の発射ストロークの開始により、層1220をカートリッジ本体1110から解放することができる。近位の層保持体に加えて遠位の層保持体を備える実施形態では、層1220の近位端1221が解放されても、層1220の遠位端1222はまだカートリッジ本体1110に解放可能に保持されている。
上記のように、エンドエフェクタアセンブリは、ステープルカートリッジに解放可能に取り付けられた植え込み可能な層を含み得る。ステープルカートリッジの層に加えて、又はその代わりに、エンドエフェクタアセンブリは、エンドエフェクタアセンブリのアンビルに解放可能に取り付けられた植え込み可能な層を含み得る。再び図7〜図10を参照すると、エンドエフェクタアセンブリ1200は、エンドエフェクタアセンブリ1200に解放可能に取り付けられたアンビル層1320を備える。アンビル層1320は、アンビル1030の近位端1011に隣接して配置された近位端1321と、アンビル1030の遠位端に隣接して配置された遠位端1322とを備える。層1320の近位端1321は、ステープルカートリッジ1205に解放可能に保持される層保持体1325を備える。層保持体1325は、図7〜図9に示すように、カートリッジ本体1060がその近位未発射位置にあるとき、スレッド1060とカートリッジ本体1110との間に挟まれるか又は捕捉される尾部を備える。主に図9を参照すると、層保持体1325の尾部は、スレッド1060の中心部分1064とスロット1114の第2縦側壁1114bとの間に配置され、それらの間の締り嵌めのおかげで、層1320の近位端1321は、カートリッジ本体1110の近位端1111に解放可能に保持される。第2側壁1114bは、層保持体の尾部1325の末端部に画定された拡大タブ1327を受容するように構成された、第2側壁1114bに画定された第2凹部1326を備える。拡大タブ1327は、スレッド1060が遠位側に進む前に、第2凹部1326から引き出されるのを防止又は少なくとも阻止するように寸法決め及び構成され得る。上記に加えて、又は上記の代わりに、スレッド1060は、層保持体1325を縦スロット1114の第2側壁1114bにピン留めするように構成された、スレッド1060から延びるディンプルを含み得る。また、上記に加えて、又は上記の代わりに、縦スロット1114の第2側壁1114bは、層保持体1325をスレッド1060にピン留めするように構成された、第2側壁1114bから延びるディンプルを含み得る。いずれにしても、主に図7及び図9を参照すると、スレッド1060の中心部分1064は、スレッド1060がその近位未発射位置にあるとき、層保持体1325が通過して延びることができる、中心部分1064に画定された凹部1065を含む。
スレッド1060がその近位位置から遠位側に進むとき、主に図10を参照すると、層保持体1325は、スレッド1060と第2側壁1114bとの間にもはや捕捉されておらず、その結果、拡大タブ1327は、第2凹部1326及び縦スロット1114から容易に滑り出ることができる。近位の層保持体1375が層1320をエンドエフェクタ1200に保持する唯一の層保持体である実施形態では、近位の層保持体1325の解放により、層1320をエンドエフェクタ1200から解放することができる。このような例では、スレッド1060及び発射バー1061の発射ストロークの開始により、層1320をエンドエフェクタ1200から解放することができる。近位の層保持体に加えて遠位の層保持体を備える実施形態では、層1320の近位端1321が解放されても、層1320の遠位端1322はまだエンドエフェクタ1200に解放可能に保持されている。例えば、層1320の遠位端1322は、遠位端1322をアンビル1030の遠位端に解放可能に保持する、遠位の層保持体1324を備える。
遠位の層保持体1324は、アンビル1030の第2カムスロット1009に延びるフックを備える。層保持体1324は、発射ストローク時にスレッド1060及び発射バー1061が遠位側に進むまで、層1320をアンビル1030に保持する。この配置は、ステープル留めされる組織に対してアンビル1030を配置する間、層1320を適所に保持するのに有用であり得る。一旦、アンビル1030が組織に対して好適に配置されると、アンビル1030は、閉鎖位置に移動され、例えば、ステープルカートリッジ1205に対して組織をクランプし得る。このような時点で、層保持体1324は、発射ストロークの全体の間、又は別の方法としては発射ストロークの一部の間、層1320をアンビル1030に保持することができる。いずれにしても、アンビル1030は、遠位の層保持体1324がアンビル1030の第2カムスロット1009から係合解除されるように、少なくとも部分的に植え込まれた層1320の遠位端1322から離れて近位側に摺動され得る。
近位の層保持体及び/又は遠位の層保持体によって層をカートリッジ本体に解放可能に保持することに加えて、又はその代わりに、層は、例えば、カートリッジ本体に画定された縦スロットに解放可能に係合される、1つ又は2つ以上の層保持体を含み得る。主に図8を参照すると、カートリッジ層1220は、縦スロット1114と整列されて縦スロット1114内に解放可能に挟まれた、縦方向の一連のタブ1223(即ち、タブ1223の列)を備える。一連のタブ1223は、層1220の近位端1221と遠位端1222との間に延びているが、層1220の全長に沿って延びていない他の配置も意図される。各タブ1223は、層1220の本体部分から延びる、例えば、カンチレバー部材を備える。タブ1223は、層1220の本体部分と一体形成されてもよく、及び/又は本体部分に組み立てられてもよい。様々な例では、各タブ1223は、例えば、T型構造、I型構造、及びV型構造のうちの少なくとも1つを備え得る。特定の例では、タブ1223は、例えば、レーザー切断工程によって形成され得る。タブ1223は、縦スロット1114の側壁1114a及び1114bに係合され、発射ストローク前及び/又は発射ストローク中に層1220とカートリッジ本体1110との間の相対運動を防止又は少なくとも阻止するように構成される。発射ストローク時に、例えば、ナイフ1062は、発射バー1061が遠位側に進むにつれてタブ1223を横に切断し得る。タブ1223が横に切断されると、横に切断されたタブ1223は、もはや層1220をカートリッジ本体1110に保持できない。その結果、発射バー1061は、タブ1223を縦スロット1114から徐々に解放することができる。特定の実施形態では、スレッド1060及び/又は発射バー1061は、遠位側に進むにつれてタブ1223を縦スロット1114から押し出し得る。いずれにしても、全てのタブ1223は、発射ストロークの完了までに解放され得るが、一部のタブ1223のみ、発射ストロークが不完全なうちに解放されてもよい。1つ又は2つ以上のタブ1223が発射ストロークの完了後もカートリッジ本体1110に係合したまま残っている場合、タブ1223は、十分な力が加わるとスロット1114から滑り出るように構成され得る。
近位の層保持体及び/又は遠位の層保持体によって層をアンビルに解放可能に保持することに加えて、又はその代わりに、層は、例えば、アンビルに画定された縦スロットに解放可能に係合される、1つ又は2つ以上の層保持体を含み得る。主に図7及び図8を参照すると、アンビル層1320は、縦カムスロット1009と整列されて縦カムスロット1009内に解放可能に挟まれた、縦方向の一連のディンプル1323(即ち、ディンプル1323の列)を備える。一連のディンプル1323は、層1320の近位端1321と遠位端1322との間に延びているが、層1320の全長に沿って延びていない他の配置も意図される。各ディンプル1323は、層1320の本体部分から延びる、例えば、隆起した凸部を備える。ディンプル1323は、層1320の本体部分と一体形成されてもよく、及び/又は本体部分に組み立てられてもよい。様々な例では、各ディンプル1323は、例えば、円筒構造を備え得る。特定の例では、ディンプル1323は、例えば、熱成形及び/又は延伸工程によって形成され得る。ディンプル1323は、カムスロット1009の側壁に係合され、発射ストローク前及び発射ストローク中に層1320とアンビル1030との間の相対運動を防止又は少なくとも阻止するように構成される。発射ストローク時に、例えば、ナイフ1062は、発射バー1061が遠位側に進むにつれてディンプル1323を横に切断し得る。ディンプル1323が横に切断されると、横に切断されたディンプル1323は、もはや層1320をアンビル1030に保持できない。その結果、発射バー1061は、ディンプル1323を縦スロット1009から徐々に解放することができる。特定の実施形態では、発射バー1061のカム1069は、発射バー1061が遠位側に進むにつれてディンプル1323をカムスロット1009から押し出し得る。いずれにしても、全てのディンプル1323は、発射ストロークの完了までに解放され得るが、一部のディンプル1323のみ、発射ストロークが不完全なうちに解放されてもよい。1つ又は2つ以上のディンプル1323が発射ストロークの完了後もアンビル1030に係合したまま残っている場合、ディンプル1323は、十分な力が加わるとスロット1009から滑り出るように構成され得る。
様々な例では、全てのディンプル1323が同じ構造を有し得る。他の例では、特定のディンプル1323は異なる構造を有していてもよい。例えば、最も近位のディンプル1323pは、ディンプル1323pより遠位側に位置するディンプル1323より大きくてもよく、その結果、ディンプル1323pは、遠位のディンプル1323より大きな保持力をアンビル1030に与えることができる。このような配置は、最も大きな保持力を有するディンプル1323を発射ストロークの最初に解放させることができる。上記に加えて、又は上記の代わりに、最も遠位のディンプル1323dが、ディンプル1323dより近位側に位置するディンプル1323より大きくてもよく、その結果、ディンプル1323dは、近位のディンプル1323より大きな保持力をアンビル1030に与えることができる。このような配置は、最も大きな保持力を有するディンプル1323を発射ストロークの最後に解放させることができる。更に、このような配置は、エンドエフェクタ1200を組織に対して配置するとき、剪断力がより大きくなり得る層1320の遠位端1322の動きを阻止するのにより有効であり得る。様々な実施形態がディンプル1323p及びディンプル1323dを含み得る。より大きなディンプル1323は、例えば、他のディンプル1323より縦に長く、幅が広く、及び/又は厚くてもよい。
様々な例では、アンビル層1320は、本体厚さを有する本体部分を備え得る。本体厚さは、例えば、アンビル1030に面する側部などの層1320の一方の側部から、例えば、アンビル1030から離れる方向に面する側部などの層1320の他方の側部を測定するとき、層1320の厚さであり得る。各ディンプル1323の厚さは、例えば、同様の方法で測定され得る。様々な実施形態では、ディンプルの厚さは、本体厚さと同じであってもよい。特定の実施形態では、ディンプルの厚さは、本体厚さより薄くてもよい。このような配置は、例えば、熱成形工程から得られる。更に、このような配置は、より薄いディンプル1323を本体部分より容易に切断することができる。特定の例では、上記に付け加えて、全てのディンプル1323は同じ厚さを有してもよいが、他の例では、例えば、最も近位のディンプル1323及び/又は最も遠位のディンプル1323などの特定のディンプル1323が他のものより厚くてもよい。
様々な別の実施形態では、例えば、カートリッジ層1200がディンプル1323を備えていてもよい。また、様々な別の実施形態では、例えば、アンビル層1300がタブ1223を備えていてもよい。
様々な例では、材料層は、例えば、バットレス材料及び/又は組織厚さコンペンセータを備え得る。材料層は、例えば、Gore SeamGuard材料、Synovis Peri−Strips材料、及び/又はポリウレタンから構成され得る。2013年2月28日に出願された米国特許出願第13/763,095号、発明の名称「LAYER ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES」(現在は、米国特許出願公開第2013/0161374号)の開示内容全体は、参照により本明細書に組み込まれる。2012年6月25日に出願された米国特許出願第13/531,619号、発明の名称「TISSUE STAPLER HAVING A THICKNESS COMPENSATOR COMPRISING INCORPORATING A HEMOSTATIC AGENT」(現在は、米国特許出願公開第2012/0318842号)、2012年6月25日に出願された米国特許出願第13/531,623号、発明の名称「TISSUE STAPLER HAVING A THICKNESS COMPENSATOR INCORPORATING AN OXYGEN GENERATING AGENT」(現在は、米国特許出願公開第2012/0318843号)、2012年6月25日に出願された米国特許出願第13/531,627号、発明の名称「TISSUE STAPLER HAVING A THICKNESS COMPENSATOR INCORPORATING AN ANTI−MICROBIAL AGENT」(現在は、米国特許出願公開第2012/0312860号)、及び2012年6月25日に出願された米国特許出願第13/531,630号、発明の名称「TISSUE STAPLER HAVING A THICKNESS COMPENSATOR INCORPORATING AN ANTI−INFLAMMATORY AGENT」(現在は、米国特許出願公開第2012/0318844号)の開示内容全体は、参照により本明細書に組み込まれる。層は、生体吸収性材料及び/又は非生体吸収性材料から構成され得る。いくつかの例では、材料層はデッキに取り付けられてもよい。少なくとも一例では、少なくとも1つの接着剤を使用して、層をデッキに解放可能に接着してもよい。いくつかの例では、例えば、1つ又は2つ以上の縫合糸又はストラップを使用して、材料層をデッキに解放可能に取り付けてもよい。特定の例では、層は材料の固体片を含み得る。いくつかの例では、層はその内部に画定された開口部を含み得る。
上記に付け加えて、ステープルカートリッジから配備されるステープルは、組織内に入る前に層を穿刺し得る。ステープルはまた、アンビルによって変形されるとき、層を再穿刺し得る。様々な例では、例えば、より厚い又はより穿刺耐性のあるポリマーストリップを層に組み込んでもよい。例えば、このようなストリップを層の組織接触面に組み込んでもよい。少なくとも一例では、各ストリップは、例えば、厚さが0.008cm(0.003インチ)であり、90/10 PLA/PCLから構成され得る。特定の例では、各ストリップは、例えば、厚さが0.015cm(0.006インチ)の25/75 PGA/PCLであり得る。ストリップは、例えば、縮充工程の一部として発泡体に溶着されてもよい。米国特許出願第14/187,383号、発明の名称「IMPLANTABLE LAYERS AND METHODS FOR ALTERING IMPLANTABLE LAYERS FOR USE WITH SURGICAL FASTENING INSTRUMENTS」の開示は、その内容全体が参照により組み込まれる。縮充工程は、独立気泡発泡体及び/又は連続組織接触面を作製するという別の目的を果たすことができる。いくつかの例では、別個の薄膜ストリップを発泡体の組織接触側に溶着してもよい。本明細書に開示する様々な方法は、ステープルの最初の穿刺、成形、及び再穿刺について異なる特性を有する、ステープルと整列された特徴又は区域を備えた、複合吸収性材料を作製することができる。
例えば、バットレス材料などの層は、任意の生体適合性材料から製造され得る。バットレス材料は、天然材料及び/又は合成材料から形成され得る。バットレス材料は、生体吸収性及び/又は非生体吸収性であってもよい。天然、合成、生体吸収性、及び非生体吸収性材料の任意の組み合わせを使用してバットレス材料を形成し得ることは、理解されるべきである。バットレス材料を製造し得る材料のいくつかの非限定例としては、例えば、ポリ(乳酸)、ポリ(グリコール酸)、ポリ(ヒドロキシブチレート)、ポリ(ホスファジン)、ポリエステル、ポリエチレングリコール、ポリエチレンオキシド、ポリアクリルアミド、ポリヒドロキシエチルメチルアクリレート、ポリビニルピロリドン、ポリビニルアルコール、ポリアクリル酸、ポリアセテート、ポリカプロラクトン、ポリプロピレン、脂肪族ポリエステル、グリセロール、ポリ(アミノ酸)、コポリ(エーテル−エステル)、ポリアルキレンオキサラート、ポリアミド、ポリ(イミノカルボナート)、ポリアルキレンオキサラート、ポリオキサエステル、ポリオルトエステル、ポリホスファゼン、及びこれらのコポリマー、ブロックコポリマー、ホモポリマー、配合物、及び/又は組み合わせが挙げられるが、これらに限定されない。
バットレス材料の形成に天然生体ポリマーを使用することができる。好適な天然生体ポリマーとしては、例えば、コラーゲン、ゼラチン、フィブリン、フィブリノーゲン、エラスチン、ケラチン、アルブミン、ヒドロキシエチルセルロース、セルロース、酸化セルロース、ヒドロキシプロピルセルロース、カルボキシエチルセルロース、カルボキシメチルセルロース、キタン、キトサン、及び/又はこれらの組み合わせが挙げられるが、これらに限定されない。天然生体ポリマーを本明細書に記載の任意の他のポリマー材料と組み合わせて、バットレス材料を生成してもよい。ヒト及び/又は動物由来のコラーゲン、例えば、I型ブタ若しくはウシコラーゲン、I型ヒトコラーゲン、又はIII型ヒトコラーゲンを使用して、バットレス材料を形成してもよい。バットレス材料は、例えば、分子量約100kDaの、主に非水和鎖からなる、変性コラーゲン、又は加熱若しくはいずれか他の方法によってその螺旋構造を少なくとも部分的に欠損しているコラーゲンから製造され得る。用語「変性コラーゲン」は、その螺旋構造を欠損しているコラーゲンを意味する。本明細書に記載の多孔質層に使用されるコラーゲンは、特にペプシン消化によって及び/又は前記のような適度な加熱後に得られるような、天然コラーゲン又はアテロコラーゲンであってもよい。コラーゲンは、酸化、メチル化、サクシニル化、エチル化、及び/又はいずれか他の既知の方法により予め化学的に修飾されていてもよい。
バットレス材料が繊維状である場合、繊維は、編物若しくは織物に好適な長繊維若しくは糸であってもよく、又は不織布材料の調製によく使用されるものなどの短繊維であってもよい。繊維は、任意の生体適合性材料から製造され得る。繊維は、天然材料又は合成材料から形成されてもよい。繊維を形成する材料は、生体吸収性又は非生体吸収性であってもよい。天然、合成、生体吸収性、及び非生体吸収性材料の任意の組み合わせを使用して繊維を形成し得ることは、理解されるべきである。繊維を製造し得る材料のいくつかの非限定例としては、ポリ(乳酸)、ポリ(グリコール酸)、ポリ(ヒドロキシブチレート)、ポリ(ホスファジン)、ポリエステル、ポリエチレングリコール、ポリエチレンオキシド、ポリアクリルアミド、ポリヒドロキシエチルメチルアクリレート、ポリビニルピロリドン、ポリビニルアルコール、ポリアクリル酸、ポリアセテート、ポリカプロラクトン、ポリプロピレン、脂肪族ポリエステル、グリセロール、ポリ(アミノ酸)、コポリ(エーテル−エステル)、ポリアルキレンオキサラート、ポリアミド、ポリ(イミノカルボナート)、ポリアルキレンオキサラート、ポリオキサエステル、ポリオルトエステル、ポリホスファゼン、及びこれらのコポリマー、ブロックコポリマー、ホモポリマー、配合物、及び/又は組み合わせが挙げられるが、これらに限定されない。バットレス材料が繊維状である場合、バットレス材料は、例えば、編物、織物、不織布技法などが挙げられるがこれらに限定されない、繊維構造の形成に好適な任意の方法を使用して形成され得る。バットレス材料が発泡体である場合、多孔質層は、例えば、組成物の凍結乾燥又はフリーズドライが挙げられるがこれらに限定されない、発泡体又は海綿体の形成に好適な任意の方法を使用して形成され得る。
バットレス材料は、止血性を有し得る。バットレス材料に出血又は大出血防止に役立つ能力を与えるのに使用され得る材料の例示の実施例としては、例えば、ポリ(乳酸)、ポリ(グリコール酸)、ポリ(ヒドロキシブチレート)、ポリ(カプロラクトン)、ポリ(ジオキサノン)、ポリアルキレンオキシド、コポリ(エーテル−エステル)、コラーゲン、ゼラチン、トロンビン、フィブリン、フィブリノーゲン、フィブロネクチン、エラスチン、アルブミン、ヘモグロビン、オバルブミン、多糖類、ヒアルロン酸、コンドロイチン硫酸、ヒドロキシエチルデンプン、ヒドロキシエチルセルロース、セルロース、酸化セルロース、ヒドロキシプロピルセルロース、カルボキシエチルセルロース、カルボキシメチルセルロース、キタン、キトサン、アガロース、マルトース、マルトデキストリン、アルギン酸塩、凝固因子、メタクリレート、ポリウレタン、シアノアクリレート、血小板アゴニスト、血管収縮剤、ミョウバン、カルシウム、RGDペプチド、タンパク質、硫酸プロタミン、イプシロン−アミノカプロン酸、硫酸鉄、亜硫酸鉄、塩化鉄、亜鉛、塩化亜鉛、塩化アルミニウム、硫酸アルミニウム、酢酸アルミニウム、過マンガン酸塩、タンニン、骨ろう、ポリエチレングリコール、フカン、及び/又はこれらの組み合わせが挙げられるが、これらに限定されない。天然生体ポリマー、特にタンパク質の使用は、止血性を有するバットレス材料の形成に有用であり得る。好適な天然生体ポリマーとしては、例えば、コラーゲン、ゼラチン、フィブリン、フィブリノーゲン、エラスチン、ケラチン、アルブミン、及び/又はこれらの組み合わせが挙げられるが、これらに限定されない。天然生体ポリマーは、バットレスの多孔質層を生成するために、任意の他の止血剤と組み合わされ得る。2013年7月30日に発行された米国特許第8,496,683号、発明の名称「BUTTRESS AND SURGICAL STAPLING APPARATUS」の開示内容全体は、参照により本明細書に組み込まれる。
様々な状況において、組織厚さコンペンセータアセンブリは、ポリマー組成物を含み得る。このポリマー組成物は、1つ又は2つ以上の合成ポリマー及び/又は1つ又は2つ以上の非合成ポリマーを含みうる。この合成ポリマーは、吸収性合成ポリマー及び/又は非吸収性合成ポリマーを含むことがある。様々な状況において、ポリマー組成物は、例えば、生体適合性発泡体を含み得る。生体適合性発泡体は、例えば、多孔質連続気泡発泡体、及び/又は多孔質独立気泡発泡体を含むことがある。生体適合性発泡体は、均一細孔形態を有することができる、又は、傾斜細孔形態(即ち、小さな細孔が一方向に発泡体の厚さを横切って大きな細孔まで徐々に寸法が増加する形態)を有することがある。様々な状況において、ポリマー組成物は、多孔質スカフォールド、多孔質マトリックス、ゲルマトリックス、ヒドロゲルマトリックス、溶液マトリックス、繊維状マトリックス、管状マトリックス、複合体マトリックス、膜状マトリックス、生体安定性ポリマー、及び生分解性ポリマー、及びこれらの組み合わせのうち1つ又は2つ以上を含み得る。例えば、組織厚さコンペンセータアセンブリは、繊維状マトリックスにより補強された発泡体を備えることがあり、又は組織を更に圧迫するために体液の存在下で膨張する付加的なヒドロゲル層を有する発泡体を備えることがある。様々な状況において、組織厚さコンペンセータアセンブリはまた、材料上のコーティング、及び/又は組織を更に圧迫するために体液の存在下で膨張する第2若しくは第3の層から構成されてもよい。このような層は、例えば、合成材料及び/又は天然由来材料でもあり得るヒドロゲルであることもあり、かつ、生体耐久性及び/又は生体分解性であることもある。特定の状況において、組織厚さコンペンセータアセンブリは、追加の柔軟性、剛性、及び/又は強度を提供し得る、例えば、繊維性不織布材料又は繊維性メッシュタイプ構成要素で強化され得る。様々な状況において、組織厚さコンペンセータアセンブリは、例えば、一方の表面に小さな細孔、もう一方の表面により大きな細孔のような傾斜構造体を呈する多孔質形態を有する。そのような形態は、成長中の組織又は止血処置用に、より最適でありうる。更に、この勾配は、様々な生体吸収性プロフィールと共に構成することもできる。短期吸収性分布は、止血に対処するために好ましく、一方、長期吸収性分布は、漏出なしでより良い組織治癒に対処することがある。
非合成ポリマーの例には、凍結乾燥した多糖類、糖たんぱく、エラスチン、プロテオグリカン、ゼラチン、コラーゲン、及び酸化再生セルロースが挙げられるがこれらに限定されない。合成吸収性ポリマーの例は、ポリ(乳酸)(PLA)、ポリ(L−乳酸)(PLLA)、ポリカプロラクトン(PCL)、ポリグリコール酸(PGA)、ポリ(トリメチレンカーボネート)(TMC)、ポリエチレンテレフタレート(PET)、ポリヒドロキシアルカノエート(PHA)、グリコリド/ε−カプロラクトンコポリマー(PGCL)、グリコリド/トリメチレンカーボネートコポリマー、ポリ(グリセロールセバケート)(PGS)、ポリジオキサノン、ポリ(オルトエステル)、ポリ無水物、多糖類、ポリ(エステルアミド)、チロシン系ポリアリレート、チロシン系ポリイミノカーボネート、チロシン系ポリカーボネート、ポリ(D,L−ラクチド−ウレタン)、ポリ(B−ヒドロキシブチレート)、ポリ(E−カプロラクトン)、ポリエチレングリコール(PEG)、ポリ[ビス(カルボキシラトフェノキシ)ホスファゼン]、ポリ(アミノ酸)、擬似ポリ(アミノ酸)、吸収性ポリウレタン、及びこれらの組み合わせを含むが、これらに限定されない。様々な状況において、ポリマー組成物は、例えば、約50重量%〜約90重量%のPLLAのポリマー組成物と、約50重量%〜約10重量%のPCLのポリマー組成物とを含むことがある。少なくとも一実施形態において、このポリマー組成物は、例えば、約70重量%のPLLAと、約30重量%のPCLとを含むことがある。様々な状況において、ポリマー組成物は、例えば、約55重量%〜約85重量%のPGAのポリマー組成物と、15重量%〜45重量%のPCLのポリマー組成物とを含むことがある。少なくとも一実施形態において、このポリマー組成物は、例えば、約65重量%のPGAと、約35重量%のPCLとを含むことがある。様々な状況において、ポリマー組成物は、例えば、約90重量%〜約95重量%のPGAのポリマー組成物と、約5重量%〜約10重量%のPLAのポリマー組成物とを含むことがある。
様々な状況において、合成吸収性ポリマーは、生体吸収性で生体適合性のエラストマーコポリマーを含み得る。好適な生体吸収性で生体適合性のエラストマーコポリマーには、限定するものではないが、イプシロン−カプロラクトンとグリコリドのコポリマー(イプシロン−カプロラクトンとグリコリドのモル比は、好ましくは約30:70〜約70:30、好ましくは35:65〜約65:35、より好ましくは45:55〜35:65である);イプシロン−カプロラクトンと、L−ラクチド、D−ラクチド、それらの配合物又は乳酸コポリマーを含めたラクチドとのエラストマーコポリマー(イプシロン−カプロラクトンとラクチドとのモル比は、好ましくは約35:65〜約65:35、より好ましくは45:55〜30:70である);p−ジオキサノン(1,4−ジオキサン−2−オン)と、L−ラクチド、D−ラクチド及び乳酸を含めたラクチドとのエラストマーコポリマー(p−ジオキサノンとラクチドとのモル比は、好ましくは約40:60〜約60:40である);イプシロン−カプロラクトンとp−ジオキサノンとのエラストマーコポリマー(イプシロン−カプロラクトンとp−ジオキサノンとのモル比は、好ましくは約30:70〜約70:30である);p−ジオキサノンと炭酸トリメチレンとのエラストマーコポリマー(p−ジオキサノンと炭酸トリメチレンとのモル比は、好ましくは約30:70〜約70:30である);炭酸トリメチレンとグリコリドとのエラストマーコポリマー(炭酸トリメチレンとグリコリドとのモル比は、好ましくは約30:70〜約70:30である);炭酸トリメチレンと、L−ラクチド、D−ラクチド、それらの配合物又は乳酸コポリマーを含めたラクチドとのエラストマーコポリマー(炭酸トリメチレンとラクチドとのモル比は、好ましくは約30:70〜約70:30である)並びにそれらの配合物が挙げられる。一実施形態において、エラストマーコポリマーは、グリコリドとイプシロン−カプロラクトンとのコポリマーである。別の実施形態において、エラストマーコポリマーは、ラクチドとイプシロン−カプロラクトンとのコポリマーである。
1995年11月21日付けで発行された、「ELASTOMERIC MEDICAL DEVICE」と題する米国特許第5,468,253号、及び2001年12月4日付けで発行された、「FOAM BUTTRESS FOR STAPLING APPARATUS」と題する米国特許第6,325,810号の開示内容は、それぞれの内容全体が参照により本明細書に組み込まれる。
様々な状況において、合成吸収性ポリマーは、例えば、90/10ポリ(グリコリド−L−ラクチド)コポリマー(Ethicon、Inc.から商品名VICRYL(ポリグラクチン(polyglactic)910)として市販)、ポリグリコリド(American Cyanamid Co.から商品名DEXONとして市販)、ポリジオキサノン(Ethicon、Inc.から商品名PDSとして市販)、ポリ(グリコリド−トリメチレンカーボネート)ランダムブロックコポリマー(American Cyanamid Co.から商品名MAXONとして市販)、75/25ポリ(グリコリド−E−カプロラクトン−ポリグレカプロラクトン25)コポリマー(Ethiconから商品名MONOCRYLとして市販)のうちの1つ又は2つ以上を含み得る。
合成非吸収性ポリマーの例は、発泡ポリウレタン、ポリプロピレン(PP)、ポリエチレン(PE)、ポリカーボネート、ナイロンのようなポリアミド、ポリ塩化ビニル(PVC)、ポリメチルメタクリレート(PMMA)、ポリスチレン(PS)、ポリエステル、ポリエーテルエーテルケトン(PEEK)、ポリテトラフルオロエチレン(PTFE)、ポリトリフルオロクロロエチレン(PTFCE)、ポリフッ化ビニル(PVF)、フッ素化エチレンプロピレン(FEP)、ポリアセタール、ポリスルホン、及びこれらの組み合わせを含むが、これらに限定されない。合成非吸収性ポリマーは、例えば、シリコーン、ポリイソプレン、及びゴムなどの発泡エラストマー及び多孔質エラストマーを含むことがあるが、これらに限定されない。様々な状況において、合成ポリマーは、W.L.Gore & Associates,Inc.から商品名GORE−TEX Soft Tissue Patchで市販されている延伸ポリテトラフルオロエチレン(ePTFE)と、Polyganicsから商品名NASOPOREで市販されているコ−ポリエーテルエステルウレタン発泡体とを含むことがある。
組織厚さコンペンセータアセンブリのポリマー組成物は、例えば、パーセント有孔率、孔径、及び/又は硬度によって特徴付けられることがある。様々な状況において、ポリマー組成物は、例えば、約30体積%〜約99体積%のパーセント有孔率を有することがある。特定の状況において、ポリマー組成物は、例えば、約60体積%〜約98体積%のパーセント有孔率を有することがある。様々な状況において、ポリマー組成物は、例えば、約85体積%〜約97体積%のパーセント有孔率を有することがある。少なくとも一実施形態において、ポリマー組成物は例えば、約70重量%のPLLAと約30重量%のPCLを含み得、例えば約90体積%の有孔率を有しうる。少なくとも1つのこのような実施形態において、結果として、ポリマー組成物は、約10体積%のコポリマーを含むことになるであろう。少なくとも一実施形態において、ポリマー組成物は例えば、約65重量%のPGAと約35重量%のPCLを含み得、例えば約93体積%〜約95体積%の有孔率を有しうる。様々な状況において、ポリマー組成物は、85体積%超の有孔率を有し得る。ポリマー組成物は、例えば、約5μm〜約2000μmの孔径を有することがある。様々な状況において、ポリマー組成物は、例えば、約10μm〜約100μmの孔径を有し得る。少なくともそのような一実施形態において、ポリマー組成物は例えば、PLLAとPCLのコポリマーを含みうる。特定の状況において、ポリマー組成物は、例えば、約100μm〜約1000μmの孔径を有し得る。少なくとも1つのこのような実施形態において、ポリマー組成物は、例えば、PLLAとPCLとのコポリマーを含むことができる。特定の態様により、ポリマー組成物の硬度は、ショア硬度で表わしてもよく、これは、例えば、ショア硬度などのデュロメーターで測定される、材料の恒久的な陥凹に対する抵抗として定義されうる。所与の材料のデュロメーター値を評価するために、「Standard Test Method for Rubber Property−Durometer Hardness」と題されるASTM手順D2240−00に従って、デュロメーターインデンターフットで、材料に対して圧力がかけられる。デュロメーターインデンターフットは、例えば15秒間などの充分な時間、材料に対して適用してよく、この測定値が適切な目盛で取得される。使用する目盛のタイプに応じて、インデンターフットが材料に完全に貫入したときに読取り値0が得られ、材料の中への貫入が起こらなかった場合に読取り値100が得られる。この読取り値は、無次元である。様々な状況において、デュロメーターは、ASTM D2240−00に従って、任意の好適な目盛、例えばタイプA及び/又はタイプOOに従って測定され得る。様々な状況において、組織厚さコンペンセータアセンブリのポリマー組成物は、例えば、約4A〜約16AのショアA硬度値を有してもよく、これはショアOO範囲で約45 OO〜約65 OOである。少なくとも1つのこのような実施形態において、ポリマー組成物は、例えば、PLLA/PCLコポリマー又はPGA/PCLコポリマーを含むことができる。様々な状況において、組織厚さコンペンセータアセンブリのポリマー組成物は、15A未満のショアA硬度値を有し得る。様々な状況において、組織厚さコンペンセータアセンブリのポリマー組成物は、10A未満のショアA硬度値を有し得る。様々な状況において、組織厚さコンペンセータアセンブリのポリマー組成物は、5A未満のショアA硬度値を有し得る。特定の状況において、ポリマー材料は、例えば、約35 OO〜約75 OOのショアOO組成値を有し得る。
様々な状況において、ポリマー組成物は、上述の特性のうち少なくとも2つを有することがある。様々な状況において、ポリマー組成物は、上述の特性のうち少なくとも3つを有することがある。重合性組成物は、85体積%〜97体積%の有孔率と、5マイクロメートル〜2000マイクロメートルの孔径と、4A〜16AのショアA硬度及び45OO〜65OOのショアOO硬度値とを有することがある。少なくとも一実施形態において、ポリマー組成物は例えば、70重量%のPLLAポリマー組成物と30重量%のPCLポリマー組成物を含み、90体積%の有孔率、100μm〜1000μmの孔サイズ、及び4A〜16AのショアA硬度、及び45 OO〜65 OOのショアOO硬度値を有しうる。少なくとも一実施形態において、ポリマー組成物は例えば、65重量%のPGAポリマー組成物と35重量%のPCLポリマー組成物を含み、93体積%〜95体積%の有孔率、10μm〜100μmの孔サイズ、及び4A〜16AのショアA硬度値、及び45 OO〜65 OOのショアOO硬度値を有しうる。
様々な状況において、ポリマー組成物は、製薬的活性薬剤を含み得る。ポリマー組成物は、治療有効量の製薬的活性薬剤を放出しうる。様々な状況において、製薬的活性薬剤は、ポリマー組成物が脱着/吸着される際に放出され得る。様々な状況において、製薬的活性薬剤は、そのポリマー組成物の上又は中を通過する液体(例えば、血液)内に放出され得る。製薬的活性薬剤の例としては、これらに限定されるものではないが、止血剤及び止血薬(例えば、フィブリン、トロンビン、及び酸化再生セルロース(ORC));抗炎症薬(例えばジクロフェナク、アスピリン、ナプロキセン、スリンダク、及びヒドロコルチゾン);抗生物質及び抗菌薬又は抗菌剤(例えば、トリクロサン、銀イオン、アンピシリン、ゲンタマイシン、ポリミキシンB、クロラムフェニコール);並びに制癌剤(例えば、シスプラチン、マイトマイシン、アドリアマイシン)が挙げられ得る。
組織厚さコンペンセータを製造するための様々な方法が、本明細書で開示されている。このような方法を使用して、例えば、ファスナカートリッジ及び/又は外科用固定器具で使用するのに好適な任意の層を製造することができる。このような層は、任意の好適な工程を使用して作製され得る、100%未満の高密度組成物を含むことができる。例えば、このような工程としては、例えば、押出加工、射出成形、製織、凍結乾燥、ガス発泡、及び/又はメルトブローイング工程が挙げられ得る。いくつかの工程は発泡体を生成し得るのに対し、他の工程は発泡体を生成し得ないが、いずれにしても、このような実施形態の全ては、本明細書に開示する全ての実施形態での使用について意図される。
以下の全ての開示内容が参照によって本明細書に組み込まれる。
1995年4月4日に発行された米国特許第5,403,312号、発明の名称「ELECTROSURGICAL HEMOSTATIC DEVICE」
2006年2月21日に発行された米国特許第7,000,818号、発明の名称「SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS」
2008年9月9日に発行された米国特許第7,422,139号、発明の名称「MOTOR−DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK」
2008年12月16日に発行された米国特許第7,464,849号、発明の名称「ELECTRO−MECHANICAL SURGICAL INSTRUMENT WITH CLOSURE SYSTEM AND ANVIL ALIGNMENT COMPONENTS」
2010年3月2日に発行された米国特許第7,670,334号、発明の名称「SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR」
2010年7月13日に発行された米国特許第7,753,245号、発明の名称「SURGICAL STAPLING INSTRUMENTS」
2013年3月12日に発行された米国特許第8,393,514号、発明の名称「SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE」
米国特許出願第11/343,803号、発明の名称「SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES」(現在は、米国特許第7,845,537号)、
2008年2月14日に出願された米国特許出願第12/031,573号、発明の名称「SURGICAL CUTTING AND FASTENING INSTRUMENT HAVING RF ELECTRODES」
2008年2月15日に出願された米国特許出願第12/031,873号、発明の名称「END EFFECTORS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT」(現在は、米国特許第7,980,443号)、
米国特許出願第12/235,782号、発明の名称「MOTOR−DRIVEN SURGICAL CUTTING INSTRUMENT」(現在は、米国特許第8,210,411号)、
米国特許出願第12/249,117号、発明の名称「POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM」(現在は、米国特許第8,608,045号)、
2009年12月24日に出願された米国特許出願第12/647,100号、発明の名称「MOTOR−DRIVEN SURGICAL CUTTING INSTRUMENT WITH ELECTRIC ACTUATOR DIRECTIONAL CONTROL ASSEMBLY」(現在は、米国特許第8,220,688号)、
2012年9月29日に出願された米国特許出願第12/893,461号、発明の名称「STAPLE CARTRIDGE」(現在は、米国特許第8,733,613号)、
2011年2月28日に出願された米国特許出願第13/036,647号、発明の名称「SURGICAL STAPLING INSTRUMENT」(現在は、米国特許第8,561,870号)、
米国特許出願第13/118,241号、発明の名称「SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS」(現在は、米国特許出願公開第2012/0298719号)
2012年6月15日に出願された米国特許出願第13/524,049号、発明の名称「ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE」(現在は、米国特許出願公開第2013/0334278号)、
2013年3月13日に出願された米国特許出願第13/800,025号、発明の名称「STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM」(現在は、米国特許出願公開第2014/0263551号)、
2013年3月13日に出願された米国特許出願第13/800,067号、発明の名称「STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM」(現在は、米国特許出願公開第2014/0263552号)、
2006年1月31日に出願された米国特許出願公開第2007/0175955号、発明の名称「SURGICAL CUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM」、及び
2010年4月22日に出願された米国特許出願公開第2010/0264194号、発明の名称「SURGICAL STAPLING INSTRUMENT WITH AN ARTICULATABLE END EFFECTOR」(現在は、米国特許第8,308,040号)。
特定の開示された実施形態と結びつけて本明細書で装置の様々な実施形態について説明したが、それらの実施形態に対して多くの修正及び変更が実施可能である。また、材料が特定の構成要素に関して開示されているが、他の材料が使用されてもよい。更に、様々な実施形態により、所定の機能又は複数の機能を実行するために、単一の構成要素を複数の構成要素によって置き換えてもよく、また複数の構成要素を単一の構成要素によって置き換えてもよい。以上の説明及び以下の特許請求の範囲は、そのような修正及び変形を全て包含することが意図される。
本明細書で開示される装置は、1度使用したら廃棄されるように設計されるか、又は、複数回使用されるよう設計可能である。だが、いずれの場合も、本装置は、少なくとも1回使用してから再度使用するために再調整することができる。再調整には、装置の分解工程、それに続く特定部品の洗浄や交換工程、及び、その後の再組み立て工程の任意の組み合わせを含むことができる。特に、装置は分解可能であり、装置の任意の数の特定部品、又は、部分を、任意の組み合わせで選択的に交換、あるいは、取り除くことができる。特定の部分を洗浄、及び/又は、交換したら、装置は、後で使用するために、再調整施設において、又は、外科手術の直前に外科チームによるいずれかによって再組み立てすることができる。当業者であれば、装置の再調整が、分解、洗浄/交換、及び再組み立てのための様々な技術を利用できることは、理解しているであろう。このような技術の使用、及び、その結果もたらされる再調整後の装置は、全て本発明の範囲内にある。
好ましくは、本明細書に記載する発明は、手術前に処理されるであろう。最初に、新規又は使用済みの器具を入手し、必要であれば洗浄する。次いで器具を滅菌することができる。ある滅菌技術では、器具は、プラスチックバッグ又はTYVEKバッグなど、閉じられて封止された容器に入れられる。次に、容器及び器具は、γ線、X線、及び高エネルギー電子など、容器を透過できる放射線照射野に入れられる。放射線は、器具上又は容器内の細菌を死滅させる。次に、滅菌された器具を滅菌容器に格納することができる。封止された容器は、医療設備において開封されるまで器具を滅菌状態に保つ。
代表的な設計を有するものとして本発明について記載してきたが、本発明は、本開示の趣旨及び範囲内で更に修正されてもよい。したがって、本出願は、その一般的原理を使用する本発明のあらゆる変形、使用、又は適合を包含するものとする。更に、本出願は、本開示からのかかる逸脱を、本発明が関連する分野において知られている又は慣例になってきたものとして包含するものとする。
全体又は部分的に、参照により本明細書に組み込まれるとされるいずれの特許、刊行物又は他の開示物も、援用される内容が現行の定義、記載、又は本開示に記載されている他の開示物と矛盾しない範囲でのみ本明細書に組み込まれるものとする。それ自体、また必要な範囲で、本明細書に明瞭に記載される開示内容は、参照により本明細書に組み込まれるあらゆる矛盾する記載に優先するものとする。参照により本明細書に組み込まれるものとするが、既存の定義、記載、又は本明細書に記載される他の開示文献と矛盾する任意の文献、又はそれらの部分は、援用文献と既存の開示内容との間に矛盾が生じない範囲においてのみ組み込まれるものとする。
〔実施の態様〕
(1) 組織をステープル留めするための外科用ステープル留め器具であって、
カートリッジ本体であって、
近位端と、
遠位端と、
組織支持面を備えるデッキと、
複数のステープル空洞と、を備える、カートリッジ本体と、
前記ステープル空洞に取り外し可能に格納された複数のステープルと、
前記ステープルを前記ステープル空洞から射出するために、遠位位置に向かって近位位置との間で移動可能な発射部材と、
前記デッキ上に配置された層であって、前記ステープルが前記ステープル空洞から射出されるとき、前記ステープルが前記層を前記組織に植え込むように構成されている、層と、
前記層を前記デッキに解放可能に保持するように構成された層保持体であって、前記発射部材が、前記層保持体に係合して前記層保持体を前記デッキに対して持ち上げるように構成されている、層保持体と、を備える、外科用ステープル留め器具。
(2) 前記層保持体が保持位置と解放位置との間で移動可能なクリップを備え、前記デッキがクリップスロットを備え、前記クリップが前記保持位置にあるとき、前記層の一部が前記クリップと前記クリップスロットとの間に挟まれる、実施態様1に記載の外科用ステープル留め器具。
(3) 前記層保持体が保持体縁を備え、前記デッキがデッキ縁を備え、前記保持体縁及び前記デッキ縁がそれらの間に前記層を解放可能に保持する、実施態様1に記載の外科用ステープル留め器具。
(4) 前記層が近位部分及び遠位部分を備え、前記層保持体が、前記カートリッジ本体の前記遠位端に配置され、前記遠位部分を前記デッキに解放可能に保持するように構成され、前記発射部材が前記近位位置にあるとき、前記近位部分が前記発射部材と前記カートリッジ本体との間に挟まれており、前記発射部材が前記遠位位置に向かって移動するとき、前記近位部分が解放される、実施態様1に記載の外科用ステープル留め器具。
(5) 前記カートリッジ本体が前記発射部材の一部を受容するように構成された縦スロットを備え、前記層が前記縦スロットと整列されて前記縦スロット内に解放可能に挟まれた一連のタブを備え、前記発射部材が前記タブに係合して前記タブを前記縦スロットから徐々に解放するように構成されている、実施態様1に記載の外科用ステープル留め器具。
(6) 組織をステープル留めするための外科用ステープル留め器具であって、
カートリッジ本体であって、
近位端と、
遠位端と、
組織支持面を備えるデッキと、
複数のステープル空洞と、を備える、カートリッジ本体と、
前記ステープル空洞に取り外し可能に格納された複数のステープルと、
近位ドライバ及び遠位ドライバを備える複数のステープルドライバと、
前記ステープルドライバを前記デッキに向かって持ち上げ、前記ステープルを前記ステープル空洞から射出するために、近位位置から遠位位置に向かって移動可能な発射部材と、
前記デッキ上に配置された層であって、前記ステープルが前記ステープル空洞から射出されるとき、前記ステープルが前記層を前記組織に植え込むように構成されている、層と、
前記層を前記デッキに解放可能に保持するように構成された層保持体であって、前記遠位ドライバが前記層保持体を前記デッキに対して引っ込めるように構成されている、層保持体と、を備える、外科用ステープル留め器具。
(7) 前記層保持体が保持位置と解放位置との間で移動可能なピンを備え、前記層がピン開口部を備え、前記層保持体が前記保持位置にあるとき、前記ピンが前記ピン開口部に配置され、前記層保持体が前記解放位置にあるとき、前記ピンが前記ピン開口部から係合解除される、実施態様6に記載の外科用ステープル留め器具。
(8) 前記層が近位部分及び遠位部分を備え、前記層保持体が、前記カートリッジ本体の前記遠位端に配置され、前記遠位部分を前記デッキに解放可能に保持するように構成され、前記発射部材が前記近位位置にあるとき、前記近位部分が前記発射部材と前記カートリッジ本体との間に挟まれており、前記発射部材が前記遠位位置に向かって移動するとき、前記近位部分が解放される、実施態様6に記載の外科用ステープル留め器具。
(9) 前記カートリッジ本体が前記発射部材の一部を受容するように構成された縦スロットを備え、前記層が前記縦スロットと整列されて前記縦スロット内に解放可能に挟まれた一連のタブを備え、前記発射部材が前記タブに係合して前記タブを前記縦スロットから徐々に解放するように構成されている、実施態様6に記載の外科用ステープル留め器具。
(10) 組織をステープル留めするための外科用ステープル留め器具であって、
カートリッジ本体であって、
近位端と、
遠位端と、
組織支持面を備えるデッキと、
複数のステープル空洞と、
縦スロットと、を備える、カートリッジ本体と、
前記ステープル空洞に取り外し可能に格納された複数のステープルと、
前記ステープルを前記ステープル空洞から射出するために、近位位置から遠位位置に向かって移動可能な発射部材であって、前記発射部材の一部が前記縦スロット内に配置されている、発射部材と、
前記デッキ上に配置された層であって、前記ステープルが前記ステープル空洞から射出されるとき、前記ステープルが前記層を前記組織に植え込むように構成されている、層と、
前記層を前記デッキに解放可能に保持するように構成された縦方向の一連の層保持体であって、前記層保持体が、前記縦スロットと整列されて前記縦スロット内に解放可能に挟まれており、前記発射部材が、前記層保持体に係合して前記層保持体を前記縦スロットから徐々に解放するように構成されている、縦方向の一連の層保持体と、を備える、外科用ステープル留め器具。
(11) 前記縦スロットが第1縦側壁及び第2縦側壁を備え、前記層保持体のそれぞれが前記第1側壁と前記第2側壁との間に解放可能に挟まれたタブを備える、実施態様10に記載の外科用ステープル留め器具。
(12) 前記層が植え込み可能な本体を備え、前記層保持体が前記植え込み可能な本体と一体形成されている、実施態様10に記載の外科用ステープル留め器具。
(13) 前記ステープルを前記デッキに向かって持ち上げるように構成された複数のステープルドライバであって、前記ステープルドライバが近位ステープルドライバ及び遠位ステープルドライバを備える、複数のステープルドライバと、
前記層を前記デッキに解放可能に保持するように構成された遠位層保持体であって、前記遠位ドライバが前記遠位層保持体を前記デッキに対して引っ込めるように構成されている、遠位層保持体と、を更に備える、実施態様10に記載の外科用ステープル留め器具。
(14) 前記遠位層保持体が保持位置と解放位置との間で移動可能なピンを備え、前記層がピン開口部を備え、前記層保持体が前記保持位置にあるとき、前記ピンが前記ピン開口部に配置され、前記層保持体が前記解放位置にあるとき、前記ピンが前記ピン開口部から係合解除される、実施態様13に記載の外科用ステープル留め器具。
(15) 前記層が近位部分及び遠位部分を備え、前記発射部材が前記近位位置にあるとき、前記近位部分が前記発射部材と前記カートリッジ本体との間に挟まれており、前記発射部材が前記遠位位置に向かって移動するとき、前記近位部分が解放される、実施態様10に記載の外科用ステープル留め器具。
(16) 前記層を前記デッキに解放可能に保持するように構成された遠位層保持体を更に備え、前記発射部材が、前記遠位層保持体に係合して前記遠位層保持体を前記デッキに対して持ち上げるように構成されている、実施態様10に記載の外科用ステープル留め器具。
(17) 前記遠位層保持体が保持位置と解放位置との間で移動可能なクリップを備え、前記デッキがクリップスロットを備え、前記クリップが前記保持位置にあるとき、前記層の一部が前記クリップと前記クリップスロットとの間に挟まれる、実施態様16に記載の外科用ステープル留め器具。
(18) 前記層保持体が保持体縁を備え、前記デッキがデッキ縁を備え、前記保持体縁及び前記デッキ縁がそれらの間に前記層を解放可能に保持する、実施態様16に記載の外科用ステープル留め器具。
(19) 組織をステープル留めするための外科用ステープル留め器具であって、
ステープルカートリッジであって、
カートリッジ本体であって、
近位端と、
遠位端と、
組織支持面を備えるデッキと、
複数のステープル空洞と、を備える、カートリッジ本体と、
前記ステープル空洞に取り外し可能に格納された複数のステープルと、
前記ステープルを前記ステープル空洞から射出するために、近位位置から遠位位置に向かって移動可能な発射部材と、を備える、ステープルカートリッジと、
前記ステープルを変形させるように構成されたアンビルと、
前記アンビルに接して配置された層であって、前記ステープルが前記ステープル空洞から射出されるとき、前記ステープルが前記層を前記組織に植え込むように構成され、前記発射部材が前記近位位置にあるとき、前記層が前記発射部材と前記カートリッジ本体との間に配置された層保持体を備え、前記発射部材が前記遠位位置に向かって移動するとき、前記層保持体が解放される、層と、を備える、外科用ステープル留め器具。
(20) 前記カートリッジ本体が前記発射部材の一部を受容するように構成された縦スロットを備え、前記縦スロットが第1側壁及び第2側壁を備え、前記発射部材が前記近位位置にあるとき、前記層保持体が前記発射部材と前記第1側壁との間に配置される、実施態様19に記載の外科用ステープル留め器具。
(21) 前記アンビルが前記発射部材の一部を受容するように構成された縦アンビルスロットを含み、前記層が前記層を前記アンビルに解放可能に保持するように構成された縦方向の一連のアンビル層保持体を更に備え、前記アンビル層保持体が、前記縦アンビルスロットと整列されて前記縦アンビルスロット内に解放可能に挟まれており、前記発射部材が、前記アンビル層保持体に係合して前記アンビル層保持体を前記縦アンビルスロットから徐々に解放するように構成されている、実施態様19に記載の外科用ステープル留め器具。
(22) 少なくとも1つのカートリッジ層保持体によって前記カートリッジ本体に解放可能に取り付けられたカートリッジ層を更に備える、実施態様19に記載の外科用ステープル留め器具。
(23) 前記カートリッジ本体が前記発射部材の一部を受容するように構成された縦カートリッジスロットを備え、前記少なくとも1つのカートリッジ層保持体が、前記カートリッジ層を前記カートリッジ本体に解放可能に保持するように構成された縦方向の一連のカートリッジ層保持体を備え、前記カートリッジ層保持体が、前記縦カートリッジスロットと整列されて前記縦カートリッジスロット内に解放可能に挟まれており、前記発射部材が、前記カートリッジ層保持体に係合して前記カートリッジ層保持体を前記縦カートリッジスロットから徐々に解放するように構成されている、実施態様22に記載の外科用ステープル留め器具。
(24) 前記少なくとも1つのカートリッジ層保持体が前記遠位端に配置された層保持体を備える、実施態様22に記載の外科用ステープル留め器具。
(25) 前記発射部材が、前記アンビルに係合するように構成された第1カムと、前記ステープルカートリッジに係合するように構成された第2カムとを備え、前記第1カムが、前記アンビル層保持体を前記アンビル縦スロットから徐々に解放するように構成され、前記第2カムが、前記カートリッジ層保持体を前記カートリッジ縦スロットから徐々に解放するように構成されている、実施態様23に記載の外科用ステープル留め器具。
(26) 前記第1カム及び前記第2カムが、前記アンビルと前記ステープルカートリッジとの間で組織ギャップを制御するように構成されている、実施態様25に記載の外科用ステープル留め器具。
(27) 前記層が層本体を備え、前記層本体が本体厚さを備え、前記アンビル層保持体のそれぞれが前記層本体から延びるディンプルを備え、前記ディンプルのそれぞれが前記本体厚さより薄いディンプル厚さを備える、実施態様19に記載の外科用ステープル留め器具。
(28) 前記アンビル層保持体のそれぞれがディンプルを備え、少なくとも1つの前記ディンプルが、第1ディンプル厚さを有する第1ディンプルを備え、少なくとも1つの前記ディンプルが、前記第1ディンプル厚さより薄い第2ディンプル厚さを有する第2ディンプルを備える、実施態様19に記載の外科用ステープル留め器具。
(29) 最も遠位のディンプルが第1ディンプルを備え、最も近位のディンプルが第1ディンプルを備え、前記第2ディンプルが前記最も近位のディンプルと前記最も遠位のディンプルとの間に配置されている、実施態様28に記載の外科用ステープル留め器具。
(30) 前記発射部材が切断部分を備え、前記発射部材が前記近位位置から前記遠位位置に向かって移動するとき、前記切断部分が前記ディンプルを切開するように構成されている、実施態様28に記載の外科用ステープル留め器具。

Claims (11)

  1. 組織をステープル留めするための外科用ステープル留め器具であって、
    カートリッジ本体であって、
    近位端と、
    遠位端と、
    組織支持面を備えるデッキと、
    複数のステープル空洞と、を備える、カートリッジ本体と、
    前記ステープル空洞に取り外し可能に格納された複数のステープルと、
    前記ステープルを前記ステープル空洞から射出するために、遠位位置に向かって近位位置との間で移動可能な発射部材と、
    前記デッキ上に配置された層であって、前記ステープルが前記ステープル空洞から射出されるとき、前記ステープルが前記層を前記組織に植え込むように構成されている、層と、
    前記層を前記デッキに解放可能に保持するように構成された層保持体であって、前記発射部材が、前記層保持体に係合して前記層保持体を前記デッキに対して持ち上げるように構成されている、層保持体と、を備え
    前記層保持体が保持位置と解放位置との間で移動可能なクリップを備え、前記デッキがクリップスロットを備え、前記クリップが前記保持位置にあるとき、前記層の一部が前記クリップと前記クリップスロットとの間に挟まれる、外科用ステープル留め器具。
  2. 前記クリップがその近位端にクリップ縁を備え、前記クリップスロットがその遠位端にクリップスロット縁を備え、前記クリップ縁及び前記クリップスロット縁がそれらの間に前記層を解放可能に保持する、請求項1に記載の外科用ステープル留め器具。
  3. 組織をステープル留めするための外科用ステープル留め器具であって、
    カートリッジ本体であって、
    近位端と、
    遠位端と、
    組織支持面を備えるデッキと、
    複数のステープル空洞と、を備える、カートリッジ本体と、
    前記ステープル空洞に取り外し可能に格納された複数のステープルと、
    前記ステープルを前記ステープル空洞から射出するために、遠位位置に向かって近位位置との間で移動可能な発射部材と、
    前記デッキ上に配置された層であって、前記ステープルが前記ステープル空洞から射出されるとき、前記ステープルが前記層を前記組織に植え込むように構成されている、層と、
    前記層を前記デッキに解放可能に保持するように構成された層保持体であって、前記発射部材が、前記層保持体に係合して前記層保持体を前記デッキに対して持ち上げるように構成されている、層保持体と、を備え、
    前記層が近位部分及び遠位部分を備え、前記層保持体が、前記カートリッジ本体の前記遠位端に配置され、前記遠位部分を前記デッキに解放可能に保持するように構成され、前記発射部材が前記近位位置にあるとき、前記近位部分が前記発射部材と前記カートリッジ本体との間に挟まれており、前記発射部材が前記遠位位置に向かって移動するとき、前記近位部分が解放される、外科用ステープル留め器具。
  4. 前記カートリッジ本体が前記発射部材の一部を受容するように構成された縦スロットを備え、前記層が前記縦スロットと整列されて前記縦スロット内に解放可能に挟まれた一連のタブを備え、前記発射部材が前記タブに係合して前記タブを前記縦スロットから徐々に解放するように構成されている、請求項1〜3のいずれか1つに記載の外科用ステープル留め器具。
  5. 組織をステープル留めするための外科用ステープル留め器具であって、
    カートリッジ本体であって、
    近位端と、
    遠位端と、
    組織支持面を備えるデッキと、
    複数のステープル空洞と、
    縦スロットと、を備える、カートリッジ本体と、
    前記ステープル空洞に取り外し可能に格納された複数のステープルと、
    前記ステープルを前記ステープル空洞から射出するために、近位位置から遠位位置に向かって移動可能な発射部材であって、前記発射部材の一部が前記縦スロット内に配置されている、発射部材と、
    前記デッキ上に配置された層であって、前記ステープルが前記ステープル空洞から射出されるとき、前記ステープルが前記層を前記組織に植え込むように構成されている、層と、
    前記層を前記デッキに解放可能に保持するように構成された縦方向の一連の層保持体であって、前記層保持体が、前記縦スロットと整列されて前記縦スロット内に解放可能に挟まれており、前記発射部材が、前記層保持体に係合して前記層保持体を前記縦スロットから徐々に解放するように構成されている、縦方向の一連の層保持体と、を備え
    前記外科用ステープル留め器具が、
    前記ステープルを前記デッキに向かって持ち上げるように構成された複数のステープルドライバであって、前記ステープルドライバが近位ステープルドライバ及び遠位ステープルドライバを備える、複数のステープルドライバと、
    前記層を前記デッキに解放可能に保持するように構成された遠位層保持体であって、前記遠位ステープルドライバが前記遠位層保持体を前記デッキに対して引っ込めるように構成されている、遠位層保持体と、を更に備える、外科用ステープル留め器具。
  6. 前記遠位層保持体が保持位置と解放位置との間で移動可能なピンを備え、前記層がピン開口部を備え、前記遠位層保持体が前記保持位置にあるとき、前記ピンが前記ピン開口部に配置され、前記遠位層保持体が前記解放位置にあるとき、前記ピンが前記ピン開口部から係合解除される、請求項に記載の外科用ステープル留め器具。
  7. 組織をステープル留めするための外科用ステープル留め器具であって、
    カートリッジ本体であって、
    近位端と、
    遠位端と、
    組織支持面を備えるデッキと、
    複数のステープル空洞と、
    縦スロットと、を備える、カートリッジ本体と、
    前記ステープル空洞に取り外し可能に格納された複数のステープルと、
    前記ステープルを前記ステープル空洞から射出するために、近位位置から遠位位置に向かって移動可能な発射部材であって、前記発射部材の一部が前記縦スロット内に配置されている、発射部材と、
    前記デッキ上に配置された層であって、前記ステープルが前記ステープル空洞から射出されるとき、前記ステープルが前記層を前記組織に植え込むように構成されている、層と、
    前記層を前記デッキに解放可能に保持するように構成された縦方向の一連の層保持体であって、前記層保持体が、前記縦スロットと整列されて前記縦スロット内に解放可能に挟まれており、前記発射部材が、前記層保持体に係合して前記層保持体を前記縦スロットから徐々に解放するように構成されている、縦方向の一連の層保持体と、を備え、
    前記層が近位部分及び遠位部分を備え、前記発射部材が前記近位位置にあるとき、前記近位部分が前記発射部材と前記カートリッジ本体との間に挟まれており、前記発射部材が前記遠位位置に向かって移動するとき、前記近位部分が解放される、外科用ステープル留め器具。
  8. 組織をステープル留めするための外科用ステープル留め器具であって、
    カートリッジ本体であって、
    近位端と、
    遠位端と、
    組織支持面を備えるデッキと、
    複数のステープル空洞と、
    縦スロットと、を備える、カートリッジ本体と、
    前記ステープル空洞に取り外し可能に格納された複数のステープルと、
    前記ステープルを前記ステープル空洞から射出するために、近位位置から遠位位置に向かって移動可能な発射部材であって、前記発射部材の一部が前記縦スロット内に配置されている、発射部材と、
    前記デッキ上に配置された層であって、前記ステープルが前記ステープル空洞から射出されるとき、前記ステープルが前記層を前記組織に植え込むように構成されている、層と、
    前記層を前記デッキに解放可能に保持するように構成された縦方向の一連の層保持体であって、前記層保持体が、前記縦スロットと整列されて前記縦スロット内に解放可能に挟まれており、前記発射部材が、前記層保持体に係合して前記層保持体を前記縦スロットから徐々に解放するように構成されている、縦方向の一連の層保持体と、を備え、
    前記外科用ステープル留め器具が、前記層を前記デッキに解放可能に保持するように構成された遠位層保持体を更に備え、前記発射部材が、前記遠位層保持体に係合して前記遠位層保持体を前記デッキに対して持ち上げるように構成されており、
    前記遠位層保持体が保持位置と解放位置との間で移動可能なクリップを備え、前記デッキがクリップスロットを備え、前記クリップが前記保持位置にあるとき、前記層の一部が前記クリップと前記クリップスロットとの間に挟まれる、外科用ステープル留め器具。
  9. 前記クリップがその近位端にクリップ縁を備え、前記クリップスロットがその遠位端にクリップスロット縁を備え、前記クリップ縁及び前記クリップスロット縁がそれらの間に前記層を解放可能に保持する、請求項に記載の外科用ステープル留め器具。
  10. 前記縦スロットが第1縦側壁及び第2縦側壁を備え、前記層保持体のそれぞれが前記第1側壁と前記第2側壁との間に解放可能に挟まれたタブを備える、請求項5〜9のいずれか1つに記載の外科用ステープル留め器具。
  11. 前記層が植え込み可能な本体を備え、前記層保持体が前記植え込み可能な本体と一体形成されている、請求項5〜9のいずれか1つに記載の外科用ステープル留め器具。
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US20220354495A1 (en) 2022-11-10
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US11337698B2 (en) 2022-05-24
US20210267592A1 (en) 2021-09-02
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