【発明の詳細な説明】 技術分野 本発明はステープル、具体的には、外科およびその他
の分野に使用される改良ステープルに関する。FIELD OF THE INVENTION The present invention relates to staples, and in particular to improved staples used in surgery and other fields.
発明の背景 ステープルは多くの用途を持つ。例えば、外科医は中
空器官または管状構造の切断端部相互を結合し（吻合）
かつ止血するために薄いワイヤステープルを使用する。
薄いワイヤステープルは均一断面および材料特性を有す
る所定長の薄いワイヤをＵ形に変形することにより形成
される。図１はクラウン101および２本の脚部102を含む
従来技術による薄いワイヤステープル100を示す。図１
に示されたステープルは均一断面および材料特性を有す
るが、材料特性はワイヤのＵ形への変形時にステープル
の脚部とクラウンとの結合領域で変化する。外科ステー
プルはステンレス鋼等の人体流体によるアタックに不活
性の材料により形成される。BACKGROUND OF THE INVENTION Staples have many uses. For example, a surgeon may connect the cut ends of a hollow organ or tubular structure (anastomosis)
And use thin wire staples to stop the bleeding.
Thin wire staples are formed by deforming a length of thin wire having a uniform cross section and material properties into a U shape. FIG. 1 shows a prior art thin wire staple 100 including a crown 101 and two legs 102. FIG.
Although the staple shown in Figure 1 has a uniform cross section and material properties, the material properties change during the deformation of the wire into a U-shape at the staple leg to crown bond region. Surgical staples are formed of materials that are inert to attacks by body fluids such as stainless steel.
ステープルを設置するときに、脚部を留める物質へ押
しつける。設置時に、いくつかのステープルは変形、即
ち、弾性限界を越えて屈曲して形状を永久的に変化させ
る。When installing staples, press the legs against the material that holds them in place. Upon installation, some staples deform, that is, bend beyond their elastic limit to permanently change shape.
図２は、脚部が屈曲して変形するときに脚部を誘導す
るためのチャンネルを有するアンビルへ脚部を付勢する
ことにより設置時Ｂ形に変形した図１のステープルを示
す。このアンビルはステープルを挿入する側と反対のス
テープル留めする物の側に位置する。図１のステープル
の変形は曲げ応力が最大になるところで生じる。FIG. 2 shows the staple of FIG. 1 deformed into a B shape when installed by biasing the leg into an anvil having channels for guiding the leg as it flexes and deforms. The anvil is located on the side of the staple that is opposite the side on which the staple is inserted. Deformation of the staple of FIG. 1 occurs where bending stress is maximized.
図２はクラウン101から異なる位置で脚部102が分離し
てＢ形ステープルへ変化した状態を示す。このように、
Ｂ形ステープルが外科に使用される場合、脚部とクラウ
ンとの間に位置する組織はその領域により程度の異なる
圧縮を受ける。FIG. 2 shows a state in which the leg portions 102 are separated from the crown 101 at different positions and changed into B-shaped staples. in this way,
When B-shaped staples are used in surgery, the tissue located between the legs and the crown is subject to varying degrees of compression depending on the area.
ステープルを使用して止血するために、ステープルに
より最小限に圧縮された組織は、最大限に圧縮される組
織が過剰圧縮または歪みにより欠損したり損傷する可能
性があるにもかかわらず、止血のために更に圧縮される
ことになる。傷痕組織の長時間にわたる収縮は悪い結果
に繋がるので、必要以上に傷痕組織を形成しないことが
重要である。Tissues that have been minimally compressed by staples for hemostasis using staples have been identified as hemostasis cells that are maximally compressed may be lost or damaged by overcompression or strain. Therefore, it will be further compressed. It is important not to form more scar tissue than necessary, as prolonged shrinkage of scar tissue can lead to poor results.
過度の傷痕組織の発生を阻止する必要があるにもかか
わらず、外科医によっては、制御された少量の組織損傷
は、組織損傷の結果として形成される傷痕組織量が過剰
でなければ、即ち、形成された傷痕組織が従来技術のＢ
形ステープルの使用により過剰の傷痕組織に繋がる問題
を生じなければ時に有益であると主張する。Despite the need to prevent the development of excessive scar tissue, some surgeons may find that a controlled, small amount of tissue damage means that the amount of scar tissue formed as a result of tissue damage is excessive, i.e., formation. The damaged scar structure is B of the prior art.
It is claimed to be sometimes beneficial if the use of shaped staples does not cause problems leading to excessive scar tissue.
本発明の課題はステープル留めした物を均一圧縮する
ステープルを提供することにある。An object of the present invention is to provide a staple that uniformly compresses a stapled object.
更に、本発明の課題は傷痕組織形成を最小限にする外
科ステープルを提供することにある。A further object of the present invention is to provide a surgical staple that minimizes scar tissue formation.
更に、本発明の課題はステープル留めした物の歪みを
最小限にするステープルを提供することにある。A further object of the present invention is to provide a staple that minimizes distortion of the stapled product.
更に、本発明の課題は癒着時間を最小限にする外科ス
テープルを提供することにある。A further object of the present invention is to provide a surgical staple that minimizes adhesion time.
更に、本発明の課題はステープル留めした物の損傷を
最小限にするステープルを提供することにある。A further object of the present invention is to provide a staple that minimizes damage to the stapled material.
更に、本発明の課題は傷痕組織の形成を少量に制御す
ることのできる外科用ステープルを提供することにあ
る。Further, it is an object of the present invention to provide a surgical staple capable of controlling scar tissue formation to a small amount.
発明の概要 上記問題および他の問題は本発明により解消され、か
つ本発明の課題は、設置時に変形抵抗が所定領域で選択
的に生じ、かかる所定領域において弱い領域で変形が優
先的に生じ、弱くない領域では変形は選択的に生じない
改良されたステープルに関する本発明により達成され
る。変形に対する抵抗が小さい所定領域は、本明細書に
おいて、以下、『変形域』と称する。変形域は変形域の
ステープル断面の最小慣性モーメントＩを小さくする、
またステープル材料の弾性係数Ｅを小さくすることによ
り形成できる。SUMMARY OF THE INVENTION The above problems and other problems are solved by the present invention, and the problem of the present invention is that deformation resistance occurs selectively in a predetermined area at the time of installation, and deformation occurs preferentially in a weak area in the predetermined area. Deformation is achieved by the present invention for improved staples where deformation does not occur selectively in non-weak areas. The predetermined region having a small resistance to deformation is hereinafter referred to as a “deformation region”. The deformation area reduces the minimum moment of inertia I of the staple cross section in the deformation area,
It can also be formed by reducing the elastic modulus E of the staple material.
本発明のステープルの好適態様において、ステープル
は２本の脚部を有し、各脚部は所定領域に変形域を有
し、この変形域はステープルが設定時にアンビルに当接
するときに生じる応力下で、変形域の抵抗よりも大きい
抵抗をもつ脚領域を介して、ステープルのクラウンから
分離しており、それによりステープルは変形域で選択的
に変形する。In a preferred embodiment of the staple of the present invention, the staple has two legs, each leg having a deformation area in a predetermined area, and the deformation area is under stress caused when the staple abuts the anvil during setting. , And is separated from the crown of the staple via a leg region having a resistance greater than that of the deformation region, whereby the staple is selectively deformed in the deformation region.
設置時に、本発明のステープルは、丸い隅をもった矩
形に変形するのが好ましい。これはステープル留めした
物の均一圧縮を可能にしかつその変形を最小限にするの
に役立つ。Upon installation, the staple of the present invention preferably deforms into a rectangle with rounded corners. This allows for uniform compression of the stapled object and helps minimize its deformation.
図１は設置前の従来技術のステープルを示す。 FIG. 1 shows a prior art staple prior to installation.
図２はＢ形に変形した後の図１の従来技術のステープ
ルを示す。FIG. 2 shows the prior art staple of FIG. 1 after being deformed into a B shape.
図３は本発明のステープルの例示態様を示す。 FIG. 3 illustrates an exemplary embodiment of the staple of the present invention.
図４は矩形に変形した後の図３のステープルを示す。 FIG. 4 shows the staple of FIG. 3 after being transformed into a rectangle.
図５は図３のステープルの可能変形域および隣接脚領
域の例示断面図（ステープル３の縮尺と異なる。）を示
す。FIG. 5 shows an exemplary cross-sectional view (different from the scale of the staple 3) of the possible deformation area and the adjacent leg area of the staple of FIG.
図６は２重に交互に並設したステープルラインを示
す。FIG. 6 shows a doubled staple line which is alternately arranged.
図７は第１タイプの例示アンビルの正面部分の断面図
である。FIG. 7 is a sectional view of a front portion of the first type exemplary anvil.
図８は第２タイプの例示アンビルの正面部分の断面図
である。FIG. 8 is a sectional view of a front portion of a second type exemplary anvil.
図９は本発明によるステプラーの顎装置の１態様を示
す。FIG. 9 illustrates one embodiment of a stepper jaw device according to the present invention.
図10は本発明に使用するステープルの装填ストリップ
（カートリッジ）を示す。FIG. 10 shows a staple loading strip (cartridge) for use in the present invention.
図11は本発明の他の態様を示し、ここでは変形域はス
テープルの装置と同時に形成される。FIG. 11 shows another embodiment of the invention in which the deformation zone is formed simultaneously with the stapling device.
図12は使用時の図11の態様を示す。 FIG. 12 shows the embodiment of FIG. 11 in use.
図13は完全に変形して組織へ設置された本発明のステ
ープルの他の態様の断面図を示す。FIG. 13 shows a cross-sectional view of another embodiment of a staple of the present invention fully deformed and placed on tissue.
図14は変形および設置前の本発明のステープルの他の
態様を示す。FIG. 14 shows another embodiment of the staple of the present invention before deformation and installation.
図15は完全にＢ形へ変形して組織へ設置された従来技
術のステープルの断面図を示す。FIG. 15 shows a cross-sectional view of a prior art staple that has been fully deformed into a B shape and placed in tissue.
図16は変形域を形成する方法を示す。 FIG. 16 shows a method of forming a deformation zone.
図17はステープルの脚部の上に形成された切欠きの図
を示す。FIG. 17 shows a view of the notch formed on the leg of the staple.
好適態様の詳細な説明 変形域は、変形がステープル設置時に所定領域で優先
的に発生するように、その領域においてステープルを弱
めることにより形成される。当分野で周知のごとく、応
力下のステープルの１領域の変形に対する抵抗はその領
域の弾性係数Ｅおよびその領域の慣性モーメントＩの程
度に依存する。１領域の上記両方または一方の性質を小
さくすることにより、その領域におけるステープルの変
形に必要な応力を小さくする。通常、ＥよりもＩを小さ
くするのが簡単である。Detailed Description of the Preferred Embodiments The deformation zone is formed by weakening the staples in that area so that deformation occurs preferentially in a given area during staple placement. As is known in the art, the resistance of a staple to deformation under stress in one region depends on the modulus of elasticity E in that region and the degree of inertia moment I in that region. Reducing one or both of the properties of one area reduces the stress required to deform the staples in that area. It is usually easier to make I smaller than E.
ステープル変形時にステープルの失敗、即ち、破損に
なるような方法により所定領域でステープルを弱めるこ
とにより変形領域を形成すべきでない。Deformation areas should not be formed by weakening the staples in certain areas in such a way that upon staple deformation the staples fail, i.e. break.
本発明のステープルの脚部はステープル留めされた物
の用件に適合するものでなければならない。即ち、変形
域の位置はステープル留めする物の厚みに適合し、かつ
所望の圧縮に適合するものでなければならず、かつステ
ープルの脚部の長さはステープル留めする物を均一に圧
縮するためにその両脚部を接近でき、かつ脚部の先端間
からの物の突出を阻止できる方法でなければならない。
かかる適合は複数のステープルの利用を必要としてよい
が、圧縮が行われ、その均一性が重要である場合に正当
化されるものである。The staple legs of the present invention must be compatible with the requirements of the stapled item. That is, the location of the deformation zone must be compatible with the thickness of the stapled object and the desired compression, and the length of the staple legs is to provide uniform compression of the stapled object. It must be possible to approach both legs and to prevent the projection of an object from between the tips of the legs.
Such adaptation may require the use of multiple staples, but is justified when compression is performed and its uniformity is important.
図３は本発明による例示ステープル300を示す。ステ
ープル300はクラウン301および２本の脚部302を有す
る。各脚部302は脚領域306および307の抵抗と比較して3
04の方向への曲げに対する抵抗が小さい変形域305を有
する。脚領域306および307は変形域305の外側にある。
ステープル300が304の方向へ働く力による応力を受ける
と、上記脚部はその方向へ屈曲して、曲げおよび変形が
変形域305で優先的に生じる。FIG. 3 illustrates an exemplary stapler 300 according to the present invention. The staple 300 has a crown 301 and two legs 302. Each leg 302 is 3 compared to the resistance of the leg regions 306 and 307.
It has a deformation area 305 with a small resistance to bending in the 04 direction. The leg regions 306 and 307 are outside the deformation zone 305.
When the staples 300 are stressed by the force acting in the direction of 304, the legs bend in that direction, and bending and deformation preferentially occur in the deformation region 305.
図４において、図３のステープルは矩形に変形した状
態で示されている。図３のステープルにより留めた物は
図２のＢ形ステープルの場合よりも均一圧縮下におかれ
る。図４は、変形域305の位置および長手、ならびにス
テープルの脚部302の長手が特定厚みを有するステープ
ル留めされる物に望ましい圧縮を得る上で、またステー
プルの両脚部の端部もしくは先端部を接近させる上で脚
部の重要なパラメタであることを示す。理想的には、ス
テープルの脚部の先端部は相互に接触する程度である。
クラウン301と変形域305との間の脚領域306の長さはス
テープル留めする物の厚みとその物質に所望される圧縮
力とに応じて設定される要件に適したものである。変形
域305と脚端部308との間の脚領域307の長さは、変形し
たステープルの両脚端部308の分離がステープル設置時
の変形により両脚端部308間で干渉することなく、最小
限になるように選択されるべきである。In FIG. 4, the staple of FIG. 3 is shown in a deformed rectangular shape. The staples of FIG. 3 are placed under more uniform compression than the B staples of FIG. FIG. 4 illustrates the location and length of the deformation zone 305, and the length of the staple legs 302 to obtain the desired compression for a stapled object having a particular thickness, and also the ends or tips of the staple legs. It is shown that this is an important parameter for the legs to approach them. Ideally, the tips of the staple legs are in contact with each other.
The length of the leg region 306 between the crown 301 and the deformation zone 305 is suitable for the requirements set depending on the thickness of the material to be stapled and the desired compression force of the material. The length of the leg region 307 between the deformation area 305 and the leg end 308 is a minimum, without the separation of the leg ends 308 of the deformed staple interfering between the leg ends 308 due to deformation during staple placement. Should be selected.
図２と図４を比較すると、図３のステープル300によ
り留めた物がＢ形ステープルによるよりも歪みが少なく
圧縮が均一であることを示す。A comparison of FIGS. 2 and 4 shows that the staple 300 clamped in FIG. 3 has less distortion and more uniform compression than the B-shaped staple.
図５において、図３の脚部302の例示断面（図３の縮
尺で表されていない）が示されている。図５（ａ）にお
いて、ステープルの脚部302の変形域305の外側の領域の
断面図が示されている。図５（ｂ）および（ｃ）には、
ステープルの脚部の変形域305の断面として２つの異な
る可能な断面が示されている。304の方向へ屈曲する図
５（ｂ）または（ｃ）に示された断面を有するステープ
ルの脚部の変形域Ｉの値は図（ａ）の断面を有する場合
よりも小さい。5, an exemplary cross-section (not shown to scale of FIG. 3) of leg 302 of FIG. 3 is shown. In FIG. 5A, a cross-sectional view of a region outside the deformation region 305 of the leg portion 302 of the staple is shown. 5 (b) and (c),
Two different possible cross-sections are shown as cross-sections of the staple leg deformation area 305. The value of the deformation area I of the leg portion of the staple having the cross section shown in FIG. 5 (b) or (c) bent in the direction of 304 is smaller than that in the case having the cross section of FIG.
図６において、図４の本発明のステープルから形成さ
れた２重に交互に並設されたステープルライン600が示
されており、各列は他の列に対してオフセットしてい
る。外科医は２重交互ステープルラインを使用して、例
えば、器官の切断端部で止血のために組織を圧縮または
吻合する。本発明のステープルは、このように、例え
ば、止血および吻合の用途を有する。In FIG. 6, double alternating side-by-side staple lines 600 formed from the inventive staples of FIG. 4 are shown, with each row offset from the other. Surgeons use double alternating staple lines to compress or anastomose tissue for hemostasis, for example at the cut end of an organ. The staples of the present invention thus have applications in, for example, hemostasis and anastomosis.
図７において、図４の変形ステープルを形成するため
に図３のステープルに使用するアンビル700の断面が示
されている。アンビル700に形成されたチャンネル701
は、ステープル300がアンビル700を付勢して脚部302が
アンビル700に当接するときにステープル脚部302の屈曲
と変形を可能する。アンビル700はステープル300を付勢
するときに固定される。7, a cross section of an anvil 700 used in the staple of FIG. 3 to form the modified staple of FIG. 4 is shown. Channel 701 formed on anvil 700
Allows the staple leg 302 to bend and deform when the staple 300 biases the anvil 700 and the leg 302 abuts the anvil 700. Anvil 700 is fixed when biasing staples 300.
図８において、図３のステープル300に使用する図７
と異なる態様のアンビル800が示されている。ステープ
ル300の脚部302はステープル留めする物（図８に示され
ていない）へ侵入した後にアンビル800のチャンネル801
へ当接する。アンビル800は、ステープル300がアンビル
800へ付勢されるときに、ステープル300の方向へ移動す
る。該アンビルの運動は当分野に周知の手段を用いて行
なわせることができる。アンビルの運動は、ステープル
脚部302が屈曲および変形するきに該脚部により留めら
れる物の歪みを最小限にする。In FIG. 8, FIG. 7 used for the staple 300 of FIG.
Anvil 800 is shown in a different embodiment. The legs 302 of the staples 300 are inserted into the staples (not shown in FIG. 8) and then channel 801 of the anvil 800.
Abut. Anvil 800, staple 300 anvil
When biased to 800, it moves towards staple 300. Movement of the anvil can be accomplished using means well known in the art. The movement of the anvil minimizes strain on the objects that are clamped by the staple legs 302 as they flex and deform.
図４に示されたように、ステープル300が変形した後
の脚部302はチャンネル701の形状に追従しない。寧ろ、
脚部302の端部308がチャンネル701の形状に追従して脚
領域306および307が相互に対して角度をもって屈曲する
（好ましくは直角）。ステプラーは所定値以上にステー
プルが屈曲するのを阻止するためにストッパ（702,80
2）を有するが、かかるストッパはステープルの設置に
は必要ない。例示ストッパ（702,802）が図示されてい
るが当分野に周知の手段を用いた他の方法を使用してス
テープルを所望点以上に変形させる程にステプラーの顎
部が接近するのを防止することができる。As shown in FIG. 4, the legs 302 after the staple 300 is deformed do not follow the shape of the channel 701. rather,
The ends 308 of the legs 302 follow the shape of the channel 701 so that the leg regions 306 and 307 bend at an angle to each other (preferably right angles). The stepper has stoppers (702,80) to prevent the staples from bending more than a predetermined value.
Although it has 2), such a stopper is not necessary for installing staples. Although exemplary stoppers (702, 802) are shown, other methods using means well known in the art can be used to prevent the stapler jaws from approaching enough to deform the staples beyond the desired point. it can.
ステプラーの顎部はステープル留めする物の厚みが均
一の場合には相互に対して、通常、平行であるが、物の
厚みは挿入すべきステプラーラインの長さにわたって変
化していることがある。図９において、他のステープル
の顎装置900が示されており、これは２つのステプラー
顎部901および902（顎部902はアンビルとして機能す
る）を含む。この態様はステープル留めする物の厚みが
外科医が挿入を望むステープルラインの長さにわたって
変化する場合に使用できる。The stepper jaws are usually parallel to each other when the thickness of the stapled object is uniform, but the object thickness may vary over the length of the stepper line to be inserted . In FIG. 9, another staple jaw device 900 is shown which includes two stepper jaws 901 and 902 (jaw 902 functions as an anvil). This embodiment can be used when the thickness of the staples varies over the length of the staple line the surgeon desires to insert.
本発明の利点を最大にしかつ良好な結果を得るため
に、図示されたように上顎部901は下顎部902に対して傾
斜している。結果として、ステプラー顎部901と902の分
離はステープル留めする物（図９に図示されていない）
の厚みの変化に対応して変化する。To maximize the benefits of the present invention and obtain good results, the upper jaw 901 is inclined with respect to the lower jaw 902 as shown. As a result, the separation of the stepper jaws 901 and 902 is stapled (not shown in FIG. 9).
Changes in response to changes in the thickness of.
図９の装置に使用する個別ステープルは、ステープル
留めする物の厚みの変化に対応するために相互に対して
異なる位置に脚部変形域を有する。特に、図９から理解
されるように、チャンネル903と接触するステープルは
その脚部変形域とステープルクラウンとの間にチャンネ
ル904と接触するステープルよりも長さの短い脚部を有
する。更に、チャンネル903に使用されるステープルの
脚部の長さはチャンネル904で使用されるステープルの
脚部長よりも短くてよい。The individual staples used in the apparatus of FIG. 9 have leg deformed areas at different positions relative to each other to accommodate changes in the thickness of the stapled object. In particular, as can be seen in FIG. 9, the staple contacting the channel 903 has a shorter leg between the staple deforming region and the staple crown than the staple contacting the channel 904. Further, the staple leg length used in channel 903 may be shorter than the staple leg length used in channel 904.
本発明のステープルは均一断面および材料特性をもっ
て製造され、かつ使用直前に外科医がステープルを変形
させることにより変形域を形成できるので、本発明のス
テープルはステープル留めする物の条件に対応する。例
えば、外科医は変形域を形成するためにステープルの脚
部を切欠くまたは綴じ、そして／またはステープルの脚
部を所望長にカットすることができる。かかる目的に使
用できる装置として当分野に周知の手段を使用できる。
かかる試みはステープルの在庫要件としての寸法を縮小
させる。The staples of the present invention are compatible with the requirements of the stapled article because the staples of the present invention are manufactured with uniform cross-sections and material properties, and the surgeon can deform the staples just prior to use to create a deformation zone. For example, the surgeon may notch or bind the legs of the staple to create the zone of deformation and / or cut the legs of the staple to the desired length. Means well known in the art can be used as a device that can be used for such a purpose.
Such attempts reduce the size of staples as an inventory requirement.
図10は従来技術ステープル100を担持した装填ストリ
ップ1001を示す。この装填ストリップ1001は所望される
変形域を形成し、かつステープルの脚部102を所望長に
カットする装置（図10に図示されていない）へ設置でき
る。かかる目的に使用できる装置として当分野に周知の
手段を利用できる。装填ストリップ1001はステープル10
0を挿入する前に適宜ステプラー（図10に図示されてい
ない）へ挿入される。FIG. 10 shows a loading strip 1001 carrying prior art staples 100. This loading strip 1001 can be placed on a device (not shown in FIG. 10) that creates the desired deformation zone and cuts the staple legs 102 to the desired length. Means well known in the art can be used as a device that can be used for such purpose. Loading strip 1001 is staple 10
Prior to inserting 0, insert into stepper (not shown in Figure 10) as appropriate.
図11は本発明の他の態様を示す。この態様において、
変形域はステープルの使用前でなくステープルを挿入す
るときに形成される。図11の装置はステープル1110をそ
の間に有するステプラー顎部1102,1103を示す（ステプ
ラー顎部1103はアンビルとして機能する。） ２つのバー1101は変形域を形成するために使用され
る。このバーは下顎部1103または上顎部1102へ取付けら
れてよい。該バーを取付ける特定方法は説明の便宜から
図１に示されておらず、本発明の作用に重要でないが、
当分野に周知の手段がかかる目的のために使用できる。FIG. 11 shows another embodiment of the present invention. In this aspect,
The deformation zone is formed when the staple is inserted rather than before the staple is used. The device of FIG. 11 shows stepper jaws 1102, 1103 with staples 1110 therebetween (stepper jaw 1103 functions as an anvil.) Two bars 1101 are used to form the zone of deformation. The bar may be attached to the lower jaw 1103 or the upper jaw 1102. The particular method of mounting the bar is not shown in FIG. 1 for convenience of description and is not critical to the operation of the invention,
Means well known in the art can be used for such purpose.
顎部1102および1103が相互の方向へ向かうときに、ス
テープル1110は各バー1101と当接してそのまわりで屈曲
かつ変形する。図12から理解されるように、ステープル
の脚部1111は脚部分1106および1107が屈曲（好ましくは
直角に）するように相互に対して、変形域がステープル
挿入前に形成される態様の場合と同様に、変形する。As the jaws 1102 and 1103 move toward each other, the staples 1110 abut each bar 1101 and bend and deform thereabout. As can be seen from FIG. 12, the leg portions 1111 of the staple are as opposed to each other such that the deformation zones are formed prior to staple insertion, such that the leg portions 1106 and 1107 bend (preferably at right angles). Similarly, it is transformed.
上記アンビルはステープルの脚部が部分的または完全
にステープル留めする物を通過した後に移動されるのが
好ましい。上記ステープルが変形した後に上記バーはス
テプラーを簡単に除去できるようにその側を移動し、ま
たはステプラーは図12の平面から１方向へ摺動してステ
ープルから離脱するように設置されてよい。かかる離脱
を可能にするための手段は図示されていないが、かかる
目的のために当分野に周知の手段を使用できる。The anvil is preferably moved after the legs of the staple have partially or completely passed through the staple. After the staples are deformed, the bar may move to its side for easy removal of the stepper, or the stepper may be installed to slide out of the staple in one direction from the plane of FIG. Means for enabling such disengagement are not shown, but means known in the art can be used for such purpose.
図13は組織12へ設置できるステープル10を含む他の態
様の側断面図を示す。ステープル10の脚部26は各々第１
セクション16および第２セクション20に囲繞された上変
形域18、ならびに第３セクション22および第２セクショ
ン20に囲繞された下変形域24を含む。ステープル10はク
ラウン14を含む。FIG. 13 shows a side cross-sectional view of another embodiment including staple 10 that can be placed on tissue 12. The legs 26 of the staple 10 are each first
It includes an upper deformation zone 18 surrounded by the section 16 and the second section 20, and a lower deformation zone 24 surrounded by the third section 22 and the second section 20. The staple 10 includes a crown 14.
ステプラー（図示せず）によるステープル10の挿入時
に、脚部26の先端部23はステープル留めする組織12へ貫
通してステプラーアンビル（図示せず）に当接し、脚部
26が下変形域24で屈曲かつ変形するときに第３セクショ
ン22を上方へ回転させる。これにより第２セクション20
および第３セクション22は相互に対して角度を形成し、
例えば、相互に対して実質的垂直になる。ステプラーが
連続的にステープル10をアンビルに対して押圧すると、
脚部26は内側へ屈曲して上変形域18で変形し、それによ
り第２セクション20は第１セクションに対して回転しか
つ第１セクションに対して角度を形成する。例えば、実
質的直角になる。脚部26は、先ず、下変形域24で屈曲
し、かつ該下変形域が上変形域よりも更に屈曲する傾向
が強いものであるのが好ましい。When the stapler 10 is inserted by the stepper (not shown), the tip end portion 23 of the leg portion 26 penetrates the tissue 12 to be stapled and abuts on the stepper anvil (not shown),
The third section 22 is rotated upward as 26 bends and deforms in the lower deformation zone 24. This allows the second section 20
And the third section 22 forms an angle with each other,
For example, they are substantially perpendicular to each other. When the stepper continuously presses the staple 10 against the anvil,
The legs 26 bend inward and deform in the upper deformation zone 18, whereby the second section 20 rotates with respect to the first section and forms an angle with respect to the first section. For example, it becomes a substantially right angle. It is preferable that the leg portion 26 first bends in the lower deformation region 24, and that the lower deformation region has a stronger tendency to bend than the upper deformation region.
ステープル設置工程が終了して脚部26が変形したとき
に、第３セクション22を図13に示されたように組織12へ
侵入させる。当然ながら、組織12への侵入量は脚部26の
先端部23に対する下変形域24の位置に依存する。理想的
には、上記上変形域は、下変形域24が完全に変形した後
に殆ど接触するように、位置決めする。これはステープ
ルの脚部26間から組織が突出するのを防止する。When the staple placement process is complete and the legs 26 are deformed, the third section 22 is penetrated into the tissue 12 as shown in FIG. Of course, the amount of penetration into the tissue 12 depends on the position of the lower deformation region 24 with respect to the tip 23 of the leg 26. Ideally, the upper deformation zone is positioned so that the lower deformation zone 24 is almost in contact after complete deformation. This prevents the tissue from protruding from between the staple legs 26.
各ステープルにより占領された領域は均一に圧縮され
ることに注意されたい。このようにして、全ステープル
留め領域の各々が均一に圧縮されて複数の領域へ分割さ
れていることを観察できる。Note that the area occupied by each staple is uniformly compressed. In this way, it can be observed that each of the entire stapling areas is uniformly compressed and divided into a plurality of areas.
図14は組織12へ設置する前の本発明のステープル10を
示す。ステープル10は変形前はＵ形であり、かつ上変形
域18および下変形域24を各脚部26上に有する。変形域18
および24はステープル10の脚部26の上述セクションを減
少させることにより、またはここに記載の他の方法によ
り形成できる。FIG. 14 shows the staple 10 of the present invention prior to placement on the tissue 12. The staple 10 is U-shaped before deformation and has an upper deformation area 18 and a lower deformation area 24 on each leg 26. Deformation area 18
And 24 can be formed by reducing the above sections of legs 26 of staple 10 or by other methods described herein.
３つの異なるセクション16,20および22を各脚部26に
形成することにより、第３セクション22は組織12への僅
かな侵入を可能にする、即ち、組織の損傷量を制御して
最小限にし、それにより傷痕組織の形成量を少なくし、
かつ第２セクション20および第１セクション16は組織12
を均一に圧縮するために使用できる。By forming three different sections 16, 20 and 22 on each leg 26, the third section 22 allows a slight penetration of the tissue 12, ie controlling and minimizing the amount of tissue damage. , Thereby reducing the amount of scar tissue formation,
And the second section 20 and the first section 16 are organized 12
Can be used for uniform compression.
図15は組織38へ設置した従来技術のＢ形ステープル28
を示す。脚部32の端部34の下には組織の空所領域36があ
り、そして傷痕組織が充填されるべきこの空所領域内に
形成される。ステープル28のクラウン30からの脚部32の
分離は脚部の長手にわたって均一ではないので、脚部に
よる組織38の圧縮は均一でない。かかる理由から、止血
を行うのがしばしば困難であり、Ｂ形ステープルを使用
する場合にはステープル留めした組織の適正栄養補給が
必要である。Ｂ形ステープルの欠点として、脚部32の端
部34はステープル留めした組織へ深く侵入して脚部が変
形するときに捩れ、そのためにステープル設置時に実質
的損傷が発生して、結果的に狭窄に発展する可能性のあ
る傷痕組織が過剰に形成され、また穴の空いた血管から
出血することになる。更に、治癒期間が長引くことにな
る。FIG. 15 shows a prior art B-shaped staple 28 installed in a tissue 38.
Is shown. Below the end 34 of the leg 32 is a void region 36 of tissue, and scar tissue is formed in this void region to be filled. The separation of the leg 32 from the crown 30 of the staple 28 is not uniform over the length of the leg, so the compression of the tissue 38 by the leg is not uniform. For this reason, hemostasis is often difficult to achieve, and proper use of B-staples requires proper nutrition of the stapled tissue. A disadvantage of B-shaped staples is that the ends 34 of the legs 32 penetrate deeply into the stapled tissue and twist as the legs deform, resulting in substantial damage during staple placement, resulting in stenosis. Excessive scar tissue, which may develop into, is created and bleeding from perforated blood vessels. Furthermore, the healing period will be prolonged.
説明の目的から、図16に示されたように、ステープル
脚部26の『内側』401とステープル脚部26の『外側』402
との間は区別する必要がある。ステープルの脚部の内側
上の切欠きに関し、図16は２つのかかる切欠きを示し、
各脚部26上の１つの切欠きは上変形域18を形成するため
に使用される。下変形域は使用されても使用されなくて
もよく、使用される場合に、説明の目的から図示されて
いないが、上述の上変形域に関する説明が可変形域に適
用できる。切欠きは過度に『シャープ』でないこと、さ
もなければ脚部のセクション16および20が相互に対して
または連続的に回転するときに、ステープルは失敗、即
ち、破損または破壊する。For purposes of illustration, as shown in FIG. 16, the “inside” 401 of the staple leg 26 and the “outside” 402 of the staple leg 26 are shown.
It is necessary to distinguish between and. Regarding the notch on the inside of the leg of the staple, Figure 16 shows two such notches,
One notch on each leg 26 is used to form the upper deformation zone 18. The lower deformation zone may or may not be used, and when used, the above description of the upper deformation zone is applicable to the variable area although not shown for the purpose of explanation. The notches should not be overly "sharp", otherwise the staples will fail, i.e., break or break, when the leg sections 16 and 20 rotate relative to each other or continuously.
脚部の内側上に許容できる切欠きを形成するために、
切欠きの両側がぶつかる連接点の半径は、ステープルを
形成する材料、例えば、ステンレス鋼またはチタン等の
金属が問題の変形域で脚部の変形時に破壊、亀裂、破砕
する程に小さなものであってはならない。切欠きは所謂
応力集中に繋がる。即ち、そのセクションにおける平均
的応力よりも相当に大きい局所応力を生じる。延性ステ
ープル材の局所的屈伸性は応力集中作用を最小限にする
が、他方、外科処置に使用するステープルは患者の健康
と幸福に危険であるためにステープルの失敗が許容され
ない臨界的使用を必要とする。屈曲するときに脚部の内
側上に形成されるシャープな切欠きの連接点で発生する
応力集中によるステープルの失敗は許容できないので、
最小半径は切欠きの連接点に存在しなければならない。
最小半径（隅肉）は少なくとも2/1000インチ（約5/1000
cm）でなければならない。シャープな切欠きではなく、
脚部の内側上に少なくとも3/1000インチ（約8/1000cm）
の隅肉を有する切欠きをもったステープルを製造するこ
とが好ましい。To make an acceptable notch on the inside of the leg,
The radii of the articulating contacts on either side of the notch are small enough that the material forming the staple, for example metal such as stainless steel or titanium, will break, crack or crush during leg deformation in the deformation region of interest. must not. Notches lead to so-called stress concentration. That is, it produces a local stress that is significantly greater than the average stress in that section. Local flexibility of ductile staple material minimizes stress concentration effects, while staples used in surgical procedures require critical use where staple failure is unacceptable as it is dangerous to the health and well-being of the patient. And Failure in stapling due to stress concentration generated at the sharp notch connecting contact formed on the inside of the leg when bending is unacceptable,
The minimum radius must be at the notch contact point.
Minimum radius (fillet) is at least 2/1000 inches (about 5/1000
cm). Not a sharp cutout,
At least 3/1000 inches on the inside of the legs
It is preferred to produce staples with notches having fillets.
図17は切欠きの両側42の連接点に隅肉40を有する切欠
きの形態の脚部26内の上変形域18の拡大図を示す。Ｒは
隅肉の半径であり、かつステープル設定時に屈曲により
ステープル脚部の破壊または破砕の可能性を最小限にし
て許容できる信頼性、即ち、設置後の脚部の続く破壊を
解消するために3/1000インチ（約8/1000cm）以上であ
る。FIG. 17 shows an enlarged view of the upper deformation area 18 in the leg 26 in the form of a notch with fillets 40 at the contact points on both sides 42 of the notch. R is the radius of the fillet, and in order to eliminate the possibility of breakage or crushing of the staple leg due to bending when stapling is set to an acceptable reliability, that is, in order to eliminate the subsequent crushing of the leg after installation. More than 3/1000 inches (about 8/1000 cm).
上述の説明は本発明の好適態様に関するものである
が、種々の改良または変更が当分野の通常の熟練者に明
らかであろう。例えば、ステープルは外科用以外の他の
用途に使用できる。２本以上の脚部を有するステープ
ル、例えば、２本の外脚部間にもう１本の脚部を有する
ステープルを使用でき、この付加的脚部はいずれの変形
域をも必要としない。While the above description relates to the preferred embodiment of the present invention, various modifications or alterations will be apparent to those of ordinary skill in the art. For example, staples can be used in other applications besides surgery. Staples with more than one leg can be used, for example staples with one leg between two outer legs, the additional legs not requiring any deformation zones.
上述の開示は外科用ステープルの使用に関して説明す
るが、かかるステープルは他の用途、例えば、ステープ
ルの下に位置する物の均一圧縮が有益であり、またその
物の穿孔は有害であるような用途に使用できる。Although the above disclosure describes the use of surgical staples, such staples have other uses, such as where uniform compression of an object underlying the staple is beneficial and where perforation of the staple is detrimental. Can be used for
本開示において特定アンビルを図示したが、本発明の
ステープルに使用されるアンビルは図示されたアンビル
のいずれかを必ずしも必要とせず、所望の変形形状を形
成するために相互に対して脚部を変形させるいずれの手
段であってよく、かつ所望量の変形が生じた後にステー
プルの変形を停止させる手段を含んでよい。更に、２本
の脚部を有するステープルについて説明したが、本発明
の原理が２本以上の脚部を有するステープルに適用でき
る、例えば、更に大きい領域を各ステープルにより圧縮
することを意図するような用途に使用できることは自明
である。本発明の範囲および主旨に属するかかる改変お
よび／または追加は次の請求の範囲により保護されるべ
きである。Although particular anvils have been illustrated in this disclosure, the anvils used in the staples of the present invention do not necessarily require any of the illustrated anvils and deform the legs relative to each other to form the desired deformed shape. Means for stopping the deformation of the staples after the desired amount of deformation has occurred. Further, while staples having two legs have been described, the principles of the present invention are applicable to staples having two or more legs, such as intending to compress a larger area with each staple. It is obvious that it can be used for various purposes. Such modifications and / or additions that fall within the scope and spirit of the invention should be protected by the following claims.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/024,501US5342396A (en) | 1993-03-02 | 1993-03-02 | Staples |
| US16639293A | 1993-11-23 | 1993-11-23 | |
| US166,392 | 1993-11-23 | ||
| US08/166,392 | 1993-11-23 | ||
| US08/024,501 | 1993-11-23 | ||
| US024,501 | 1993-11-23 |
| Publication Number | Publication Date |
|---|---|
| JPH08507708A JPH08507708A (en) | 1996-08-20 |
| JP2672713B2true JP2672713B2 (en) | 1997-11-05 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP6520120AExpired - Fee RelatedJP2672713B2 (en) | 1993-03-02 | 1994-03-01 | Surgical equipment |
| Country | Link |
|---|---|
| EP (1) | EP0689400A4 (en) |
| JP (1) | JP2672713B2 (en) |
| AU (1) | AU704533B2 (en) |
| BR (1) | BR9405840A (en) |
| CA (1) | CA2155750C (en) |
| WO (1) | WO1994020030A1 (en) |
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