JP2007512102A - 流体の吸引のための携帯可能な手動ポンプ - Google Patents

流体の吸引のための携帯可能な手動ポンプ Download PDF

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JP2007512102A
JP2007512102A JP2006541538A JP2006541538A JP2007512102A JP 2007512102 A JP2007512102 A JP 2007512102A JP 2006541538 A JP2006541538 A JP 2006541538A JP 2006541538 A JP2006541538 A JP 2006541538A JP 2007512102 A JP2007512102 A JP 2007512102A
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アラム・ハサン
リー・ピーター
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ザ ヘンリー エム． ジャクソン ファウンデーション フォー ザ アドヴァンスメント オブ ミリタリー メディシン， インク．
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    • A61M39/24—Check- or non-return valves
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B24—GRINDING; POLISHING
    • B24B—MACHINES, DEVICES, OR PROCESSES FOR GRINDING OR POLISHING; DRESSING OR CONDITIONING OF ABRADING SURFACES; FEEDING OF GRINDING, POLISHING, OR LAPPING AGENTS
    • B24B5/00—Machines or devices designed for grinding surfaces of revolution on work, including those which also grind adjacent plane surfaces; Accessories therefor
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    • B24—GRINDING; POLISHING
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    • B24B5/36—Single-purpose machines or devices
    • B24B5/37—Single-purpose machines or devices for grinding rolls, e.g. barrel-shaped rolls
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B24—GRINDING; POLISHING
    • B24D—TOOLS FOR GRINDING, BUFFING OR SHARPENING
    • B24D3/00—Physical features of abrasive bodies, or sheets, e.g. abrasive surfaces of special nature; Abrasive bodies or sheets characterised by their constituents
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    • A61M1/71—Suction drainage systems
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    • A61M2205/071—General characteristics of the apparatus having air pumping means hand operated
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    • A61M2205/078—General characteristics of the apparatus having air pumping means foot operated

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Abstract

本発明は、患者の体腔から血液、血塊、体液そして空気を含む流体の有効な除去のための手動操作ポンプ（１０）を提供する。この手動操作ポンプは流体管（１２，１４）との接続に適合し、また、効率的に流体の流れを一方向に制御することができる一方向弁（１６，２０）を備えている。一方向弁が適当に配置されれば、その検出感度によって、ポンプに対する手動圧縮を必要とせずに重力だけで、流体の流れは弁（１６，２０）を通じてポンプ（１０）から出て行くことができる。

Description

本特許出願は、２００３年１１月２０日に出願した米国仮特許出願第６０／５２３，３２１号の優先権を主張し、その仮出願の全内容を本特許出願に取入れ本特許発明の一部とする。
本発明は、患者の体腔から体液を排除するポンプに関する。特に血気胸を患っている患者から体液を排除するために用いることができる手動操作ポンプに関する。
戦場において最も主要な死因となるのは穿通性胸部外傷である。穿通性胸部外傷を患った兵士は直ちに処置を施す必要があります。前線および市街地での戦闘において迅速に兵士を運搬するができないことは負傷した兵士に高いレベルの医療ケアを受けさせるための迅速な運搬を妨げる。患者の胸膜腔から血液および空気を吸引するための従来使用されている機器は、たとえば、Pleur-Evac(R)（ファイザー社のDeknatel Division製）のような陰圧水封デバイスに接続している大量静注用胸腔ドレーンである。このような現在使用可能な排液システムは扱いにくく、かさばるうえ負傷兵の輸送過程において操作しにくい問題がある。さらに、野外環境において従来の排液システムにとって継続的な吸引はほとんど不可能である。貫通性外傷が気胸を引き起こすことは経験から常識とされている。兵士が防護具を身に着けたためこのようなケースは幸いにして減少してきた。しかしながら、このような胸の外傷の緊急措置は依然として大きな医療難問として残っている。ハイムリック（Heimlich）弁のような一方向弁が軽い気胸に用いられ、効率的であるとされるが、その大きな欠点は、重力もしくは胸郭内の気圧の増強によって排液するようにデザインされていることと、傷ついた肺の再膨張および血液または血塊の吸出しを促す吸引をさせることができないことにある。
Pope, A; French, G.; Longnecker, D. eds.; Fluid Resusciation: State of the Science for Treating Combat Casualties and Civilian Injuries., Washington, DC, National Academy Press: 1999:9-16. Groves, J;, Operations in Urban Envirnoments, Mil. Rev. 1998: July-August 31-40. Milton, TR.; Urban Operations: Future War, Mil. Rev. 1994: February 37-46. Mabry, RL; Holcomb, JB; Baker, AM; et al. United Army Rangers in Somalia: An Analysis of Combat Casualties on an Urban Battlefield, J. Trauma, 2000; 49: 515-529. Bellamy, RF; The Cause of Death in Conventinal Land Warfare: Implications for Combat Casualty Care Research, Mil. Med. 1984; 55-62. Bilski, T; Baker, B; Grove, JR; Battlefield Casualties Treated at Camp Rhino, Afghanistan: Lessons Learned, J. Trauma, 2003; 54: 841-821. Heimlich, HJ; Valve Drainage of the Pleural Cavity. Dis. Chest. 1968; 53:282-287. Campisi, P; Voitk, AJ; Outpatient Treatment of Spontaneous Pneumothorax in a Community Hospital Using a Heimlich Flutter valve; A Case Series, J. Emerg. Med. 1997: 15:115-119. Lodi, R; Stefani. A; A New Portable Chest Drainage Device, Ann. Thorac. Surg., 2000; 69:998-1001. Schweitzer, EF; Hauer, JM; Swan. KG; et al., Use of Heimlich Valve in Compact Autotransfusion Device. J. Trauma. 1987;27: 537-542.
したがって、連続吸引を行うことができないもしくは簡単にできない緊急または野外環境において、患者から体液の除去に有効な吸引、特に外傷による血気胸の有効な治療を促進するための手動操作ポンプに対する需要がある。
本発明は、緊急事態下患者から体液をより早く、より簡単に取り除くことができる手動操作ポンプを提供する。
また、本発明は、血気胸患者に対する処置において体液を有効に取り除くことができる手動操作ポンプを提供する。
また、本発明は、手動駆動によって断続的に体腔から血液、血塊、体液そして空気を効果的に取り除くことができる効果的なポンプデバイスを提供する。
また、本発明は、患者から体液の除去を促進するために吸込み導管と排水導管とに取り付けることができる手動操作ポンプを提供する。
また、本発明は、患者の体腔から血塊および体液またはその両者を有効的に取り除くため、標準胸膜チューブ、気管内チューブおよび体内に留置されているカテーテルのような管の幅に取り付けて使うことができる手動操作ポンプを提供する。
また、本発明は、ポンプが手動的に稼動されるとき、体液の移動を一方向にのみに限定して流せる一方向弁を有する手動操作ポンプを提供する。
また、本発明は、手動操作が操作者の手や足または体の一部のいずれかとコンタクトすることによって達成される、患者の体腔から体液の除去のための手動操作ポンプを提供する。
また、本発明は、自己輸血デバイスに選択的に接続することができるように作られた手動操作ポンプを提供する。
また、本発明は、手動による操作することなく重力のみで体液の移動を一方向にのみに流せることができる機能をもつ一方向弁を有する手動操作ポンプを提供する。
また、本発明は、ウォールサクション（wall suction）、頑丈なコンテナー、水封デバイスもしくは電気の補助を必要とせず、体腔から血液、血塊、体液そして空気を効果的に取り除くことができる手動操作ポンプを提供する。
また、本発明は、体腔から血液、血塊、体液そして空気を効果的に取り除くことができる、連続した複数のポンプに接続することができる手動操作ポンプシステムを提供する。
また、本発明は、５ｍｍから１００ｍｍＨｇの範囲内の陰圧を起こす、体腔から血液、血塊、体液そして空気を効果的に取り除くことができる手動操作ポンプを提供する。
現在使用されている手動吸引デバイスは緊急事態における患者のケアと初期処置とに使用することができない。外傷性血気胸のために重傷状態もしくは危篤状態にある、戦闘での負傷者に対する緊急措置を施すためにある有用なデバイスが待たれる。のど、気道もしくは胸から血液もしくは空気を吸引することができる手動操作ポンプは胸に傷を患った負傷者の処置に最も有益である。本発明のポンプデバイスは、たとえば、気管内チューブ（気道内に設置されたチューブ）の場所が正しいか否かをチェックし、鼻、口および気道からの分泌物を吸引し、もしくは手術の間に体腔に挿入されている多くの排液管から体液を吸い出すような他の医療処置に適用することもできる。ポンプは、消毒して繰り返して再利用されるように、もしくは、コストパフォーマンスの観点から使い捨てできるように製造およびデザインされることができる。
現在、電気もしくはバッテリーによる操作の吸引デバイスは使用されているが、軍隊が常に危険な状況にいるため、特に患者の輸送する際に電気やバッテリーに頼らない吸引デバイスを有することは大きなメリットである。一方向弁および排液管のような水封式を採用している従来のデバイスは、吸引装置に接続されて受動的に吸引するしかできない。市販の電気吸引デバイスの取り扱いは煩雑で、戦闘現場もしくは輸送途中には適さない。さらに、電源の供給が中断された場合にこのようなデバイスは突然に使えなくなることになる。別の一方向弁（デバイス）もあるが、それは重力もしくは胸部内の圧力を増強させることによって好ましくない空気や体液を押し出す仕組みになっている。本発明は、胸部の外傷もしくは他の外傷によって、命を救うために手動操作ポンプが必要とされる危篤状態に陥る患者の体腔から大量な体液（たとえば、血液、水、粘液、血塊、空気等）を吸引することができる手動操作吸引デバイスを提供する。
患者の体腔から体液の除去のために現在提供される標準のケアおよび従来のデバイスと異なって、本発明は、扱いにくくかさばる、電気ウォールサクションもしくはバッテリーによる作動する吸引機と異なる。これは小さく簡単に作られていて、極端な状況、緊急事態もしくは戦闘状態下において容易に運搬することができる。さらに、従来の使用されているハイムリック弁と異なり、体液の除去を重力もしくは胸部内部の気圧を増大させることに頼らず、血液もしくは血塊の吸出しを促進するような吸引をすることなく、本発明は非常に効率的に患者の体腔から体液、血塊、および空気を除去することができる。
図１に示されているように、小さく、携帯しやすく簡単に使用することができる本発明の手動ポンプ（１０）に、実質上、流入管（１２）もしくは流出管（１４）のいずれかとして使用可能な流体管が取り付けられることは可能である。ここで重要なのは、流入管（１２）と直接に接続する部分において、本発明のポンプには、体液、血塊および空気を流入管（１２）からポンプ内（１８）へと流せるとともにその流れを流入管（１２）に逆流させることを制限する一方向流入弁（１６）が設けられている。同様に、流出管（１４）と直接的に接続している部分において、本発明のポンプには、体液、血塊および空気をポンプ内（１６）から流出管（１４）へと流せる一方向流出弁（２０）が設けられている。この一方向流出弁（２０）は同様に流出管からポンプ内（１８）への逆流を制限する。本発明に用いられる一方向弁は、一方向弁として知られ従来から用いられたどんなものでもよく、また、必要があればこのポンプデバイスが重力のみによって液体の流れをデバイスに通過させるように配置することができるものから選択されることができる。
ポンプ（１０）は、繰り返した手動圧縮に耐えられる十分強く、ポンプの本体（２２）を圧縮するに当りオペレーターが操作しやすくなるような十分柔らかく、長期的かつ反復使用に耐久性を有し、使用の間どんな漏れとも防げる流体密封性を有する、材料で作られる。ポンプの本体（２２）の円筒型空気袋に使われる材料として、天然、合成もしくはブレンドされた、手動操作ポンプの操作要求に適した材料であればよい。ポンプの製造に用いられる材料は、消毒して反復使用に耐えられるものでもよく、もしくはコスト効果を考慮して使い捨てのものでもよい。
本発明の手動操作ポンプは、特に救急治療の開業医または軍隊の医者もしくは衛生兵にとって直ちに使える、周知されかつ通常使用されている胸腔ドレーン、気管内もしくはカテーテルとよく合い、それらの管との接続に非常に適合する。このシンプルなデザイン、携帯に適した軽さおよび多くの流体管との接続が必要とされる場合の適合性は、厳しい環境下の運搬に大きな利アドバンテージを提供している。
緊急事態下の軍における医療のニーズへの上述した利点に加え、本発明がウォールサクション、硬いコンテナー、水もしくは電気を必要としないという更なる運搬上利点を有することから、本発明のデバイスは、民間の地上救急車もしくは吸引を必要とする緊急輸送用医療ヘリコプターのような民生用にも非常に有用なデバイスである。さらに、本デバイスは、もし必要があれば自己輸血ユニットに接続することができる流出管に適合させることができる。さらに、本発明のデバイスは、手動操作ポンプが必要とされるどんな環境下でも適用することができる。
本発明のデバイスの実施例は、２本透明なビニルチューブ（長さ４インチ、内径が０．５インチ）をアダプターもしくは２つの一方向弁で円筒型ゴム製空気袋（１．５インチ×３インチ）と接続することで準備される。空気袋を圧縮するときに、ゴム製空気袋の両側にそれぞれ取り付けられる一方向弁は流れを一つの方向にのみ移動させることを確実にする（図１を参照）。その流入ビニルチューブは胸膜吸引チューブに取り付けられるのに対しその流出チューブは吸引した血液の量を測るために集積袋に取り付けられる。
本発明の技術思想をテストするために豚の穿通性胸部外傷モデルが用意された。このテストの目的は、本発明の手動操作ポンプの操作有効性と従来のデバイスおよび一般とされた重い血気胸を吸引するときの標準ケアと比べることである。本発明のポンプは胸腔内出血している豚の穿通性胸部外傷モデルでテストされた。表１は、テストグループ１、２および３から得たテストデータを示した。テストグループ１は、従来の標準ケアモデルによるデータであった。テストグループ２は、従来用いられる胸部チューブに接続した本発明の手動操作ポンプによるデータであった。テストグループ３は、本発明の手動操作ハンドポンプが上記従来から用いられた胸部チューブとの接続よりむしろ気管内チューブとの接続に適応性があることを示すようにデザインされている。表１のデータから、本発明の手動操作ポンプから得たすべてのデータより、従来の標準ケアに比べより優れたことと、また従来胸部チューブもしくは気管内チューブのいずれかに接続した場合でもより効果的であることと、が見受けられた。
Figure 2007512102
この比較実験の結果は要約され、図２で示された。さらに、本発明のデバイスが最大限毎分１リットル水をポンプすることができることが発見された。そのポンプの吸引量が気管内に生じた陰圧に影響を与える。
とりわけ、一つのポンプは１２ｍｍＨｇの陰圧を生じさせるが複数の連続するポンプなら最大で−８０−９０ｍｍＨｇの圧力を生じさせることができる。
本発明のポンプは、ポンプ本体（２２）をいずれかの手動方法で圧縮することで、手動操作されることができる。たとえば、片手のみでの圧縮による操作することができるような大きさに作られる本発明のポンプは上記本発明の技術的思想に属する。オペレーターの両手による操作することができるようなわずかに大きめに作られる本発明のポンプも本発明の技術的思想に属する。足もしくはペダル動作で圧縮させることができ、またはすべり防止のために織目の写った表面を有する大きさ、形に作られる本発明のポンプも本発明の技術的思想に属する。オペレーターの体のいずれかの部分が本発明のポンプの本体（２２）を圧縮することができることも本発明の技術的思想に属する。さらに、流入管および流出管として使用されるいずれかの形、構造、材料、もしくはサイズの管は本発明で用いられることができる。
本発明の手動操作ポンプの適合性が、重力のみによる体液を一方向弁そしてポンプの順に通して輸送させるようなこのデバイスの設置を可能にした。よって、選択的に自己輸血デバイスと連結することができるように作られるこの手動操作ポンプが本発明の技術範囲内である。さらに、本発明のポンプは、チューブがきっちりと気管の正しい位置に設置されていることをチェックし、そのポンプに吸い出す用ハンドルを取り付けて、口から分泌物を吸い出すためことと、外科手術に用いられる排水管、カテーテル、もしくは他の管から液体を吸い出すこととが可能である。
図１は、本発明の手動操作ポンプの基本態様の平面図である。 図２は、標準胸膜チューブを用いた場合と、気管内チューブを用いた場合とで本発明の手動操作ポンプの使用から得た操作結果に比べ、血気胸処置のため標準ケアとして用いた従来のデバイスの比較例の結果を示した。

Claims (16)

  1. 第一末端と第二末端とその両末端の間に配置する圧縮可能なセンター部分とを有する流体密封ポンプ本体と、
    流入管につなぐことができる、その第一末端に取り付けられる流入コネクタと、
    流出管につなぐことができる、その第二末端に取り付けられる流出コネクタと、
    体液の流れをその流入管からその流入コネクタを通してそのポンプ本体へと許可する一方、そのポンプ本体からその流入コネクタにそしてその流入管へと逆流することを防ぐことができる、その流入コネクタとそのポンプ本体との間に設置される一方向流入弁と、
    体液の流れをそのポンプ本体からその流出コネクタ及びその流出管へと許可する一方、その流出コネクタ及びその流出管からそのポンプ本体へと逆流することを防ぐことができる、その流出コネクタとそのポンプ本体との間に設置される一方向流出弁と、
    からなる患者の体腔から体液の排出のための手動操作ポンプ。
  2. 上記流入管が標準胸部チューブ、気管内チューブおよびカテーテルからなるグループから選ばれることを特徴とする請求項１の手動操作ポンプ。
  3. 上記流入管が標準の胸部チューブであることを特徴とする請求項２に記載の手動操作ポンプ。
  4. 上記流入管が気管内チューブであることを特徴とする請求項２に記載の手動操作ポンプ。
  5. 上記流入管がカテーテルであることを特徴とする請求項２に記載の手動操作ポンプ。
  6. 圧縮可能な上記センター部分が、一人のオペレーターの片手による操作で効果的にポンプを圧縮することができる大きさに作られることを特徴とする請求項１に記載の手動操作ポンプ。
  7. 圧縮可能な上記センター部分が、一人以上のオペレーターの両手による操作で効果的にポンプを圧縮することができる大きさに作られることを特徴とする請求項１に記載の手動操作ポンプ。
  8. 圧縮可能な上記センター部分が、一人のオペレーターの足でそのセンター部分を圧迫する操作で効果的にポンプを圧縮することができる大きさに作られることを特徴とする請求項１に記載の手動操作ポンプ。
  9. 圧縮可能な上記センター部分の上記表面の少なくとも一部が、織目の写った表面であることを特徴とする請求項１に記載の手動操作ポンプ。
  10. 上記ポンプが血気胸患者の体腔から効果的に体液、血塊そして空気を除去することを特徴とする請求項１に記載の手動操作ポンプ。
  11. 上記ポンプが自己輸血デバイスに接続することができるように適合していることを特徴とする請求項１に記載の手動操作ポンプ。
  12. 上記ポンプが重力のみによって体液を流すように設置されるとき、上記一方向流入弁および上記一方向流出弁が、その体液を効果的にその流入弁および流出弁を通過させることを特徴とする請求項１に記載の手動操作ポンプ。
  13. 上記ポンプが、手動のみによって効果的に患者の体腔から体液を除去することを特徴とする請求項１に記載の手動操作ポンプ。
  14. 上記ポンプが、一組として提供する手動操作ポンプシステムの最初のポンプとして、少なくとも１つ追加可能な手動操作ポンプへの接続に適合していることを特徴とする請求項１に記載の手動操作ポンプ。
  15. 上記ポンプが５ｍｍから１００ｍｍのＨｇの範囲内の陰圧を起こすとき、そのポンプが血液、血塊、体液そして空気を効率的に除去することを特徴とする請求項１に記載の手動操作ポンプ。
  16. 請求項１に記載の手動操作ポンプを提供するステップと、
    体液を除去する対象となる患者の体内に上記流出管の末端部を挿入するステップと、
    体内から液体を除去するために手動でそのポンプ本体のその圧縮可能なセンター部分を断続的に圧縮するステップと、
    からなら患者の体腔から体液を除去する方法。
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US9393353B2 (en) 2016-07-19
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US9907887B2 (en) 2018-03-06
US8636721B2 (en) 2014-01-28
US20080091174A1 (en) 2008-04-17
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IL175132A0 (en) 2006-09-05
US20140182594A1 (en) 2014-07-03
CA2546434A1 (en) 2005-06-09
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US10213532B2 (en) 2019-02-26
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US20180256789A1 (en) 2018-09-13
US20160317724A1 (en) 2016-11-03

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