JP3859085B2 - ポータブル傷治療装置 - Google Patents
ポータブル傷治療装置 Download PDFInfo
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- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
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- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
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- A61M2205/00—General characteristics of the apparatus
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- A61M2205/00—General characteristics of the apparatus
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- A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
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- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S604/00—Surgery
- Y10S604/902—Suction wands
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- Surgical Instruments (AREA)
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Description
特許協力条約出願第GB95/01983号(第WO96/05873号)は、傷に進入する流体を透過できる多孔質パッドと、傷をカバーし、傷の周りを気密シールする包帯と、傷から流体を吸引するよう傷に負圧を加えるようパッドを吸引ポンプに接続する排液チューブと、傷から吸引された流体を収集するためのキャニスタとを備えた、傷の治療を促進するための装置を開示している。上記出願に記載された装置は臨床上効果的であるが、使用上、いくつかの限界があることが証明されている。
上記特許協力条約出願に記載の装置は、広範な異なるタイプおよびサイズの傷を治療するのに有効である。しかしながら患者は長時間にわたってこの装置で治療を受けなければならないことがある。患者がベッドに拘束されている場合には、このことは大きな問題とならないが、患者が移動できる場合、治療を行っている間、長時間、拘束されることとなる。
従って、本発明の課題は、特に適当に移動できる患者にとってより便利に使用でき、次の説明から明らかとなるような所定の別の利点を有する装置を提供することにある。
本発明によれば、傷内に導入する液透過性多孔質パッドと、傷を覆い、傷の周りを実質的に気密シールする包帯と、傷に吸引力を加えて傷から液を吸引する吸引ポンプ及び吸引液を捕集するキャニスタを内蔵したポータブルハウジングと、前記パッドを前記ポータブルハウジング内の前記キャニスタを介して前記ポンプに接続する吸引排液チューブと、前記キャニスタ内の出口側に配設されたフィルタバリアとを備えた哺乳動物の傷の治癒を促進するための治療装置に於いて、前記装置は、傷部位における圧力をモニターできるように前記多孔質パッドを圧力検出手段に接続する別の導管を備えていることを特徴とする治療装置が提供される。
前記治療装置のポータブルハウジングは、該ハウジングを前記哺乳動物に支持させるハーネス又はベルトを備えていることが好ましい。
一般に、装置の着用をより快適にするよう、ハウジングは患者の身体に支持されるようになっている側面が湾曲した表面を有する。更に、制御装置および傷に加えられる治療の状態を表示する表示器は、ハウジングの上面に設けられ、よって患者が、例えば加えられている吸引圧のレベルおよびかかる治療のプログラムを容易に見ることができるようになっていることが好ましい。
吸引ポンプは電動モータで駆動することが好ましく、かかるモータのための電池をハウジング内に収容できる。しかしながら一般的には、電池用の別個のハウジングを設けることがより好ましい。その理由は、これら電池はハウジングの重量をバランスさせるようにベルトまたはハーネス上に、ポンプおよびキャニスタ用のハウジングと同じような形状のハウジング内に入れるのが好ましいからである。キャニスタが満杯となったとき、これを容易に取り外し、交換できるよう、例えばラッチまたは同様な解放機構により、キャニスタをハウジング内に取り外し自在に取り付けなければならない。
(患者が容易に持ち運びできない上記特許協力条約出願に記載されたタイプの固定式装置と対照的に)ポータブル治療装置では治療中の傷部位に広がる圧力を測定することはあまり容易ではない。この理由は、圧力は治療中の傷とポンプとの間の静水圧の高さに一部が依存しており、この高さは患者の移動に応じて治療中に変わり得るからである。本発明に係る装置は、傷部位またはその近くの領域を、ハウジング内に設けられた圧力検出手段に接続するような別の導管を設けることによって、この問題を解消している。この圧力検出手段は患者が運動するのにかかわらず、かかる圧力を所定の範囲内に維持するようプログラムされたマイクロプロセッサにリンクできる。このような操作は、例えばポンプと傷部位との間の静水圧が増した場合にポンプの速度を高めるか、または逆に静水圧が低下した場合にポンプの速度を下げるようポンプに信号を送ることによって行うことができる。このような特徴は、上記特許協力条約出願に記載されたタイプの固定式治療装置でも利用できる。
上記特許協力条約出願に記載された装置では、キャニスタ内の液面レベルは静電容量測定によってモニタされている。キャニスタが満杯状態となったことを測定する、より簡単な方法は、キャニスタ内の圧力低下を測定または検出する方法であることが判っている。この圧力低下はキャニスタの出口端部の領域にフィルタバリアを設けることによって大きくすることができる。従って、キャニスタ内の液面高さがフィルタを実質的に詰まらせるような高さに達すると、導管内のキャニスタとポンプとの間で急激な圧力変化が生じる。キャニスタが満杯状態となった点は、この圧力変化をモニタすることによって正確に測定できる。
次の説明および添付図面から本発明の別の利点および特徴が明らかとなろう。
図1は、本発明に係わる装置の略図であり、
図2Aおよび2Bは、ポンプおよびキャニスタのハウジングの図であり、
図3Aおよび3Bは、ベルトおよびハーネスに支持された装置のそれぞれの図であり、
図4は、内容を示すハウジングの分解図であり、
図5A〜5Fは、好ましい形態のキャニスタおよび複数穴を有するチューブの断面の種々の図を示し、
図6A〜6Dは、ハウジングを包帯に接続するための発泡体包帯コネクタの種々の図を示し、
図6Eは、変形された複数穴を有するチューブの断面を示し、
図7Aおよび7Bは、本装置と共に使用するための外科用ドレープの平面図および斜視図を示す。
添付図面を参照すると本ポータブル治療装置は丸みがつけられたコーナーおよび着用者の身体に快適に取り付けできるように凹状に湾曲された側面211を有するハウジング210(図2Aおよび2Bに最良に示されている)を含む。表面が湾曲したハウジングの形状の設計は、ユーザーまたはユーザーの介護者を突くような鋭いコーナーまたはエッジをなくしている。上部表面212はほぼ平らであり、LCD(液晶)スクリーン213を有し、このスクリーンに詳細な情報、例えば加えられた圧力をディスプレイすることができる。圧力および治療間隔を調節するための制御ボタン214が設けられており、ハウジング内にキャニスタを収容するための手段も設けられており、キャニスタを取り外したり、挿入したりするためのスナップ解放カバー215が配置されている。
図3Aおよび3Bは、患者の身体にハウジング210を支持する方法を略図で示している。図3Aではベルト216にハウジング210が支持されており、そのハウジングの重量は充電可能な電池パックを含む同じように丸みのつけられたケーシング217によってバランスがとられている。図3Bは、ハーネス218にハウジングが支持され、ハウジング219内に電池パックが内蔵され、このハウジング219もハーネスによって支持されている別の構造を示す。
図4は、ハウジング内の主要部品を示すハウジング210の分解図を示し、ハウジングはベルトまたはハーネスに取り付けるための外側ベルトクリップ21を有する前方シェル成形品1と、後方シェル成形品2から成る。
ハウジングシェル1内には電動モータ6Aと連動する吸引ポンプ6が設けられており、このポンプはシリコンゴムチューブ103によってキャニスタ100のためのコンパートメント20内のキャニスタ差込口7Aに接続されている。チューブ10を介して第2キャニスタ差込口7Bには圧力レリーフバルブ8も接続されており、チューブ103および10の双方はT字形コネクタTを介して圧力トランスジューサ(図示せず)に接続されている。プリント回路基板5にはマイクロプロセッサ4が取り付けられており、膜アセンブリ3は液晶インジケータと制御ボタンとを組み込んでいる。
本装置は、特定患者に対する圧力および治療条件を記憶する手段を含むことができ、これら条件は医師により後にプリントアウトできる。これとは異なり、患者が治療を受けた状態を遠隔地のステーションから医師によって問い合わせできるように装置はモデムおよび電話ジャックを含んでもよい。
キャニスタ100はキャビティ20に押込嵌合され、その下端はカバー30内に支持されている。カバー30はフィンガー31を含み、これらフィンガー31はキャニスタを所定位置に保持するようにリップ32と解放自在に係合できる。キャニスタおよびラッチ機構は、ラッチが係合されると差込口7Aおよび7Bがキャニスタの頂部に形成された管状の突起33および34とシールされた状態で係合または当接するようになっている。
本装置の作動方法は図1の略図から理解できよう。図1ではキャニスタ100はチューブ101を介して傷の位置にある多孔質の包帯102に接続しており、ポンプ6に接続されたチューブ103によりキャニスタを介して傷の位置に吸引力が加えられ、チューブ103内の圧力はトランスジューサ105によって検出されるようになっている。
第2チューブ106は一端が傷部位102に接続され、また圧力レリーフバルブ8および第2トランスジューサ108にも接続されている。チューブ106および101を、後に説明する態様で、マルチ区画チューブ内に組み合わせることができる。チューブ106およびトランスジューサ108により傷部位における圧力を測定し、モニタすることができる。液体または固体粒子がチューブ103に進入しないようにキャニスタ100の出口端部またはその近くにフィルタ109が設けられている。このフィルタは疎水性または好ましくは疎脂肪性である無菌フィルタである。従って、フィルタの表面に水性液および油性液のビーズが形成される。通常の使用中、フィルタの両端で生じる圧力低下が大きくならないように、フィルタには充分な量の空気流が通過する。
フィルタが詰まるような高さにキャニスタ内の液体が到達するとすぐに、チューブ103内にかなり大きい負圧が生じ、この負圧はトランスジューサ105によって検出される。トランスジューサ105はかかる圧力変化をキャニスタが満杯になった状態として解釈する回路に接続されており、この回路は液晶にメッセージとしてこのことを伝え、および/またはキャニスタの交換が必要である旨のブザー音を発生するトランスジューサはポンプの作動を自動的に停止させてもよい。
傷部位に間欠的に吸引力を加えたい場合、圧力レリーフバルブ8により傷部位の圧力を迅速に大気圧にすることができる。従って、例えば、10分間隔で圧力を軽減するようなプログラムが装置に組まれている場合、バルブ8はこれら間隔で所定時間開き、圧力を傷部位の圧力に等しくし、吸引力を回復するように閉じる。傷部位に一定の吸引力(すなわち負圧)が加えられている時には、バルブ8は閉じたままであり、大気からのリークがないことが理解できよう。この状態では、トランスジューサ105によって検出される所望レベルの負圧(すなわち大気圧より低い所望の圧力)を維持するよう、ポンプを連続的に作動させず、時々作動させるだけで、傷部位の負圧を維持することが可能である。このような作動により電力を節約でき、電池からの給電により装置を長時間作動させることが可能である。傷部位に接続された2本の別個のチューブを作動する代わりに、キャニスタを通して接続された1本のチューブ内にチューブ106および101を収容することが好ましい。従って、例えばチューブ103および101は、チューブ106によって表示された環状空間によって囲まれた内側チューブを含むことができる。この状態は、図5A〜5Fおよび変形例として図6Eに示されている。
別の実施例として図6Eに示されるように、複数穴を有するチューブを構成できる。この実施例では内側ボア606はライン101(図1参照)を含み、傷部位から液体を抽出するのに使用される。(図1にライン106で表示される)空気流は、チューブの壁内に位置する導管607を下方に通過する。これら導管607をチューブを中心に90度の間隔に離間させたことにより、複数穴を有するチューブがねじれたり、結束することによる空気流の詰まりの恐れが最少にされている。
図5Eは、キャニスタの好ましい形状の頂部の平面図であり、キャビティ20内の空間に良好に嵌合できるように断面としてほぼ三角形の形状が選択されている(図4参照)。キャニスタの上部に設けられた管状突起はそれぞれ導管124および121とキャニスタの内側で接続されている(図5Bの断面図参照)ので、図1においてライン103および106によって表示された管の間の分離を維持できる。キャニスタのベースにおいて、成形品125により図5Bに示されるマルチ区画チューブ126への接続が容易となっている。チューブ126は成形品125における差込口128に嵌合するような寸法にされた中心ボア127を有する。同時に中心126の外側壁は成形品125の内側壁129をシールする。従って、区画室124は中心ボア127と接続し、区画室121はチューブ126の環状スペース130と接続する。このように導管130は図1に示すようにライン106に対応し、中心ボア127はライン101に対応する。
区画されたチューブは傷部位102までずっと連続していなくてもよいが、傷部位に近い1本のボアチューブの短い部分に接続することができる。
傷部位102において包帯内で空気のリークが生じた場合、このリークをトランスジューサ105および108により検出し、所定時間の間、不充分な負圧を表示し、リークのアラーム、例えば好ましくは可聴警告音と共に液晶にメッセージをトリガーできる。
一般に、ポンプ6はダイヤフラム式ポンプであるが、他のタイプのポンプおよびここに使用されているものと均等な部品に置き換えることも可能である。
図6A〜6Dは、傷部位において複数穴を有するチューブを取り付けるためのコネクタの種々の図を示す。図7および7Bは傷部位にて多孔質包帯にコネクタを取り付けるための外科用ドレープの平面図および斜視図をそれぞれ示す。コネクタは中心に設けられたスパウト602を有するプラスチック成形品であるディスク状のカップ601を含む。スパウト602は複数穴を有するチューブ、例えば図5Fまたは6Eに示されるようなタイプのチューブの端部を密な状態でスライド嵌合しながら受け入れるような寸法となっている。使用の際、傷の大きさに対応して多孔質包帯をカットし、上で引用した特許協力条約出願第WO96/05873号の図10に示されているように、傷に包帯を当てる。ルーメンを発泡体の包帯に挿入する代わりに、多孔質包帯にカップ601を押し付け、これを外科用ドレープで固定する。しかしながら所望する場合には、ルーメンの端部をスパウト内に挿入し、更に発泡体内に押し込むこともできる。図7Aおよび7Bに示されるような外科用ドレープを使ってコネクタ、ルーメンおよび包帯を固定できる。ドレープは片面が感圧性アクリル樹脂接着剤でコーティングされたポリウレタンフィルム701を含む。ドレープのすべての層を貫通するように孔702がカットされており、この孔はスパウト602の外側横断面にほぼ対応するような大きさとなっている。フィルム701はフィルムを傷部位の周りにて患者の皮膚に接着すると同時に、コネクタを多孔質包帯に固定できるようにする全体の大きさを有する。傷の周りに気密なキャビティが形成されるよう、傷の周りに充分な重なり部分が設けられる。
別の形態では、図7AにおけるX−Xラインに沿ってドレープをカットすることにより、ドレープを2つの部分に分けることができる。このような構造により、外科用ドレープの2つの部分は図6Dに示されるように、Y−Yラインに沿って互いに重なるように外科用ドレープの2つの部分を重ねることにより、傷をシールできる。
外科用ドレープは、例えばポリエチレン製の保護用膜703および使用前に剥離して感圧性接着層を露出させるライナー704を含むことができる。ポリエチレンフィルムは傷部位上でフィルムを容易に延ばすことができるように、接着剤でコーティングされていない取り扱いバー705、706を含むこともできる。包帯は多孔質の可撓性プラスチック発泡体、例えば特に上記特許協力条約出願WO96/05873に記載されているタイプの、網状の連続気泡可撓性ポリウレタン発泡体のパッドであることが好ましい。
これとは異なり、可撓性ポリビニルアセテートまたはポリビニルアルコール発泡体から製造した網状の連続気泡発泡体を使用することもできる。後者のポリビニルアルコール発泡体は疎水性であるので有利である。他の疎水性の連続気泡発泡体も使用できる。
別の治療法では、手術後、傷内に発泡体の包帯を縫合し、複数穴を有するカテーテルによってポンプユニットに発泡体の包帯を接続してもよい。次に、外科医が決定する時間の間、例えば約6時間から4、5日の期間、連続的、または間欠的に負圧を加えることができる。この期間の後に包帯を除き、傷を再縫合する。このような治療により、手術後の傷の肉芽形成の速度および傷の治療が改善される。
Claims (7)
- 傷内に導入する液透過性多孔質パッドと、傷を覆い、傷の周りを実質的に気密シールする包帯と、傷に吸引力を加えて傷から液を吸引する吸引ポンプ及び吸引液を捕集するキャニスタを内蔵したポータブルハウジングと、前記パッドを前記ポータブルハウジング内の前記キャニスタを介して前記ポンプに接続する吸引排液チューブと、前記キャニスタ内の出口側に配設されたフィルタバリアとを備えた哺乳動物の傷の治癒を促進するための治療装置に於いて、
前記装置は、傷部位における圧力をモニターできるように前記多孔質パッドを圧力検出手段に接続する別の導管を備えていることを特徴とする治療装置。 - 前記ポータブルハウジングを前記哺乳動物に支持させるハーネス又はベルトを更に備えた請求項1記載の治療装置。
- 前記ポータブルハウジングが前記哺乳動物の身体に支持されるようになっている側に湾曲した表面を有し、前記ハウジングの上面側に設けられた制御装置を有する請求項2記載の治療装置。
- 前記キャニスタとポンプとの間のチューブ内の圧力変化を検出し、キャニスタ内の液体がフィルタバリアのかなりの部分を覆った時に圧力変化の信号を送り、キャニスタが満杯になったことを表示するようになっている圧力検出手段を更に備えた請求項1記載の治療装置。
- フィルタバリアがキャニスタからの出口全体をカバーし、液体がフィルタバリア全体を実質的にカバーした時に、前記圧力検出手段がキャニスタをポンプに接続するチューブ内の負圧の急激な増加を示す信号を発生するよう、前記バリア内の孔の寸法が定められている請求項4記載の治療装置。
- 前記多孔質パッドを圧力検出手段に接続する別の導管に空気を導入するためのレリーフバルブと、傷部位に間欠的な吸引力を加えることができるようバルブの動作を制御するための手段を含む請求項1記載の治療装置。
- 一本のチューブが多孔質パッドとハウジングとをリンクし、前記チューブが長手方向に区分され、吸引力を加えるための導管及び前記圧力検出手段に接続するための別の導管となっている請求項6記載の治療装置。
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- 1996-11-14 AT AT96938357T patent/ATE203174T1/de active
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- 1996-11-14 DE DE19681649T patent/DE19681649T1/de not_active Withdrawn
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- 1996-11-14 WO PCT/GB1996/002802 patent/WO1997018007A1/en active IP Right Grant
- 1996-11-14 DE DE69613997T patent/DE69613997T2/de not_active Expired - Lifetime
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- 1996-11-14 ES ES01200016T patent/ES2204800T3/es not_active Expired - Lifetime
- 1996-11-14 EP EP96938357A patent/EP0865304B1/en not_active Expired - Lifetime
- 1996-11-14 GB GB9919710A patent/GB2336546B/en not_active Expired - Lifetime
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- 1998-12-16 HK HK00107892A patent/HK1029536A1/xx not_active IP Right Cessation
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2012029908A (ja) * | 2010-07-30 | 2012-02-16 | Gunze Ltd | 陰圧治療装置 |
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