JP5469731B2 - 流体圧送、熱交換、熱検知および伝導率検知用システム、器具および方法 - Google Patents
流体圧送、熱交換、熱検知および伝導率検知用システム、器具および方法 Download PDFInfo
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- JP5469731B2 JP5469731B2 JP2012246205A JP2012246205A JP5469731B2 JP 5469731 B2 JP5469731 B2 JP 5469731B2 JP 2012246205 A JP2012246205 A JP 2012246205A JP 2012246205 A JP2012246205 A JP 2012246205A JP 5469731 B2 JP5469731 B2 JP 5469731B2
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- pump
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Images
Classifications
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
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- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
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Description
2006年4月14日出願、米国特許仮出願第60/792,073号、「体外温熱治療システムおよび方法(Extracorporeal Thermal Therapy Systems and Methods)」;
2006年8月4日出願、米国特許仮出願第60/835,490号、「体外温熱治療システムおよび方法(Extracorporeal Thermal Therapy Systems and Methods)」;
2007年2月27日出願、米国特許仮出願第60/904,024号、「血液透析システムおよび方法(Hemodialysis System and Methods)」;および
2007年4月2日出願、米国特許仮出願第60/921,314号、「センサ装置(Sensor Apparatus)」。
米国特許出願、「熱交換システム、器具および方法(HEAT EXCHANGE SYSTEMS, DEVICES AND METHODS)」(代理人整理番号1062/E77);
米国特許出願、「液体圧送システム、器具および方法(LIQUID PUMPING SYSTEM, DEVICE AND METHOD)」(代理人整理番号1062/E78);および
米国特許出願、「熱および伝導率検知システム、器具および方法(THERMAL AND CONDUCTIVITY SENSING SYSTEMS, DEVICES, AND METHODS)」(代理人整理番号1062/E79)。
少なくとも1つの往復容積式ポンプであって、それぞれ
湾曲した堅固なチャンバ壁、
可撓膜および堅固なチャンバ壁が圧送チャンバを規定するように堅固なチャンバ壁に取り付けられた可撓膜、
堅固なチャンバ壁を通過して圧送チャンバへ流入する流体を、(a)堅固なチャンバ壁に対して実質的に接線方向、(b)圧送チャンバへ流入する低せん断流を供給する方向の少なくとも一方に方向づける入口、および、
堅固なチャンバ壁を通過して圧送チャンバから流出する流体を、(a)堅固なチャンバ壁に対して実質的に接線方向、(b)圧送チャンバから流出する低せん断流を供給する方向の少なくとも一方に方向づける出口を有するポンプを提供すること;
熱交換器を提供すること;ならびに
流体を熱交換器に通すために流体を源から少なくとも1つの往復容積式ポンプを用いて圧送すること
を備える、方法が提供される。
少なくとも1つの往復容積式ポンプであって、それぞれ
湾曲した堅固なチャンバ壁;
可撓膜および堅固なチャンバ壁が圧送チャンバを規定するように堅固なチャンバ壁に取り付けられた可撓膜;
堅固なチャンバ壁を通過して圧送チャンバへ流入する流体を、(a)堅固な、チャンバ壁に対して実質的に接線方向、(b)圧送チャンバへ流入する低せん断流を供給する方向の少なくとも一方に方向づける入口;および、
堅固なチャンバ壁を通過して圧送チャンバから流出する流体を、(a)堅固な、チャンバ壁に対して実質的に接線方向、(b)圧送チャンバから流出する低せん断流を供給する方向の少なくとも一方に方向づける出口を有するポンプ;ならびに
少なくとも1つのポンプと流体連通し熱交換器に受容されるようになされた熱交換器構成部品、
を備える使い捨てユニットが提供される。
使い捨てユニットの熱交換器構成部品を受容する熱交換器;
熱交換器構成部品を通して流体を圧送するために使い捨てユニットの少なくとも1つのポンプを動作させる気体圧式作動システム;および
気体圧式作動システムを制御する制御器
を備える熱交換器システムが提供される。
往復容積式ポンプを提供すること;
患者アクセス器具とポンプとの間の第1の部分を有し、ポンプと熱交換器との間の第2の部分を有する流管を提供すること;
流管の第1の部分および第2の部分それぞれに流管の一方向のみの流れを可能とする弁を提供すること;および
患者アクセス器具と熱交換器との間に血液の流れを生じさせるためにポンプを作動させること
を備える方法が提供される。
血液を加温する熱交換器;
患者アクセス器具と熱交換器との間で血液を移動する往復容積式ポンプであって、入口管と出口管を有するポンプ;
入口管内に位置し、ポンプから流出する血液の流れを防止する第1の弁;および
出口管内に位置し、ポンプへ流入する血液の流れを防止する第2の弁
を備えるシステムが提供される。
上記請求項のいずれか一項に記載のポンプを備え、
未加温血液用の入口と加温血液用の出口を有する熱交換流路;
電力を血液が吸収する熱に変換する電気熱変換器;
入口に位置し、熱交換器に流入する血液の温度を測定する第1の温度センサ;
出口に位置し、熱交換器から流出する血液の温度を測定する第2の温度センサ;
熱交換器を通過している血液の流量を測定する計測システム;および
変換器、第1および第2の温度センサおよび計測システムと連通する制御器であって、変換器によって使用されている電力量に関する情報を受信し、第1および第2の温度センサから温度情報を受信し、計測システムから流量情報を受信し、故障状態が存在するかどうか判定するために受信した情報を分析し、故障状態が検出された場合には信号を発する制御器を更に含む熱交換器が提供される。
未加温血液用の入口;
加温血液用の出口;
入口から出口への流路;
流路に重なっており、第1および第2の加温素子を少なくとも含む加温素子のセットであって、第2の加温素子が出口近くの流路近傍に位置し、第1の加温素子が第2の加温素子の上流側の地点の流路近傍に位置する加温素子のセット;
第1の加温素子の上流側の流路近傍に位置する第1の温度センサ;
第1および第2の加温素子の間の流路近傍に位置する第2の温度センサ;および
第1および第2の温度センサから温度情報を受信し、第1および第2のセンサによって測定されている温度差が限界を超えた場合に信号を発する制御器
を備える熱交換器が提供される。
未加温血液用の入口;
加温血液用の出口;
入口から出口への流路;
流路に重なっており、第1、第2および第3の加温素子を少なくとも含む加温素子のセットであって、第3の加温素子が出口近くの流路近傍に位置し、第2の加温素子が第3の加温素子に先立つ地点の流路近傍に位置し、第1の加温素子が第2の加温素子に先立つ地点の流路近傍に位置する加温素子のセット;
第1および第2の加温素子の間の流路近傍に位置する第1の温度センサ;
第2および第3の加温素子の間の流路近傍に位置する第2の温度センサ;および
第1および第2の温度センサから温度情報を受信し、第1および第2のセンサによって測定されている温度差が限界を超えた場合に信号を発する制御器
を備える熱交換器が提供される。
未加温血液用の入口;
加温血液用の出口;
電力を血液が吸収する熱に変換する電気熱変換器;
入口に位置し、熱交換器に流入する血液の温度を測定する第1の温度センサ;
出口に位置し、熱交換器から流出する血液の温度を測定する第2の温度センサ;
熱交換器を通過している血液の流量を測定する計測システム;および
変換器、第1および第2の温度センサおよび計測システムと連通する制御器であって、変換器によって使用されている電力量に関する情報を受信し、第1および第2の温度センサから温度情報を受信し、計測システムから流量情報を受信し、故障状態が存在するかどうか判定するために受信した情報を分析し、故障状態が検出された場合には信号を発する制御器
を備える熱交換器が提供される。
未加温血液用の入口;
加温血液用の出口;
電力を血液が吸収する熱に変換する電気熱変換器;
入口から出口への血液の流路を内包し、主として熱可塑性材料でできている使い捨てユニット;
流路サーモウェル内の血液と変換器との間の抵抗を測定する導電率センサ;および
導電率センサと連通し、測定された抵抗が安全パラメータを満たさない場合には信号を発する制御器
を備える熱交換器が提供される。
未加温血液用の入口、
加温血液用の出口、および
入口から出口への血液の流路
を有する使い捨てユニット;ならびに
流路内の血液を加温する加温器であって、加温器は、使い捨てユニットの第1側に熱を伝える第1の熱伝導性のプレート、および使い捨てユニットの第1のプレートと反対側の第2側に熱を伝える第2の熱伝導性のプレートを含み、第1および第2のプレートが制御器によって作動され次第使い捨て器具から血液を押し出すために互いに押し合うようになされている、加温器を有するベースユニット
を備える熱交換器が提供される。
患者の体の第1の場所に位置づけられる第1の温度プローブから温度示度を読み取ること;
患者の体の第2の場所に位置づけられる第2の温度プローブから温度示度を読み取ること;
第1および第2のプローブからの温度示度を比較すること;
第1および第2の温度プローブを患者の体に位置決めすること;
第1の場所または第2の場所からの温度示度があらかじめ設定した限界を上回っているかどうか判定すること;および
第1のプローブからの温度示度が第2のプローブからの温度示度からあらかじめ設定した範囲内にある場合であって、第1または第2の場所からの示度があらかじめ設定した限界を上回っている場合に配置信号を発することを備える方法が提供される。
患者からの血液を加温し加温血液を患者に圧送する熱交換器システムを提供すること;
患者から熱交換器システムへ第1の温度プローブを接続し、熱交換器システムが第1の温度プローブから受信した温度情報に基づいて血液の加温および圧送を制御し、第1の温度プローブから受信した温度情報をオペレータに表示すること;
オペレータによって別の第2の温度プローブを用いて患者温度を監視すること;および
温度プローブのどちらかが許容できない温度示度を伝達した場合に処置を終了することを備える方法が提供される。
「回転楕円体」とは、主軸の一方、すなわち、長軸または短軸周りに回転させた楕円に対応する三次元形状を意味し、三次元の卵形、偏球および長球、球、ならびにこれらに実質的に同等の形状を含む。
本発明の実施形態は、一般に、生体液(例えば、血液または腹水)、治療液(例えば、薬剤溶液)、または界面活性剤液などの流体を圧送するために使用されるある種の往復容積式ポンプ(以下、「ポッド」、「ポンプポッド」または「ポッドポンプ」と呼ぶことがある)に関する。ある種の実施形態は特に、流体が入口から出口へ圧送される際に流体に低せん断力および低乱流を付与するように構成されている。このような実施形態は、そうしたせん断力によって損傷を受けるおそれのある流体(例えば、血液、特に溶血しやすい加温血液)または乱流によって損傷を受けるおそれのある流体(例えば、乱流の存在下で発泡するもしくは損傷を受ける、または不安定になるおそれのある界面活性剤またはその他の流体)を圧送する際に特に有用になり得る。
図3は、本発明の例示的実施形態による往復容積式ポンプ25を示す。本実施形態において、往復容積式ポンプ25は基本的に、大型の圧送システムの一構成要素として使用し得る自己完結型ユニット(以下、「ポッド」と呼ぶことがある)である。往復容積式ポンプ25は、例えば、超音波溶着またはその他の技法によってポッド壁30のところで連結させた「上」部分(「圧送チャンバ壁」とも呼ぶ)31および「下」部分(「作動チャンバ壁」とも呼ぶ)32を含む。なお、「上」および「下」という用語は相対的なものであって、ここでは図3に示す向きに関して便宜上用いたものである。ポッドが好ましくは(必ずではないが)球状の内部空洞を有するように、部分31と32はそれぞれ、好ましくは半球状(必ずではないが)の堅固な内部表面を有する。
一般的に、上記のタイプの往復容積式ポンプは、ポンプを通る流体流を制御するための各種弁を含んでもよく、または弁と併用してもよい。従って、例えば、往復容積式ポンプは、入口弁および/または出口弁を含んでもよく、または入口弁および/または出口弁と併用してもよい。弁は、受動式でも能動式でもよい。図3に示す例示的実施形態においては、往復容積式ポンプ25は、受動一方向入口逆止弁35および受動一方向出口逆止弁36を含む。入口逆止弁35は、流体が入口34を通じて圧送チャンバに吸引されることを可能にするが、入口34での逆流を実質的に防止する。出口逆止弁36は、流体が圧送チャンバから出口37を通じて圧送されることを許容するが、出口37での逆流を実質的に防止する。
図3に示す実施形態において、入口34および出口37は、圧送チャンバ壁31の内部表面に対して実質的に接線方向の角度で流体を圧送チャンバに流入出させるように向きが決められている。従って、入口34を通って圧送チャンバに向かう流体は、圧送チャンバの容積が最大となる位置に膜が近づく際でも膜33に対して垂直になることが避けられる。この入口34および出口37の向きは、一般に圧送される流体に対して相当な応力を加える遠心ポンプと比較すると、圧送される液体に対するせん断力を減少させやすい。
図20は、本発明の代替的実施形態による、例えば大型流体制御カセットに組み入れ得る代替的なポンプポッド2025の断面図である。本実施形態において、ポンプポッドは3つの堅固な部品、すなわち、「上」プレート2091、中間プレート2092および「下」プレート2093(なお、「上」および「下」という用語は相対的なものであって、ここでは図20に示す向きに関して便宜上用いたものである)から形成されている。上プレートおよび下プレート2091、2093は両側が平坦でもよいが、中間プレート2092は各種流体路、チャンバおよびポートを規定する通路、窪みおよび穴を備えている。ポンプポッド2025を形成するため、上プレーおよび下プレート2091、2093は、一体となって半回転楕円体状チャンバを規定する概して半回転楕円体状の部分を含んでもよい。
圧送システムが流体を圧送する多数のポンプポッドを使用し得るという点にも留意すべきである。ポンプポッドは個別に使用されてもよく、この場合ポンプポッドは個別に制御されてもよい。または、例えば、共通の源から流体を吸引するために多数のポンプポッドの入口を相互接続する、流体を共通の送出先に送出するために多数のポンプポッドの出口を相互接続する、および/または共通の気体圧インターフェースを通じて多数のポンプポッドを制御するためにそれらのポンプポッドの気体圧ポートを相互接続するなど、ポンプポッドを様々な方式で相互接続してもよい。各種実施形態においては、多数のポンプポッドを、実質的に連続した流れを供給するために別位相(すなわち、1つの圧送チャンバが空のときに別の圧送チャンバが充填中となる)で動作させても、脈動する流れを供給するために同一位相で動作させても、またはその他の方式で動作させてもよい。同位相での動作のためには、ベースステーションがポンプポッドを同時に動作させられるよう、多数のポンプポッド用の単一の気体圧インターフェースを設けてもよい。同様に、ベースステーションが弁を同時に動作させられるよう、多数の弁用の単一の気体圧インターフェースを設けてもよい。
上記のタイプのポンプポッドは、異なるチャンバ構成および/または異なるストロークサイズで構成することも可能であるという点に留意すべきである。従って、例えば、ポンプ容積の異なるポンプポッドが提供され得る。更に、容積の異なるポンプポッドが、対応する標準化された気体圧ポートインターフェースを有する共通の圧送システムまたは装置(例えば、ベースユニット)へ容易に取り付けおよび取り外しできるようするために、標準化された気体圧ポート構成(そしておそらくは標準化された作動チャンバ壁構成)を備えたポンプ容積の異なるポンプポッドが提供され得る。例えば、ベースユニットは、小児用の容積の小さいポンプポッドを受容できるとともに、大人用の容積の大きいポンプポッドを受容できるようになる。気体圧ポートは、ベースユニットの気体圧式作動システムに即座にかつ容易に接続−および脱着−できるようになされていることが好ましい。ある種の実施形態においては、ポンプポッドは使い捨てであると考えられ、個別にまたは大型の使い捨てシステムの一部として提供されてもよい。
ある種の実施形態においては、ポンプポッドダイヤフラムは、特に圧送チャンバに面する側に小さな隆起したバンプ、溝、または他の構造を備えていてもよい。図46Aおよび46Bは、本発明の例示的実施形態による、隆起したバンプ39を有する例示的な膜33を示す。このような隆起したバンプ39または他の隆起した構造は、具体的には、圧送チャンバ容積が最大時でも、膜を堅固な圧送チャンバ壁から離しておくことによって、流体の塊が入口および出口から離れたところに滞るのを防ぐ。このように空間を開けることが、血液が圧送チャンバの周辺部から出口へと流れるための流れの通り道を開状態に保つ。図46Aおよび46Bに示す例示的実施形態では、膜の端縁に近い領域にはバンプが存在しないように、バンプ39は、膜の端縁から離れた部分に位置している。一般的に、こうした構成は、膜の端縁に近い部分が圧送チャンバ壁に接触することを可能にし、これが流体を端縁から出口に向かって押し流しやすくする。
2.1. 圧力作動システム
図4は、図3に示すポンプポッド25などのポンプポッドを作動させるのに使用し得る、本発明の例示的実施形態による圧力作動システム40の実施形態を示す概略図である。圧力作動システム40は、ポンプポッド25の作動チャンバ42内の気体に対して正および負の加圧状態を間欠的にまたは交互に供給することができる。ポンプポッド25−可撓膜33、入口34、出口37、気体圧ポート38、圧送チャンバ41、作動チャンバ42、ならびに、場合によっては入口逆止弁35および出口逆止弁36または他の弁を含む−は、大型の使い捨てシステムの一部であってもよい。気体圧式作動システム40−作動チャンバ圧力トランスデューサ44、正供給弁47、負供給弁48、正圧気体貯留器51、負圧気体貯留器52、正圧貯留器圧力トランスデューサ45、負圧貯留器圧力トランスデューサ46と共にユーザインターフェースコンソール(例えば、タッチパネル画面)を含む電子制御器49を含む−は、ベースユニットの一部であってもよい。
上で論じたように、ポンプポッド入口および出口には受動逆止弁に代えて能動弁を用いてもよい。能動弁は、より高度な制御を可能にし、自由度を高めることができる(一般に複雑さおよびコストの増加を代償とするが)。中でも、能動弁は、流体流の逆転を可能にする。これは、例えば、プライミング、空気パージ、および/またはある種の状態(例えば、閉塞、閉鎖、漏れ、管のはずれ)の検出および緩和を容易にするのに用いることも可能である。管のはずれに関していえば、もし出口管がはずれた場合、流れを逆転させると空気が出口を通じて圧送チャンバに吸い込まれ得る。このような空気の流れは、ダイヤフラムを動かすのに必要な仕事量を検出する技術を含む、様々な技術のいずれかを用いて検出することが可能である。管が安全に接続されている場合、流れを逆転させて出口を通じて流体を引き込むには通常はいくらかの仕事量が必要であるが、戻り管がはずれている場合は、ポンプが空気を戻り管に引き込んでいるため流れを逆転させるのに必要な仕事はもっとずっと小さくなる。流れを逆転させてすぐに制御器が異常な流れの状態を検出した場合は、制御器はシステムに患者からの血液の圧送を停止させることが好ましい。
正常なポンプ動作中、制御器49は通常作動チャンバ圧力トランスデューサ44からの圧力情報を監視し、この情報に基づいて、最小圧送チャンバ容積位置にまで膜33を付勢し、その位置に到達した後は膜33を最大圧送チャンバ容積位置にまで引き戻すために動弁機構(弁47、48)を制御する。本実施形態においては、体積は、完全な流体送出ストロークの回数を数えることによって測定してもよい(例えば、体積=完全なストローク回数×圧送チャンバ容積)。
Kfluidpath×mpod=∫stroke(Ppod−Pheight_diff)dt
ここで、
Kfluidpathは流体路内の抵抗、
mpodはポッドに内包される流体の質量、
Ppodはポンプポッド内の圧力
Pheight_diffはポッドと患者の間の揚程に起因する圧力
Ppod=Kfluidpathm’+Pheight_diff
ここで、m’は質量流量。
一般的に、単一のポンプポッドは脈動的に動作する。まず、流体を吸引し、次いで流体を圧送する。脈動的な動作は、ある種の用途には必要、望ましい、または特有であるかもしれない(例えば、1本の針を通じて患者から血液を抜き出し患者に戻す体外血液処置は、1本の針を通じて同時に血液を患者から抜き出し圧送して患者に戻すことは一般に不可能なので、本質的に脈動的である)。
上記のように、図4の気体圧式作動システム40における正供給弁47および負供給弁48は、2値のオンオフ弁ではなく可変絞り弁でもよい。可変弁を使用することにより、全貯留器圧力を膜にかける代わりに、作動チャンバ42および膜33に加えられる圧力を貯留器51、52内の圧力の一部にするように容易に制御することができる。これにより、ポンプ容積、ポンプストロークサイズまたはポンプ作動圧力などの運転パラメータが異なるポンプポッドに同じ貯留器または一組の貯留器を使用することが容易になる。当然、貯留器圧力は一般に各種ポンプポッドの膜に加えることが求められる圧力よりも高いことが必要だが、1つのポンプポッドは例えば貯留器圧力の半分の圧力で作動させられるかもしれないし、別のポンプポッドは同じ貯留器を用いて例えば貯留器圧力の4分の1の圧力で作動させられるかもしれない。従って、異なるポンプポッドがそれぞれ異なる圧力で動作するように設計されていても、可変弁を用いることで、これらのポンプ全てで同じ貯留器または一組の貯留器を共有しても、異なる圧力で作動させ得る。圧送中に生じるまたは変化する条件に対応するために、ポンプポッドで用いる圧力を変化させてもよい。例えば、チューブがねじれてシステムのチューブを通る流れが減少した場合に、この増加した制約を相殺するためにポンプポッドに用いている正圧または負圧の一方または両方を増加させてもよい。
上記のタイプの往復容積式ポンプおよびこれに関連する制御システムは、種々様々な流体圧送用途に使用し得る。特に、人工または体外血液圧送を伴う用途での使用に(これに限らないが)非常に適している。例えば、数例を挙げると、血液加温または冷却処置、血液透析ならびに他の血液処理およびろ過処置(例えば、プラズマフェレーシスおよびアフェレーシス)、心臓バイパスおよび他の血液補助循環処置(例えば、心室補助)、心筋保護(心臓バイパスその他の一部としての)、肺バイパスまたは人工肺および他の体外血液酸素供給を伴う用途、ならびに化学療法および他の薬剤処置(例えば、局所的温熱化学療法)などである。例えば、ある種の実施形態においては、上記のタイプの往復容積式ポンプおよびそれに関連する制御システムは、血液などの流体を加温または冷却するための熱交換器システムに使用し得る。例示的な熱交換器システムを以下に説明する。
本発明の実施形態は、一般に血液などの流体を加温または冷却するのに使用可能な熱交換器システムに関する。血液加温システムは、特に全身加温処置(例えば、体温を上げて低体温症に対抗する、またはC型肝炎ならびに場合によっては一部のタイプのがん、HIV/エイズ、慢性関節リウマチおよび乾癬などのある種の疾病に対抗するための)、または局所的温熱化学療法処置に有用となり得る。例示的な熱交換器システムを、まず全身加温処置の一部として血液を圧送・加温する場合について説明し、次に局所的温熱化学療法処置に関して説明する。なお、当然ながら、このような熱交換器システムは、流体を加温および/または冷却する他の用途にも使用し得る。加えて、以下に説明する例示的な熱交換器システムは上記のタイプのポンプポッドを組み入れているが、実施形態はポンプポッドの使用に限られない。各種代替的実施形態では、他のタイプのポンプを使用してもよい。
先に論じたように、血液加温システムは、全身加温処置(例えば、体温を上げて低体温症に対抗する、または感染肝臓細胞からウイルスを除去できるレベルに核心体温を上げることでC型肝炎に対抗するための)に使用し得る。一般的に、C型肝炎用の全身加温処置は、核心体温を長時間摂氏約41.6度(華氏107度)に上げる必要がある。典型的な処置は、30〜60分の昇温期間、80〜120分の持続期間および30〜45分の冷却期間を含めて3〜4時間かかることがある。核心体温、従って熱交換器システムによって発生させる流体温度は、患者をほぼ一定の目標核心温度に保つために注意深く制御しなければならない。核心温度が低すぎると処置の効果が得られず、核心温度が高くなりすぎると患者に悪影響を与えかねない。
図1は、本発明の例示的実施形態による熱交換器システム10を示す。熱交換器システム10は、ベースユニット11、および使い捨てユニット16を含む。更に以下で説明するように、使い捨てユニット16は、使い捨てユニット16の熱交換器バッグ(例えば、図2および48に示すような熱交換器バッグ21)がベースユニット11の熱交換器部分に入るようにベースユニット11内に装着される。患者からの血液が使い捨てユニット16、具体的には熱交換器バッグ21を循環すると、血液は熱交換器によって加温され、患者に戻される。このような循環中、血液はずっと使い捨てユニット16内にあって、一般にはベースユニット11の構成部品には接触することはない。使い捨てユニット16は、一般に患者の処置後は廃棄されるという点で「使い捨て」であると考えられ、一方、ベースユニット11は新しい使い捨てユニット16を装着するだけで繰り返し再利用できる。実際には、ベースユニット11は使い捨てユニットの再利用を防ぐ機構(例えば、バーコード、RFID(Radio Frequency Identification:無線周波数認証)タグ、または使い捨てユニットと関連付けた他の識別具を使用したもの)を含んでも良い。
図25は、本発明の例示的実施形態によるベースユニット11を示す。図47Aは、本発明の例示的実施形態によるベースユニット11の内部構成部品のいくつかを示し、図47Bはベースユニット11の後面斜視図を示す。ベースユニット11は、特に、熱交換器2541、気体圧式作動システム40、使い捨て器具インターフェース2500(マニホールドインターフェースとも呼ぶ)、患者インターフェース、制御器、ユーザインターフェースコンソール13および換気システム2701を含む。気体圧式作動システム40は概して図4に示すタイプのものであるが、2つのポンプポッドそれぞれ用の気体圧インターフェース、弁およびセンサを備えてもよい。使い捨て器具インターフェースは、以下に論じるように、熱交換器の上流側および下流側で血液温度の監視を可能にするとともに、他のパラメータの監視を可能にするため、使い捨てユニットに熱的および電気的に接続可能な2つのセンサを含んでもよい。患者インターフェースは、1以上の温度プローブから温度情報(具体的には患者温度情報)を受信する1以上の温度入力部2702を含んでもよい。ユーザインターフェースコンソールは、ユーザがシステムの動作を制御および監視することを可能にする。例示的実施形態において、制御器は熱交換器およびポンプポッドの動作を、特に使い捨て器具インターフェースから受信した血液温度情報、気体圧式作動システムから受信した圧力情報、患者インターフェースから受信した患者温度情報、およびユーザインターフェースコンソールから受信したユーザ入力に基づいて制御する。
上記のように、熱交換器システム用の使い捨てユニットは、通常、血液が熱交換器を通過する際に流れる熱交換器バッグを含む。熱交換器バッグは、1以上の流体路を含んでもよい。以下に説明する一例示的実施形態においては、熱交換器バッグは、2つの流体入口を共通の流体出口に接続する単一の流体路を含む。以下に説明する別の例示的実施形態においては、熱交換器バッグは単一の入口および単一の出口を有する単一の流体路を含む。熱交換器バッグは、通常可撓性のプラスチック材料でできている。ただし、熱交換器バッグは、他の材料でできていてもよく、熱伝導性を向上させるために金属材料または他の材料を含んでもよい。
図13Aは、図25に示す熱交換器2541の詳細を示す。本実施形態においては、ベースユニットの一番上に位置するドア18内に上加温プレート12が搭載されている。下加温プレート14はドア18の下のベースユニット11内に位置している。使い捨てユニット16の一部である熱交換器バッグ21が、ドア18を閉じたときにバッグ21が2枚の加温プレート12、14の間になるように下加温プレート14の上に配置される。この配置構成は、概して単一プレート配置構成よりもより多くの熱を速く血液に伝えることを可能とする。ただし、代替的実施形態においては、熱交換器バッグ21の上または下に単一のプレートを用いてもよく、および/または他のタイプの加温素子を用いてもよい。ドア18、および/または上プレート12は、熱交換器から空気を抜くため、または上プレート12とバッグ21の連結性を向上させるため(例えば、バッグ21の上面を引っ張って上プレート12に接触させる真空を生成することによって)、気体圧式シール用トラックを含んでもよい。
図49Aおよび49Bは、それぞれ本発明の例示的実施形態による、図2のマニホールド130の斜視背面図および斜視底面図を示す。図49Aは、バッグ21の流体通路150の入口開口部および出口開口部に接続するためのバッグ入口コネクタおよびバッグ出口コネクタ2053、2054を示す。バッグ入口コネクタ2053は、入口23a、23bと流体連通し、バッグ出口コネクタ2054は出口27と流体連通する。サーモウェル133a、および133bが、それぞれ出口流体路および入口流体路内に示されている。ベースユニット11から気体圧ポート138a、138bに気体圧を供給するのに使用される気体圧インターフェース139a、139bが示されている。
図6は、本発明の例示的実施形態による、使い捨てユニット16の接続状態の概略図である。使い捨てユニット16をプライミングした後、入口カテーテル67および出口カテーテル68が患者の一血管、または複数の血管に挿入される。数個の患者温度プローブ66が患者の上または中に配設される。これらのプローブ66は、起こりうる患者の過熱を監視するため、患者温度情報を制御器に提供する。
ある種の実施形態においては、サーモウェル133a、133bの一方または両方と上加温プレートおよび下加温プレート12、14の一方または両方との間の導電率を測定することによって、熱交換器バッグ21の漏れの検出を達成し得る。先に論じたように、ベースユニット11は、ベースユニット11と使い捨てユニット16の電気的接続を提供にするサーモウェル133a、133bとインターフェース接続するセンサ61、62を含む。ベースユニット11は、通常同じく導電性である各加温プレート12、14それぞれに接続された電気プローブを更に含む。漏れがある場合、サーモウェルと加温プレートとの間の導電率が実質的に増加する(漏れ口を通過している流体は一般にバッグの材料よりも電気をよく通すため)はずである。正常時は、バッグを作っているプラスチック材料は比較的良好な絶縁体なので、サーモウェルに接触している電気プローブと加温プレート上の各電気プローブとの間の抵抗は非常に高い。しかし、漏れがあると、バッグの漏れ口を通過している液体(例えば、血液)は良好な電気の導体を供給する。そのため、漏れがあると抵抗が大きく低下する。従って、これらの電気プローブと連通している制御器は、プローブ間の導電率を測定し、導電率がある一定量増加したときには警告信号を発する。
血液加温行為においては、患者が安全限界を超えて過熱されるのを防ぐため、患者の温度は注意深く監視されなければならない。ある種の実施形態においては、少なくとも2つの別々の温度プローブが患者の中に、例えば、1つが腹部−膀胱または直腸に、膀胱壁または直腸壁に接触した状態で−もう1つが鼻道に、鼻道の後壁に接触した状態で位置づけられる(患者温度は単一のプローブまたは3つ以上プローブを用いても監視可能であり、他の場所からでもまたは他の方法でも、例えば、患者が吐き出す空気を監視することによっても監視可能である)。両センサが正しく位置決めされている場合、2つのプローブの温度示度はある一定の範囲内になるはずである。2つのプローブからの温度示度が互いに大きく異なる場合、制御器は警告信号を発するおよび/または加温行為を中止してもよい。血液加温行為の準備中、プローブが患者に挿入される際に2つのプローブの示度は互いに比較され、更に正常な患者温度示度と比較されてもよい。2つのプローブが互いのあらかじめ設定した範囲で、正常な患者温度示度の範囲に入れば、プローブを位置決めしている医療職員は、いつプローブを正しく位置決めしたのかがわかる。
図27は、本発明の例示的実施形態による、例示的なユーザインターフェース画面を示す。画面の右手側には、(上から下に)処置の現在の段階を表示するための、各種治療の段階(すなわち、システム待機、事前チェック、プライミング、昇温、持続、冷却、および治療終了)に対応するインジケータ(この、例では、「昇温」が強調表示されており、治療が現在昇温段階にあることを示している)、例えば、現在の段階の残り時間または経過時間を示すための段階進行度インジケータ、およびオペレータが治療を制御するのに使用する4つの制御ボタン(例えば、処置一時停止、処置停止、処置開始または再開、および次段階へ進む)を含む、各種治療制御ボタンが含まれている。なお、この4つの制御ボタンは、オペレータが前の段階に戻してしまうことを防止する。画面の左手側は、オペレータが患者情報、状態情報、温度グラフ、流量グラフ、および記録を提供する画面をタブから選択できるようになっている。
上記の実施形態においては、流体は熱交換器の2枚のプレートの間に配置された熱交換器バッグを通されて加温または冷却される。当然、本発明は、決して熱交換器バッグまたはプレートの使用に限られるものではない。代替的実施形態においては、熱交換器バッグを他のタイプの熱交換器とともに用いてもよい(例えば、熱交換器バッグを丸めてチューブ状のチャンバに配置する、または他のタイプの熱交換器、例えば、オーブン、冷蔵庫、水槽、またはラジエータに配置することも可能である)。これに加え、またはこれに代えて、他のタイプの流体導管(例えば、或る長さのチューブ、および/またはラジエータ)を1以上のプレートと共に用いてもよい。熱交換器は、加温能および/または冷却能を含んでもよい。実際、熱交換器システムが同じ処置の一部として(例えば、血液を加温処置のために加温し、処置後急速に正常な温度に戻すことが可能なように)、または別の処置の一部として(例えば、ベースユニットが一患者に加温処置を提供し、その後別の患者に冷却処置を提供可能なように)加温および冷却の両方の用途に使えるように、熱交換器は、加温能および冷却能の両方を含むことも可能である。
図45は、本発明の例示的実施形態による局所的温熱化学療法処置システム2600を表す。システム2600は、ベースユニット2611、および使い捨てユニット2601を含むという点で基本的に上記のタイプの熱交換器システムの類似バージョンである。上記のシステムと同様、ベースユニット2611は、熱交換器、気体圧式制御システム、制御器、およびビルトインユーザインターフェース画面2606を含む。使い捨て器具2601(例えば、カセット)は、2つのポンプポッド2625aおよび2625b、単一の入口2602、単一の出口2603、および薬品送出インターフェース2604(本例では注射器インターフェースだが、代替的実施形態では他のタイプのインターフェース、例えば、ルアーポートまたは注射針が含まれてもよい)を含む。
熱および/または伝導率センサの各種実施形態を説明する。このような熱/伝導率センサは、種々様々な用途に使用することができ、決して流体の熱/伝導率測定、または熱交換器システムとの関連での熱/伝導率測定に限られるものではない。
一例示的実施形態においては、サーモウェルが温度検知プローブを収容するために用いられる。対象媒体(例えば、血液などの液体)にサーモウェルは直接接触し、検知プローブは直接接触しない。主に、サーモウェルの熱力学特性および検知プローブの構築様式によって決定される熱伝達性に基づいて、検知プローブは対象媒体の特性を対象媒体に直接接触することなく判定することができる。センサ装置配置構成の精度および効率は、プローブおよびサーモウェルの構築材料および形態を含むがこれに限らない多くの要因に依存する。
図57を参照すると、検知プローブ5800の例示的実施形態の断面図が示されている。ハウジング5804は先端5802に続く中空構造である。先端は熱伝導性の高い材料でできている。本例示的実施形態においては、ハウジング5804は断熱性の材料でできている。一部の実施形態においては、ハウジングは断熱性および電気絶縁性の材料でできている。本例示的実施形態においては、ハウジング5804は断熱性および電気絶縁性の材料であるプラスチックでできている。先端5802は直接対象媒体に接触する、または、サーモウェルと嵌め合わされる。
センサ装置の説明のため、センサ装置を例示的実施形態に関して説明する。本例示的実施形態は、図62A、62Bおよび図64に示され、代替的例示的実施形態が63Aおよび63Bに示されている。センサ装置の代替的実施形態においては、検知プローブはサーモウェルの外で使用することができる。しかし、本明細書において、センサ装置は既に単独で説明した。従って、以下に続く説明では、この目的のため検知プローブおよびサーモウェルを含むセンサ装置の例示的実施形態の一実施形態を説明する。
図66を参照すると、センサ装置システムが示されている。本システムにおいて、センサ装置は、流体管5108を内包する器具の中に示されている。センサ装置は、検知プローブ6000およびサーモウェル5100を含む。本実施形態においては、サーモウェル5100および流体管5108は使い捨て部分であり、検知プローブ6000は再利用可能部分である。再利用可能部分にはばね6700も含まれる。ばね6700および検知プローブ6000は、ハウジング6708内に位置している。ハウジング6708は任意の機械、容器、器具、またはその他の中にあってよい。ばね6700は、円錐形、コイルばね、波形ばね、またはウレタンばねである。
ポンプポッド、熱交換器システムおよび熱/伝導率センサの各種タイプおよび構成を上に説明した。なお、構成部品の各種組み合わせから種々様々な実施形態が生み出され得る。例えば、ある種の熱交換器システムは、ポンプポッドまたは熱/伝導率センサなしで構成しても、ポンプポッドを含むが熱/伝導率センサを含まずに構成しても、または熱/伝導率センサを含むがポンプポッドを含まずに構成してもよい。ポンプポッドは種々様々な用途に用いることができ、決して熱交換器システムでの使用または体液もしくは医療用流体の圧送用に限られるものではない。熱/伝導率センサは、種々様々な用途に使用することができ、決して流体の熱/伝導率測定、または熱交換器システムとの関連での熱/伝導率測定に限られるものではない。
Claims (11)
- 半回転楕円体状である堅固なチャンバ壁であって、可撓膜が取り付けられる周囲を有して前記可撓膜および前記チャンバ壁が圧送チャンバを画定する、チャンバ壁と;
前記チャンバ壁を通過して前記圧送チャンバへ流入する液体流れを方向づける入口と;
前記チャンバ壁を通過して前記圧送チャンバから流出する液体流れを方向づける出口と;
前記可撓膜の動きを制限し前記圧送チャンバの最大容積を制限する堅固な制限構造であって、前記可撓膜および前記堅固な制限構造が作動チャンバを画定する堅固な制限構造であり、該堅固な制限構造は正圧または負圧下の流体が前記作動チャンバと連通する作動ポートを有しており、該作動ポートは動弁機構を通じて正圧流体貯留器および負圧流体貯留器と接続するようになされ、該動弁機構は前記作動チャンバと前記貯留器のそれぞれとの間の制御流体の流れを制御する、堅固な制限構造と;
前記作動チャンバの圧力を測定する作動チャンバ圧力トランスデューサと;
前記作動チャンバ圧力トランスデューサから圧力情報を受信し、前記動弁機構を制御するようになされた制御器とを備え;
前記制御器が、異常な液体流れの状態を検出するために、前記作動チャンバ圧力トランスデューサからの圧力情報を1ストローク期間に亘って積分するようになされた;
往復容積式圧送システム。 - 前記堅固な制限構造は,前記チャンバ壁の周囲に接続される;
請求項1の往復容積式圧送システム。 - 前記可撓膜が前記堅固なチャンバ壁と前記堅固な制限構造との間の所定位置に保持される;
請求項2の往復容積式圧送システム。 - 前記貯留器内の流体が気体である;
請求項1の往復容積式圧送システム。 - 前記気体が空気である;
請求項4の往復容積式圧送システム。 - 前記異常な液体流れの状態は、液体流れの抵抗の変化またはポンプのストローク中に移動される質量の変化を含む;
請求項1ないし5のいずれかの往復容積式圧送システム。 - 前記制御器は、連続したポンプストロークの間で積分した前記圧力情報の変化を検出し、異常な液体流れの状態の存在を示すようになされた;
請求項1ないし5のいずれかの往復容積式圧送システム。 - 前記制御器は、複数のポンプストロークの間で積分した前記圧力情報の変化を検出するようになされ;
該積分した前記圧力情報は、ローパスフィルタを通して前記制御器で処理される;
請求項1ないし5のいずれかの往復容積式圧送システム。 - 前記制御器は、以前のポンプストロークより短い、複数の連続したポンプストローク期間を検出するようになされ;
該複数の連続した短いポンプストロークの検出は、異常な液体流れの状態の存在を示すとされる;
請求項1ないし5のいずれかの往復容積式圧送システム。 - 前記異常な液体流れの状態は、液体が流れる管の閉塞を含み;
前記制御器は、異常な液体流れの状態の存在を示すようになされる;
請求項9の往復容積式圧送システム。 - 前記制御器は、前記動弁機構を制御して前記可撓膜に一連の圧力パルスを送るようになされ、所定数の圧力パルスの後のポンプストロークの終了の検出は、前記正圧流体貯留器または負圧流体貯留器と前記作動チャンバとの間の前記制御流体の漏れを示す;
請求項1ないし5のいずれかの往復容積式圧送システム。
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