JPWO2019209867A5 - - Google Patents

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JPWO2019209867A5
JPWO2019209867A5 JP2020557979A JP2020557979A JPWO2019209867A5 JP WO2019209867 A5 JPWO2019209867 A5 JP WO2019209867A5 JP 2020557979 A JP2020557979 A JP 2020557979A JP 2020557979 A JP2020557979 A JP 2020557979A JP WO2019209867 A5 JPWO2019209867 A5 JP WO2019209867A5
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catheter
catheter treatment
compartment
package
tray
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JP2021521932A (en
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Priority claimed from PCT/US2019/028784 external-priority patent/WO2019209867A1/en
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Priority to JP2023167711A priority Critical patent/JP2023181166A/en
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カテーテル処置用パッケージであって、カテーテル処置用コンポーネントを含み、前記カテーテル処置用コンポーネントは、
尿道カテーテルと、
前記尿道カテーテルに流体的に接続された排尿バッグと、
１つまたは複数の尿サンプルの無菌収集のために、前記尿道カテーテルの尿サンプリングポートまたは前記排尿バッグに流体的に接続するように構成されたサンプリングポートアクセスデバイスと、
カテーテル処置を容易にするように構成されたカテーテル処置用トレイとを備え、前記カテーテル処置用トレイは、
前記尿道カテーテルを保持するように構成された第１のコンパートメントと、
コンパートメント間接続によって前記第１のコンパートメントに接続され、かつ前記排尿バッグを保持するように構成された第２のコンパートメントと、
前記サンプリングポートアクセスデバイスを保持するように構成された第３のコンパートメントと、
前記カテーテル処置用トレイに組み込まれたカテーテル処置のための段階的指示とを備える、カテーテル処置用パッケージ。 A catheter treatment package that includes a catheter treatment component , said catheter treatment component .
Urethral catheter and
A urination bag fluidly connected to the urinary catheter and
A sampling port access device configured to fluidly connect to the urine sampling port of the urinary catheter or the urination bag for aseptic collection of one or more urine samples.
The catheter treatment tray comprises a catheter treatment tray configured to facilitate catheterization, said catheter treatment tray.
A first compartment configured to hold the urinary catheter and
A second compartment connected to the first compartment by an intercompartment connection and configured to hold the urination bag.
A third compartment configured to hold the sampling port access device,
A catheter treatment package with stepwise instructions for catheter treatment incorporated in the catheter treatment tray. 前記排尿バッグは入口ポートおよび出口ポートを含み、
前記出口ポートは、前記サンプリングポートアクセスデバイスを用いた１つまたは複数の尿サンプルの無菌収集のためにその中に組み込まれた尿サンプリングポートを含む、請求項１に記載のカテーテル処置用パッケージ。 The urination bag includes an inlet port and an exit port.
The catheter treatment package of claim 1, wherein the outlet port comprises a urine sampling port incorporated therein for aseptic collection of one or more urine samples using the sampling port access device. 前記サンプリングポートアクセスデバイスは、バレルと、前記サンプリングポートアクセスデバイスを前記尿道カテーテルの前記尿サンプリングポートまたは前記排尿バッグに流体的に接続するように構成された前記バレルの端の先端と、前記バレルと同軸の中空の針とを含み、
前記針は、前記バレルの前記先端に流体的に接続されているが、前記バレルの前記先端から離れるように向けられている、請求項１または２に記載のカテーテル処置用パッケージ。 The sampling port access device includes a barrel, the tip of the end of the barrel configured to fluidly connect the sampling port access device to the urine sampling port of the urinary catheter or the urination bag, and the barrel. Including with a coaxial hollow needle,
The catheter treatment package of claim 1 or 2, wherein the needle is fluidly connected to the tip of the barrel but directed away from the tip of the barrel. 前記カテーテル処置用コンポーネントは、前記サンプリングポートアクセスデバイスと共に使用するように構成された１つまたは複数のセプタムストッパー付き試験管をさらに含み、
一つまたは複数の前記試験管における各試験管は、大気圧よりも低い内圧を有し、
一つまたは複数の前記試験管における各試験管は、尿検査用の製剤、微生物学的分析用の製剤を含むように、または添加物や防腐剤を含まないように独立して構成される、請求項１～３のうち何れか一項に記載のカテーテル処置用パッケージ。 The catheter treatment component further comprises a test tube with one or more septum stoppers configured for use with the sampling port access device.
Each test tube in one or more of the test tubes has an internal pressure lower than atmospheric pressure and
Each test tube in one or more of the test tubes is independently configured to contain a urinalysis formulation, a microbiological analysis formulation, or no additives or preservatives. The package for catheter treatment according to any one of claims 1 to 3. 前記カテーテル処置用コンポーネントは、１つまたは複数の綿棒、消毒皮膚洗浄剤のパッケージ、または消毒皮膚洗浄剤内の１つまたは複数の綿棒のパッケージを含む、請求項１～４のうち何れか一項に記載のカテーテル処置用パッケージ。 One of claims 1-4, wherein the catheter treatment component comprises one or more cotton swabs, a package of disinfectant skin cleansers, or a package of one or more cotton swabs in a disinfectant skin cleanser. The catheter treatment package described in. 前記カテーテル処置用トレイは、１つまたは複数の前記綿棒、前記消毒皮膚洗浄剤のパッケージ、または前記消毒皮膚洗浄剤内の１つまたは複数の綿棒のパッケージを保持するように構成された隔離された第４のコンパートメントをさらに含む、請求項５に記載のカテーテル処置用パッケージ。 The catheter treatment tray is isolated to hold one or more swabs, a package of the disinfectant skin cleanser, or a package of one or more swabs in the disinfectant skin cleanser. The catheter treatment package of claim 5, further comprising a fourth compartment. 前記第４のコンパートメントは、ウェルと、１つまたは複数の綿棒をそれぞれその中に保持するように構成されたスナップインタブを備えた１つまたは複数のチャネルとを含み、
１つまたは複数の前記チャネルは、１つまたは複数の前記チャネルにスナップインされたとき、１つまたは複数の前記綿棒の１つまたは複数の綿棒ヘッドがそれぞれ前記ウェル内に配置されるように前記カテーテル処置用トレイの上部または下部に対して角度が付けられている、請求項６に記載のカテーテル処置用パッケージ。 The fourth compartment comprises a well and one or more channels with snap-in tabs configured to hold one or more swabs in it, respectively.
The channel may be snapped into the channel such that one or more swab heads of the one or more swabs are respectively placed in the well when snapped into the one or more channels. The catheter treatment package of claim 6, which is angled with respect to the top or bottom of the catheter treatment tray. 前記カテーテル処置用コンポーネントは、カテーテル処置に従って前記尿道カテーテルを潤滑するように構成された潤滑剤を含む容器をさらに含む、請求項１～７のうち何れか一項に記載のカテーテル処置用パッケージ。 The catheter treatment package according to any one of claims 1 to 7, wherein the catheter treatment component further includes a container containing a lubricant configured to lubricate the urinary catheter according to the catheter treatment. 前記カテーテル処置用トレイは、前記第１のコンパートメントによって少なくとも部分的に囲まれ、前記潤滑剤を含む前記容器を保持し、かつそこから潤滑剤が分配されるように構成された第５のコンパートメントをさらに含む、請求項８に記載のカテーテル処置用パッケージ。 The catheter treatment tray is at least partially enclosed by the first compartment to hold the container containing the lubricant and to distribute the lubricant from the fifth compartment. The catheter treatment package according to claim 8, further comprising. 前記カテーテル処置用コンポーネントは、前記排尿バッグからの１つまたは複数の尿サンプルの少なくともクリーンな収集のために構成された標本容器をさらに含む、請求項１～８のうち何れか一項に記載のカテーテル処置用パッケージ。 The catheter treatment component is described in any one of claims 1-8, further comprising a specimen container configured for at least a clean collection of one or more urine samples from the urination bag. Catheter treatment package. 前記カテーテル処置用トレイは、前記第１のコンパートメントによって少なくとも部分的に囲まれ、かつ前記標本容器を保持するように構成された第５のコンパートメントをさらに含む、請求項１０に記載のカテーテル処置用パッケージ。 The catheter treatment package of claim 10, wherein the catheter treatment tray further comprises a fifth compartment that is at least partially enclosed by the first compartment and configured to hold the specimen container. .. 前記カテーテル処置用コンポーネントは、一組の検査用手袋およびアンダーパッドをさらに含む、請求項１～１１のうち何れか一項に記載のカテーテル処置用パッケージ。 The catheter treatment package according to any one of claims 1 to 11, further comprising a set of examination gloves and an underpad. 前記カテーテル処置用パッケージの包装をさらに含み、前記包装は、
前記カテーテル処置用トレイおよびその中の前記カテーテル処置用コンポーネントを覆うように構成された一枚の紙または板紙と、
前記カテーテル処置用パッケージの内容物の無菌状態を維持するように構成され、前記カテーテル処置用トレイおよびその中の前記カテーテル処置用コンポーネントの周りに巻き付けられた中央材料室（ＣＳＲ）ラップと、
前記カテーテル処置用パッケージの外側包装であって、前記カテーテル処置用パッケージを組み立てる時点から前記カテーテル処置用パッケージを使用する時点までの前記カテーテル処置用パッケージの内容物の損失を防ぐとともに、前記カテーテル処置用パッケージのエチレンオキシド滅菌の時点から前記カテーテル処置用パッケージを使用する時点までの前記カテーテル処置用パッケージの前記内容物の汚染を防ぐように構成された前記外側包装とを含む、請求項１～１２のうち何れか一項に記載のカテーテル処置用パッケージ。 Further including the packaging of the catheter treatment package, the packaging is
A piece of paper or paperboard configured to cover the catheter treatment tray and the catheter treatment component therein.
A central material chamber (CSR) wrap configured to maintain the sterile condition of the contents of the catheter treatment package and wrapped around the catheter treatment tray and the catheter treatment component therein.
The outer packaging of the catheter treatment package, which prevents loss of the contents of the catheter treatment package from the time when the catheter treatment package is assembled to the time when the catheter treatment package is used, and is used for the catheter treatment. Of claims 1-12, comprising the outer packaging configured to prevent contamination of the contents of the catheter treatment package from the time of ethylene oxide sterilization of the package to the time of use of the catheter treatment package. The catheter treatment package according to any one. カテーテル処置用パッケージであって、カテーテル処置用コンポーネントを含み、前記カテーテル処置用コンポーネントは、
尿道カテーテルと、
前記尿道カテーテルに流体的に接続された排尿バッグと、
１つまたは複数の尿サンプルの無菌収集のために、前記排尿バッグの出口ポートに組み込まれた尿サンプリングポートに流体的に接続するように構成されたサンプリングポートアクセスデバイスと、
消毒性皮膚洗浄剤とともに使用するように構成された１つまたは複数の綿棒と、
前記尿道カテーテルを潤滑するために構成された潤滑剤を含む容器と、
カテーテル処置を容易にするように構成された成形されたカテーテル処置用トレイとを備え、前記カテーテル処置用トレイは、
前記尿道カテーテルを保持するように構成された尿道カテーテルコンパートメントと、
コンパートメント間接続によって前記尿道カテーテルコンパートメントに接続され、かつ前記排尿バッグを保持するように構成された排尿バッグコンパートメントと、
前記サンプリングポートアクセスデバイスを保持するように構成されたサンプリングポートアクセスデバイスコンパートメントと、
１つまたは複数の前記綿棒を保持するように構成された隔離された皮膚洗浄コンパートメントと、
前記尿道カテーテルコンパートメントによって囲まれたカテーテル潤滑コンパートメントであって、前記潤滑剤を含む前記容器を保持するように構成されるとともに、そこから前記潤滑剤が分配される前記カテーテル潤滑コンパートメントと、
カテーテル処置のための段階的指示であって、前記カテーテル処置用トレイにエンボス加工されているか、前記カテーテル処置用トレイにプリントされているか、または前記カテーテル処置用トレイにエンボス加工されて且つ前記カテーテル処置用トレイにプリントされている前記段階的指示とを備え、
カテーテル処置のための前記段階的指示の少なくとも幾つかは、前記カテーテル処置用コンポーネントが前記カテーテル処置用トレイから取り外されると明らかになる、カテーテル処置用パッケージ。 A catheter treatment package that includes a catheter treatment component , said catheter treatment component .
Urethral catheter and
A urination bag fluidly connected to the urinary catheter and
A sampling port access device configured to fluidly connect to a urine sampling port built into the outlet port of the urination bag for aseptic collection of one or more urine samples.
With one or more swabs configured for use with antiseptic skin cleansers,
A container containing a lubricant configured to lubricate the urinary catheter,
The catheter treatment tray comprises a molded catheter treatment tray configured to facilitate catheterization.
A urinary catheter compartment configured to hold the urinary catheter and
A urination bag compartment that is connected to the urinary catheter compartment by an intercompartment connection and is configured to hold the urination bag.
With the sampling port access device compartment configured to hold the sampling port access device,
With an isolated skin cleansing compartment configured to hold one or more of the swabs,
A catheter lubrication compartment surrounded by the urethral catheter compartment, the catheter lubrication compartment configured to hold the container containing the lubricant and to which the lubricant is distributed.
Step-by-step instructions for catheterization, either embossed on the catheter treatment tray, printed on the catheter treatment tray, or embossed on the catheter treatment tray and said catheter treatment. With the step-by-step instructions printed on the tray for
A catheter treatment package, wherein at least some of the stepwise instructions for catheter treatment are revealed when the catheter treatment component is removed from the catheter treatment tray. カテーテル処置用パッケージを製造するための方法であって、
カテーテル処置を容易にするように構成されたカテーテル処置用トレイを成形することであって、尿道カテーテルコンパートメントを成形することと、コンパートメント間接続によって前記尿道カテーテルコンパートメントに接続された排尿バッグコンパートメントを成形することと、サンプリングポートアクセスデバイスコンパートメントを成形することと、を備える前記成形することと、
カテーテル処置のための段階的指示を前記カテーテル処置用トレイに組み込むことと、
カテーテル処置用コンポーネントを前記カテーテル処置用トレイに配置することとを備え、前記カテーテル処置用コンポーネントを前記カテーテル処置用トレイに配置することは、
尿道カテーテルを前記尿道カテーテルコンパートメントに配置することと、
排尿バッグを前記排尿バッグコンパートメントに配置することであって、前記排尿バッグは、前記尿道カテーテルおよび前記排尿バッグをそれぞれ前記尿道カテーテルコンパートメントおよび前記排尿バッグコンパートメントに配置することが、前記尿道カテーテルを前記コンパートメント間接続を横切るように配置することを含むように、前記尿道カテーテルに流体的に接続されていることと、
サンプリングポートアクセスデバイスを前記サンプリングポートアクセスデバイスコンパートメントに配置することであって、前記サンプリングポートアクセスデバイスは、１つまたは複数の尿サンプルの無菌収集のために、前記尿道カテーテルの尿サンプリングポートまたは前記排尿バッグに流体的に接続されるように構成されていることと、を備える方法。 A method for manufacturing catheter treatment packages,
Forming a catheter treatment tray configured to facilitate catheterization, forming the urinary catheter compartment and forming the urinary bag compartment connected to the urinary catheter compartment by intercompartmental connection. The molding and the molding and the molding which comprises the sampling port access device compartment.
Incorporating step-by-step instructions for catheterization into the catheterization tray and
Placing the catheter treatment component on the catheter treatment tray comprises placing the catheter treatment component on the catheter treatment tray.
Placing a urinary catheter in the urinary catheter compartment
Placing the urination bag in the urination bag compartment, wherein the urination bag places the urethral catheter and the urination bag in the urethral catheter compartment and the urination bag compartment, respectively. Being fluidly connected to the urethral catheter, including disposing across the inter-connection.
By disposing the sampling port access device in the sampling port access device compartment, the sampling port access device is the urine sampling port of the urinary catheter or the urination for the aseptic collection of one or more urine samples. A method that is configured to be fluidly connected to the bag and comprises. 前記カテーテル処置用コンポーネントを前記カテーテル処置用トレイに配置することは、前記排尿バッグコンパートメント内の前記排尿バッグの上または下のいずれかに、前記サンプリングポートアクセスデバイスと共に使用するように構成された１つまたは複数のセプタムストッパー付き試験管を配置することをさらに含む、請求項１５に記載の方法。 Placing the catheter treatment component on the catheter treatment tray is configured to be used with the sampling port access device either above or below the urination bag in the urination bag compartment. 15. The method of claim 15, further comprising arranging one or more test tubes with septum stoppers. 前記カテーテル処置用トレイを成形することは、隔離された皮膚洗浄コンパートメントを成形することをさらに含み、
前記カテーテル処置用コンポーネントを前記カテーテル処置用トレイに配置することは、１つまたは複数の綿棒を前記皮膚洗浄コンパートメントに配置すること、消毒皮膚洗浄剤のパッケージを前記皮膚洗浄コンパートメントに配置すること、または前記消毒皮膚洗浄剤内の一つまたは複数の綿棒のパッケージを前記皮膚洗浄コンパートメントに配置することをさらに含む、請求項１５または１６に記載の方法。 Molding the catheter treatment tray further comprises molding an isolated skin wash compartment.
Placing the catheter treatment component in the catheter treatment tray means placing one or more cotton swabs in the skin cleansing compartment, placing a package of antiseptic skin cleansing agent in the skin cleansing compartment. 15 or 16. The method of claim 15 or 16, further comprising placing a package of one or more cotton swabs in the disinfectant skin cleanser in the skin cleansing compartment. 前記カテーテル処置用トレイを成形することは、前記尿道カテーテルコンパートメントによって少なくとも部分的に囲まれたカテーテル潤滑コンパートメントを成形することをさらに含み、
前記カテーテル処置用コンポーネントを前記カテーテル処置用トレイに配置することは、前記カテーテル潤滑コンパートメントに潤滑剤を含む容器を配置することを含む、請求項１５～１７のうち何れか一項に記載の方法。 Molding the catheter treatment tray further comprises molding a catheter lubrication compartment that is at least partially enclosed by the urinary catheter compartment.
The method of any one of claims 15-17, wherein placing the catheter treatment component in the catheter treatment tray comprises placing a container containing the lubricant in the catheter lubrication compartment. .. 前記カテーテル処置用コンポーネントを前記カテーテル処置用トレイに配置することは、前記カテーテル処置用トレイの１つまたは複数のコンパートメントの中または上に一組の検査用手袋を配置することと、アンダーパッドを折りたたんで、該アンダーパッドを前記一組の検査用手袋の上に配置することとをさらに備える、請求項１５～１８のうち何れか一項に記載の方法。 Placing the catheter treatment component on the catheter treatment tray involves placing a set of examination gloves in or on one or more compartments of the catheter treatment tray and placing an underpad. The method of any one of claims 15-18, further comprising folding and placing the underpad on the set of test gloves. 前記カテーテル処置用コンポーネントを含む前記カテーテル処置用トレイの上に一枚の紙または板紙を配置して紙または板紙で覆われたカテーテル処置用トレイを形成することと、
前記紙または板紙で覆われた前記カテーテル処置用トレイを中央材料室（ＣＳＲ）ラップで包み、ＣＳＲラップで包まれたカテーテル処置用トレイを形成することと、
前記ＣＳＲラップで包まれた前記カテーテル処置用トレイを外側包装に入れてカテーテル処置用パッケージを形成することと、
エチレンオキシド滅菌により前記カテーテル処置用パッケージを滅菌することとを備える、請求項１５～１９のうち何れか一項に記載の方法。 Placing a piece of paper or paperboard on top of the catheter treatment tray containing the catheter treatment component to form a paper or paperboard-covered catheter treatment tray.
The catheter treatment tray covered with the paper or paperboard is wrapped with a central material chamber (CSR) wrap to form a catheter treatment tray wrapped with the CSR wrap.
The catheter treatment tray wrapped in the CSR wrap is placed in an outer package to form a catheter treatment package.
The method according to any one of claims 15 to 19, comprising sterilizing the catheter treatment package by ethylene oxide sterilization.
JP2020557979A 2018-04-24 2019-04-23 Catheter procedure package and its method Pending JP2021521932A (en)

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