JPWO2020214856A5 - Securement device for stabilizing an elongated medical device and method of securing a catheter assembly - Google Patents

Securement device for stabilizing an elongated medical device and method of securing a catheter assembly Download PDF

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JPWO2020214856A5
JPWO2020214856A5 JP2021561824A JP2021561824A JPWO2020214856A5 JP WO2020214856 A5 JPWO2020214856 A5 JP WO2020214856A5 JP 2021561824 A JP2021561824 A JP 2021561824A JP 2021561824 A JP2021561824 A JP 2021561824A JP WO2020214856 A5 JPWO2020214856 A5 JP WO2020214856A5
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catheter
catheter assembly
fixation device
skin surface
patient
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JP2022529044A (en
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Priority claimed from PCT/US2020/028583 external-priority patent/WO2020214856A1/en
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Description

本発明は、長尺状医療部材を安定させるための固定装置およびカテーテルアセンブリの固定方法に関する。 The present invention relates to a fixation device and method for securing a catheter assembly for stabilizing an elongated medical device .

Claims (10)

前記アンカーパッドの基端側縁部から延びるとともに、前記固定装置の中心軸線と位置合わせされて前記長尺状医療部材と患者の皮膚表面との間に配置される保護パッドをさらに備えた、請求項１～５のいずれか一項に記載の固定装置。 further comprising a protective pad extending from a proximal edge of said anchor pad and aligned with a central axis of said fixation device and positioned between said elongated medical member and a patient's skin surface. Item 6. The fixing device according to any one of Items 1 to 5. 前記保護パッドが、中心発泡体層と、保護パッドの上面に配置された剥離剤とを有しており、保護パッドが、前記長尺状医療部材によって引き起こされる皮膚表面の擦過傷を抑制するように構成されている、請求項６に記載の固定装置。 The protective pad has a central foam layer and a release agent disposed on an upper surface of the protective pad such that the protective pad inhibits skin surface abrasion caused by the elongated medical device . 7. The fixation device of claim 6, wherein: 前記長尺状医療部材が、ミッドラインカテーテル、透析カテーテル、中心静脈カテーテル（ＣＶＣ）、末梢挿入型中心静脈カテーテル（ＰＩＣＣ）、末梢静脈カテーテル（ＰＩＶ）、フォーリーカテーテル、尿路カテーテル、栄養チューブまたはバルーンカテーテルである、請求項１～８のいずれか一項に記載の固定装置。 The elongate medical member is a midline catheter, a dialysis catheter, a central venous catheter ( CVC ) , a peripherally inserted central venous catheter ( PICC ) , a peripheral venous catheter ( PIV) , a Foley catheter, or a urinary tract. A fixation device according to any one of claims 1 to 8, which is a catheter, feeding tube or balloon catheter. カテーテルの挿入部位を介してカテーテルアセンブリの内側部分を患者の体内に挿入した後に前記カテーテルアセンブリの外側部分を安定させる固定装置であって、
溝部を画定している保持具本体部と、
前記保持具本体部を支持している第１の装着翼部および第２の装着翼部であって、第１の装着翼部および第２の装着翼部の先端側縁部が前記カテーテルの挿入部位を越えて先端側に延びている第１の装着翼部および第２の装着翼部と、
前記第１の装着翼部を支持している第１のアンカーパッドおよび前記第２の装着翼部を支持している第２のアンカーパッドと、
前記第１のアンカーパッドおよび前記第２のアンカーパッドの基端側に配置され、前記カテーテルアセンブリの外側部分と患者の皮膚表面との間に配置される保護パッドと、を備えた固定装置。 A fixation device for stabilizing an outer portion of a catheter assembly after the inner portion of the catheter assembly has been inserted into a patient's body through a catheter insertion site, comprising:
a retainer body defining a groove;
A first mounting wing and a second mounting wing supporting the retainer main body, wherein distal side edges of the first mounting wing and the second mounting wing support the insertion of the catheter. a first attachment wing and a second attachment wing extending distally beyond the site;
a first anchor pad supporting the first mounting wing and a second anchor pad supporting the second mounting wing;
and a protective pad positioned proximally of the first and second anchor pads and positioned between an outer portion of the catheter assembly and a patient's skin surface. 前記ノーズ部が、前記カテーテルアセンブリの張力緩和部を所定の角度に曲げるように構成され、カテーテルアセンブリの外側部分の軸線が前記患者の皮膚表面に対して実質的に平行に延びる、請求項１５に記載の固定装置。 16. The claim 15 , wherein the nose section is configured to bend the strain relief of the catheter assembly at a predetermined angle, the axis of the outer portion of the catheter assembly extending substantially parallel to the skin surface of the patient. Fixing device as described. 前記第１の装着翼部および第２の装着翼部が、該第１の装着翼部と第２の装着翼部との間に前記抗菌ディスクを受容するように構成されている、請求項１５に記載の固定装置。 16. The first and second mounting wings are configured to receive the antimicrobial disc between the first and second mounting wings. 4. A fixation device as described in . 前記保持具本体部に対する前記カテーテルアセンブリの回転を抑制するとともに前記保持具本体部に対してカテーテルアセンブリを位置合わせするように構成された回転防止機能部をさらに備えた、請求項１０～１７のいずれか一項に記載の固定装置。 18. Any one of claims 10 to 17, further comprising an anti-rotation feature configured to restrain rotation of the catheter assembly relative to the retainer body and align the catheter assembly relative to the retainer body. or a fixing device according to claim 1. 前記カテーテルアセンブリが、カテーテルアセンブリの外側部分が前記保持具本体部と正しく位置合わせされていることを示すために、前記観察窓と位置合わせされるように構成された着色部を有している、請求項２１に記載の固定装置。 the catheter assembly having a colored portion configured to align with the viewing window to indicate proper alignment of an outer portion of the catheter assembly with the retainer body; 22. The fixation device of claim 21 . カテーテルアセンブリを固定する方法であって、
固定装置を提供することであって、該固定装置が、
前記カテーテルアセンブリの少なくとも一部分を受容するように構成された溝部を画定している保持具本体部と、
前記保持具本体部を支持している装着翼部と、
前記装着翼部に接続しているとともに、下面に接着層が配置されているアンカーパッドと、
前記接着層上に配置された第１の部分と、第１の縁部に沿って前記第１の部分と一体的に形成され、前記第１の縁部の反対側の第２の縁部まで横方向外向きに延びている第２の部分とを有する剥離ライナーと、を備えることと、
前記カテーテルアセンブリの一部分を前記溝部内に受容させることと、
前記固定装置の底面を患者の皮膚表面に対して配置することと、
前記第２の部分を横方向外向きに付勢することと、
前記第１の縁部から前記第２の縁部まで、前記剥離ライナーの第１の部分を接着層から剥がすことと、
前記保持具本体部を患者の皮膚表面に接着することと、からなる方法。 A method of securing a catheter assembly, comprising:
To provide a fixation device, the fixation device comprising:
a retainer body defining a channel configured to receive at least a portion of the catheter assembly;
a mounting wing supporting the retainer main body;
an anchor pad connected to the mounting wings and having an adhesive layer disposed on its lower surface;
a first portion disposed on the adhesive layer and integrally formed with the first portion along a first edge to a second edge opposite the first edge; a release liner having a second portion extending laterally outward;
receiving a portion of the catheter assembly within the groove;
placing the bottom surface of the fixation device against the patient's skin surface;
biasing the second portion laterally outward;
peeling a first portion of the release liner from the adhesive layer from the first edge to the second edge;
adhering the retainer body to the patient's skin surface. 前記保持具本体部のノーズ部と皮膚表面との間で長手方向基端側に抗菌ディスクをスライドさせることをさらに含み、前記ノーズ部が、前記抗菌ディスクに当接して前記抗菌ディスクをノーズ部と皮膚表面との間に保持するように角度が付けられている、請求項２４～２９のいずれか一項に記載の方法。 Further comprising sliding an antimicrobial disc longitudinally proximally between a nose portion of the retainer body and the skin surface, the nose portion abutting the antimicrobial disc to move the antimicrobial disc against the nose portion. 30. The method of any one of claims 24-29, wherein it is angled to hold it between the skin surface.
JP2021561824A 2019-04-17 2020-04-16 Catheter fixation device with extended anchor pad and release liner fastening function Pending JP2022529044A (en)

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US201962835312P 2019-04-17 2019-04-17
US62/835,312 2019-04-17
PCT/US2020/028583 WO2020214856A1 (en) 2019-04-17 2020-04-16 Catheter securement device including extended anchor pad and release liner clasping features

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JPWO2020214856A5 true JPWO2020214856A5 (en) 2023-03-28

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