JPWO2020010152A5 - - Google Patents
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- JPWO2020010152A5 JPWO2020010152A5 JP2020571546A JP2020571546A JPWO2020010152A5 JP WO2020010152 A5 JPWO2020010152 A5 JP WO2020010152A5 JP 2020571546 A JP2020571546 A JP 2020571546A JP 2020571546 A JP2020571546 A JP 2020571546A JP WO2020010152 A5 JPWO2020010152 A5 JP WO2020010152A5
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- catheter assembly
- antibacterial
- catheter
- antibacterial coating
- hub
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- 230000000844 anti-bacterial Effects 0.000 claims description 135
- 239000011248 coating agent Substances 0.000 claims description 87
- 238000000576 coating method Methods 0.000 claims description 87
- RYGMFSIKBFXOCR-UHFFFAOYSA-N copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 claims description 53
- 229910052802 copper Inorganic materials 0.000 claims description 53
- 239000010949 copper Substances 0.000 claims description 53
- KDLHZDBZIXYQEI-UHFFFAOYSA-N palladium Chemical compound [Pd] KDLHZDBZIXYQEI-UHFFFAOYSA-N 0.000 claims description 30
- 239000012530 fluid Substances 0.000 claims description 28
- 230000001737 promoting Effects 0.000 claims description 25
- 230000000875 corresponding Effects 0.000 claims description 21
- 238000005260 corrosion Methods 0.000 claims description 17
- 229910052751 metal Inorganic materials 0.000 claims description 17
- 239000002184 metal Substances 0.000 claims description 17
- 229910052763 palladium Inorganic materials 0.000 claims description 15
- -1 polyethylene Polymers 0.000 claims description 14
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims description 13
- 229910052737 gold Inorganic materials 0.000 claims description 13
- 239000010931 gold Substances 0.000 claims description 13
- 239000002131 composite material Substances 0.000 claims description 12
- RTAQQCXQSZGOHL-UHFFFAOYSA-N titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 12
- 229910052719 titanium Inorganic materials 0.000 claims description 12
- 239000010936 titanium Substances 0.000 claims description 12
- 229920001296 polysiloxane Polymers 0.000 claims description 8
- 239000004698 Polyethylene (PE) Substances 0.000 claims description 7
- 239000004743 Polypropylene Substances 0.000 claims description 7
- 239000000203 mixture Substances 0.000 claims description 7
- 229920000515 polycarbonate Polymers 0.000 claims description 7
- 239000004417 polycarbonate Substances 0.000 claims description 7
- 229920000573 polyethylene Polymers 0.000 claims description 7
- 229920000642 polymer Polymers 0.000 claims description 7
- 229920001155 polypropylene Polymers 0.000 claims description 7
- 229920002635 polyurethane Polymers 0.000 claims description 7
- 239000004814 polyurethane Substances 0.000 claims description 7
- 229920000915 polyvinyl chloride Polymers 0.000 claims description 7
- 239000004800 polyvinyl chloride Substances 0.000 claims description 7
- 229910000881 Cu alloy Inorganic materials 0.000 claims description 5
- 239000011159 matrix material Substances 0.000 claims description 5
- 238000005234 chemical deposition Methods 0.000 claims description 4
- 238000004070 electrodeposition Methods 0.000 claims description 4
- 238000007772 electroless plating Methods 0.000 claims description 4
- 238000005289 physical deposition Methods 0.000 claims description 4
- 229910052718 tin Inorganic materials 0.000 claims description 4
- 239000011135 tin Substances 0.000 claims description 4
- ATJFFYVFTNAWJD-UHFFFAOYSA-N tin hydride Chemical compound [Sn] ATJFFYVFTNAWJD-UHFFFAOYSA-N 0.000 claims description 4
- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 claims description 4
- 229910052721 tungsten Inorganic materials 0.000 claims description 4
- 239000010937 tungsten Substances 0.000 claims description 4
- HCHKCACWOHOZIP-UHFFFAOYSA-N zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims description 4
- 229910052725 zinc Inorganic materials 0.000 claims description 4
- 239000011701 zinc Substances 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 230000000712 assembly Effects 0.000 claims 1
- 150000002739 metals Chemical class 0.000 claims 1
- 230000000576 supplementary Effects 0.000 description 11
- 238000005536 corrosion prevention Methods 0.000 description 3
- 229910001020 Au alloy Inorganic materials 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000006011 modification reaction Methods 0.000 description 2
- 239000000306 component Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000000813 microbial Effects 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 230000001568 sexual Effects 0.000 description 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 1
Description
この場合もまた、抗菌コーティング４２は、２つ以上の層のコンポジットである。抗菌コーティング４２は、銅ベース層１０２を含む。任意選択的に、抗菌コーティング４２は、オーバーコート１０８を含み、銅ベース層１０２は、医療機器の表面とオーバーコート１０８との間にあり、それによって図１４Ａに示される抗菌コーティング４２Ａを形成する。図１４Ｂは、図９のカテーテル１０のカテーテルチューブ１２、ハブ１６の遠位端部、または延長脚部１８の管腔面４４などの単一ルーメン医療機器１００の管状部の内面すなわち管腔面４４上の抗菌コーティング４２Ａを示すが、図１４Ｃは、カテーテル１０の前述の管状部の外面または反管腔側表面４６上の抗菌コーティング４２Ａを示す。図１４Ｄは、図１のカテーテル１０のカテーテルチューブ１２の管腔面４４またはハブ１６の遠位端部の管腔面４４などの二重ルーメン医療機器１００の管状部の内面すなわち管腔面４４上の抗菌コーティング４２Ａを示すが、図１４Ｅはカテーテル１０の前述の管状部の外面すなわち反管腔側表面４６上の抗菌コーティング４２Ａを示す。示されていないが、抗菌コーティング４２Ａは、カテーテル１０の前述の管状部の内面４４および外面４６の両方の上にあり得る。 Again, the antibacterial coating 42 is a composite of two or more layers. The antibacterial coating 42 comprises a copper base layer 102. Optionally, the antibacterial coating 42 comprises an overcoat 108, the copper base layer 102 is between the surface of the medical device and the overcoat 108, thereby forming the antibacterial coating 42A shown in FIG. 14A. 14B shows the inner surface or luminal surface 44 of a tubular portion of a single lumen medical device 100 , such as the catheter tube 12 of the catheter 10 of FIG. 9, the distal end of the hub 16, or the luminal surface 44 of the extended leg 18. The above antibacterial coating 42A is shown, with FIG. 14C showing the antibacterial coating 42A on the outer surface or antiluminal surface 46 of the aforementioned tubular portion of the catheter 10. FIG. 14D shows the inner surface of the tubular portion of the double lumen medical device 100 , such as the lumen surface 44 of the catheter tube 12 of the catheter 10 of FIG. 14E shows the antibacterial coating 42A on the outer surface of the aforementioned tubular portion of the catheter 10, ie, the antiluminal surface 46. Although not shown, the antibacterial coating 42A can be on both the inner and outer surfaces 44 and 46 of the aforementioned tubular portion of the catheter 10.
抗菌コーティング４２の銅ベース層１０２に加えて、抗菌コーティング４２は接着促進層１０４を含み得、接着促進層１０４は医療機器の内面または外面と銅ベース層１０２との間にあり、それによって図１５Ａに示される抗菌コーティング４２Ｂを形成する。任意選択的に、抗菌コーティング４２Ｂは、オーバーコート１０８を含み、銅ベース層１０２が接着促進層１０４とオーバーコート１０８との間に配置される。図１５Ｂは図９のカテーテル１０のカテーテルチューブ１２、ハブ１６の遠位端部、または延長脚部１８の管腔面４４などの単一ルーメン医療機器１００の管状部の内面すなわち管腔面４４上の抗菌コーティング４２Ｂを示すが、図１５Ｃは、カテーテル１０の前述の管状部の外面すなわち反管腔側表面４６上の抗菌コーティング４２Ｂを示す。抗菌コーティング４２Ｂは、図１のカテーテル１０などの二重ルーメン医療機器１００の管状部の内面４４上または外面４６上のいずれにも示されていないが、抗菌コーティング４２Ｂはそのような医療機器の内面４４または外面４６に適用され得、抗菌コーティング４２Ｂを備えている図１４Ｄおよび１４Ｅの横断面に類似した横断面を有する二重ルーメンの医療機器になることを理解されたい。示されていないが、抗菌コーティング４２Ｂは、カテーテル１０の前述の管状部の内面４４上および外面４６上の両方にあり得る。 In addition to the copper base layer 102 of the antibacterial coating 42, the antibacterial coating 42 may include an adhesion promoting layer 104, which is located between the inner or outer surface of the medical device and the copper base layer 102, thereby FIG. 15A. Form the antibacterial coating 42B shown in. Optionally, the antibacterial coating 42B comprises an overcoat 108 in which the copper base layer 102 is placed between the adhesion promoting layer 104 and the overcoat 108. FIG. 15B is on the inner surface or luminal surface 44 of a tubular portion of a single lumen medical device 100 , such as the catheter tube 12 of the catheter 10 of FIG. 9, the distal end of the hub 16, or the luminal surface 44 of the extension leg 18. FIG. 15C shows the antibacterial coating 42B on the outer surface of the aforementioned tubular portion of the catheter 10, ie, the antiluminal surface 46. Although the antibacterial coating 42B is not shown on either the inner surface 44 or the outer surface 46 of the tubular portion of the double lumen medical device 100 such as the catheter 10 of FIG. 1, the antibacterial coating 42B is the inner surface of such a medical device. It should be appreciated that it may be applied to the 44 or the outer surface 46, resulting in a double lumen medical device having a cross section similar to the cross section of FIGS. 14D and 14E with an antibacterial coating 42B. Although not shown, the antibacterial coating 42B can be on both the inner surface 44 and the outer surface 46 of the aforementioned tubular portion of the catheter 10.
抗菌コーティング４２の銅ベース層１０２に加えて、抗菌コーティング４２は、腐食防止層１０６を含み得、銅ベース層１０２は、腐食防止層１０６と医療機器の内面または外面との間にあり、それによって図１６Ａに示される抗菌コーティング４２Ｃを形成する。任意選択的に、抗菌コーティング４２Ｃは、オーバーコート１０８を含み、腐食防止層１０６が銅ベース層１０２とオーバーコート１０８との間に配置される。図１６Ｂは、図９のカテーテル１０のカテーテルチューブ１２、ハブ１６の遠位端部、または延長脚部１８の管腔面４４などの単一ルーメン医療機器１００の管状部の内面すなわち管腔面４４上の抗菌コーティング４２Ｃを示すが、図１６Ｃは、カテーテル１０の前述の管状部の外面すなわち反管腔側表面４６上の抗菌コーティング４２Ｃを示す。抗菌コーティング４２Ｃは、図１のカテーテル１０などの二重ルーメン医療機器１００の管状部の内面４４上または外面４６上のいずれにも示されていないが、抗菌コーティング４２Ｃはそのような医療機器の内面４４または外面４６に適用され得、抗菌コーティング４２Ｃを備えている図１４Ｄおよび１４Ｅの横断面に類似した横断面を有する二重ルーメンの医療機器になることを理解されたい。示されていないが、抗菌コーティング４２Ｃは、カテーテル１０の前述の管状部の内面４４上および外面４６上の両方にあり得る。 In addition to the copper base layer 102 of the antibacterial coating 42, the antibacterial coating 42 may include a corrosion protection layer 106, wherein the copper base layer 102 is between the corrosion protection layer 106 and the inner or outer surface of the medical device. The antibacterial coating 42C shown in FIG. 16A is formed. Optionally, the antibacterial coating 42C comprises an overcoat 108, with the corrosion protection layer 106 disposed between the copper base layer 102 and the overcoat 108. FIG. 16B shows the inner surface or luminal surface 44 of a tubular portion of a single lumen medical device 100 , such as the catheter tube 12 of the catheter 10 of FIG. 9, the distal end of the hub 16, or the luminal surface 44 of the extended leg 18. Although the antibacterial coating 42C above is shown, FIG. 16C shows the antibacterial coating 42C on the outer surface of the aforementioned tubular portion of the catheter 10, ie, the antiluminal surface 46. The antibacterial coating 42C is not shown on either the inner surface 44 or the outer surface 46 of the tubular portion of the double lumen medical device 100 such as the catheter 10 of FIG. 1, but the antibacterial coating 42C is the inner surface of such a medical device. It should be appreciated that it may be applied to the 44 or the outer surface 46, resulting in a double lumen medical device having a cross section similar to the cross section of FIGS. 14D and 14E with an antibacterial coating 42C. Although not shown, the antibacterial coating 42C can be on both the inner surface 44 and the outer surface 46 of the aforementioned tubular portion of the catheter 10.
抗菌コーティング４２は、接着促進層１０４および腐食防止層１０６の両方を含み得、銅ベース層１０２は接着促進層１０４と腐食防止層１０６との間にあり、接着促進層１０４は銅ベース層１０２と医療機器の内面または外面との間にあり、それによって図１７Ａに示される抗菌コーティング４２Ｄを形成する。任意選択的に、抗菌コーティング４２Ｄはオーバーコート１０８を含み、腐食防止層１０６が銅ベース層１０２とオーバーコート１０８との間に配置される。図１７Ｂは、図９のカテーテル１０のカテーテルチューブ１２、ハブ１６の遠位端部、または延長脚部１８の管腔面４４などの単一ルーメン医療機器１００の管状部の内面すなわち管腔面４４上の抗菌コーティング４２Ｄを示すが、図１７Ｃは、カテーテル１０の前述の管状部の外面すなわち反管腔側表面４６上の抗菌コーティング４２Ｄを示す。抗菌コーティング４２Ｄは、図１のカテーテル１０などの二重ルーメンの医療機器の管状部の内面４４上または外面４６上のいずれにも示されていないが、抗菌コーティング４２Ｄはそのような医療機器の内面４４または外面４６に適用され得、抗菌コーティング４２Ｄを備えている図１４Ｄおよび１４Ｅの横断面に類似した横断面を有する二重ルーメンの医療機器になることを理解されたい。示されていないが、抗菌コーティング４２Ｄは、カテーテル１０の前述の管状部の内面４４上および外面４６上の両方にあり得る。 The antibacterial coating 42 may include both an adhesion-promoting layer 104 and a corrosion-preventing layer 106, with the copper base layer 102 between the adhesion-promoting layer 104 and the corrosion-preventing layer 106, and the adhesion-promoting layer 104 with the copper-based layer 102. It is between the inner or outer surface of the medical device, thereby forming the antibacterial coating 42D shown in FIG. 17A. Optionally, the antibacterial coating 42D comprises an overcoat 108, with the corrosion protection layer 106 disposed between the copper base layer 102 and the overcoat 108. FIG. 17B shows the inner surface or luminal surface 44 of a tubular portion of a single lumen medical device 100 , such as the catheter tube 12 of the catheter 10 of FIG. 9, the distal end of the hub 16, or the luminal surface 44 of the extended leg 18. Although the antibacterial coating 42D above is shown, FIG. 17C shows the antibacterial coating 42D on the outer surface of the aforementioned tubular portion of the catheter 10, ie, the antiluminal surface 46. Although the antibacterial coating 42D is not shown on either the inner surface 44 or the outer surface 46 of the tubular portion of a double lumen medical device such as the catheter 10 of FIG. 1, the antibacterial coating 42D is the inner surface of such a medical device. It should be appreciated that it may be applied to the 44 or the outer surface 46, resulting in a double lumen medical device having a cross section similar to the cross section of FIGS. 14D and 14E with an antibacterial coating 42D. Although not shown, the antibacterial coating 42D can be on both the inner surface 44 and the outer surface 46 of the aforementioned tubular portion of the catheter 10.
ルアーコネクタ１９に加えて、図６は、また、図９のカテーテル１０の延長脚部１８の内面すなわち管腔面５８、または、図１のカテーテル１０の一対の延長脚部１８の内面すなわち管腔面５８が、抗菌コーティング４２を含み得ることを示している。抗菌コーティング４２は、ルアーコネクタ１９が連結されるカテーテル１０の延長脚部１８を通ってルアーコネクタ１９の内面４４から遠位に微生物が移動することを防ぎ得る。図６に示されていないが、図９のカテーテル１０の延長脚部１８の外面すなわち反管腔側表面４６または図１のカテーテル１０の一対の延長脚部１８の外面すなわち反管腔側表面は、代わりに、または加えて、抗菌コーティング４２をそれらの少なくとも近位端部および遠位端部に含み得る。ルアーコネクタ１９などのコネクタと同様に、延長脚部１８のような延長脚部の外面すなわち反管腔側表面は、臨床医またはカテーテル１０の他の使用者による比較的広範囲の物理的接触により、特に微生物汚染の影響を受けやすい。 In addition to the luer connector 19, FIG. 6 also shows the inner surface or lumen surface 58 of the extension leg 18 of the catheter 10 of FIG. 9 or the inner surface or lumen of the pair of extension legs 18 of the catheter 10 of FIG. It is shown that the surface 58 may include an antibacterial coating 42. The antibacterial coating 42 can prevent microorganisms from migrating distally from the inner surface 44 of the luer connector 19 through the extension leg 18 of the catheter 10 to which the luer connector 19 is connected. Although not shown in FIG. 6, the outer surface or antiluminal surface of the extension leg 18 of the catheter 10 of FIG. 9 or the antiluminal surface of the pair of extension legs 18 of the catheter 10 of FIG. 1 is , Alternatively, or in addition, antibacterial coatings 42 may be included at least at their proximal and distal ends. Similar to connectors such as the luer connector 19, the outer surface or antiluminal surface of the extension leg, such as the extension leg 18, is subject to relatively extensive physical contact by the clinician or other user of the catheter 10. Especially susceptible to microbial contamination.
いくつかの特定の実施形態が本明細書に開示され、特定の実施形態が若干詳細に開示されるが、それらの特定の実施形態が本明細書に提供される概念の範囲を限定する意図はない。追加の適応および／または変更は当業者に現れ得、より広い態様において、これらの適応および／または変更もまた包含される。したがって、本明細書に提供される概念の範囲から逸脱することなく、特定の実施形態から逸脱がなされる場合がある。
［付記１］ カテーテルアセンブリを通る流体通路の対応するハブ部分を画定する少なくとも１つのハブルーメンを含むハブと、前記ハブに連結されたカテーテルチューブであって、前記カテーテルアセンブリを通る前記流体通路の対応するカテーテルチューブ部分を画定する少なくとも１つのカテーテルチューブルーメンを含む前記カテーテルチューブと、前記ハブに連結された少なくとも１つの延長脚部であって、前記カテーテルアセンブリを通る前記流体通路の対応する延長脚部部分を画定する延長脚部ルーメンを含む前記少なくとも１つの延長脚部と、前記カテーテルアセンブリの内面上、前記カテーテルアセンブリの外面上、または前記カテーテルアセンブリの前記内面上および前記外面上の両方における非溶出性の抗菌コーティングであって、腐食防止層と前記カテーテルアセンブリの前記内面または前記外面との間の銅ベース層、前記銅ベース層と前記カテーテルアセンブリの前記内面または前記外面との間の接着促進層、またはそれらの組み合わせを含む、２つ以上の層のコンポジットである、前記抗菌コーティングとを備える抗菌カテーテルアセンブリ。
［付記２］ 前記接着促進層は接着促進金属を含む、付記１に記載の抗菌カテーテルアセンブリ。
［付記３］ 前記接着促進金属はポリウレタン、ポリカーボネート、ポリエチレン、ポリプロピレン、ポリ塩化ビニル、およびシリコーンから選択されるポリマーへの前記銅ベース層の接着を促進する、付記２に記載の抗菌カテーテルアセンブリ。
［付記４］ 前記接着促進金属は金、パラジウム、およびチタンから選択される、付記２または３に記載の抗菌カテーテルアセンブリ。
［付記５］ 前記銅ベース層は実質的に純銅、銅と金、パラジウム、亜鉛、または錫との銅合金、または銅およびタングステンの銅マトリックスコンポジットである、付記１～４のうちのいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記６］ 前記腐食防止層は金、パラジウム、およびチタンから選択される耐腐食性金属を含む、付記１～５のうちのいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記７］ 前記抗菌コーティングは２つの層を含み、前記２つの層は前記接着促進層および前記銅ベース層である、付記１～６のうちのいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記８］ 前記抗菌コーティングは２つの層を含み、前記２つの層は前記銅ベース層および前記腐食防止層である、付記１～６のうちのいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記９］ 前記抗菌コーティングは３つの層を含み、前記３つの層は前記接着促進層、前記銅ベース層および前記腐食防止層である、付記１～６のうちのいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記１０］ 前記抗菌コーティングは、前記カテーテルアセンブリを通る前記流体通路の前記対応するハブ部分を画定する前記ハブルーメンを含む前記カテーテルアセンブリの前記内面上にある、付記１～９のうちのいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記１１］ 前記抗菌コーティングは、前記カテーテルアセンブリを通る前記流体通路の前記対応する延長脚部部分を画定する前記延長脚部ルーメンを含む前記カテーテルアセンブリの前記内面上にある、付記１～１０のうちのいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記１２］ 前記抗菌コーティングは、前記延長脚部の少なくとも近位端部と遠位端部との間の前記延長脚部の反管腔側表面を含む前記カテーテルアセンブリの前記外面上にある、付記１～１１のうちのいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記１３］ 前記抗菌コーティングは、前記カテーテルチューブの経皮的領域の反管腔側表面を含む前記カテーテルアセンブリの前記外面上にある、付記１～１２のうちのいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記１４］ 前記延長脚部に連結された少なくとも１つのルアーコネクタをさらに備え、前記抗菌コーティングは前記流体通路と流体連通する前記ルアーコネクタの内面を含む前記カテーテルアセンブリの前記内面上、前記ルアーコネクタの外面を含む前記カテーテルアセンブリの外面上、またはそれらの組み合わせ上である、付記１～１３のうちのいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記１５］ 抗菌カテーテルアセンブリであって、前記カテーテルアセンブリを通る一対の流体通路の対応するハブ部分を画定する一対のハブルーメンを含む、分岐ハブと、前記ハブに連結されたカテーテルチューブであって、前記カテーテルアセンブリを通る前記一対の流体通路の対応するカテーテルチューブ部分を画定する一対のカテーテルチューブルーメンを含む、前記カテーテルチューブと、前記ハブに連結された一対の延長脚部であって、各延長脚部は、前記カテーテルアセンブリを通る前記一対の流体通路の対応する延長脚部部分を画定する延長脚部ルーメンを含む、一対の延長脚部と、一対のルアーコネクタであって、各ルアーコネクタは前記一対の延長脚部の１つの延長脚部に連結された、一対のルアーコネクタと、前記カテーテルアセンブリの内面上、前記カテーテルアセンブリの外面上、または前記カテーテルアセンブリの前記内面上および前記外面上の両方における非溶出性抗菌コーティングであって、前記抗菌コーティングは腐食防止層と前記カテーテルアセンブリの前記内面または前記外面との間の銅ベース層、前記銅ベース層と前記カテーテルアセンブリの前記内面または前記外面との間の接着促進層、またはそれらの組み合わせを含む、２つ以上の層のコンポジットである、非溶出性抗菌コーティングとを備える、抗菌カテーテルアセンブリ。
［付記１６］ 前記接着促進層は、ポリウレタン、ポリカーボネート、ポリエチレン、ポリプロピレン、ポリ塩化ビニル、およびシリコーンから選択されるポリマーへの前記銅ベース層の接着を促進し、前記接着促進層は金、パラジウム、およびチタンから選択される金属を含む、付記１５に記載の抗菌カテーテルアセンブリ。
［付記１７］ 前記銅ベース層は実質的に純銅、銅と金、パラジウム、亜鉛、または錫との銅合金、または銅およびタングステンの銅マトリックスコンポジットである、付記１５または１６に記載の抗菌カテーテルアセンブリ。
［付記１８］ 前記腐食防止層は、金、パラジウム、およびチタンから選択される耐腐食性金属を含む、付記１５～１７のうちのいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記１９］ 前記抗菌コーティングは２つの層を含み、前記２つの層は前記接着促進層および前記銅ベース層、または、前記銅ベース層および前記腐食防止層である、付記１５～１８のいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記２０］ 前記抗菌コーティングは３つの層を含み、前記３つの層は前記接着促進層、前記銅ベース層、および前記腐食防止層である、付記１５～１８のいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記２１］ 前記抗菌コーティングは、前記カテーテルアセンブリを通る前記一対の流体通路の前記対応するハブ部分を画定する前記ハブルーメンを含む前記カテーテルアセンブリの前記内面上にある、付記１５～２０のいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記２２］ 前記抗菌コーティングは、前記カテーテルアセンブリを通る前記一対の流体通路の前記対応する延長脚部部分を画定する前記延長脚部ルーメンを含む前記カテーテルアセンブリの前記内面上にある、付記１５～２１のいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記２３］ 前記抗菌コーティングは、前記カテーテルアセンブリを通る前記一対の流体通路の対応するルアーコネクタ部を画定する各ルアーコネクタの内面を含む前記カテーテルアセンブリの前記内面上、各ルアーコネクタの外面を含むカテーテルアセンブリの外面上、またはそれらの組み合わせ上にある、付記１５～２２のいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記２４］ 前記抗菌コーティングは、各延長脚部の少なくとも近位端部と遠位端部との間の、前記一対の延長脚部の反管腔側表面を含む、前記カテーテルアセンブリの前記外面上にある、付記１５～２３のいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記２５］ 前記抗菌コーティングは、前記カテーテルチューブの経皮的領域の反管腔側表面を含む、前記カテーテルアセンブリの前記外面上にある、付記１５～２４のいずれか１つに記載の抗菌カテーテルアセンブリ。
［付記２６］ 抗菌カテーテルアセンブリの製造方法であって、前記カテーテルアセンブリの１つ以上の構成要素の内面、外面、または前記内面および前記外面の両方に非溶出性抗菌コーティングを適用することであって、前記抗菌コーティングは、腐食防止層と前記抗菌コーティングが適用される前記内面または前記外面との間の銅ベース層、前記銅ベース層と前記抗菌コーティングが適用される前記内面または前記外面との間の接着促進層、またはそれらの組み合わせを含む２つ以上の層のコンポジットである、前記抗菌コーティングを適用することと、前記カテーテルアセンブリを形成するために前記カテーテルアセンブリの前記構成要素を連結することとを備える、方法。
［付記２７］ 前記抗菌コーティングを適用することは、金、パラジウム、およびチタンから選択される金属の物理蒸着、化学蒸着、電着、または無電解めっきによって、前記カテーテルアセンブリの前記１つ以上の構成要素のうちの任意の構成要素の前記内面または前記外面に前記接着促進層を適用することを含み、前記接着促進層が適用される前記内面または前記外面はポリウレタン、ポリカーボネート、ポリエチレン、ポリプロピレン、ポリ塩化ビニル、およびシリコーンから選択されるポリマーを含む、付記２６に記載の方法。
［付記２８］ 前記抗菌コーティングを適用することは、銅、銅合金、または銅マトリックスコンポジットの物理蒸着、化学蒸着、電着、または無電解めっきによって、前記カテーテルアセンブリの前記１つ以上の構成要素のうちの任意の構成要素の前記内面または前記外面に前記銅ベース層を適用することを含み、前記銅ベース層が適用される前記内面または前記外面はポリウレタン、ポリカーボネート、ポリエチレン、ポリプロピレン、ポリ塩化ビニル、およびシリコーンから選択されるポリマー、または前記接着促進層を含む、付記２６に記載の方法。
［付記２９］ 前記抗菌コーティングを適用することは、金、パラジウム、またはチタンの物理蒸着、化学蒸着、電着、または無電解めっきによって前記カテーテルアセンブリの前記１つ以上の構成要素のうちの任意の構成要素の前記内面または前記外面に前記腐食防止層を適用することを含み、前記腐食防止層が適用される前記内面または前記外面は前記銅ベース層を含む、付記２６に記載の方法。
［付記３０］ 前記カテーテルアセンブリの前記構成要素を連結することは、前記カテーテルアセンブリを形成するためにカテーテルチューブをハブに挿入することと、少なくとも１つの延長脚部を前記ハブに挿入することと、前記延長脚部を少なくとも１つのルアーコネクタに挿入することとを含み、前記カテーテルアセンブリは、カテーテルチューブルーメンの内面、ハブルーメンの内面、および延長脚部ルーメンの内面によって画定される流体通路を有する、付記２６～２９のいずれか１つに記載の方法。
Although some specific embodiments are disclosed herein and certain embodiments are disclosed in some detail, the intent of these particular embodiments to limit the scope of the concepts provided herein is intended. do not have. Additional indications and / or modifications may appear to those of skill in the art, and in broader embodiments, these indications and / or modifications are also included. Accordingly, there may be deviations from a particular embodiment without departing from the scope of the concepts provided herein.
[Appendix 1] Correspondence between a hub containing at least one hub bloom that defines a corresponding hub portion of a fluid passage through the catheter assembly and a catheter tube connected to the hub and the fluid passage through the catheter assembly. The catheter tube comprising at least one catheter tube lumen defining the catheter tube portion to be catheterized and the corresponding extension leg of the fluid passage through the catheter assembly which is at least one extension leg connected to the hub. Non-eluting on the inner surface of the catheter assembly, on the outer surface of the catheter assembly, or both on the inner surface and the outer surface of the catheter assembly, with said at least one extension leg containing an extension leg lumen defining a portion. A sexual antibacterial coating, a copper base layer between the anticorrosion layer and the inner or outer surface of the catheter assembly, and an adhesion promoting layer between the copper base layer and the inner or outer surface of the catheter assembly. , Or an antibacterial catheter assembly comprising said antibacterial coating, which is a composite of two or more layers comprising a combination thereof.
[Appendix 2] The antibacterial catheter assembly according to Annex 1, wherein the adhesion promoting layer contains an adhesion promoting metal.
[Appendix 3] The antibacterial catheter assembly according to Annex 2, wherein the adhesion promoting metal promotes adhesion of the copper base layer to a polymer selected from polyurethane, polycarbonate, polyethylene, polypropylene, polyvinyl chloride, and silicone.
[Appendix 4] The antibacterial catheter assembly according to Annex 2 or 3, wherein the adhesion promoting metal is selected from gold, palladium, and titanium.
[Appendix 5] The copper base layer is substantially pure copper, a copper alloy of copper and gold, palladium, zinc, or tin, or a copper matrix composite of copper and tungsten, any one of Supplements 1 to 4. The antibacterial catheter assembly described in one.
[Appendix 6] The antibacterial catheter assembly according to any one of Annex 1 to 5, wherein the anticorrosion layer comprises a corrosion resistant metal selected from gold, palladium, and titanium.
[Appendix 7] The antibacterial catheter assembly according to any one of Supplementary note 1 to 6, wherein the antibacterial coating comprises two layers, the two layers being the adhesion promoting layer and the copper base layer.
[Appendix 8] The antibacterial catheter assembly according to any one of Annex 1 to 6, wherein the antibacterial coating comprises two layers, the two layers being the copper base layer and the corrosion protection layer.
[Appendix 9] The antibacterial coating comprises three layers, the three layers being the adhesion promoting layer, the copper base layer and the corrosion prevention layer, according to any one of the appendices 1 to 6. Antibacterial catheter assembly.
[Appendix 10] The antibacterial coating is any of Annex 1-9, which is on the inner surface of the catheter assembly containing the hub lumen defining the corresponding hub portion of the fluid passage through the catheter assembly. The antibacterial catheter assembly according to one.
[Appendix 11] The antibacterial coating is on the inner surface of the catheter assembly comprising the extension leg lumen defining the corresponding extension leg portion of the fluid passage through the catheter assembly, according to appendices 1-10. The antibacterial catheter assembly according to any one of them.
[Appendix 12] The antibacterial coating is on the outer surface of the catheter assembly, including the antiluminal surface of the extension leg between at least the proximal and distal ends of the extension leg. The antibacterial catheter assembly according to any one of Supplementary note 1 to 11.
[Supplementary Note 13] The antibacterial coating according to any one of Supplementary note 1 to 12, wherein the antibacterial coating is on the outer surface of the catheter assembly including the antiluminal surface of the percutaneous region of the catheter tube. Catheter assembly.
[Appendix 14] Further comprising at least one luer connector coupled to the extension leg, the antibacterial coating is on the inner surface of the catheter assembly including the inner surface of the luer connector that is fluid communicating with the fluid passage, said luer connector. The antibacterial catheter assembly according to any one of Supplementary note 1 to 13, which is on the outer surface of the catheter assembly including the outer surface of the above, or on a combination thereof.
[Appendix 15] An antibacterial catheter assembly, a bifurcated hub comprising a pair of hub blooms defining a corresponding hub portion of a pair of fluid passages through the catheter assembly, and a catheter tube connected to the hub. , A pair of extension legs connected to the catheter tube and the hub, comprising a pair of catheter tube lumens defining a corresponding catheter tube portion of the pair of fluid passages through the catheter assembly, each extension. The legs are a pair of extension legs and a pair of lure connectors, each of which comprises an extension leg lumen defining a corresponding extension leg portion of the pair of fluid passages through the catheter assembly. A pair of luer connectors connected to one extension leg of the pair of extension legs and on the inner surface of the catheter assembly, on the outer surface of the catheter assembly, or on the inner surface and outer surface of the catheter assembly. A non-eluting antibacterial coating in both, said antibacterial coating is a copper base layer between the anticorrosion layer and the inner or outer surface of the catheter assembly, the copper base layer and the inner or outer surface of the catheter assembly. An antibacterial catheter assembly comprising a non-eluting antibacterial coating, which is a composite of two or more layers, comprising an adhesion promoting layer between and, or a combination thereof.
[Appendix 16] The adhesion promoting layer promotes adhesion of the copper base layer to a polymer selected from polyurethane, polycarbonate, polyethylene, polypropylene, polyvinyl chloride, and silicone, and the adhesion promoting layer is gold, palladium, and the like. 25. The antibacterial catheter assembly according to Appendix 15, which comprises a metal selected from titanium and titanium.
[Appendix 17] The antibacterial catheter assembly according to Annex 15 or 16, wherein the copper base layer is substantially pure copper, a copper alloy of copper and gold, palladium, zinc, or tin, or a copper matrix composite of copper and tungsten. ..
[Supplementary Note 18] The antibacterial catheter assembly according to any one of Supplementary note 15 to 17, wherein the corrosion-preventing layer contains a corrosion-resistant metal selected from gold, palladium, and titanium.
[Appendix 19] The antibacterial coating comprises two layers, wherein the two layers are the adhesion promoting layer and the copper base layer, or the copper base layer and the corrosion prevention layer. The antibacterial catheter assembly according to one.
[Appendix 20] The antibacterial coating according to any one of Supplementary note 15 to 18, wherein the antibacterial coating comprises three layers, the three layers being the adhesion promoting layer, the copper base layer, and the corrosion prevention layer. Catheter assembly.
[Appendix 21] The antibacterial coating is any of Annex 15-20, which is on the inner surface of the catheter assembly containing the hub lumen defining the corresponding hub portion of the pair of fluid passages through the catheter assembly. The antibacterial catheter assembly according to one.
[Appendix 22] The antibacterial coating is on the inner surface of the catheter assembly comprising the extension leg lumen defining the corresponding extension leg portion of the pair of fluid passages through the catheter assembly, appendix 15-. 21. The antibacterial catheter assembly according to any one of 21.
[Appendix 23] The antibacterial coating comprises an inner surface of each luer connector that defines a corresponding luer connector portion of the pair of fluid passages through the catheter assembly, on the inner surface of the catheter assembly, and an outer surface of each luer connector. The antibacterial catheter assembly according to any one of Supplementary note 15 to 22, which is on the outer surface of the catheter assembly or on a combination thereof.
[Appendix 24] The antibacterial coating comprises the antiluminal surface of the pair of extension legs between at least the proximal and distal ends of each extension leg, said outer surface of the catheter assembly. The antibacterial catheter assembly according to any one of Supplementary note 15 to 23, which is described above.
[Appendix 25] The antibacterial catheter according to any one of Annex 15 to 24, wherein the antibacterial coating comprises the antiluminal surface of the percutaneous region of the catheter tube and is on the outer surface of the catheter assembly. assembly.
[Appendix 26] A method of manufacturing an antibacterial catheter assembly, wherein the non-eluting antibacterial coating is applied to the inner surface, the outer surface, or both the inner surface and the outer surface of one or more components of the catheter assembly. The antibacterial coating is a copper base layer between the antibacterial layer and the inner or outer surface to which the antibacterial coating is applied, and between the copper base layer and the inner or outer surface to which the antibacterial coating is applied. Applying the antibacterial coating, which is a composite of two or more layers comprising an adhesion-promoting layer, or a combination thereof, and connecting the components of the catheter assembly to form the catheter assembly. How to prepare.
[Appendix 27] Applying the antibacterial coating comprises the one or more configurations of the catheter assembly by physical deposition, chemical deposition, electrodeposition, or electroless plating of a metal selected from gold, palladium, and titanium. The inner or outer surface to which the adhesion-promoting layer is applied comprises applying the adhesion-promoting layer to the inner or outer surface of any component of the element, polyurethane, polycarbonate, polyethylene, polypropylene, polyvinyl chloride. 26. The method of Appendix 26, comprising a polymer selected from vinyl and silicone.
[Appendix 28] The application of the antibacterial coating is by physical deposition, chemical deposition, electrodeposition, or electroless plating of copper, copper alloys, or copper matrix composites of the one or more components of the catheter assembly. The inner or outer surface to which the copper base layer is applied comprises applying the copper base layer to the inner or outer surface of any of the components, polyurethane, polycarbonate, polyethylene, polypropylene, polyvinyl chloride, and the like. 26. The method of Appendix 26, comprising a polymer selected from and silicone, or the adhesion promoting layer.
[Appendix 29] The application of the antibacterial coating is any of the one or more components of the catheter assembly by physical deposition, chemical deposition, electrodeposition, or electroless plating of gold, palladium, or titanium. 26. The method of Appendix 26, comprising applying the corrosion protection layer to the inner or outer surface of the component, wherein the inner or outer surface to which the corrosion protection layer is applied comprises a copper base layer.
[Appendix 30] Connecting the components of the catheter assembly includes inserting the catheter tube into the hub to form the catheter assembly and inserting at least one extension leg into the hub. The catheter assembly comprises inserting the extension leg into at least one luer connector, the catheter assembly having a fluid passage defined by the inner surface of the catheter tube lumen, the inner surface of the hub bloom men, and the inner surface of the extended leg lumen. The method according to any one of Supplementary Provisions 26 to 29.
Claims (23)
前記ハブに連結されたカテーテルチューブであって、前記カテーテルアセンブリを通る前記流体通路の対応するカテーテルチューブ部分を画定する少なくとも１つのカテーテルチューブルーメンを含む前記カテーテルチューブと、
前記ハブに連結された少なくとも１つの延長脚部であって、前記カテーテルアセンブリを通る前記流体通路の対応する延長脚部部分を画定する延長脚部ルーメンを含む前記少なくとも１つの延長脚部と、
前記カテーテルアセンブリの内面上、前記カテーテルアセンブリの外面上、または前記カテーテルアセンブリの前記内面上および前記外面上の両方における非溶出性の抗菌コーティングであって、耐腐食性金属の外側腐食防止層と前記カテーテルアセンブリの前記内面または前記外面を覆う内側接着促進層との間の銅ベース層を含む、３つ以上の層のコンポジットである、前記抗菌コーティング
とを備える抗菌カテーテルアセンブリ。 A hub containing at least one hub lumen defining the corresponding hub portion of the fluid passage through the catheter assembly.
With the catheter tube attached to the hub, the catheter tube comprising at least one catheter tube lumen defining a corresponding catheter tube portion of the fluid passage through the catheter assembly.
The at least one extension leg coupled to the hub and comprising an extension leg lumen defining a corresponding extension leg portion of the fluid passage through the catheter assembly.
A non-eluting antibacterial coating on the inner surface of the catheter assembly, on the outer surface of the catheter assembly, or both on the inner surface and the outer surface of the catheter assembly, with and in front of the outer corrosion resistant layer of corrosion resistant metal. An antibacterial catheter assembly comprising said antibacterial coating, which is a composite of three or more layers, including a copper base layer between the inner or outer surface of the catheter assembly and an inner adhesion promoting layer.
前記カテーテルアセンブリを通る一対の流体通路の対応するハブ部分を画定する一対のハブルーメンを含む、分岐ハブと
前記ハブに連結されたカテーテルチューブであって、前記カテーテルアセンブリを通る前記一対の流体通路の対応するカテーテルチューブ部分を画定する一対のカテーテルチューブルーメンを含む、前記カテーテルチューブと、
前記ハブに連結された一対の延長脚部であって、各延長脚部は、前記カテーテルアセンブリを通る前記一対の流体通路の対応する延長脚部部分を画定する延長脚部ルーメンを含む、一対の延長脚部と、
一対のルアーコネクタであって、各ルアーコネクタは前記一対の延長脚部の１つの延長脚部に連結された、一対のルアーコネクタと、
前記カテーテルアセンブリの内面上、前記カテーテルアセンブリの外面上、または前記カテーテルアセンブリの前記内面上および前記外面上の両方における非溶出性抗菌コーティングであって、耐腐食性金属の外側腐食防止層と前記カテーテルアセンブリの前記内面または前記外面を覆う内側接着促進層との間の銅ベース層を含む、３つ以上の層のコンポジットである、非溶出性抗菌コーティングとを備える、抗菌カテーテルアセンブリ。 An antibacterial catheter assembly
A bifurcation hub and a catheter tube connected to the hub, comprising a pair of hubs that define a corresponding hub portion of the pair of fluid passages through the catheter assembly, of the pair of fluid passages through the catheter assembly. The catheter tube and the catheter tube comprising a pair of catheter tube fluids defining the corresponding catheter tube portion.
A pair of extension legs coupled to the hub, each extension leg comprising a pair of extension leg lumens defining a corresponding extension leg portion of the pair of fluid passages through the catheter assembly. With extended legs,
A pair of lure connectors, each lure connector being connected to one extension leg of the pair of extension legs, and a pair of lure connectors.
A non-eluting antibacterial coating on the inner surface of the catheter assembly, on the outer surface of the catheter assembly, or both on the inner surface and the outer surface of the catheter assembly, the outer corrosion resistant layer of corrosion resistant metal and said. An antibacterial catheter assembly comprising a non-eluting antibacterial coating, which is a composite of three or more layers, including a copper base layer between the inner or outer surface of the catheter assembly and an inner adhesion promoting layer.
前記カテーテルアセンブリの１つ以上の構成要素の内面、外面、または前記内面および前記外面の両方に非溶出性抗菌コーティングを適用することであって、前記抗菌コーティングは、耐腐食性金属の外側腐食防止層と前記カテーテルアセンブリの前記内面または前記外面を覆う内側接着促進層との間の銅ベース層を含む３つ以上の層のコンポジットである、前記抗菌コーティングを適用することと、
前記カテーテルアセンブリを形成するために前記カテーテルアセンブリの前記構成要素を連結することとを備える、方法。 A method for manufacturing antibacterial catheter assemblies.
The application of a non-eluting antibacterial coating to the inner surface, outer surface, or both the inner surface and the outer surface of one or more components of the catheter assembly, wherein the antibacterial coating prevents the outer corrosion of corrosion resistant metals. Applying the antibacterial coating, which is a composite of three or more layers including a copper base layer between the layer and the inner adhesion facilitating layer covering the inner or outer surface of the catheter assembly .
A method comprising connecting the components of the catheter assembly to form the catheter assembly.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862693327P | 2018-07-02 | 2018-07-02 | |
| US62/693,327 | 2018-07-02 | ||
| PCT/US2019/040414 WO2020010152A1 (en) | 2018-07-02 | 2019-07-02 | Antimicrobial catheter assemblies and methods thereof |
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| Publication Number | Publication Date |
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| JP2021530264A JP2021530264A (en) | 2021-11-11 |
| JPWO2020010152A5 true JPWO2020010152A5 (en) | 2022-06-10 |
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| Application Number | Title | Priority Date | Filing Date |
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| JP2020571546A Pending JP2021530264A (en) | 2018-07-02 | 2019-07-02 | Antibacterial catheter assembly and its method |
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| Country | Link |
|---|---|
| US (2) | US11730863B2 (en) |
| EP (1) | EP3817785A4 (en) |
| JP (1) | JP2021530264A (en) |
| CN (1) | CN215915829U (en) |
| WO (1) | WO2020010152A1 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2023239993A1 (en) * | 2022-06-09 | 2023-12-14 | Novaflux Inc. | Drug-releasing catheter extender-lengthener and catheter extension tube |
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