WO2023146752A1 - Bouchon antimicrobien pour un orifice d'un dispositif intraveineux - Google Patents

Bouchon antimicrobien pour un orifice d'un dispositif intraveineux Download PDF

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Publication number
WO2023146752A1
WO2023146752A1 PCT/US2023/010503 US2023010503W WO2023146752A1 WO 2023146752 A1 WO2023146752 A1 WO 2023146752A1 US 2023010503 W US2023010503 W US 2023010503W WO 2023146752 A1 WO2023146752 A1 WO 2023146752A1
Authority
WO
WIPO (PCT)
Prior art keywords
cap
port
absorbent material
annular
disposed
Prior art date
Application number
PCT/US2023/010503
Other languages
English (en)
Inventor
Yiping Ma
Original Assignee
Becton, Dickinson And Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/094,796 external-priority patent/US20230233829A1/en
Application filed by Becton, Dickinson And Company filed Critical Becton, Dickinson And Company
Publication of WO2023146752A1 publication Critical patent/WO2023146752A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/20—Closure caps or plugs for connectors or open ends of tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/162—Tube connectors; Tube couplings having provision for disinfection or sterilisation with antiseptic agent incorporated within the connector

Definitions

  • Intravenous devices can employ ports to provide quick access to a patient’s vasculature. These ports also enable the intravenous devices to remain within the patient’s vasculature even when no access to the vasculature is needed.
  • a port of an intravenous device When a port of an intravenous device is not in use, it is desirable to maintain the port clean and free from bacteria and other microbes. If the port becomes contaminated with microbes while not in use, it is possible that the microbes will be flushed into the patient’s vasculature once the port is again used for accessing the patient’s vasculature. Accordingly, maintaining sterility of the port is essential to reduce a risk of infection.
  • the subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced.
  • the present disclosure relates generally to a cap for a port of an intravenous device, as well as related devices and methods.
  • the present disclosure relates to a cap that provides both intraluminal and extraluminal antimicrobial protection.
  • the cap may include an antimicrobial solution for extraluminal protection and an antimicrobial coating for intraluminal protection.
  • the cap for the port of the intravenous device may include a solid post configured to insert into a port of an intravenous device.
  • the cap may include an annular collar surrounding the solid post.
  • the solid post may be tapered inwardly.
  • the solid post may extend further distally than the annular collar.
  • the cap may include an annular cavity disposed between the solid post and the annular collar.
  • the cap may include an absorbent material containing the antimicrobial solution.
  • the absorbent material may be disposed within the annular cavity such that the absorbent material is compressible.
  • the absorbent material in response to the cap being connected to the port of the intravenous device, the absorbent material may be configured to be compressed causing the antimicrobial solution to flow onto the port of the intravenous device.
  • the cap may include the antimicrobial coating disposed on a distalmost surface of the solid post.
  • the solid post may include an annular stepped surface, a proximal portion proximate and proximal to the annular stepped surface, and a distal portion proximate and distal to the annular stepped surface.
  • an outer circumference of the distal portion may be less than an outer circumference of the proximal portion.
  • the antimicrobial coating may be disposed on the distal portion and surround the distal portion. In some embodiments, the antimicrobial coating may be flush with the proximal portion.
  • the annular stepped surface may be disposed within the annular collar. In some embodiments, the annular stepped surface may be disposed distal to the annular collar. In some embodiments, the antimicrobial coating disposed on the distal portion may include an outer diameter less than an outer diameter of the proximal portion. In some embodiments, the antimicrobial coating may cover an entirety of the distalmost surface and is flush with a distal end of the solid post. [0007] In some embodiments, a lid portion may be disposed at a proximal end of the cap. In some embodiments, the annular collar and the solid post may extend from the lid portion. In some embodiments, the lid portion may include a circular disc and close the annular cavity. In some embodiments, the cap may include a cover coupled to the annular collar and covering the antimicrobial coating.
  • an intravenous device may include the port and the cap coupled to the port.
  • the cap may include a solid post configured to insert into the port.
  • the cap may include the annular collar surrounding the solid post, and the annular cavity disposed between the solid post and the annular collar.
  • the cap may include the absorbent material containing the antimicrobial solution.
  • the absorbent material may be disposed within the annular cavity such that the absorbent material is compressible.
  • the absorbent material in response to the cap being connected to the port, the absorbent material may be configured to be compressed causing the antimicrobial solution to flow onto the port.
  • the port may include a septum.
  • the septum in response to the cap being connected to the port, the septum may contact the absorbent material to compress the absorbent material causing the antimicrobial solution to flow onto the septum.
  • the septum in response to the cap being connected to the port, the septum may contact the absorbent material to compress the absorbent material causing the antimicrobial solution to flow onto the septum and an outer surface of the port.
  • the cap may include the antimicrobial coating disposed on a distalmost surface of the solid post.
  • the intravenous device may include a connector.
  • a proximal end of the connector may include the port.
  • the connector may include a cavity distal to the port.
  • the antimicrobial coating may be disposed within the cavity.
  • the solid post may include the annular stepped surface, the proximal portion proximate and proximal to the annular stepped surface, and the distal portion proximate and distal to the annular stepped surface.
  • the outer circumference of the distal portion may be less than the outer circumference of the proximal portion.
  • the antimicrobial coating may be disposed on the distal portion and surround the distal portion. In some embodiments, the antimicrobial coating may be flush with the proximal portion.
  • the annular stepped surface may be disposed distal to the annular collar.
  • Figure 1A is an upper perspective view of an example connector of an intravenous device
  • Figure IB is a cross-sectional view of an example connector of the intravenous device
  • Figure 2A is an upper perspective view of an example cap, according to some embodiments.
  • Figure 2B is a cross-sectional view of the cap of Figure 2A, according to some embodiments.
  • Figure 2C is a cross-sectional view of the cap of Figure 2A coupled to the connector, according to some embodiments;
  • Figure 3A is an upper perspective view of an example cap, according to some embodiments.
  • Figure 3B is a cross-sectional view of the cap of Figure 3A, according to some embodiments.
  • Figure 3C is a cross-sectional view of the cap of Figure 3 A coupled to the connector, according to some embodiments;
  • Figure 4A is an upper perspective view of an example cap, according to some embodiments.
  • Figure 4B is a cross-sectional view of the cap of Figure 4A, according to some embodiments.
  • Figure 4C is a cross-sectional view of the cap of Figure 4A coupled to the connector, according to some embodiments.
  • Figure 5A is an upper perspective view of an example cap, according to some embodiments;
  • Figure 5B is a cross-sectional view of the cap of Figure 5A, according to some embodiments;
  • Figure 5C is a cross-sectional view of the cap of Figure 5 A coupled to the connector, according to some embodiments.
  • Figure 6A is an upper perspective view of an example cap, according to some embodiments.
  • Figure 6B is a cross-sectional view of the cap of Figure 6A, according to some embodiments.
  • Figure 6C is a cross-sectional view of the cap of Figure 6A coupled to the connector, according to some embodiments.
  • Figure 7A is an upper perspective view of an example cover disposed on an example cap, according to some embodiments.
  • Figure 7B is a cross-sectional view of the cover on the cap of Figure 7A, according to some embodiments.
  • a connector 10 of an intravenous device may include a proximal end 12 and a distal end 14.
  • distal refers to a portion that is described which is further from a user
  • proximal refers to a portion that is being described which is closer to the user.
  • Figures 1A-1B illustrate an example of the connector 10.
  • the connector 10 may include any suitable needle-free connector of an intravenous device.
  • the distal end 14 may include a male luer 15 and/or a collar 16 surrounding the male luer 15.
  • the proximal end 12 may include a port 18, which may be threaded. In some instances, the port 18 may include a female luer.
  • the port 18 may include a septum 20 extending therethrough and sealing an interior of the connector 10 from an exterior environment.
  • a lumen 21 of the connector 10 extending through the proximal end 12 and the distal end 14 may include a cavity 22 distal to the port 18.
  • the cavity 22 may be wider than the male luer 15.
  • the intravenous device may include a catheter assembly, which may be coupled to the connector 10.
  • a cap 30 for the port 18 of the intravenous device, or another similar port may include a solid post 32 configured to insert into the port 18.
  • the cap 30 may include an annular collar 36 surrounding the solid post 32.
  • the annular collar 36 may include threads such that the annular collar 36 is configured to be threaded to the port 18.
  • the annular collar 36 may not include the threads and may be configured to be slip fit with the port 18.
  • the cap 30 may include an annular cavity 38 disposed between the solid post 32 and the annular collar 36.
  • the cap 30 may include an absorbent material 40 containing an antimicrobial solution.
  • the antimicrobial solution may include chlorhexidine gluconate (CHG), alcohol, or another suitable antimicrobial solution.
  • the absorbent material 40 may be disposed within the annular cavity 38 such that the absorbent material 40 is compressible.
  • the absorbent material 40 may be annular.
  • Figure 2B illustrates the absorbent material 40 uncompressed, according to some embodiments.
  • Figure 2C illustrates the absorbent material 40 compressed when the connector 10 is capped, according to some embodiments.
  • the septum 20 or another portion of the connector 10 may contact the absorbent material 40 to compress the absorbent material 40 causing the antimicrobial solution to flow onto the septum 20.
  • the septum 20 of the connector 10 may contact the absorbent material 40 to compress the absorbent material 40.
  • the antimicrobial solution may flow onto an extraluminal portion of the septum 20 outside of the lumen 21, providing antimicrobial protection.
  • the septum 20 in response to the cap 30 being connected to the port 18, the septum 20 may contact the absorbent material 40 to compress the absorbent material 40 causing the antimicrobial solution to flow onto the septum 20 and/or an outer surface of the port 18.
  • the antimicrobial solution may flow distally through a space between the septum 20 and an inner surface of the port 18 as illustrated, for example, in Figure 2C.
  • the solid post 32 may be tapered inwardly such as an outer surface of a male luer taper. In some embodiments, the solid post 32 may be tapered inwardly in a distal direction along all or a portion of a length of the solid post 32, which may facilitate insertion of the solid post 32 through the septum 20. In these embodiments, the solid post 32 may include a truncated cone shape. In some embodiments, the solid post 32 may be cylindrical.
  • the cap 30 may include an antimicrobial coating 42 disposed on a distalmost surface 44 of the solid post 32.
  • the cap 30 may provide intraluminal and/or extraluminal antimicrobial protection.
  • the cap 30 may include the antimicrobial solution for extraluminal protection and only the antimicrobial coating 42 for intraluminal protection.
  • the antimicrobial coating 42 may be configured to elute an antimicrobial agent in response to contact with a catheter lock solution disposed within the lumen 21 and the cavity 22.
  • the antimicrobial coating 42 may include chlorhexidine acetate (CHA), silver, a combination of CHA and silver, or another suitable antimicrobial coating.
  • the solid post 32 that is cylindrical or just slightly tapered may facilitate the distalmost surface 44 being larger to accommodate more antimicrobial coating 42.
  • the solid post 32 may extend further distally than the annular collar 36, which may facilitate placement of the antimicrobial coating 42 deep within the lumen 21, such as, for example, in the cavity 22.
  • the distalmost surface 44 may be planar or generally planar.
  • the solid post 32 may include an annular stepped surface 46, a proximal portion 48 proximate and proximal to the annular stepped surface 46, and a distal portion 50 proximate and distal to the annular stepped surface 46.
  • the distal portion may be proximate the distalmost surface 44.
  • an outer circumference of the distal portion 50 may be less than an outer circumference of the proximal portion 48.
  • the antimicrobial coating 42 may be disposed on the distal portion 50 and surround the distal portion 50.
  • the annular stepped surface 46 may allow the antimicrobial coating 42 to be flush with the proximal portion 48.
  • the antimicrobial coating 42 may not increase an outer diameter of the solid post 32 and thus may not affect a surface of a cylinder or the male luer taper of the solid post 32.
  • the antimicrobial coating 42 may maintain a same angle as the distal portion 50.
  • the annular stepped surface 46 may be disposed distal to the annular collar 36, which may concentrate the antimicrobial coating 42 distally within the lumen 21, where the antimicrobial coating 42 may come into increased contact with the catheter lock solution.
  • the annular stepped surface 46 may allow the antimicrobial coating 42 to extend annular around the solid post 32, increasing a length of the antimicrobial coating 42 along the solid post 32 while not increasing the outer diameter of the solid post 32.
  • a lid portion 52 may be disposed at a proximal end 54 of the cap 30.
  • the annular collar 36 and the solid post 32 may extend distally from the lid portion 52.
  • the lid portion 52 may include a circular disc and/or may close the annular cavity 38.
  • the absorbent material 40 may contact the lid portion 52 and may be configured to be compressed towards the lid portion 52.
  • the antimicrobial coating 42 may cover an entirety of the distalmost surface 44 and may be flush with a distal end 56 of the solid post 32. In these embodiments, the antimicrobial coating 42 may not increase an outer diameter of the solid post 32 and thus may not affect a surface of a cylinder or the male luer taper of the solid post 32. In some embodiments, the antimicrobial coating 42 may maintain a same angle as the distal end 56. In some embodiments, the antimicrobial coating 42 covering the entirety of the distalmost surface 44 may increase an amount of antimicrobial coating 42 present in the lumen 21 to provide antimicrobial protection.
  • Figure 3B illustrates the absorbent material 40 uncompressed, according to some embodiments.
  • Figure 3C illustrates the absorbent material 40 compressed when the connector 10 is capped, according to some embodiments.
  • the antimicrobial coating 42 disposed on the distalmost surface 44 may include an outer diameter less than an outer diameter of the distalmost surface 44, creating an annular step between the distalmost surface 44 and the antimicrobial coating 42.
  • the outer diameter of the antimicrobial coating 42 less than the outer diameter of the distalmost surface 44 may facilitate extension of the antimicrobial coating 42 further into the connector 10, which may be narrower.
  • the connector 10 may include the cavity 22 distal to the port.
  • Figure 4B illustrates the absorbent material 40 uncompressed, according to some embodiments.
  • Figure 4C illustrates the absorbent material 40 compressed when the connector 10 is capped, according to some embodiments.
  • the antimicrobial coating 42 disposed on the distal portion 50 may include an outer diameter less than an outer diameter of the proximal portion 48, creating an annular step between the distal portion 50 and the antimicrobial coating 42.
  • the outer diameter of the antimicrobial coating 42 less than the outer diameter of the proximal portion 48 may facilitate extension of the antimicrobial coating 42 further into the connector 10, which may be narrower.
  • Figure 5B illustrates the absorbent material 40 uncompressed, according to some embodiments.
  • Figure 5C illustrates the absorbent material 40 compressed when the connector 10 is capped, according to some embodiments.
  • the annular stepped surface 46 may be disposed within the annular collar 36.
  • the antimicrobial coating 42 may contact the absorbent material 40, which may be soaked with saline solution or ionized water.
  • the antimicrobial coating 42 in response to the antimicrobial coating 42 contacting the absorbent material 40 after assembly of the cap 30 (such as, for example, during sterilization, transportation, and/or storage), the antimicrobial coating 42 may elute an antimicrobial agent, producing an antimicrobial solution that may then protect extraluminal surfaces of the connector 10 when the connector 10 is capped.
  • Figure 6B illustrates the absorbent material 40 uncompressed, according to some embodiments.
  • Figure 6C illustrates the absorbent material 40 compressed when the connector 10 is capped, according to some embodiments.
  • the cap 30 may include a cover 58, which may be coupled to the annular collar 36.
  • the cover 58 may cover the antimicrobial coating 42.
  • the cover 58 may seal off the cap 30 and prevent evaporation of the antimicrobial solution in the absorbent material 40.
  • the cover 58 may be attached to a surface of the cap 30, such as the annular collar 36, using pressure sensitive adhesive (PSA), a mechanical snap feature, or another suitable means.
  • PSA pressure sensitive adhesive
  • a user may remove the cover 58 from a remaining portion of the cap 30 before coupling the cap 30 to the connector 10 or capping the connector 10.
  • the cover 58 may include a tab 60, which may facilitate peeling off of the cover 58 by the user. It is understood that the cover 58 may be used with any of the embodiments of the cap 30 of Figures 2-6. Moreover, it is understood that one or more of the embodiments of Figures 2-6 may be combined such that a particular embodiment may include be similar to one or more other embodiments in terms of one or more components and/or operation.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Un bouchon pour un orifice d'un dispositif intraveineux peut comprendre un montant solide conçu pour s'insérer dans un orifice d'un dispositif intraveineux. Le bouchon peut comprendre un collier annulaire entourant le montant solide, et une cavité annulaire disposée entre le montant solide et le collier annulaire. Le bouchon peut comprendre un matériau absorbant contenant une solution antimicrobienne. Le matériau absorbant peut être disposé à l'intérieur de la cavité annulaire de telle sorte que le matériau absorbant est compressible. En réponse au fait que le bouchon est relié à l'orifice du dispositif intraveineux, le matériau absorbant peut être configuré pour être comprimé, amenant la solution antimicrobienne à s'écouler sur l'orifice du dispositif intraveineux.
PCT/US2023/010503 2022-01-25 2023-01-10 Bouchon antimicrobien pour un orifice d'un dispositif intraveineux WO2023146752A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202263302918P 2022-01-25 2022-01-25
US63/302,918 2022-01-25
US18/094,796 US20230233829A1 (en) 2022-01-25 2023-01-09 Cap for a port of an intravenous device
US18/094,796 2023-01-09

Publications (1)

Publication Number Publication Date
WO2023146752A1 true WO2023146752A1 (fr) 2023-08-03

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PCT/US2023/010503 WO2023146752A1 (fr) 2022-01-25 2023-01-10 Bouchon antimicrobien pour un orifice d'un dispositif intraveineux

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WO (1) WO2023146752A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090008393A1 (en) * 2007-01-16 2009-01-08 Howlett Michael W Nestable sterility-protecting caps with fluid reservoir for separated connectors
US20120022469A1 (en) * 2010-07-22 2012-01-26 Carefusion 303, Inc. Needleless valve infection prevention and pre-opening device
US20190351212A1 (en) * 2018-05-15 2019-11-21 Baxter International Inc. Disinfectant caps for luer access devices
US20200269033A1 (en) * 2017-11-09 2020-08-27 3M Innovative Properties Company Disinfecting cap for luer devices
US20210205596A1 (en) * 2020-01-06 2021-07-08 Icu Medical, Inc. Antimicrobial cap for luer connector

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090008393A1 (en) * 2007-01-16 2009-01-08 Howlett Michael W Nestable sterility-protecting caps with fluid reservoir for separated connectors
US20120022469A1 (en) * 2010-07-22 2012-01-26 Carefusion 303, Inc. Needleless valve infection prevention and pre-opening device
US20200269033A1 (en) * 2017-11-09 2020-08-27 3M Innovative Properties Company Disinfecting cap for luer devices
US20190351212A1 (en) * 2018-05-15 2019-11-21 Baxter International Inc. Disinfectant caps for luer access devices
US20210205596A1 (en) * 2020-01-06 2021-07-08 Icu Medical, Inc. Antimicrobial cap for luer connector

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