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NZ789739B2 - Antimicrobial and antithrombogenic gaseous release device and related systems and methods - Google Patents
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NZ789739B2 - Antimicrobial and antithrombogenic gaseous release device and related systems and methods - Google Patents

Antimicrobial and antithrombogenic gaseous release device and related systems and methods Download PDF

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Publication number
NZ789739B2
NZ789739B2 NZ789739A NZ78973920A NZ789739B2 NZ 789739 B2 NZ789739 B2 NZ 789739B2 NZ 789739 A NZ789739 A NZ 789739A NZ 78973920 A NZ78973920 A NZ 78973920A NZ 789739 B2 NZ789739 B2 NZ 789739B2
Authority
NZ
New Zealand
Prior art keywords
housing
reservoir
connector
opening
antithrombogenic
Prior art date
Application number
NZ789739A
Other versions
NZ789739A (en
Inventor
James Freasier
Gidon Ofek
Christopher Quach
Original Assignee
Becton Dickinson And Company
Filing date
Publication date
Priority claimed from US17/128,868 external-priority patent/US11872367B2/en
Application filed by Becton Dickinson And Company filed Critical Becton Dickinson And Company
Publication of NZ789739A publication Critical patent/NZ789739A/en
Publication of NZ789739B2 publication Critical patent/NZ789739B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1586—Holding accessories for holding infusion needles on the body
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0019—Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0056—Catheters; Hollow probes characterised by structural features provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like
    • 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
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0258—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0266—Nitrogen (N)
    • A61M2202/0275—Nitric oxide [NO]
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0205—Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/005—Anatomical parts of the body used as an access side to the body
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • 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
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • 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
    • 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
    • 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
    • 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
    • A61M39/18—Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor

Abstract

system (56) for infusing a gas into a vascular access device including a catheter interface (60), which includes a distal end (62), a proximal end (64), and a lumen (66) extending between the distal end and the proximal end. The system also includes a connector (68) disposed on an outer surface (70) of the catheter interface. The connector is configured to be coupled to a reservoir (10). The reservoir includes a housing (12), which includes an opening (14) and a gas impermeable wall (16). The opening is configured to be coupled to the connector of the catheter interface. The reservoir also includes a molecular precursor (18) to a gaseous agent (20) that is suspended in a hydrogel (22) and disposed within the housing. The gaseous agent may be antimicrobial, antithrombogenic, or both antimicrobial and antithrombogenic. The molecular precursor with its gaseous agent prevents catheter-related blood-stream infections (CRBSIs), a common complication when using vascular access devices. The molecular precursor does away with coatings applied to surfaces of vascular access devices in which the antithrombogenic activity of the coating diminish over the indwelling period and therefore lowering the effectiveness of said coating.

Claims (17)

1. A reservoir, comprising: a housing, comprising an opening and a gas impermeable wall, wherein the opening is configured to couple to a vascular access device, and wherein the opening comprises a membrane that is gas-permeable and hydrophobic; and a molecular precursor to a gaseous agent suspended in a hydrogel disposed within the housing, wherein the gaseous agent is antimicrobial, antithrombogenic, or both antimicrobial and antithrombogenic.
2. The reservoir of claim 1, wherein the gaseous agent is nitric oxide.
3. The reservoir of claim 1 or claim 2, wherein the molecular precursor to the gaseous agent is selected from S-nitroso-N-acetylpenicillamine, S-nitrosoglutathione, sodium nitroprusside, or a combination thereof.
4. The reservoir of any one of the preceding claims, wherein the housing further comprises a gas permeable partition that separates the housing into a first chamber and a second chamber, wherein the first chamber comprises the molecular precursor to the gaseous agent suspended in the hydrogel and the second chamber comprises a catalyst for the molecular precursor, wherein the second chamber is separated from the first chamber by a pierceable water impermeable membrane. MARKED-UP
5. The reservoir of claim 1, wherein the housing comprises an upper housing and a lower housing, wherein the upper housing and the lower housing comprise the gas impermeable wall and the lower housing further comprises the opening, wherein the upper housing is configured to couple to the lower housing.
6. The reservoir of claim 5, wherein the housing further comprises a piercing mechanism, wherein upon coupling the reservoir to the vascular access device the piercing mechanism pierces a water impermeable membrane.
7. The reservoir of any one of the preceding claims, wherein the housing further comprises a removable or pierceable seal that covers the opening.
8. The reservoir of any one of the preceding claims, further comprising a wick that penetrates the housing.
9. A system for infusing a gas into a vascular access device, comprising: a catheter interface, wherein the catheter interface comprises a distal end, a proximal end, and one or more lumens extending between the distal end and the proximal end; and a connector disposed on an outer surface of the catheter interface, wherein the connector is configured to couple to a reservoir and allow passage of a gaseous agent from the reservoir to the one or more lumens, wherein the reservoir comprises: MARKED-UP a housing comprising an opening and an impermeable wall, wherein the opening is configured to couple to the connector of the catheter interface and wherein the opening comprises a membrane that is gas-permeable and hydrophobic; and a molecular precursor to the gaseous agent suspended in a hydrogel disposed within the housing, wherein the gaseous agent is antimicrobial, antithrombogenic, or both antimicrobial and antithrombogenic.
10. The system of claim 9, wherein the gaseous agent permeates through the connector and into the lumen, wherein the gaseous agent provides antimicrobial, antithrombogenic, or both antimicrobial and antithrombogenic protection to at least one surface of the catheter system.
11. The system of claim 9 or claim 10, further comprising a fluid pathway in fluid communication between the reservoir and the lumen.
12. The system of any one of claims 9 to 11, wherein the connector is a luer connector or a molded junction fitting such that the reservoir housing mechanically couples to a catheter adapter in an interference fit.
13. The system of any one of claims 9 to 12, wherein the connector further comprises a recessed projection and the opening of the housing further comprises a seal, wherein upon coupling the connector to the reservoir the recessed projection pierces the seal. MARKED-UP
14. The system of any one of claims 9 to 13, wherein the connector further comprises a membrane, wherein the membrane is gas-permeable and hydrophobic.
15. A system for infusing a gas into a vascular access device, comprising: a stabilization device configured to couple to the vascular access device; and a reservoir comprising: a housing, comprising an opening and a gas impermeable wall, wherein the opening is configured to couple to the vascular access device and comprises a membrane that is gas-permeable and hydrophobic and the impermeable wall is coupled to the stabilization device; a molecular precursor to a gaseous agent suspended in a hydrogel disposed within the housing, wherein the gaseous agent is antimicrobial, antithrombogenic or both antimicrobial and antithrombogenic.
16. The system of claim 15, wherein the stabilization device further comprises an adhesive pad such that the stabilization device anchors the vascular access device to an insertion site.
17. The system of claim 15 or claim 16, wherein the vascular access device further comprises a connector disposed on an outer surface, wherein the connector is a molded junction fitting such that the opening of the housing couples to the vascular access device in an interference fit.
NZ789739A 2020-12-22 Antimicrobial and antithrombogenic gaseous release device and related systems and methods NZ789739B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062956546P 2020-01-02 2020-01-02
US17/128,868 US11872367B2 (en) 2020-01-02 2020-12-21 Antimicrobial and antithrombogenic gaseous release device and related systems and methods
PCT/US2020/066632 WO2021138154A1 (en) 2020-01-02 2020-12-22 Antimicrobial and antithrombogenic gaseous release device and related systems and methods

Publications (2)

Publication Number Publication Date
NZ789739A NZ789739A (en) 2024-09-27
NZ789739B2 true NZ789739B2 (en) 2025-01-07

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