Antimicrobial and antithrombotic gas release device and related system and method
A storage vessel with a hydrogel-based gaseous agent system addresses the limitations of existing coatings by providing continuous antimicrobial and antithrombotic protection to vascular access devices, reducing CRBSI risk and maintaining effectiveness over time.
Patent Information
- Authority / Receiving Office
- KR · KR
- Patent Type
- Patents
- Current Assignee / Owner
- BECTON DICKINSON & CO
- Filing Date
- 2020-12-22
- Publication Date
- 2026-07-29
AI Technical Summary
Existing vascular access devices face challenges with antimicrobial and antithrombotic coatings that are costly, difficult to apply, and lose effectiveness over time, increasing the risk of catheter-associated bloodstream infections (CRBSI) due to biofilm formation.
A storage vessel containing a molecular precursor for a gaseous agent suspended in a hydrogel, which is released through a catalyst to provide continuous antimicrobial and antithrombotic protection when coupled to a vascular access device, using a system with a gas-permeable membrane and perforation mechanism to control agent release.
The system provides sustained antimicrobial and antithrombotic protection to vascular access devices, reducing the risk of infections and biofilm formation, and is cost-effective with regenerable components.
Smart Images

Figure 112022079038049-PCT00001_ABST
Abstract
Description
Background Technology
[0001] When using vascular access devices, catheter-associated bloodstream infection (CRBSI) can be a common complication. Vascular access device infections leading to CRBSI can be caused by the failure to regularly clean the device, non-sterile insertion techniques, or pathogens entering the fluid flow path through both ends of the route after insertion. Studies show that increased catheter stay length increases the risk of CRBSI. When a vascular access device begins to become contaminated, pathogens attach to the device, colonize it, and form biofilms. Biofilms are resistant to most biocides and provide a sufficient source of pathogens that enter the patient's bloodstream and cause infection.
[0002] Antimicrobial or antithrombotic agents have been incorporated into coatings applied to the surfaces of vascular access devices. However, applying such coatings to the device can be difficult or costly. Other problems with these coatings include increased manufacturing costs for vascular access devices and the requirement of relatively long periods for solvent evaporation or coating curing. Furthermore, the antimicrobial or antithrombotic activity of the coating decreases over time, reducing the effectiveness of the antimicrobial or antithrombotic agent. Therefore, there is a demand in the industry for improved means to provide antimicrobial and antithrombotic capabilities to various types of medical devices, particularly those associated with infusion therapy.
[0003] The subject matter disclosed and claimed herein is not limited to embodiments that address any disadvantage or operate only in environments such as those described above. Instead, this background is provided merely to describe an exemplary technical field in which some of the embodiments described herein may be practiced. Prior art literature
[65535] U.S. Patent Application Publication No. 2015 / 0202422 U.S. Patent Application Publication No. 2019 / 0234540 U.S. Patent Application Publication No. 2015 / 0231384 means of solving the problem
[0004] The present disclosure relates to a storage vessel for receiving a molecular precursor for a gaseous agent suspended in a hydrogel disposed within a housing, and to a related system and method, wherein the gaseous agent is antimicrobial or antithrombotic. In some embodiments, the storage vessel may comprise a housing having an opening and a gas-impermeable wall. The opening may be configured to be coupled to a vascular access device. In some embodiments, the storage vessel may also comprise a molecular precursor for a gaseous agent that may be suspended in a hydrogel and disposed within a housing. In some embodiments, the gaseous agent may be antimicrobial, antithrombotic, or both antimicrobial and antithrombotic.
[0005] In some embodiments, the opening of the housing may also include a membrane. In some embodiments, the membrane may be gas-permeable and hydrophobic. In some embodiments, the housing may also include a removable or perforable seal covering the opening. In some embodiments, the molecular precursor for the gas agent may be S-nitroso-N-acetylpenicillamine, S-nitrosoglutathione, sodium nitroprusside, or a combination thereof. In some embodiments, the gas agent may be nitric oxide.
[0006] In some embodiments, the housing of the storage container may include a gas-permeable compartment that separates the housing into a first chamber and a second chamber. In some embodiments, the first chamber may include a molecular precursor for a gas agent suspended in a hydrogel, and the second chamber may include a catalyst for a molecular precursor for releasing the gas agent. In some embodiments, the second chamber may include a catalyst within the housing. In some embodiments, the catalyst may be water or saline solution. In some embodiments, the catalyst may further include a metal catalyst. In some embodiments, the second chamber may be separated from the hydrogel by a perforable water-impermeable membrane.
[0007] In some embodiments, the storage container housing may include an upper housing and a lower housing. In some embodiments, both the upper housing and the lower housing may include a gas impermeable wall. In some embodiments, the lower housing may further include an opening, and the upper housing may be configured to be coupled to the lower housing.
[0008] In some embodiments, the housing may also include a perforation mechanism for perforating a water-impermeable membrane when coupling the storage vessel to a vascular access device to catalyze the production of a gaseous agent from a molecular precursor. In some embodiments, the storage vessel may include a wick that penetrates the housing.
[0009] In some embodiments, a system for injecting gas into a vascular access device may include a catheter interface. In some embodiments, the catheter interface may include a distal end, a proximal end, and one or more lumens extending between the distal and proximal ends. In some embodiments, the catheter interface may include a connection disposed on the outer surface of the catheter interface. In some embodiments, the connection may be configured to be coupled to a reservoir and to allow the passage of a gaseous agent from the reservoir to one or more lumens. In some embodiments, the reservoir comprises a housing and a molecular precursor for the gaseous agent suspended within a hydrogel disposed within the housing. In some embodiments, the gaseous agent may penetrate through the connection and into one or more lumens. In some embodiments, the gaseous agent may provide antimicrobial or antithrombotic protection, or both antimicrobial and antithrombotic protection, to the surface of the catheter system.
[0010] In some embodiments, the system for injecting gas into a vascular access device may include a fluid path fluidly communicating between a reservoir and one or more lumens. In some embodiments, the connection may be a Luer connector or a molded joint fitting. In some embodiments, the reservoir housing may be mechanically coupled to a catheter adapter by a press fit. In some embodiments, the connection may also include a recessed projection mechanism. In some embodiments, the opening of the housing may include a seal, and the recessed projection may puncture the seal when the connection is coupled to the reservoir. In some embodiments, the connection may include a gas-permeable and hydrophobic membrane.
[0011] In some embodiments, a system for injecting gas into a vascular access device may include a stabilization device configured to be coupled to the vascular access device and a reservoir. In some embodiments, the reservoir may include a housing and a molecular precursor for a gaseous agent suspended within a hydrogel disposed within the housing. In some embodiments, the stabilization device may also include an adhesive pad so that the stabilization device secures the vascular access device to the insertion site. In some embodiments, the vascular access device may include a connection disposed on an external surface. In some embodiments, the connection may be a molded bonding fitting so that an opening in the housing is coupled to a catheter system by a press fit.
[0012] It will be understood that both the general description above and the specific description below are examples and illustrative and do not limit the invention as claimed. It should be understood that various embodiments are not limited to the arrangements and means depicted in the drawings. Furthermore, it should be understood that embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of various embodiments of the invention unless claimed. Accordingly, the following detailed description is not meant to be restrictive. Brief explanation of the drawing
[0013] Exemplary embodiments will be described and explained with additional specificity and detail through the use of the attached drawings. FIG. 1a is a cross-sectional view of an exemplary storage container according to some embodiments. FIG. 1b is a cross-sectional view of another exemplary storage container according to some embodiments. FIG. 2a is a cross-sectional view of another exemplary storage container according to some embodiments. FIG. 2b is a cross-sectional view of another exemplary storage container according to some embodiments. FIG. 2c is a cross-sectional view of another exemplary storage container according to some embodiments. FIG. 2d is a cross-sectional view of another exemplary storage container according to some embodiments. FIG. 2e is a cross-sectional view of another exemplary storage container according to some embodiments. FIG. 2f is a cross-sectional view of another exemplary storage container according to some embodiments. FIG. 3a is a top view of a blood vessel access device according to some embodiments. FIG. 3b is a cross-sectional view of the vascular access device of FIG. 4a according to some embodiments. FIG. 4a is a side view of a blood vessel access device and a storage container according to some embodiments. FIG. 4b is a cross-sectional view of the vascular access device of FIG. 5a according to some embodiments. FIG. 4c is a side view of another exemplary vascular access device according to some embodiments. FIG. 4d is a cross-sectional view of another exemplary storage container according to some embodiments. FIG. 4e is a side view of another exemplary vascular access device according to some embodiments. FIG. 5a is a top perspective view of an exemplary stabilization device according to some embodiments. FIG. 5b is a cross-sectional view of the stabilization device of FIG. 6a according to some embodiments. Specific details for implementing the invention
[0014] Now, referring to FIGS. 1a and 1b, in some embodiments, the storage container (10) may include a housing (12) which may include an opening (14) and a gas-impermeable wall (16). In some embodiments, the opening (14) may be configured to be coupled to a vascular access device. In some embodiments, the storage container (10) may include a molecular precursor (18) for a gaseous agent (20) suspended in a hydrogel (22). In some embodiments, the hydrogel (22) may be placed within the housing (12). In some embodiments, the gaseous agent (20) may be antibacterial, antithrombotic, or both antibacterial and antithrombotic.
[0015] In some embodiments, the opening (14) may include a membrane (24). In some embodiments, the membrane (24) may retain the hydrogel (22) within the housing (12). In some embodiments, the membrane (24) may be hydrophobic. In some embodiments, the membrane (24) may be gas permeable. In some embodiments, a gas agent (20) may pass through the membrane (24), and the hydrogel (22) is retained within the housing (12). In some embodiments, the membrane (24) may be composed of silicone. In some embodiments, the membrane (24) may be a polyester copolymer. In some embodiments, the membrane (24) may be a fluorinated polymer. In other embodiments, the membrane (24) may be composed of any suitable material known in the art that is hydrophobic and gas permeable.
[0016] In some embodiments, the gaseous agent (20) may be nitric oxide. In some embodiments, the gaseous agent (20) may be any other gas exhibiting antibacterial and / or antithrombotic properties. In some embodiments, the molecular precursor (18) may be S-nitroso-N-acetylpenicillamine (SNAP), S-nitrosoglutathione, sodium nitroprusside (SNP), or a combination thereof. In some embodiments, the molecular precursor (18) may be any precursor for the gaseous agent that can be suspended within the hydrogel (22), or any other type of suitable antibacterial or antithrombotic agent delivery system known in the art. In some embodiments, the hydrogel (22) may be polyethylene glycol (PEG). In other embodiments, the hydrogel (22) may be alginate or other suitable hydrogel.
[0017] In some embodiments, the housing (12) may be cylindrical. In some embodiments, the gas impermeable wall (16) may be impermeable to the gas agent (20). In some embodiments, the gas impermeable wall (16) is impermeable to the molecular precursor (18) and the hydrogel (22). In some embodiments, the gas impermeable wall (16) may be made of high-hardness urethane. In some embodiments, the gas impermeable wall (16) may be polyester, high-density polyethylene, polypropylene, polystyrene, or any suitable plastic or material known in the art. In some embodiments, the gas impermeable wall (16) may be spherical, cubic, or other geometric shapes.
[0018] In some embodiments, the membrane (24) may be mechanically coupled to the inner wall of the gas impermeable wall (16). In some embodiments, the membrane (24) may be coupled to the gas impermeable wall with an adhesive. In some embodiments, the housing (12) may further include a seal (26) covering the opening (14). In some embodiments, the seal (26) may protect the membrane from being perforated or exposed. In some embodiments, the seal (26) may be removable and / or perforable. In some embodiments, the seal (26) may be impermeable to any type of gas or fluid. In some embodiments, the seal (26) may be foil, plastic, or any suitable seal known in the art. In some embodiments, the seal (26) may be coupled to the housing (12) with an adhesive or any other suitable attachment method.
[0019] In some embodiments, the storage container (10) may also include a compartment (28) that may be gas permeable. In some embodiments, the compartment (28) may separate the housing (12) into a first chamber (30) and a second chamber (32). In some embodiments, the first chamber (30) may contain a molecular precursor (18) suspended in the hydrogel (22), and the second chamber (32) may contain a catalyst for the molecular precursor (18). In some embodiments, the compartment (28) may separate the housing (12) so that the first chamber (30) and the second chamber (32) are approximately the same size. In some embodiments, the second chamber (32) may be close to the opening (14). In some embodiments, the compartment (28) may separate the housing (12) so that the first chamber (30) is larger than the second chamber (32). In some embodiments, the compartment (28) can separate the storage container (10) so that both the first chamber (30) and the second chamber (32) are close to the opening (14) and / or the membrane (24).
[0020] Now, referring to FIGS. 2a through 2e, in some embodiments, the second chamber (32) may be separated from the first chamber (30) by a perforable water-impermeable membrane (34). In some embodiments, the second chamber (32) may be a thin film of water or saline solution within the housing (12). In some embodiments, the second chamber (32) may include a water-soluble catalyst (36).
[0021] In some embodiments, the catalyst (36) for the molecular precursor (18) may comprise pure water, deoxidized water, deionized water, or ionized water. In other embodiments, the catalyst (36) may comprise an aqueous buffer solution. In some embodiments, the catalyst (36) may be a metal. In some embodiments, the catalyst (36) may comprise an aqueous solution having a catalyst ion or element. In some embodiments, the catalyst (36) may be an ion or element that may include copper, iron, zinc, selenium, or a combination thereof. In some embodiments, the aqueous buffer solution may be any suitable solution known in the art.
[0022] In some embodiments, water or an aqueous solution may initiate the release of nitric oxide from the molecular precursor (18). In some embodiments, SNAP, SNP, S-nitrosoglutathione and other nitrating agents may spontaneously denitrify or donate nitric oxide in the aqueous solution. In some embodiments, SNP may be readily soluble in water and / or a buffer solution and release nitric oxide in the presence of water. In some embodiments, the storage container (10) may continuously release the gaseous agent (20).
[0023] In some embodiments, the housing (12) may include a perforation mechanism (38). In some embodiments, the perforation mechanism (38) may be configured to perforate a perforable water-impermeable membrane (34). In some embodiments, upon perforation of the perforable water-impermeable membrane (34), the molecular precursor (18) may be wetted and the gaseous agent (20) may be released from the hydrogel (22). In some embodiments, the perforation mechanism (38) may perforate the water-impermeable membrane (34) when coupling the storage container (10) to a blood vessel access device.
[0024] In some embodiments, the perforation mechanism (38) may include a pointed end (40). In some embodiments, upon contact between the pointed end (40) and the perforable water-impermeable membrane (34), water and / or a buffer solution passes through the perforable water-impermeable membrane (34) to hydrate the hydrogel (22). In some embodiments, the perforation mechanism (38) may be coupled to the housing (12). In some embodiments, the perforation mechanism (38) may extend to or beyond the outer surface of the housing (12). In some embodiments, the perforation mechanism (38) may extend through the membrane (24). In some embodiments, the perforation mechanism (38) may extend outside the gas-impermeable wall (16). In some embodiments, the pointed end (40) perforates the perforable water-impermeable membrane (34) by pushing a portion of the perforation mechanism (38) that extends to or beyond the outer surface of the housing (12). In some embodiments, the perforation mechanism (38) may be pushed by coupling the storage container (10) to a vascular access device. In some embodiments, the perforation mechanism (38) may be pressed by a user, such as a clinician.
[0025] Referring to FIGS. 2c through 2e, in some embodiments, the housing (12) may comprise two separable parts, an upper housing (42) and a lower housing (44). In some embodiments, both the upper housing (42) and the lower housing (44) may comprise a gas impermeable wall (16). In some embodiments, the lower housing (44) may comprise an opening (14). In some embodiments, the upper housing (42) may be configured to be coupled to the lower housing (44).
[0026] In some embodiments, the upper housing (42) may include a first chamber (30). In other embodiments, the upper housing (42) may include a second chamber (32). In some embodiments, the upper housing (42) may include both the first chamber (30) and the second chamber (32). In some embodiments, the upper housing (42) may include a perforation mechanism (38).
[0027] In some embodiments, the lower housing (44) may include a first chamber (30). In other embodiments, the lower housing (44) may include a second chamber (32). In some embodiments, the lower housing (44) may include both the first chamber (30) and the second chamber (32). In some embodiments, the lower housing (44) may include a perforation mechanism (38). In some embodiments, the perforation mechanism (38) may be conical in shape. In some embodiments, the perforation mechanism (38) may be integrated into the upper housing (42) or the lower housing (44) and may perforate the water-impermeable membrane (34) when coupling the storage container (10) to a blood vessel access device.
[0028] In some embodiments, the upper housing (42) and the lower housing (44) may be constructed of the same material. In some embodiments, both the upper housing (42) and the lower housing (44) may be constructed of high-hardness urethane. In some embodiments, the high-hardness urethane may prevent the gas agent (20) from diffusing or flowing outside the gas impermeable wall (16). In some embodiments, the upper housing (42) may be constructed of a material having greater hardness than the lower housing (44). In other embodiments, the lower housing (44) may have greater hardness than the upper housing (42).
[0029] In some embodiments, the upper housing (42) and the lower housing (44) may have the same size. In some embodiments, the volume and / or length of the upper housing (42) and the lower housing (44) may have the same size. In some embodiments, the upper housing (42) or the lower housing (44) may have different sizes. In some embodiments, the first chamber (30) containing the molecular precursor (18) suspended in the hydrogel (22) may have a longer length than the second chamber (32) containing the catalyst for the molecular precursor (18). In some embodiments, the longer length of the first chamber (30) may prevent the perforation mechanism (38) from accidentally perforating the membrane (24).
[0030] In some embodiments, the upper housing (42) and the lower housing (44) may be coupled together by a clipping mechanism (46). In some embodiments, the clipping mechanism (46) may include a tooth (48) and a clip (50) that are coupled together and maintain the upper housing (42) being coupled to the lower housing (44). In some embodiments, the clipping mechanism (46) may have a plurality of teeth (48) so that the upper housing (42) and the lower housing (44) can ratchet together, and thus the perforation mechanism (38) perforates the water-impermeable membrane (34) when the upper housing (42) and the lower housing (44) are pushed together.
[0031] In some embodiments, the storage container (10) may include a safety mechanism (52) capable of preventing the perforation mechanism (38) from accidentally perforating the water-impermeable membrane (34). In some embodiments, the safety mechanism (52) may be a cylindrical spacer between the upper housing (42) and the lower housing (44). In some embodiments, the safety mechanism (52) may be removed so that the safety mechanism (52) can be removed and discarded before coupling the storage container (10) to a blood vessel access device. In some embodiments, the safety mechanism (52) may be compressed.
[0032] Now, referring to FIG. 2f, in some embodiments, the storage container (10) may include a wick (54). In some embodiments, the wick (54) may be a water-carrying or solution-carrying device that allows water and / or an aqueous solution to be carried into the housing (12) to wet the hydrogel (22). In some embodiments, the wick (54) may extend through a membrane (24) or through a gas-impermeable wall (16). In some embodiments, the wick (54) may be configured to be wetted when the storage container is coupled to a vascular access device. In some embodiments, the wick (54) may be constructed of synthetic fibers. In some embodiments, the wick (54) may be constructed of polyester. In other embodiments, the wick (54) may be constructed of cotton, other natural fibers, or any other suitable wicking material.
[0033] Now, referring to FIGS. 3a and 3b, in some embodiments, a system (56) for injecting gas into a vascular access device (58) may include a catheter interface (60). In some embodiments, the catheter interface (60) may include a distal end (62), a proximal end (64), and one or more lumens (66) extending between the distal end (62) and the proximal end (64). In some embodiments, the catheter interface (60) may include a catheter adapter. In some embodiments, the catheter interface (60) may include any suitable vascular access device (58).
[0034] In some embodiments, the system (56) may include a connection (68) disposed on the outer surface (70) of the catheter interface (60). In some embodiments, the connection (68) may be configured to be coupled to a storage container (10). In some embodiments, the gaseous agent (20) may penetrate through the connection (68) and into one or more lumens (66). One or more lumens (66) may include at least one inner surface (72) of the catheter interface (60). In some embodiments, the gaseous agent (20) may provide antibacterial, antithrombotic, or antibacterial and antithrombotic protection to the outer surface (70) and / or inner surface (72) of the catheter interface (60). In some embodiments, the gaseous agent (20) may provide antibacterial and / or antithrombotic protection to the outer surface (70) by diffusion through the catheter interface (60). In some embodiments, after the molecular precursor (18) is depleted, the storage container (10) may be removed from the connection (68) and replaced. Thus, the storage container (10) is regenerable or replaceable as needed, and accordingly provides antibacterial and / or antithrombotic protection to the inner surface (72) and / or outer surface (70) of the catheter interface (60).
[0035] Now, referring to FIGS. 4a and 4b, in some embodiments, the connection portion (68) may be located on the upper portion of the catheter interface (60) opposite the portion of the catheter interface (60) that can come into contact with the surface of the patient's skin. In some embodiments, the catheter interface (60) may include a fluid path (74) that fluidly communicates between one or more lumens (66) and a reservoir (10). In some embodiments, the fluid path (74) may be an open path for gas and / or liquid. In some embodiments, the fluid path (74) may be only gas-permeable. In some embodiments, the connection portion (68) may include a connection membrane (76). In some embodiments, the connection membrane (76) may be gas-permeable and hydrophobic. In some embodiments, a gas agent (20) may penetrate through the outer surface (70) of the catheter interface (60).
[0036] In some embodiments, the connection portion (68) may include a molded bonding fitting (78) that can be coupled to the storage container (10) by a press fit. In some embodiments, the molded bonding fitting (78) may include an extension fitting (80) that extends from the surface of the catheter interface (60). In some embodiments, the storage container may be coupled by a press fit to the inner surface of the extension fitting (80). In other embodiments, the storage container (10) may be coupled by a press fit to the outer surface of the extension fitting (80). The extension fitting (80) may provide greater accessibility to the storage container (10) when it is necessary to remove or replace the storage container.
[0037] In some embodiments, the molded bonding fitting (78) may include a recessed fitting (82). In some embodiments, the storage container (10) may be joined to the inner surface of the recessed fitting (82) by a press fit. In some embodiments, the recessed fitting (82) may minimize the protrusion of the storage container (10) from the outer surface (70) of the catheter interface (60).
[0038] Now, referring to FIG. 4c and FIG. 4d, in some embodiments, the connection (68) may be a lure connection (84). In some embodiments, the connection (68) may include a lure connection thread (86) that can be coupled to a lure connection thread included on the outer surface of the gas impermeable wall (16) of the storage container (10). In some embodiments, the connection (68) may include a male or female lure thread (86). In some embodiments, the lure connection (84) of the storage container may facilitate easy access to or replacement of the storage container when necessary.
[0039] Now, referring to FIG. 4e, in some embodiments, the connection portion (68) may include a recessed protrusion (88). In some embodiments, the recessed protrusion (88) may extend from a recessed fitting (82) of the catheter interface (50). As previously described, the opening (14) of the housing (12) of the storage container (10) may include a seal portion (26). In some embodiments, when the storage container (10) is coupled to the connection portion (68), the recessed protrusion (88) may puncture the seal portion (26), thereby allowing a gaseous agent (20) to be delivered from the storage container (10) through the connection portion (68) into one or more lumens (66). In some embodiments, the recessed protrusion (88) may include a fluid path (74) through the recessed protrusion.
[0040] Now, referring to FIGS. 5a and 5b, in some embodiments, a system (90) for injecting gas into a blood vessel access device (58) may include a stabilization device (92). In some embodiments, the stabilization device (92) may be configured to be coupled to the blood vessel access device (58). In some embodiments, the system (90) may include a storage container (94). In some embodiments, the storage container (94) may include a housing (96) having an opening (98) and a gas impermeable wall (100). In some embodiments, the opening (98) may be configured to be coupled to the blood vessel access device (58), and the gas impermeable wall (100) may be configured to be coupled to the stabilization device (92). In some embodiments, the storage container (94) may include a molecular precursor (18) for a gas agent (20). In some embodiments, the molecular precursor (18) may be suspended within a hydrogel (22) disposed within a housing (96). In some embodiments, the stabilization device (92) is a StatLock available from Becton, Dickinson & Company. ® It may be a stabilization device and may include a storage container (94).
[0041] In some embodiments, the storage container (94) may be similar or identical to one or more of the storage containers (10) described in relation to FIGS. 1a and 1b, FIGS. 2a to 2c, and FIGS. 4a to 4e in relation to one or more included features and / or operations.
[0042] In some embodiments, the stabilization device (92) may include an adhesive pad (102) and a retaining member (104). In some embodiments, the retaining member (104) may be coupled to the adhesive pad (102), and the adhesive pad (102) may be fixed or attached to an insertion site on the patient's skin. In some embodiments, the adhesive pad (102) may be secured by an adhesive placed on the lower surface of the adhesive pad (102). In some embodiments, the retaining member (104) may be configured to accommodate and secure the vascular access device (58) in place. In some embodiments, the retaining member (104) may be configured to be coupled to a storage container (94). In some embodiments, the retaining member (104) may include several sub-components, including a base (106), a cover (108), and a latch (110) for coupling the retaining member (104) to the vascular access device (58).
[0043] In some embodiments, the vascular access device (58) includes a connection (68) disposed on an outer surface (70). In some embodiments, the connection (68) may include a molded bonding fitting (78) so that the opening (98) of the housing (96) can be coupled to the vascular access device (58) by a press fit. In some embodiments, the storage container (94) may be coupled to the stabilization device (92) by a press fit. In some embodiments, the storage container (94) may be removed from the stabilization device (92) and replaced. In other embodiments, the storage container (94) may be coupled to the stabilization device (92) with an adhesive or glue.
[0044] In some embodiments, the base (106) of the retaining portion (104) couples the retaining portion (104) to the adhesive pad (102). In some embodiments, the cover (108) is coupled to the storage container (94). In some embodiments, the cover (108) can be removed from the retaining portion (104) and replaced. Thus, when the cover (108) is removed and replaced with another storage container (94), the stabilization device (22) can be retained. In some embodiments, the latch (110) can be coupled to the blood vessel access device (58) by a press fit. In some embodiments, the storage container (94) can serve as the latch (110) because the storage container (94) can be coupled to the blood vessel access device (58) by a press fit.
[0045] In some embodiments, the opening (98) may include a membrane (112). In some embodiments, the membrane (112) may be similar or identical to one or more of the membranes (24) described in relation to FIG. 1a and 1b, FIG. 2c, and FIG. 3a and 3b, with respect to one or more included features and / or operations.
[0046] All examples and conditional language mentioned herein are intended for educational purposes to assist readers in understanding the invention and concepts provided by the inventors to contribute to the art, and are not to be considered limited to such specifically cited examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications may be made without departing from the spirit and scope of the invention.
Claims
Claim 1 A storage container comprising: a housing including an opening and a gas-impermeable wall, wherein the opening is configured to be coupled to a vascular access device, and the opening comprises a gas-permeable and hydrophobic membrane; and a storage container comprising a molecular precursor for a gaseous agent suspended in a hydrogel disposed within the housing, wherein the gaseous agent is antibacterial, antithrombotic, or both antibacterial and antithrombotic. Claim 2 delete Claim 3 In paragraph 1, a storage container in which the gas agent is nitric oxide. Claim 4 A storage container according to claim 1, wherein the molecular precursor for the gas agent is selected from S-nitroso-N-acetylpenicillamine, S-nitrosoglutathione, sodium nitroprusside, or a combination thereof. Claim 5 A storage container according to claim 1, wherein the housing further comprises a gas-permeable compartment separating the housing into a first chamber and a second chamber, the first chamber comprises a molecular precursor for a gas agent suspended in a hydrogel, the second chamber comprises a catalyst for the molecular precursor, and the second chamber is separated from the first chamber by a perforable water-impermeable membrane. Claim 6 A storage container according to claim 5, wherein the housing comprises an upper housing and a lower housing, the upper housing and the lower housing comprise the gas impermeable wall, the lower housing further comprises an opening, and the upper housing is configured to be coupled to the lower housing. Claim 7 In paragraph 6, the housing further comprises a perforation mechanism, and when the opening of the housing is coupled to a blood vessel access device, the perforation mechanism perforates a water-impermeable membrane, the storage container. Claim 8 A storage container according to claim 1, wherein the housing further comprises a removable or perforable seal covering an opening. Claim 9 A storage container according to claim 1, further comprising a wick penetrating the housing. Claim 10 A system for injecting gas into a vascular access device, comprising: a catheter interface including a distal end, a proximal end, and one or more lumens extending between the distal end and the proximal end; and a connection disposed on the outer surface of the catheter interface, wherein the connection is configured to be coupled to a reservoir and to allow the passage of a gas agent from the reservoir to one or more lumens, wherein the reservoir comprises: a housing including an opening and an impermeable wall, wherein the opening is configured to be coupled to the connection of the catheter interface; and a molecular precursor for said gas agent suspended in a hydrogel disposed within the housing, wherein the gas agent is antibacterial, antithrombotic, or both antibacterial and antithrombotic. Claim 11 A system according to paragraph 10, wherein the gaseous agent penetrates through the connection and into the lumen, and the gaseous agent provides antibacterial, antithrombotic, or antibacterial and antithrombotic protection to at least one surface of the catheter system. Claim 12 A system according to claim 10, further comprising a fluid path fluidly communicating between a storage container and a lumen. Claim 13 A system according to claim 10, wherein the connecting part is a Luer connecting part or a molded joint fitting, and accordingly, the storage container housing is mechanically coupled to the catheter adapter by an interference fit. Claim 14 A system according to claim 10, wherein the connecting portion further includes a recessed protrusion, the opening of the housing further includes a sealing portion, and when the connecting portion is coupled to a storage container, the recessed protrusion punctures the sealing portion. Claim 15 In paragraph 10, the connection further comprises a membrane, and the membrane is gas-permeable and hydrophobic, system. Claim 16 In paragraph 10, the opening of the storage container further comprises a membrane, and the membrane is gas-permeable and hydrophobic, system. Claim 17 A system for injecting gas into a vascular access device: a stabilizing device configured to be coupled to the vascular access device; and a storage container comprising: a housing comprising an opening and a gas impermeable wall, wherein the opening is configured to be coupled to the vascular access device and the impermeable wall is coupled to the stabilizing device; a storage container comprising a molecular precursor for a gas agent suspended in a hydrogel disposed within the housing, wherein the gas agent is antibacterial, antithrombotic, or both antibacterial and antithrombotic. Claim 18 In paragraph 17, the stabilization device further comprises an adhesive pad to secure the vascular access device to the insertion site. Claim 19 In paragraph 17, the vascular access device further comprises a connection disposed on an external surface, the connection being a molded joint fitting, and accordingly, an opening of the housing being coupled to the vascular access device by a press fit. Claim 20 In paragraph 17, the opening of the housing further comprises a membrane, and the membrane is gas-permeable and hydrophobic, system.