Instrument delivery system with antibacterial function

Abstract

The device provided herein is a device including a housing having a proximal end, a distal end, and sidewalls defining an interior therebetween, and a fluid conduit movably received within the interior of the housing and having a proximal end and a distal end, the fluid conduit including a first conduit portion at the proximal end of the fluid conduit, at least a portion of the first conduit portion being coated with an antibacterial coating, and a second conduit portion at the distal end of the fluid conduit, the fluid conduit being configured to advance from a first proximal position where the second conduit portion does not extend beyond the distal end of the catheter of the intravenous catheter assembly to a second distal position where the second conduit portion extends beyond the distal end of the catheter of the intravenous catheter assembly.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Application No. 63 / 388,391, filed on July 12, 2022, entitled "Instrument Delivery System whith Antimicrobial Features", the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] Provided herein are devices and systems for use in vascular access, particularly devices and systems for use in blood collection via an indwelling peripheral catheter.

Background Art

[0003] Vascular access devices (VADs) can access a patient's peripheral vasculature. VADs can be for short (days), intermediate (weeks), or long-term (months to years) indwelling. VADs may be used for infusion therapy and / or blood collection.

[0004] A common type of VAD is an over-the-needle peripheral intravenous catheter (PIVC). Currently, the use of PIVCs for fluid infusion or blood collection can have several limitations, including the introduction of instruments for blood collection via PIVCs, which can lead to the introduction of microorganisms and catheter-related bloodstream infections (CRBSIs). Thus, there is a need in the art for devices and systems that enable the introduction of instruments into PIVCs with a reduced risk of causing infection.

Summary of the Invention

[0005] Provided herein is a blood collection device for withdrawing blood through an intravenous catheter assembly, the device comprising a housing having a proximal end, a distal end, and a sidewall defining an interior therebetween; a fluid conduit movably received within the housing and having a proximal end and a distal end; a first conduit portion at the proximal end of the fluid conduit, at least a portion of the first conduit portion being coated with an antibacterial coating; and a second conduit portion at the distal end of the fluid conduit, wherein the fluid conduit is configured to advance from a first proximal position where the second conduit portion does not extend beyond the distal end of the catheter of the intravenous catheter assembly to a second distal position where the second conduit portion extends beyond the distal end of the catheter of the intravenous catheter assembly.

[0006] According to one embodiment of the present invention, the antibacterial coating is an antibacterial lubricant.

[0007] According to one embodiment of the present invention, the antibacterial lubricant comprises a silicone-based lubricant and an antibacterial composition.

[0008] According to one embodiment of the present invention, the antibacterial coating comprises one or more of chlorhexidine gluconate and chlorhexidine diacetate.

[0009] According to one embodiment of the present invention, the connector is at least partially coated with an antibacterial composition.

[0010] According to one embodiment of the present invention, the connector comprises a plurality of arms configured to engage a needleless connector.

[0011] According to an embodiment of the present invention, the connector comprises a proboscis configured to penetrate a septum of the needleless connector.

[0012] According to one embodiment of the present invention, the proboscis is at least partially coated with an antibacterial coating.

[0013] According to one embodiment of the present invention, the antibacterial coating is an antibacterial lubricant.

[0014] According to one embodiment of the present invention, the antibacterial lubricant includes a silicone-based lubricant and an antibacterial composition.

[0015] According to one embodiment of the present invention, the antibacterial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate.

[0016] According to one embodiment of the present invention, the antibacterial coating is configured to release one or more antibacterial compositions.

[0017] Also provided herein is a blood collection device for withdrawing blood through an intravenous catheter assembly, the blood collection device including a housing having a proximal end, a distal end having a connector for reversibly connecting the blood collection device to a catheter, and a side wall defining an interior therebetween, the connector being at least partially coated with an antibacterial coating, a fluid conduit being variably accommodated within the housing and having a proximal end and a distal end, the fluid conduit having a first conduit portion at the proximal end of the fluid conduit and a second conduit portion at the distal end of the fluid conduit, the fluid conduit being configured to advance from a first proximal position where the second conduit portion does not extend beyond the distal end of the catheter of the intravenous catheter assembly to a second distal position where it extends beyond the distal end of the intravenous catheter assembly.

[0018] According to one embodiment of the present invention, the connector includes a plurality of arms configured to engage with a needleless connector.

[0019] According to an embodiment of the present invention, the connector includes a proboscis configured to penetrate a septum of a needleless connector.

[0020] According to one embodiment of the present invention, the proboscis is at least partially coated with an antibacterial coating.

[0021] According to one embodiment of the present invention, the antibacterial coating is an antibacterial lubricant.

[0022] According to one embodiment of the present invention, the antibacterial lubricant includes a silicone-based lubricant and an antibacterial composition.

[0023] According to one embodiment of the present invention, the antibacterial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate.

[0024] According to one embodiment of the present invention, the antibacterial coating is configured to release one or more antibacterial compositions. Also, as used herein, a catheter system is provided that includes a catheter assembly including a catheter adapter having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, and a catheter fixed to the catheter adapter and extending distally from the catheter adapter, and a catheter system in which the catheter has a distal end and a proximal end, and a blood sampling device. The blood sampling device includes a housing including a proximal end, a distal end, and a sidewall defining an interior therebetween, the housing having at its distal end a connector for reversibly connecting the blood sampling device to an intravenous catheter assembly, a fluid conduit being movably received within the housing interior and having a proximal end and a distal end. The fluid conduit includes a first conduit portion at the proximal end of the fluid conduit and a second conduit portion at the distal end of the fluid conduit, at least a portion of the second conduit portion being coated with an antibacterial coating, the fluid conduit being movable from a first proximal position where the second conduit portion does not extend beyond the distal end of the catheter of the intravenous catheter assembly to a second distal position where the second conduit portion extends beyond the connector and / or a second distal position where the second conduit portion extends beyond the distal end of the catheter of the intravenous catheter assembly.

[0025] According to an embodiment of the present invention, the catheter assembly includes a needleless access connector, and the distal end of the blood sampling device housing is reversibly connectable to the needleless access connector. BRIEF DESCRIPTION OF THE DRAWINGS

[0026]

Figure 1

Figure 2A

Figure 2B

Figure 3

[0027] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to one of ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the invention.

[0028] For purposes of the description hereinafter, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "topmost", "bottommost", "lateral", "longitudinal", and derivatives thereof shall relate to the invention as oriented in the drawings. However, it will be understood that the invention may assume various alternative variations, unless expressly specified to the contrary. It should also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting.

[0029] It should be understood that any numerical range recited herein is intended to include all sub-ranges subsumed therein. For example, a range of "1 to 10" is intended to include all sub-ranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, i.e., ranges having a minimum value of 1 or more and a maximum value of 10 or less.

[0030] Devices and systems are provided herein for introducing an instrument through an indwelling catheter, such as a peripheral intravenous catheter (PIVC). Specific devices (e.g., a blood sampling device) are shown in the accompanying figures and described below, but those skilled in the art will understand that the antimicrobial function described herein may be useful in any number of different devices for introducing an instrument, including instruments such as tubes, probes, sensors, wiring, optical fibers, guidewires, and the like.

[0031] Referring now to FIG. 1, a non-limiting embodiment of a catheter assembly 10 useful with a blood sampling device is shown, as described hereinbelow. The catheter assembly 10 can include a catheter adapter 12 that can include a distal end 14 and a proximal end 16. In some embodiments, the catheter adapter 12 can include an additional port 18. In some embodiments, the port 18 may be disposed between the distal end 14 and the proximal end 16. In some embodiments, the port 18 may be disposed at the proximal end 16. In some embodiments, the first catheter adapter 12 can include a first lumen 20 that extends through the distal end 14 and the proximal end 16. The first lumen 20 may be sealed at the proximal end 16 of the catheter adapter 12.

[0032] In some non-limiting embodiments or aspects, the catheter assembly 10 may include a catheter 22 extending from the distal end 14. In some embodiments, the first catheter 22 may include a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter. The catheter 22 may be formed of any suitable material and may be of any useful length, as is known to those skilled in the art. In some non-limiting embodiments or aspects, the catheter assembly 10 may include a first fluid conduit 24 extending from the port 18. The first fluid conduit 24 may be formed of any suitable material known to those skilled in the art, may have a distal end 26 and a proximal end 28, and the first fluid conduit 24 may be coupled to the port 18 at its distal end 26. In some non-limiting embodiments or aspects, a connector 30 may be coupled to the proximal end 28 of the first fluid conduit 24. The connector 30 may be a T-connector (e.g., one lateral port disposed at an angle of 90 degrees with respect to the longitudinal axis of the connector 30), a Y-connector (e.g., one lateral port disposed at an angle of 25 degrees, 60 degrees, or 75 degrees with respect to the longitudinal axis of the connector 30), or any other type of connector known in the art, and may include a second lumen therethrough having any number of branches suitable for the type of connector.

[0033] In some non-limiting embodiments or aspects, the catheter assembly 10 may include an extension set (integrated with or removably attachable to the catheter adapter 12, the connector 30, and / or the needleless access connector 32) that includes a second fluid conduit such as the second fluid conduit 34. The extension set is known to those skilled in the art and is commercially available, for example, from Becton, Dickinson and Company. In some non-limiting embodiments or aspects, the second fluid conduit 34 may include a luer connection 36 at its end. In some non-limiting embodiments or aspects, the extension set may include a clamp 40 to enable occlusion of the second fluid conduit 34. The clamp 40 and the second fluid conduit 34 may be formed of any suitable material known to those skilled in the art. In a non-limiting embodiment, the second lumen (e.g., within the connector 30) has an inner diameter that is substantially equal to the inner diameter of the first fluid conduit 24 and / or the second fluid conduit 34.

[0034] The catheter assembly 10 may include a needleless access connector 32 and / or a second fluid conduit 34. Suitable needleless access connectors 32 can include any split septum connector and / or those having a direct fluid path access. The needleless access connector 32 is known to those skilled in the art and is commercially available, for example, from Becton, Dickinson and Company under the trade names MAXPLUS, MAXZERO, Q-SYTE, and SmartSite. The non-limiting embodiments of FIGS. 1 and 3 show a needleless access connector disposed in the connector 30, but those skilled in the art will understand that a suitable needleless access connector can also be disposed on the luer 36. In a non-limiting embodiment, the needleless access connector 32 includes a septum 33 such as a self-sealing septum. In a non-limiting embodiment, the septum 33 is a slit type septum. As described below, the blood collection device described herein may be reversibly attachable to the needleless access connector 32, and one or more portions of the blood collection device may penetrate the septum 33.

[0035] Turning to FIGS. 2A-2B, a non-limiting embodiment of a device for introducing an instrument is shown. As described above, the illustrated embodiment is a device (e.g., blood sampling device 100) for introducing a fluid conduit for blood sampling, but those skilled in the art will understand that the application of an antibacterial coating and / or lubricant to the portion of the device housing achieves the object of the present invention, including the reduction / prevention of CRBSI. Exemplary blood sampling devices are described, for example, in U.S. Patent Application Publication No. 2020 / 0316346 and U.S. Patent No. 10,300,247, the contents of which are hereby incorporated by reference in their entirety. The blood sampling device 100 may include, at its distal end 102, one or more structures for reversibly coupling to the catheter assembly 10, for example via a needleless access connector 32 as shown in FIG. 3. The blood sampling device 100 may include, in a non-limiting embodiment, a lock 150 at its distal end 102 that includes one or more arms 154 and a tip 152 for coupling to one or more portions of the catheter assembly 10. The lock 130 may be of any suitable size and / or shape and may be formed of any suitable material(s), such as plastic. The lock 150 is illustrated in this figure as a plurality of arms 154 and tips 152, but those skilled in the art will understand that any connection or coupling, such as a luer, can be used as long as the distal end 102 of the blood sampling device 100 can pass through the connection to the access catheter assembly 10.

[0036] The blood collection device 100 includes a fluid flow conduit 110 that is at least partially received within the housing of the device 100. In a non-limiting embodiment, the conduit 110 is movably received within the blood collection device 100 such that when the device 100 is coupled to a catheter assembly, the conduit 110 is advanceable through the catheter adapter 12 and the catheter 22 and into the patient's vasculature. In a non-limiting embodiment, the fluid flow conduit 110 is movable within the tip 153 such that while the tip 153 enters a connector on the catheter assembly 10, such as the needleless access connector 32, the fluid flow conduit 110 can move relative to the tip 153 to access the catheter assembly 10. As shown in FIG. 3, the fluid flow conduit 110 can include a distal conduit portion 114 and a proximal conduit portion 112. The blood collection device 100 can include a luer lock access device (LLAD), such as the LLAD 46 shown in FIG. 3, at the proximal end of the proximal conduit portion for reversibly coupling to one or more devices for performing blood collection, such as a luer connector 116. The LLAD 46 may receive a vacuum container for withdrawing blood through the conduit 110. In a non-limiting embodiment, a syringe can be used to withdraw blood by connecting such a syringe to the luer connector 116 (e.g., without the need for the LLAD 46).

[0037] The blood collection device 100 may include one or more antimicrobial compositions on one or more of its components. Suitable antimicrobial compositions for use in medical devices accessing the vascular system are known to those skilled in the art and are disclosed in U.S. Patent Nos. 10,792,399, 10,792,398, 10,589,063, 9,956,379, 9,675,793, 8,426,348, 8,754,020, and 8,691,887, the entire contents of which are incorporated herein by reference, and may include those containing silver, those containing chlorhexidine such as chlorhexidine acetate, chlorhexidine diacetate, and / or chlorhexidine gluconate, and similar compositions. In a non-limiting embodiment, for example, one or more antimicrobial compositions as described above can be included in a lubricant, for example, included in a lubricant applied to a lock 150, including but not limited to at least a portion of the surface (e.g., outer surface) of the fluid flow conduit 110 and / or one or more portions of the housing of the blood collection device 100 (e.g., the tip 152). Lubricants suitable for medical devices accessing the vascular system are known to those skilled in the art and include, without limitation, those disclosed in U.S. Patent Nos. 9,956,379, 9,675,793, 8,426,348, 8,754,020, and 8,691,887, such as silicones including polydimethylsiloxane-containing lubricants, and similar compositions. In a non-limiting embodiment, the antimicrobial composition can be included in a matrix (e.g., a crosslinked or polymerized coating) that allows the antimicrobial composition to be released, for example, by contact with a liquid (e.g., blood) or exposure to one or more enzymes (e.g., in blood) when the blood collection device is received within the catheter assembly 10.Suitable matrices for the release of the composition, e.g., controlled release, are known to those skilled in the art and may include the matrices disclosed in U.S. Patent Nos. 8,821,455, 8,691,887, and 8,512,294, and U.S. Patent Application Publication Nos. 2013 / 0255061, 2010 / 0135949, and 2010 / 0136209, the contents of which are hereby incorporated by reference in their entirety.

[0038] In non-limiting embodiments, one or more antimicrobial compositions may be included as an insert received within fluid flow conduit 110 on at least a portion of one or more portions (on its inner and / or outer surfaces) of fluid flow conduit 110 and / or as a coating on a lock 150 such as tip 152. Continuing to refer to FIGS. 2A-2B, blood collection device 100 may optionally include an antimicrobial coating on at least a portion thereof, including a lubricant such as coating 153 on tip 152 and / or coating 111 on fluid flow conduit 110. Although coating 111 is shown on the outer surface of fluid flow conduit 110, those skilled in the art will understand that the inner surface of fluid flow conduit 110 may be at least partially coated with composition 111 and / or an insert may be included within fluid flow conduit 110. Further, the accompanying drawings illustrate blood collection device 100 with fluid flow conduit 110 that may include coatings as described above and elsewhere in this specification, but those skilled in the art will understand that other components of device 100, e.g., but not limited to, wires, probes, occluders, guidewires, fibers, sensors, and similar components may be similarly coated.

[0039] Referring to FIG. 3, a system is shown that includes a catheter assembly 10 as described above and a blood sampling device 100 as described above. In the illustrated non-limiting embodiment, the blood sampling device 100 is optionally and reversibly coupled to the needleless access connector 32 of the catheter assembly 10 via a lock 150. As described above, the tip of the lock 150 (not shown) may be at least partially coated with an antibacterial coating and / or a lubricant, and optimally includes one or more antibacterial compositions. When the coated tip is inserted into a part of the catheter assembly 10, such as the needleless access connector 32, the antibacterial composition may be introduced and optionally eluted (e.g., released from the tip). Optionally, or in addition to the foregoing, at least a portion of the fluid conduit 110, such as the distal conduit portion 114, may be coated with an antibacterial coating and / or a lubricant that optimally includes one or more antibacterial compositions. When the coated fluid conduit 110 advances into a part of the catheter assembly 10, such as within the needleless access connector 32, the antibacterial composition may be introduced and optionally eluted (e.g., released from the fluid conduit 110). By introducing the antibacterial composition into one or more components of the catheter assembly 10, the likelihood of CRBSI can be reduced or eliminated.

[0040] The present disclosure has been described in detail for purposes of illustration based on what is presently considered to be the most practical and preferred embodiments or aspects thereof, such detail being for that purpose only, and it is to be understood that the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates, to the extent possible, that one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

**Claim 1** A blood sampling device (100) for withdrawing blood through an intravenous catheter assembly (10), the blood sampling device (100) comprising: A housing having a proximal end (104), a distal end (102), and a sidewall defining an interior therebetween, the housing comprising a connector (150) at the distal end (102) for reversibly connecting the blood sampling device (100) to the intravenous catheter assembly (10); A fluid conduit (110) movably received within the housing of the blood sampling device (100) and having a proximal end and a distal end, the fluid conduit (110) of the blood sampling device (100) comprising: A first conduit portion (112) at the proximal end of the fluid conduit (110) of the blood sampling device (100); A second conduit portion (114) at the distal end of the fluid conduit (110) of the blood sampling device (100), at least a portion of the second conduit portion (114) of the blood sampling device (100) being coated with an antibacterial coating (111); The fluid conduit (110) of the blood sampling device (100) is configured to advance from a first proximal position where the second conduit portion (114) does not extend beyond the distal end of the catheter (22) of the intravenous catheter assembly (10) to a second distal position where the second conduit portion (114) extends beyond the connector (150) and / or beyond the distal end of the catheter (22) of the intravenous catheter assembly (10). **Claim 2** The blood sampling device (100) according to claim 1, wherein the antibacterial coating (111) is an antibacterial lubricant. **Claim 3** The blood sampling device (100) according to claim 2, wherein the antibacterial lubricant comprises a silicone-based lubricant and an antibacterial composition. **Claim 4** The blood sampling device (100) according to claim 1, wherein the antibacterial coating (111) comprises one or more of chlorhexidine gluconate and chlorhexidine diacetate. **Claim 5** The blood sampling device (100) according to claim 1, wherein the connector (150) is at least partially coated with an antibacterial composition. **Claim 6** The blood sampling device (100) according to claim 1, wherein the connector (150) comprises a plurality of arms configured to engage a needleless connector. **Claim 7** The blood collection device (100) according to claim 6, wherein the connector includes a mouthpiece (152) configured to penetrate a partition wall (33) of the needleless connector (32).

8. The blood collection device (100) according to claim 7, wherein the mouthpiece (152) is at least partially coated with an antibacterial coating (153).

9. The blood collection device (100) according to claim 8, wherein the antibacterial coating (153) is an antibacterial lubricant.

10. The blood collection device (100) according to claim 9, wherein the antibacterial lubricant includes a silicone-based lubricant and an antibacterial composition.

11. The blood collection device (100) according to claim 10, wherein the antibacterial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate.

12. The blood collection device (100) according to claim 1, wherein the antibacterial coating (111) is configured to release one or more antibacterial compositions.

13. A blood collection device (100) for withdrawing blood through an intravenous catheter assembly, the blood collection device (100) comprising: A housing including a proximal end (104), a distal end (102) including a connector (150) for reversibly connecting the blood collection device (100) to the intravenous catheter assembly (10), and a side wall defining an interior therebetween, wherein the connector (150) is at least partially coated with an antibacterial coating (111); A fluid conduit (110) movably received within the housing of the blood collection device (100) and having a proximal end and a distal end, wherein the fluid conduit (110) of the blood collection device (100) includes: A first conduit portion (112) at the proximal end of the fluid conduit (110) of the blood collection device (100); A second conduit portion (114) at the distal end of the fluid conduit (110) of the blood collection device (100). The fluid conduit (110) of the blood collection device (100) is configured to advance from a first proximal position where the second conduit portion (114) does not extend beyond the distal end of the catheter (22) of the intravenous catheter assembly (10) to a second distal position where the second conduit portion (114) extends beyond the connector (150) and / or beyond the distal end of the catheter (22) of the intravenous catheter assembly (10), the blood collection device (100). **Claim 14** The blood collection device (100) according to claim 13, wherein the connector (150) comprises a plurality of arms (154) configured to engage with a needleless connector (32). **Claim 15** The blood collection device (100) according to claim 14, wherein the connector (150) comprises a mouthpiece (152) configured to penetrate a partition wall (33) of the needleless connector (32). **Claim 16** The blood collection device (100) according to claim 15, wherein the mouthpiece (152) is at least partially coated with the antibacterial coating (153). **Claim 17** The blood collection device (100) according to claim 16, wherein the antibacterial coating (153) is an antibacterial lubricant. **Claim 18** The blood collection device (100) according to claim 17, wherein the antibacterial lubricant comprises a silicone-based lubricant and an antibacterial composition. **Claim 19** The blood collection device (100) according to claim 18, wherein the antibacterial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate. **Claim 20** The blood collection device (100) according to claim 13, wherein the antibacterial coating (111) is configured to release one or more antibacterial compositions. **Claim 21** An intravenous catheter assembly (10), comprising: a catheter adapter (12) having a distal end (14), a proximal end (16), and a lumen (20) extending between the distal end (14) and the proximal end (16); a catheter (22) fixed to the catheter adapter (12) and extending distally from the catheter adapter (12), the catheter (22) having a distal end and a proximal end; a blood collection device (100) for withdrawing blood through the intravenous catheter assembly (10), the blood collection device (100) comprising: A housing having a proximal end (104), a distal end (102), and a sidewall defining an interior therebetween, the housing comprising a connector (150) at the distal end (102) for reversibly connecting the blood sampling device (100) to the intravenous catheter assembly (10). A fluid conduit (110) movably received within the housing interior of the blood sampling device (100) and having a proximal end and a distal end, the fluid conduit (110) of the blood sampling device (100) comprising A first conduit portion (112) at the proximal end of the fluid conduit (110) of the blood sampling device (100); A second conduit portion (114) at the distal end of the fluid conduit (110) of the blood sampling device (100), at least a portion of the second conduit portion (114) of the blood sampling device (100) being coated with an antibacterial coating (111). A catheter system, wherein the fluid conduit (110) of the blood sampling device (100) is configured to advance from a first proximal position where the second conduit portion (114) does not extend beyond the distal end of the catheter (22) of the intravenous catheter assembly (10) to a second distal position where the second conduit portion (114) extends beyond the connector (150) and / or beyond the distal end of the catheter (22) of the intravenous catheter assembly (10). Claim 22 The system according to claim 21, wherein the catheter assembly (22) includes a needleless access connector (32), and the distal end (102) of the housing of the blood sampling device is reversibly connectable to the needleless access connector (32).

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