Patent Application
20240016427
Provided herein are devices and systems for use in vascular access, and, in particular, devices and systems for use with blood draw through indwelling peripheral catheters.
A vascular access device (VAD) may access peripheral vasculature of a patient. A VAD may be indwelling for short term (days), moderate term (weeks), or long term (months to years). VADs may be used for infusion therapy and/or for blood withdrawal.
A common type of VAD is an over-the-needle peripheral intravenous catheter (PIVC). Currently, there may be several limitations to the use of a PIVC for fluid infusion or blood draw, including the introduction of instruments for blood withdrawal through the PIVC, which can lead to introduction of microbes and catheter-related blood stream infections (CRBSIs). Accordingly, there is a need in the art for devices and systems that allow for the introduction of instruments into a PIVC with reduced risk of causing infections.
Provided herein is a blood draw device for withdrawing blood through an intravenous catheter assembly, the device including a housing having a proximal end, a distal end, and a sidewall therebetween defining an interior, a fluid conduit displaceably received within the housing interior 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, at least a portion of the first conduit portion coated with an antimicrobial coating and a second conduit portion at the distal end of the fluid conduit, wherein the fluid conduit is configured to be advanced from a first, proximal position in which the second conduit portion does not extend beyond a distal end of a catheter of the intravenous catheter assembly to a second, distal position in which the second conduit portion extends beyond a distal end of a catheter of the intravenous catheter assembly.
In accordance with an embodiment of the present invention, the antimicrobial coating is an antimicrobial lubricant.
In accordance with an embodiment of the present invention, the antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition.
In accordance with an embodiment of the present invention, the antimicrobial coating comprises one or more of chlorhexidine gluconate and chlorhexidine diacetate.
In accordance with an embodiment of the present invention, the connector is at least partially coated with an antimicrobial composition.
In accordance with an embodiment of the present invention, the connector comprises a plurality of arms configured to engage a needleless connector.
In accordance with an embodiment of the present invention, the connector comprises a proboscis configured to pierce a septum of the needleless connector.
In accordance with an embodiment of the present invention, the proboscis is at least partially coated with an antimicrobial coating.
In accordance with an embodiment of the present invention, the antimicrobial coating is an antimicrobial lubricant.
In accordance with an embodiment of the present invention, the antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition.
In accordance with an embodiment of the present invention, the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate.
In accordance with an embodiment of the present invention, the antimicrobial coating is configured to release one or more antimicrobial compositions.
Also provided herein is a blood draw device for withdrawing blood through an intravenous catheter assembly, the blood draw device including a housing having a proximal end, a distal end having a connector for reversibly connecting the blood draw device to a catheter, and a sidewall therebetween defining an interior, wherein the connector is at least partially coated with an antimicrobial coating, a fluid conduit displaceably received within the housing interior 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, wherein the fluid conduit is configured to be advanced from a first, proximal position in which the second conduit portion does not extend beyond a distal end of a catheter of the intravenous catheter assembly to a second, distal position in which the second conduit portion extends beyond a distal end of a catheter of the intravenous catheter assembly.
In accordance with an embodiment of the present invention, the connector comprises a plurality of arms configured to engage a needleless connector.
In accordance with an embodiment of the present invention, the connector comprises a proboscis configured to pierce a septum of the needleless connector.
In accordance with an embodiment of the present invention, the proboscis is at least partially coated with the antimicrobial coating.
In accordance with an embodiment of the present invention, the antimicrobial coating is an antimicrobial lubricant.
In accordance with an embodiment of the present invention, the antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition.
In accordance with an embodiment of the present invention, the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate.
In accordance with an embodiment of the present invention, the antimicrobial coating is configured to release one or more antimicrobial compositions. Also provided herein is a catheter system, including a catheter assembly including a catheter adapter having a distal end, a proximal end, a lumen extending between the distal end and the proximal end, and a catheter secured to the catheter adapter and extending distally from the catheter adapter, wherein the catheter has a distal end and a proximal end, and a blood draw device. The blood draw device includes a housing comprising a proximal end, a distal end, and a sidewall therebetween defining an interior, the housing comprising a connecter at the distal end thereof for reversibly connecting the blood draw device to the intravenous catheter assembly, a fluid conduit displaceably 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 coated with an antimicrobial coating, wherein the fluid conduit is configured to be advanced from a first, proximal position in which the second conduit portion does not extend beyond a distal end of a catheter of the intravenous catheter assembly to a second, distal position in which the second conduit portion extends beyond the connector and/or beyond a distal end of a catheter of the intravenous catheter assembly.
In accordance with an embodiment of the present invention, the catheter assembly comprises a needleless access connector, and wherein the distal end of the blood draw device housing is reversibly coupleable to the needleless access connector.
The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.
For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
It should be understood that any numerical range recited herein is intended to include all values and 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, that is, having a minimum value equal to or greater than 1 and a maximum value of equal to or less than 10.
Provided herein are devices and systems for introducing instruments through indwelling catheters, such as peripheral intravenous catheters (PIVCs). While certain devices (e.g., blood draw devices) are shown in the accompanying figures and described below, those of skill will appreciate that antimicrobial features described herein may be useful in any number of different devices for introducing an instrument, including instruments ranging from tubes, probes, sensors, wiring, fiber optics, guidewires, etc.
Referring now to
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. Catheter 22 may be formed of any suitable material and may be of any useful length, as known to those of skill 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. First fluid conduit 24 may be formed of any suitable material known to those of skill in the art, and may have a distal end 26 and a proximal end 28, and first fluid conduit 24 may be coupled, at distal end 26 thereof, to port 18. In some non-limiting embodiments or aspects, a connector 30 may be coupled to a proximal end 28 of first fluid conduit 24. Connector 30 may be a t-connector (e.g., one side port arranged at a 90 degree angle relative to a longitudinal axis of connector 30), a y-connector (e.g., one side port arranged at a 25, a 60, or a 75 degree angle relative to a longitudinal axis of 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.
In some non-limiting embodiments or aspects, catheter assembly 10 may include an extension set (integrated into or removably coupleable to catheter adapter 12, connector 30, and/or needleless access connector 32) including a second fluid conduit, such as second fluid conduit 34. Extension sets are known to those of skill in the art and are commercially available from, for example, Becton, Dickinson and Company. In some non-limiting embodiments or aspects, second fluid conduit 34 may include a luer connection 36 at an end thereof. In some non-limiting embodiments or aspects, the extension set may include a clamp 40, to allow for occlusion of second fluid conduit 34. Clamp 40 and second fluid conduit 34 may be formed of any suitable materials known to those of skill in the art. In non-limiting embodiments, second lumen (e.g., within connector 30) has an inner diameter that is substantially equivalent to an inner diameter of first fluid conduit 24 and/or second fluid conduit 34.
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 with direct fluid path access. Needleless access connectors 32 are known to those of skill in the art and are commercially available from, for example, Becton, Dickinson and Company under the tradenames MAXPLUS, MAXZERO, Q-SYTE, and SMARTSITE. While the non-limiting embodiments of
Turning to
Blood draw device 100 includes a fluid flow conduit 110 received at least partially within a housing of the device 100. In non-limiting embodiments, conduit 110 is movably received within blood draw device 100, such that, when device 100 is coupled to a catheter assembly, conduit 110 is advanceable through catheter adapter 12 and catheter 22, to enter a patient's vasculature. In non-limiting embodiments, fluid flow conduit 110 is moveable within proboscis 153, such that while proboscis 153 enters a connector on catheter assembly 10, such as needleless access connector 32, fluid flow conduit 110 may move relative to proboscis 153 to access catheter assembly 10. As shown in
Blood draw device 100 may include one or more antimicrobial compositions on one or more components thereof. Suitable antimicrobial compositions for use in medical devices that access the vasculature are known to those of skill in the art, and can include, without limitation, those disclosed in U.S. Pat. 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 contents of which are incorporated herein by reference in their entirety, those containing silver, those containing chlorhexidine, such as chlorhexidine acetate, chlorhexidine diacetate, and/or chlorhexidine gluconate, and like compositions. In non-limiting embodiments, one or more antimicrobial compositions, for example those described above, can be included in a lubricant, for example a lubricant applied to at least a portion of a surface (e.g., an outer surface) of fluid flow conduit 110 and/or one or more portions of housing of blood draw device 100, including, without limitation, lock 150 (e.g., proboscis 152). Suitable lubricants for medical devices that access the vasculature are known to those of skill in the art, and can include, without limitation, those disclosed in U.S. Pat. Nos. 9,956,379; 9,675,793; 8,426,348; 8,754,020; and 8,691,887, those including silicone, such as polydimethylsiloxane-containing lubricants, and like compositions. In non-limiting embodiments, antimicrobial composition may be included in a matrix (e.g., a cross-linked or polymerized coating) that allows for the antimicrobial composition to be released, e.g., by virtue of being contacted with a liquid (e.g., blood) or by being exposed to one or more enzymes (e.g., in blood), as the blood draw device is received within catheter assembly 10. Suitable matrices for release, e.g., controlled release, of compositions are known to those of skill in the art and may include those disclosed in U.S. Pat. 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 incorporated herein by reference in their entirety.
In non-limiting embodiments, one or more antimicrobial compositions are included as an insert received within fluid flow conduit 110, as a coating on at least a portion of one or more portions of fluid flow conduit 110 (on an inner and/or outer surface thereof), and/or lock 150, such as proboscis 152. With continuing reference to
Turning to
Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and 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 that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.
The present application claims priority to U.S. Provisional Application Ser. No. 63/388,391, entitled “Instrument Delivery System with Antimicrobial Features” filed Jul. 12, 2022, the entire disclosure of which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63388391 | Jul 2022 | US |
