Patent Application
20240099618
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. Among these limitations are that the smaller gauge of the blood collection device that is necessary to pass through the PIVC to the patient's vasculature can result in increased dwell times due to low flow rates. This increased dwell time can result in thrombogenesis and failure of the blood collection device. 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 thrombogenesis.
Provided herein is a 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 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, wherein at least a portion of the fluid conduit is configured to be antithrombogenic.
In certain configurations, the fluid conduit comprises a polyurethane and/or a silicone material.
In certain configurations, at least a portion of the fluid conduit is coated with an antithrombogenic composition.
In certain configurations, the antithrombogenic composition is one or more of a hydrophilic material, heparin, a heparin mimetic, a hydrophilic lubricant, a fluorinated lubricant, and a triblock polymer.
In certain configurations, the triblock polymer comprises polyethylene oxide) (PEO) and poly(propyiene oxide) (PPO).
In certain configurations, the triblock polymer is a PEO-PPO-PEO polymer.
In certain configurations, the composition comprises poly(ethylene glycol), one or more sulfate and/or sulfonate groups, and heparin.
In certain configurations, at least a portion of the fluid conduit includes an antithrombogenic composition.
In certain configurations, the antithrombogenic composition includes a fluoro-containing moiety, a silicone moiety, and/or a poly(ethylene glycol)-containing moiety.
In certain configurations, at least a portion of the second conduit portion includes and/or is coated with an antithrombogenic composition.
In certain configurations, the second conduit portion is coated, on an inner and inner surface thereof, with an antithrombogenic composition.
In certain configurations, substantially the entire fluid conduit comprises and/or is coated with an antithrombogenic composition.
In certain configurations, the first conduit portion includes and/or is coated with an antithrombogenic composition.
In certain configurations, the connector comprises a plurality of arms configured to engage a needleless connector.
In certain configurations, the connector includes a proboscis configured to pierce a septum of the needleless connector.
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 as described herein.
In certain configurations, 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 antithrombogenic 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 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 removeably 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. Another example of a needleless access connector is the NSYTE Needle-Free Connector manufactured by NP Medical. 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 152, such that while proboscis 152 enters a connector on catheter assembly 10, such as needleless access connector 32, fluid flow conduit 110 may move relative to proboscis 152 to access catheter assembly 10. As shown in
In some embodiments, the distal conduit portion 114 may have much smaller outside diameter to allow access through catheter 22. Blood draw device 100 may include, at a proximal end of proximal conduit portion, a luer connector 116 for reversibly coupling to one or more devices to effectuate blood draw, such as a luer lock access device (LLAD), e.g., LLAD 46 as shown in
Blood draw device 100 may include one or more antithrombogenic compositions on and/or integrated with one or more components thereof. Suitable antithrombogenic and/or anticoagulant compositions for use in medical devices that access the vasculature are known to those of skill in the art. The terms “antithrombogenic” and “anticoagulant” are used interchangeably herein, and suitable compositions can be applied to, for example in the form of a film and/or a coating, one or more surfaces of one or more components of blood draw device 100, and/or may be used in the manufacture of one or more components (e.g., antithrombogenic moieties may be included in polymeric materials used during the production of components) of blood draw device 100.
Suitable compositions include without limitation, heparin, heparin-mimetic materials, heparin, albumin, hydrophobic lubricants, fluorinated lubricants, compositions including fluoro-containing functional moieties, silicone-containing functional moieties, and/or poly(ethylene glycol) (PEG) functional moieties, antithrombogenic polymers (e.g., those containing one or both of poly(ethylene oxide) (PEO)/sulfatelsidfonate and poly(propylene oxide) (PPO), poly(2-methoxyethyl acrylate)), and combinations, phosphorylcholine, pro-drugs, and derivatives thereof. Suitable antithrombogenic compositions are also available commercially, for example the Astute® Antithrombogenic Coating sold by Biolnteractions Ltd. (Reading, UK). In non-limiting embodiments, the antithrombogenic composition includes heparin, PEG, and one or more sulfate and/or sulfonate-containing compositions. In non-limiting embodiments, the antithrombogenic composition is a PEO-PPO-PEO triblock copolymer.
In non-limiting embodiments, an antithrombogenic composition may be included with any material used to form the one or more components of blood draw device 100. For example, conduit 110 may be formed of a polymeric material, such as a polyimide material, polyurethane materials, and/or silicone material, and one or more antithrombogenic compositions may be included, as a moiety (in a polymer backbone and/or as a pendant group), therewith. Suitable compositions include those listed above, but in non-limiting embodiments include fluoro-containing functional moieties, silicone-containing functional moieties, and/or poly(ethylene glycol) (PEG) functional moieties. Suitable conduits 110 may be formed of the foregoing material by, for example, extrusion techniques. Suitable antithrombogenic compositions can be provided as films and/or coatings on any region of conduit 110, for example, on a portion of distal conduit portion 114 (including, e.g., a portion that enters the patient's vasculature), along the length of conduit 110, or only on a smaller-diameter portion of conduit 110. To this end, conduit 110 may be formed of portions having varying diameters. In order to allow for access through catheter 22, distal conduit portion 114 (optionally including one or more portions of fluid conduit 110 received within housing 102), may be of a smaller diameter than proximal conduit portion 112, which is not received within housing 102. The coatings described herein may be included on inner and/or outer surfaces of any portion of fluid conduit 110, along discrete portions, substantially the entirety of the length of conduit 110, and/or along the entirety of the length of conduit 110 (including discrete portions, substantially along the entire length of, or along the entire length of, distal portion 114, any portion of conduit 110 received within housing 102, and/or proximal portion 112).
Non-limiting embodiments of the foregoing are illustrated in
In non-limiting embodiments, antithrombogenic compositions may be included in a matrix (e.g., a cross-linked or polymerized coating) that allows for the antithrombogenic 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, a lubricant (including, for example, those described above) may be applied to at least a portion of a surface (e.g., an inner surface and/or 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). Other 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.
As noted above, while the accompanying figures exemplify a blood draw device 100 with fluid flow conduit 110 that may include a coating as described above and elsewhere herein, those of skill will appreciate that other components of a device 100, such as, without limitation, wires, probes, obturators, guidewires, fibers, sensors, and like components can similarly be coated with an antithrombogenic composition.
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. 63/408,982 entitled “Instrument Delivery System with Antithrombogenic Features” filed Sep. 22, 2022, the entire disclosure of which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63408982 | Sep 2022 | US |
