Device delivery system with antithrombogenic function

Abstract

The device provided herein includes a housing having a proximal end, a distal end, and a sidewall therebetween defining an interior; and a fluid conduit movably received within the housing interior, the fluid conduit 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 configured to advance from a first proximal position where the second conduit portion does not extend beyond the distal end of a catheter of an intravenous catheter assembly to a second distal position where the second conduit portion extends beyond the distal end of a catheter of an intravenous catheter assembly, at least a portion of the fluid conduit configured to be antithrombotic.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Application No. 63 / 408,982, filed September 22, 2022, entitled "Device Delivery System with Antithrombotic Functionality," 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, and in particular, for use in blood sampling via an indwelling peripheral catheter. [Background technology]

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

[0004] A common type of VAD is the over-the-needle peripheral intravenous catheter (PIVC). Currently, there are several limitations to using a PIVC for infusion or blood collection. Among these limitations is the smaller gauge of the blood collection device required to pass through the PIVC into the patient's vasculature, which can result in increased dwell time due to low flow rates. This increased dwell time can lead to clot formation and failure of the blood collection device. Therefore, there is a need in the art for devices and systems that allow for the introduction of instruments into a PIVC with a reduced risk of causing clot formation. Summary of the Invention

[0005] The device provided herein includes a housing having a proximal end, a distal end, and a sidewall therebetween defining an interior; and a fluid conduit movably received within the housing interior, the fluid conduit 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 configured to advance from a first proximal position where the second conduit portion does not extend beyond the distal end of a catheter of an intravenous catheter assembly to a second distal position where the second conduit portion extends beyond the distal end of a catheter of an intravenous catheter assembly, at least a portion of the fluid conduit configured to be antithrombotic.

[0006] In certain configurations, the fluid conduit comprises a polyurethane and / or silicone material.

[0007] In certain configurations, at least a portion of the fluid conduit is coated with an anti-thrombogenic composition.

[0008] In certain configurations, the antithrombotic composition is one or more of a hydrophilic material, heparin, a heparin mimetic, a hydrophilic lubricant, a fluorinated lubricant, and a triblock polymer.

[0009] In certain configurations, the triblock polymer comprises poly(ethylene oxide) (PEO) and / or poly(propylene oxide) (PPO).

[0010] In a particular configuration, the triblock polymer is a PEO-PPO-PEO polymer.

[0011] In certain configurations, the composition comprises poly(ethylene glycol), one or more sulfate and / or sulfonate groups, and heparin.

[0012] In certain configurations, at least a portion of the fluid conduit comprises an anti-thrombotic composition.

[0013] In certain configurations, the antithrombotic composition comprises a fluoro-containing moiety, a silicone moiety, and / or a poly(ethylene glycol)-containing moiety.

[0014] In certain configurations, at least a portion of the second conduit section comprises and / or is coated with an anti-thrombotic composition.

[0015] In certain configurations, the second conduit portion is coated at and on its interior surface with an anti-thrombotic composition.

[0016] In certain configurations, substantially the entire fluid conduit comprises and / or is coated with the anti-thrombotic composition.

[0017] In certain configurations, the first conduit portion comprises and / or is coated with an anti-thrombotic composition.

[0018] In certain configurations, the connector comprises a plurality of arms configured to engage a needleless connector.

[0019] In certain configurations, the connector includes a proboscis configured to pierce the septum of the needleless connector.

[0020] Also provided herein is a catheter system including a catheter assembly including a catheter adapter having a distal end, a proximal end, and a lumen extending between the distal and proximal ends, and a catheter secured to the catheter adapter and extending distally from the catheter adapter, the catheter having a distal end and a proximal end and a blood collection device as described herein.

[0021] In certain configurations, the catheter assembly includes a needleless access connector, and the distal end of the blood collection device housing is reversibly coupleable to the needleless access connector. [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 is a perspective view of a non-limiting embodiment of a prior art catheter assembly useful with the blood collection devices described herein. [Figure 2A] FIG. 2A is a side view of a non-limiting embodiment of a blood collection device described herein. [Figure 2B] FIG. 2B is a side view of a non-limiting embodiment of a blood collection device described herein. [Figure 3A] FIG. 3A is a partial cross-sectional side view of a non-limiting embodiment of a blood collection device described herein. [Figure 3B] FIG. 3B is a partial cross-sectional side view of a non-limiting embodiment of a blood collection device described herein. [Figure 3C] FIG. 3C is a partial cross-sectional side view of a non-limiting embodiment of a blood collection device described herein. [Figure 4] FIG. 4 is a perspective view of a non-limiting embodiment of a system including a blood collection device described herein. DETAILED DESCRIPTION OF THE INVENTION

[0023] The following description is provided to enable any person skilled in the art to make and use the described embodiments intended to practice the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0024] Hereinafter, for purposes of explanation, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and their derivatives will refer to the present invention as oriented in the drawings. However, it will be understood that the present invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting.

[0025] It should be understood that any numerical range recited herein is intended to include all subranges subsumed therein. For example, a range of "1 to 10" is intended to include all subranges between (and including) the stated minimum of 1 and the stated maximum of 10, i.e., ranges having a minimum of 1 or more and a maximum of 10 or less.

[0026] Provided herein are devices and systems for introducing instruments through an indwelling catheter, such as a peripheral intravenous catheter (PIVC). While particular devices (e.g., blood collection devices) are shown in the accompanying figures and described below, those skilled in the art will understand that the antithrombotic features described herein may be useful in any number of different devices for introducing instruments, including a range of instruments such as tubes, probes, sensors, wiring, fiber optics, guidewires, etc.

[0027] Referring now to FIG. 1 , a non-limiting embodiment of a catheter assembly 10 useful with a blood collection device, as described herein below, is shown. The catheter assembly 10 may include a catheter adapter 12, which may include a distal end 14 and a proximal end 16. In some embodiments, the catheter adapter 12 may include an additional port 18. In some embodiments, the port 18 may be located between the distal end 14 and the proximal end 16. In some embodiments, the port 18 may be located at the proximal end 16. In some embodiments, the first catheter adapter 12 may include a first lumen 20 extending 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.

[0028] 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. The 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. The 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 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. Connector 30 may be a t-connector (e.g., one lateral port positioned at a 90 degree angle relative to the longitudinal axis of connector 30), a y-connector (e.g., one lateral port positioned at a 25 degree, 60 degree, or 75 degree angle relative to the longitudinal axis of connector 30), or any other type of connector known in the art, and may include a second lumen therethrough with any number of branches appropriate to the type of connector.

[0029] In some non-limiting embodiments or aspects, the catheter assembly 10 may include an extension set (integral to or removably connectable to the catheter adapter 12, connector 30, and / or needleless access connector 32) that includes a second fluid conduit, such as the second fluid conduit 34. Extension sets are known to those of skill in the art and are 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 of skill in the art. In non-limiting embodiments, the second lumen (e.g., within the connector 30) has an inner diameter substantially equal to the inner diameter of the first fluid conduit 24 and / or the second fluid conduit 34.

[0030] The catheter assembly 10 may include a needleless access connector 32 and / or a second fluid conduit 34. Suitable needleless access connectors 32 may include any split septum connector and / or those with direct fluid pathway access. Needleless access connectors 32 are known to those skilled in the art and are commercially available, for example, from Becton, Dickinson and Company under the trade names MAXPLUS, MAXZERO, Q-SYTE, and SmartSite. Another example of a needleless access connector is the NSYTE needleless connector manufactured by NP Medical. While the non-limiting embodiment of FIGS. 1 and 4 shows a needleless access connector disposed on a connector 30, those skilled in the art will understand that a suitable needleless access connector may also be disposed on a luer 36. In a non-limiting embodiment, the needleless access connector 32 includes a septum 33, such as a self-healing septum. In a non-limiting embodiment, the septum 33 is a slit-type septum. As explained below, the blood collection devices described herein may be reversibly coupleable to needleless access connector 32, and one or more portions of the blood collection device may penetrate septum 33.

[0031] 2A-2B, non-limiting embodiments of a device for introducing an instrument are shown. As mentioned above, the illustrated embodiment is a device for introducing a fluid conduit for blood collection (e.g., blood collection device 100), but those skilled in the art will understand that applying an anti-thrombogenic coating and / or lubricant to portions of the device housing will achieve the objectives of the present invention, including reducing / preventing the formation of blood clots. Exemplary blood collection 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 incorporated herein by reference in their entireties. Blood collection device 100 may include a housing 102 and one or more structures for reversibly coupling to a catheter assembly 10 at the distal end of housing 102, for example, via a needleless access connector 32 as shown in FIG. 4. In a non-limiting embodiment, the blood collection device 100 may include a lock 150 at the distal end of the housing 102, the lock 150 including one or more arms 154 and proboscises 152 for coupling to one or more portions of the catheter assembly 10. The lock 150 may be of any suitable size and / or shape and may be formed of any suitable material(s), such as plastic. While the lock 150 is illustrated in this figure as multiple arms 154 and proboscises 152, one skilled in the art will understand that any connection or coupling, e.g., a luer, may be used so long as the distal end of the housing 102 of the blood collection device 100 can pass through a connection that accesses the catheter assembly 10.

[0032] Blood collection device 100 includes a fluid flow conduit 110 that is at least partially received within the housing of device 100. In a non-limiting embodiment, conduit 110 is movably received within blood collection device 100 such that when device 100 is coupled to a catheter assembly, conduit 110 is advanceable through catheter adapter 12 and catheter 22 and enters the patient's vascular system. In a non-limiting embodiment, fluid flow conduit 110 is movable within nasal cavity 152 such that nasal cavity 152 enters a connector on catheter assembly 10, such as needleless access connector 32, while fluid flow conduit 110 can move relative to nasal cavity 152 to access catheter assembly 10. As shown in FIG. 4 , fluid flow conduit 110 can include a distal conduit portion 114 and a proximal conduit portion 112. In some embodiments, distal conduit portion 114 and proximal conduit portion 112 can have different inner and outer diameters.

[0033] In some embodiments, the distal conduit portion 114 may have a much smaller outer diameter to allow access through the catheter 22. The blood collection device 100 may include a luer connector 116 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 lock access device (LLAD) as shown in FIG. 4, e.g., LLAD 46. The LLAD 46 may accept a vacuum container for drawing blood through the conduit 110. In a non-limiting embodiment, a syringe may be used to draw blood by connecting such a syringe to the luer connector 116 (e.g., without the need for an LLAD 46).

[0034] Blood collection device 100 may include one or more antithrombotic compositions on and / or integrated with one or more components thereof. Suitable antithrombotic and / or anticoagulant compositions for use in medical devices that access the vasculature are known to those skilled in the art. The terms "antithrombotic" and "anticoagulant" are used interchangeably herein, and suitable compositions can be applied to one or more surfaces of one or more components of blood collection device 100, e.g., in the form of a film and / or coating, and / or can be used in the manufacture of one or more components of blood collection device 100 (e.g., an antithrombotic moiety can be included in a polymeric material used during the manufacture of a component).

[0035] Suitable compositions include, but are not limited to, heparin, heparin mimetics, heparin, albumin, hydrophobic lubricants, fluorinated lubricants, compositions containing 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) / sulfate / sulfonate and poly(propylene oxide) (PPO), poly(2-methoxyethyl acrylate)), and combinations thereof, phosphorylcholine, prodrugs, and derivatives. Suitable antithrombogenic compositions are also commercially available, such as the Astute® antithrombogenic coating sold by BioInteractions Ltd. (Reading, UK). In a non-limiting embodiment, the antithrombogenic composition comprises heparin, PEG, and one or more sulfate- and / or sulfonate-containing compositions. In a non-limiting embodiment, the antithrombogenic composition is a PEO-PPO-PEO triblock copolymer.

[0036] In non-limiting embodiments, the antithrombotic composition may be included in any material used to form one or more components of the blood collection device 100. For example, the conduit 110 may be formed from a polymeric material, such as a polyimide material, a polyurethane material, and / or a silicone material, and one or more antithrombotic compositions may be included therein (within the polymer backbone and / or as pendant groups). 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. A suitable conduit 110 may be formed from the aforementioned materials, for example, by extrusion techniques. A suitable antithrombotic composition may be provided as a film and / or coating on any region of the conduit 110, for example, on a portion of the distal conduit portion 114 (e.g., including the portion entering the patient's vasculature), along the length of the conduit 110, or only on a smaller diameter portion of the conduit 110. To this end, the conduit 110 may be formed from portions having various diameters. To allow access through the catheter 22, the distal conduit portion 114 (optionally including one or more portions of the fluid conduit 110 that are received within the housing 102) may be of a smaller diameter than the proximal conduit portion 112 that is not received within the housing 102. The coatings described herein may be included on the interior and / or exterior surfaces of any portion of the fluid conduit 110, a separate portion, substantially the entire length of the conduit 110, and / or along the entire length of the conduit 110 (including a separate portion, substantially the entire distal portion 114, any portion of the conduit 110 that is received within the housing 102, and / or the proximal portion 112).

[0037] The aforementioned non-limiting embodiments are illustrated in Figures 3A-3C. Specifically, Figure 3A illustrates a non-limiting embodiment in which the entire fluid conduit 110 (including the distal conduit portion 114, the portion(s) of the conduit 110 received within the housing 102, and the proximal conduit portion 112) is coated with an anti-thrombotic composition along its inner surface. Figure 3B illustrates a non-limiting embodiment in which only the inner surface of the distal conduit portion 114 and the portion of the conduit 110 received within the housing 102 are coated with an anti-thrombotic composition. Figure 3C illustrates a non-limiting embodiment in which only the distal conduit portion 114 is coated with an anti-thrombotic composition. In Figure 3C, both the inner and outer surfaces of the distal conduit portion 114 are coated.

[0038] In a non-limiting embodiment, the antithrombotic composition can be contained in a matrix (e.g., a cross-linked or polymerized coating) that allows the antithrombotic composition to be released, for example, by contact with a fluid (e.g., blood) or by exposure to one or more enzymes (e.g., in the blood) as the blood collection device is received within the catheter assembly 10. Suitable matrices for release, e.g., controlled release, of the composition are known to those skilled in the art and can include those 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 incorporated herein by reference in their entireties.

[0039] 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., interior and / or exterior) of fluid flow conduit 110, including, but not limited to, lock 150 (e.g., nasal passage 152), and / or one or more portions of the housing of blood collection device 100. Other suitable lubricants for medical devices that access the vasculature are known to those skilled in the art and include, but are not limited to, those disclosed in U.S. Patent Nos. 9,956,379, 9,675,793, 8,426,348, 8,754,020, and 8,691,887, including silicones such as polydimethylsiloxane-containing lubricants, and similar compositions.

[0040] As noted above, the accompanying drawings illustrate a blood collection device 100 with a fluid flow conduit 110 that may include the coatings described above and elsewhere herein, however, one skilled in the art will understand that other components of the device 100, such as, but not limited to, wires, probes, occluders, guidewires, fibers, sensors, and similar components, may similarly be coated with an antithrombotic composition.

[0041] Referring to FIG. 4, a system including a catheter assembly 10 as described above and a blood collection device 100 as described above is shown. In the illustrated non-limiting embodiment, the blood collection device 100 is coupled, optionally reversibly, to the needleless access connector 32 of the catheter assembly 10 via a lock 150. Referring to the non-limiting embodiment of FIG. 3C (although one skilled in the art will understand that the following applies to any embodiment of the coated fluid conduit 110 or other device described herein), the distal conduit portion 114 may be coated with an anti-thrombotic composition. As the fluid conduit 110 advances through a portion of the catheter assembly 10, such as the needleless access connector 32, the distal conduit portion may advance through the catheter 22. By including an anti-thrombotic composition as a coating on one or more surfaces of the distal conduit portion 114, thrombus formation may be inhibited, allowing blood collection to proceed without blockages caused by thrombus formation and without the development of thrombi in the patient's vasculature.

[0042] While the present disclosure has been described in detail for purposes of illustration based on what are presently considered to be the most practical and preferred embodiments or aspects, it should be understood that such detail is for that purpose only, 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 within the spirit and scope of the appended claims. For example, it should 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.

Claims

1. 1. A blood collection device for withdrawing blood via an intravenous catheter assembly, comprising: a housing having a proximal end, a distal end, and a sidewall defining an interior therebetween, the housing including a connector at the distal end for reversibly connecting the blood collection device to the intravenous catheter assembly; a fluid conduit movably received within the housing interior, the fluid conduit having a proximal end and a distal end, a first conduit portion at the proximal end of the fluid conduit; a second conduit portion at the distal end of the fluid conduit; a fluid conduit comprising: Including, 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 a catheter of the intravenous catheter assembly, to a second distal position, where the second conduit portion extends beyond the connector and / or beyond the distal end of a catheter of the intravenous catheter assembly; A blood collection device wherein at least a portion of the fluid conduit is configured to be anti-thrombogenic.

2. The blood collection device of claim 1 , wherein the fluid conduit comprises a polyurethane and / or silicone material.

3. The blood collection device of claim 1 , wherein at least a portion of the fluid conduit is coated with an anti-thrombotic composition.

4. The blood collection device of claim 3 , wherein the antithrombotic composition is one or more of a hydrophilic material, heparin, a heparin mimetic, a hydrophilic lubricant, a fluorinated lubricant, and a triblock polymer.

5. The blood collection device of claim 3 , wherein the triblock polymer comprises poly(ethylene oxide) (PEO) and poly(propylene oxide) (PPO).

6. The blood collection device of claim 3, wherein the triblock polymer is a PEO-PPO-PEO polymer.

7. The blood collection device of claim 3 , wherein the composition comprises poly(ethylene glycol), one or more sulfate and / or sulfonate groups, and heparin.

8. The blood collection device of claim 1 , wherein at least a portion of the fluid conduit comprises an antithrombotic composition.

9. The blood collection device of claim 8 , wherein the antithrombotic composition comprises a fluoro-containing moiety, a silicone moiety, and / or a poly(ethylene glycol)-containing moiety.

10. The blood collection device of claim 1 , wherein at least a portion of the second conduit portion comprises and / or is coated with an anti-thrombotic composition.

11. The blood collection device of claim 10, wherein the second conduit portion is coated on its interior and inner surface with an anti-thrombotic composition.

12. The blood collection device of claim 1 , wherein substantially the entire fluid conduit comprises and / or is coated with an anti-thrombotic composition.

13. The blood collection device of claim 1 , wherein the first conduit portion comprises and / or is coated with an anti-thrombotic composition.

14. The blood collection device of claim 1 , wherein the connector comprises a plurality of arms configured to engage a needleless connector.

15. The blood collection device of claim 14 , wherein the connector comprises a nasal cavity configured to pierce a septum of the needleless connector.

16. 1. A catheter assembly comprising: a catheter adapter having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end; a catheter secured to the catheter adapter and extending distally from the catheter adapter, the catheter having a distal end and a proximal end; a catheter assembly including:

1. A blood collection device comprising: a housing having a proximal end, a distal end, and a sidewall defining an interior therebetween, the housing including a connector at the distal end for reversibly connecting the blood collection device to the intravenous catheter assembly; a fluid conduit movably received within the housing interior, the fluid conduit having a proximal end and a distal end, a first conduit portion at the proximal end of the fluid conduit; a second conduit portion at the distal end of the fluid conduit; a fluid conduit including: a blood collection device comprising: Equipped with 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 a catheter of the intravenous catheter assembly, to a second distal position, where the second conduit portion extends beyond the connector and / or beyond the distal end of a catheter of the intravenous catheter assembly; A catheter system, wherein at least a portion of the fluid conduit is configured to be anti-thrombogenic.

17. The system of claim 16, wherein the catheter assembly includes a needleless access connector, and the distal end of the blood collection device housing is reversibly coupleable to the needleless access connector.

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