Blood collection device for small sample collection through peripheral venous catheters - Patents.com

Abstract

A vascular access device is disclosed that includes a tube having a proximal end, a distal end, and a sidewall therebetween defining an interior, the interior being configured to receive blood through one or more openings at the distal end of the tube when the distal end of the tube is disposed in a blood vessel, and an obturator slidably disposed relative to the tube and received within the interior of the tube.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application Serial No. 63 / 317,325, entitled "BLOOD COLLECTION DEVICE FOR SMALL SAMPLE COLLECTION THROUGH A PERIPHERAL VEIN CATHETER," filed March 7, 2022, the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure relates generally to devices for use in intravenous (IV) catheter assemblies, and more particularly to devices for the collection of small volumes of blood through peripheral venous catheters. [Background technology]

[0003] Recent developments in the peripheral intravenous catheter ("PIVC") field have led to the emergence of technology designed to facilitate blood collection from indwelling PIVCs. These devices have focused on ensuring the collection of a high quality sample and reducing hemolysis. The primary way by which these devices work is to insert a guidewire, probe or tube through the tip of the catheter. This creates a flow path through the clot or fibrin that may block the tip of the catheter. A syringe or empty container can then be used for collection of the blood sample without the need to prick the patient with an additional needle stick.

[0004] PoC testing comprises portable test systems that can rapidly deliver results using small volumes of blood samples, such as glucose testing. Samples are typically collected via finger pricks or through indwelling vascular access devices. However, the majority of vascular access devices are not optimized for the collection of small samples. Thus, a need exists to provide low volume blood collection options from PIVCs to meet the increasing demand for PoC testing. Summary of the Invention

[0005] Generally provided herein is a blood collection device having a tube having a proximal end, a distal end and a sidewall therebetween defining an interior, and an obturator slidably disposed relative to the tube and received within the interior of the tube, the interior being configured to receive blood through one or more openings at the distal end of the tube when the distal end of the tube is disposed within a blood vessel.

[0006] In one configuration, the obturator is slidable relative to the tube between a retracted position in which the obturator blocks one or more openings at the distal end of the tube and an extended position in which the obturator does not block one or more openings at the distal end of the tube.

[0007] In one configuration, the obturator is slidable relative to the tube between an extended position in which it does not block one or more openings at the distal end of the tube and an extended position in which it blocks one or more openings at the distal end of the tube.

[0008] In one configuration, the obturator comprises a support wire. In another configuration, the blood collection device comprises a vent plug disposed within the interior of the tube configured to allow air to pass therethrough.

[0009] In one configuration, the obturator comprises a tip configured to prevent sample contamination in the interior of the tube. Optionally, the tube has an opening at a proximal end, and the obturator is positioned to expel blood from the interior of the tube through the opening at the proximal end of the tube. In one configuration, the tube comprises a coil disposed at its distal end.

[0010] Provided herein is a blood collection device having an outer tube having a proximal end, a distal end and a sidewall therebetween defining an interior configured to receive blood when the distal end of the tube is disposed in a blood vessel, and an inner tube received within the interior of the outer tube and slidably and / or rotatably disposed relative to the outer tube, the inner tube having a proximal end, a distal end and a sidewall therebetween and having one or more openings at its distal end.

[0011] In one configuration, the inner tube is slidable relative to the outer tube between a retracted position in which the outer tube blocks one or more openings at the distal end of the inner tube and an extended position in which the one or more openings at the distal end of the inner tube are not blocked.

[0012] In one configuration, the outer tube has one or more openings at its distal end, and the inner tube is rotatable relative to the outer tube between a first position in which the one or more openings at the distal end of the outer tube do not match the one or more openings at the distal end of the inner tube, and a second position in which the one or more openings at the distal end of the outer tube match the one or more openings at the distal end of the inner tube, thereby allowing blood to flow into the interior of the outer tube.

[0013] In one configuration, the blood collection device comprises a vent plug disposed within the interior of the tube configured to allow air to pass therethrough. Optionally, the inner tube comprises a tip configured to prevent sample contamination within the interior of the tube. The outer tube and / or the inner tube may comprise a coil disposed at their distal ends.

[0014] Provided herein is a blood collection device comprising: a syringe barrel having a proximal end, a distal end and a sidewall therebetween defining an interior configured to receive a blood sample; a slidable collection tube received within the interior of the syringe barrel; a tube plunger having a proximal end, a distal end and a sidewall therebetween, the tube plunger being slidably received within the interior of the syringe barrel and coupled to the collection tube; and a sample plunger being slidably received within the interior of the syringe barrel and configured such that blood is drawn into the collection tube interior through the distal end of the collection tube, the collection tube having a proximal end, a distal end having one or more openings therein and a sidewall therebetween defining a collection tube interior in fluid communication with the interior of the syringe barrel and configured to receive blood therein when the distal end of the collection tube is disposed in a blood vessel.

[0015] In one configuration, the proximal end of the syringe is configured to reversibly couple to an indwelling catheter. The proximal end of the syringe barrel comprises a Luer connector.

[0016] In one configuration, the tube plunger is coupled to a proximal end of the collection tube, and the collection tube and tube plunger may be configured such that distal movement of the tube plunger moves the collection tube distally a corresponding distance.

[0017] In one configuration, the sample plunger may be slidably received within the tube plunger and is configured such that proximal movement of the sample plunger draws blood through the collection tube and into the syringe barrel.

[0018] In one configuration, the collection tubes include a plurality of openings at their distal ends.The blood collection device may further include a septum at the distal end of the syringe barrel.

[0019] In one configuration, the tube plungers include one or more vent holes at their distal ends. The collection tubes may include a coil disposed at their distal ends.

[0020] Provided herein is a blood collection system having a vascular access device, the vascular access device comprising a vascular access device housing having a proximal end, a distal end, and a sidewall therebetween defining a vascular access device interior, and a collection tube slidably disposed within the vascular access device interior between a retracted position and an extended position, the collection tube having a proximal end, a distal end, and a sidewall therebetween defining a collection tube interior configured to receive blood therein when the distal end is disposed in a blood vessel, and the blood collection device comprising a housing having a proximal end, a distal end configured to reversibly couple to the vascular access device, and a sidewall therebetween defining a blood collection device interior, the blood collection device interior configured to be in fluid communication with the collection tube interior.

[0021] In one configuration, the distal end of the blood collection device is reversibly coupled to the proximal end of the collection tube such that when the collection tube is placed in a venous blood vessel, blood flows through the collection tube and into the blood collection device.

[0022] In one configuration, the blood collection device includes a septum at its distal end.

[0023] In one configuration, blood collection devices include one or more vents at their distal ends, the vents being configured to allow air to pass therethrough.

[0024] In one configuration, the vent is disposed in a vent cap that is reversibly coupled to the proximal end of the blood collection device housing.

[0025] In some configurations, the blood collection device housing may be compressed.

[0026] In some configurations, the blood collection device further comprises one or more blood stabilizing chemicals therein.

[0027] In one configuration, the one or more blood stabilizing chemicals include one or more of heparin, sodium citrate, and ethylenediaminetetraacetic acid.

[0028] In one configuration, one or more blood stabilizing chemicals are provided in or on the porous matrix at or near the distal end of the housing such that blood enters the housing through the distal end, passes through the porous matrix, and the one or more blood stabilizing chemicals are released into the blood.

[0029] In one configuration, the porous substrate is an open cell foam.

[0030] In one configuration, the collection tube includes a coil disposed at its distal end.

[0031] In one configuration, the distal end of the collection tube has an outer diameter that is the same as the outer diameter of the coil.

[0032] In one configuration, the distal end of the collection tube is tapered. [Brief description of the drawings]

[0033] [Figure 1] FIG. 1 shows a perspective view of a catheter assembly. [Figure 2A] FIG. 2A shows a cross-sectional view of a non-limiting blood collection device described herein. [Figure 2B] FIG. 2B shows a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 3A] FIG. 3A shows a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 3B] FIG. 3B shows a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 4A] FIG. 4A shows a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 4B] FIG. 4B shows a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 4C] FIG. 4C shows a side view of a blood collection device according to a non-limiting embodiment described herein. [Figure 5A] FIG. 5A shows a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 5B] FIG. 5B shows a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 5C] FIG. 5C shows a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 5D] FIG. 5D shows a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 5E] FIG. 5E shows a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 6]FIG. 6 illustrates a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 7] FIG. 7 illustrates a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 8A] FIG. 8A shows a perspective view of a blood collection system and device according to non-limiting embodiments described herein. [Figure 8B] FIG. 8B shows a side view of a blood collection system and device according to non-limiting embodiments described herein. [Figure 9A] FIG. 9A shows a cross-sectional view of a blood collection device according to a non-limiting embodiment described herein. [Figure 9B] FIG. 9B shows a side view of a blood collection device according to non-limiting embodiments described herein. [Figure 9C] FIG. 9C shows a side view of a blood collection device according to a non-limiting embodiment described herein. [Figure 9D] FIG. 9D shows a side view of a blood collection system and device according to non-limiting embodiments described herein. [Figure 9E] FIG. 9E shows a cross-sectional view of a blood collection device according to non-limiting embodiments described herein. [Figure 10A] FIG. 10A shows a side view of a blood collection device according to a non-limiting embodiment described herein. [Figure 10B] FIG. 10B shows a side view of a blood collection device according to non-limiting embodiments described herein. [Figure 11] FIG. 11 shows a side view of a blood collection system according to non-limiting embodiments described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] The following description is presented to enable one of ordinary skill in the art to make and use the described embodiments contemplated for practicing the invention. Various modifications, equivalents, substitutions, and alternatives will be apparent to those of ordinary skill in the art. Such modifications, equivalents, substitutions, and alternatives are intended to be within the spirit and scope of the invention.

[0035] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and derivatives thereof will refer to the present invention as it faces the drawings. However, it should be understood that the present invention may assume various alternative modifications unless expressly specified to the contrary. Moreover, the specific devices illustrated in the accompanying drawings and described in the following specification are merely illustrative of the present invention. It should be understood that these are exemplary embodiments, and therefore specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0036] Any numerical range recited herein is intended to include all values ​​and subranges recited therein. For example, "1 to 10" is intended to include all subranges between the recited minimum value of 1 and the recited maximum value of 10 (and inclusive), with a minimum value of 1 and values ​​greater than 1, and a maximum value of 10 and values ​​less than 10.

[0037] 1 , a non-limiting embodiment of a catheter assembly 10 is shown which 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 a side port 18 disposed between the distal end 14 and 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.

[0038] In some non-limiting embodiments, the first catheter assembly 10 may include a first catheter 22 extending from the distal end 14. In some embodiments, the first catheter 22 may include a peripheral venous catheter, a midline catheter, or a peripherally inserted central venous catheter. The catheter 22 may be formed of any suitable material known to those of skill in the art and may be of any useful length. In some non-limiting embodiments, the first catheter assembly 10 may include a first fluid conduit 24 extending from the side port 18. The first fluid conduit 24 may be formed of any suitable material known to those of skill in the art and may include a distal end 26 and a proximal end 28, and may be coupled at its distal end 26 to the side port 18. In some non-limiting embodiments, 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 side port disposed at 90 degrees relative to the longitudinal axis of connector 30), a y-connector (e.g., one side port disposed at 25, 60, or 75 degrees relative to the longitudinal axis of connector 30), or any other type of known connector, and may have a second lumen therethrough with any number of branches suitable for the type of connector.

[0039] In some non-limiting embodiments, the catheter assembly 10 may include an extension set that includes a second fluid conduit 34. In non-limiting embodiments, the connector 30 may include a side port to which an extension set (e.g., the second fluid conduit 34) may be coupled. Extension sets are known to those of skill in the art and are available, for example, from Becton, Dickinson and Company under the trade names MAXPLUS, MAXZERO, NEUTRACLEAR, Q-SYTE, and SMARTSITE. In some non-limiting embodiments, the second fluid conduit 34 may include a luer connector 36 at its end. In some non-limiting embodiments, the extension set may include a clamp 40 to close 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 some non-limiting embodiments or configurations, the second lumen 31 has an inner diameter substantially equal to the inner diameter of the first fluid conduit 24 and / or the second fluid conduit 34 .

[0040] The catheter assembly 10 may include a needleless access connector 32 and / or a second fluid conduit 34. Needleless access connectors 32 are known to those of ordinary skill in the art and are available, for example, from Becton, Dickinson and Company under the trade names SMARTSITE and Q-SYTE.

[0041] The blood collection device and system, as described herein and illustrated in Figures 2A-11, may be reversibly coupled to one or more components of a catheter assembly 10, such as, for example, the catheter adapter 12, the needleless access connector 32, and / or the luer connector 36, as shown in Figure 1. Referring to Figures 2A-3B, a non-limiting embodiment of a blood collection device 100 is shown that may be used with an indwelling catheter, such as, for example, as shown in Figure 1. The device shown in Figures 2A-3B may include a collection tube 110 having a proximal end 112, a distal end 114, and a sidewall 116 therebetween that defines an interior 118. The interior 118 may be configured to receive a blood sample therein. The collection tube 110 may be formed from any suitable material, such as a suitable flexible polymer that may pass through one or more curves in a catheter assembly 10, such as, for example, as shown in Figure 1. In a non-limiting embodiment, the collection tube 110 may be formed from a polyimide. The collection tube 110 may have a constant outside diameter (OD) or may include a taper of any suitable length / angle.

[0042] The blood collection device 100 may further include an obturator 140. The obturator 140 may include a proximal end, a distal end, a tip 142 at the distal end, and a support wire 144 that assists in sliding the obturator 140 relative to the collection tube 110. The tip 142 of the obturator 140 is positioned to assist in crossing an obstruction, such as a thrombus, in the blood vessel in which the blood collection device 100 is disposed. The tip 142 may be configured to prevent contamination, for example, by including one or more sealing members, to prevent contamination of the sample when the blood collection device 100 is disposed in the blood vessel and the sample is obtained, as described below. Once placed within the blood vessel, the obturator 140 is extended (FIG. 2B) or retracted (FIG. 3B) to place the interior 118 of the collection tube 110 in fluid communication with one or more openings at or near the distal end of the collection tube 110, thereby allowing blood to flow into the interior 118.

[0043] In a non-limiting embodiment, collection tube 110 may include a vent plug 120 configured to displace air from interior 118, which may aid in allowing blood to flow in and / or be withdrawn from interior 118, for example, through application of a vacuum by displacing air in interior 118. In a non-limiting embodiment, vent plug 120 is liquid impermeable such that blood does not flow proximally out of collection tube 110. In this manner, obturator 140 may be retracted or extended to seal the distal end of collection tube 110 and permit removal of blood collection device 100 from the blood vessel along with the sample retained in interior 118.

[0044] In a non-limiting embodiment, blood collection device 100 is configured to expel a blood sample from its distal end. For example, a medical professional using device 100 to withdraw a small sample from an indwelling catheter, such as a PIVC, would then use obturator 140 as a plunger, similar to a standard syringe, to expel blood from the distal end of collection tube 110. In this manner, liquid impermeable vent plug 120 may act as a stopper, typically with a standard syringe.

[0045] 4A-4C, a non-limiting embodiment of a blood collection device 200 is shown. The non-limiting embodiment shown may include an outer (e.g., collection) tube 210 having a proximal end 212, a distal end 214, and a sidewall 216 therebetween that defines an interior 218. The interior 218 may be configured to receive a blood sample therein. The device 200 may include a proximal end 242, a distal end 244, and an inner tube 240 having one or more openings at or near the distal end 242. As shown in FIGS. 4A-4C, the distal end of the inner tube 240 may include a tip that may function to traverse obstructions, clots, and prevent contamination of the interior 218 of the outer tube 210, for example, to prevent contamination of a sample received within the interior 218. The outer tube 210 and the inner tube 240 may be formed of any suitable material known to those of skill in the art, such as a flexible polymer that allows the device 200 to pass through one or more curves in a catheter assembly, as shown in FIG. In a non-limiting embodiment, the outer tube 210 and / or the inner tube 240 may be formed of polyimide. In a non-limiting embodiment, the outer tube and / or the inner tube 240 include a vent plug (not shown) and are optionally liquid impermeable to allow air to move to the outside of the interior 218, thus allowing blood to flow into the interior 218.

[0046] In a non-limiting embodiment, the inner tube 240 and the outer tube 210 may be slidable and / or rotatable relative to one another. In a non-limiting embodiment, the inner tube 240 is slidable relative to the outer tube 210 such that the inner tube 240 may extend distally when the distal end 214 of the outer tube 210 is disposed in a blood vessel. In this manner, one or more openings in the inner tube 240 may be positioned such that the interior 218 of the outer tube 210 is in fluid communication with the blood vessel, allowing blood to enter the interior 218.

[0047] In a non-limiting embodiment, inner tube 240 may be rotatable relative to outer tube 210, and outer tube 210 may include one or more openings at or near its distal end 214. Inner tube 240 may be rotatable between a first position in which one or more openings in inner tube 240 do not match one or more openings in outer tube 210, thereby blocking blood from flowing into interior 218, and a second position in which one or more openings in inner tube 240 match one or more openings in outer tube 210, thereby placing interior 218 in fluid communication with a blood vessel and allowing blood to enter interior 218.

[0048] 5A-7, a non-limiting embodiment of a blood collection device 300 is shown. In the non-limiting embodiment shown, the device 300 resembles a syringe and may include a syringe barrel 310 having a proximal end 312, optionally with one or more finger flanges 313, a distal end 314, and a sidewall 316 therebetween that defines an interior 318 configured to receive a blood sample. The syringe barrel 310 may optionally include a septum 319 disposed in the interior 318 at or near the distal end 314. The septum 319 may be a pierceable septum and may be of a fluid impermeable structure. The syringe barrel 310 may be constructed of any useful material, such as glass or plastic, and may include one or more features at the distal end 314 for reversibly connecting the barrel to one or more components of a catheter assembly, such as that shown in FIG. 1. For example, the distal end 314 of the syringe barrel 310 may include a luer, a clip, an element to aid in a friction fit, and / or another type of coupling feature known in the medical arts. The device 300 may further include a collection tube 340 having a proximal end 341, a distal end 342, and a sidewall 343 therebetween that defines a collection tube interior 344. The collection tube 340 may be formed of any suitable material known to those of skill in the art, such as a flexible polymer that allows the collection tube 340 to be passed through one or more curves during a catheter assembly, as shown in FIG.

[0049] Collection tube 340 may be slidable relative to syringe barrel 310 between a retracted position in which distal end 314 is within syringe barrel 310 or within distal end 314 of syringe barrel 310, and an extended position in which distal end 342 of collection tube 340 extends beyond syringe barrel 310 or beyond distal end 314 of syringe barrel 310, e.g., into a blood vessel. The collection tube may include one or more openings 345 at or near its distal end 342 to allow blood to enter interior 344, as shown in FIG. 6, although one skilled in the art will understand that one or more openings 345 may be located at one or more locations along sidewall 343.

[0050] The device 300 may include a tube plunger 320 received within the syringe barrel interior 318. The tube plunger 320 may be coupled to a collection tube 340 and may be slidable relative to the syringe barrel 310, the tube plunger 320 having a proximal end 322, a distal end 324, and a sidewall 325 therebetween that defines an interior 326. The tube plunger 320 may have one or more air vents 321 disposed at or near its distal end 324 (FIG. 7) to allow air to pass from the syringe barrel interior 318 to the surrounding environment during movement of the tube plunger 320. The tube plunger 320 may be configured to move the collection tube 340 and, in some embodiments, may be coupled to a proximal end 341 of the collection tube 340. The device 300 may include a sample plunger 328. The sample plunger 328 may be received within the interior 326 of the tube plunger 320. Tube plunger 320 and / or sample plunger 328 may, independently, be provided with one or more finger flanges and / or thumb pads to allow a user to operate device 300 when necessary to obtain a blood sample, for example, as described below.

[0051] The device 300 may be used to collect a small blood sample. When the distal end of the syringe barrel 310 is coupled to a catheter, such as one or more components of the catheter assembly 10 shown in FIG. 1, both the tube plunger 320 and the sample plunger 328 may initially be in a fully retracted position as shown in FIG. 5A. The collection tube 340, by virtue of its placement in the interior 326 of the tube plunger 320, is then deployed by pushing the sample plunger 328, moving the tube plunger and the collection tube 340 connected thereto distally and positioning the distal end 342 of the collection tube 340 in a blood vessel. Once in position, the sample plunger 328 is removed and blood is drawn into the collection tube interior 344 through one or more openings 345 at or near the distal end 342 of the collection tube 340, as shown in FIG. 5C. The tube plunger 320 may then be removed, optionally removing the collection tube 340 within the syringe barrel interior 318 and allowing the device 300 to be disconnected from the catheter assembly, as shown in FIGS. 5D-5E.

[0052] 8-11, a non-limiting embodiment of a blood collection system including a vascular access device 450 and a blood collection device 400 is shown. The vascular access device 450 may be the same as or similar to that described in U.S. Pat. No. 10,300,247, the entire disclosure of which is incorporated herein by reference. The blood collection device 400 has a proximal end 412, a distal end 414, and a sidewall 415 therebetween that defines an interior 422. The housing interior 422 may be of any suitable shape that promotes mixing with one or more chemicals provided therein, for example, as described below. The housing 410 may be formed of a resilient material such that the sidewall 415 may be compressed by application of a compressive force, for example, by a user's finger, but returns to its original state after the compressive force applied thereto is released. The sidewall 415 may include one or more transparent portions to provide visual confirmation that a blood sample is received within the interior 422. The distal end 414 may have one or more coupling features, such as a clip, a luer coupling, elements that aid in a friction fit, and the like, that may be reversibly connectable to the vascular access device 450. The blood collection device 400 may include a septum 416 at its distal end 414 and a vent 426 at its proximal end 412. The vent 426 may be configured to allow air to pass when the housing sidewall 415 is compressed and / or when a blood sample is introduced into the interior 422. In a non-limiting embodiment, the vent 426 is provided reversibly connected to a vent cap 424, which is optionally removed to distribute the collected blood sample through an opening at the proximal end by compressing the housing sidewall 415. In a non-limiting embodiment, compressing the housing sidewall 415 distributes the collected blood sample through the distal end 414 of the housing 410. 10A-10B, an embodiment of device 400 is shown in use. Fig. 10A shows the embodiment in a pre-use position, where device 400 is not coupled to a vascular access device 450. A user compresses sidewall 415 to expel air from interior 422.As shown in 10B, device 400 may then be coupled at its distal end 414 to the proximal end of a vascular access device 450 via any suitable connection. The user then releases sidewall 415, as shown in 10B, to allow blood to be withdrawn and the blood drawn into the interior 422 of the housing. Device 400 is then disconnected and the sample transferred to the PoC device, for example, by compressing sidewall 415 again.

[0053] For example, the blood stabilization device may be reversibly connectable to the vascular access device 450 such that a collection tube 420 carried by and slidable relative to the vascular access device 450 is advanced through the blood vessel by a user advancing the tab 421 distally. As shown in FIG. 9A, the collection tube 420 may be positioned to pierce the septum 416 and thus be in fluid communication with the interior 422 of the housing. Blood received within the interior of the collection tube 420 may then be passed through the interior 422 of the housing by passive or active venting, for example, through the venting of air through the vent 426. In another embodiment (shown in FIGS. 9C and 9D), the tab 421 may be connected to the device housing 410. The tab 421 may be connected to the housing 410 in any suitable manner, for example, by friction fit, clips, and / or another mechanism known to one of skill in the art. In a non-limiting embodiment, one or more side arms of tab 421 interact with proximal end 414 of housing 410, as shown in FIG. 9C, and / or tab 421 interacts with housing 410 via a circumferential fit (by sliding over or through distal end 414 of housing 410), as shown, for example, in FIG. 9D.

[0054] In a non-limiting embodiment, the device 400 includes one or more blood stabilizing chemicals. The blood stabilizing chemicals may be coated on the interior surface of the sidewall 415. In a non-limiting embodiment, the device 400 includes a porous substrate 418, such as an open cell foam, disposed at or proximal to the distal end 414 of the housing 410 and / or having one or more blood stabilizing chemicals applied or embedded thereon, such that when a blood sample enters the interior 422 of the housing, the blood flows through the substrate and the one or more chemicals are then mixed with the blood sample. In a non-limiting embodiment, the one or more blood stabilizing chemicals are dispersed within the cells of the open cell foam to promote the effect of mixing and flow through the incorporation of the blood stabilizing chemicals. In a non-limiting embodiment, the open cell foam may be formed of a soft, deformable open cell foam that is inert to blood, such as melamine foam or formaldehyde-melamine-sodium sulfite copolymer, such as BASOTECT foam commercially available from BSAF (Ludwigshafen, Germany). The open cell foam may be a hydrophilic open cell foam that is flexible and substantially resistant to heat and organic solvents. In some embodiments, the foam may comprise a sponge material. One or more blood stabilizing chemicals may be incorporated into the open cell foam by immersing the foam in a liquid solution of one or more blood stabilizing chemicals and water, followed by evaporation of the water to form dry additive particles finely dispersed throughout the internal structure of the foam.

[0055] In non-limiting embodiments, one or more porous substrates 418 may be included in the interior 422 of the housing, as shown, for example, in Figure 9E. While Figure 9E shows a second porous substrate disposed proximal to the proximal end of the housing 410, one of ordinary skill in the art will understand that additional porous substrates 418 may be disposed in any suitable location within the interior 422 of the housing. Exemplary arrangements of such porous substrates may be found in U.S. Patent Application Publication No. 2019 / 0265134, the entire disclosure of which is incorporated herein by reference.

[0056] In a non-limiting embodiment, one or more beads coated and / or impregnated with one or more blood stabilizing chemicals can be included in the interior 422 of the housing and mixed with the blood sample received therein. Suitable blood stabilizing chemicals are known to those of skill in the art and can include one or more of heparin, ethylenediaminetetraacetic acid (EDTA), and / or a citrate salt, such as sodium citrate.

[0057] With reference to FIG. 11, in a non-limiting embodiment of the blood collection system and device disclosed herein, as illustrated in FIG. 11, a blood collection device or vascular access device 450 includes a collection tube 455 as previously described. While the illustrated embodiment of FIG. 11 shows a vascular access device 450, one skilled in the art will understand that the features provided at the distal end of the collection tube 455 may be applied to collection tubes, including blood collection devices described herein. In a non-limiting embodiment, the collection tube 455 includes a coil 456 at its distal end. The coil 456 may be formed from suitable materials, such as metals and alloys, e.g., Nitinol alloys, polymers, etc., so long as the material has sufficient rigidity to assist the collection tube 455 in passing occlusions, clots, or obstructions within the vessel in which the collection tube 455 is placed. In a non-limiting embodiment, the material has sufficient flexibility to avoid or minimize unnecessary damage to the vessel wall. In a non-limiting embodiment, the coil 456 is coupled to the collection tube 455. In a non-limiting embodiment, collection tube 455 has the same or similar OD as coil 456. In a non-limiting embodiment, collection tube 455 tapers distally and has a larger OD than coil 456 to the same or similar OD as coil 456.

[0058] Although the present invention has been described in detail for illustrative purposes based on what are presently considered to be the most practical and preferred embodiment or embodiments, such detail is for such purpose, and the present invention is not limited to the disclosed embodiment, but on the contrary, modifications and equivalent arrangements are intended to be within the spirit and scope of the appended claims. For example, the present invention can be considered, to the extent possible, that one or more features of any of the above-discussed embodiments can be combined with one or more features of any other embodiment or embodiment.

Claims

1. 1. A blood collection device comprising: a tube having a proximal end, a distal end, and a sidewall therebetween defining an interior, the interior being configured to receive blood through one or more openings at the distal end of the tube when the distal end of the tube is disposed in a blood vessel; an obturator slidably disposed relative to the tube and received within the interior of the tube.

2. 2. The blood collection device of claim 1, wherein the obturator is slidable relative to the tube between a retracted position in which the obturator blocks one or more openings at the distal end of the tube and an extended position in which one or more openings at the distal end of the tube are unblocked.

3. 2. The blood collection device of claim 1, wherein the obturator is slidable relative to the tube between an extended position in which the obturator does not block one or more openings at the distal end of the tube and an extended position in which the obturator blocks one or more openings at the distal end of the tube.

4. The blood collection device of claim 1 , wherein the obturator comprises a support wire.

5. 10. The blood collection device of claim 1, further comprising a vent plug configured within the interior of the tube, the vent plug configured to allow air to pass therethrough.

6. The blood collection device of claim 1 , wherein the obturator comprises a tip configured to prevent sample contamination in the interior of a tube.

7. 2. The blood collection device of claim 1, wherein the tube has an opening at a proximal end, and the obturator is configured to expel blood from within the tube through the opening at the proximal end of the tube.

8. The blood collection device of claim 1 , wherein the tube includes a coil disposed at a distal end thereof.

9. 1. A blood collection device comprising: an outer tube having a proximal end, a distal end and a sidewall therebetween defining an interior configured to receive blood when the distal end of the tube is disposed in the blood vessel; an inner tube received within the interior of the outer tube and slidably and / or rotatably disposed relative to the outer tube, the inner tube having a proximal end, a distal end and a sidewall therebetween, the inner tube having one or more openings at its distal end; Blood collection device.

10. 10. The blood collection device of claim 9, wherein the inner tube is slidable relative to the outer tube between a retracted position in which the outer tube blocks one or more openings at the distal end of the inner tube and an extended position in which one or more openings at the distal end of the inner tube are unblocked.

11. 10. The blood collection device of claim 9, wherein the outer tube has one or more openings at its distal end, and the inner tube is rotatable relative to the outer tube between a first position in which the one or more openings at the distal end of the outer tube do not match with the one or more openings at the distal end of the inner tube, and a second position in which the one or more openings at the distal end of the outer tube match with the one or more openings at the distal end of the inner tube, thereby allowing blood to flow into the interior of the outer tube.

12. 10. The blood collection device of claim 9, further comprising a vent plug disposed within the interior of the tube configured to allow air to pass therethrough.

13. 10. The blood collection device of claim 9, wherein the inner tube comprises a tip configured to prevent sample contamination within the interior of the tube.

14. 10. The blood collection device of claim 9, wherein the outer tube and / or the inner tube include a coil disposed at a distal end thereof.

15. 1. A blood collection device comprising: a syringe barrel having a proximal end, a distal end and a sidewall therebetween defining an interior configured to receive a blood sample; a slidable collection tube received within the interior of the syringe barrel, the collection tube having a proximal end, a distal end having one or more openings therein, and a sidewall therebetween defining a collection tube interior in fluid communication with the interior of the syringe barrel, the collection tube being configured to receive blood when the distal end of the collection tube is disposed in a blood vessel; a tube plunger having a proximal end, a distal end and a sidewall therebetween, the tube plunger being slidably received within the interior of the syringe barrel and connected to the collection tube; and A blood collection device comprising a sample plunger slidably received within the interior of the syringe barrel and configured such that blood is drawn into the collection tube through a distal end of the collection tube.

16. 16. The blood collection device of claim 15, wherein the proximal end of the syringe is configured for reversible connection to an indwelling catheter.

17. The blood collection device of claim 15 , wherein the proximal end of the syringe barrel comprises a Luer connector.

18. 16. The blood collection device of claim 15, wherein the tube plunger is coupled to a proximal end of the collection tube.

19. 16. The blood collection tube of claim 15, wherein the collection tube and the tube plunger are configured such that distal movement of the tube plunger causes the collection tube to move distally a corresponding distance.

20. 16. The blood collection tube of claim 15, wherein the sample plunger is slidably received within the tube plunger.

21. 16. The blood collection device of claim 15, wherein the sample plunger is configured such that proximal movement of the sample plunger draws blood through the collection tube and into the syringe barrier.

22. 16. The blood collection device of claim 15, wherein the collection tubes include a plurality of openings at their distal ends.

23. 16. The blood collection device of claim 15, further comprising a septum at a distal end of the syringe barrel.

24. 16. The blood collection device of claim 15, wherein the tube plungers include one or more air vents at their distal ends.

25. 16. The blood collection device of claim 15, wherein the collection tubes include coils disposed at their distal ends.

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