Vascular access blood collection device with integrated point-of-care small volume blood collection device

Abstract

1. An instrument advancement device comprising: a housing including a distal end and a proximal end; an instrument disposed within the housing; an advancement element; and a blood sample collection tube inserted into the distal end of the housing, the advancement element configured to advance the instrument distally to the distal end of the housing in response to movement of the advancement element relative to the housing, and the blood sample collection tube configured to receive a small blood sample.

Description

[Technical field]

[0001] SUMMARY The present disclosure is directed to vascular access blood collection devices, and in particular to vascular access blood collection devices having integrated point-of-care small volume blood collection devices. [Background technology]

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 309,904, entitled "Vascular Access Blood Draw Device with Integrated Point-Of-Care Small Volume Blood Collection Device," filed February 14, 2022, which is incorporated by reference in its entirety.

[0003] Catheters are commonly used for a variety of fluid infusion therapies. For example, catheters can be used to infuse a patient with fluids, such as saline, various medications, and total parenteral nutrition. Catheters are also used to withdraw blood from a patient.

[0004] A common type of catheter device includes an over-the-needle catheter. As the name suggests, an over-the-needle catheter can be fitted over an introducer needle that has a sharpened distal end. The catheter assembly can include a catheter adapter, a catheter extending distally from the catheter adapter, and an introducer needle extending through the catheter. The catheter and introducer needle can be assembled such that the distal end of the introducer needle extends beyond the distal end of the catheter, with the bevel of the needle pointing away from the patient's skin just prior to insertion into the skin. Typically, the catheter and introducer needle are inserted through the skin at a shallow angle into the patient's vascular system.

[0005] To confirm proper placement of the introducer needle and / or catheter within the blood vessel, the clinician will typically confirm the presence of a "flashback" of blood in the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood draws or infusions.

[0006] Recent developments in the peripheral intravenous catheter (PIVC) field have led to the emergence of technologies designed to facilitate blood collection and indwelling PIVC. These devices focus on the ability to reliably collect high-quality blood samples and reduce hemolysis. The primary way these devices work is by inserting a guidewire, probe, tube, or other instrument through the lumen of the catheter. This placement creates a fluid pathway that penetrates any blood clots or fibrin that may be occluding the catheter tip. A blood sample can then be collected using a syringe or vacutainer without the need to expose the patient to further punctures.

[0007] Point-of-care (POC) testing involves the use of portable testing systems that can provide rapid results using a small blood sample, such as glucose testing. Typically, blood samples are collected via finger prick or existing vascular access. However, most vascular access devices are not optimized for collection of small blood samples. The current field is moving toward miniaturized and personalized healthcare with the goal of POC testing that provides rapid diagnostic results with a single drop of blood. Currently, in anticipation of an increase in POC diagnostic testing, there is a need to provide an option to collect POC blood samples from a PIVC.

[0008] Infusing or withdrawing blood using a catheter can be difficult for several reasons, especially as the catheter remains in place for extended periods of time. A fibrin sheath or thrombus can form on the inner surface of the catheter assembly, the outer surface of the catheter assembly, or within the vasculature near the distal end of the catheter. The fibrin sheath or thrombus can result in occlusion or narrowing of the fluid pathway through the catheter, which can impair infusing and / or withdrawing a quality blood sample.

[0009] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in such environments. Rather, this background is only provided to illustrate one example technology area in which some embodiments described herein may be practiced. Summary of the Invention [Means for solving the problem]

[0010] In one non-limiting embodiment or aspect of the present disclosure, there is provided an instrument advancement device including a housing including a distal end and a proximal end, an instrument disposed within the housing, an advancing element, and a blood sample collection tube inserted into the distal end of the housing, the instrument configured to advance distally toward the distal end of the housing in response to movement of the advancing element relative to the housing, and the blood sample collection tube configured to receive a small volume blood sample of between 0.3 and 500 microliters.

[0011] In some non-limiting embodiments or aspects of the present disclosure, the small blood sample is between 0.3 and 100 microliters. The device may include a septum disposed at a proximal end of the device, and the blood sample collection tube is inserted into the device through the septum to receive the small blood sample. The blood sample collection tube is configured to be removed from the housing after the small blood sample is received in the blood sample collection tube. The blood sample collection tube is configured to be operatively connected to a point-of-care system to test the small blood sample. The blood sample collection tube includes a flexible member at a proximal end of the blood sample collection tube to generate a suction force to draw the small blood sample into the blood sample collection tube.

[0012] In one non-limiting embodiment or aspect, an instrument advancement device is provided that includes a housing including a distal end and a proximal end, an instrument disposed within the housing, an advancement element, and a blood sample collection device integrated into the distal end of the housing, the instrument configured to advance distally toward the distal end of the housing in response to movement of the advancement element relative to the housing.

[0013] In some non-limiting embodiments or aspects of the present disclosure, the opening of the blood sample collector is in fluid communication with a fluid path defined by the instrument. The blood sample collector is configured to be removed from the housing upon receipt of a small amount of blood sample into the blood sample collector for point-of-care testing. The small amount of blood sample may be 0.3-500 microliters or 0.3-100 microliters. A fluid chamber access port is defined at a distal end of the housing to receive the blood sample collector. The fluid chamber access port includes a seal that prevents blood from flowing out of the housing after the blood sample collector is removed from the housing. The blood sample collector is pre-attached to the fluid chamber access port. The fluid chamber access port includes a valve member that moves between an open position, in which blood freely flows into the blood sample collector, and a closed position, in which blood is prevented from flowing into the blood sample collector.

[0014] In one non-limiting embodiment or aspect, an instrument advancement device is provided that includes a housing including a distal end and a proximal end, an instrument disposed within the housing, an advancement element, a blood sample access port defined in the housing, and an inner barrel rotatable relative to the housing, wherein the instrument is configured to advance distally toward the distal end of the housing in response to movement of the advancement element relative to the housing.

[0015] In some non-limiting embodiments or aspects of the present disclosure, the inner barrel defines an opening that is rotatable into alignment with the blood sample access port and out-of-alignment with the blood sample access port, in the aligned state allowing blood to flow into a blood sample collector operatively connected to the instrument advancement device and in the out-of-alignment preventing blood from flowing into the blood sample collector. The housing further includes a handle operably coupled to the inner barrel, the handle rotating the inner barrel relative to the housing. The inner barrel defines an opening that is rotatable into alignment with the opening and out-of-alignment with the opening, in the aligned state allowing blood to flow into a blood sample collector operatively connected to the instrument advancement device and in the out-of-alignment preventing blood from flowing into the blood sample collector.

[0016] In one non-limiting embodiment or aspect of the present disclosure, there is provided an instrument advancing device including a housing including a distal end and a proximal end, an instrument disposed within the housing, an advancing element, and a blood sample collection device, the instrument configured to advance distally toward the distal end of the housing in response to movement of the advancing element relative to the housing, the blood sample collection device operatively connected to the instrument advancing device to collect a small blood sample of between 0.3 and 500 microliters.

[0017] In some non-limiting embodiments or aspects of the present disclosure, the blood sample taker is operatively connected to a proximal end of the advancing element. The advancing element defines a fluid pathway for fluidly connecting the blood sample taker to a fluid pathway defined by the instrument. The blood sample taker is configured to be detached from the advancing element after a small blood sample is received by the blood sample taker for analysis by the point-of-care device. The small blood sample may be between 0.3 and 100 microliters.

[0018] The present disclosure is also directed to the following:

[0019] Item 1: An instrument advancement device including a housing including a distal end and a proximal end, an instrument disposed within the housing, an advancement element, and a blood sample collection tube inserted into the distal end of the housing, the instrument configured to advance distally toward the distal end of the housing in response to movement of the advancement element relative to the housing, and the blood sample collection tube configured to receive a small volume blood sample of between 0.3 and 500 microliters.

[0020] Clause 2: The instrument advancement apparatus of clause 1, wherein the instrument includes a septum at a proximal end of the instrument, the blood sample collection tube being inserted through the septum into the instrument to receive a small blood sample.

[0021] Clause 3: The instrument advancement device of clause 1 or clause 2, wherein the blood sample collection tube is configured to be removed from the housing after a small blood sample has been received in the blood sample collection tube.

[0022] Clause 4: The instrument advancement device of clause 3, wherein the blood sample collection tube is configured to be operatively connected to a point-of-care system to test a small blood sample.

[0023] Clause 5: An instrument advancement device as described in any of clauses 1 to 4, wherein the blood sample collection tube includes a flexible member at a proximal end of the blood sample collection tube to create a suction force to draw a small blood sample into the blood sample collection tube.

[0024] Clause 6: An instrument advancement device including a housing including a distal end and a proximal end, an instrument disposed within the housing, an advancement element, and a blood sample collection device integrated at the distal end of the housing, the instrument configured to advance in a distal direction toward the distal end of the housing in response to movement of the advancement element relative to the housing.

[0025] Clause 7: The instrument advancement device of clause 6, wherein the opening of the blood sample collection device is in fluid communication with a fluid pathway defined by the instrument.

[0026] Clause 8: The instrument advancement device of clause 6 or clause 7, wherein the blood sample collection device is configured to be removed from the housing upon receipt of a small blood sample into the blood sample collection device for point-of-care testing.

[0027] Clause 9: The instrument advancement device of any of clauses 6 to 8, further comprising a fluid chamber access port defined in a distal end of the housing for receiving a blood sample collection device.

[0028] Clause 10: An instrument advancement device as described in any of clauses 7 to 9, wherein the fluid chamber access port includes a seal that prevents blood from exiting the housing after the blood sample collection device is removed from the housing.

[0029] Clause 11: An instrument advancement device as described in any of clauses 6 to 10, wherein the blood sample collection device is pre-attached to the fluid chamber access port.

[0030] Clause 12: An instrument advancement device as described in any of clauses 6 to 11, wherein the fluid chamber access port includes a valve member that moves between an open position in which blood can freely flow into the blood sample collection device and a closed position in which blood is prevented from flowing into the blood sample collection device.

[0031] Clause 13: An instrument advancement device including a housing including a distal end and a proximal end, an instrument disposed within the housing, an advancement element, a blood sample access port defined in the housing, and an inner barrel rotatable relative to the housing, the instrument configured to advance in a distal direction toward the distal end of the housing in response to movement of the advancement element relative to the housing.

[0032] Clause 14: The instrument advancement device of clause 13, wherein the inner barrel defines an opening that is rotatable into an aligned position with the blood sample access port and an unaligned position with the blood sample access port, and in the aligned position, permits blood to flow into a blood sample collection device operatively connected to the instrument advancement device and in the unaligned position, prevents blood from flowing into the blood sample collection device.

[0033] Clause 15: The instrument advancement device of clause 13 or clause 14, wherein the housing further includes a handle operably coupled to the inner barrel for rotating the inner barrel relative to the housing.

[0034] Clause 16: An instrument advancement device as described in any of clauses 13 to 15, wherein the inner barrel defines an opening and the blood sample collection device is rotatable into an aligned position with the opening and into an out-of-alignment position with the opening, the aligned position permitting blood to flow into the blood sample collection device operatively connected to the instrument advancement device and the out-of-alignment position preventing blood from flowing into the blood sample collection device.

[0035] Clause 17: An instrument advancement device including a housing including a distal end and a proximal end, an instrument disposed within the housing, an advancement element, and a blood sample collection device, the instrument configured to advance distally toward the distal end of the housing in response to movement of the advancement element relative to the housing, the blood sample collection device operatively connected to the instrument advancement device to collect a small volume blood sample of between 0.3 and 500 microliters.

[0036] Clause 18: The instrument advancement apparatus of clause 17, wherein the blood sample collection device is operatively connected to a proximal end of the advancement element.

[0037] Clause 19: An instrument advancement device as described in clause 17 or clause 18, wherein the advancement element defines a fluid pathway for fluidly connecting the blood sample collection device to a fluid pathway defined by the instrument.

[0038] Clause 20: An instrument advancement device as described in any of clauses 17 to 19, wherein the blood sample collection device is configured to be detached from the advancement element after a small blood sample has been received by the blood sample collection device for analysis by the point-of-care device.

[0039] Example embodiments are described with additional specificity and detail through the use of the accompanying drawings, in which: [Brief description of the drawings]

[0040] [Figure 1A] 1 is a top perspective view of an exemplary instrument advancement device showing an exemplary advancement element in an exemplary initial or retracted position, according to some embodiments. [Figure 1B] FIG. 1B is a longitudinal cross-sectional view of the instrument advancement device of FIG. 1A. [Figure 1C] 1B is a longitudinal cross-sectional view of the instrument advancement device of FIG. 1A showing the advancement element in an initial or retracted position according to some embodiments. [Figure 1D] 1D is a cross-sectional view of the instrument advancement device of FIG. 1A taken along section line 1D-1D of FIG. 1A, according to some embodiments. [Figure 1E] FIG. 1D is an expanded view of a portion of FIG. 1D according to some embodiments. [Figure 1F] 1F-1F is a cross-sectional view of the instrument advancement device of FIG. 1A taken along section line 1F-1F of FIG. 1A, according to some embodiments. [Diagram 2] FIG. 1 is a side view of an instrument advancement device according to some embodiments. [Diagram 3] FIG. 1 is a side view of an instrument advancement device according to some embodiments. [Figure 4] FIG. 1 is a side view of an instrument advancement device according to some embodiments. [Diagram 5] FIG. 1 is a side view of an instrument advancement device according to some embodiments with a sample access port in a closed state. [Figure 6] FIG. 1 is a side view of an instrument advancement device according to some embodiments with a sample access port in an open state. [Figure 7] FIG. 1 is a side view of an instrument advancement device according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will still be readily apparent to those skilled in the art. All such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0042] Unless expressly indicated otherwise, the use of numerical values ​​in the various ranges specified in this application describes both the minimum and maximum values ​​within the stated range as approximations, as if preceded by the word "about". In this manner, slight variations above and below the stated ranges can be used to achieve substantially the same results as the values ​​within the range. Also, unless otherwise indicated, the disclosure of these ranges is intended to be a continuous range including every value between the minimum and maximum values. For the definitions provided herein, these definitions refer to forms, synonyms, and grammatical variations of those terms.

[0043] The figures attached to this application are representative in nature and should not be construed to imply any particular scale or orientation unless specifically indicated. In the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "upper", "lower", "horizontal", "vertical" and their derivatives are intended to refer to the present invention as oriented in the drawing figures. However, it should be understood that the present invention may assume various alternative modifications and sequences of steps unless expressly specified to the contrary. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting.

[0044] The present disclosure is directed to a vascular access device delivery device that provides needleless delivery of a probe or tube to a patient's vascular system for blood collection using an integrated low-volume blood sample collection device for POC testing. These blood sample collection containers may be optimized to dispense blood to a variety of POC systems and devices, including cartridges for POC systems or test strips such as for glucose monitors. In one aspect or embodiment, the low-volume blood sample discussed herein is 0.3 to 500 microliters. In a further aspect or embodiment, the low-volume blood sample discussed herein is 0.3 to 100 microliters.

[0045] 1A-1F, in some embodiments, an instrument advancement device 100 may be configured to deliver an instrument 102 through a catheter of a catheter assembly. In some embodiments, the instrument 102 may be advanced through the catheter to displace any previous obstructions in the catheter or vasculature (e.g., thrombus or fibrin sheath at the catheter tip, venous occlusions, valves, etc.) to create a clear path for fluid flow. In some embodiments, the instrument 102 may reduce or eliminate obstructions and improve catheter patency for blood sampling and drug and fluid delivery during catheter dwell time.

[0046] In some embodiments, the instrument 102 may include a guidewire, a probe, a guidewire or probe having one or more sensors, or another suitable instrument. In some embodiments, the sensors may be used for patient or device monitoring and may include sensors that measure pressure, temperature, pH, blood chemistry, oxygen saturation, flow, or another physiological characteristic.

[0047] In some embodiments, the catheter may include a peripheral venous catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, the catheter through which the device 102 can be delivered may be pre-inserted into the patient's vascular system or may remain in the vascular system as the device 102 is advanced through the catheter.

[0048] In some embodiments, the instrument 102 may be disposed within a housing 104. The housing 104 may be configured to protect the instrument 102 from damage and / or contamination from the surrounding external environment. In some embodiments, the housing 104 may be rigid or semi-rigid. In some embodiments, the housing 104 may be constructed using one or more of stainless steel, aluminum, polycarbonate, metal, ceramic, plastic, and other suitable materials. In some embodiments, the housing 104 may include a proximal end 106, a distal end 108, and a slot 120. In some embodiments, the slot 120 may extend parallel to a longitudinal axis of the housing 104.

[0049] In some embodiments, instrument advancement device 100 may include an advancement element 122. Advancement element 122 may extend through slot 120. Advancement element 122 may be configured to move linearly along slot 120 between a retracted position, such as that shown in FIG. 1A, and an advanced position. In some embodiments, a user may pinch or grasp advancement element 122 to move advancement element 122 between the retracted and advanced positions.

[0050] In some embodiments, the distal end 108 of the housing 104 may include a distal connector 124. In some embodiments, the distal connector 124 may include opposing lever arms 126a, 126b. In some embodiments, the distal ends of the opposing lever arms 126a, 126b may be configured to move away from one another in response to pressure applied to the proximal ends of the opposing lever arms 126a, 126b. In some embodiments, in response to removal of pressure applied to the proximal ends of the opposing lever arms 126a, 126b, the distal ends may move toward one another to clamp a portion of a catheter assembly, such as, for example, a needleless connector, another connector, or the proximal end of a catheter adapter. In some embodiments, the distal connector 124 may include a blunt cannula 127 or a male luer configured for insertion into a portion of the catheter assembly.

[0051] In some embodiments, the distal connector 124 may include any suitable connector. For example, the distal connector 124 may include a threaded male luer, a slip male luer, a threaded male luer with a spin lock, a threaded male luer with a snap connection with a removable blunt cannula, a slip male luer with a snap connection with a removable blunt cannula, or other suitable connector. In some embodiments, the distal connector 124 may include one or more bond pockets, each of which may be configured to receive an extension tube. In some embodiments, the distal connector 124 may be integrally formed with the body of the housing 104, including the slot 120.

[0052] In some embodiments, the instrument 102 may include a first end 128 and a second end 130. In some embodiments, moving the advancing element 122 from the retracted position to the advanced position may advance the second end 130 of the instrument 102 beyond the distal end 108 of the housing 104. In some embodiments, moving the advancing element 122 to the advanced position may cause the instrument 102 to be introduced into and / or through the catheter assembly. In some embodiments, in response to introducing the instrument 102 into and / or through the catheter assembly, the instrument 102 may access a fluid pathway of the catheter assembly and / or the patient's vasculature.

[0053] In some embodiments, a catheter of a catheter assembly that has been in the vasculature for a long time may be subject to stenosis, indentation, kinking, blockage by debris (e.g., fibrin or platelet clots), or the tip of the catheter may become attached to the vasculature. Thus, drawing blood using a catheter may be difficult. In some embodiments, the instrument 102 may have a diameter smaller than that of the catheter of the catheter assembly to provide access to the patient's vasculature without the need for an additional puncture. In some embodiments, the instrument 102 may provide a pathway for drawing a blood sample. Thus, in some embodiments, the instrument advancement device 100 may be used for needleless blood draws and / or infusions.

[0054] In some embodiments, an extension tube may be coupled to the instrument advancement device 100 and may be used for blood withdrawal and / or transfusion. In some embodiments, the extension tube may extend from a port in the housing 104. In some embodiments, a septum 136 may be included within the housing 104 to allow the instrument 102 to be advanced and / or retracted while maintaining a closed fluid path. In some embodiments, the instrument 102 may be configured to extend through the septum 136. In some embodiments, in the advanced position, the septum 136 may be located proximal to the port and distal to the advancement element 122. In some embodiments, the septum 136 may comprise silicone, rubber, elastomer, or other suitable material. In some embodiments, the septum 136 may include an opening, slit, or the like for passing the instrument 102 therethrough.

[0055] In some embodiments, the inner surface 142 of the housing 104 may include one or more grooves. For example, the inner surface 142 may include a first groove 144 and / or a second groove 146. In some embodiments, the first groove 144 and / or the second groove 146 may be disposed in the housing 104 between the proximal end 106 and the distal end 108. In some embodiments, the instrument 102 may be disposed in the first groove 144 and / or the second groove 146. In some embodiments, the first groove 144 and / or the second groove 146 may include a support wall 148, another support wall 150 opposite the support wall, and a bottom 152 extending between the support wall 148 and the other support wall 150. In some embodiments, the first groove 144 and / or the second groove 146 may be open to the side opposite the bottom 152. In some embodiments, the first groove 144 and / or the second groove 146 may be straight and / or configured to guide the instrument 102 as it is advanced distally and / or retracted proximally.

[0056] In some embodiments, the advancement element 122 may include an arcuate channel 154, which may be U-shaped. In some embodiments, the instrument 102 may extend and move through the arcuate channel 154. In some embodiments, the first end 128 of the instrument 102 may be fixed. In some embodiments, the first end 128 of the instrument may be fixed within the housing 104. In some embodiments, in response to movement of the advancement element 122 a first distance, the second end of the instrument 102 may be configured to advance distally a second distance. In some embodiments, the second distance may be twice the first distance. In some embodiments, the second distance may be greater than twice the first distance. In these and other embodiments, the instrument 102 may extend through multiple U-shapes or other arcuate shapes. In some embodiments, the distal end 108 of the housing 104 may include a compressible portion 156 proximate a chamber 158 configured to hold blood. In some embodiments, the compressible portion 156 may be constructed of a flexible material that may have a lower durometer than the portion of the housing 104 that surrounds the compressible portion 156. In some embodiments, a blood collection path 159 may extend within the chamber 158 and / or through the extension tube 132.

[0057] In some embodiments, the first groove 144 and / or the second groove 146 open opposite the bottom 152 such that the instrument 102 tends to buckle as the advancement element 122 advances distally, as shown, for example, in FIG. 1B. Thus, in some embodiments, one or more support features may be used. Support features may be further described in U.S. Provisional Patent Application No. 63 / 164,976, filed March 23, 2021, entitled VASCULAR ACCESS DEVICE TO REDUCE BUCKLING OF AN INSTRUMENT, which is incorporated by reference in its entirety.

[0058] Referring to FIG. 2, according to one non-limiting embodiment or aspect of the present disclosure, the instrument advancement device 100 may include additional features for drawing blood from a patient's blood pathway. In this embodiment, a blood sample collection tube 200 may be disposed within the housing 104. In one example, the blood sample collection tube 200 may be a capillary tube. The blood sample collection tube 200 may be disposed such that a tip 202 of the blood sample collection tube 200 is proximate to the septum 136. Using the instrument advancement device 100, the blood sample collection tube 200 may be forced through the septum 136 and into the fluid pathway as blood flows through the fluid pathway to draw a blood sample from the fluid pathway. After drawing the blood sample, the blood sample collection tube 200 may be removed to dispense the blood sample into a point-of-care (POC) instrument or device for testing and analysis. In one embodiment, the blood sample collection tube 200 may be vented to allow air to escape from the interior cavity of the blood sample collection tube 200. The handle 204 of the blood sample collection tube 200 may include a flexible member 206, such as a valve, that may be compressed or squeezed to create suction within the blood sample collection tube 200 to draw a blood sample from the fluid path into the blood sample collection tube 200.

[0059] Referring to FIG. 3, according to one non-limiting embodiment or aspect of the present disclosure, the instrument advancement device 100 may include additional features for drawing blood from a patient's blood path. The instrument advancement device 100 may include a blood sample collection vial 300 integrated into the housing 104 of the instrument advancement device 100 near the distal end of the instrument advancement device 100. An opening 302 of the blood sample collection vial 300 may be in the fluid path of the instrument advancement device 100. After drawing blood through the instrument advancement device 100, the blood sample may be drawn into the blood sample collection vial 300 by capillary action or by compressing a valve on the blood sample collection vial 300 to create a vacuum. The blood sample collection vial 300 may then be removed from the instrument advancement device 100 and the blood sample may be dispensed into a POC device or instrument for testing and analysis. Blood may be dispensed by squeezing the valve of the vial 300 to squeeze the blood out.

[0060] 4, according to one non-limiting embodiment or aspect of the present disclosure, the instrument advancement device 100 may include additional features for drawing blood from a patient's blood pathway. The instrument advancement device 100 may include a fluid chamber access port 400. A blood sample draw device 402 may be pre-attached to the fluid chamber access port 400. The blood sample draw device 402 may be removed after the user has drawn the blood sample. A seal may be defined within the fluid chamber access port 400 to prevent blood from flowing out of the instrument advancement device 100 upon removal of the POC blood sample draw device 402.

[0061] The blood sample may be introduced into the blood sample collector 402 by the following means: air venting via venous pressure; application of a user squeeze and fill process (user activation); or vacuum tube pressure collapsing a non-vented flexible acquisition device prior to filling upon removal of the vacuum tube. It is also contemplated that other suitable means for obtaining a blood sample using the blood sample collector 402 may be used with the present disclosure. In one example, the blood sample collector 402 may not be connected to a fluid path at the outset to avoid drawing air into the instrument advancement device 100 or blood sample collector 402. After completing the vacuum tube collection of a large volume of blood sample, the blood sample collector 402 may be actuated to establish fluid communication with the instrument advancement device 100 and allow the blood sample collector 402 to fill with the blood sample via venous pressure. In another example, the blood sample collector 402 may include a valve feature that remains closed during the vacuum tube collection of a large volume of blood sample. After collection of a large volume blood sample, the user may release or open the valve feature to establish fluid communication with the instrument advancement device 100. After the blood sample has been dispensed into the blood sample taker 402, the valve feature may be closed to allow removal of the blood sample taker 402 without leakage of blood from the instrument advancement device 100.

[0062] 5 and 6, according to one non-limiting embodiment or aspect, the instrument advancement device 100 may include additional features for withdrawing blood from a patient's blood pathway. The instrument advancement device 100 may include two concentric cylinders within the housing 104. The two concentric cylinders may be rotated relative to one another to open and close a sample access port 500 defined within the housing 104. The inner barrel defines an opening 502 that faces upward when in a closed position such that fluid flows only through the large volume sample fluid pathway through the housing 104. When a user is ready to withdraw a small volume blood sample, the handle 504 is rotated to open the sample access port fluid pathway, aligning the inner barrel opening 502 with the sample access port 500 and establishing fluid communication with the small volume sample fluid pathway. In another embodiment, the sample access port 500 may be configured to rotate relative to the main fluid pathway of the instrument advancement device 100 to open and close the small volume sample fluid pathway.

[0063] 7, according to one non-limiting embodiment or aspect, the instrument advancement device 100 may include additional features for drawing blood from a patient's blood pathway. A blood sample drawer 600 may be disposed proximal to the advancement element 122. A fluid pathway 602 may be established via the advancement element 122 between the large volume fluid pathway of the instrument advancement device 100 and the blood sample drawer 600. After drawing a blood sample through the instrument advancement device 100, the blood sample drawer 600 may be actuated to draw a small volume of blood sample through the fluid pathway 602. The blood sample drawer 600 may then be removed and used to dispense the blood sample to a POC instrument or device for testing and analysis.

[0064] In some of the embodiments of the instrument advancement device 100 shown in Figures 3-6, the blood sample collector may be vented to allow air to escape as venous pressure forces the blood sample into the blood sample collector. The blood sample collector may be compressible to dispense a blood sample when the blood sample collector is compressed or squeezed.

[0065] The various examples of the instrument advancement device 100 described above provide a user with the ability to dispense small amounts of blood from the instrument advancement device 100 for POC testing and analysis. Additionally, these various instrument advancement devices 100 eliminate the need for separate collection and transport devices for blood sample testing and analysis. Additionally, these various instrument advancement devices 100 eliminate the need for lancing and finger sticks commonly associated with POC blood draws.

[0066] Although the invention has been described in detail above, those skilled in the art will recognize that modifications can be made within the true spirit of the invention.

Claims

1. a housing including a distal end and a proximal end; an instrument disposed within the housing; Progressive elements and a blood sample collection tube insertable into the distal end of the housing; 1. An instrument advancement device comprising: the instrument is configured to advance distally toward a distal end of the housing in response to movement of an advancement element relative to the housing; The blood sample collection tube is configured to receive a small blood sample of 0.3 to 500 microliters.

16. An instrument advancement device comprising:

2. 2. The instrument advancement apparatus of claim 1, wherein the small blood sample volume is between 0.3 and 100 microliters.

3. 2. The instrument advancement apparatus of claim 1, wherein the instrument includes a septum at a proximal end of the instrument, the blood sample collection tube being inserted into the instrument through the septum to receive a small blood sample.

4. 10. The instrument advancement device of claim 1, wherein the blood sample collection tube is configured to be removed from the housing after a small blood sample has been received in the blood sample collection tube.

5. 5. The instrument advancement apparatus of claim 4, wherein the blood sample collection tube is configured to be operatively connected to a point-of-care system for testing a small blood sample.

6. 10. The instrument advancement apparatus of claim 1, wherein the blood sample collection tube includes a flexible member at a proximal end of the blood sample collection tube for creating a suction force to draw a small blood sample into the blood sample collection tube.

7. a housing including a distal end and a proximal end; an instrument disposed within the housing; Progressive elements and a blood sample collection device integrated into the distal end of the housing; 1. An instrument advancement device comprising: The instrument is configured to advance distally toward a distal end of the housing in response to movement of an advancement element relative to the housing.

16. An instrument advancement device comprising:

8. 8. The instrument advancement device of claim 7, wherein the opening of the blood sample collection device is in fluid communication with a fluid pathway defined by the instrument.

9. the blood sample collection device is configured to be removed from the housing upon receipt of a small blood sample into the blood sample collection device for point-of-care testing; Small blood samples are between 0.3 and 500 microliters 8. The instrument advancement apparatus of claim 7.

10. 8. The instrument advancement device of claim 7, further comprising a fluid chamber access port defined in a distal end of the housing for receiving a blood sample collection device.

11. 9. The instrument advancement device of claim 8, wherein the fluid chamber access port includes a seal that prevents blood from exiting the housing after the blood sample collection device is removed from the housing.

12. 8. The instrument advancement device of claim 7, wherein the blood sample collection device is pre-attached to the fluid chamber access port.

13. 8. The instrument advancement device of claim 7, wherein the fluid chamber access port includes a valve member that moves between an open position in which blood may freely flow into the blood sample collector and a closed position in which blood is prevented from flowing into the blood sample collector.

14. a housing including a distal end and a proximal end; an instrument disposed within the housing; Progressive elements and a blood sample access port defined in the housing; An inner cylinder that is rotatable relative to the housing; 1. An instrument advancement device comprising: The instrument is configured to advance distally toward a distal end of the housing in response to movement of an advancement element relative to the housing.

16. An instrument advancement device comprising:

15. 15. The instrument advancement device of claim 14, wherein the inner barrel defines an opening that is rotatable into alignment with the blood sample access port and out-of-alignment with the blood sample access port, the aligned opening permitting blood to flow into a blood sample collection device operatively connected to the instrument advancement device and the out-of-alignment opening preventing blood from flowing into the blood sample collection device.

16. 15. The instrument advancement apparatus of claim 14, wherein the housing further includes a handle operably coupled to the bushing for rotating the bushing relative to the housing.

17. 15. The instrument advancement device of claim 14, wherein the inner barrel defines an opening, and the blood sample access port is rotatable into alignment with the opening and out of alignment with the opening, in the aligned position allowing blood to flow into a blood sample collection device operatively connected to the instrument advancement device and in the out of alignment position preventing blood from flowing into the blood sample collection device.

18. a housing including a distal end and a proximal end; an instrument disposed within the housing; Progressive elements and Blood sample collection device and 1. An instrument advancement device comprising: the instrument is configured to advance distally toward a distal end of the housing in response to movement of an advancement element relative to the housing; The blood sample collection device is operatively connected to the instrument advancement device to collect small blood samples of between 0.3 and 500 microliters.

16. An instrument advancement device comprising:

19. 20. The instrument advancement apparatus of claim 18, wherein the blood sample collection device is operatively connected to a proximal end of the advancement element.

20. 20. The instrument advancement device of claim 18, wherein the advancement element defines a fluid pathway for fluidly connecting the blood sample collection device to a fluid pathway defined by the instrument.

21. 20. The instrument advancement device of claim 18, wherein the blood sample collection device is configured to be detached from the advancement element after a small blood sample has been received by the blood sample collection device for analysis by the point-of-care device.

22. 20. The instrument advancement apparatus of claim 18, wherein the small blood sample volume is between 0.3 and 100 microliters.

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