Point-of-care collection and transfer devices with Luer lock access devices and syringe compatibility

Abstract

The instrument advancement device includes a housing including a fluid pathway, a distal end, and a proximal end, an instrument disposed within the housing, an advancement element configured to advance the instrument distal to the distal end of the housing in response to movement of the advancement element relative to the housing, a miniature sample-dispensing device connected to the proximal end of the housing, and a blood collection device connected to the proximal end of the miniature sample-dispensing device, the blood collection device configured to receive an evacuated blood collection container, the miniature sample-dispensing device removable from the housing and configured to dispense a blood sample.

Description

[Technical field]

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

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 309,926, entitled "Point-of-Care Collection and Transfer Device with Luer Lock Access Device and Syringe Compatibility," filed February 14, 2022, the entire disclosure of which is incorporated by reference in its entirety. [Background technology]

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

[0004] A common type of catheter device is what is called an "over-the-needle" catheter. As the name suggests, an over-the-needle catheter may be mounted over an introducer needle with a sharp distal tip. The catheter assembly may 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 may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing away from the patient's skin. The catheter and introducer needle are typically inserted at a shallow angle through the skin into the patient's vascular system.

[0005] To verify proper placement of the introducer needle and / or catheter within the blood vessel, the clinician will typically confirm that there is a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily occlude flow within the vasculature and withdraw the introducer needle, leaving the catheter in place for subsequent blood collection or transfusion.

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

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

[0008] Infusion and blood collection using catheters can be difficult for several reasons, especially as catheter dwell time increases. Fibrin sheaths or clots can form on the inner surface of the catheter assembly, the outer surface of the catheter assembly, or within the vasculature near the distal tip of the catheter. The fibrin sheaths or clots can block or narrow the fluid pathway through the catheter, which can compromise infusion and / or collection of a high quality blood sample.

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

[0010] In one aspect or embodiment, the instrument advancement device includes a housing including a fluid pathway, a distal end, and a proximal end, an instrument disposed within the housing, an advancement element configured to advance distal to the distal end of the housing in response to movement of the advancement element relative to the housing, a miniature sample-dispensing device connected to the proximal end of the housing, and a blood collection device connected to the proximal end of the miniature sample-dispensing device, The blood collection device is configured to receive an evacuated blood collection container, where the miniature sample-dispensing device is removable from the housing and configured to dispense a blood sample.

[0011] The miniature sample-dispensing device may be configured to receive a volume of between 0.3 and 500 microliters.The miniature sample-dispensing device may be configured to receive a volume of between 0.3 and 100 microliters.

[0012] The miniature sample-dispensing device may be integrally formed with the blood collection device. The miniature sample-dispensing device may be removably attached to the blood collection device. The miniature sample-dispensing device may include a needleless connector configured to be connected to the blood sample collection device.

[0013] The miniature sample dispensing device may be configured to be compressed to dispense fluid from the miniature sample dispensing device.The miniature sample dispensing device may be configured to be attached to a syringe barrel to dispense fluid from the miniature sample dispensing device.

[0014] In a further aspect or embodiment, the blood sample collection system includes a vascular access device, a miniature sample-dispensing device connected to the vascular access device, and a blood collection device connected to a proximal end of the miniature sample-dispensing device, the blood collection device configured to receive an evacuated blood collection container, where the miniature sample-dispensing device is removable from the vascular access device and configured to dispense a blood sample.

[0015] The vascular access device may be a catheter adapter including a catheter and a patient connector, and the miniature sample dispensing device is connected to the patient connector. The patient connector may be connected to the catheter adapter via a tube. The vascular access device may include an extension tube.

[0016] The miniature sample-dispensing device may be vented to provide blood flashback during use of the vascular access device. [Brief description of the drawings]

[0017] Exemplary embodiments will be described and explained with additional specificity and detail through the use of accompanying drawings. [Figure 1A] FIG. 1A 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] FIG. 1C is a longitudinal cross-sectional view of the instrument advancement device of FIG. 1A showing an advancement element in an initial or retracted position, according to some embodiments. [Figure 1D] FIG. 1D is a cross-sectional view of the instrument advancement device of FIG. 1A taken along line 1D-1D in FIG. 1A, according to some embodiments. [Figure 1E] FIG. 1E is an expanded view of a portion of FIG. 1D, according to some embodiments. [Figure 1F] FIG. 1F is a cross-sectional view of the instrument advancement device of FIG. 1A taken along line 1F-1F of FIG. 1A, according to some embodiments. [Diagram 2] FIG. 2 is a perspective view of an instrument advancement device and a blood sample collection device according to one non-limiting example or embodiment of the present disclosure. [Diagram 3] FIG. 3 is a side view of an instrument advancement device and a blood sample collection device according to one non-limiting example or embodiment of the present disclosure. [Figure 4] FIG. 4 is a perspective view of a vascular access device and a blood sample collection device according to one non-limiting example or embodiment of the present disclosure. [Diagram 5] FIG. 5 is a perspective view of the blood sample collection device of FIG. 4 dispensing a small blood sample into a blood testing cartridge. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for practicing 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.

[0019] The use of numerical values ​​in the various ranges specified in this application, unless expressly indicated otherwise, is described as approximations, as if both the minimum and maximum values ​​in the stated ranges were preceded by the word "about". In this manner, small 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 as a continuous range including all values ​​between the minimum and maximum values. For the definitions provided herein, the definitions refer to word forms, cognates, and grammatical variations of those words or phrases.

[0020] The figures accompanying this application are representative in nature and should not be construed to imply any particular scale or orientation unless specifically indicated. For purposes of description hereinafter, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "vertical", and their derivatives refer to the present invention as oriented in the drawings. However, it will be understood that the present invention may assume various alternative variations and process sequences unless expressly specified to the contrary. As such, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered as limiting.

[0021] The present disclosure is directed to vascular access instrument advancement devices that provide needle-free delivery of a probe or tube to a patient's vascular system for blood collection (drawing) with an integrated low-volume blood sample collection device for POC testing. These blood sample collection containers can be optimized to distribute blood to a variety of POC systems and instruments, including cartridges for POC systems and off-test strips such as glucose monitors.

[0022] 1A-1F, in some embodiments, instrument advancement device 100 may be configured to deliver instrument 102 through a catheter of a catheter assembly. In some embodiments, instrument 102 may be advanced through any occlusion in the catheter or vasculature (e.g., a clot or fibrin sheath at the tip of the catheter, a collapsed vein, a valve, etc.) to create a clear path for fluid flow. In some embodiments, instrument 102 may reduce or eliminate occlusions during catheter dwell time, improving catheter patency for drug and fluid delivery, as well as blood acquisition.

[0023] In some embodiments, the instrument 102 may include a guidewire, a probe, a guidewire or probe with 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 measuring pressure, temperature, pH, blood chemistry, oxygen saturation, flow, or another physiological characteristic. The instrument 102 may be a flow tube or other suitable blood collection instrument. In some embodiments, the instrument advancement device 100 may be a PIVO™ blood collection device available from Velano Vascular. In one embodiment, the instrument advancement device is the same as or similar to the blood collection device shown in U.S. Pat. No. 11,090,461, which is incorporated herein by reference in its entirety.

[0024] In some embodiments, the catheter may include a peripheral IV catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, the catheter through which the instrument 102 may be delivered may have been previously inserted into the patient's vasculature and may be placed within the vasculature as the instrument 102 is advanced through the catheter.

[0025] In some embodiments, the instrument 102 may be disposed within a housing 104, which 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 made of one or more of stainless steel, aluminum, polycarbonate, metal, ceramic, plastic, and another suitable material. 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.

[0026] In some embodiments, instrument advancement device 100 may include an advancement element 122 that may extend through slot 120 and may be configured to move linearly along slot 120 between a retracted position and an advanced position, for example, as shown in FIG 1A. In some embodiments, a user may pinch or grasp advancement element 122 to move advancement element 122 between the retracted position and the advanced position.

[0027] In some embodiments, the distal end 108 of the housing 104 can include a distal connector 124. In some embodiments, the distal connector 124 can include opposing lever arms 126a, 126b. In some embodiments, the distal ends of the opposing lever arms 126a, 126b can 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 can move toward one another to latch onto 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 can include a blunt cannula 127 or a male luer configured for insertion into a portion of a catheter assembly.

[0028] In some embodiments, the distal connector 124 can include any suitable connector. For example, the distal connector 124 can include a threaded male luer, a slip male luer, a threaded male luer with a spin lock, a threaded male luer with a removable blunt cannula snap connection, a slip male luer with a removable blunt cannula snap connection, or other suitable connector. In some embodiments, the distal connector 124 can include one or more mating pockets, each of which can be configured to receive an extension tube. In some embodiments, the distal connector 124 can be monolithically formed as a single unit with the body of the housing 104, including the slot 120.

[0029] 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 a retracted position to an 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 introduce the instrument 102 into a catheter assembly and / or through a catheter. In some embodiments, in response to the instrument 102 being introduced into the catheter assembly and / or through the catheter, the instrument 102 may access a fluid pathway of the catheter assembly and / or the patient's vasculature.

[0030] In some embodiments, the catheter of the catheter assembly that has a significant residence time in the vasculature may be susceptible to stenosis, collapse, kinking, blockage by debris (e.g., fibrin or platelet clots), and adhesion of the tip of the catheter to the vasculature. Thus, blood collection using the catheter may be difficult. In some embodiments, the instrument 102 may have a diameter less than that of the catheter of the catheter assembly to provide access to the patient's vasculature without any additional needle stick. In some embodiments, the instrument 102 may clear a path for collecting a blood sample. Thus, in some embodiments, the instrument advancement device 100 may be used for needleless blood collection and / or fluid injection.

[0031] In some embodiments, an extension tube may be coupled to the instrument advancement device 100, and the extension tube may be used for blood withdrawal and / or fluid injection. In some embodiments, the extension tube may extend from a port in the housing 104. In some embodiments, a septum 136 may be 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, the septum 136 may be disposed proximal to the port and distal to the advancement element 122 in the advanced position. In some embodiments, the septum 136 may comprise silicone, rubber, elastomer, or another suitable material. In some embodiments, the septum 136 may include an opening, slit, or the like, to accommodate the instrument 102 through.

[0032] 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 148, 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 opposite the bottom 152. In some embodiments, the first groove 144 and / or the second groove 146 can be configured to straighten and / or guide the instrument 102 as it is advanced distally and / or retracted proximally.

[0033] In some embodiments, the advancement element 122 may include an arc-shaped channel 154, which may be U-shaped. In some embodiments, the instrument 102 may extend and move through the arc-shaped 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 130 of the instrument 102 may be configured to distally advance a second distance. In some embodiments, the second distance may be twice the first distance. In some embodiments, the second distance may be more than twice the first distance. In these and other embodiments, the instrument 102 may extend through multiple U-shapes or other arc 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, compressible portion 156 may be constructed of a flexible material that may have a lower durometer than the portion of housing 104 that surrounds compressible portion 156. In some embodiments, blood collection path 159 may extend within chamber 158 and / or through extension tube 132.

[0034] In some embodiments, because first groove 144 and / or second groove 146 are open opposite bottom 152, instrument 102 may tend to buckle in response to distal advancement of advancement element 122, as shown, for example, in FIG. 1B. Thus, in some embodiments, one or more support features may be used. Support features are further described in U.S. Patent Application No. 63 / 164,976, filed March 23, 2021, entitled "VASCULAR ACCESS DEVICE FOR REDUCING INSTRUMENT BUCKLING," which may be incorporated by reference herein in its entirety.

[0035] Referring to FIG. 2, according to one non-limiting embodiment or aspect of the present disclosure, the instrument advancing device 100 may include additional features for drawing blood from a patient's blood pathway. In this embodiment, a miniature sample-dispensing device 200 is connected to a fluid pathway 218 of the instrument advancing device 100, and a blood draw device 210 is connected to a proximal end 212 of the miniature sample-dispensing device 200. The blood draw device 210 is configured to receive an evacuated blood draw container 214, such as a BD Vacutainer® blood draw tube. The miniature sample-dispensing device 200 is removable from the housing 104 and configured to dispense a blood sample. In one aspect or embodiment, the blood draw device 210 is a BD Vacutainer® Luer-Lok™ access device. The instrument advancing device 100 and the miniature sample-dispensing device 200 may be configured to dispense a small volume of blood sample to a POC system, such as a blood cartridge or test strip, which may be used in a glucose monitor. Although the compact sample-dispensing device 200 is shown in conjunction with the instrument advancement device 100, the compact sample-dispensing device 200 may be used directly with a catheter or catheter adapter.

[0036] In one aspect or embodiment, the miniature sample-dispensing device 200 is configured to receive volumes between 0.3 and 500 microliters. In one aspect or embodiment, the miniature sample-dispensing device 200 is configured to receive volumes between 0.3 and 100 microliters.

[0037] As shown in FIG. 2, in one aspect or embodiment, the miniature sample-dispensing device 200 is integrally formed with the blood collection device 210.

[0038] As shown in Fig. 3, in a further aspect or embodiment, the miniature sample-dispensing device 200 is removably attached to the blood collection device 210. When removable from the blood collection device 210, the miniature sample-dispensing device 200 may include a needleless connector 216 configured to connect to the blood sample collection device 210, as shown in Fig. 3. The needleless connector 216 is configured to prevent fluid leakage from the miniature sample-dispensing device 200 when removed from the blood sample collection device 210.

[0039] The miniature sample dispensing device 200 may be fluidly connected to the fluid path 218 of the instrument 102 of the instrument advancing device 100, which may be an extension set with a connector or flow tube. The instrument advancing device 100 may be used to draw a small blood sample from the patient into the blood sample collection device 210. The small blood sample may then be dispensed into the POC cartridge after aspiration of all evacuated collection containers is completed to ensure an uncontaminated blood sample. Blood droplets of the small blood sample may be deposited on the blood cartridge for analysis and testing by the POC testing system.

[0040] As shown in FIG. 4, a blood sample collection system 300 according to an aspect or embodiment of the present application is shown. The blood sample collection system 300 includes a vascular access device 302, a miniature sample dispensing device 200 connected to the vascular access device 302, and a blood draw device 210 connected to a proximal end 212 of the miniature sample dispensing device 200. The miniature sample dispensing device 200 is detachable from the vascular access device 302 and configured to dispense a blood sample. In an aspect or embodiment, the vascular access device 302 is a catheter adapter including a catheter 304 and a patient connector 306, and the miniature sample dispensing device 200 is connected to the patient connector 306. The patient connector 306 may be connected to the catheter adapter via a tube 308. In an aspect or embodiment, the vascular access device 302 includes an extension tubing set 310. The vascular access device 302 may further include a needle 311 or needle insertion assembly (not shown) configured to position the catheter 304 within the patient's vasculature.

[0041] As mentioned above, the miniature sample-dispensing device 200 may be integrally formed with the blood collection device 210 or may be detachable from the blood collection device 210. The miniature sample-dispensing device 200 is configured along the fluid path of the vascular access device 302 and is configured to be removed after blood collection with the evacuated blood collection container or syringe is completed, thereby ensuring that any waste volumes are removed from the system 300. In one aspect or embodiment, the miniature sample-dispensing device 200 is vented to provide blood flashback during use of the vascular access device 302.

[0042] 5, the miniature sample dispensing device 200 is configured to be compressed to dispense fluid from the miniature sample dispensing device 200, or alternatively, the miniature sample dispensing device 200 is configured to be attached to a syringe barrel 312 to dispense fluid from the miniature sample dispensing device 200. The miniature sample dispensing device 200 may be used to dispense blood samples to POC systems 316 including cartridges, test strips, or any other suitable configuration. In one aspect or embodiment, the sample is dispensed from a distal end 314 of the miniature sample dispensing device 200.

[0043] In one aspect or embodiment, the miniature sample dispensing device 200 includes a fluid path geometry configured to prevent hemolysis of the blood sample. In one aspect or embodiment, the fluid path geometry reduces the flow rate of blood in the fluid path, which in turn can reduce the shear rate for hemolysis management. The fluid path of the miniature sample dispensing device 200 can have an inner diameter, length, and / or contours configured to provide a predetermined flow rate configured to minimize or prevent hemolysis of the blood sample. In some aspects or embodiments, the miniature sample dispensing device 200 includes one of the flow path geometries shown and described in U.S. Patent Application Publication No. 2021 / 10186394, which is incorporated herein by reference in its entirety.

[0044] Although the invention has been described in light of the above detailed description, those skilled in the art will appreciate that modifications can be made which remain within the spirit of the invention.

Claims

1. 1. An instrument advancement device comprising: a housing having a fluid pathway, a distal end, and a proximal end; an instrument disposed within the housing; an advancement element configured to advance the instrument distal to the distal end of the housing in response to movement of the advancement element relative to the housing; and a miniature sample dispensing device connected to the proximal end of the housing; a blood collection device connected to a proximal end of the miniature sample-dispensing device, the blood collection device configured to receive an evacuated blood collection container, the miniature sample-dispensing device removable from the housing and configured to dispense a blood sample; an instrument advancement device comprising:

2. The instrument advancement device of claim 1 , wherein the miniature sample-dispensing device is configured to receive a volume of between 0.3 and 500 microliters.

3. The instrument advancement device of claim 2 , wherein the miniature sample-dispensing device is configured to receive a volume of between 0.3 and 100 microliters.

4. The instrument advancement device of claim 1 , wherein the miniature sample dispensing device is integrally formed with the blood collection device.

5. The instrument advancement device of claim 1 , wherein the miniature sample dispensing device is removably attached to the blood collection device.

6. The instrument advancement device of claim 5 , wherein the miniature sample-dispensing device comprises a needleless connector configured to connect to the blood sample collection device.

7. The instrument advancement device of claim 1 , wherein the miniature sample-dispensing device is configured to be squeezed to dispense fluid from the miniature sample-dispensing device.

8. The instrument advancement device of claim 1 , wherein the miniature sample dispensing device is configured to be attached to a syringe barrel for dispensing fluid from the miniature sample dispensing device.

9. 1. A blood sample collection system comprising: A vascular access device; a miniature sample dispensing device connected to the vascular access device; a blood collection device connected to a proximal end of the miniature sample-dispensing device, the blood collection device configured to receive an evacuated blood collection container, the miniature sample-dispensing device detachable from the vascular access device and configured to dispense a blood sample; 1. A blood sample collection system comprising:

10. 10. The blood sample collection system of claim 9, wherein the vascular access device includes a catheter adapter including a catheter and a patient connector, and the miniature sample dispensing device is connected to the patient connector.

11. The blood sample collection system of claim 10 , wherein the patient connector is connected to the catheter adapter via a tube.

12. The blood sample collection system of claim 10 , wherein the vascular access device comprises an extension tube.

13. The blood sample collection system of claim 9 , wherein the miniature sample-dispensing device is configured to receive a volume of between 0.3 and 500 microliters.

14. The blood sample collection system of claim 9 , wherein the miniature sample-dispensing device is configured to receive a volume of between 0.3 and 100 microliters.

15. The blood sample collection system of claim 9 , wherein the miniature sample-dispensing device is integrally formed with the blood collection device.

16. The blood sample collection system of claim 9 , wherein the miniature sample-dispensing device is removably attached to the blood collection device.

17. The blood sample collection system of claim 16 , wherein the miniature sample-dispensing device comprises a needleless connector configured to be connected to the blood sample collection device.

18. The blood sample collection system of claim 9 , wherein the miniature sample-dispensing device is configured to be squeezed to dispense fluid from the miniature sample-dispensing device.

19. The blood sample collection system of claim 9 , wherein the miniature sample dispensing device is configured to be attached to a syringe barrel for dispensing fluid from the miniature sample dispensing device.

20. 10. The blood sample collection system of claim 9, wherein the miniature sample-dispensing device is vented to provide blood flashback during use of the vascular access device.

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