Blood collection device with non-contact advancement device

Abstract

Provided herein is a blood collection device including an introducer having a housing with a guide tube fixedly contained therein, the guide tube defining a guide lumen. A catheter arrangement movable within the guide lumen includes a catheter defining a first catheter lumen, a secondary catheter defining a second catheter lumen, and a catheter fitting coupled between the catheter and the secondary catheter to fluidly connect the first and second catheter lumens. An advancement member movable longitudinally along the introducer includes an array of pinching members disposed within the housing, the array of pinching members configured to pinch the guide tube and move along the guide tube as the advancement member is moved. In response to moving the advancement member distally along the housing, the pinching members push the catheter fitting distally within the guide lumen, thereby also advancing the catheter and the secondary catheter distally.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 400,498, filed August 24, 2022, entitled "Blood Collection Device with Non-Contact Advancement Device," the entire disclosure of which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION Provided herein are devices and components for use in vascular access, and in particular, for use in blood sampling via an indwelling catheter. [Background technology]

[0002] 2. Description of Related Art Catheters are frequently used to administer fluids to and from the body. In a variety of settings, including hospitals and home care, patients receive fluids, medications, and blood products through vascular access devices (VADs), which include such catheters, inserted into the patient's vascular system. A typical VAD includes a plastic catheter that is inserted into a patient's vein, and the length of the catheter varies, for example, from a few centimeters if the VAD is a peripheral intravenous catheter (PIVC) to several centimeters if the VAD is a central venous catheter (CVC).

[0003] Recent developments in the PIVC field have led to the emergence of technologies designed to facilitate blood collection using an indwelling PIVC and an associated blood collection device. These blood collection devices emphasize the ability to reliably collect high-quality blood samples and reduce hemolysis. The primary method by which these devices function is by employing an introducer to insert a catheter, probe, tubing, or other instrument through the PIVC's catheter lumen. The introducer is attached to the PIVC's catheter adapter, which provides for catheter insertion. For example, the catheter adapter may include a needleless access connector, allowing a catheter to be introduced to provide access to the PIVC and the patient's vasculature. A syringe or vacutainer can then be used to collect the blood sample without the need for the patient to undergo an additional needlestick.

[0004] An introducer for a blood collection device typically includes a housing, a catheter movable within the housing and extendable therefrom for advancement into the placed PIVC, and an advancement member that can be actuated by an operator relative to the housing. That is, the advancement member is moved distally by the operator, causing corresponding movement of the catheter relative to the housing, so that the catheter can be advanced from the housing into the placed PIVC. However, during deployment of the catheter for the blood collection device, particularly when the proximal end of the catheter reaches a curved region of the PIVC (near where the PIVC enters the skin) and is caused to bend back and forth as it passes along the vein, the catheter for the blood collection device is subjected to column loads that can cause the catheter to bend, twist, and / or deform. Once the catheter is bent, additional force applied to the catheter can subsequently cause the catheter to fold back on itself and collapse.

[0005] Another problem associated with using existing blood collection devices with indwelling PIVCs is the potential for microbial introduction into the PIVC's fluid pathway, which can lead to catheter-related bloodstream infections (CRBSIs). That is, using existing introducers to introduce or withdraw catheters or other instruments into the PIVC can introduce microbial organisms into the PIVC's fluid pathway. Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, there is a need in the art for a blood collection device and its introducer that provides for advancement of the catheter into the PIVC while minimizing the possibility of bending, kinking, or deformation of the catheter. There is also a need in the art for a blood collection device and its introducer that provides an additional barrier to the entry of microorganisms into the PIVC fluid pathway. [Means for solving the problem]

[0007] Summary of the Invention Provided herein is a blood collection device for use with a peripheral intravenous catheter (PIVC). The blood collection device includes an introducer having a housing extending longitudinally between a proximal end and a distal end and a guide tube secured within the housing and extending longitudinally, the guide tube defining a guide lumen. The blood collection device also includes a catheter arrangement movable within the guide lumen, the catheter arrangement including a catheter defining a first catheter lumen and having a proximal end and a distal end, a secondary catheter defining a second catheter lumen and having a proximal end and a distal end, and a catheter fitting coupled between the proximal end of the catheter and the distal end of the second catheter, fluidly connecting the first catheter lumen and the second catheter lumen. The blood collection device further includes a longitudinally movable advancement member coupled to the introducer, the advancement member including an array of pinching members disposed within the housing, the pinching members configured to pinch the guide tube and move along the guide tube when the advancement member is moved. In response to moving the advancement member distally along the housing, the arrangement of pinch members pushes the catheter fitting distally within the guide lumen, causing the catheter and secondary catheter to also be advanced distally.

[0008] In some embodiments, the advancement member includes a push tab disposed on an exterior surface of the housing and actuatable by a user to move longitudinally, and a body coupled to the push tab via a connector, the body being disposed within the interior volume of the housing and including a channel formed therethrough for receiving the guide tube, and the array of pinch members being integral with the body. The connector is seated within a longitudinally extending groove of the housing, the connector being slidable within the groove to enable longitudinal movement of the advancement member.

[0009] In some embodiments, the arrangement of pinching members includes a plurality of bearings seated within recesses or cavities formed in the body, the plurality of bearings extending into the channel to pinch the guide tube.

[0010] In some embodiments, the array of pinching members includes a plurality of protrusions formed as part of the body and extending into the channel to pinch the guide tube, the plurality of protrusions including spherical or cylindrical protrusions.

[0011] In some embodiments, the array of pinch members is configured so that at least one pinch member of the array of pinch members is disposed on each of opposing ends of the catheter fitting to capture the catheter fitting therebetween.

[0012] In some embodiments, the guide tube is a flexible material that flexes or bends when pinched by an array of pinch members.

[0013] In some embodiments, the guide tube includes a lubricant applied to the guide lumen to facilitate movement of the catheter array within the guide lumen.

[0014] In some embodiments, the guide tube supports movement of the catheter array through the guide lumen along the entire length of the housing and prevents kinking of the catheters during longitudinal movement of the advancement member.

[0015] In some embodiments, the catheter fitting includes a fitting body having a first end engageable with the proximal end of the catheter and a second end engageable with the distal end of the secondary catheter, the fitting body having a hollow structure that allows fluid flow between the catheter and the secondary catheter. The fitting body includes a plurality of seats that engage with the array of pinch members via the guide tube, such that the catheter fitting is pushed within the guide lumen in response to movement of the advancement member along the housing.

[0016] In some embodiments, the housing includes an end wall at a proximal end of the housing, the end wall including an opening formed therein, the opening receiving the secondary catheter and providing for movement of the secondary catheter relative to the housing.

[0017] According to one aspect, the catheter and secondary catheter are advanced distally without direct contact between the advancement member and the catheter arrangement via an arrangement of pinch members that press against the catheter fitting within the guide lumen.

[0018] According to one aspect, in response to moving the advancement member proximally along the housing, an arrangement of pinch members pushes the catheter fitting proximally within the guide lumen, causing the catheter and secondary catheter to also be retracted proximally.

[0019] Another blood collection device for use in a PIVC is provided, the blood collection device including an introducer having a housing extending longitudinally between a proximal end and a distal end and a longitudinally extending guide tube fixedly contained within the housing, the guide tube defining a guide lumen. The blood collection device also includes a catheter array movable within the guide lumen, the catheter array including a catheter defining a first catheter lumen and having proximal and distal ends, a secondary catheter defining a second catheter lumen and having proximal and distal ends, and a catheter fitting coupled between the proximal end of the catheter and the distal end of the secondary catheter, fluidly connecting the first and second catheter lumens. The blood collection device further includes an advancement member configured to move longitudinally along the housing and, in response to such movement, advance the catheter array distally or retract the catheter array proximally in a contactless manner. The advancement member includes an arrangement of pinch members disposed within the housing, the pinch members configured to pinch the guide tube and push the catheter fitting within the guide lumen when the advancement member is moved, thereby advancing the catheter and secondary catheter distally or retracting the catheter proximally.

[0020] In some embodiments, the array of pinch members is configured so that at least one pinch member of the array of pinch members is disposed on each of opposing ends of the catheter fitting to capture the catheter fitting therebetween.

[0021] In some embodiments, the advancement member includes a push tab disposed on an exterior surface of the housing and actuatable for longitudinal movement by a user, and a body coupled to the push tab via a connector, the body being disposed within the interior volume of the housing and including a channel therethrough for receiving the guide tube, and the array of pinch members being integral with the body. The connector is seated within a longitudinally extending groove in the housing, the connector being slidable within the groove to enable movement of the advancement member in the longitudinal direction.

[0022] In some embodiments, the arrangement of pinching members includes a plurality of bearings seated within recesses or cavities formed in the body, the plurality of bearings extending into the channel to pinch the guide tube.

[0023] In some embodiments, the array of pinching members is formed as part of the body and includes a plurality of protrusions that extend into the channel to pinch the guide tube, the plurality of protrusions comprising spherical or cylindrical protrusions.

[0024] In some embodiments, the catheter fitting includes a fitting body having a first end engageable with the proximal end of the catheter and a second end engageable with the distal end of the secondary catheter, the fitting body having a hollow structure that allows fluid flow between the catheter and the secondary catheter. The fitting body includes a plurality of seats that engage with the array of pinch members via the guide tube, such that the catheter fitting is pushed within the guide lumen in response to movement of the advancement member along the housing.

[0025] In some embodiments, the guide tube includes a lubricant applied to the guide lumen to facilitate movement of the catheter array within the guide lumen.

[0026] According to one aspect, the guide tube supports movement of the catheter array through the guide lumen along the entire length of the housing during longitudinal movement of the advancement member and prevents kinking of the catheter during advancement or retraction thereof. [Brief explanation of the drawings]

[0027] [Figure 1] 1 is a perspective view of a blood collection device in which embodiments of the present application may be incorporated. [Figure 2] FIG. 2 is an exploded view of the blood collection device of FIG. 1. [Figure 3] 2 is a perspective view of a first member of an introducer housing included in the blood collection device of FIG. 1. FIG. [Figure 4] 2 is a perspective view of a second member of an introducer housing included in the blood collection device of FIG. 1. FIG. [Figure 5] 5 is a rear perspective view of an introducer housing formed by joining the first member shown in FIG. 3 to the second member shown in FIG. 4. FIG. [Figure 6] FIG. 6 is a front perspective view of the introducer housing shown in FIG. 5. [Figure 7A] 7 is a cross-sectional view of an advancement member of the blood collection device taken along line 7-7 of FIG. 1, according to an embodiment. [Figure 7B] 7 is a cross-sectional view of an advancement member of a blood collection device taken along line 7-7 of FIG. 1 according to another embodiment. [Figure 8] 8 is a cross-sectional view of a portion of the blood collection device taken along line 8-8 of FIG. 1, according to an embodiment. [Figure 9] 2 is a side cross-sectional view of the blood collection device of FIG. 1 in a first configuration. [Figure 10] 2 is a side cross-sectional view of the blood collection device of FIG. 1 in a second configuration. DETAILED DESCRIPTION OF THE INVENTION

[0028] Description of the Invention The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain 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 invention.

[0029] As used herein, the terms "proximal" and "distal" refer to directions closer to and away from a user who places the device in contact with a patient, respectively. Thus, for example, the end of the device that first contacts the patient's body would be the distal end, while the opposite end of the device (e.g., the end of the device that is manipulated by the user) would be the proximal end of the device.

[0030] Spatial or directional terms such as "left," "right," "inside," "outside," "upper," and "lower" should not be considered limiting as the present invention may contemplate various alternative orientations.

[0031] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "lower," "lateral," "longitudinal," and derivatives thereof will refer to the present invention as it is oriented in the drawings. However, it should be understood that the present invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention.

[0032] Terms such as "first," "second," etc. are not intended to refer to a particular order or chronology, but rather to different conditions, characteristics, or elements.

[0033] As used herein, "at least one" is synonymous with "one or more." For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more of A alone, or one or more of B alone, or one or more of C alone, or one or more of A and one or more of B, or one or more of A and one or more of C, or one or more of B and one or more of C, or one or more of all of A, B, and C.

[0034] 1-10 illustrate a blood collection device 100 (and different configurations in which it can be operated) according to an embodiment of the present disclosure. The blood collection device 100 may be of any suitable shape, size, or configuration and may be coupled to a PIVC or other catheter (not shown in FIGS. 1-14 ), for example, via a lock and / or adapter. As described in further detail herein, a user may transition the blood collection device 100 from a first configuration to a second configuration to advance a catheter through an existing, installed, and / or indwelling PIVC (i.e., when the blood collection device 100 is coupled to a PIVC) such that at least one end of the catheter is positioned distal to the PIVC. Furthermore, because peripheral venous lines each have different shapes, sizes, and / or configurations that may vary based, for example, on the manufacturer of the PIVC and / or its intended use, the blood collection device 100 may be configured to couple to a PIVC having any suitable configuration and allow at least a portion of the catheter to be advanced through the PIVC. Additionally, the blood collection device 100 may be manipulated by the user to position the distal surface of the catheter a predetermined and / or desired distance beyond the distal surface of the PIVC and positioned within a portion of the vein receiving substantially unimpeded blood flow.

[0035] 1 and 2, blood collection device 100 includes introducer 102, lock 104, catheter 106, secondary catheter 108, catheter fitting 110, and advancement member 112. Introducer 102 may be of any suitable shape, size, or configuration. For example, in some embodiments, introducer 102 may be an elongated member having a substantially circular cross-sectional shape. In some embodiments, the shape of introducer 102 and / or one or more features or surface finish of at least the outer surface of introducer 102 may be arranged to improve the ergonomics of blood collection device 100, which may in some cases enable a user to operate blood collection device 100 with one hand (i.e., one-handed use).

[0036] 1-6, introducer 102 of blood collection device 100 includes introducer housing 114 having first housing member 116 and second housing member 118 coupled together to form overall housing 114. Although introducer housing 114 is shown as being formed from first housing member 116 and second housing member 118, it will be appreciated that introducer housing 114 could, according to other embodiments, be formed as a single, unitary structure.

[0037] First housing member 116 includes a proximal end 120, a distal end 122, an inner surface 124, and an upper surface 126. Proximal end 120 of first housing member 116, and more particularly, the proximal wall of first housing member 116, defines a notch 128 configured to selectively receive a portion of secondary catheter 108, as described in further detail herein.

[0038] Second housing member 118 has a proximal end 130, a distal end 132, an inner surface 134, and an upper surface 136. As described above with reference to first housing member 116, proximal end 130 of second housing member 118, and more particularly, the proximal wall of second housing member 118, defines a notch 138 configured to selectively receive a portion of secondary catheter 108.

[0039] As described in more detail herein, a portion of the advancement member 112 is configured to be advanced along the introducer housing 114 when a user moves the advancement member 112 relative to the introducer housing 114. Distal movement of the advancement member 112 along the introducer housing 114 facilitates advancement of the tube or catheter arrangement 140 (comprised of the catheter 106, the secondary catheter 108, and the catheter fitting 110) through a portion of the blood collection device 100, such that the catheter 106 may be advanced into a portion of the PIVC and / or a portion of the blood vessel.

[0040] 5 and 6, first housing member 116 is configured to be coupled to second housing member 118 to collectively form introducer housing 114. First housing member 116 and second housing member 118 collectively form proximal end 142 and distal end 144 of introducer housing 114 and collectively define a top surface 145 and an interior volume 146 of introducer housing 114.

[0041] 5 , proximal end 142 of introducer housing 114 defines opening 148. Specifically, opening 148 is generally formed and / or defined by notch 128 of first housing member 116 and notch 138 of second housing member 118. As described in more detail herein, opening 148 is configured to accommodate a portion of secondary catheter 108, which can be moved within opening 148 to enable advancement of secondary catheter 108 relative to introducer housing 114.

[0042] 6 , distal end 144 of introducer housing 114 includes and / or otherwise forms coupler 150. In other words, distal end 122 of first housing member 116 and distal end 132 of second housing member 118 collectively form coupler 150 at distal end 144 of introducer housing 114. Coupler 150 may be of any suitable shape, size, and / or configuration. For example, coupler 150 may form a set of threads that may form a threaded connection with an associated threaded portion of lock 104, as described in more detail herein.

[0043] Lock 104 of blood collection device 100 is coupled to the introducer via coupler 150, which is configured to couple introducer 102 to the PIVC and / or any suitable intermediate instrument or adapter coupled to the PIVC. In the illustrated embodiment, lock 104 has coupler 152, blunt cannula 154, first arm 156, and second arm 158, as shown in FIG. 2, although it will be appreciated that lock 104 could have alternative configurations, such as blunt cannula 154 instead being a luer, luer slip, or needle. Furthermore, lock 104 defines a lumen 160 extending through coupler 152 and blunt cannula 154. Coupler 152 is configured to couple lock 104 to coupler 150 of introducer housing 114. Specifically, in this embodiment, coupler 152 includes and / or forms one or more protrusions configured to selectively engage threads defined and / or formed by coupler 150 of introducer housing 114, thereby forming a threaded connection.

[0044] Blunt-angled cannula 154 extends from coupler 152 and is disposed between first arm 156 and second arm 158. Blunt-angled cannula 154 may be of any suitable shape, size, and / or configuration. In some embodiments, blunt-angled cannula 154 may have a length sufficient to extend at least partially into the PIVC or through the adapter and at least partially into the PIVC. Additionally, blunt-angled cannula 154 may have an inner diameter (the diameter of the surface at least partially defining lumen 160) that is equal to or slightly larger than the outer diameter of a portion of catheter 106. Thus, lumen 160 of lock 104 may receive a portion of catheter 106 when blood collection device 100 is transitioned between the first and second configurations.

[0045] As best shown in FIGS. 2-4 , introducer 102 includes a guide tube 162 that is contained within the interior volume 146 of introducer housing 114 when first and second housing members 116, 118 are coupled together. Guide tube 162 is oriented in a longitudinal direction 164 and extends between the proximal and distal ends 142, 144 of introducer housing 114. Proximal and distal ends 166, 168 of guide tube 162 are supported on inner surfaces 124, 134 of first and second housing members 116, 118 by cradles 170 formed on opposite ends of introducer housing 114. Cradles 170 formed on inner surfaces 124, 134 of first and second housing members 116, 118 are configured to hold guide tube 162 in a desired position relative to opening 148 in a stable arrangement secured to introducer housing 114. When secured within cradle 170, guide tube 162 is fixedly positioned relative to introducer housing 114 and is positioned such that the centerline of guide tube 162 (in longitudinal direction 164) is aligned with the centerline of opening 148 in introducer housing 114. Guide tube 162 is sized to have a diameter greater than the diameter of opening 148, such that the perimeter / circumference of opening 148 is contained within the perimeter / circumference of guide tube 162.

[0046] According to embodiments, the guide tube 162 may be formed of a semi-rigid material that can flex or bend radially inward when pressure is applied perpendicular to the outer surface of the guide tube 162. Thus, the guide tube 162 may be formed of, by way of non-limiting example, polyurethane, silicone, or other plastic. According to embodiments, the guide tube 162 may also be extruded with a lubricating additive or have a lubricant applied to its interior or exterior surface to facilitate movement of the catheter array 140 through a lumen 172 defined by the guide tube 162 ("guide lumen"), as described in further detail herein.

[0047] According to an embodiment, at least a portion of the catheter 106, a portion of the secondary catheter 108, and the catheter fitting 110, i.e., the catheter array 140, are movably disposed within a lumen 172 of the guide tube 162. As shown in Figures 2 and 7A and 7B, the catheter 106 has a proximal end 174 and a distal end 176 and defines a lumen 178, and the secondary catheter 108 has a proximal end 180 and a distal end 182 and defines a lumen 184. The proximal end 174 of the catheter 106 is coupled to a first end 186 of a body 188 of the catheter fitting 110, while the distal end 182 of the secondary catheter 108 is coupled to a second end 190 of the body 188 of the catheter fitting 110. The body 188 of the catheter fitting 110 is configured as a hollow structure, and the lumen 184 of the secondary catheter 108 is in fluid communication with the lumen 178 of the catheter 106 through the catheter fitting 110.

[0048] In some embodiments, the secondary catheter 108 may have a larger diameter than the catheter 106, such that when the proximal end 174 of the catheter 106 and the distal end 182 of the secondary catheter 108 are coupled to the catheter fitting 110, the proximal end 174 of the catheter 106 is at least partially disposed within a lumen 184 defined by the secondary catheter 108. In some embodiments, such an arrangement may reduce and / or substantially prevent leakage associated with fluid flowing between the catheter 106 and the secondary catheter 108, for example. In some embodiments, such an arrangement may limit, reduce, and / or substantially prevent hemolysis of a volume of blood as it flows through the catheter 106 and the secondary catheter 108. In this manner, when the secondary catheter 108 is connected to a fluid reservoir, fluid source, syringe, vacuum aspirator, or pump (via coupler 191 provided at the proximal end 180 of the secondary catheter 108), the secondary catheter 108 establishes fluid communication between the reservoir, fluid source, pump, etc. and the catheter 106. Additionally, in some embodiments, the secondary catheter 108 may also have a clamp (not shown) provided thereon, such as a slide clamp or pinch clamp, to facilitate stopping flow through the secondary catheter 108.

[0049] According to an embodiment, the body 188 of the catheter fitting 110 also includes a plurality of seats 192 on the body 188 that, when engaged by the advancement member 112 (via the guide tube 162), provide for advancement of the catheter fitting 110 through the guide tube 162, as described in more detail herein. The seats 192 may be formed as recesses or other surface features that can be engaged by the advancement member 112 and provide a secure engagement therebetween.

[0050] As described in more detail herein, a portion of the advancement member 112 is configured to be advanced along a top surface 145 of the introducer housing 114 when a user moves the advancement member 112 relative to the introducer housing 114. Distal movement of the advancement member 112 along the introducer housing 114 facilitates advancement of the catheter array 140 through a portion of the blood collection device 100, and the catheter 106 may be advanced into a portion of the PIVC and / or a portion of a blood vessel. That is, the advancement member 112 may be moved relative to the introducer housing 114 to move the catheter 106 between a first position in which the catheter 106 is disposed within the introducer housing 114 (e.g., the catheter 106 is disposed entirely within the interior volume 146 of the introducer housing 114, or within the introducer housing 114 and the lock 104) and a second position in which the distal end 176 of the catheter 106 is at least partially disposed at a location distal to the lock 104 and / or the PIV (not shown) when the lock 104 is coupled to the PIV.

[0051] The structure of the advancement member 112 and its placement within the introducer housing 114, according to an embodiment, is shown in further detail in Figures 7A and 7B, and 8. The advancement member 112 can be generally characterized as including a first portion 194, a second portion 196, and a connector 198 extending therebetween. The first portion 194 of the advancement member 112 is disposed on the upper surface 145 of the introducer housing 114, and the second portion 196 of the advancement member 112 is disposed within the interior volume 146. The connector 198 extends downwardly from the first portion 194 to connect to the second portion 196, coupling the first and second portions together. The connecting portion 198 is inserted into a track 200 formed in the top surface 145 of the introducer housing 114 (i.e., in the track 200 formed between the top surface 126 of the first housing and the top surface 128 of the second housing) and slides within the track 200 when the user restrains the first portion 194 and moves the advancement member 112 relative to the introducer housing 114.

[0052] According to one embodiment, first portion 194 of advancement member 112 is configured as a tab 202 that can be restrained and / or manipulated by a user (e.g., by the user's finger or thumb) to move advancement member 112 relative to introducer housing 114. According to an embodiment, tab 202 can be rounded or flat at the top and can include, for example, a series of ridges and / or any suitable surface finish that can improve the ergonomics of advancement member 112 and / or blood collection device 100.

[0053] The second portion 196 of the advancement member 112 is a body 204 that is disposed within the interior volume 146 defined by the introducer housing 114. The body 204 may be of any suitable shape, size, and / or configuration that provides for smooth movement of the advancement member 112 relative to the introducer housing 114, and thus may have a size and shape that is related to and / or based at least in part on the size and / or shape of the introducer housing 114. The body 204 includes a channel 206 formed therethrough and extending in the longitudinal direction 164. The channel 206 is sized to receive the guide tube 162 therein, and thus the diameter of the channel 206 is at least slightly larger than the diameter of the guide tube 162.

[0054] An array of pinch members 208 is integral with (or disposed relative to) the body 204 and extends radially inward into the channel 206. The pinch members 208 are configured to provide localized compression to the guide tube 162 and engage one or more features (e.g., seat 192) of the catheter fitting 110 through the guide tube 162, providing advancement of the catheter 106 (as part of the catheter array 140) without direct contact between the advancement member 112 and the catheter fitting 110 coupled to the catheter 106. The pinch members 208 may be provided as rollers, bearings, low-friction sliding surfaces (e.g., with a low-friction material and / or a lubricant added thereto), etc., and may be round, angled, spherical, or cylindrical, depending on the embodiment, although it will be understood that the pinch members 208 should provide smooth movement and sliding of the advancement member along the guide tube 162 with minimal friction therebetween.

[0055] To provide localized compression of the guide tube 162 in the area engaged by the pinch members 208, a portion of the pinch members is positioned above the guide tube 162 (and catheter fitting 110) and a portion of the pinch members is positioned below the guide tube 162 (and catheter fitting 110), and the vertical distance between opposing pinch members 208 is less than the outer diameter of the guide tube 162. As the pinch members 208 move longitudinally along the guide tube 162 during movement of the advancement member 112, the pinch members 208 maintain contact with the guide tube 162 and apply localized compression to the guide tube 162, which causes the guide tube 162 to flex or bend radially inward.

[0056] In addition to being positioned both above and below the catheter fitting 110, the pinch members 208 are also positioned at opposite ends of the catheter fitting 110. That is, a portion of the pinch member 208 is positioned distally from the catheter fitting 110 adjacent the first end 186 of the catheter fitting 110, and another portion of the pinch member 208 is positioned proximally from the catheter fitting 110 adjacent the second end 190 of the catheter fitting 110, such that the catheter fitting 110 is captured by the pinch members 208. Because the catheter fitting 110 is captured between the pinch members 208, any movement of the advancement member 112 relative to the introducer housing 114 will result in corresponding movement of the catheter array 140 relative to the introducer housing 114.

[0057] 7A , the pinch member 208 is provided as a bearing 210 seated in a recess or cavity 212 formed in the body 204 and extending into the channel 206 to pinch the guide tube 162. By way of example, an array of four cylindrical bearings 210 is provided on the advancement member 112, with a first pair of cylindrical bearings 210 positioned above and below the catheter fitting 110 adjacent the first end 186 of the catheter fitting 110 and a second pair of cylindrical bearings 210 positioned above and below the catheter fitting 110 adjacent the second end 190 of the catheter fitting 110. The bearings 210 align with seats 192 formed in the catheter fitting 110 and properly engage the catheter fitting 110 via the guide tube 162, facilitating smooth movement of the catheter array 140.

[0058] 7B , the pinching members 208 are provided as a plurality of protrusions 214 integrally formed with the body 204 and extending into the channel 206 to pinch the guide tube 162. By way of example, an array of four cylindrical protrusions 214 may be provided on the body 204, with a first pair of cylindrical protrusions 214 positioned above and below the catheter fitting 110 adjacent the first end 186 of the catheter fitting 110, and a second pair of cylindrical protrusions 214 positioned above and below the catheter fitting 110 adjacent the second end 190 of the catheter fitting 110. The protrusions 214 align with seats 192 formed on the catheter fitting 110 to properly engage the catheter fitting 110 through the guide tube 162 and facilitate smooth movement of the catheter array 140.

[0059] 9 and 10, there is shown a transition between a first and second configuration of blood collection device 100. Prior to use, blood collection device 100, catheter 106 may be in the first configuration, and may be transitioned by a user (e.g., a doctor, physician, nurse, technician, phlebotomist, etc.) from the first configuration (FIG. 9) to the second configuration (FIG. 10) to place at least distal end 176 of catheter 106 in a location distal to introducer housing 114 (e.g., within or distal to an indwelling PIV (not shown)).

[0060] When catheter 106 is disposed in a first position within introducer housing 114, blood collection device 100 is in the first configuration of Figure 9. In some embodiments, when catheter 106 is in the first position, substantially the entire catheter 106 is disposed within introducer housing 114. In other embodiments, when catheter 106 is in the first position, catheter 106 is disposed within introducer housing 114 and lock 104.

[0061] When the blood collection device 100 is in the first position, the advancement member 112 is disposed in a proximal position, and a user can restrain the tab 202 of the advancement member 112 to move the advancement member 112 relative to the introducer housing 114, which in turn moves the catheters 106 (as part of the catheter array 140) from a first position (e.g., disposed within the introducer housing 114) toward a second position. That is, as described above, the pinch member 208 of the advancement member 112 deflects and pinches the guide tube 162 to engage the catheter fitting 110 (i.e., the seat 192 of the catheter fitting 110, FIGS. 7A and 7B ), allowing movement of the catheter array 140 within the guide tube and relative to the introducer housing 114. In this manner, the catheter 106 is moved through the interior volume 146 and the lumen 160 of the lock 104 such that at least the distal end 176 of the catheter 106 is positioned distally outside the lock 104 .

[0062] When the catheter 106 is positioned in the second position, the blood collection device 100 is in the second position of FIG. 10 . The second position of the catheter 106 is achieved when the distal end 176 of the catheter 106 is positioned at a desired location relative to the distal end of the PIVC. In some cases, for example, the distal end of the catheter 106 may be substantially flush with the distal end of the PIVC when the catheter 106 is in the second position. In other examples, the distal end of the catheter 106 may extend a predetermined distance beyond the distal end of the PIVC (e.g., distal to the distal end of the PIVC), such that the distal face of the catheter 106 is positioned within the vein a predetermined distance beyond the distal face of the catheter 106 (e.g., a location within the vein that is substantially free of debris (e.g., fibrin / thrombus) that would otherwise surround the distal end portion of the PIVC).

[0063] When catheter 106 is in the second position (e.g., when blood collection device 100 is in the second configuration, as shown in FIG. 10 ), a user may establish fluid communication between a fluid reservoir, fluid source, syringe, etc. and catheter 106. Blood collection device 100 may then aspirate a volume of blood from the vein based, at least in part, on positioning the distal face of catheter 106 a predetermined and / or desired distance beyond the distal face of the PIVC. Optionally, after a desired volume of blood has been drawn and / or a desired volume of medication has been administered to the patient, the user may retract catheter 106 to the first position by moving advancement member 112 proximally, e.g., returning advancement member 112 to its proximal-most position.

[0064] Advantageously, the blood collection device embodiments described herein provide a means for contactless advancement of a catheter into the PIVC and the patient's vasculature. A guide tube is disposed within the introducer housing to provide a lumen through which the catheter array can travel. An advancement member travels along the outer surface of the guide tube and engages the catheter array through the guide tube, providing advancement of the catheter array. The catheter array is supported by the guide tube as it advances through the introducer housing, thereby preventing the catheter from bending, kinking, and / or deforming during advancement. The guide tube also provides a barrier to potential microbial intrusion into the blood collection device and the fluid pathway of the PIVC, thereby reducing the risk of CRBSI.

[0065] While the present disclosure has been described in detail for purposes of illustration, based on what are presently considered to be the most practical and preferred embodiments or aspects, it should be understood that such detail is for that purpose only, and the present disclosure is not limited to the disclosed embodiments or aspects, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. 1. A blood collection device for use with a peripheral intravenous catheter (PIVC), said blood collection device comprising: An introducer, the introducer comprising: a housing extending longitudinally between a proximal end and a distal end; the introducer comprising a guide tube fixedly contained within the housing and extending in the longitudinal direction, the guide tube defining a guide lumen; a catheter array movable within the guide lumen, the catheter array comprising: a catheter defining a first catheter lumen and having a proximal end and a distal end; a secondary catheter defining a second catheter lumen and having a proximal end and a distal end; the catheter arrangement comprising: a catheter fitting coupled between the proximal end of the catheter and the distal end of the secondary catheter to fluidly connect the first catheter lumen and the second catheter lumen; an advancement member coupled to the introducer and movable in the longitudinal direction, the advancement member comprising an arrangement of pinch members disposed within the housing, the pinch members configured to pinch the guide tube and move along the guide tube when the advancement member is moved; In response to moving the advancement member distally along the housing, the arrangement of pinch members pushes the catheter fitting distally within the guide lumen, resulting in the catheter and the secondary catheter also being advanced distally.

2. 2. The blood collection device of claim 1, wherein the advancement member comprises: a push tab disposed on an exterior surface of the housing and actuatable by a user to move in the longitudinal direction; a body coupled to the push tab via a connection, the body being disposed within the interior volume of the housing and including a channel formed therethrough for receiving the guide tube, the arrangement of pinch members being integral with the body; The blood collection device, characterized in that the connecting portion is seated within a longitudinally extending groove within the housing, the connecting portion being slidable within the groove to allow movement of the advancement member in the longitudinal direction.

3. 3. The blood collection device of claim 2, wherein the pinching member arrangement comprises a plurality of bearings seated within recesses or cavities formed in the body, the bearings extending into the channel to pinch the guide tube.

4. 3. The blood collection device of claim 2, wherein the array of pinching members is formed as part of the body and comprises a plurality of protrusions extending into the channel to pinch the guide tube, the plurality of protrusions comprising spherical or cylindrical protrusions.

5. 2. The blood collection device of claim 1, wherein the array of pinch members is configured such that at least one pinch member of the array of pinch members is positioned at each of opposing ends of the catheter fitting to capture the catheter fitting therebetween.

6. 2. The blood collection device of claim 1, wherein the guide tube comprises a flexible material that flexes or bends when pinched by the arrangement of pinching members.

7. 10. The blood collection device of claim 1, wherein the guide tube includes a lubricant applied to the guide lumen to facilitate movement of the catheter array within the guide lumen.

8. 2. The blood collection device of claim 1, wherein the guide tube supports movement of the catheter array through the guide lumen along the entire length of the housing during longitudinal movement of the advancement member, preventing kinking of the catheters.

9. 10. The blood collection device of claim 1, wherein the catheter fitting comprises a fitting body having a first end engageable with the proximal end of the catheter and a second end engageable with the distal end of the secondary catheter, the fitting body comprising a hollow structure that allows fluid flow between the catheter and the secondary catheter. The blood collection device is characterized in that the fitting body has a plurality of seats that engage with the arrangement of pinch members through the guide tube, such that the catheter fitting is pushed within the guide lumen in response to movement of the advancement member along the housing.

10. 2. The blood collection device of claim 1, wherein the housing includes an end wall at the proximal end of the housing, the end wall including an opening formed therein that receives the secondary catheter and provides for movement of the secondary catheter relative to the housing.

11. 2. The blood collection device of claim 1, wherein the catheter and the secondary catheter are advanced distally via the pinch member arrangement that presses against the catheter fitting within the guide lumen without direct contact between the advancement member and the catheter arrangement.

12. 2. The blood collection device of claim 1, wherein in response to moving the advancement member proximally along the housing, the arrangement of pinch members pushes the catheter fitting proximally within the guide lumen, such that the catheter and the secondary catheter are also retracted proximally.

13. 1. A blood collection device for use with a peripheral intravenous catheter (PIVC), said blood collection device comprising: An introducer, the introducer comprising: a housing extending longitudinally between a proximal end and a distal end; the introducer comprising a guide tube fixedly contained within the housing and extending in the longitudinal direction, the guide tube defining a guide lumen; a catheter array movable within the guide lumen, the catheter array comprising: a catheter defining a first catheter lumen and having a proximal end and a distal end; a secondary catheter defining a second catheter lumen and having a proximal end and a distal end; a catheter fitting coupled between the proximal end of the catheter and the distal end of the secondary catheter, fluidly connecting the first catheter lumen and the second catheter lumen; an advancement member configured to move in the longitudinal direction along the housing and to contactlessly advance or proximally retract the catheter array in response to such movement; The advancing member includes an arrangement of pinch members disposed within the housing, the arrangement of pinch members configured to pinch the guide tube and push the catheter fitting within the guide lumen when the advancing member is moved, thereby advancing the catheter and the secondary catheter distally or retracting them proximally.

14. 14. The blood collection device of claim 13, wherein the array of pinch members is configured such that at least one pinch member of the array of pinch members is positioned at each of opposing ends of the catheter fitting to capture the catheter fitting therebetween.

15. 14. The blood collection device of claim 13, wherein the advancement member comprises: a push tab disposed on an exterior surface of the housing and actuatable by a user to move in the longitudinal direction; a body coupled to the push tab via a connection, the body being disposed within the interior volume of the housing and including a channel formed therethrough for receiving the guide tube, the pinch member arrangement being integral with the body; The blood collection device, characterized in that the connecting portion is seated within a groove extending in the longitudinal direction within the housing, and the connecting portion is slidable within the groove to allow movement of the advancement member in the longitudinal direction.

16. 16. The blood collection device of claim 15, wherein the pinching member arrangement comprises a plurality of bearings seated within recesses or cavities formed in the body, the plurality of bearings extending into the channel and pinching the guide tube.

17. 16. The blood collection device of claim 15, wherein the pinching member arrangement comprises a plurality of protrusions integrally formed with the body, the plurality of protrusions extending into the channel to pinch the guide tube, and the plurality of protrusions comprising spherical or cylindrical protrusions.

18. 14. The blood collection device of claim 13, wherein the catheter fitting comprises a fitting body having a first end engageable with the proximal end of the catheter and a second end engageable with the distal end of the secondary catheter, the fitting body comprising a hollow structure that allows fluid flow between the catheter and the secondary catheter, and the fitting body comprising a plurality of seats that engage with an array of pinch members through the guide tube, such that the catheter fitting is pushed within the guide lumen in response to movement of the advancement member along the housing.

19. 14. The blood collection device of claim 13, wherein the guide tube includes a lubricant applied to the guide lumen to facilitate movement of the catheter array within the guide lumen.

20. 14. The blood collection device of claim 13, wherein the guide tube supports movement of the catheter array through the guide lumen along the entire length of the housing during longitudinal movement of the advancement member, preventing kinking of the catheters during advancement or retraction of the catheters.

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