Blood collection device with buckling prevention function

Abstract

A blood sampling device for use with a peripheral intravenous catheter (PIVC) includes a catheter, an introducer, and an actuator movably coupled to the introducer. The actuator is configured to move relative to the introducer to move the catheter between a first position and a second position. In the first position, the distal end of the catheter is disposed within the introducer. In the second position, the distal end of the catheter is disposed beyond the distal end of the introducer. The introducer defines a groove extending from the proximal end of the introducer to the distal end of the introducer. The groove is disposed within the internal space of the introducer and at a position closer to the bottom surface than the top surface. The groove is configured to receive a portion of the catheter during use of the blood sampling device.

Description

Technical Field

[0001] The present disclosure generally relates to a blood collection device having an anti-buckling function.

Background Art

[0002] (Cross-reference to Related Applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 342,366, entitled "Blood Draw Device with Anti-Buckling Feature," filed May 16, 2022, which is hereby incorporated by reference in its entirety.

[0003] (Description of Background Art) When used with an indwelling venous (IV) catheter, a blood collection device can include a displaceable catheter that advances beyond the tip of the indwelling catheter for blood collection. In many cases, advancing the displaceable catheter can encounter obstacles and cause deflection of the catheter. Examples of obstacles include friction of seals within the blood collection device, a serpentine path within an integral catheter, pinching of the catheter tube when inserted into the skin, blood clots, fibrin, valves, and the like. Such deflection can reduce the ability of the displaceable catheter to extend beyond the tip of the indwelling catheter, and thus limit its use for blood collection.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Accordingly, there is a need in the art for a device that limits buckling and ensures timely and effective blood collection.

Means for Solving the Problems

[0005] In one aspect or embodiment, a blood collection device for use with a peripheral intravenous catheter (PIVC) includes a catheter having a proximal end, a distal end, and a sidewall defining a lumen therebetween, an introducer having a proximal end, a distal end, and a sidewall defining an internal space configured to movably receive the catheter therebetween, the introducer having an upper surface and a lower surface disposed opposite the upper surface, and an actuator movably coupled to the introducer. The actuator is configured to move relative to the introducer to move the catheter between a first position and a second position, wherein in the first position, the distal end of the catheter is disposed within the introducer, and in the second position, the distal end of the catheter is disposed beyond the distal end of the introducer. The introducer defines a groove extending in a direction extending from the proximal end of the introducer to the distal end of the introducer. The groove is disposed within the internal space of the introducer and closer to the bottom surface than the upper surface. The groove is configured to receive a portion of the catheter during use of the blood collection device.

[0006] The groove may extend from the distal end of the introducer to the proximal end of the introducer. The groove may extend only a portion of the length extending from the distal end of the introducer to the proximal end of the introducer. The groove may be hemispherical.

[0007] In a further aspect or embodiment, a blood sampling device for use with a peripheral intravenous catheter (PIVC) includes a catheter having a proximal end, a distal end, and a sidewall defining a lumen therebetween, an introducer having a proximal end, a distal end, and a sidewall defining an internal space configured to movably receive the catheter therebetween, the introducer having an upper surface and a lower surface disposed opposite the upper surface, and an actuator movably coupled to the introducer. The actuator is configured to move relative to the introducer to move the catheter between a first position and a second position, wherein in the first position, the distal end of the catheter is disposed within the introducer, and in the second position, the distal end of the catheter is disposed beyond the distal end of the introducer. The introducer includes a ridge disposed within the internal space and extending radially inwardly, the ridge extending in a direction extending from the proximal end of the introducer to the distal end of the introducer. The ridge is configured to engage a portion of the catheter during use of the blood sampling device.

[0008] The ridge may extend from the distal end to the proximal end of the introducer. The ridge may extend only a portion of the length extending from the distal end to the proximal end of the introducer. The ridge may be disposed closer to the upper surface than the lower surface of the introducer. The introducer may include a first portion and a second portion attached to the first portion, the second portion including a vertical sidewall and a horizontal wall defining at least a portion of the upper surface of the introducer. The ridge may be disposed on the vertical sidewall of the second member of the introducer. The ridge may be disposed on the horizontal wall of the second member of the introducer.

[0009] In a further aspect or embodiment, a blood sampling device for use with a peripheral intravenous catheter (PIVC) includes a catheter having a proximal end, a distal end, and a sidewall defining a lumen therebetween, an introducer having a proximal end, a distal end, and a sidewall defining an internal space configured to movably receive the catheter therebetween, and an actuator movably coupled to the introducer. The introducer includes an actuator surface, a top surface, and a bottom surface located below the top surface that define an actuator space. The actuator is configured to move relative to the introducer to move the catheter between a first position and a second position, wherein in the first position, the distal end of the catheter is disposed within the introducer, and in the second position, the distal end of the catheter is disposed beyond the distal end of the introducer. The actuator has a first portion disposed outside the introducer and a second portion disposed within the internal space of the introducer. The second portion of the actuator includes a lower body disposed within the actuator space. The actuator surface is adapted to the top surface of the lower body of the second portion of the actuator.

[0010] The lower body of the second portion of the actuator may have a circular cross-section, and at least a portion of the actuator surface may be curved to conform to the top surface of the lower body of the second portion of the actuator. The actuator surface may extend around at least 225 degrees of the circumference of the lower body of the second portion of the actuator. The actuator surface may extend around at least 300 degrees of the circumference of the lower body of the second portion of the actuator.

[0011] In a further aspect or embodiment, a blood sampling device for use with a peripheral intravenous catheter (PIVC) includes a catheter having a proximal end, a distal end, and a sidewall defining a lumen therebetween, an introducer having a proximal end, a distal end, and a sidewall defining an internal space configured to movably receive the catheter therebetween, and an actuator movably coupled to the introducer. The introducer includes an actuator surface defining an actuator space, an upper surface, and a bottom surface located below the upper surface. The actuator is configured to move relative to the introducer to move the catheter between a first position and a second position. In the first position, the distal end of the catheter is disposed within the introducer, and in the second position, the distal end of the catheter is disposed beyond the distal end of the introducer. The actuator has a first portion disposed outside the introducer and a second portion disposed within the internal space of the introducer. The second portion of the actuator includes a lower body disposed within the actuator space. The device further includes a rail insert disposed between the lower body of the second portion of the actuator and the actuator surface, and the rail insert extends in a direction extending from the proximal end to the distal end of the introducer. The rail insert is configured to engage a portion of the catheter during use of the blood sampling device.

[0012] The actuator may move relative to the rail insert. The rail insert may be flexible. The rail insert may extend only a portion of the length extending from the distal end to the proximal end of the introducer.

Brief Description of the Drawings

[0013]

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Mode for Carrying Out the Invention

[0014] The following description is provided to enable a person of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will still be readily apparent to a person of ordinary skill in the art. It is intended that all such modifications, variations, equivalents, and alternatives be included within the spirit and scope of the present invention.

[0015] In the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "side", "longitudinal", and derivatives thereof are with respect to the present invention oriented in the figures. However, it should be understood that the present invention may assume various alternative variations, except where contrary matters are explicitly specified. Also, it should be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0016] It should be understood that the numerical ranges referred to herein are intended to include all values and subranges subsumed therein. For example, the range "1 to 10" is intended to include all subranges between (and including) the explicitly stated minimum value 1 and the explicitly stated maximum value 10, i.e., subranges having a minimum value of 1 or more and a maximum value of 10 or less.

[0017] U.S. Patent No. 11,090,461, which is hereby incorporated by reference in its entirety and forms a part of this specification, discloses a medical device including a fluid transfer device.

[0018] Referring to FIGS. 1 and 2, in one aspect or embodiment, a fluid transfer device 100 for venipuncture via a peripheral venous line or catheter of a first configuration and a second configuration, respectively, is shown. The fluid transfer device 100 (also referred to herein as a "blood collection device" or a "transfer device") can be of any suitable shape, size, and / or configuration. As will be described in more detail herein, the transfer device 100 is configured to be connected and / or otherwise engaged with an indwelling peripheral venous catheter (PIVC) 105 and to transfer fluid (e.g., aspirate blood) from a part of a patient and / or transfer fluid (e.g., inject a drug or substance) to a part of the patient.

[0019] The transfer device 100 includes at least an introducer 110, a catheter 160 (or cannula), and an actuator 170. The introducer 110 can be of any suitable configuration. For example, in some embodiments, the introducer 110 can be an elongated member having a substantially circular cross-sectional shape. In some embodiments, the shape of the introducer 110 and / or one or more features or surface finishes of at least the outer surface of the introducer 110 can be arranged to improve the ergonomics of the transfer device 100, thereby, in some examples, enabling a user to operate the transfer device 100 with one hand (i.e., one-handed use).

[0020] The introducer 110 has a proximal end 111 and a distal end 112 and defines an internal space 113. Although not shown in FIGS. 1 and 2, the proximal end 111 of the introducer 110 can include an opening or port configured to movably receive a portion of the catheter 160. In this way, a first portion of the catheter 160 can be disposed within the internal space 113 and a second portion of the catheter 160 can be disposed outside the internal space 113. The opening or port can be of any suitable configuration. For example, in some embodiments, the opening and / or port can include a seal configured to form a substantially fluid-tight seal against the outer surface of a portion of the catheter 160 disposed therein. In other embodiments, the arrangement of the opening and / or port is such that, as will be described in more detail herein with reference to particular embodiments, the user can selectively contact the catheter 160 with the surface of the proximal end 111 that defines the opening and / or port, resulting in clamping and / or pinching of the catheter 160 such that the lumen of the catheter 160 can be selectively occluded.

[0021] The distal end 112 of the introducer 110 includes and / or is coupled to a lock, which is configured to physically and fluidly couple the introducer 110 to the PIVC 105 (see, e.g., FIG. 2). For example, in some embodiments, the distal end 112 can include a coupler such as a Luer Lok™ coupler configured to physically and fluidly couple to the associated coupler of the lock. In some embodiments, the lock is configured to selectively engage and / or contact the PIVC 105 and is configured to couple the introducer 110 to the PIVC 105. For example, in some embodiments, the shape, size, and / or arrangement of the lock is such that the lock makes three-point contact with the PIVC 105. In some embodiments, as described in more detail herein, when a portion of the lock (e.g., a blunt-tipped cannula) is inserted into a portion of the PIVC 105, the aforementioned arrangement can provide structural rigidity and / or support to the PIVC 105.

[0022] In some aspects or embodiments, the distal end 112 of the introducer 110 can include a support member or the like and / or can be coupled to a support member or the like, and the support member is operable in positioning the introducer 110 and / or the delivery device 100 at a predetermined angle relative to the target surface. For example, in some embodiments, the lock arrangement can be such that contacting a predetermined portion of the lock with the target surface positions the introducer 110 and / or the delivery device 100 at a predetermined and / or desired angle relative to the target surface. In other embodiments, a support member or the like can be coupled to the distal end 112 of the introducer 110 and configured to position the introducer 110 and / or the delivery device 100 at a predetermined and / or desired angle relative to the target surface. In some embodiments, the target surface can be the skin surface of the body into which the PIVC 105 is inserted (e.g., the outer surface such as the patient's arm). In some aspects or embodiments, the predetermined angle can be, for example, between about 0° and about 30°, between about 4° and about 15°, between about 8° and about 10°, or any other suitable angle.

[0023] In some aspects or embodiments, the distal end 112 of the introducer 110 (and / or the lock) can include a seal or the like, and the seal or the like can be transitioned from a sealed configuration to a substantially open configuration to place at least a portion of the internal space 113 in fluid communication with the lock. The seal can include a backflow prevention mechanism such as a one-way valve, and for example, can limit and / or substantially prevent fluid from flowing past the catheter 160 in the proximal direction through the seal while advancing the catheter 160 distally through the seal.

[0024] As described above, the introducer 110 defines an internal space 113 that extends between a proximal end portion 111 and a distal end portion 112. As shown in FIGS. 1 and 2, the internal space 113 has and / or defines a first portion 114 configured to receive a first portion 171 of the actuator 170 and a second portion 115 configured to receive the catheter 160 and a second portion 175 of the actuator 170. More specifically, the inner surface of the introducer 110 that defines the internal space 113 has a serpentine cross-sectional shape (not shown in FIGS. 1 and 2) such that, for example, the axis defined by the first portion 114 of the internal space 113 can be parallel to and offset from the axis defined by the second portion 115 of the internal space 113. In this way, the first portion 114 of the internal space 113 can be spaced apart from the second portion 115 of the internal space 113 without being fluidly isolated from it. The first portion 114 of the internal space 113 can extend through the wall of the introducer 110. In other words, the introducer 110 can define slots, channels, tracks, openings, etc. that are in fluid communication with the first portion 114 of the internal space 113. Conversely, the second portion 115 of the internal space 113 can be entirely defined and / or (at least circumferentially) surrounded by the introducer 110. Further, in some aspects or embodiments, the serpentine cross-sectional shape of the internal space 113 is such that the second portion 115 cannot be seen (e.g., is out of sight line) through slots or the like that are in fluid communication with the first portion 114 of the internal space 113, and as a result, contamination of the catheter 160 disposed therein can be limited and / or substantially prevented.

[0025] The catheter 160 of the transfer device 100 includes a proximal end 161 and a distal end 162, and defines a lumen 163 that extends through the proximal end 161 and the distal end 162. The catheter 160 is movably disposed within a second portion 115 of the internal space 113 defined by the introducer 110 and is connected to the actuator 170. The catheter 160 can be moved between a first position and a second position (e.g., by movement of the actuator 170) to transition the transfer device 100 between a first configuration and a second configuration, respectively. More specifically, when the catheter 160 is in the first position (FIG. 1), at least the distal end 162 of the catheter 160 is disposed within the second portion 115 of the internal space 113. When the catheter 160 is in the second position (FIG. 2), at least a portion of the catheter 160 extends through the PIVC 105, and the distal end of the catheter 160 is disposed distally with respect to a portion of the PIVC 105. Although not shown in FIGS. 1 and 2, in some embodiments, the transfer device 100 can include a secondary catheter or the like that is connected to the actuator 170 and is in fluid communication with the catheter 160. In such embodiments, the secondary catheter can be disposed, for example, proximally with respect to the catheter 160 and configured to extend through an opening and / or port defined by the proximal end 111 of the introducer 110. In this way, the proximal end of the secondary catheter can be connected to a vacuum (air or liquid) source, a fluid reservoir, a fluid source, a syringe, etc., and as a result, the catheter 160 can be placed in fluid communication with them. Further, in embodiments including a secondary catheter, when the catheter 160 is in the first position, the catheter 160 can be completely disposed within the introducer 110.

[0026] Catheter 160 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, at least a portion of catheter 160 can have an outer diameter (e.g., between 10 gauge and 30 gauge). The outer diameter is substantially the same as or slightly smaller than the inner diameter defined by a portion of the lock coupled to the distal end 112 of introducer 110. In this way, the inner surface of the portion of the lock can guide catheter 160 as catheter 160 moves between the first position and the second position. Such an arrangement can limit and / or substantially prevent bending, deformation, and / or twisting of a portion of the catheter as a portion of catheter 160 is moved between the first position and the second position. Catheter 160 can have a length sufficient to position the distal face of catheter 160 at a desired position relative to the distal face of PIVC 105 when catheter 160 is in the second position. In other words, the length of catheter 160 can be sufficient to define a predetermined and / or desired distance between the distal face of catheter 160 and the distal face of PIVC 105 when catheter 160 is in the second position. In some embodiments, by positioning the distal face of catheter 160 a predetermined and / or desired distance from the distal face of PIVC 105, the distal face of catheter 160 can be positioned at a desired position within the vein, as described in further detail herein, for example.

[0027] The catheter 160 can be formed from any suitable material or combination of materials, and as a result, the catheter 160 can have any suitable rigidity or durometer. In some embodiments, at least a portion of the catheter 160 is formed of a braided material or the like, whereby the flexibility of the catheter 160 in response to forces such as bending forces can be varied, modified, and / or changed. In some aspects or embodiments, forming the catheter 160 of a braided material or the like can reduce the likelihood of twisting and / or deformation of the catheter 160 in other undesirable manners. Additionally, forming at least a portion of the catheter 160 of a braided material can result in compression and / or deformation in response to a compressive force (e.g., an axial force or the like) exerted in the direction of the longitudinal centerline defined by the catheter 160. In this way, the catheter 160 can, for example, absorb a portion of the force associated with a collision with an obstacle or the like. As will be described in more detail herein, in some embodiments, at least a portion of the catheter 160 can deform in response to a force associated with a collision with such an obstacle or the like.

[0028] The actuator 170 of the transfer device 100 can be of any suitable shape, size, and / or configuration. As described above, the actuator 170 includes a first portion 171 movably disposed within a first portion 114 of the internal space 113 and a second portion 175 movably disposed within a second portion 115 of the internal space 113 and coupled to the catheter 160. Although not shown in FIGS. 1 and 2, the actuator 170 can have a cross-sectional shape related to the cross-sectional shape of the internal space 113 (e.g., a serpentine cross-sectional shape) and / or a corresponding cross-sectional shape in other ways. Accordingly, the axis defined by the first portion 171 of the actuator 170 is parallel to and offset from the axis defined by the second portion 175 of the actuator 170.

[0029] The arrangement of the actuator 170 and the introducer 110 is such that the first portion 171 extends through slots or the like in fluid communication with the first portion 114 of the internal space 113. Thus, the first region of the first portion 171 of the actuator 170 is disposed outside the introducer 110, and the second region of the first portion 171 of the actuator 170 is disposed within the first portion 114 of the internal space 113. In this way, the user can engage the first region of the first portion 171 of the actuator 170 and move the actuator 170 relative to the introducer 110 to move the catheter 160 coupled to the second portion 175 of the actuator 170 between a first position and a second position. Although not shown in FIGS. 1 and 2, in some embodiments, the first portion 171 of the actuator 170 can include tabs, protrusions, and / or surfaces that contact the outer surface of the introducer 110. In such embodiments, the outer surface of the introducer 110 can include a set of ribs, ridges, bumps, grooves, etc., and as the actuator 170 moves relative to the introducer 110, the tabs, protrusions, and / or surfaces of the first portion 171 advance along the set of ribs, ridges, bumps, grooves, etc., resulting in a tactile output or feedback (acoustic, tactile, and visual), thereby providing the user with an indication related to the position of the distal end 162 of the catheter 160.

[0030] In some aspects or embodiments, the arrangement of the first portion 171 of the actuator 170 and the outer surface of the introducer 110 is such that the actuator 170 is arranged at an angle with respect to the introducer 110. That is, the contact between the first portion 171 of the actuator 170 and the outer surface of the introducer 110 causes the actuator 170 to be inclined with respect to the introducer 110. Accordingly, the longitudinal centerline of the actuator 170 can be non-parallel to the longitudinal centerline of the introducer 110. Further, as will be described in more detail herein, with the actuator 170 coupled to the proximal end 161 of the catheter 160, the angling and / or tilting of the actuator 170 provides a force (e.g., a preloading force, etc.) sufficient to bend at least a portion of the catheter 160 (e.g., to place the catheter 160 in a deflected configuration).

[0031] In some aspects or embodiments, the transfer device 100 can be arranged in the first configuration before use (e.g., shipping, storage, preparation in the first configuration, etc.). During use, the user can operate the transfer device 100 to connect the introducer 110 to the indwelling PIVC 105 (e.g., via a lock coupled and / or assembled to the introducer 110). With the transfer device 100 connected to the PIVC 105, the user engages the first portion 171 of the actuator 170 to move the actuator 170 relative to the introducer 110, as a result of which the catheter 160 can be moved from a first position (e.g., a position disposed within the introducer 110) towards a second position. The arrangement of the actuator 170 and the introducer 110 is such that the relative advancement of the actuator 170 with respect to the introducer 110 produces a tactile output and / or feedback configured to provide the user with an indication related to the relative position of the distal end 162 of the catheter 160 with respect to the introducer 110 and / or the PIVC 105. For example, as described above, based on the tactile feedback, or any other suitable indication, the user can position the catheter 160 in the second position and extend the distal surface of the catheter 160 beyond the distal surface of the PIVC 105 by a desired distance.

[0032] Using the catheter 160 in the second position (e.g., using the delivery device 100 in the second configuration shown in FIG. 2), the user can establish fluid communication between the fluid reservoir, fluid source, syringe, etc. and the catheter 160. For example, as described above, in some embodiments, the user can connect a secondary catheter (not shown) to the fluid reservoir, fluid source, syringe, etc. After placing the catheter 160 in the second position, it has been described that fluid communication is established between the catheter 160 and the fluid reservoir or fluid source. However, in other embodiments, the user can establish fluid communication between the catheter 160 and the fluid reservoir or fluid source before moving the actuator 170 relative to the introducer 110. Next, using the catheter 160 in fluid communication with the fluid reservoir and / or fluid source, the delivery device 100 can transfer fluid from the patient or transfer fluid to the patient via the catheter 160 that extends through and beyond the PIVC 105.

[0033] In some instances, when the user advances the catheter 160 from the first position to the second position (via the actuator 170), the catheter 160 may collide with an obstacle or the like. In some such examples, the catheter 160 can be configured to bend, deform, and / or undergo other structural changes in response to the force exerted by the user. That is, the force (e.g., activation force or operating force) that the user exerts on the actuator 170, which is sufficient to move the catheter 160 towards the second position in situations other than a collision with an obstacle, causes at least partial bending, deformation, and / or reconfiguration of the catheter 160 when the catheter 160 collides with an obstacle or the like. Further, when at least a portion of the catheter 160 is in a preloaded state (e.g., bent, curved, deflected, refracted, and / or deformed according to the angle of the actuator 170 as described above), some deflection, deformation, and / or structural change of the catheter 160 can be determined, predicted, etc. in advance.

[0034] Referring to FIGS. 3-9, a fluid transfer device 200 according to a further embodiment is shown. The fluid transfer device 200 (also referred to herein as a "blood collection device" or a "transfer device") can be of any suitable shape, size, or configuration and can be connected, for example, to a PIVC (not shown in FIGS. 3-9) via a lock and / or an adapter. As will be described in more detail herein, the user can transition the transfer device 200 from a first configuration to a second configuration and advance a catheter through an existing, placed, and / or indwelling PIVC (i.e., when the transfer device 200 is connected to the PIVC) and position at least the distal end portion of the catheter in a distal position relative to the PIVC. Further, the transfer device 200 can be positioned using each of the peripheral venous lines having shapes, sizes, and / or configurations that can vary, for example, based on the manufacturer of the PIVC and / or its intended method of use, and the transfer device 200 can be connected to a PIVC having any suitable configuration, and then at least a portion of the catheter can be advanced through the PIVC substantially without twisting, snagging, breaking, and / or otherwise structurally changing the catheter in an undesirable manner. In addition, the user can operate the transfer device 200 and position the distal surface of the catheter at a predetermined and / or desired distance beyond the distal surface of the PIVC and into a portion of the vein that receives substantially unobstructed blood flow.

[0035] Referring to FIGS. 3 to 5, the transfer device 200 includes an introducer 210, a lock 240, a catheter 260, a secondary catheter 265, and an actuator 270. The introducer 210 can be of any suitable shape, size, or configuration. For example, in some embodiments, the introducer 210 can be an elongated member having a substantially circular cross-sectional shape. In some embodiments, the shape of the introducer 210 and / or one or more features or surface finishes of at least the outer surface of the introducer 210 can be arranged to improve the ergonomics of the transfer device 200, thereby, in some instances, enabling a user to operate the transfer device 200 with one hand (i.e., single-handed use).

[0036] Referring to FIGS. 3-9, the introducer 210 of the transfer device 200 includes a first member 220 and a second member 230 that are coupled to form the introducer 210 collectively. The first member 220 includes a proximal end 221 and a distal end 222. The actuator 270 includes a first portion 271, a second portion 275, and a wall 277 extending therebetween. The first portion 271 of the actuator 270 is disposed at least partially within a first portion 214 of the internal space defined by the introducer 210, and the second portion 275 of the actuator 270 is disposed within a second portion 215 of the internal space. By engaging the first portion 271 of the actuator 270 and / or operating it by a user (e.g., by a finger or thumb of the user), the actuator 270 can be moved relative to the introducer 210. The first portion 271 of the actuator 270 can include, for example, a set of ridges and / or any suitable surface finish to improve, for example, the ergonomic function of the actuator 270 and / or the transfer device 200. The first portion 271 of the actuator 270 includes a tab 273 disposed at or near the proximal end of the engagement member 272. The tab 273 can be any suitable tab, rail, ridge, bump, protrusion, knob, roller, slider, etc. The tab 273 is configured to selectively engage with a rib 237 on the outer surface of the second member 230 of the introducer 210. The proximal end 211 of the introducer 210 defines an opening 217.

[0037] Referring to FIGS. 7-9, conventionally, the second portion 275 defines an opening 276 configured to receive the proximal end 261 of the catheter 260 and the distal end 267 of the secondary catheter 265. A portion of the secondary catheter 265 is disposed within the opening 217 defined by the introducer and is connected to the second portion 275 of the actuator 270. At the same time, the proximal end 266 of the secondary catheter 265 is disposed outside the introducer 210. The proximal end 266 of the secondary catheter 265 is connected to the coupler 269 and / or, in another case, includes the coupler 269. The coupler 269 is configured to physically and fluidly connect the secondary catheter 265 to any suitable device such as, for example, a fluid reservoir, a fluid source, a syringe, a vacuum container holder (e.g., configured to have or be connected to a sheath needle), a pump, etc. Disposing the distal end 267 of the secondary catheter 265 within the opening 276 of the actuator 270 limits the minimum height or diameter of the second portion 275 of the actuator 270. For example, in the conventional arrangement of the actuator 270 in FIGS. 7 and 8, the actuator may be overmolded onto the secondary catheter 265, in which case a predetermined wall thickness of the material of the actuator 270 surrounding the secondary catheter 265 is required. As shown in FIG. 9, the medical practitioner exerts a force on the actuator 270 to relatively move the actuator 270 distally with respect to the introducer 210, and as a result, as indicated by the arrow DD, the catheter 260 can be moved toward the second position (e.g., the distal position). However, in some examples, the catheter 260 (e.g., the distal end of the catheter 260) may encounter or collide with an obstacle or the like that obstructs or prevents further distal movement of the catheter 260. When the distal end of the catheter 260 is in contact with an obstacle, a "clutch" (e.g., deflection, deformation, bending, curving, etc.) of the catheter 260 occurs due to the force (e.g., in the DD direction) exerted by the medical practitioner on the actuator 270.

[0038] Referring to FIG. 10, in one aspect or embodiment of the present invention, the introducer 110, 210 of either the device 100 or the device 200 includes a top surface 302 and a bottom surface 304 located on the side opposite the top surface 302, and defines a groove 306 extending in a direction extending from the proximal ends 111, 211 of the introducers 110, 210 to the distal ends 112, 212 of the introducers 110, 210. The groove 306 is disposed within the internal space 113 of the introducers 110, 210 and at a position closer to the bottom surface 304 than the top surface 302. The groove 306 is configured to receive a portion of the catheters 160, 260 during use of the blood collection devices 100, 200. More specifically, the groove 306 receives a portion of the catheters 160, 260 to prevent the catheters 160, 260 from curving upward and to prevent the catheters 160, 260 from moving into the slot between the first portions 114, 214 and the second portions 115, 215 of the introducers 110, 210. In some aspects or embodiments, the groove 306 extends from the distal ends 112, 212 of the introducers 110, 210 to the proximal ends 111, 211 of the introducers 110, 210. In some aspects or embodiments, the groove 306 extends only a portion of the length extending from the distal ends 112, 212 of the introducers 110, 210 to the proximal ends 111, 211 of the introducers 110, 210. The groove 306 is hemispherical, but other suitable shapes may be utilized.

[0039] Referring to FIGS. 11 and 12, in one aspect or embodiment of the present invention, the introducers 110, 210 of either the device 100 or the device 200 include a top surface 310, a bottom surface 312 disposed opposite the top surface 310, and a ridge 314 disposed within the internal space 113 and extending radially inwardly. The ridge 314 extends in a direction extending from the proximal ends 111, 211 of the introducers 110, 210 to the distal ends 112, 212 of the introducers 110, 210. The ridge 314 is configured to engage a portion of the catheters 160, 260 during use of the blood collection devices 100, 200. In some aspects or embodiments, the ridge 314 extends from the distal ends 112, 212 of the introducers 110, 210 to the proximal ends 111, 211 of the introducers 110, 210. In some aspects or embodiments, the ridge 314 extends only a portion of the length extending from the distal ends 112, 212 of the introducers 110, 210 to the proximal ends 111, 211 of the introducers 110, 210. The ridge 314 is disposed closer to the top surface 310 than the bottom surface 312, although other suitable arrangements may be utilized. The second portions 115, 214 of the introducers 110, 210 include vertical sidewalls 316 and horizontal sidewalls 318 that define at least a portion of the top surface 310 of the introducers 110, 210. In one aspect or embodiment, as shown in FIG. 11, the ridge 314 is disposed on the vertical sidewall 316 of the second portions 115, 215 of the introducers 110, 210. In one aspect or embodiment, as shown in FIG. 12, the ridge 314 is disposed on the horizontal sidewall 318 of the second portions 115, 215 of the introducers 110, 210. The ridge 314 is configured to engage the catheters 160, 260 as the catheters 160, 260 slide over the introducers 110, 210 during use of the blood transfer devices 100, 200. The ridge may be flat, angled downwardly in a direction extending from the top surface of the introducers 110, 210 towards the bottom surface of the introducers 110, 210, or curved, although other suitable shapes may be utilized.

[0040] Referring to FIG. 13, in one aspect or embodiment of the present invention, the introducer 110, 210 of either the device 100 or the device 200 includes an upper surface 322, a bottom surface 324 located below the upper surface 322, and an actuator surface 326 that defines an actuator space 328. The second portions 175, 275 of the actuators 170, 270 include a lower body 330 disposed within the actuator space. The actuator surface 326 conforms to the upper surface 332 of the lower body 330 of the second portions 175, 275 of the actuators 170, 270. As described above, the first portions 171, 271 of the actuators 170, 270 are disposed outside the introducers 110, 210, and the second portions 175, 275 of the actuators 170, 270 are disposed within the internal space 113 of the introducers 110, 210. In some aspects or embodiments, the lower body 330 of the second portions 175, 275 of the actuators 170, 270 has a circular cross-section, and at least a portion of the actuator surface 326 is curved to conform to the upper surface 332 of the lower body 330 of the second portions 175, 275 of the actuators 170, 270. In some aspects or embodiments, the actuator surface 326 extends over at least 225 degrees around the lower body 330 of the second portions 175, 275 of the actuators 170, 270. In some aspects or embodiments, the actuator surface 326 extends over at least 300 degrees around the lower body 330 of the second portions 175, 275 of the actuators 170, 270. The actuator surface 326 is configured to engage with the catheters 160, 260 during use of the devices 100, 200 so that the catheters 160, 260 remain within the actuator space 328 as the catheters 160, 260 are advanced. Confining the catheters 160, 260 within the small diameter of the actuator space 328 is configured to reduce the amount of bending of the catheters 160, 260, thereby reducing the likelihood of twisting or buckling of the catheters 160, 260.

[0041] Referring to FIGS. 14 and 15, in one aspect or embodiment of the present invention, the introducer 110, 210 of either the device 100 or the device 200 includes a top surface 340, a bottom surface 342 located below the top surface 340, and an actuator surface 344 that defines an actuator space 346. The second portions 175, 275 of the actuators 170, 270 include a lower body 348 disposed within the actuator space 346. As shown in FIGS. 14 and 15, the devices 100, 200 may also include a rail insert 350 disposed between the lower body 348 of the second portions 175, 275 of the actuators 170, 270 and the actuator surface 344. The rail insert 350 extends in a direction extending from the proximal ends 111, 211 of the introducers 110, 210 to the distal ends 112, 212 of the introducers 110, 210. The rail insert 350 is configured to engage a portion of the catheters 160, 260 during use of the blood collection devices 100, 200. In some aspects or embodiments, the actuators 170, 270 move relative to the rail insert 350. The rail insert 350 may be connected or fixed to the introducers 110, 210, or may float or move relative to both the introducers 110, 210 and the actuators 170, 270. In some aspects or embodiments, the rail insert 350 is flexible. The rail insert 350 may be as flexible as the catheters 160, 260, may be less flexible than the catheters 160, 260, or may be more flexible than the introducers 110, 210. The rail insert 350 extends only a portion of the length extending from the distal ends 112, 212 of the introducers 110, 210 to the proximal ends 111, 211 of the introducers 110, 210, but other suitable lengths and arrangements may be utilized.

[0042] Referring to FIG. 16, in one aspect or embodiment of the present invention, the introducers 110, 210 of either the device 100 or the device 200 are similar to the embodiments of FIGS. 11 and 12. However, the first portions 114, 214 and / or the second portions 115, 215 of the introducers 110, 210 can define one or more tracks 360 configured to prevent the catheters 160, 260 from deviating from the gap 362 between the first portions 114, 214 and the second portions 115, 215 in which the actuators 170, 270 extend. The track 360 may be a recess defined by the first portions 114, 214 and / or the second portions 115, 215 of the introducers 110, 210, and may include hooked portions and / or curved portions configured to restrain the catheters 160, 260.

[0043] Referring to FIGS. 17-19, in a further aspect or embodiment of the present invention, the introducers 110, 210 of either the device 100 or the device 200 may be similar to the embodiments of FIGS. 11 and 12, but include various shapes of the actuators 170, 270, and the gap 370 between the first portions 114, 214 and the second portions 115, 215 of the introducers 110, 210. The portions of the actuators 170, 270 extending through the gap 370 and / or the gap 362 define a meandering path and may include various narrow spaces configured to prevent the catheters 160, 260 from passing through the gap 370.

[0044] This disclosure is described in detail for purposes of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects. However, those details are for illustrative purposes only, and this disclosure is not limited to the disclosed embodiments or aspects. On the contrary, it is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that this 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. A catheter having a proximal end, a distal end, and a sidewall defining a lumen therebetween; An introducer having a proximal end, a distal end, and a sidewall defining an internal space therebetween, the internal space being configured to movably receive the catheter, the introducer having a top surface and a bottom surface located opposite the top surface; An actuator movably coupled to the introducer, A blood sampling device for use with a peripheral intravenous catheter (PIVC) comprising: The actuator is configured to move relative to the introducer to move the catheter between a first position and a second position, wherein in the first position, the distal end of the catheter is disposed within the introducer, and in the second position, the distal end of the catheter is disposed beyond the distal end of the introducer; The introducer defines a groove extending in a direction extending from the proximal end of the introducer to the distal end of the introducer; The groove is disposed within the internal space of the introducer and at a position closer to the bottom surface than the top surface; The groove is configured to receive a portion of the catheter during use of the blood sampling device. A blood sampling device characterized by the above.

2. The blood sampling device according to claim 1, wherein the groove extends from the distal end of the introducer to the proximal end of the introducer.

3. The blood sampling device according to claim 1, wherein the groove extends only a portion of the length extending from the distal end of the introducer to the proximal end of the introducer.

4. The blood sampling device according to claim 1, wherein the groove is hemispherical.

5. A catheter having a proximal end, a distal end, and a sidewall defining a lumen therebetween; An introducer having a proximal end, a distal end, and a sidewall defining an internal space therebetween, the internal space being configured to movably receive the catheter, the introducer having a top surface and a bottom surface located opposite the top surface; An actuator movably coupled to the introducer, A blood sampling device for use with a peripheral intravenous catheter (PIVC) comprising: The actuator is configured to move relative to the introducer to move the catheter between a first position and a second position, wherein at the first position, the distal end of the catheter is disposed within the introducer, and at the second position, the distal end of the catheter is disposed beyond the distal end of the introducer. The introducer is disposed within an internal space and includes a ridge extending radially inward. The ridge extends in a direction extending from the proximal end of the introducer to the distal end of the introducer. The ridge is configured to engage a portion of the catheter during use of the blood sampling device. A blood sampling device characterized by the above. **Claim 6** The blood sampling device according to claim 5, wherein the ridge extends from the distal end of the introducer to the proximal end of the introducer. **Claim 7** The blood sampling device according to claim 5, wherein the ridge extends only a part of the length extending from the distal end of the introducer to the proximal end of the introducer. **Claim 8** The blood sampling device according to claim 5, wherein the ridge is disposed at a position closer to the upper surface than the lower surface of the introducer. **Claim 9** The introducer includes a first portion and a second portion attached to the first portion, and the second portion includes a vertical side wall and a horizontal side wall defining at least a part of the upper surface of the introducer. The blood sampling device according to claim 8. **Claim 10** The blood sampling device according to claim 9, wherein the ridge is disposed on the vertical side wall of the second member of the introducer. **Claim 11** The blood sampling device according to claim 9, wherein the ridge is disposed on the horizontal wall of the second member of the introducer. **Claim 12** A catheter having a proximal end, a distal end, and side walls defining a lumen therebetween; An introducer having a proximal end, a distal end, and side walls defining an internal space therebetween, the internal space being configured to movably receive the catheter, the introducer having an upper surface and a bottom surface located on the opposite side of the upper surface; An actuator movably coupled to the introducer; A blood sampling device for use with a peripheral intravenous catheter (PIVC), comprising: The actuator is configured to move relative to the introducer to move the catheter between a first position and a second position. In the first position, the distal end of the catheter is disposed within the introducer. In the second position, the distal end of the catheter is disposed beyond the distal end of the introducer. The actuator has a first portion disposed outside the introducer and a second portion disposed within the internal space of the introducer. The second portion of the actuator includes a lower body disposed within the actuator space. The actuator surface conforms to the upper surface of the lower body of the second portion of the actuator. A blood sampling device characterized by the above.

13. The lower body of the second portion of the actuator has a circular cross-section, and at least a part of the actuator surface is curved so as to conform to the upper surface of the lower body of the second portion of the actuator. The blood sampling device according to claim 12.

14. The actuator surface extends over at least 225 degrees around the lower body of the second portion of the actuator. The blood sampling device according to claim 13.

15. The actuator surface extends over at least 300 degrees around the lower body of the second portion of the actuator. The blood sampling device according to claim 13.

16. A blood sampling device for use with a peripheral intravenous catheter (PIVC), comprising: a catheter having a proximal end, a distal end, and a sidewall defining a lumen therebetween; an introducer having a proximal end, a distal end, and a sidewall defining an internal space therebetween, the internal space being configured to movably receive the catheter, the introducer including an actuator surface defining an actuator space, the introducer having an upper surface and a bottom surface located on the opposite side of the upper surface. An actuator movably coupled to an introducer, the actuator being configured to move relative to the introducer to move a catheter between a first position and a second position, wherein in the first position, a distal end of the catheter is disposed within the introducer, and in the second position, the distal end of the catheter is disposed beyond a distal end of the introducer, the actuator having a first portion disposed outside the introducer and a second portion disposed within an internal space of the introducer, the second portion of the actuator including a lower body disposed within an actuator space, the actuator; A rail insert disposed between a lower body of the second portion of the actuator and an actuator surface, the rail insert extending in a direction extending from a proximal end of the introducer to a distal end of the introducer, the rail insert being engaged with a portion of the catheter during use of the blood collection device, the rail insert; A blood collection device characterized by comprising the above.

17. The blood collection device according to claim 16, wherein the actuator moves relative to the rail insert.

18. The blood collection device according to claim 16, wherein the rail insert is flexible.

19. The blood collection device according to claim 16, wherein the rail insert extends only a part of a length extending from a distal end of the introducer to a proximal end of the introducer.

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