Tube support for blood suction device

Abstract

A blood aspiration 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, a secondary catheter having a proximal end, a distal end, and a sidewall defining a lumen, an introducer having a proximal end, a distal end, and a sidewall defining an interior volume configured to movably receive the catheter, and an actuator movably coupled to the introducer. The actuator has a first portion disposed outside the introducer and a second portion disposed in the interior volume of the introducer. The second portion of the actuator has a main body having a first height and an extension having a second height. The main body and the extension define an opening, and the catheter and the secondary catheter are attached to the actuator and in fluid communication with the opening.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application Serial No. 63 / 273,259, entitled "TUBE SUPPORT FOR BLOOD DRAWING APPARATUS," filed October 29, 2021, the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] 2. Background of the Invention FIELD OF THEINVENTION The present disclosure relates generally to medical devices for use with intravenous (IV) catheters, and more particularly to medical devices having features for limiting deflection of flexible catheters.

[0003] 2. Description of Related Art When used with an indwelling venous catheter, the blood aspiration device may include a displaceable catheter that is advanced beyond the tip of the indwelling venous catheter for blood collection. Often, as the displaceable catheter is advanced, it may encounter obstacles that may result in catheter deflection. Examples of obstacles include friction of seals within the blood aspiration device, tortuous paths within the integral catheter, pinching of the catheter tube as it burrows into the skin, thrombus, fibrin, and valves. Such deflection may reduce the ability of the displaceable catheter to extend beyond the tip of the indwelling catheter, thus limiting its use for blood collection. Thus, there is a need in the art for a device that limits buckling and ensures timely and effective blood collection.

[0004] Summary of the Invention In one aspect or embodiment, a blood aspiration device for use with a peripheral intravenous catheter (PIVC) includes a catheter having a proximal end, a distal end, and a sidewall therebetween defining a lumen, a secondary catheter having a proximal end, a distal end, and a sidewall therebetween defining a lumen, an introducer configured to movably receive the catheter having a proximal end, a distal end, and a sidewall therebetween defining an interior volume, and an actuator movably coupled to the introducer. The actuator has a first portion disposed outside the introducer and a second portion disposed within the interior volume of the introducer, the second portion of the actuator comprising a main body having a first height and an extension having a second height. The second height is less than the first height. The main body and extension define an opening, and the catheter and the secondary catheter are attached to the actuator and in fluid communication with the opening. At least a portion of the extension is received within the lumen of the secondary catheter.

[0005] The extension of the second portion of the actuator may be entirely received within a lumen of the secondary catheter. The first height of the actuator main body may be equal to or less than the height of the secondary catheter. The actuator main body, the actuator extension, and the secondary catheter may be circular in cross-section, and the first height of the actuator main body, the second height of the actuator extension, and the height of the secondary catheter are the respective diameters of the actuator main body, the actuator extension, and the secondary catheter.

[0006] The interior volume of the introduction portion may have a height, the height of the interior volume of the introduction portion being less than 5% greater than the first height of the main body of the actuator.

[0007] The interior volume of the introduction portion may have a height, the height of the interior volume of the introduction portion being less than 10% greater than the first height of the main body of the actuator.

[0008] The actuator may be attached to the secondary catheter via an adhesive positioned between the secondary catheter and an extension of the second portion of the actuator.The actuator may be attached to the secondary catheter via a solvent bond at an interface between the secondary catheter and an extension of the second portion of the actuator.

[0009] The actuator may be attached to the secondary catheter by at least one barb positioned on an extension of the second portion of the actuator.

[0010] The introducer may define a groove extending in a direction extending from the proximal end of the introducer to the distal end of the introducer, the groove being positioned within an interior volume of the introducer and configured to receive a portion of the catheter during use of the blood drawing device. The introducer may include a first member and a second member attached to the first member, the first member and the second member defining a gap configured to receive a portion of the first portion of the actuator, the introducer groove being configured to prevent migration of the catheter through the gap during use of the blood drawing device.

[0011] The distal end of the introducer may have a lock configured to connect the introducer to an IV line. The proximal end of the catheter may be received within the opening of the actuator. The proximal end of the secondary catheter may include a coupler.

[0012] The actuator may be configured to move relative to the introducer to move the catheter between a first position in which the catheter is disposed within the introducer and a second position in which a distal end of the catheter is disposed beyond the distal end of the introducer.

[0013] In one aspect or embodiment, a blood aspiration device for use with a PIVC includes a catheter having a proximal end, a distal end, and a sidewall defining a lumen therebetween, a second 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 interior volume configured to movably receive the catheter therebetween, and an actuator movably coupled to the introducer. The actuator has a first portion disposed outside the introducer and a second portion disposed within the interior volume of the introducer, the catheter and the second catheter being attached to the actuator. The actuator is configured to move relative to the introducer to move the catheter between a first position where the catheter is disposed within the introducer and a second position where 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 being positioned within the interior volume of the introducer and configured to receive a portion of the catheter during use of the blood aspiration device.

[0014] The introducer may include a first member and a second member attached to the first member, the first member and the second member defining a gap configured to receive a portion of the first portion of the actuator, and the groove of the introducer may be configured to prevent the catheter from migrating through the gap during use of the blood drawing device. The first member may include a top flange and a body extending from the top flange, the top flange of the first member defining the groove. The groove may extend from the distal end of the introducer to the proximal end. The groove may extend a portion of the length extending from the distal end of the introducer to the proximal end of the introducer. [Brief description of the drawings]

[0015] [Figure 1] FIG. 1 is a schematic diagram of a blood drawing device in a first configuration according to an embodiment of the present disclosure. [Diagram 2] FIG. 2 is a schematic diagram of the blood drawing device of FIG. 1 in a second configuration according to an embodiment of the present disclosure. [Diagram 3]FIG. 3 is a perspective view of a blood drawing device according to an embodiment of the present disclosure. [Figure 4] FIG. 4 is an exploded perspective view of the blood suction device of FIG. [Diagram 5] FIG. 5 is a partial rear view of the blood suction device of FIG. [Figure 6] FIG. 6 is a side view of the blood suction device of FIG. [Figure 7] FIG. 7 is a cross-sectional view of a prior art blood suction device. [Figure 8] FIG. 8 is an enlarged cross-sectional view of area A shown in FIG. [Figure 9] FIG. 9 is a cross-sectional view of a prior art blood suction device showing the catheter in a deflected position. [Figure 10] FIG. 10 is a partial cross-sectional view of a blood drawing device according to an embodiment of the present disclosure. [Figure 11] FIG. 11 is a partial cross-sectional view of a blood drawing device according to a further embodiment of the present disclosure. [Figure 12] FIG. 12 is a cross-sectional view of an actuator according to a further embodiment of the present disclosure. [Figure 13] FIG. 13 is a cross-sectional view of a blood drawing device according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Description of the invention The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for carrying out 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.

[0017] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and their derivatives shall refer to the invention as oriented in the drawing figures. It should be understood, however, that the invention may contemplate 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 invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0018] It should be understood that the numerical ranges recited herein are intended to include all values ​​and subranges subsumed therein. For example, a range "1 to 10" is intended to include all subranges between (and including) the recited minimum of 1 and the recited maximum of 10, i.e., subranges having minimums equal to or greater than 1 and maximums equal to or less than 10.

[0019] US Pat. No. 11,090,461, which discloses a medical device including a fluid transfer device, is incorporated herein by reference in its entirety.

[0020] 1 and 2, in one aspect or embodiment, a fluid transfer device 100 for venous blood withdrawal via a peripheral venous line or catheter in a first and second configuration, respectively, is shown. The fluid transfer device 100 (also referred to herein as a "blood drawing device" or "transfer device") may be of any suitable shape, size, and / or configuration. As described in further detail herein, the transfer device 100 is configured to couple to and / or otherwise engage an indwelling peripheral venous catheter (PIVC) 105 to transfer fluid from a portion of a patient (e.g., drawing blood) and / or to transfer fluid to a portion of a patient (e.g., injecting a medication or substance).

[0021] Delivery 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 an outer surface of the introducer 110 can be arranged to improve the ergonomics of the introducer 110, which can, in certain implementations, enable a user to operate the delivery device 100 with one hand (i.e., one-handed use).

[0022] The introducer 110 has a proximal end portion 111 and a distal end portion 112 and defines an interior volume 113. Although not shown in FIGS. 1 and 2, the proximal end portion 111 of the introducer 110 may include an opening or port configured to movably receive a portion of the catheter 160. As such, a first portion of the catheter 160 may be disposed within the interior volume 113 and a second portion of the catheter 160 may be disposed outside the interior volume 113. The opening or port may be of any suitable configuration. For example, in some embodiments, the opening and / or port may include a seal or the like configured to form a substantially fluid-tight seal with an outer surface of the portion of the catheter 160 disposed therein. In other embodiments, the opening and / or port may be positioned such that a user may selectively place the catheter 160 in contact with a surface of the proximal end portion 111 that defines the opening and / or port, such that the catheter 160 may be clamped and / or pinched to selectively occlude the lumen of the catheter 160, as described in further detail herein with reference to certain embodiments.

[0023] The distal end portion 112 of the introducer 110 includes and / or is coupled to a lock 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 portion 112 can include a coupler, such as a Luer Lok™, or the like, configured to physically and fluidly couple to an associated coupler of the lock. In some embodiments, the lock is configured to selectively engage and / or contact the PIVC 105 to couple the introducer 110 thereto. For example, in some embodiments, the shape, size, and / or arrangement of the lock is such that the lock forms three-point contact with the PIVC 105. In some embodiments, such an arrangement can provide structural rigidity and / or support to the PIVC 105 when a portion of the lock (e.g., a blunt tip cannula, etc.) is inserted into a portion of the PIVC 105, as described in further detail herein.

[0024] In some aspects or embodiments, the distal end portion 112 of the introducer 110 can include and / or be coupled to a support member or the like that is actuable 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 can be positioned such that placing a predetermined portion of the lock in contact with the target surface, in turn, 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 portion 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 implementations, the target surface can be a skin surface of the body (e.g., an outer surface of the patient's arm, etc.) into which the PIVC 105 is inserted. In some aspects or embodiments, the predetermined angle can be, for example, about 0° to about 30°, about 4° to about 15°, about 8° to about 10°, or any other suitable angle.

[0025] In some aspects or embodiments, the distal end portion 112 of the introducer 110 (and / or the lock) can include a seal or the like that can be transitioned from a sealed configuration to a substantially open configuration to place at least a portion of the interior volume 113 in fluid communication with the lock. The seal can include an anti-reflux mechanism, such as a one-way valve, that can limit and / or substantially prevent the flow of fluid in a proximal direction through the seal outside of the catheter 160, while allowing the catheter 160 to be advanced distally therethrough.

[0026] As discussed above, the introducer 110 defines an interior volume 113 extending between the proximal end portion 111 and the distal end portion 112. The interior volume 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 a catheter 160 and a second portion 175 of the actuator 170, as shown in FIGS. 1 and 2. More specifically, the inner surface of the introducer 110 defining the interior volume 113 can have, for example, a serpentine cross-sectional shape (not shown in FIGS. 1 and 2) such that an axis defined by the first portion 114 of the interior volume 113 is parallel to and offset from an axis defined by the second portion 115 of the interior volume 113. In this manner, the first portion 114 of the interior volume 113 can be spaced from the second portion 115 of the interior volume 113 without being fluidly isolated therefrom. The first portion 114 of the interior volume 113 can extend through a wall of the introducer 110. In other words, the introducer 110 can define a slot, channel, track, opening, and / or the like that is in fluid communication with the first portion 114 of the interior volume 113. Conversely, the second portion 115 of the interior volume 113 can be entirely defined and / or surrounded (at least circumferentially) by the introducer 110. Furthermore, in some aspects or embodiments, the serpentine cross-sectional shape of the interior volume 113 is such that the second portion 115 is not visible (e.g., out of line of sight) through a slot or the like that is in fluid communication with the first portion 114 of the interior volume 113, thereby limiting and / or substantially preventing contamination of the catheter 160 disposed therein.

[0027] The catheter 160 of the delivery device 100 includes a proximal end portion 161 and a distal end portion 162 and defines a lumen 163 extending therethrough. The catheter 160 is movably disposed within the second portion 115 of the interior volume 113 defined by the introducer 110 and is coupled to an actuator 170. The catheter 160 can be moved (e.g., via movement of the actuator 170) between a first position and a second position to transition the delivery device 100 between a first configuration and a second configuration, respectively. More specifically, at least the distal end portion 162 of the catheter 160 is disposed within the second portion 115 of the interior volume 113 when the catheter 160 is in the first position (FIG. 1), and at least a portion of the catheter 160 extends through the PIVC 105 to place the distal end of the catheter 160 in a distal position relative to the portion of the PIVC 105 when the catheter 160 is in the second position (FIG. 2). Although not shown in FIGS. 1 and 2, in some embodiments, the delivery device 100 can include a secondary catheter or the like coupled to the actuator 170 and in fluid communication with the catheter 160. In such embodiments, the secondary catheter can be disposed in a proximal position relative to the catheter 160 and configured to extend through an opening and / or port defined by the proximal end portion 111 of the introducer 110, for example. In this manner, the proximal end portion of the secondary catheter can be coupled to a vacuum (air or liquid) source, a fluid reservoir, a fluid source, a syringe, or the like, thereby placing the catheter 160 in fluid communication therewith. Additionally, in embodiments including a second catheter, catheter 160 may be disposed entirely within introducer 110 when catheter 160 is in the first position.

[0028] The catheter 160 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, at least a portion of the catheter 160 can have an outer diameter (e.g., 10 gauge to 30 gauge) that is substantially similar to or slightly smaller than an inner diameter defined by a portion of the lock coupled to the distal end portion 112 of the introducer 110. In this manner, the inner surface of the portion of the lock can guide the catheter 160 as the catheter 160 is moved between the first and second positions. Such an arrangement can limit and / or substantially prevent bending, deformation, and / or kinking of the portion of the catheter 160 as the portion is moved between the first and second positions. The catheter 160 can have a length sufficient to position a distal surface of the catheter 160 in a desired position relative to a distal surface of the PIVC 105 when the catheter 160 is in the second position. In other words, the length of catheter 160 may be sufficient to define a predetermined and / or desired distance between a distal surface of catheter 160 and a distal surface of PIVC 105 when catheter 160 is in the second position. In some embodiments, positioning the distal surface of catheter 160 a predetermined and / or desired distance from the distal surface of PIVC 105 may enable the distal surface of catheter 160 to be positioned at a desired location within a vein, for example, as described in further detail herein.

[0029] The catheter 160 may be formed from any suitable material or combination of materials such that the catheter 160 may have any suitable stiffness or durometer. In some embodiments, at least a portion of the catheter 160 may be formed from a braided material or the like, which may change, modify, and / or alter the flexibility of the catheter 160 in response to bending forces or the like. In some aspects or embodiments, forming the catheter 160 from a braided material or the like may reduce the likelihood of kinking and / or otherwise deforming in an undesirable manner. Additionally, forming at least a portion of the catheter 160 from a braided material may provide compression and / or deformation in response to compressive forces (e.g., axial forces, etc.) exerted in the direction of a longitudinal centerline defined by the catheter 160. In this manner, the catheter 160 may absorb a portion of the forces associated with, for example, impacting an obstacle or the like. As described in more detail herein, in some implementations, at least a portion of the catheter 160 may deform in response to forces associated with impacting such an obstacle or the like.

[0030] The actuator 170 of the delivery 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 the first portion 114 of the interior volume 113 and a second portion 175 movably disposed within the second portion 115 of the interior volume 113 and coupled to the catheter 160. Although not shown in FIGS. 1 and 2, the actuator 170 can have a cross-sectional shape that relates to and / or otherwise corresponds to the cross-sectional shape of the interior volume 113 (e.g., a serpentine cross-sectional shape). Thus, an axis defined by the first portion 171 of the actuator 170 is parallel to and offset from an axis defined by the second portion 175 of the actuator 170.

[0031] The actuator 170 and the introducer 110 are arranged such that the first portion 171 extends in fluid communication with the first portion 114 of the interior volume 113, such as through a slot. In this manner, a first region of the first portion 171 of the actuator 170 is disposed outside the introducer 110, and a second region of the first portion 171 of the actuator 170 is disposed in the first portion 114 of the interior volume 113. In this manner, a 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 a tab, protrusion, and / or surface that contacts an exterior surface of the introducer 110. In such an embodiment, the outer surface of the introducer 110 may include, for example, a set of ribs, ridges, bumps, grooves, and / or the like along which the tabs, protrusions, and / or surface of the first portion 171 advance when the actuator 170 is moved relative to the introducer 110, resulting in tactile output or feedback (audio, tactile, and visual) that may provide an indication to the user related to the position of the distal end portion 162 of the catheter 160.

[0032] 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 disposed at an angle relative to the introducer 110. That is, contact of the first portion 171 of the actuator 170 with the outer surface of the introducer 110 tilts the actuator 170 relative to the introducer 110. Thus, the longitudinal centerline of the actuator 170 may be non-parallel to the longitudinal centerline of the introducer 110. Furthermore, angling and / or tilting the actuator 170 while the actuator 170 is coupled to the proximal end portion 161 of the catheter 160 may exert a force (e.g., a preload force, etc.) on the catheter 160 sufficient to bend at least a portion of the catheter 160 (e.g., disposing the catheter 160 in a biased configuration), as described in further detail herein.

[0033] In some aspects or embodiments, the delivery device 100 may be disposed in a first configuration prior to use (e.g., shipped, stored, prepared, etc., in the first configuration). In use, a user may manipulate the delivery device 100 to couple the introducer 110 to the indwelling PIVC 105 (e.g., via a lock coupled to and / or associated with the introducer 110). With the delivery device 100 coupled to the PIVC 105, a user may engage a first portion 171 of the actuator 170 to move the actuator 170 relative to the introducer 110, thereby moving the catheter 160 from a first position (e.g., disposed within the introducer 110) toward a second position. The arrangement of the actuator 170 and introducer 110 is such that advancing the actuator 170 relative to the introducer 110 produces a tactile output and / or feedback configured to provide a user with an indication related to the relative position of the distal end portion 162 of the catheter 160 relative to the introducer 110 and / or the PIVC 105. For example, based on the tactile feedback or any other suitable indication, the user may position the catheter 160 in a second position, as described above, such that the distal surface of the catheter 160 extends a desired distance beyond the distal surface of the PIVC 105.

[0034] With the catheter 160 in the second position (e.g., with the transfer device 100 in the second configuration shown in FIG. 2 ), a user can establish fluid communication between the catheter 160 and a fluid reservoir, fluid source, syringe, or the like. For example, as described above, in some embodiments, a user can couple a secondary catheter (not shown) to a fluid reservoir, fluid source, syringe, or the like. Although fluid communication between the catheter 160 and a fluid reservoir or fluid source has been described as being established after the catheter 160 is placed in the second position, in other embodiments, a user can establish fluid communication between the catheter 160 and a fluid reservoir or fluid source before moving the actuator 170 relative to the introducer 110. With the catheter 160 in fluid communication with the fluid reservoir and / or fluid source, the transfer device 100 can then transfer fluid from or to the patient via the catheter 160 extending through and beyond the PIVC 105.

[0035] In some examples, the catheter 160 may encounter an obstacle or the like as the user advances the catheter 160 (via the actuator 170) from a first position to a second position. In such cases, the catheter 160 may be configured to bend, deform, and / or reconfigure in response to a force applied by the user. That is, a force exerted by the user on the actuator 170 (e.g., an actuation or activation force) sufficient to otherwise move the catheter 160 toward the second position results in a deflection, deformation, and / or reconfiguration of at least a portion of the catheter 160 when the catheter 160 encounters an obstacle or the like. Additionally, in a state in which at least a portion of the catheter 160 is preloaded (e.g., a state in which the catheter 160 is bent, bowed, biased, deflected, and / or deformed in response to the angle of the actuator 170, as described above), the deflection, deformation, and / or reconfiguration of the portion of the catheter 160 may be predetermined, predicted, etc.

[0036] 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 suction device" or "transfer device") may be of any suitable shape, size, or configuration, and may be coupled to a PIVC (not shown in FIGS. 3-9) via, for example, a lock and / or an adapter. As described in further detail herein, a user may transition the transfer device 200 from a first configuration to a second configuration to advance a catheter through an existing, positioned, and / or indwelling PIVC (i.e., when the transfer device 200 is coupled thereto) such that at least a distal portion of the catheter is disposed in a distal position relative to the PIVC. Further, because peripheral venous lines each have a shape, size, and / or configuration that may vary based on, for example, the manufacturer of the PIVC and / or its intended use, the delivery device 200 may be configured to allow the delivery device 200 to be coupled to a PIVC having any suitable configuration and thereafter to advance at least a portion of the catheter substantially through the PIVC without kinking, catching, breaking, and / or otherwise reconfiguring the catheter in an undesirable manner. In addition, the delivery device 200 may be manipulated by a user to position a distal surface of the catheter a predetermined and / or desired distance beyond a distal surface of the PIVC to be positioned within a portion of the vein receiving substantially unimpeded blood flow.

[0037] 3-5, transfer device 200 includes introducer 210, lock 240, catheter 260, secondary catheter 265, and actuator 270. Introducing portion 210 can be of any suitable shape, size, or configuration. For example, in some embodiments, introducing portion 210 can be an elongated member having a substantially circular cross-sectional shape. In some embodiments, the shape of introducing portion 210 and / or one or more features or surface finishes of at least an outer surface of introducing portion 210 can be arranged to improve the ergonomics of transfer device 200, which in some examples can enable a user to operate transfer device 200 with one hand (i.e., one-handed use).

[0038] 3-9, the introducer 210 of the transfer device 200 includes a first member 220 and a second member 230 coupled to collectively form the introducer 210. The first member 220 includes a proximal end portion 221 and a distal end portion 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 an interior volume 213 defined by the introducer 210, and the second portion 275 of the actuator 270 is disposed within a second portion 215 of the interior volume 213. The first portion 271 of the actuator 270 can be engaged and / or manipulated by a user (e.g., by the user's finger or thumb) to move the actuator 270 relative to the introducer 210. The first portion 271 of the actuator 270 may include a set of ridges and / or any suitable surface finish, which may, for example, enhance the ergonomic features of the actuator 270 and / or the delivery device 200. The first portion 271 of the actuator 270 includes a tab 273 disposed at or near a proximal end portion of the engagement member 272. The tab 273 may be any suitable tab, rail, ridge, bump, protrusion, knob, roller, slider, or the like. The tab 273 is configured to selectively engage a rib 237 on an outer surface of the second member 230 of the introducer 210. The proximal end portion 211 of the introducer 210 defines an opening 217.

[0039] 7-9, conventionally, the second portion 275 defines an opening 276 configured to receive the proximal end portion 261 of the catheter 260 and the distal end portion 267 of the secondary catheter 265. A portion of the secondary catheter 265 is disposed within the opening 217 defined by the introducer such that the distal end portion 267 is at least partially disposed in the second portion 215 of the interior volume 213 and coupled to the second portion 275 of the actuator 270, while the proximal end portion 266 of the secondary catheter 265 is disposed outside of the introducer 210. The proximal end portion 266 of the secondary catheter 265 is coupled to and / or includes a coupler 269. The coupler 269 is configured to physically and fluidly couple the secondary catheter 265 to any suitable device, such as, for example, a fluid reservoir, a fluid source, a syringe, a vacuum vessel holder (e.g., having or configured to be coupled to a sheath needle), a pump, or the like. Positioning the distal end portion 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 of FIGS. 7 and 8, the actuator may be overmolded onto the secondary catheter 265, which requires a certain wall thickness of the material of the actuator 270 surrounding the secondary catheter 265. As shown in FIG. 9, a medical practitioner may apply a force to the actuator 270 to move the actuator 270 distally relative to the introducer 210, thereby moving the catheter 260 toward its second position (e.g., a distal position), as shown by arrow DD. In some instances, however, the catheter 260 (e.g., the distal end of the catheter 260) may encounter or collide with an obstacle or the like that impedes or prevents further distal movement of the catheter 260. When the distal end of catheter 260 contacts an obstacle, a force exerted by the medical professional on actuator 270 (e.g., in the DD direction) results in a “clutch” (e.g., deflection, deformation, bending, warping, etc.) of catheter 260.

[0040] 10-12, in one aspect or embodiment of the present invention, the actuator 170, 270 of either the device 100 or the device 200 includes a first portion 302 disposed outside the introducer 110, 210 and a second portion 304 disposed within the interior volume 113, 213 of the introducer 110, 210, the second portion 304 of the actuator 170, 270 having a main body 306 having a first height 308 and an extension 310 having a second height 312. The second height 312 is less than the first height 308. The main body 306 and the extension 310 define an opening 314, and the catheter 160, 260 and the secondary catheter 165, 265 are attached to the actuator 170, 270 and are in fluid communication with the opening 314. At least a portion of the extension 310 is received within a lumen 316 of the secondary catheter 165, 265. By providing the extension 310 of the second portion 304 of the actuator 170, 270 within the lumen 316 of the secondary catheter 165, 265, the space 318 between the second portion 304 of the actuator 170, 270 and the introducer 110, 210 is minimized, thereby further confining the catheter 160, 260 within the introducer 110, 210 and limiting the amount of deflection of the catheter 160, 260 during use of the device 100, 200.

[0041] 10-12 , in one aspect or embodiment, the extension 310 of the second portion 304 of the actuator 170, 270 is received entirely within the lumen 316 of the secondary catheter 165, 265, although other suitable arrangements and locations may be utilized. The first height 308 of the main body 306 of the actuator 170, 270 may be equal to or less than the height 320 of the secondary catheter 165, 265. The main body 306 of the actuator 170, 270, the extension 310 of the actuator 170, 270, and the secondary catheter 165, 265 may be circular in cross-section, and the first height 308 of the main body 306 of the actuator 170, 270, the second height 312 of the extension 310 of the actuator 170, 270, and the height 320 of the secondary catheter 165, 265 may be the respective diameters of the main body 306 of the actuator 170, 270, the extension 310 of the actuator 170, 270, and the secondary catheter 165, 265. In one aspect or embodiment, the height 322 of the interior volume 113, 213 of the introducer 110, 210 may be less than 5% greater than the first height 308 of the main body 306 of the actuator 170, 270. In one aspect or embodiment, the height 322 of the interior volume 113 , 213 of the inlet 110 , 210 is less than 10% greater than the first height 308 of the main body 306 of the actuator 170 , 270 .

[0042] 10 , in one aspect or embodiment, the actuator 170, 270 is attached to the secondary catheter 165, 265 via an adhesive positioned between the secondary catheter 165, 265 and the extension 310 of the second portion 304 of the actuator 170, 270. The actuator 170, 270 may also be attached to the secondary catheter 165, 265 via solvent bonding or an interference fit at the interface between the secondary catheter 165, 265 and the extension 310 of the second portion 304 of the actuator 170, 270.

[0043] 11 and 12, in one aspect or embodiment, the actuator 170, 270 is attached to the secondary catheter 165, 265 via at least one barb 330 positioned on the extension 310 of the second portion 304. The actuator 170, 270 is attached to the secondary catheter 165, 265 via at least one barb 330 disposed on the extension 310 of the second portion 304. As shown in FIG. 12, the actuator 170, 270 includes a plurality of barbs 330, each barb 330 extending radially outward from the extension 310 of the actuator 170, 270, although one or more barbs 330 may be provided.

[0044] Referring to FIG. 13, in one aspect or embodiment, the introducer 110, 210 of any of the delivery devices 100, 200 defines a groove 360 ​​extending in a direction extending from the proximal end 111, 211 of the introducer 110, 210 to the distal end 112, 212 of the introducer 110, 210, and the groove 360 ​​is positioned within the internal volume 113, 213 of the introducer 110, 210 and configured to receive a portion of the catheter 160, 260 during use of the delivery device 100, 200. The introducer 110, 210 may include a first member 362 and a second member 364 attached to the first member 362, the first member 362 and the second member 364 defining a gap 366 configured to receive a portion of the first portion 302 of the actuator 170, 270, and the groove 360 ​​of the introducer 110, 210 configured to prevent the catheter 160, 260 from migrating through the gap 366 during use of the device 100, 200. For example, as shown in FIG. 9, when the catheter 160, 260 is bent or deflected, the groove 360 ​​engages at least a portion of the catheter 160, 260 to limit the movement of the catheter 160, 260 and prevent the catheter 160, 260 from migrating through the gap 366. 13, the first member 362 includes a top flange 368 and a body 370 extending from the top flange 368, the top flange 368 of the first member 362 defining a groove 360. In one aspect or embodiment, the groove 360 ​​extends from the distal end 112, 212 of the introducer 110, 210 to the proximal end 111, 211 of the introducer 110, 210. In one aspect or embodiment, the groove 360 ​​extends only a portion of the length extending from the distal end 112, 212 of the introducer 110, 210 to the proximal end 111, 211 of the introducer 110, 210.

[0045] 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 is to be understood that such details are for this purpose only and that the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to 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 aspiration 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; a secondary 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 interior volume therebetween configured to movably receive the catheter; an actuator movably coupled to the introducer, the actuator having a first portion disposed outside the introducer and a second portion disposed in the interior volume of the introducer, the second portion of the actuator comprising a main body having a first height and an extension having a second height, the second height being less than the first height, the main body and the extension defining an opening, the catheter and the secondary catheter attached to the actuator and in fluid communication with the opening, and at least a portion of the extension received within the lumen of the secondary catheter; A blood suction device comprising:

2. The blood drawing device of claim 1 , wherein the extension of the second portion of the actuator is received entirely within the lumen of the secondary catheter.

3. 2. The blood drawing device of claim 1, wherein the first height of the main body of the actuator is equal to or less than the height of the secondary catheter.

4. 4. The blood aspiration device of claim 3, wherein the main body of the actuator, the extension of the actuator, and the secondary catheter are circular in cross section, and the first height of the main body of the actuator, the second height of the extension of the actuator, and the height of the secondary catheter are diameters of the main body of the actuator, the extension of the actuator, and the secondary catheter, respectively.

5. 2. The blood drawing device of claim 1, wherein the interior volume of the introduction portion has a height, and the height of the interior volume of the introduction portion is less than 5% greater than the first height of the main body of the actuator.

6. 2. The blood drawing device of claim 1, wherein the interior volume of the introduction portion has a height, and the height of the interior volume of the introduction portion is less than 10% greater than the first height of the main body of the actuator.

7. The blood drawing device of claim 1 , wherein the actuator is attached to the secondary catheter via an adhesive positioned between the secondary catheter and the extension of the second portion of the actuator.

8. 2. The blood drawing device of claim 1, wherein the actuator is attached to the secondary catheter via a solvent bond at an interface between the secondary catheter and the extension of the second portion of the actuator.

9. 2. The blood drawing device of claim 1, wherein the actuator is attached to the secondary catheter via at least one barb located on the extension of the second portion of the actuator.

10. 2. The blood drawing device of claim 1, wherein 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 being positioned within the interior volume of the introducer and configured to receive a portion of the catheter during use of the blood drawing device.

11. 11. The blood withdrawal device of claim 10, wherein the introducer comprises a first member and a second member attached to the first member, the first member and the second member defining a gap configured to receive a portion of the first portion of the actuator, and the groove in the introducer configured to prevent the catheter from moving through the gap during use of the blood withdrawal device.

12. The blood drawing device of claim 1 , wherein the distal end of the introducer has a lock configured to couple the introducer to an intravenous line.

13. The blood aspiration device of claim 1 , wherein the proximal end of the catheter is received within the opening of the actuator.

14. The blood drawing device of claim 1 , wherein the proximal end of the secondary catheter includes a coupler.

15. 2. The blood drawing device of claim 1, wherein the actuator is configured to move relative to the introducer to move the catheter between a first position in which the catheter is disposed within the introducer and a second position in which the distal end of the catheter is disposed beyond the distal end of the introducer.

16. 1. A blood aspiration 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; a secondary 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 interior volume therebetween configured to movably receive the catheter; an actuator movably coupled to the introducer section, the actuator having a first portion disposed outside the introducer section and a second portion disposed within the internal volume of the introducer section, the catheter and the secondary catheter attached to the actuator, the actuator configured to move relative to the introducer section to move the catheter between a first position in which the catheter is disposed within the introducer section and a second position in which the distal end of the catheter is disposed beyond the distal end of the introducer section, the introducer section defining a groove extending in a direction extending from the proximal end of the introducer section to the distal end of the introducer section, the groove being positioned within the internal volume of the introducer section and configured to receive a portion of the catheter during use of the blood drawing device; A blood suction device comprising:

17. 17. The blood withdrawal device of claim 16, wherein the introducer comprises a first member and a second member attached to the first member, the first member and the second member defining a gap configured to receive a portion of the first portion of the actuator, and the groove in the introducer configured to prevent the catheter from moving through the gap during use of the blood withdrawal device.

18. 18. The blood drawing set of claim 17, wherein the first member comprises a top flange and a body extending from the top flange, the top flange of the first member defining the groove.

19. The blood suction device according to any one of claims 16 to 18, wherein the groove extends from the distal end of the introducer to the proximal end of the introducer.

20. 19. The blood suction device according to claim 16, wherein the groove extends a portion of the length extending from the distal end of the introducer to the proximal end of the introducer.

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