Offset Fluid Path for a Blood Aspiration Device

Abstract

A blood suction 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, and an introducer having a proximal end, a distal end, and a sidewall therebetween defining an internal volume configured to movably receive the catheter, the introducer defining a longitudinal axis, an introducer, and an actuator movably coupled to the introducer and connected to the catheter. The actuator has a first portion positioned outside the introducer and a second portion disposed within the internal volume of the introducer, and the catheter has a first portion extending parallel to the longitudinal axis of the introducer and a second portion extending obliquely to the longitudinal axis of the introducer.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application Serial No. 63 / 344,242, filed on May 20, 2022, entitled "Offset Fluid Path for a Blood Aspiration Device", the entire disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Background of the Invention Field of the Invention The present disclosure generally relates to an offset fluid path for a blood aspiration device.

[0003] Description of Related Art A blood collection device, when used with an indwelling venous catheter, may include a displaceable catheter that is advanced beyond the tip of the indwelling venous catheter for blood collection. Often, when the displaceable catheter is advanced, it encounters obstacles, and as a result, the catheter may be deflected. Examples of obstacles include friction of seals within the blood collection device, tortuous paths within an integral catheter, pinching of the catheter tube when penetrating the skin, blood clots, fibrin, valves, and the like. Such deflection reduces the ability of the displaceable catheter to extend beyond the tip of the indwelling catheter and thus may limit its use for blood collection.

Summary of the Invention

[0004] 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 that defines a lumen, and an introducer having a proximal end, a distal end, and a sidewall therebetween that defines an internal volume configured to movably receive the catheter, the introducer defining a longitudinal axis, and an actuator movably coupled to the introducer and connected to the catheter. The actuator has a first portion disposed outside the introducer and a second portion disposed within the internal volume of the introducer. The catheter has a first portion extending parallel to the longitudinal axis of the introducer and a second portion extending obliquely to the longitudinal axis of the introducer.

[0005] 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 blood aspiration device further includes a secondary catheter having a proximal end, a distal end, and a sidewall therebetween that defines a lumen, and the secondary catheter may be connected to the actuator. The proximal end of the secondary catheter may include a connector.

[0006] The actuator includes a body and an extension portion, the body of the actuator extending parallel to the longitudinal axis of the introducer, and the extension portion of the actuator may receive the catheter and extend obliquely to the longitudinal axis of the introducer.

[0007] The introducer defines a groove extending in a direction from the proximal end of the introducer to the distal end of the introducer, the groove being located within the internal volume of the introducer and configured to receive a portion of the catheter during use of the blood aspiration device. The groove may be U-shaped, V-shaped, and / or quadrilateral.

[0008] 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 having a proximal end, a distal end, and a sidewall therebetween defining an internal volume configured to movably receive the catheter, the introducer defining a longitudinal axis, 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 internal volume of the introducer. The actuator includes a catheter connection coupled to the catheter and a secondary catheter connection coupled to the secondary catheter. The catheter and the secondary catheter each extend parallel to the longitudinal axis of the introducer, and the catheter is offset from the secondary catheter by a distance.

[0009] The catheter connection may be offset from the secondary catheter connection via an angled body portion.

[0010] The actuator includes a body having a top surface and a bottom surface positioned opposite the top surface, and the catheter connection may extend from the bottom surface of the actuator body. The secondary catheter connection may extend between the top surface and the bottom surface of the actuator body.

[0011] In one aspect or embodiment, a method of forming a catheter for a blood aspiration device for use with a peripheral intravenous catheter (PIVC) includes a catheter defining a lumen, an introducer defining an internal volume configured to movably receive the catheter, the introducer defining a longitudinal axis, and an actuator movably coupled to the introducer and coupled to the catheter, the method including molding the catheter such that the catheter includes a first portion extending parallel to the longitudinal axis of the introducer and a second portion extending obliquely to the longitudinal axis of the introducer.

[0012] Forming the catheter may include pulling a curved core pin. Forming the catheter may also include bending a second portion of the catheter relative to a first portion of the catheter.

Brief Description of the Drawings

[0013]

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Mode for Carrying Out the Invention

[0014] Description of the Invention The following description is provided to enable one of ordinary skill 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 one of ordinary skill in the art. All such modifications, variations, equivalents, and alternatives are intended to be included within the spirit and scope of the invention.

[0015] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and their derivatives are related to the invention as oriented in the drawing figures. However, it should be understood that the invention may assume various alternative variations unless explicitly specified to the contrary. Also, it should 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, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein are not to be considered limiting.

[0016] Any numerical range described herein is intended to include all values and sub-ranges subsumed therein. For example, the range of "1 to 10" is intended to include all sub-ranges having a minimum value that is greater than or equal to 1 and a maximum value that is less than or equal to 10, i.e., between (and including) the recited minimum value of 1 and the recited maximum value of 10.

[0017] U.S. Patent No. 11,090,461, which is hereby incorporated by reference in its entirety, discloses a medical device including a blood aspiration device.

[0018] Referring to FIGS. 1 and 2, in one aspect or embodiment, a blood aspiration device 100 for bloodletting via a peripheral venous line or catheter of a first configuration and a second configuration, respectively, is shown. The blood aspiration device 100 (also referred to herein as the "blood aspiration device" or the "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 to and / or otherwise engaged with an indwelling peripheral intravenous catheter (PIVC) 105 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 elongate 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 enhance the ergonomic operability of the transfer device 100, thereby enabling, in some examples, a user to operate the transfer device 100 with one hand (i.e., single-handed use). The introducer 110 defines a longitudinal axis L1.

[0020] The introduction part 110 has a proximal end part 111 and a distal end part 112, and defines an internal volume part 113. Although not shown in FIGS. 1 and 2, the proximal end part 111 of the introduction part 110 can include an opening or port configured to movably receive a part of the catheter 160. Thus, the first part of the catheter 160 can be disposed within the internal volume part 113, and the second part of the catheter 160 can be disposed outside the internal volume part 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 with the outer surface of the part 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 specific embodiments, the user can selectively contact and dispose the catheter 160 on the surface of the proximal end part 111 that defines the opening and / or port, such that the catheter 160 can be clamped and / or pinched to selectively occlude the lumen of the catheter 160.

[0021] The distal end part 112 of the introduction part 110 is configured to physically and fluidly connect the introduction part 110 to the PIVC 105 (see, for example, FIG. 2), and includes and / or is coupled to a lock. For example, in some embodiments, the distal end part 112 can include a connector such as a Luer Lok (trademark) configured to physically and fluidly couple to a related connector of the lock. In some embodiments, the lock is configured to selectively engage and / or contact the PIVC 105 to connect the introduction part 110 thereto. For example, in some embodiments, the shape, size, and / or arrangement of the lock is such that the lock contacts the PIVC 105 at three points. In some embodiments, such an arrangement can provide structural rigidity and / or support to the PIVC 105 when a part of the lock (such as a blunt-tipped cannula) is inserted into a part of the PIVC 105, as will be described in more detail herein.

[0022] In some aspects or embodiments, the distal end portion 112 of the introducer 110 can include a support member or the like that is operable when positioning the introducer 110 and / or the delivery device 100 at a predetermined angle relative to the target surface, and / or can be coupled to a support member or the like. For example, in some embodiments, the lock arrangement can be such that a predetermined portion of the lock is placed in contact with the target surface, which in turn can be used to position 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 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 a patient's arm). In some aspects or embodiments, the predetermined angle can be, for example, from about 0° to about 30°, from about 4° to about 15°, from about 8° to about 10°, or any other suitable angle.

[0023] 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, which can be transitioned from a sealed configuration to a substantially open configuration to place at least a portion of the internal volume 113 in fluid communication with the lock. The seal can include a backflow prevention mechanism such as a one-way valve, which can, for example, allow the catheter 160 to advance distally therethrough while restricting and / or substantially preventing fluid flow in the proximal direction through the seal outside the catheter 160.

[0024] As described above, the introduction part 110 defines an internal volume part 113, which extends between the proximal end part 111 and the distal end part 112. The internal volume part 113 has and / or defines a first part 114 configured to receive the first part 171 of the actuator 170 and a second part 115 configured to receive the catheter 160 and the second part 175 of the actuator 170, as shown in FIGS. 1 and 2. More specifically, the inner surface of the introduction part 110 that defines the internal volume part 113 can have, for example, a meandering cross-sectional shape (not shown in FIGS. 1 and 2), and the axis defined by the first part 114 of the internal volume part 113 is parallel to and offset from the axis defined by the second part 115 of the internal volume part 113. In this way, the first part 114 of the internal volume part 113 can be spaced from the second part 115 of the internal volume part 113 without being fluidly isolated therefrom. The first part 114 of the internal volume part 113 can extend through the wall of the introduction part 110. In other words, the introduction part 110 can define slots, channels, tracks, openings, and / or the like that are in fluid communication with the first part 114 of the internal volume part 113. Conversely, the second part 115 of the internal volume part 113 can be entirely defined and / or surrounded (at least circumferentially) by the introduction part 110. Further, in some aspects or embodiments, the meandering cross-sectional shape of the internal volume part 113 is such that the second part 115 cannot be seen (e.g., is out of sight) through slots or the like through which the second part 115 is in fluid communication with the first part 114 of the internal volume part 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 portion 161 and a distal end portion 162, and defines a lumen 163 that extends through the proximal end portion 161 and the distal end portion 162. The catheter 160 is movably disposed within a second portion 115 of the internal volume portion 113 defined by the introduction portion 110 and is connected to the actuator 170. The catheter 160 can be moved between a first position and a second position (e.g., via movement of the actuator 170) to shift the transfer 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 internal volume portion 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 and positions the distal end of the catheter 160 at a distal position relative to a 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 transfer device 100 can include a secondary catheter or the like that is coupled to the actuator 170 and in fluid communication with the catheter 160. In such embodiments, the secondary catheter can be disposed, for example, at a proximal position relative to the catheter 160 and can be configured to extend through an opening and / or port defined by the proximal end portion 111 of the introduction portion 110. In this way, the proximal end portion of the secondary catheter can be connected to a vacuum (air or liquid) source, a fluid reservoir, a fluid source, a syringe, etc., thereby disposing the catheter 160 in fluid communication therewith. Further, in embodiments including a secondary catheter, the catheter 160 can be disposed entirely within the introduction portion 110 when the catheter 160 is in the first position.

[0026] The catheter 160 can have 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 the same as or slightly smaller than the inner diameter defined by a locking portion coupled to the distal end portion 112 of the introducer 110. In this way, the inner surface of the locking portion can guide the catheter 160 as the catheter 160 is moved between the first position and the second position. Such an arrangement can limit and / or substantially prevent bending, deformation, and / or kinking of the portion as the portion of the catheter 160 is moved between the first position and the second position. The catheter 160 can have a length sufficient to position the distal surface of the catheter 160 at a desired position relative to the distal surface of the PIVC 105 when the catheter 160 is in the second position. In other words, the length of the catheter 160 can be sufficient to define a predetermined and / or desired distance between the distal surface of the catheter 160 and the distal surface of the PIVC 105 when the catheter 160 is in the second position. In some embodiments, positioning the distal surface of the catheter 160 at a predetermined and / or desired distance from the distal surface of the PIVC 105 enables, for example, positioning the distal surface of the catheter 160 at a desired position within a blood vessel, as described in more detail herein.

[0027] Catheter 160 can be formed from any suitable material or combination of materials, which enables the catheter 160 to have any suitable rigidity or durometer. In some embodiments, at least a portion of the catheter 160 can be formed of a braided material or the like, which can vary, modify, and / or change the flexibility of the catheter 160 in response to, for example, bending forces. In some aspects or embodiments, forming the catheter 160 of a braided material or the like can reduce the possibility of kinking and / or deforming in otherwise 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 forces 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 forces associated with colliding with such an obstacle or the like.

[0028] The actuator 170 of the transfer device 100 can have 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 volume 113 and a second portion 175 movably disposed within a second portion 115 of the internal volume 113 and connected 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 volume 113 (e.g., a serpentine cross-sectional shape) and / or correspond 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 actuator 170 and the introducer 110 are arranged such that the first portion 171 extends through a slot or the like and is in fluid communication with the first portion 114 of the internal volume portion 113. In this way, 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 volume portion 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 connected 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, for example, a set of ribs, ridges, bumps, grooves, etc., and when the actuator 170 is moved relative to the introducer 110, the tabs, protrusions, and / or surfaces of the first portion 171 advance along this, which can provide a tactile output or feedback (acoustic, tactile, and visual), which can provide the user with an indication related to the position of the distal end portion 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 introduction portion 110 is such that the actuator 170 is arranged at an angle with respect to the introduction portion 110. That is, the contact between the first portion 171 of the actuator 170 and the outer surface of the introduction portion 110 causes the actuator 170 to be inclined with respect to the introduction portion 110. Accordingly, the longitudinal center line of the actuator 170 can be non-parallel to the longitudinal center line of the introduction portion 110. Further, with the actuator 170 coupled to the proximal end portion 161 of the catheter 160, angling and / or tilting the actuator 170 will, as described in more detail herein, cause a force (e.g., a pre-loaded force, etc.) sufficient to bend at least a portion of the catheter 160 to act on the catheter 160 (e.g., the catheter 160 is arranged in a biased configuration).

[0031] In some aspects or embodiments, the delivery device 100 can be arranged in a first configuration prior to use (e.g., shipped, stored, prepared, etc. in the first configuration). During use, the user can operate the delivery device 100 to couple the introduction portion 110 to the indwelling PIVC 105 (e.g., via a lock coupled to the introduction portion 110 and / or a lock combined with the introduction portion 110). With the delivery device 100 coupled to the PIVC 105, the user can engage the first portion 171 of the actuator 170 to move the actuator 170 relative to the introduction portion 110, and as a result, move the catheter 160 from a first position (e.g., disposed within the introduction portion 110) toward a second position. The arrangement of the actuator 170 and the introduction portion 110 is configured to provide tactile output and / or feedback such that advancing the actuator 170 relative to the introduction portion 110 provides the user with an indicator related to the position of the distal end portion 162 of the catheter 160 relative to the introduction portion 110 and / or the PIVC 105. For example, based on the tactile feedback or any other suitable indicator, the user can, as described above, position the catheter 160 in the second position such that the distal surface of the catheter 160 extends beyond the distal surface of the PIVC 105 by a desired distance.

[0032] With the catheter 160 in the second position (e.g., with the transfer 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. 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.

[0033] In some cases, 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 such a case, the catheter 160 can be configured to bend, deform, and / or reconfigure in response to the force applied by the user. That is, otherwise the force sufficient to move the catheter 160 towards the second position exerted by the user on the actuator 170 (e.g., starting force or operating force) will cause at least some deflection, deformation, and / or reconfiguration of the catheter 160 when the catheter 160 collides with an obstruction or the like. Further, in a state where at least a part of the catheter 160 is pre-loaded (e.g., bent, bowed, biased, deflected, and / or deformed in response to the angle of the actuator 170 as described above), some deflection, deformation, and / or reconfiguration of the catheter 160 can be predetermined, predictable, etc.

[0034] Referring to FIGS. 3-9, a blood aspiration device 200 according to a further embodiment is shown. The blood aspiration device 200 (also referred to herein as the "blood aspiration device" or the "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 thereto) such that at least the distal portion of the catheter is disposed at a distal position relative to the PIVC. Further, since the peripheral venous lines can each have a shape, size, and / or configuration that can vary, for example, based on the manufacturer of the PIVC and / or its intended method of use, the transfer device 200 is arranged such that the transfer device 200 is connected to a PIVC having any suitable configuration and subsequently at least a portion of the catheter can be advanced substantially through the PIVC without kinking, snagging, breaking, and / or otherwise reconfiguring the catheter in an undesirable manner. Additionally, the transfer device 200 can be operated by the user to dispose the distal surface of the catheter a predetermined and / or desired distance beyond the distal surface of the PIVC and within a portion of the vein that receives a substantially unobstructed blood flow.

[0035] Referring to FIGS. 3-5, the transfer device 200 includes an introduction portion 210, a lock 240, a catheter 260, a secondary catheter 265, and an actuator 270. The introduction portion 210 can be of any suitable shape, size, or configuration. For example, in some embodiments, the introduction portion 210 can be an elongated member having a substantially circular cross-sectional shape. In some embodiments, the shape of the introduction portion 210 and / or one or more features or surface finishes of at least the outer surface of the introduction portion 210 can be arranged to improve the ergonomics of the transfer device 200, which in some examples can enable the user to operate the transfer device 200 with one hand (i.e., one-handed use). The introduction portion 210 defines a longitudinal axis L2.

[0036] Referring to FIG. 3-9, the introduction part 210 of the transfer device 200 includes a first member 220 and a second member 230 that are connected so as to collectively form the introduction part 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 the internal volume portion 213 defined by the introduction part 210, and the second portion 275 of the actuator 270 is disposed within a second portion 215 of the internal volume portion 213. The first portion 271 of the actuator 270 can be engaged and / or operated by a user (e.g., by the user's finger or thumb) to move the actuator 270 relative to the introduction part 210. The first portion 271 of the actuator 270 can include a set of ridges and / or any suitable surface finish that can enhance, 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 portion 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 introduction part 210. The proximal end portion 211 of the introduction part 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 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 within the second portion 215 of the internal volume portion 213 and is connected to the second portion 275 of the actuator 270, while the proximal end portion 266 of the secondary catheter 265 is disposed outside the introducer 210. The proximal end portion 266 of the secondary catheter 265 is coupled to and / or includes a connector 269. The connector 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 container holder (configured to have or be coupled to a trocar), a pump, etc. 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 in FIGS. 7 and 8, the actuator may be overmolded onto the secondary catheter 265, which requires a predetermined wall thickness of the material of the actuator 270 surrounding the secondary catheter 265. As shown in FIG. 9, a healthcare provider can apply a force to the actuator 270 to move the actuator 270 in the distal direction relative to the introducer 210, and as a result, move the catheter 260 towards a second position (e.g., a distal position) as indicated by arrow DD. However, in some cases, the catheter 260 (e.g., the distal end of the catheter 260) may encounter or collide with an obstacle or the like that prevents further distal movement of the catheter 260. When the distal end of the catheter 260 is in contact with an obstacle, the force (e.g., in the DD direction) exerted on the actuator 270 by the healthcare provider causes a "grip" (e.g., deflection, deformation, bending, warping, etc.) of the catheter 260.

[0038] Refer to FIGS. 10 and 11. In one aspect or embodiment of the present application, the catheter 160 or 260 of either the device 100 or the device 200 has a first portion 302 extending parallel to the longitudinal axes L1, L2 of the introduction portions 110, 210, and a second portion 304 extending obliquely to the longitudinal axes L1, L2 of the introduction portions 110, 210. The second portion 304 of the catheters 160, 260 is configured to position the catheters 160, 260 closer to the introduction portions 110, 210 within the internal volume portions 113, 213, such that during use of the devices 100, 200, the catheters 160, 260 are supported by the introduction portions 110, 210, thereby minimizing the curvature and / or kinking of the catheters 160, 260.

[0039] Referring to FIG. 12, in one aspect or embodiment, the actuators 170, 270 include a body 306 and an extension portion 308, and the body 306 of the actuators 170, 270 extends parallel to the longitudinal axes L1, L2 of the introduction portions 110, 210. The extension portion 308 of the actuators 170, 270 receives the catheters 160, 260 and extends obliquely to the longitudinal axes L1, L2 of the introduction portions 110, 210. As shown in FIG. 12, the secondary catheters 165, 265 extend parallel to the longitudinal axes L1, L2 of the introduction portions 110, 210 from the body 306. The second portion 304 of the catheters 160, 260 extends from the extension portion 308. In one aspect or embodiment, the extension portion 308 extends at an angle of 2 to 45 degrees with respect to the longitudinal axes L1, L2 of the introduction portions 110, 210. In another aspect, the extension portion 308 extends at an angle of 5 to 20 degrees with respect to the longitudinal axes L1, L2 of the introduction portions 110, 210. The catheters 160, 260 may be received within the extension portion 308 or positioned on the extension portion 308.

[0040] Referring to FIGS. 13 - 15, in one aspect or embodiment, a method of forming catheters 160, 260 having a first portion 302 and a second portion 304 includes bending catheters 160, 260 downward by pulling a curved core pin to mold catheters 160, 260 (FIG. 13), or pre - forming catheters 160, 260 to provide the first portion 302 and the second portion 304 (FIGS. 14A, 14B, and 15). In one embodiment, the tube may be placed on the mold core pin before being placed within the actuator mold. The polymer is then injected around the core pin and the tube to form the actuator. The core pin is subsequently pulled from the mold, and the actuator remains adhered to the tube. In a standard molding configuration, the core pin is straight and is designed to be easily pulled from the mold, but in certain embodiments of the present invention, the core pin is angled and bent to hold the tube in the desired shape during molding. The core pin must then be bent when it is pulled from the assembly. The core pin must be hard enough to hold a specific shape within the mold, but then must be flexible enough to bend during removal. FIGS. 13 - 14 illustrate the concept of a curved core pin. Alternatively, as shown in FIG. 15, a straight core pin is shown, but in this configuration, the core pin is angled and pulled from the mold relative to the core pin at the other end such that the tube forms an angle downward.

[0041] Referring to FIGS. 16A - 18, in one aspect or embodiment of the present invention, an actuator 170, 270 of either device 100 or device 200 includes a catheter connection 312 connected to catheters 160, 260 and a secondary catheter connection 314 connected to secondary catheters 165, 265. Catheters 160, 270 and secondary catheters 165, 265 each extend parallel to the longitudinal axes L1, L2 of the introduction portions 110, 210, and catheters 160, 260 are offset from secondary catheters 165, 265 by a distance 316.

[0042] Referring to FIGS. 16A and 16B, in one aspect or embodiment, the catheter connection portion 312 is offset from the secondary catheter connection portion 314 via an angled body portion 318. The offset of the catheters 160, 260 from the secondary catheters 165, 265 is in a direction perpendicular to the longitudinal axes L1, L2 of the introducers 110, 210, which positions the catheters 160, 260 toward the bottom of the introducers 110, 210 within the internal volume portions 113, 213, minimizing the degree to which the catheters 160, 260 kink and / or buckle.

[0043] Referring to FIGS. 17 and 18, in one aspect or embodiment, the actuators 170, 270 include a body 330 having a top surface 332 and a bottom surface 334 positioned opposite the top surface 332. The catheter connection portion 312 extends from the bottom surface 334 of the body 330 of the actuators 170, 270. The secondary catheter connection portion 314 extends between the top surface 332 and the bottom surface 334 of the body 330 of the actuators 170, 270.

[0044] Referring to FIGS. 19 and 20, in some aspects or embodiments, the introducers 110, 210 of either the device 100 or the device 200 define a groove 340 that extends in a direction from the proximal end portions 111, 211 of the introducers 110, 210 to the distal end portions 112, 212 of the introducers 110, 210. The groove 340 is positioned within the internal volume portions 113, 213 of the introducers 110, 210 and is configured to receive a portion of the catheters 160, 260 during use of the devices 100, 200. The groove 340 may be U-shaped, V-shaped, or quadrilateral, although other suitable shapes may be utilized. The groove 340 is configured to support the catheters 160, 260 from three sides (left, right, and bottom) to further support the catheters 160, 260 during use and prevent kinking and / or buckling of the catheters 160, 260. The groove 340 may extend from the distal end portions 112, 212 of the introducers 110, 210 to the proximal end portions 111, 211, may extend from the distal end portions 112, 212 of the introducers 110, 210 to a position intermediate the distal end portions 112, 212 and the proximal end portions 111, 211 of the introducers 110, 210, or may extend between the distal end portions 112, 212 and the proximal end portions 111, 211 of the introducers 110, 210.

[0045] In some aspects or embodiments, the catheters 160, 260 are formed from a polyimide tube, although other suitable materials may be utilized. Further, in some aspects or embodiments, the catheters 160, 260 may be a guide wire, a sensor, or other device that may be inserted into the vasculature or a vascular access device.

[0046] This disclosure is described in detail for the purpose of explanation based on what is currently considered to be the most practical and preferred embodiment or aspect. However, such details are for that purpose only, and this disclosure is not limited to the disclosed embodiment or aspect. 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 blood suction device for use with a peripheral intravenous catheter (PIVC), comprising: a catheter having a proximal end portion, a distal end portion, and a side wall therebetween, defining a lumen; an introducer having a proximal end portion, a distal end portion, and a side wall therebetween, defining an internal volume configured to movably receive the catheter, the introducer defining a longitudinal axis, the introducer, and an actuator movably coupled to the introducer and connected to the catheter, the actuator having a first portion disposed outside the introducer and a second portion disposed within the internal volume of the introducer, the catheter having a first portion extending parallel to the longitudinal axis of the introducer and a second portion extending obliquely to the longitudinal axis of the introducer, the actuator; A blood suction device comprising the above.

2. The blood suction device according to claim 1, wherein 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 portion of the catheter is disposed beyond the distal end portion of the introducer.

3. The blood suction device according to claim 1, further comprising a secondary catheter having a proximal end portion, a distal end portion, and a side wall therebetween, defining a lumen, the secondary catheter being connected to the actuator.

4. The blood suction device according to claim 3, wherein the proximal end portion of the secondary catheter comprises a connector.

5. The blood suction device according to claim 1, wherein the actuator comprises a body and an extension portion, the body of the actuator extending parallel to the longitudinal axis of the introducer, and the extension portion of the actuator receiving the catheter and extending obliquely to the longitudinal axis of the introducer.

6. The blood suction device according to claim 1, wherein the introducer defines a groove extending in a direction from the proximal end portion of the introducer to the distal end portion of the introducer, the groove being positioned within the internal volume of the introducer and configured to receive a portion of the catheter during use of the blood suction device.

7. The blood suction device according to claim 6, wherein the groove is at least one of U-shaped, V-shaped, and rectangular.

8. A blood suction device for use with a peripheral intravenous catheter (PIVC), a catheter having a proximal end portion, a distal end portion, and a side wall therebetween, defining a lumen, a secondary catheter having a proximal end portion, a distal end portion, and a side wall therebetween, defining a lumen, an introducer having a proximal end portion, a distal end portion, and a side wall therebetween, defining an internal volume configured to movably receive the catheter, the introducer defining a longitudinal axis, and an actuator movably coupled to the introducer, the actuator having a first portion disposed outside the introducer and a second portion disposed within the internal volume of the introducer, the actuator comprising a catheter connection portion connected to the catheter and a secondary catheter connection portion connected to the secondary catheter, the catheter and the secondary catheter each extending parallel to the longitudinal axis of the introducer, the catheter being offset from the secondary catheter by a distance, a blood suction device comprising the above components.

9. The blood suction device according to claim 8, wherein the catheter connection portion is offset from the secondary catheter connection portion via an angled body portion.

10. The blood suction device according to claim 8, wherein the actuator comprises a body having a top surface and a bottom surface positioned opposite the top surface, and the catheter connection portion extends from the bottom surface of the body of the actuator.

11. The blood suction device according to claim 10, wherein the secondary catheter connection portion extends between the top surface and the bottom surface of the body of the actuator.

12. The blood suction device according to claim 8, wherein 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 portion of the catheter is disposed beyond the distal end portion of the introducer.

13. The introducing portion defines a groove extending in a direction from the proximal end portion to the distal end portion of the introducing portion, and the groove is disposed within the internal volume portion of the introducing portion and is configured to receive a part of the catheter during use of the blood suction device. The blood suction device according to claim 12.

14. The blood suction device according to claim 13, wherein the groove is at least one of a U shape, a V shape, and a quadrilateral shape.

15. The blood suction device according to claim 8, wherein the catheter is offset downward from the secondary catheter.

16. The blood suction device according to claim 8, wherein the catheter is offset upward from the secondary catheter.

17. The blood suction device according to claim 8, wherein the catheter is offset laterally from the secondary catheter.

18. A method of forming a catheter for a blood suction device for use with a peripheral intravenous catheter (PIVC), the blood suction device comprising a catheter defining a lumen, an introducing portion defining an internal volume portion configured to movably receive the catheter, the introducing portion defining a longitudinal axis, the introducing portion, and an actuator movably coupled to the introducing portion and connected to the catheter, the method comprising a step of molding the catheter to include a first portion extending parallel to the longitudinal axis of the introducing portion and a second portion extending obliquely to the longitudinal axis of the introducing portion. A method comprising.

19. The method according to claim 18, wherein molding the catheter includes pulling a curved core pin.

20. The method according to claim 18, wherein molding the catheter includes bending the second portion of the catheter with respect to the first portion of the catheter.

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