Instrument conveying device

Abstract

Provided herein is an instrument delivery device for use with an intravenous catheter assembly. The instrument delivery device includes a housing having a proximal end portion and a distal end portion, where the housing includes a first housing portion and a second housing portion arranged side-by-side and coupled together to define an interior volume. The instrument delivery device further includes an instrument movably received within the interior volume; a coupling device positioned at the distal end portion of the housing and configured to couple the housing to a pathway connector of an intravenous catheter assembly; and an advancement member configured to move relative to the housing to advance the distal end of the instrument beyond the distal portion of the housing and into the intravenous catheter assembly. The housing includes a visualization aid configured to improve visibility of the instrument within the interior volume of the housing.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 508,597, filed on June 16, 2023, and entitled “Instrument Advancement Device with Enhanced Instrument Viewing,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] Provided herein are instrument advancement devices for use in vascular access, particularly instrument advancement devices incorporating components or features for enhanced instrument visualization. Background Art

[0004] Catheters are often used to inject and remove fluids from the body. Patients in various settings, including in hospitals and home care, receive fluids, medications, and blood products via a vascular access device (VAD), which includes such a catheter inserted into the patient's vascular system. A common VAD includes a plastic catheter inserted into a patient's vein, where, as an example, the length of the catheter varies from a few centimeters long when the VAD is a peripheral intravenous catheter (PIVC) to many centimeters long when the VAD is a central venous catheter (CVC).

[0005] As is known in the art, instrument propulsion devices are often used in conjunction with an indwelling PIVC to assist in blood drawing, infusion, or for sensing or other purposes. When such instrument propulsion devices are used to assist in blood drawing, these devices (i.e., "blood drawing devices") focus on the ability to reliably collect high-quality blood samples and reduce hemolysis. The primary method by which these instrument propulsion devices work is to insert a catheter, probe, tubing, or other instrument into the catheter lumen passing through the PIVC using an introducer, wherein the introducer is attached to the catheter adapter of the PIVC for inserting the catheter. For example, the catheter adapter may include a needleless access connector thereon, through which a catheter may be guided to provide access to the PIVC and into the patient's vascular system. If blood drawing is performed, a syringe or vacutainer may be used to collect a blood sample without subjecting the patient to additional needle sticks.

[0006] The introducer of the instrument advancement device generally includes: a housing; an instrument (i.e., a catheter or other probe, tubing, or instrument) that is movable within the housing so as to be able to extend from the housing and thereby be advanced into the indwelling PIVC; and an advancement member that can be actuated relative to the housing by an operator. That is, the operator can move the advancement member distally to cause the instrument to make a corresponding movement relative to the housing so that the instrument can be pushed out of the housing and advanced into the indwelling PIVC.

[0007] It should be appreciated that the instrument advancement device can be used in many different environments and under varying conditions. For example, for various reasons, it may be necessary or desirable to draw blood at night or in an environment lacking light (e.g., for the health of the patient, such as to enable them to fall asleep), resulting in reduced / deteriorated visibility of the clinician operating the introducer. In this case, when the catheter (or other instrument) is advanced through the housing, it may be difficult for the clinician to observe the catheter (or other instrument), so that the clinician may not be able to determine the position of the distal end of the catheter and its position relative to the instrument advancement device and the indwelling PIVC. In some cases, it should be appreciated that the instrument (i.e., catheter or probe) may bend during its advancement (such as when encountering an obstacle or other resistance), and it is important to be able to observe this possible bending during advancement to prevent kinking of the probe, which may cause damage to the instrument and / or make it difficult to draw blood.

[0008] Therefore, there is a need in the art for an instrument advancement device and an introducer therefor that provide improved visibility during operation of the device, including the ability to visualize the distal end of a catheter or other instrument as it is advanced through operation of the introducer. Summary of the invention

[0009] The present invention provides an instrument delivery device for use with an intravenous catheter assembly. The instrument delivery device includes a housing having a proximal portion and a distal portion, wherein the housing includes a first housing portion and a second housing portion, the first housing portion and the second housing portion being arranged side by side and coupled together to define an internal volume. The instrument delivery device also includes: an instrument that is movably accommodated within the internal volume; a coupling device that is positioned at the distal portion of the housing and is configured to couple the housing to a passage connector of the intravenous catheter assembly; and a propulsion member that is configured to move relative to the housing to propel the distal end of the instrument beyond the distal portion of the housing and into the intravenous catheter assembly. The housing includes a visualization aid that is configured to improve the visibility of the instrument within the internal volume of the housing.

[0010] In some embodiments, each of the first shell portion and the second shell portion is formed of a transparent or translucent material, wherein each of the first shell portion and the second shell portion includes a top region, a bottom region, and a side region.

[0011] In some embodiments, the visualization aid comprises a coating applied to the first housing portion, the coating being applied to an inner surface of the first housing portion at at least one side region.

[0012] In some embodiments, the coating comprises an opaque coating having a first color, and wherein the device has a second color darker than the first color such that the coating contrasts with the device.

[0013] In some embodiments, the coating forms a one-way mirror that can be seen through from a first side but has opaque or reflective properties on an opposing second side.

[0014] In some embodiments, the visualization aid includes a side region of each of the first shell portion and the second shell portion.

[0015] In some embodiments, the thickness of the side region of each of the first housing portion and the second housing portion is less than the thickness of the top region and the bottom region to facilitate better visualization of the instrument through the side region.

[0016] In some embodiments, a side region of each of the first housing portion and the second housing portion has an inner surface and an outer surface, wherein each of the inner surface and the outer surface comprises a planar surface.

[0017] In some embodiments, the side region of each of the first shell portion and the second shell portion has an inner surface and an outer surface, wherein the outer surface comprises a curved surface and the inner surface comprises a flat surface or a convex surface having a radius larger than a radius of the curved outer surface.

[0018] In some embodiments, the side region of each of the first shell portion and the second shell portion includes a smooth outer surface without any steps or recesses, and the smooth outer surface minimizes refraction and reflection of the light when the light passes through the side region.

[0019] In some embodiments, the visualization aid includes a sticker applied to a side region of the first shell portion, the sticker being applied to an outer surface of the side region and having a first color, and wherein the instrument has a second color that is darker than the first color such that the instrument contrasts with the sticker.

[0020] In some embodiments, the visualization aid comprises a sleeve secured to an outer surface of the first housing portion, the sleeve having a first color, and wherein the instrument has a second color darker than the first color such that the instrument contrasts with the sleeve.

[0021] In some embodiments, the visualization aid includes an insert located within the interior volume and positioned adjacent to the inner surface of the shell, the insert having a first color, and wherein the instrument has a second color darker than the first color so that the instrument contrasts with the insert, and wherein the insert is movable from a first position adjacent to a side region of the first shell portion to a second position adjacent to a side region of the second shell portion via a knob located on the shell.

[0022] In some embodiments, the visualization aid includes an opaque material forming the first shell portion, wherein the second shell portion is formed from a transparent or translucent material, the opaque material has a first color, and wherein the instrument has a second color that is darker than the first color such that the first shell portion contrasts with the instrument.

[0023] In some embodiments, the visualization aid includes a translucent material forming the first shell portion and the second shell portion, the translucent material having a first colored color, and wherein the instrument has a second color darker than the first color such that the first shell portion and the second shell portion contrast with the instrument.

[0024] In some embodiments, at least one of the first shell portion and the second shell portion includes a co-molded component having a top region, a bottom region, and a side region, wherein the top region and the bottom region are formed of an opaque material and the side region is formed of a transparent material, and wherein the visualization aid includes the side region.

[0025] In some embodiments, each of the first shell portion and the second shell portion is formed of an opaque material, wherein each of the first shell portion and the second shell portion includes a top area, a bottom area, and a side area, and wherein the visualization aid includes a window formed in the side area of ​​at least one of the first shell portion and the second shell portion, wherein a transparent member is fixed in the window.

[0026] The present invention also provides an instrument delivery device for use with an intravenous catheter assembly. The instrument delivery device includes a housing having a proximal portion and a distal portion, wherein the housing includes a first housing portion and a second housing portion, the first housing portion and the second housing portion being arranged side by side and coupled together to define an internal volume. The instrument delivery device also includes: an instrument that is movably accommodated within the internal volume; a coupling device that is positioned at the distal portion of the housing and is configured to couple the housing to a passage connector of the intravenous catheter assembly; and a propulsion member that is configured to move relative to the housing to propel the distal end of the instrument beyond the distal portion of the housing and into the intravenous catheter assembly. The instrument includes a visualization aid that is configured to improve the visibility of the instrument within the internal volume of the housing.

[0027] In some embodiments, the visualization aid comprises a plurality of stripes formed on the instrument, each stripe of the plurality of stripes extending circumferentially around the instrument.

[0028] In some embodiments, the visualization aid comprises a coloration of the instrument, wherein the coloration of the instrument is darker than the coloration of the housing such that the instrument contrasts with the housing.

[0029] In some embodiments, the visualization aid comprises positioning of the instrument within the interior volume of the housing, the instrument being positioned off-center relative to a centerline of the interior volume extending longitudinally between the proximal and distal portions of the housing. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 is a perspective view of a catheter system according to an aspect of the present disclosure;

[0031] Figure 2 According to one aspect of the present disclosure, Figure 1 A perspective view of a blood drawing device for use with a catheter system;

[0032] Figure 3 According to one aspect of the present disclosure Figure 2 An exploded view of the blood drawing device;

[0033] Figure 4 yes Figure 2 A side view of a blood drawing device showing the catheter tube in a first retracted position;

[0034] Figure 5 yes Figure 2 A side view of a blood drawing device showing the catheter tube in a second extended position;

[0035] Fig. 6A and Figure 6B According to one aspect of the present disclosure Figure 2 A perspective view of various parts of a blood drawing device housing of a blood drawing device, the blood drawing device including a visualization aid element disposed thereon;

[0036] Figure 7 According to one aspect of the present disclosure Figure 2 A cross-sectional perspective view of a blood drawing device including a visualization aid disposed thereon;

[0037] Fig. 8A and Figure 8B According to one aspect of the present disclosure Figure 2 A perspective view of various parts of a blood drawing device housing of a blood drawing device, the blood drawing device including a visualization aid element disposed thereon;

[0038] Fig. 9 According to one aspect of the present disclosure Figure 2 A cross-sectional perspective view of a blood drawing device including a visualization aid disposed thereon;

[0039] Fig.10 According to one aspect of the present disclosure Figure 2 A cross-sectional perspective view of a blood drawing device including a visualization aid disposed thereon;

[0040] Fig.11 According to one aspect of the present disclosure Figure 2 A cross-sectional view of a blood drawing device including a visualization aid disposed thereon;

[0041] Fig.12 According to one aspect of the present disclosure Figure 2 A cross-sectional view of a blood drawing device including a visualization aid disposed thereon;

[0042] Fig.13 According to one aspect of the present disclosure Figure 2 A cross-sectional view of a blood drawing device including a visualization aid disposed thereon;

[0043] Fig.14 According to one aspect of the present disclosure Figure 2 A cross-sectional view of a blood drawing device including a visualization aid disposed thereon;

[0044] Fig.15 According to one aspect of the present disclosure Figure 2 A cross-sectional view of a blood drawing device including a visualization aid disposed thereon;

[0045] Fig.16 According to one aspect of the present disclosure Figure 2 A cross-sectional perspective view of a blood drawing device including a visualization aid disposed thereon;

[0046] Fig.17 According to one aspect of the present disclosure Figure 2 A side perspective view of a portion of a blood drawing device including a visualization aid disposed thereon;

[0047] Fig.18 According to one aspect of the present disclosure Figure 2 A perspective view of a blood drawing device including a visualization aid disposed thereon;

[0048] Fig.19 According to one aspect of the present disclosure Figure 2 A perspective view of a first housing portion of a blood drawing device including a visualization aid disposed thereon;

[0049] Fig. 20A According to one aspect of the present disclosure Figure 2 A perspective view of a blood drawing device including a visualization aid disposed thereon;

[0050] Fig. 20B yes Fig. 20A A cross-sectional perspective view of the blood drawing device taken along line 20B-20B;

[0051] Fig.21 According to one aspect of the present disclosure Figure 2 An exploded view of a blood drawing device including a visualization aid disposed thereon;

[0052] Fig. 22 According to one aspect of the present disclosure Figure 2 A cross-sectional perspective view of a blood drawing device including a visualization aid disposed thereon; and

[0053] Fig.23 is a perspective view of a catheter system according to another aspect of the present disclosure. DETAILED DESCRIPTION

[0054] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for implementing the present invention. However, various modifications, equivalents, variations and substitutions will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents and substitutions are intended to fall within the spirit and scope of the present invention.

[0055] Hereinafter, for the purpose of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the present invention as oriented in the accompanying drawings. However, it should be understood that the present invention may adopt various alternative variations unless expressly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0056] As used in this specification, the words "proximal" and "distal" refer to the direction closer to and away from a user who places the device in contact with a patient, respectively. Thus, for example, the end of the device that first contacts the patient's body would be the distal end of the device, while the opposite end of the device that is manipulated by the user would be the proximal end of the device.

[0057] Provided herein are devices and systems for guiding instruments through indwelling catheters (such as, peripheral intravenous catheters (PIVC), peripherally inserted central catheters (Peripherally Inserted Central Catheter, PICC), central venous catheters (CVC) and midline catheters). Although certain catheter assemblies are shown in the drawings and described below, it will be appreciated by those skilled in the art that the devices and systems described herein can be useful in any number of different catheter assembly configurations.

[0058] Reference now Figure 1 , Figure 1 A non-limiting embodiment of a catheter system 10 is shown, which is used to facilitate the delivery of an instrument into an indwelling catheter, such as may be desired to draw blood from a patient. The catheter system 10 may include a catheter assembly 12 having a catheter adapter 14 and an associated catheter 16. The catheter adapter 14 may include a distal end 18 and a proximal end 20. In some embodiments, the catheter adapter 14 may include an additional adapter port 22, which may be disposed between the distal end 18 and the proximal end 20, or at the proximal end 20. The catheter adapter 14 may include a first lumen 24 extending through the distal end 18 and the proximal end 20, and the first lumen 24 may be sealed at the proximal end 20 of the catheter adapter 14. As known to those skilled in the art, the catheter 16 may be formed of any suitable material and may have any useful length. The catheter 16 extends from the distal end 18 of the catheter adapter 14 and may be placed into the vasculature of the patient, wherein the distal end or tip 26 of the catheter 16 is appropriately positioned within a vein to enable blood to be drawn from the patient.

[0059] In some non-limiting embodiments or aspects, the catheter assembly 12 may include a first fluid conduit 30 extending from the adapter port 22. The first fluid conduit 30 may be formed of any suitable material known to those skilled in the art and may have a distal end 32 and a proximal end 34. The distal end 32 of the first fluid conduit 30 is coupled to the adapter port 22, and the proximal end 34 of the first fluid conduit 30 may be coupled to a connector 36. The connector 36 may be a t-type connector (e.g., a side port is arranged at a 90 degree angle relative to the longitudinal axis of the connector 36), a y-type connector (e.g., a side port is arranged at a 25 degree, 60 degree, or 75 degree angle relative to the longitudinal axis of the connector 36) or any other type of connector known in the art. The connector 36 includes a second lumen 38 passing therethrough having any number of branches suitable for the type of connector, such as branches extending between the distal and proximal ends of the connector 36 and branches provided to the port 44 of the connector 36.

[0060] In some non-limiting embodiments or aspects, catheter assembly 12 may include a needleless access connector 46 coupled to the proximal end 42 of connector 36, wherein the needleless access connector 46 provides an access port to catheter assembly 12. As an example, needleless access connector 46 may be configured as a slit-type diaphragm connector or a self-healing diaphragm connector. In the illustrated embodiment, the access port provided by needleless access connector 46 is a near-patient access port near the insertion site of catheter 16, but it can be appreciated that access ports can be provided at other alternative positions close enough to the insertion site, and the access port allows the blood-drawing catheter tubing to be advanced into the catheter 16 of indwelling and to exceed the distal end of the catheter of this indwelling. For example, the access port provided in order to advance the blood-drawing catheter tubing into the catheter 16 of indwelling can be located on another connector, and this another connector is, for example, a proximal connector on the extension kit (described below) of catheter assembly 12.

[0061] In some non-limiting embodiments or aspects, the catheter assembly 12 can also include an extension kit 48 coupled to the port 44 of the connector 36. The extension kit 48 can include a second fluid conduit 50 coupled to the port 44 at an end 52 of the second fluid conduit 50 and a Luer connector 54 at an opposite end 56, wherein a clamp 57 is disposed on the second fluid conduit 50 to allow occlusion of the second fluid conduit.

[0062] The catheter system 10 also includes an instrument delivery device 60 that can be operated to introduce an instrument into the catheter assembly 12 and into the patient's vasculature. In some embodiments, as described below, the instrument delivery device 60 can include a blood drawing device ("blood drawing device 60") that guides the catheter tubing through the catheter assembly 12 and into the patient's vasculature to obtain a blood sample from the patient. However, it should be recognized that according to various aspects of the present disclosure, the instrument delivery device 60 can be changed to introduce a guidewire, a probe, or other sensor into the patient's vasculature, and it should be understood that the following description of the blood drawing device should not limit the scope of the present disclosure.

[0063] like Figure 1 shown, and in Figures 2 to 4 As described in more detail in , according to a non-limiting embodiment, the blood drawing device 60 includes at least a housing 62, a coupling device 64, a catheter tube 66, and a propulsion member 68. As will be described in further detail below, the catheter tube 66 is movable within the housing 62 so that a portion of the catheter tube 66 can be moved from a first position or a retracted position ( Figure 4 ) is advanced to a second position or advanced position outside the housing 62 ( Figure 5 ), so that the distal end of the catheter tube can be routed into the catheter assembly 12. Once a portion of the catheter tube 66 has been routed into the catheter assembly 12 and passed through the distal end 26 of the indwelling catheter 16, the catheter tube 66 can be used to collect a blood sample.

[0064] According to an embodiment, the size of the catheter tubing 66 is set to enable it to be introduced into the fluid path of the catheter assembly 12 (i.e., introduced into the lumen of the catheter 16, the first lumen 24 of the catheter adapter 14, and the first fluid conduit 30), and to be advanced through the fluid path. Therefore, the catheter tubing 66 can have an outer diameter (e.g., between 10 gauge and 30 gauge) that is smaller than the smallest lumen of the fluid path of the catheter assembly. The catheter tubing 66 can have a length sufficient to place the distal end 70 of the catheter tubing 66 in a desired position in the fluid path of the catheter system 10. Therefore, in one embodiment, the catheter tubing 66 can have a sufficient length so that the distal end 70 of the catheter tubing is advanced out of the housing 62 and advanced through the catheter assembly (i.e., through the connector 36, the first fluid conduit 30, the catheter adapter 14, and the catheter 16), and always pass through the distal end 26 of the catheter 16.

[0065] like Figures 1 to 5As shown, the housing 62 of the blood drawing device 60 can be an elongated member having a proximal end 72 and a distal end 74, and defining an internal volume 76. In some embodiments, the housing 62 can be formed by a pair of housing portions 78a, 78b (e.g., a first housing portion 78a and a second housing portion 78b), which are arranged side by side and coupled together to define the internal volume 76. The housing 62 can include one or more features or one or more surface finishes on its outer surface, which can be arranged to increase the ergonomics of the blood drawing device 60, which in some cases can allow a user to manipulate the blood drawing device with one hand (i.e., one-handed use). In addition, the housing 62 can be constructed of a transparent or translucent material that provides at least partial visibility of the internal volume 76 of the housing so that a clinician can determine the positioning of the catheter tubing 66 within the housing 62, as explained in further detail below.

[0066] The coupling device 64 of the blood drawing device 60 is disposed at the distal end 74 of the housing 62, wherein the coupling device 64 is connected to the housing 62 via, for example, Figure 1 The needleless access connector 46 shown is used to provide a reversible coupling of the blood drawing device 60 to the catheter assembly 12. In some embodiments, the coupling device 64 is configured as a lock 80, which includes a blunting sleeve 82 and a locking arm 84 for coupling to the needleless access connector 46 of the catheter assembly 12, wherein the blunting sleeve 82 and the locking arm 84 form three contact points with the needleless access connector. However, it will be understood by those skilled in the art that any connector or coupling member (e.g., a Luer connector) can be used as long as the distal end 70 of the catheter tubing 66 can reach the catheter assembly 12 through the coupling device.

[0067] The propulsion member 68 of the blood drawing device 60 includes a first portion 86 and a second portion 88. The first portion 86 is movably disposed along an upper surface 90 of the housing 62, and the second portion 88 is movably disposed within the interior volume 76 of the housing 62. The propulsion member 68 and the housing 62 are arranged so that a connecting portion (not shown) of the propulsion member 68 that couples the first portion 86 and the second portion 88 is seated within a slot 92 formed in the upper surface 90 of the housing 62, which slot generally extends between the proximal end 72 and the distal end 74 of the housing 62. When the first portion 86 and the second portion 88 are coupled together, movement of the first portion 86 along the upper surface 90 of the housing 62 causes the second portion 88 to move correspondingly within the interior volume 76.

[0068] like Figures 1 to 5As shown, the first portion 86 of the advancement member 68 can be configured as a tab having a contact surface 94a that can be engaged by a user and an underside 94b that contacts an outer surface (e.g., upper surface 90) of the housing 62. In such an embodiment, the upper surface 90 of the housing 62 can include a track 96 (e.g., a set of ribs, a set of ridges, a set of protrusions, and / or a set of grooves, etc.) along which the underside 94b of the tab or protrusion advances when the user engages the advancement member 68. In this manner, the user can engage the first portion 86 of the advancement member 68 and can move the advancement member 68 relative to the housing 62.

[0069] like Figure 3 As shown, the second portion 88 includes an opening 98 extending therethrough that is configured to grip or retain a portion of the catheter tubing 66. Because the portion of the catheter tubing 66 is retained within the opening 98 of the second portion 88, movement of the advancement member 68 relative to the housing 62 causes a corresponding movement of the catheter tubing 66 relative to the housing 62. In this manner, the distal end 70 of the catheter tubing 66 can be selectively moved out of the interior volume 76 of the housing 62 or moved back into the interior volume as desired, such as by advancing the distal end 70 of the catheter tubing 66 out of the housing 62 when the blood drawing device 60 has been coupled to the catheter assembly 12 and a blood sample is to be collected.

[0070] Further Figures 1 to 5 As shown, the blood drawing device 60 includes an auxiliary conduit 102 disposed at the proximal end 72 of the housing 62. The auxiliary conduit 102 has a proximal portion 104 and a distal portion 106, and defines a lumen 108. A portion of the auxiliary conduit 102 is disposed within an opening 110 formed in the proximal end 72 of the housing 62 and extends through the opening. As such, the proximal portion 104 is at least partially disposed outside the housing 62, and the distal portion 106 is at least partially disposed within the housing 62, wherein the distal portion 106 is coupled to the second portion 88 of the propulsion member 68. In some embodiments, the auxiliary conduit 102 can have a larger diameter than the diameter of the catheter tubing 66, and when a certain amount of blood flows through the catheter tubing 66 and the auxiliary conduit 102, the larger diameter can serve to limit, reduce and / or substantially prevent hemolysis of the certain amount of blood. According to embodiments of the present disclosure, the proximal portion 104 of the secondary conduit 102 is coupled to and / or otherwise includes a coupler 112 that is configured to mate with a collection device (not shown) that can be used with the blood drawing device 60 to collect a blood sample for subsequent analysis. According to some embodiments, the coupler 112 can be configured as a Luer connector (i.e., a female Luer connector) that is configured to mate with a corresponding Luer connector (i.e., a male Luer connector) of the collection device.

[0071] According to various aspects of the present disclosure, reference is now made to FIG. 6A to FIG. 22 , the blood drawing device 60 is configured to incorporate components or features therein that provide improved viewing of the catheter tubing 66 during operation of the blood drawing device 60, i.e., "visualization aids." That is, one or more components or features of the blood drawing device 60 can be configured to improve visualization of the catheter tubing 66 during operation of the blood drawing device 60, such that the positioning of the catheter tubing 66 and / or any bending or other deformation of the catheter tubing 66 can be identified as the catheter tubing 66 is advanced and / or retracted relative to the housing 62 and enters the catheter assembly 12. As described in further detail below, according to some aspects of the present disclosure, at least a portion of the housing 62 of the blood drawing device 60 can be specifically modified to provide improved viewing of the catheter tubing 66, including modifications to the structure of the housing 62 and / or the materials forming the housing 62, applying one or more coatings to the housing 62, or adding components to the housing 62. According to other aspects of the present disclosure, components within the housing 62 can be displaced and / or modified to provide improved viewing of the catheter tubing 66.

[0072] According to some embodiments, Fig. 6A , Figure 6B and Figure 7 As shown, at least one of the shell portions 78a, 78b of the shell 62 includes a paint, finish or coating 120 (hereinafter referred to as "coating 120") applied thereto that enables improved viewing of the conduit tubing 66. In this embodiment, each of the shell portions 78a, 78b is formed of a transparent or translucent material 121 that provides at least partial visibility of its interior volume 76, but at least one of the shell portions 78a, 78b includes the coating 120 applied thereto, wherein the coating 120 is preferably applied to an interior surface 122 of the shell 62, but it should be appreciated that the coating may be applied to an exterior surface 124 of the shell 62 instead.

[0073] In one embodiment, the coating 120 applied to the housing 62 (eg, the second housing portion 78b) is an opaque coating that provides improved visibility of the conduit tubing 66 and / or prevents light from entering the interior volume 76 where the conduit tubing 66 is located.

[0074] exist Fig. 6A and Figure 6BIn an embodiment, an opaque coating 120 is applied to an inner surface 122 of a portion of the housing (e.g., the first housing portion 78a) along a side region 126 of the housing. In one embodiment, the opaque coating 120 can have a white or other light-hued color, and where the coating 120 is applied to the side region 126, the coating 120 serves as a background that provides improved contrast between the catheter tubing 66 and the housing 62 so as to provide improved visibility of the catheter tubing 66. In another embodiment, the coating 120 applied to the side region 126 of the housing portion (e.g., the first housing portion 78a) is a coating that serves as a one-way mirror that can be seen through from the proximal side, but has opaque or reflective properties on the other side to achieve improved visualization. When using the blood drawing device 60, the clinician can better observe the catheter tubing 66 via the mirror-type coating 120 that reflects back the image of the catheter tubing.

[0075] exist Figure 7 In some embodiments, an opaque coating 120 is applied to the interior surface 122 of the housing 62 along some surfaces of the top region 128 and the bottom region 130 of the housing portions 78a, 78b. With the coating 120 applied to some surfaces of the top region 128 and the bottom region 130 of the housing portions 78a, 78b, the opaque coating 120 functions to prevent any light from entering the interior volume 76 where the conduit tubing 66 is located. In some embodiments, the opaque coating 120 applied to the interior surface 122 of the housing 62 can have a matte finish that serves to further diffuse light within the interior volume 76 of the housing 62.

[0076] According to some embodiments, FIG. 8A to FIG. 17 As shown, the structure of the housing 62 and / or the one or more materials comprising the housing 62 enable improved viewing of the catheter tubing 66 within the interior of the housing 62 .

[0077] like Fig. 8A and Figure 8BAs shown, according to some embodiments, at least one of the housing portions 78a, 78b is formed (i.e., molded) from a white or lighter colored material 123 that improves visibility of the conduit tubing 66. According to one aspect, one housing portion (e.g., the first housing portion 78a) is formed from a white or light colored opaque material 123, while the other housing portion (e.g., the second housing portion 78b) is formed from a transparent or translucent material 121 that provides visibility to the interior volume 76 of the housing 62. The white or light colored opaque material of the first housing portion 78a contrasts with the darker color of the conduit tubing 66 to provide improved visibility of the conduit tubing 66 when the housing 62 is rotated to a desired orientation, wherein the opaque housing 62 serves as a background for the conduit tubing 66.

[0078] According to another embodiment, each of the housing portions 78a, 78b may be formed of a translucent material having a white or light hue that contrasts with the darker color of the catheter tubing 66 to provide improved visibility of the catheter tubing 66. In such an embodiment, no specific rotation or orientation of the housing 62 is required because the light hue of the translucent material of the housing portions 78a, 78b may provide a background for the catheter tubing 66 in multiple orientations.

[0079] According to other embodiments, the housing 62 (i.e., the housing portions 78a, 78b) is formed of a transparent or translucent material 121 that is modified to enable improved viewing of the catheter tubing 66 within the interior volume 76 of the housing 62. That is, the housing 62 can be constructed such that at least the side regions 126 of each of the housing portions 78a, 78b are formed to increase visibility of the catheter tubing 66 within the housing 62. In one embodiment, and as Fig. 9 As shown, the thickness of the side regions 126 can be reduced (compared to the top region 128 and the bottom region 130 of the housing 62) to facilitate better visualization. Fig.10 As shown, the trim 131 of the interior surface 122 of one or more side regions 126 may be modified to reduce glare on the one or more regions.

[0080] Reference now Figures 11 to 15 In some embodiments, the shape of the side region 126 is controlled to improve visualization of the catheter tube 66 within the interior of the housing 62.

[0081] In one embodiment, and as Fig.11As shown, the side region 126 of the housing 62 is constructed as a flat (rather than curved) surface to minimize glare and promote easy visualization. That is, both the inner surface 122 and the outer surface 124 of the side region 126 are formed to be flat so as to create a planar lens that can be oriented by the clinician during use of the blood drawing device 60, thereby eliminating glare from the side region 126. Although the cylindrical shape of the side region 126 will act as a mirror that reflects any external light source along its length (so that there is always a portion of the housing 62 that reflects external light back to the user's eyes, regardless of the housing orientation), the side region 126 is formed as a flat side that will only reflect light in one direction, thereby allowing the user to rotate the housing 62 along the axis of the housing to direct the reflected light away from the user's eyes to thereby improve visibility.

[0082] In one embodiment, and as Fig.12 and Fig.13 As shown, the inner surface 122 of one or both side regions 126 has a different shape than its outer surface 124. In one configuration, and as shown in FIG. Fig.12 As shown, the inner surface 122 of one or both side regions 126 has a convex shape to increase the visibility of the catheter tube 66 for easier visualization. Fig.13 As shown, the inner surface 122 of one or both side regions 126 has a flat shape (while the outer surface 124 remains curved) to again increase the visibility of the catheter tube 66 to facilitate visualization. Fig.13 As shown, a flat surface may also be provided on the side of the advancement member 68. In yet another configuration, and as shown Fig.14 As shown, the outer surface 124 of the side region may be curved at a smaller radius than the inner surface 122 , wherein the smaller radius reduces glare of light from broad lines to smaller lines and also adds a magnifying effect to the visibility of the conduit tube 66 .

[0083] In another embodiment, and as Fig.15 As shown, the inner surface 122 and / or the outer surface 124 of one or both side regions 126 are "smoothed" to remove any steps, recesses, or other additional surface features from the housing 62 so as to provide a smooth surface on the housing 62. Removing such additional surface features from the housing 62 can minimize the amount of refracted and reflected light by the housing 62 as it passes through the housing, thereby improving visibility of the conduit tube 66 within the housing 62.

[0084] According to another embodiment, and as Fig.16As shown, one or both of the housing portions 78a, 78b are formed as a co-molded component including two different materials. That is, some sections / areas of one or both of the housing portions 78a, 78b (e.g., the top region 128 and the bottom region 130 of each housing portion) can be formed of an opaque material 123, while other sections / areas of one or both of the housing portions 78a, 78b (e.g., the side regions or side "windows" 132 of each housing portion) are formed of a clear or transparent material 121. In some embodiments, each of the housing portions 78a, 78b is formed as a co-molded component having a transparent side window 132, so that two (2) opposing side windows 132 are formed in the housing 62 to provide visibility of the conduit tubing 66. In other embodiments, only one of the housing portions 78a, 78b is formed as a co-molded component having a transparent side window 132 such that only a single side window 132 is formed in the housing 62 to provide visibility of the catheter tube 66.

[0085] In some embodiments, and as Fig.17 As shown, rather than being formed as a co-molded component having a side window 132 formed of a different material, the housing 62 can be formed such that the side window disposed therein is initially formed as an open slot or side slot 134. The open side slot 134 can be formed along the entire length or a portion of the length of the housing 62 and can have a transparent material 136 (e.g., glass, a clear plastic insert, or a clear plastic film) inserted into the open side slot that provides visibility of the interior volume 76 of the housing 62 to enable visualization of the catheter tubing 66.

[0086] According to other aspects of the present disclosure, additional components may be added on or in the housing 62 to provide improved viewing of the catheter tubing 66 during operation of the blood drawing device 60 .

[0087] refer to Fig.18According to one embodiment, a sticker 138 may be provided with the blood drawing device 60, which sticker may be applied to the housing 62 (by a clinician) when the blood drawing device 60 is in use to achieve improved visualization of the catheter tubing 66. The sticker 138 may be configured in white (or other light colors), which sticker may be applied to the side regions of the housing 62 (applied to either of the housing portions 78a, 78b) to provide a white background that contrasts with the catheter tubing 66, thereby improving visualization of the catheter tubing. In one embodiment, the sticker 138 may be initially provided separately from the housing 62, so that the sticker 138 may be selectively applied to the desired housing portions 78a, 78b, thereby allowing the clinician to select which side to apply the sticker to, and allowing the clinician to use the sticker 138 only when needed. In another embodiment, multiple stickers 138 may be pre-applied to both sides of the housing 62, and then one of the stickers 138 may be removed from the desired side of the housing 62 by the clinician to provide visualization of the catheter tube 66 through the desired side of the housing 62. In some embodiments, tabs 141 may be provided on the stickers 138 to enable the stickers to be more easily removed from the housing 62.

[0088] refer to Fig.19 According to another embodiment, a sleeve 140 may be provided separately from the housing 62, which sleeve may be snapped onto the housing 62 when the blood drawing device 60 is used (by a clinician) to provide improved visualization of the catheter tubing 66. The sleeve 140 may be snapped onto either of the housing portions 78a, 78b ( Fig.19 The sleeve 140 can be configured as a white (or other light colored) sleeve 140 that provides a light background that contrasts with the darker catheter tubing 66 to improve visualization of the catheter tubing. Alternatively, the sleeve 140 can be configured as a darker colored sleeve 140 that provides a dark background that contrasts with the white or other light colored catheter tubing 66 to improve visualization of the catheter tubing.

[0089] refer to Fig. 20A and Fig. 20BAccording to another embodiment, an insert 142 can be provided separately from the housing 62, the insert being permanently fixed on the outer surface of the housing or fixed within the interior volume 76 of the housing, and being movable between different positions when the blood drawing device 60 is used (by a clinician) to achieve improved visualization of the catheter tubing 66. The insert 142 can generally conform to a portion of the outer (or inner) surface 122 of the housing 62 (e.g., conform to the side region 126 of the housing). The insert 142 can be configured as a white (or other light-colored) insert 142 that provides a light-colored background that contrasts with the darker catheter tubing 66 to improve visualization of the catheter tubing. When using the blood drawing device 60, the clinician can position the insert 142 in a desired position (e.g., in a right position or a left position), wherein movement of the insert 142 is provided via a knob 145 located on the outer surface of the housing 62 (e.g., located on the proximal surface of the housing 62 and surrounding the auxiliary catheter 102). The clinician can rotate the knob 145 to translate the insert 142 to the desired side of the housing 62 , wherein the insert 142 acts to block light from the housing 62 and provide a contrasting background for visualization of the catheter tube 66 .

[0090] According to other aspects of the present disclosure, the catheter tubing 66 can be configured to provide improved viewing of the catheter tubing within the housing 62 during operation of the blood drawing device 60. According to some embodiments, the catheter tubing 66 can be configured such that at least a portion thereof is painted black or another dark color that contrasts with a lighter (e.g., white) color background provided in the housing 62 (according to any of the previous embodiments described herein). In some embodiments, the entire catheter tubing 66 can be painted black / dark (e.g., by forming the tubing from a black / dark polyimide material), while in other embodiments, black stripes 144 can be provided on the catheter tubing 66, such as by applying black stripes 144 at different locations on the polyimide catheter tubing 66, wherein each stripe 144 extends circumferentially around the catheter tubing 66, such as Fig.21 shown.

[0091] According to some embodiments, in order to provide improved viewing of the catheter tube 66 within the housing 62, as shown in FIG. Fig. 22As shown, the conduit fitting 66 can be positioned eccentrically within the interior volume 76 of the housing 62 (relative to a centerline 146 of the housing 62 extending longitudinally of the housing). That is, it should be appreciated that when the conduit fitting 66 is centered within the interior volume 76, the conduit fitting 66 can be positioned in an area of ​​the interior volume 76 where optical glare from the housing 62 negatively affects visualization of the conduit fitting 66. Thus, the conduit fitting 66 can be positioned eccentrically within the interior volume 76 of the housing 62 relative to the centerline 146 in an area where optical glare is reduced, thereby making visualization of the conduit fitting 66 within the housing 62 easier.

[0092] Thus, according to the embodiments described herein, the blood drawing device 60 is configured to provide improved viewing of the catheter tubing 66 as it is advanced into the catheter assembly and through the catheter assembly into the patient's vein. A visualization aid is provided in the blood drawing device 60 that is configured to improve visibility of the interior volume 76 of the housing and the catheter tubing 66 therein during operation of the blood drawing device 60, such that the condition (e.g., bending or twisting) and positioning of the catheter tubing 66 can be determined as the catheter tubing 66 is advanced and / or retracted relative to the housing 62 and into the catheter assembly 12.

[0093] It should be appreciated that aspects of the present disclosure are not limited to Figures 1 to 22 While the particular blood drawing device 60 is shown and described, blood drawing devices having other suitable configurations may also incorporate aspects of the present disclosure. Fig.23 , Fig.23A catheter system 10 is shown that includes a blood drawing device 150 according to another embodiment of the present disclosure. The blood drawing device 150 includes a housing 152 having a proximal end 154 and a distal end 156, and a propulsion member 158 that is slidably received within the housing 152 (i.e., received within an interior volume 160 of the housing 152). In the illustrated embodiment, the propulsion member 158 is configured as one or more telescoping cylinders 158a that are configured in a telescoping relationship with the housing 152 so that the propulsion member 158 can be completely or nearly completely slidably received within the interior volume 160 of the housing 152. The propulsion member 158 also includes a proximal end 162 and a distal end 164, and in a non-limiting embodiment, the propulsion member 158 can have a variable diameter along its length. As one example, the distal end 164 of the pusher member 158 can have a larger diameter than the diameter of the rest of the pusher member 158, such that when the pusher member 158 is retracted, one or more features on the housing 152 can interact with the enlarged portion of the pusher member 158 to prevent the pusher member 158 from being completely pulled out of the housing 152. As another example, the diameter of the distal end 164 of the pusher member 158 can be smaller than the diameter of the rest of the pusher member 158 to maintain the pusher member 158 in a position in a blood draw forward condition, thereby freeing the operator's hands to manipulate additional components (e.g., a vacuum blood collection tube).

[0094] The blood drawing device 150 also includes a catheter tube 166 having a proximal end 168 and a distal end 170. The catheter tube 166 is housed within the interior volume 160 of the housing 152 and can be advanced and / or retracted relative to the housing 152 by displacement of the advancement member 158 relative to the housing 152. In some embodiments, the catheter tube 166 can be coupled to the advancement member 158 via an attachment 172 disposed at the distal end 164 of the advancement member 158, such that displacement of the advancement member 158 relative to the housing 152 causes a corresponding displacement of the catheter tube 166. In a non-limiting embodiment, as previously described with respect to the blood drawing device 60 and its operation, the catheter tube 166 can be advanced from a first position, in which the distal end 170 of the catheter tube 166 is located within the housing 152, to a second position, in which the distal end 170 of the catheter tube 166 is located distal to the housing 152 (and also distal to the catheter 16).

[0095] The blood drawing device also includes a coupling device 174 located thereon, which can be connected to Figures 1 to 12150 is the same as the coupling device 64 shown and described in the blood drawing device of . That is, the coupling device 174 is configured as a lock 80, which includes a blunting sleeve 82 and a locking arm 84 for coupling to the needleless access connector 46 of the catheter assembly 12, wherein the blunting sleeve 82 and the locking arm 84 form three contact points with the needleless access connector. However, it should be understood that alternative embodiments of the blood drawing device 150 may include another type of coupling device 174 to secure the blood drawing device 150 to the catheter assembly 12, and another type of coupling device includes a Luer connector, a clamp, a blunted plastic sleeve, a blunted metal sleeve, a hybrid Luer (e.g., with a sleeve) friction fitting, etc. According to aspects of the present disclosure, the auxiliary catheter 102 can be routed through the telescopic cylinder 158a of the propulsion member 158, wherein the auxiliary catheter 102 provides fluid communication between the catheter tube 166 and a coupler 112 disposed at the proximal portion 104 of the auxiliary catheter 102, wherein the coupler 112 is configured to mate with a collection device (not shown).

[0096] As described in detail above, the blood drawing device 150 may incorporate one or more visualization aids therein that are configured to improve visibility of the catheter tubing 166 during operation of the blood drawing device 150, such that the condition (e.g., bending / torsion) and positioning of the catheter tubing 166 may be determined as the catheter tubing 166 is advanced and / or retracted relative to the housing 152 and enters the catheter assembly 12. According to various aspects of the present disclosure, visualization of the catheter tubing 166 may be improved by modifying the housing 152 (e.g., modifying the structure of the housing 152, the material forming the housing 152, and / or applying one or more coatings to the housing 152), adding components to the housing 152, and / or by moving / modifying the catheter tubing 166 within the housing 152. According to various embodiments, the visualization aids may be modified to improve visibility of the catheter tubing 166. FIG. 6A to FIG. 22 Any visual aids shown in the embodiments are incorporated into Fig.23 In the blood drawing device 150.

[0097] Although the present disclosure has been described in detail based on what are currently considered to be the most practical and preferred embodiments or aspects for the purpose of illustration, it should be understood that such detail is only for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but rather, the present disclosure is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. An instrument delivery device for use with an intravenous catheter assembly, the instrument delivery device comprising: a housing having a proximal portion and a distal portion, the housing comprising a first housing portion and a second housing portion, wherein the first housing portion and the second housing portion are arranged side by side and coupled together to define an interior volume; an instrument movably received within the interior volume; a coupling device positioned at the distal portion of the housing and configured to couple the housing to an access connector of an intravenous catheter assembly; and an advancement member configured to move relative to the housing to advance the distal end of the device beyond the distal portion of the housing and into the intravenous catheter assembly, Wherein the housing comprises a visualization aid configured to improve visibility of the instrument within the interior volume of the housing.

2. The device delivery device according to claim 1, wherein: Each of the first shell portion and the second shell portion is formed of a transparent or translucent material, wherein each of the first shell portion and the second shell portion includes a top region, a bottom region, and a side region.

3. The device delivery device according to claim 2, wherein: The visualization aid comprises a coating applied to the first housing portion, the coating being applied to an inner surface of the first housing portion at least at the side region.

4. The device delivery device according to claim 3, wherein: The coating comprises an opaque coating having a first color, and wherein the device has a second color that is darker than the first color such that the coating contrasts with the device.

5. The device delivery apparatus according to claim 3, wherein: The coating forms a one-way mirror that can be seen through from a first side but has opaque or reflective properties on an opposing second side.

6. The instrument delivery device according to claim 2, wherein: The visualization aid includes the side region of each of the first housing portion and the second housing portion.

7. The device delivery apparatus according to claim 6, wherein: The side regions of each of the first and second housing portions have a thickness that is less than the thickness of the top and bottom regions to facilitate better visualization of the instrument through the side regions.

8. The device delivery apparatus according to claim 6, wherein: The side region of each of the first housing portion and the second housing portion has an inner surface and an outer surface, wherein each of the inner surface and the outer surface comprises a planar surface.

9. The instrument delivery device according to claim 6, wherein: The side region of each of the first and second housing portions has an inner surface and an outer surface, wherein the outer surface comprises a curved surface, and the inner surface comprises a flat surface or a convex surface having a radius greater than a radius of the curved outer surface.

10. The instrument delivery device according to claim 6, wherein: The side region of each of the first housing portion and the second housing portion includes a smooth outer surface without any steps or recesses, the smooth outer surface minimizing refraction and reflection of light when the light passes through the side region.

11. The device delivery apparatus according to claim 2, wherein: The visualization aid comprises a sticker applied to the side region of the first housing portion, the sticker being applied to an outer surface of the side region and having a first color, and wherein the instrument has a second color darker than the first color such that the instrument contrasts with the sticker.

12. The instrument delivery device according to claim 2, wherein: The visualization aid includes a sleeve secured to an outer surface of the first housing portion, the sleeve having a first color, and wherein the instrument has a second color darker than the first color such that the instrument contrasts with the sleeve.

13. The instrument delivery device of claim 2, wherein: The visualization aid includes an insert within the interior volume positioned adjacent to an interior surface of the shell, the insert having a first color, and wherein the instrument has a second color darker than the first color such that the instrument contrasts with the insert, and wherein the insert is movable via a knob on the shell from a first position adjacent to the side region of the first shell portion to a second position adjacent to the side region of the second shell portion.

14. The instrument delivery device of claim 1, wherein: The visualization aid includes an opaque material forming the first shell portion, wherein the second shell portion is formed from a transparent or translucent material, the opaque material has a first color, and wherein the instrument has a second color that is darker than the first color so that the first shell portion contrasts with the instrument.

15. The instrument delivery device of claim 1, wherein: The visualization aid includes a translucent material forming the first shell portion and the second shell portion, the translucent material having a first pigmented color, and wherein the instrument has a second color darker than the first color such that the first shell portion and the second shell portion contrast with the instrument.

16. The instrument delivery device of claim 1, wherein: At least one of the first housing portion and the second housing portion comprises a co-molded component having a top region, a bottom region, and a side region, wherein the top region and the bottom region are formed of an opaque material and the side region is formed of a transparent material; and Wherein, the visualization aid includes the side area.

17. The instrument delivery device of claim 1, wherein: Each of the first housing portion and the second housing portion is formed of an opaque material, wherein each of the first housing portion and the second housing portion includes a top region, a bottom region, and a side region; and Wherein, the visualization aid comprises a window formed in the side region of at least one of the first shell part and the second shell part, wherein a transparent member is fixed in the window.

18. An instrument delivery device for use with an intravenous catheter assembly, the instrument delivery device comprising: a housing having a proximal portion and a distal portion, the housing comprising a first housing portion and a second housing portion, wherein the first housing portion and the second housing portion are arranged side by side and coupled together to define an interior volume; an instrument movably received within the interior volume; a coupling device positioned at the distal portion of the housing and configured to couple the housing to an access connector of an intravenous catheter assembly; and an advancement member configured to move relative to the housing to advance the distal end of the device beyond the distal portion of the housing and into the intravenous catheter assembly, and Wherein the instrument comprises a visualization aid configured to improve visibility of the instrument within the interior volume of the housing.

19. The instrument delivery device of claim 18, wherein: The visualization aid includes a plurality of striations formed on the instrument, each striation of the plurality of striations extending circumferentially around the instrument.

20. The instrument delivery device of claim 18, wherein: The visualization aid includes a coloration of the instrument, wherein the coloration of the instrument is darker than the coloration of the housing such that the instrument contrasts with the housing.

21. The instrument delivery device of claim 18, wherein: The visualization aid includes positioning of the instrument within the interior volume of the housing, the instrument being positioned off-center relative to a centerline of the interior volume extending longitudinally between the proximal and distal portions of the housing.

Images