Instrument advance device with enhanced instrument visibility

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 and distal portion, the housing comprising a first housing portion and a second housing portion, the first and second housing portions being positioned side by side and coupled together to define an internal volume. The instrument delivery device also includes an instrument movably received within the internal volume, a coupling device positioned in the distal portion of the housing and configured to couple the housing to the access connector of the intravenous catheter assembly, and a forwarding member configured to move relative to the housing to advance the distal end of the instrument beyond the distal portion of the housing into the intravenous catheter assembly. The housing includes a visualization aid configured to improve the visibility of the instrument within the internal volume of the housing.

Description

Technical Field

[0001] Provided herein is an instrument advancement device for use in vascular access, particularly an instrument advancement device incorporating components or features for enhancing the viewing of an instrument.

Background Art

[0002] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / ˈfaɪf.ˈəʊ.eɪt / 508,597, filed on June 16, 2023, titled "Instrument Advancement Device with Enhanced Instrument Viewing", the disclosure of which is hereby incorporated by reference in its entirety.

[0003] Catheters are frequently used to administer liquids entering and exiting the body. Patients in various situations, including hospitals and home care, receive liquids, medications, and blood products through a vascular access device (VAD) that includes such a catheter inserted into the patient's vascular system. A typical VAD includes a plastic catheter inserted into the patient's vein, and the length of the catheter varies, for example, from a few centimeters when the VAD is a peripheral intravenous catheter (PIVC) to many centimeters when the VAD is a central venous catheter (CVC).

[0004] As is known in the art, instrument advancement devices are often used in conjunction with indwelling PIVCs to facilitate blood collection or for sensing or other purposes. When such instrument advancement devices are used to facilitate blood collection, the device (i.e., the “blood collection device”) focuses on its ability to reliably collect high-quality blood samples and reduce hemolysis. The primary way these instrument advancement devices work is by employing an introducer for inserting a catheter, probe, tube, or other instrument through the catheter lumen of the PIVC, the introducer being attached to a catheter adapter of the PIVC that provides catheter insertion. For example, the catheter adapter may include a needleless access connector on it into which a catheter can be introduced to provide access to the PIVC and the patient’s vascular system. When blood collection is performed, a syringe or vacuuminer (registered trademark) can then be used to collect the blood sample without exposing the patient to additional needle sticks.

[0005] An introducer for an instrument advancement device typically includes a housing, an instrument (i.e., a catheter or other probe, tube, or instrument) that is movable within the housing so as to be extendable from there for advancement into an indwelling PIVC, and an advancement member that can be actuated by an operator relative to the housing. That is, the advancement member may be moved distally by the operator to cause a corresponding movement of the instrument relative to the housing, as a result the instrument may advance from the housing into the indwelling PIVC.

[0006] It is recognized that instrument advancement devices may be used in many different environments and under various conditions. For example, for various reasons, it may be necessary or desired to perform blood collection at night or in environments with insufficient light (e.g., for the patient's health, such as to allow the patient to sleep), thereby reducing / poor visibility for the clinician operating the instrument advancement device. Under such conditions, it may be difficult for the clinician to visualize the catheter (or other instrument) as it advances through the housing, and therefore the clinician may not be able to determine the position of the distal tip of the catheter and its position relative to the instrument advancement device and the indwelling PIVC. In some cases, it is recognized 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 observe such potential bending during advancement to prevent the probe from twisting, which could cause damage to the probe and / or make it difficult to perform blood collection.

[0007] Therefore, there is a need in the art for an instrument advancing device and its introducer that provides improved visibility during device operation, including the ability to visualize the distal end of a catheter or other instrument as it advances due to the action of the introducer. [Overview of the project]

[0008] Provided herein is an instrument delivery device for use with an intravenous catheter assembly. The instrument delivery device includes a housing having a proximal and distal portion, the housing comprising a first housing portion and a second housing portion, the first and second housing portions being positioned side by side and coupled together to define an internal volume. The instrument delivery device also includes an instrument movably received within the internal volume, a coupling device positioned in the distal portion of the housing and configured to couple the housing to the access connector of the intravenous catheter assembly, and a forwarding member configured to move relative to the housing to advance the distal end of the instrument beyond the distal portion of the housing into the intravenous catheter assembly. The housing includes a visualization aid configured to improve the visibility of the instrument within the internal volume of the housing.

[0009] In some embodiments, each of the first and second housing portions is formed of a transparent or translucent material, and each of the first and second housing portions includes an upper region, a lower region, and a side region.

[0010] In some embodiments, the visualization aid includes a coating applied to a first housing portion, the coating being applied to the inner surface of the first housing portion on at least one side region.

[0011] In some embodiments, the coating includes an opaque coating having a first color, and the fixture has a second color that is darker than the first color so that the coating contrasts with the fixture.

[0012] In some embodiments, the coating is transparent from a first side, but forms an opaque or reflective unidirectional mirror on the opposing second side.

[0013] In some embodiments, the visualization aid includes the lateral regions of a first housing portion and a second housing portion, respectively.

[0014] In some embodiments, the side regions of the first and second housing portions have a thickness less than that of the upper and lower regions to facilitate better visualization of the instrument passing through the side region.

[0015] In some embodiments, the side regions of the first and second housing portions each have an inner surface and an outer surface, each of which includes a plane.

[0016] In some embodiments, each side region of the first and second housing portions has an inner surface and an outer surface, the outer surface including a curved surface and the inner surface including a flat or convex surface having a larger radius than the curved outer surface.

[0017] In some embodiments, each side region of the first and second housing portions includes a smooth outer surface without any steps or recesses, and the smooth outer surface minimizes the refraction and reflection of light as it passes through the side region.

[0018] In some embodiments, the visualization aid includes a sticker applied to a side region of a first housing portion, the sticker being applied to the outer surface of the side region and having a first color, and the device having a second color that is darker than the first color so that the device is contrasted with the sticker.

[0019] In some embodiments, the visualization aid includes a sleeve fixed to the outer surface of a first housing portion, the sleeve having a first color, and the device having a second color that is darker than the first color so that the device is contrasted with the sleeve.

[0020] In some embodiments, the visualization aid includes an insert positioned adjacent to the inner surface of the housing within its internal volume, the insert having a first color, and the device having a second color that is darker than the first color so that the device is contrasted with the insert, and the insert is movable via a twist knob located on the housing from a first position adjacent to the lateral region of a first housing portion to a second position adjacent to the lateral region of a second housing portion.

[0021] In some embodiments, the visualization aid comprises an opaque material on which a first housing portion is formed, and a second housing portion formed of a transparent or translucent material, wherein the opaque material has a first color, and the device has a second color that is darker than the first color so that the first housing portion is contrasted with the device.

[0022] In some embodiments, the visualization aid includes a translucent material on which a first housing portion and a second housing portion are formed, the translucent material having a colored first color, and the device having a second color that is darker than the first color so that the first housing portion and the second housing are contrasted with the device.

[0023] In some embodiments, at least one of a first housing portion and a second housing portion includes a co-molded part having an upper region, a lower region, and a side region, wherein the upper and lower regions are formed of an opaque material and the side region is formed of a transparent material, and the visual aid includes the side region.

[0024] In some embodiments, each of the first and second housing portions is formed of an opaque material, and each of the first and second housing portions includes an upper region, a lower region, and a side region, and the visualization aid includes a window formed in at least one side region of the first and second housing portions, and a transparent member is fixed within the window.

[0025] Also 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, the housing including 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 movably received within the internal volume, a coupling device disposed at the distal end portion of the housing and configured to couple the housing to an access connector of the intravenous catheter assembly, and an advancement member configured to move relative to the housing to advance a distal end of the instrument into the intravenous catheter assembly beyond the distal end portion of the housing. The instrument includes a visualization aid configured to enhance the visibility of the instrument within the internal volume of the housing.

[0026] In some embodiments, the visualization aid includes a plurality of stripes formed on the instrument, each of the plurality of stripes extending circumferentially around the instrument.

[0027] In some embodiments, the visualization aid includes a coloring of the instrument, the coloring of the instrument being darker than the coloring of the housing such that the instrument is contrasted from the housing.

[0028] In some embodiments, the visualization aid includes disposing the instrument within the internal volume of the housing, the instrument being disposed off-center with respect to a centerline of the internal volume that extends longitudinally between the distal end and the proximal end of the housing.

Brief Description of the Drawings

[0029] [Figure 1] Figure 1 is a perspective view of a catheter system according to aspects of the present disclosure. [Figure 2] Figure 2 is a perspective view of a blood collection device usable with the catheter system of Figure 1 according to aspects of the present disclosure. [Figure 3] Figure 3 is an exploded view of the blood collection device of Figure 2 according to aspects of the present disclosure. [Figure 4] Figure 4 is a side view of the blood collection device shown in Figure 2, showing the catheter tube in the first storage position. [Figure 5] Figure 5 is a side view of the blood collection device shown in Figure 2, with the catheter tube in the second extended position. [Figure 6A] Figure 6A is a perspective view of a portion of the blood collection device housing of the blood collection device of Figure 2, including a visualization aid provided thereon, according to one aspect of the present disclosure. [Figure 6B] Figure 6B is a perspective view of a portion of the blood collection device housing of the blood collection device of Figure 2, including a visualization aid provided thereon, according to one aspect of the present disclosure. [Figure 7] Figure 7 is a cross-sectional perspective view of the blood collection device of Figure 2, including a visualization aid provided thereon, according to an aspect of this disclosure. [Figure 8A] Figure 8A is a perspective view of a portion of the blood collection device housing of the blood collection device of Figure 2, including a visualization aid provided thereon, according to one aspect of the present disclosure. [Figure 8B] Figure 8B is a perspective view of a portion of the blood collection device housing of the blood collection device of Figure 2, including a visualization aid provided thereon, according to one aspect of the present disclosure. [Figure 9] Figure 9 is a cross-sectional perspective view of the blood collection device of Figure 2, including a visualization aid provided thereon, according to an aspect of this disclosure. [Figure 10] Figure 10 is a cross-sectional perspective view of the blood collection device of Figure 2, including a visualization aid provided thereon, according to an aspect of this disclosure. [Figure 11] Figure 11 is a cross-sectional perspective view of the blood collection device of Figure 2, including a visualization aid provided thereon, according to an aspect of this disclosure. [Figure 12] Figure 12 is a cross-sectional perspective view of the blood collection device of Figure 2, including a visualization aid provided thereon, according to an aspect of this disclosure. [Figure 13] Figure 13 is a cross-sectional perspective view of the blood collection device of Figure 2, including a visualization aid provided thereon, according to an aspect of this disclosure. [Figure 14] Figure 14 is a cross-sectional perspective view of the blood collection device of Figure 2, including a visualization aid provided thereon, according to an aspect of this disclosure. [Figure 15] Figure 15 is a cross-sectional perspective view of the blood collection device of Figure 2, including visualization aids provided thereon, according to an aspect of this disclosure. [Figure 16] Figure 16 is a cross-sectional perspective view of the blood collection device of Figure 2, including a visualization aid provided thereon, according to an aspect of this disclosure. [Figure 17] Figure 17 is a partial side perspective view of the blood collection device of Figure 2, including visualization aids provided thereon, according to an aspect of this disclosure. [Figure 18] Figure 18 is a perspective view of the blood collection device of Figure 2, including a visualization aid provided thereon, according to an aspect of this disclosure. [Figure 19] Figure 19 is a perspective view of the blood collection device of Figure 2, including visualization aids provided thereon, according to an aspect of this disclosure. [Figure 20A] Figure 20A is a perspective view of the blood collection device of Figure 2, including a visualization aid provided thereon, according to an aspect of this disclosure. [Figure 20B] Figure 20B is a cross-sectional perspective view of the blood collection device shown in Figure 20A. [Figure 21] Figure 21 is an exploded view of the blood collection device of Figure 2, including visualization aids provided thereon according to an aspect of this disclosure. [Figure 22] Figure 22 is a cross-sectional perspective view of the blood collection device of Figure 2, including a visualization aid provided thereon, according to an aspect of this disclosure. [Figure 23] Figure 23 is a perspective view of a catheter system according to another aspect of this disclosure. [Modes for carrying out the invention]

[0030] The following description is provided to enable those skilled in the art to manufacture and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutes will be readily apparent to those skilled in the art. All such modifications, variations, equivalents, and substitutes are intended to be within the spirit and scope of the invention.

[0031] Hereinafter, for illustrative purposes, “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “upper surface,” “lower surface,” “lateral direction,” “vertical direction,” and their derivatives shall be used in reference to the orientation of the invention as described herein in the drawings. However, it should be understood that the invention may be based on various alternative modifications unless expressly specified otherwise. It should also be understood that the specific devices shown in the accompanying drawings and described herein are merely exemplary embodiments of the invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be construed as limiting.

[0032] As used herein, the terms “proximal” and “distal” refer to the directions closer to and farther from the user who will be making contact with the patient, respectively. For example, the end of the device that first makes contact with the patient's body is the distal end, and the opposite end of the device being operated by the user is the proximal end of the device.

[0033] Provided herein are devices and systems for introducing instruments via indwelling catheters such as peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. While specific catheter assemblies are shown in the accompanying figures and described below, those skilled in the art will understand that the disinfection probes described herein may be useful in any number of different catheter assembly configurations.

[0034] Referring here to Figure 1, a non-limiting embodiment of a catheter system 10 for facilitating the delivery of instruments to an indwelling catheter, such as when it is desirable for blood collection from a patient, is shown. 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 located between the distal end 18 and the proximal end 20, or located at the proximal end 20. The catheter adapter 14 may include a first lumen 24 that penetrates 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. The catheter 16 may be formed from any suitable material known to those skilled in the art and may be of any useful length. The catheter 16 extends from the distal end 18 of the catheter adapter 14 and can be positioned within the patient's vascular system with its distal end or tip 26 appropriately positioned in a vein to allow blood collection from the patient.

[0035] In some non-limiting embodiments or aspects, the catheter assembly 12 may include a first fluid conduit 30 extending from the port 22. The first fluid conduit 30 may be formed of any suitable material well 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 may be connected to the port 22, and the proximal end 34 of the first fluid conduit 30 may be connected to a connector 36. The connector 36 may be a T-connector (for example, one side port positioned at a 90-degree angle to the longitudinal axis of the connector 36), a Y-connector (for example, one side port positioned at a 25-degree, 60-degree, or 75-degree angle to the longitudinal axis of the connector 36), or any other type of connector well known to those skilled in the art. The connector 36 includes a second lumen 38 having any number of branches suitable for the type of connector, such as a branch extending between the distal and proximal ends of the connector 36 and a branch provided to the port 44 of the connector 36.

[0036] In some non-limiting embodiments or aspects, the catheter assembly 12 includes a needle-free access connector 46 coupled to the proximal end 42 of the connector 36, the needle-free access connector 46 providing an access port to the catheter assembly 12. The needle-free access connector 46 may be configured, for example, as a split septum connector or a self-healing septum connector. In the illustrated embodiment, the access port provided by the needle-free access connector 46 is a patient-proximal access port close to the insertion site of the catheter 16, but it is understood that the access port may be located at other alternative locations close enough to the insertion site to allow the blood collection catheter tube to advance into the indwelling catheter 16 and protrude beyond its distal end. For example, the access port providing the advancement of the blood collection catheter tube into the indwelling catheter 16 may be located on another connector, such as the proximal connector on an extension set (described below) of the catheter assembly 12.

[0037] In some non-limiting embodiments or aspects, the catheter assembly 12 may include an extension set 48 connected to a port 44 of the connector 36. The extension set 48 includes a second fluid conduit 50, the port 44 connected to one end 52 of the conduit 50 and the other end 56 having a Luer connector 54, the second fluid conduit 50 being provided with a clamp 57 that can be closed.

[0038] The catheter system 10 further includes an instrument delivery device 60 which can be operated to introduce an instrument into the catheter assembly 12 and into the patient's vascular system. In some embodiments, as referred to below, the instrument delivery device 60 may include a blood collection device ("blood collection device 60") which introduces the catheter tube through the catheter assembly 12 into the patient's vascular system to obtain a blood sample from the patient. However, according to aspects of the present disclosure, it is recognized that the instrument delivery device 60 may instead introduce a guidewire, probe, or other sensor into the patient's vascular system, and it should be understood that the following description of the blood collection device should not limit the scope of the present disclosure.

[0039] As shown in Figure 1 and in more detail in Figures 2-4, according to a non-limiting embodiment, the blood collection device 60 includes at least a housing 62, a coupling device 64, a catheter tube 66, and an advancing member 68. As will be described in more detail below, the catheter tube 66 is movable within the housing 62 and a portion of the catheter tube 66 can be advanced from a first position or storage position within the housing 62 (Figure 4) to a second position or advancing position outside the housing 62 (Figure 5), thereby allowing the distal end of the catheter tube 66 to be fed into the catheter assembly 12. Once the portion of the catheter tube 66 is fed into the catheter assembly 12 and passes the distal tip 26 of the indwelling catheter 16 and protrudes outward, the catheter tube 66 may enable the collection of a blood sample.

[0040] According to one embodiment, the catheter tube 66 is designed to be sized to allow introduction into and advancement through the fluid pathways of the catheter assembly 12 (i.e., the lumen of the catheter 16, the lumen 24 of the catheter adapter 14, and the first fluid conduit 30). Thus, the catheter tube 66 may have an outer diameter smaller than the smallest lumen of the fluid pathway of the catheter assembly (e.g., between 10 gauge and 30 gauge). The catheter tube 66 may be long enough to position its distal end 70 at a desired location within the fluid pathway of the catheter system 10. Thus, in one embodiment, the catheter tube 66 may be long enough to advance its distal end 70 from the housing 62 through the catheter assembly (i.e., through the connector 36, fluid conduit 30, catheter adapter 14, and catheter 16) and fully advance through the distal tip 26 of the catheter 16.

[0041] As shown in Figures 1-5, the housing 62 of the blood collection device 60 may be an elongated member having a proximal end 72 and a distal end 74 that defines an internal volume 76. In some embodiments, the housing 62 may be formed from a pair of housing portions 78a, 78b that are arranged side by side and joined together to define the internal volume 76. The housing 62 may have one or more features or surface finishes on its outer surface to improve the ergonomic characteristics of the blood collection device 60, and in some cases, allow the user to operate the blood collection device 60 with one hand (i.e., use it with one hand). Furthermore, the housing 62 may be made of a transparent or translucent material that provides at least partial visibility into its internal volume 76 so that the positioning of the catheter tube 66 within the housing 62 can be confirmed by a clinician, as will be described in more detail below.

[0042] The coupling device 64 of the blood collection device 60 is provided at the distal end 74 of the housing 62 and provides reversible coupling of the blood collection device 60 to the catheter assembly 12, such as via a needleless access connector 46, as shown in Figure 1. In some embodiments, the coupling device 64 is configured as a lock 80 including a blunt-end cannula 82 and a locking arm 84 for coupling to the needleless access connector 46 of the catheter assembly 12, with the blunt-end cannula 82 and locking arm 84 forming three contact points thereto. However, those skilled in the art will understand that any connection or coupling, such as a Luer, is usable, as long as the distal end 70 of the catheter tube 66 passes through the coupling device 64 and reaches the catheter assembly 12.

[0043] The forward member 68 of the blood collection device 60 includes a first portion 86 and a second portion 88. The first portion 86 is movably positioned along the upper surface 90 of the housing 62, and the second portion 88 is movably positioned within the internal volume 76 of the housing 62. The arrangement of the forward member 68 and the housing 62 is configured such that a coupling portion (not shown) connecting the first portion 86 and the second portion 88 of the forward member 68 fits into a slot 92 formed in the upper surface 90 of the housing 62, the slot 92 generally extending 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, the movement of the first portion 86 along the upper surface 90 of the housing 62 results in the corresponding movement of the second portion 88 within the internal volume 76.

[0044] As shown in Figures 1-5, the first portion 86 of the forward member 68 may be configured as a tab having a contact surface 94a that can be engaged by the user and a lower surface 94b that contacts the outer surface 90 of the housing 62. In such an embodiment, the upper surface 90 of the housing 62 may be provided with a track 96 consisting of, for example, a set of ribs, protrusions, projections, grooves and / or similar, and when the forward member 68 is engaged by the user, the lower surface 94b of the tab or projection advances along the track 96. In this way, the user can engage with the first portion 86 of the forward member 68 and move the forward member 68 relative to the housing 62.

[0045] As shown in Figure 3, the second portion 88 includes an opening 98 extending through it, configured to grasp or hold a portion of the catheter tube 66. Because a portion of the catheter tube 66 is held within the opening 98 of the second portion 94, when the advancing member 68 moves relative to the housing 62, the catheter tube 66 also undergoes a corresponding movement relative to the housing 62. In this way, the distal end 70 of the catheter tube 66 can be selectively moved out of the internal volume 76 of the housing 62 as desired, such as when the blood collection device 60 is coupled to the catheter assembly 12 and a blood sample is collected, thereby advancing the distal end 70 of the catheter tube 66 out of the housing 62.

[0046] As further shown in Figures 1 to 5, the blood collection device 60 includes a secondary catheter 102 provided at the proximal end 72 of the housing 62. The secondary catheter 102 has a proximal end 104 and a distal end 106 that define a lumen 108. A portion of the secondary catheter 102 is positioned within an opening 110 formed at the proximal end 72 of the housing 62 and extends through the opening 110. Thus, the proximal end 104 is at least partially positioned outside the housing 62, the distal end 106 is at least partially positioned inside the housing 62, and the distal end 106 is coupled to a second portion 88 of the forward member 68. In some embodiments, the secondary catheter 102 may have a larger diameter than the catheter tube 66, which may function to limit, reduce, and / or substantially prevent hemolysis of a certain amount of blood when a certain amount of blood flows through the catheter 66 and the secondary catheter 102. According to embodiments of the present disclosure, the proximal end 104 of the secondary catheter 102 is coupled to and / or otherwise includes a coupler 112 configured to mate with a collection device (not shown) which is usable with a blood collection device 60 to collect a blood sample for subsequent analysis. According to some embodiments, the coupler 112 may be configured as a Luer connection (i.e., a female Luer connection) configured to mate with a corresponding Luer connection (i.e., a male Luer connection) of the collection device.

[0047] According to aspects of the present disclosure, with reference to Figures 6-22, the blood collection device 60 is configured to incorporate within it a component or feature, i.e., a “visualization aid,” that provides improved visibility of the catheter tube 66 during the operation of the device 60. That is, one or more components or features of the device 60 may be configured to improve the visualization of the catheter tube 66 during the operation of the blood collection device 60 so that the positioning of the catheter tube 66 and / or any bending or other deformation of the catheter tube 66 is identified as the catheter tube 66 moves forward and / or backward relative to the housing 62 and into the catheter assembly 12. According to some aspects of the present disclosure, as will be described in more detail below, at least a portion of the housing 62 of the blood collection device 60 may be specifically modified to provide improved visibility of the catheter tube 66, including modifications to the structure of the housing 62 and / or the material on which the housing 62 is formed, the application of a coating to the housing 62, or the addition of components to the housing 62. According to further aspects of the present disclosure, components within the housing 62 may be moved and / or modified to improve the visibility of the catheter tube 66.

[0048] In some embodiments, as shown in Figures 6A and 6B and Figure 7, at least one of the housing portions 78a, 78b of the housing 62 includes a paint, finish, or coating 120 (hereinafter, "coating 120") applied thereto, which allows for improved visibility of the catheter tube 66. In such embodiments, each of the housing portions 78a, 78b is formed of a transparent or translucent material 121 that provides at least partial visibility into its internal volume 76, but at least one of the housing portions 78a, 78b includes a coating 120 applied thereto, which is preferably applied to the inner surface 122 of the housing 62, although the coating may instead be applied to the outer surface 124 of the housing 62.

[0049] In one embodiment, the coating 120 applied to the housing 62 (e.g., housing portion 78b) is an opaque coating that improves the visibility of the catheter tube 66 and / or prevents light from entering the internal volume 76 in which the catheter tube 66 is located.

[0050] In the embodiments of Figures 6A and 6B, the opaque coating 120 is applied to the inner surface 122 of a portion of the housing (e.g., housing portion 78a) along its lateral region 126. In one embodiment, the opaque coating 120 may have a white or other light-colored tint, and when the coating 120 is applied to the lateral region 126, the coating 120 acts as a background that provides an improved contrast between the catheter tube 66 and the housing 62, providing improved visibility of the catheter tube 66. In another embodiment, the coating 120 applied to the lateral region 126 of the housing portion (e.g., housing portion 78a) is a coating that functions as a one-way mirror that can be seen through from the near side, but has opaque or reflective properties on the other side, enabling improved visualization. When using the blood collection device 60, the clinician can better visualize the catheter tube 66 through the mirror-type coating 120 that reflects its back image.

[0051] In the embodiment shown in Figure 7, the opaque coating 120 is applied to the inner surface 122 of the housing 62 along several surfaces of the upper and lower regions 128, 130 of the housing portions 78a, 78b. Once the coating 120 is applied to several surfaces of the upper and lower regions 128, 130 of the housing portions 78a, 78b, the opaque coating 120 functions to prevent light from entering the internal volume 76 in which the catheter tube 66 is located. In some embodiments, the opaque coating 120 applied to the inner surface 122 of the housing 62 may have a matte finish that helps to further diffuse light within the internal volume 76 of the housing 62.

[0052] According to some embodiments, as shown in Figures 8-17, the structure of the housing 62 and / or the material from which the housing 62 is composed allows for an improved view of the catheter tube 66 inside the housing 62.

[0053] As shown in Figures 8A and 8B, 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 to improve the visibility of the catheter tube 66. According to one embodiment, one housing portion (e.g., housing portion 78a) is formed from a white or light-colored opaque material 123, while the other housing portion (e.g., housing portion 78b) is formed from a transparent or translucent material 121 that provides visibility into the internal volume 76 of the housing 62. The white or light-colored opaque material of housing portion 78a is in contrast to the darker color of the catheter tube 66 so that the housing 62 provides improved visibility of the catheter tube 66 when it is rotated to a desired orientation in which the opaque housing 62 serves as a background for the catheter tube 66.

[0054] According to another embodiment, each of the housing portions 78a and 78b may be formed of a translucent material having a white or lighter shade that contrasts with the darker color of the catheter tube 66, thereby providing improved visibility of the catheter tube 66. In such embodiments, the lightly colored translucent material of the housing portions 78a and 78b can provide a background for the catheter tube 66 in multiple orientations, so no particular rotation or orientation of the housing 62 is required.

[0055] According to other embodiments, the housing 62 (i.e., housing portions 78a, 78b) is formed of a transparent or translucent material 121 modified to allow improved visibility of the catheter tube 66 within the internal volume 76 of the housing 62. That is, the housing 62 may be configured such that at least the lateral regions 126 of each of the housing portions 78a, 78b are formed to increase the visibility of the catheter tube 66 within the housing 62. In one embodiment, as shown in Figure 9, the thickness of the lateral region 126 (compared to the upper region 128 and lower region 130 of the housing 62) may be reduced to facilitate better visualization. In another embodiment, as shown in Figure 10, the finish 131 of the inner surface 122 of the lateral region 126 may be modified to reduce glare on the region.

[0056] Referring here to Figures 11-15, in some embodiments, the shape of the lateral region 126 is controlled to improve the visualization of the catheter tube 66 inside the housing 62.

[0057] In one embodiment, as shown in Figure 11, the side region 126 of the housing 62 is configured as a flat surface (instead of curved) to minimize glare and facilitate visualization. That is, both the inner surface 122 and outer surface 124 of the side region 126 are formed flat, creating a flat lens that can be oriented by the clinician during use of the blood collection device 60, and glare is eliminated from the side region 126. The cylindrical shape of the side region 126 acts as a mirror that reflects any external light source along its length (so there is always a part of the housing 62 that reflects external light to the user's eye regardless of the orientation of the housing), but forming the side region 126 as a flat side reflects light in only one direction, thereby allowing the user to rotate the housing 62 along its axis to move the reflected light away from the eye, thereby improving visibility.

[0058] In other embodiments, as shown in Figures 12 and 13, the inner surface 122 of one or both side regions 126 has a different shape from its outer surface 124. In one configuration, as shown in Figure 12, the inner surface 122 of one or both side regions 126 is convex to add a magnifying effect to the visibility of the catheter tube 66 for easier visualization. In another configuration, as shown in Figure 13, the inner surface 122 of one or both side regions 126 has a flat shape (while the outer surface 124 remains curved), again adding a magnifying effect to the visibility of the catheter tube 66 for easier visualization. As further shown in Figure 13, a flat surface may also be provided on the side of the forward member 68. In yet another configuration, as shown in Figure 14, the outer surface 124 of the side region may be curved with a smaller radius than the inner surface 122, the smaller radius reduces glare from light from a wide line to a narrow line and also adds a magnifying effect to the visibility of the catheter tube 66.

[0059] In another embodiment, as shown in Figure 15, the inner and / or outer surfaces 122, 124 of one or both side regions 126 are “smoothed” to remove any steps, depressions, or other extra surface features from the housing 62 so as to provide a smooth surface to the housing 62. Removal of such extra surface features from the housing 62 minimizes the amount of light refracted and reflected when passing through the housing 62, and thus improves the visibility of the catheter tube 66 within the housing 62.

[0060] According to another embodiment, as shown in Figure 16, one or both of the housing portions 78a, 78b are formed as a co-molded part containing two different materials. That is, some sections / regions of one or both of the housing portions 78a, 78b (e.g., upper region 128 and lower region 130 of each housing portion) may be formed from an opaque material 123, while other sections / regions of one or both of the housing portions 78a, 78b (e.g., side regions or "windows" 132 of each housing portion) may be formed from a clear or transparent material 121. In some embodiments, each of the housing portions 78a, 78b is formed as a co-molded part with clear side windows 132, such that two (two) opposing side windows 132 are formed within the housing 62 to provide visibility of the catheter tube 66. In other embodiments, only one of the housing portions 78a, 78b is formed as a co-molded part with a transparent side window 132, and only such a single side window 132 is formed within the housing 62 to provide visibility of the catheter tube 66.

[0061] In some embodiments, instead of the housing 62 being formed as a co-molded part having a side window 132 formed of a different material, as shown in Figure 17, the housing 62 may instead be formed so that a side window is provided therein, which is initially formed as an opening slot 134. The opening side slot 134 may be formed along the entire length or a portion of the housing 62, and a transparent material 136 such as glass, a clear plastic insert, or a clear plastic film may be inserted therein, which provides visibility into the internal volume 76 of the housing 62 to enable visualization of the catheter tube 66.

[0062] According to other aspects of the present disclosure, additional components may be added on or within the housing 62 to provide improved visibility of the catheter tube 66 during operation of the device 60.

[0063] Referring to Figure 18, according to one embodiment, the sticker 138 may be provided with the blood collection device 60, which can be applied to the housing 62 (by a clinician) when the device 60 is in use to enable improved visualization of the catheter tube 66. The sticker 138 may be applied to a lateral area of ​​the housing 62 (on either housing portion 78a, 78b) and may be configured as white (or another light color) to provide a contrasting white background to the catheter tube 66 and improve its visualization. In one embodiment, the sticker 138 may be selectively applied to a desired housing portion 78a, 78b, thereby enabling the clinician to choose which side to apply it to and enabling the clinician to use the sticker 138 only when needed. In another embodiment, the sticker 138 may be pre-applied to both sides of the housing 62 to provide visualization of the catheter tube 66 through a desired side of the housing 62, and one of the stickers 138 is then removed by the clinician from the desired side of the housing 62. In some embodiments, a tab 140 is provided on the sticker 138 to facilitate removal from the housing 62.

[0064] Referring to Figure 19, according to another embodiment, the sleeve 140 may be provided separately from the housing 62, which can be snapped onto the housing 62 when the device 60 is in use, in order to enable improved visualization of the catheter tube 66. The sleeve 140 may be snapped onto the lateral region of either housing portion 78a, 78b (portion 78a in Figure 19), thereby enabling right-handed or left-handed use of the blood collection device 60. The sleeve 140 may be configured as a white (or other light-colored) sleeve 140 that provides a light-colored background in contrast to the darker catheter tube 66 in order to improve its visualization. Alternatively, the sleeve 140 may be configured as a dark-colored sleeve 140 that provides a dark background in contrast to the white or other light-colored catheter tube 66 in order to improve its visualization.

[0065] Referring to Figures 20A and 20B, according to another embodiment, the insert 142 may be provided separately from the housing 62, permanently fixed on its outer surface or within its internal volume 76, and movable between different positions (by the clinician) when the device 60 is in use, allowing for improved visualization of the catheter tube 66. The insert 142 may generally fit into a portion of the outer (or inner) surface 122 of the housing 62, such as the lateral region 126 of the housing 62. The insert 142 may be configured as a white (or other light-colored) insert 142 to provide a bright background in contrast to the darker catheter tube 66 in order to improve its visualization. When using the blood collection device 60, the clinician can position the insert 142 in a desired position (e.g., right-side or left-side), and the movement of the insert 142 is provided via a twist knob 145 located on the outer surface of the housing 62, such as the proximal end face of the housing 62, and surrounding the secondary catheter 102. The clinician may turn the twist knob 145 to translate the insert 142 to a desired side of the housing 62, so that the insert 142 functions to block light from the housing 62 and provide a contrasting background for visualization of the catheter tube 66.

[0066] According to other embodiments of this disclosure, the catheter tube 66 may be configured to provide its improved visibility within the housing 62 during the operation of the device 60. According to some embodiments, the catheter tube 66 may be provided such that at least a portion of it is black or another dark color, in contrast to a lighter (e.g., white) colored background provided to the housing 62 (according to any of the earlier embodiments described herein). As shown in Figure 21, in some embodiments, the entire catheter tube 66 may be colored black / dark, for example, by forming the tube from a black / dark polyimide material, while in other embodiments, black stripes 144 may be provided on the catheter tube 66, for example, by painting black stripes 144 onto the polyimide tube 66 at various positions, each of which extends circumferentially around the catheter tube 66.

[0067] According to some embodiments, as shown in Figure 22, the catheter tube 66 may be positioned off-center within the internal volume 76 of the housing 62 (extending longitudinally along the centerline 146 of the housing 62) in order to provide an improved view of the catheter tube 66 within the housing 62. That is, when the catheter tube 66 is at the center of the internal volume 76, it is recognized that the catheter tube 66 may be positioned in a region of the internal volume 76 where optical glare from the housing 62 adversely affects the visualization of the catheter tube 66. Therefore, the catheter tube 66 may be positioned off-center within the internal volume 76 of the housing 62 with respect to the centerline 146 in a region where optical glare is reduced, thus facilitating the visualization of the catheter tube 66 within the housing 62.

[0068] Accordingly, according to the embodiments described herein, the blood collection device 60 is configured to improve the observation of the catheter tube 66 as it advances into the catheter assembly and enters the patient's vein through the catheter assembly. Visualization aids are provided to the blood collection device 60 so as to improve the visibility of the internal volume 76 of the housing and the catheter tube 66 therein during the operation of the blood collection device 60, and so as to determine the state (e.g., bend or twist) and position of the catheter tube 66 as it advances and / or retracts relative to the housing 62 and into the catheter assembly 12.

[0069] It is recognized that the embodiments of this disclosure are not limited to the specific blood collection device 60 shown and described in Figures 1-22, and that other blood collection devices having a suitable structure may also incorporate embodiments of this disclosure. Referring here to Figure 23, a catheter system 10 is shown that includes a blood collection device 150 according to another embodiment of this disclosure. The blood collection device 150 includes a housing 152 having a proximal end 154 and a distal end 156, and a forward member 158 that is slidably received within the housing 152 (i.e., within the internal volume 160 of the housing 152). In the illustrated embodiment, the forward member 158 is provided as one or more telescopic cylinders 158a provided in an extension-to-extension relationship with the housing 152, so that the forward member 158 can be fully or almost fully slidably received within the internal volume 160 of the housing 152. The forward member 158 also includes a proximal end 162 and a distal end 164, and in a non-limiting embodiment, the forward member 158 may have a variable diameter along its length. As an example, the distal end 164 of the advance member 158 may have a larger diameter than the rest of the advance member 158 so that when the advance member 158 is retracted, one or more features on the housing 152 can interact with the enlarged portion of the advance member 158 to prevent the advance member 158 from being fully withdrawn from the housing 152. As another example, the distal end 164 of the advance member 158 may have a smaller diameter than the rest of the advance member 158 so that the advance member 158 is held in place in the blood collection advance position, thereby freeing the operator's hands to handle additional components (e.g., a Vacutainer™ tube).

[0070] The blood collection device 150 further includes a catheter tube 166 having a proximal end 168 and a distal end 170. The catheter tube 166 is received within the internal volume 160 of the housing 152 and can be advanced and / or retracted relative to the housing 152 by the displacement of the advance member 158 relative to the housing 152. In some embodiments, the catheter tube 166 can be joined to the advance member 158 via a joint 172 provided at the distal end 164 of the advance member 158 such that the displacement of the advance member 158 relative to the housing 152 causes a corresponding displacement of the catheter tube 166. In some non-limiting embodiments, 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 distal to the catheter 16), as described above with respect to the blood collection device 60 and its operation.

[0071] The blood collection device also includes a coupling device 174 on which it may be identical to the coupling device shown and described in the blood collection devices of Figures 1-12. That is, the coupling device 174 is configured as a lock 80 comprising a blunt-ended cannula 82 and a locking arm 84 for connection to the needleless access connector 46 of the catheter assembly 12, with the blunt-ended cannula 82 and the locking arm 84 forming three contact points thereto. However, it is understood that alternative embodiments of the blood collection device 150 may include another type of coupling device 174 for securing the blood collection device 150 to the catheter assembly 12, including Luer connectors, clips, blunt-ended plastic cannulas, blunt-ended metal cannulas, hybrid Luer (e.g., with cannula), friction mating, etc. According to aspects of the present disclosure, the secondary catheter 102 may be advanced through the telescopic cylinder 158a of the forward member 158, and the secondary catheter 102 provides a fluid connection between a catheter tube 166 and a coupler 112 provided at the proximal end 104 of the secondary catheter 102, the coupler 112 is configured to engage with a collection device (not shown).

[0072] As described in detail above, the blood collection device 150 may incorporate one or more visualization aids configured to improve the visibility of the catheter tube 166 during the operation of the blood collection device 150, so that the state (e.g., bend / twist) and positioning of the catheter tube 166 can be determined as the catheter tube 166 moves forward and / or backward relative to the housing 152 and into the catheter assembly 12. According to embodiments of the present disclosure, visualization of the catheter tube 166 may be improved by modifying the housing 152 (e.g., modifying the structure of the housing 152, the material on which the housing 152 is formed, and / or applying a coating to the housing 152), adding components to the housing 152, and / or shifting / modifying the catheter tube 166 within the housing 152. According to embodiments, any of the visualization aids shown in the embodiments of Figures 6 to 22 may be incorporated into the blood collection device 150 of Figure 23.

[0073] While this disclosure is described in detail based on the most practical and preferred embodiments or aspects currently available, such details are for illustrative purposes only and should be understood as being intended to include modifications and equivalent configurations within the spirit and scope of the appended claims, rather than limiting this disclosure to the disclosed embodiments or aspects. For example, it should be understood that, to the extent possible, this disclosure is intended to allow for the combination of one or more features of any embodiment with one or more features of other embodiments.

Claims

1. An instrument delivery device for use with intravenous catheter assemblies, A housing having a proximal end portion and a distal end portion, wherein the housing comprises a first housing portion and a second housing portion, the housing portion and the second housing portion being arranged side by side and joined together to define an internal volume, A device movably housed within the aforementioned internal volume, A coupling device positioned at the distal end portion of the housing and configured to connect the housing to the access connector of an intravenous catheter assembly, A forward member configured to move relative to the housing and advance the distal end of the device beyond the distal end portion of the housing into the intravenous catheter assembly, Equipped with, The housing comprises a visualization aid configured to improve the visibility of the instrument within the internal volume of the housing, wherein the instrument delivery device is provided.

2. The instrument delivery device according to claim 1, wherein each of the first housing portion and the second housing portion is formed of a transparent or translucent material, and each of the first housing portion and the second housing portion comprises an upper region, a lower region, and a side region.

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

4. The instrument delivery device according to claim 3, wherein the coating consists of an opaque coating having a first color, and the instrument has a second color that is darker than the first color so that the coating is contrasted with the instrument.

5. The instrument delivery device according to claim 3, wherein the coating is transparent from a first side, but forms an opaque or reflective unidirectional mirror on the opposing second side.

6. The instrument delivery device according to claim 2, wherein the visualization aid comprises the side regions of the first housing portion and the second housing portion, respectively.

7. The instrument delivery device according to claim 6, wherein each of the side regions of the first and second housing portions has a thickness less than the thickness of the upper and lower regions in order to facilitate better visualization of the instrument passing through the side region.

8. The instrument delivery device according to claim 6, wherein each of the side regions of the first and second housing portions has an inner surface and an outer surface, and each of the inner surface and the outer surface has a flat surface.

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

10. The instrument delivery device according to claim 6, wherein each of the side regions of the first and second housing portions includes a smooth outer surface free of any steps or indentations, and the smooth outer surface minimizes refraction and reflection of light as it passes through the side region.

11. The device delivery device 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 the outer surface of the side region and having a first color, and the device having a second color that is darker than the first color in contrast to the sticker.

12. The instrument delivery device according to claim 2, wherein the visualization aid comprises a sleeve fixed to the outer surface of the first housing portion, the sleeve having a first color, and the instrument having a second color that is darker than the first color in contrast to the sleeve.

13. The visualization aid comprises an insert disposed within the internal volume adjacent to the inner surface of the housing, wherein the insert has a first color, and the instrument has a second color that is darker than the first color, in contrast to the insert, and the insert is movable via a twist knob located on the housing from a first position adjacent to the lateral region of the first housing portion to a second position adjacent to the lateral region of the second housing portion.

14. The instrument delivery device according to claim 1, wherein the visualization aid is made of an opaque material on which the first housing portion is formed, and the second housing portion is made of a transparent or translucent material, the opaque material having a first color, and the instrument having a second color that is darker than the first color so that the first housing portion is contrasted with the instrument.

15. The visualization aid comprises a translucent material on which the first housing portion and the second housing portion are formed, the translucent material having a dyed first color, and the instrument having a second color darker than the first color so that the first housing portion and the second housing are contrasted with the instrument, the instrument delivery device according to claim 1.

16. The instrument delivery device according to claim 1, wherein at least one of the first housing portion and the second housing portion comprises a co-molded part having an upper region, a lower region and a side region, the upper region and the lower region being formed of an opaque material, the side region being formed of a transparent material, and the visualization aid comprising the side region.

17. Each of the first housing portion and the second housing portion is formed of an opaque material, and each of the first housing portion and the second housing portion comprises an upper region, a lower region, and a side region. The instrument delivery device according to claim 1, wherein the visualization aid comprises a window formed in at least one of the side regions of the first housing portion and the second housing portion, and the transparent member is fixed within the window.

18. An instrument delivery device for use with intravenous catheter assemblies, A housing having a proximal end portion and a distal end portion, wherein the housing comprises a first housing portion and a second housing portion, the housing portion and the second housing portion being arranged side by side and joined together to define an internal volume, A device movably housed within the aforementioned internal volume, A coupling device positioned at the distal end portion of the housing and configured to connect the housing to the access connector of an intravenous catheter assembly, A forward member configured to move relative to the housing and advance the distal end of the device beyond the distal end portion of the housing into the intravenous catheter assembly, Equipped with, The instrument is an instrument delivery device comprising a visualization aid configured to improve the visibility of the instrument within the internal volume of the housing.

19. The instrument delivery device according to claim 1, wherein the visualization aid comprises a plurality of stripes formed on the instrument, each of the plurality of stripes extending circumferentially around the instrument.

20. The instrument delivery device according to claim 1, wherein the visualization aid includes coloring of the instrument, the coloring of the instrument being darker than the coloring of the housing so that the instrument is contrasted with the housing.

21. The instrument delivery device according to claim 1, wherein the visualization aid includes positioning the instrument within the internal volume of the housing, the instrument being positioned off-center with respect to the centerline of the internal volume extending longitudinally between the distal and proximal ends of the housing.

Images