Instrument delivery device and catheter system

Abstract

An instrument delivery device for use with an intravenous catheter assembly and a catheter system are provided herein. The instrument delivery device includes a housing having a proximal end portion and a distal end portion and defining an interior volume; an instrument, the instrument being movably accommodated within the interior volume; a coupling device positioned at the distal end portion of the housing and configured to couple the housing to an access connector of an intravenous catheter assembly; 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; and a light generating element at least partially disposed within the housing and configured to generate light capable of visualizing the instrument.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 468,097, filed on May 22, 2023, entitled "Instrument Advancement Device with Light - Enabled Instrument Viewing", the entire content of which is incorporated herein by reference. Technical Field

[0003] Provided herein are instrument advancement devices for use in vascular access, particularly instrument advancement devices incorporating components for light - enabled instrument viewing. Background Art

[0004] Catheters are often used to inject fluids into and withdraw 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) that includes such a catheter inserted into the patient's vascular system. Common VADs include plastic catheters inserted into a patient's vein, where, by way of example, the length of the catheter varies from a few centimeters when the VAD is a peripheral intravenous catheter (PIVC) to several centimeters when the VAD is a central venous catheter (CVC).

[0005] As is known in the art, instrument advancement devices are often used in conjunction with indwelling PIVCs to facilitate blood drawing and / or infusion. When such instrument advancement devices are used to assist with blood drawing, these devices (i.e., "blood drawing devices") focus on the ability to reliably collect high - quality blood samples and reduce hemolysis. The main way these instrument advancement devices operate is by using a introducer to insert a catheter, probe, tubing, or other instrument through the catheter lumen of the PIVC, where 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 the catheter can be introduced to provide access to the PIVC and into the patient's vasculature. If blood drawing is performed, a syringe or vacutainer can be used to collect the blood sample without subjecting the patient to an additional needle stick.

[0006] The introducer of the instrument propulsion device generally includes: a housing; an instrument (i.e., a catheter or other probe, tube, or instrument) that can move within the housing to be able to extend out of the housing and thus be advanced into an indwelling PIVC; and a propulsion member that can be actuated by an operator relative to the housing. That is, the operator can move the propulsion member distally to cause a corresponding movement of the instrument 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 recognized that the instrument propulsion device can be used in many different environments and varying conditions. For example, it may be necessary to draw blood at night or in an environment with insufficient light, resulting in reduced / poor visibility for the clinician to operate the introducer. In such a case, when the catheter (or other instrument) is being advanced through the housing, it may be difficult for the clinician to observe the catheter (or other instrument), making it impossible for the clinician to determine the position of the distal end of the catheter and its position relative to the instrument propulsion device and the indwelling PIVC. Additionally, if during insertion, the end of the instrument hits an obstacle and requires remedial or position adjustment for successful advancement, the need for such remedial / adjustment may not be obvious without visualization.

[0008] Therefore, there is a need in the art for an instrument propulsion device and its introducer that provide improved visibility during the operation of the device, including being able to visualize the distal end (or other part) of the catheter or other instrument when the catheter or other instrument is being advanced through the operation of the introducer. Summary of the Utility Model

[0009] Provided herein is 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 and defining an internal volume; an instrument movably received within the internal volume; a coupling device positioned at the distal portion of the housing and configured to couple the housing to an access connector of the intravenous catheter assembly; a propulsion 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; and a light generating element at least partially disposed within the housing and configured to generate light capable of visualizing the instrument.

[0010] In some embodiments, the light generating element includes an illumination element positioned adjacent to the distal portion or the proximal portion of the housing.

[0011] In some embodiments, the instrument delivery device includes an optical fiber extending from the illumination element and configured to transmit light along the length of the optical fiber.

[0012] In some embodiments, the light generating element includes one or more light emitting diodes (LEDs).

[0013] In some embodiments, the one or more LEDs are fixed to the inner surface of the housing.

[0014] In some embodiments, the light generating element includes a light strip, the light strip includes a plurality of LEDs disposed on a substrate, and the light strip is fixed to the inner surface of the housing.

[0015] In some embodiments, the propulsion member includes a first portion and a second portion, the first portion is configured to move along the outer surface of the housing, the second portion is connected to the first portion and is located within the internal volume, the second portion engages with the instrument, wherein the one or more LEDs are located at the distal end of the second portion of the propulsion member such that when the propulsion member moves relative to the housing, the one or more LEDs move with the propulsion member.

[0016] In some embodiments, the instrument delivery device includes a battery for powering the one or more LEDs, and the battery is mounted on the second portion of the propulsion member.

[0017] In some embodiments, the one or more LEDs include micro-LEDs having a size of 1.5 mm × 1.5 mm or smaller.

[0018] In some embodiments, the housing is formed of fluorescent plastic.

[0019] In some embodiments, the instrument delivery device includes an electrical circuit having an open state and a closed state, the electrical circuit provides power to the light generating element when in the closed state, wherein when the propulsion member is in an initial position at the proximal portion of the housing, the electrical circuit is in the open state, and wherein when the propulsion member moves distally from the initial position, the electrical circuit switches from the open state to the closed state such that the light generating element receives power from the electrical circuit and the light generating element is caused to emit light.

[0020] In some embodiments, the electrical circuit is configured to change the color of light output from the light generating element based on the positioning of the propulsion member.

[0021] In some embodiments, the light generating element includes a luminescent coating applied to at least a portion of the instrument, and the luminescent coating generates light after exposure to ambient light.

[0022] The present disclosure also provides a catheter system, the catheter system including an intravenous catheter assembly, the intravenous catheter assembly including: a catheter including a distal end and a proximal end, the catheter defining a lumen extending between the distal end and the proximal end; and an access connector configured to provide access to the lumen of the catheter. The catheter system further includes an instrument delivery device that is capable of being coupled to the access connector, the instrument delivery device including: a housing having a proximal portion and a distal portion and defining an internal volume; an instrument movably received within the internal volume; a coupling device positioned at the distal portion of the housing and configured to couple the housing to the access connector of the intravenous catheter assembly; a propulsion member configured to move relative to the housing to advance a distal end of the instrument beyond the distal portion of the housing and into the intravenous catheter assembly; and a light generating element at least partially disposed within the housing and configured to generate light capable of visualizing the instrument.

[0023] In some embodiments, the light generating element includes: an illumination element positioned adjacent to the proximal portion of the housing; and an optical fiber extending from the illumination element and configured to transmit light along the length of the optical fiber.

[0024] In some embodiments, the light generating element includes one or more light emitting diodes (LEDs), wherein the one or more LEDs are fixed to the inner surface of the housing or to a portion of the propulsion member positioned within the internal volume of the housing.

[0025] In some embodiments, the one or more LEDs include micro-LEDs having a size of 1.5 mm × 1.5 mm or less, and wherein the instrument delivery device further includes a battery for powering the micro-LEDs.

[0026] In some embodiments, the instrument delivery device includes an electrical circuit having an open state and a closed state, the electrical circuit providing power to the light generating element when in the closed state, wherein the electrical circuit is in the open state when the propulsion member is in an initial position at the proximal portion of the housing, and wherein when the propulsion member moves distally from the initial position, the electrical circuit transitions from the open state to the closed state such that the light generating element receives power from the electrical circuit and the light generating element is caused to emit light.

[0027] In some embodiments, the light generating element includes a light emitting coating applied to at least a portion of the instrument, the light emitting coating generating light after being exposed to ambient light.

[0028] In some embodiments, the housing is formed of a fluorescent plastic. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 is a perspective view of a catheter system according to one aspect of the present disclosure;

[0030] Figure 2 is a perspective view of a blood drawing device that can be used with Figure 1 the catheter system;

[0031] Figure 3 is a perspective view of Figure 2 the blood drawing device according to one aspect of the present disclosure;

[0032] Figure 4 is Figure 2 a side view of the blood drawing device, showing the catheter fitting in a first retracted position;

[0033] Figure 5 is Figure 2 a side view of the blood drawing device, showing the catheter fitting in a second extended position;

[0034] Figure 6A and Figure 6B are perspective views of portions of a blood drawing device housing according to one aspect of the present disclosure, the blood drawing device housing including a lighting element disposed on the blood drawing device housing;

[0035] Figure 7A and Figure 7B are perspective views of portions of a blood drawing device housing according to one aspect of the present disclosure, the blood drawing device housing including a lighting element disposed on the blood drawing device housing;

[0036] Figure 8A and Figure 8B are perspective views of portions of a blood drawing device housing according to one aspect of the present disclosure, the blood drawing device housing including a lighting element disposed on the blood drawing device housing;

[0037] Figure 9 is an exploded view of a blood drawing device according to one aspect of the present disclosure;

[0038] Figure 10 is Figure 9 a perspective view of the advancing member of the blood drawing device;

[0039] Figure 11 is an exploded view of a blood drawing device according to one aspect of the present disclosure;

[0040] Figure 12 is Figure 11Cross-sectional view of the catheter fitting of the blood drawing device taken along line 12-12, wherein the catheter fitting has a light-emitting coating;

[0041] Figure 13 is a perspective view of a catheter system according to another aspect of the present disclosure. Detailed implementation mode

[0042] The following description is provided to enable those skilled in the art to make and use the described embodiments expected to implement the present utility model. However, various modifications, equivalents, variations, and alternatives will still be obvious to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present utility model.

[0043] Hereinafter, for the purpose of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall be related to the present utility model oriented as in the drawings. However, it should be understood that unless there is a clear contrary indication, the present utility model can adopt various alternative variations. 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 utility model. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered restrictive.

[0044] As used in this specification, the terms "proximal" and "distal" respectively refer to the direction closer to the user who places the device in contact with the patient and the direction away from the user. Thus, for example, the end of the device that first contacts the patient's body will be the distal end of the device, and the opposite end of the device operated by the user will be the proximal end of the device.

[0045] Devices and systems are provided herein for guiding instruments through indwelling catheters such as peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. Although certain catheter assemblies are shown in the drawings and described below, those skilled in the art will recognize that the devices and systems described herein can be useful in any number of different catheter assembly configurations.

[0046] Now refer to Figure 1 , Figure 1Illustrates a non - limiting embodiment of a catheter system 10 for facilitating the delivery of an instrument into an indwelling catheter, such as may be required to draw blood from a patient (or for other sensing purposes). 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 is 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 a patient's vasculature, where the distal end or tip 26 of the catheter 16 is appropriately positioned within a vein to enable blood drawing from the patient.

[0047] In some non - limiting embodiments or aspects, the catheter assembly 12 may include a first fluid conduit 30 extending from the adapter port 22.

[0048] 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.

[0049] The distal end 32 of the first fluid conduit 30 is coupled to the adapter port 22, while the proximal end 34 of the first fluid conduit 30 may be coupled to a connector 36. The connector 36 may be a T - connector (e.g., one side port is arranged at a 90 - degree angle relative to the longitudinal axis of the connector 36), a Y - connector (e.g., one side port is arranged at a 25 - degree angle, 60 - degree angle, 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 may include a second lumen 38 passing through the connector, which has any number of branches suitable for that type of connector, such as branches extending between the distal and proximal ends of the connector 36 and branches leading to ports 44 of the connector 36.

[0050] In some non-limiting embodiments or aspects, the catheter assembly 12 can include a needleless access connector 46 that is coupled to the proximal end 42 of the connector 36, wherein the needleless access connector 46 provides an access port to the catheter assembly 12. As an example, the needleless access connector 46 can be configured as a split septum connector or a self-sealing septum connector. In the illustrated embodiment, the access port provided by the needleless access connector 46 is a near-patient access port proximate to the insertion site of the catheter 16, but it should be appreciated that the access port can be provided at other alternative locations that are sufficiently close to the insertion site and that allow a blood draw catheter fitting or other probe to be advanced into the indwelling catheter 16 and beyond the distal end of the catheter. For example, an access port provided for advancing a blood draw catheter fitting into the indwelling arterial catheter 16 can be located on another connector, such as a proximal connector on an extension kit (described below) of the catheter assembly 12.

[0051] In some non-limiting embodiments or aspects, the catheter assembly 12 can further include an extension kit 48 that is coupled to the port 44 of the connector 36. The extension kit 48 can include: a second fluid conduit 50 that is coupled to the port 44 at an end 52 of the second fluid conduit 50; and a luer fitting 54 that is located at an opposite end 56, wherein a clamp 57 is provided on the second fluid conduit 50 to allow closure of the second fluid conduit 50.

[0052] The catheter system 10 further 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 draw device (“blood draw device 60”) that guides a catheter fitting through the catheter assembly 12 and into the patient's vasculature to obtain a blood sample from the patient. However, it should be appreciated that, in accordance with aspects of the present disclosure, the instrument delivery device 60 can alternatively introduce a guide wire, probe, or other sensor into the patient's vasculature, and thus it should be understood that the following description of the blood draw device should not limit the scope of the present disclosure.

[0053] As Figure 1 shown and more particularly described in Figures 2 to 4 , according to non-limiting embodiments, the blood draw device 60 includes at least a housing 62, a coupling device 64, a catheter fitting 66, and a propulsion member 68. As will be described in further detail below, the catheter fitting 66 is movable within the housing 62 such that a portion of the catheter fitting 66 is advanced from a first position or retracted position ( Figure 4 ) inside the housing 62 to a second position or advanced position outside the housing 62 (Figure 5 ), so that the distal end of the catheter fitting can be inserted into the catheter assembly 12. Once a portion of the catheter fitting 66 has been inserted into the catheter assembly 12 and extends beyond the distal end 26 of the indwelling catheter 16, the catheter fitting 66 can be capable of collecting a blood sample.

[0054] According to an embodiment, the catheter fitting 66 is sized to be introduced into the fluid path of the catheter assembly 12 (i.e., 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. Thus, the catheter fitting 66 can have an outer diameter that is smaller than the minimum lumen of the fluid path of the catheter assembly (e.g., between 10 gauge and 30 gauge). The catheter fitting 66 can have a length sufficient to place the distal end 70 of the catheter fitting 66 at a desired position within the fluid path of the catheter system 10. Thus, in one embodiment, the catheter fitting 66 can have a sufficient length such that the distal end 70 of the catheter fitting extends out of the housing 62 and through the catheter assembly (i.e., through the connector 36, the first fluid conduit 30, the catheter adapter 14, and the catheter 16) and beyond the distal end 26 of the catheter 16.

[0055] As Figures 1 to 5 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 that are coupled together to define the internal volume 76. The housing 62 can include one or more features or surface finishes on the outer surface of the housing that can be arranged to improve the ergonomics of the blood drawing device 60, which in some cases can allow a user to manipulate the blood drawing device 60 with one hand (i.e., single-handed use). Additionally, the housing 62 can be constructed of a transparent or translucent material (e.g., fluorescent plastic) that provides at least partial visibility of the internal volume 76 of the housing, such that a clinician can determine the positioning of the catheter fitting 66 within the housing 62, as will be explained in more detail below.

[0056] 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 provides a reversible coupling of the blood drawing device 60 to the catheter assembly 12 (such as via Figure 1The needleless access connector 46) shown. In some embodiments, the coupling device 64 is configured as a lock 80 that includes a blunt cannula 82 and a locking arm 84 for coupling to the needleless access connector 46 of the catheter assembly 12, wherein the blunt cannula 82 and the locking arm 84 form three contact points with the needleless access connector. However, those skilled in the art will recognize that any connection or coupling, such as a Luer fitting, can be used as long as the distal end 70 of the catheter fitting 66 can pass through the coupling device 64 to reach the catheter assembly 12.

[0057] The advancement 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 the upper surface 90 of the housing 62, and the second portion 88 is movably disposed within the internal volume 76 of the housing 62. The advancement member 68 and the housing 62 are arranged such that the connecting portion (not shown) that couples the first portion 86 and the second portion 88 of the advancement member 68 is located within a slot 92 formed in the upper surface 90 of the housing 62, and the slot 92 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 a corresponding movement of the second portion 88 within the internal volume 76.

[0058] As Figures 1 to 5 shown, the first portion 86 of the advancement member 68 can be configured as a lug having a contact surface 94a that can be engaged by a user and a bottom surface 94b that contacts an outer surface (e.g., the 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, ridges, protrusions, and / or grooves, etc.), and when the user engages the advancement member 68, the bottom surface 94b of the lug or protrusion advances along the track. In this way, the user can engage the first portion 86 of the advancement member 68 and move the advancement member 68 relative to the housing 62.

[0059] As Figure 3 shown, the second portion 88 includes an opening 98 that extends through the second portion and is configured to clamp or hold a portion of the catheter fitting 66. Since a portion of the catheter fitting 66 is held 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 fitting 66 relative to the housing 62. In this way, the distal end 70 of the catheter fitting 66 can be selectively moved out of or back into the internal volume 76 of the housing 62 as needed, such as when the blood drawing device 60 has been coupled to the catheter assembly 12 and a blood sample is to be collected, causing the distal end 70 of the catheter fitting 66 to be advanced out of the housing 62.

[0060] Further as Figures 1 to 5As shown, the blood drawing device 60 includes an auxiliary catheter 102 disposed at the proximal end 72 of the housing 62. The auxiliary catheter 102 has a proximal portion 104 and a distal portion 106 and defines a lumen 108. A portion of the auxiliary catheter 102 is disposed within an opening 110 formed in the proximal end 72 of the housing 62 and extends through the opening. Thus, the proximal portion 104 is at least partially disposed outside the housing 62, and the distal portion 106 is at least partially disposed inside the housing 62, wherein the distal portion 106 is coupled to the second portion 88 of the propulsion member 68. In some embodiments, the diameter of the auxiliary catheter 102 may be greater than the diameter of the catheter fitting 66, which can serve to limit, reduce, and / or substantially prevent hemolysis of a certain volume of blood as that volume of blood flows through the catheter fitting 66 and the auxiliary catheter 102. According to an embodiment of the present disclosure, the proximal portion 104 of the auxiliary catheter 102 is coupled to and / or otherwise includes a coupler 112 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 may be configured as a Luer connector (i.e., a female Luer connector) configured to mate with a corresponding Luer connector (i.e., a male Luer connector) of the collection device.

[0061] In accordance with aspects of the present disclosure, with reference now to Figures 6A to 12 , the blood drawing device 60 is configured to incorporate into the blood drawing device components or elements that provide optically enabled viewing of the catheter fitting 66 during operation of the blood drawing device 60, i.e., "light generating elements". That is, light generating elements are provided in the blood drawing device 60 that are configured to generate light sufficient to view / illuminate the catheter fitting 66 during operation of the blood drawing device 60 such that the positioning of the catheter fitting 66 can be determined as the catheter fitting 66 is advanced and / or retracted relative to the housing 62 and into the catheter assembly 12.

[0062] According to one embodiment, the blood drawing device 60 includes one or more illumination elements 116 within the housing 62, the one or more illumination elements being configured to emit light from the housing. According to an embodiment of the present disclosure, the one or more illumination elements 116 may be configured as any of a plurality of suitable light sources; however, in an exemplary embodiment, the one or more illumination elements 116 may be provided as light emitting diodes (LEDs) (hereinafter referred to as "LED 116").

[0063] According to some embodiments, the one or more LEDs 116 may be secured to the housing 62 within the internal volume 76, such as to the inner surface of the housing at one or more locations of the housing. AsFigure 3 , Figure 6A and Figure 6B As shown in Figure 3 , Figure 6A , and Figure 6B , one or more LEDs 116 may be disposed at the proximal end 72 of the housing 62, at the distal end 74 of the housing 62, and / or at a location between the proximal and distal ends of the housing 62.

[0064] As Figure 7A and Figure 7B shown in Figure 7A and Figure 7B , according to one aspect of the present disclosure, when an LED 116 (or LEDs 116) is positioned at one end of the housing 62, such as the proximal end 72, an optical fiber 118 connected to the LED 116 may be provided (for each lighting element 116). The optical fiber 118 is composed of one or more glass fibers having a certain composition and thickness, and these glass fibers provide light transmission (from the lighting element 116) along the length of the optical fiber. In some embodiments, the optical fiber 118 may be configured such that light is emitted from the optical fiber along the entire length of the optical fiber. In other embodiments, multiple portions of the optical fiber 118 may be surrounded by a cladding layer (not shown), which is composed of one or more layers of material having a refractive index lower than that of the glass fibers of the optical fiber 118, wherein the cladding is disposed at positions spaced apart along the length of the optical fiber 118 such that light is emitted from the optical fiber 118 at the positions of the openings in the cladding.

[0065] As Figure 8A and Figure 8B shown in Figure 8A and Figure 8B , in some embodiments, multiple LEDs 116 may be provided as part of a light strip 120 fixed to the inner surface of the housing 62. The light strip 120 may include a substrate 122, and multiple LEDs 116 are positioned on the substrate. In some embodiments, the LEDs 116 may be equally spaced along the length of the substrate 122, wherein the light strip 120 extends longitudinally along the housing 62 at least partially between the proximal end 72 and the distal end 74 of the housing 62. In other embodiments, the LEDs 116 may be positioned on the substrate 122 such that the light strip 120 illuminates certain key advancement points or regions where the catheter fitting 66 is most likely to experience bending and flexing.

[0066] According to embodiments of the present disclosure, due to the small size of the blood drawing device 60 (and its housing 62), the LEDs 116 may be configured as micro-LEDs sized to fit within the housing 62. The micro-LEDs may have a size of, for example, 1.5 mm × 1.5 mm (0.06 inches × 0.06 inches) to allow the LEDs 116 to be incorporated into the existing architecture of the blood drawing device 60.

[0067] In accordance with aspects of the present disclosure, the LED 116 may be powered by an associated power system, which, in an exemplary embodiment, may be one or more batteries 124 configured to power one or more LEDs 116. The one or more batteries 124 may be configured as button cells or watch batteries, which, by way of non-limiting example, have a reduced size (e.g., a diameter of 6.8 mm (0.27 inches)) to also permit the battery to be located within the housing 62.

[0068] As Figure 9 and Figure 10 shown, in some embodiments, one or more LEDs 116 may be secured to the advancement member 68 (i.e., secured to the second portion 88 of the advancement member) such that when the advancement member is translated relative to the housing 62, the one or more LEDs 116 will move with the advancement member 68. The one or more LEDs 116 may be positioned on the distally facing surface of the second portion 88 of the advancement member 68, i.e., within the internal volume 76 of the housing 62. In some embodiments, the battery 124 may also be provided on or as part of the advancement member 68. The battery 124 may be received within a recess formed in the second portion 88 (such as formed in the laterally facing surface of the second portion 88 ( Figure 10 )) so as not to interfere with the movement of the advancement member 68 relative to the housing 62.

[0069] In accordance with some aspects of the present disclosure, as Figure 9 and Figure 10 shown, a power circuit 126 is provided in the instrument delivery device 60 that selectively provides power from a power source (e.g., the battery 124) to one or more LEDs 116 during operation of the instrument delivery device 60. The power circuit 126 may be configurable between an open state and a closed state, such as via one or more switches (not shown) included in the power circuit. Thus, the power circuit 126 may operate to provide / transfer power to the one or more LEDs 116 when in the closed state and to block the provision / transfer of power to the one or more LEDs 116 when in the open state.

[0070] In some embodiments, the operation / configuration of the power circuit 126 in the open state and the closed state and the switching of the power circuit 126 from the open state to the closed state can be controlled based on the positioning of the advancement member 68 relative to the housing 62. In one embodiment, when the advancement member 68 is in its home position at the proximal end 72 of the housing 62, the power circuit 126 can be configured in the open state, and in response to the advancement member 68 moving distally from the home position, i.e., advancing towards the distal end 74 of the housing 62, the power circuit 126 can be switched from the open state to the closed state such that one or more LEDs 116 receive power from the power circuit 126 and the one or more LEDs 116 are caused to emit light. Thus, in embodiments where one or more LEDs 116 are positioned on the advancement member 68, the one or more LEDs 116 can be powered in response to the advancement member 68 moving distally (to advance the catheter fitting 66), wherein when the advancement member 68 moves distally from its home position, the power circuit 126 is configured in the closed state to transmit power to the one or more LEDs 116. In other embodiments, when the catheter fitting 66 has been advanced sufficiently to consider starting blood draw, the one or more LEDs 116 can be powered. In such embodiments, the power circuit 126 can be switched from the open state to the closed state when a feature of the catheter fitting 66 is exposed to the patient's blood or when, based on some other signal in the catheter, the advancement is considered sufficient. In some embodiments, in addition to powering the one or more LEDs 116 through the power circuit 126, the power circuit 126 (or another associated control circuit) can control the illumination of the one or more LEDs 116, such as the color of light output from the one or more LEDs. For example, the color of the one or more LEDs can alternate, wherein for an initial advancement of the catheter fitting 66, the one or more LEDs 116 illuminate with red light and when the catheter fitting 66 has been advanced sufficiently to perform blood draw (or when the device is a probe, to obtain a reading from a sensor located thereon) illuminate with green light. In other embodiments, when the catheter fitting 66 has been advanced sufficiently to perform blood draw, the power circuit 126 can cause an indicator light to illuminate.

[0071] Now refer to Figure 11 and Figure 12, according to one aspect of the present disclosure, a light generating element is provided in the blood drawing device 60, and the light generating element is in the form of a luminescent material or coating 128 applied to one or more components in the blood drawing device 60. The luminescent material 128 is configured to emit light from the luminescent material in response to exposure to ambient light. According to non-limiting examples, the biocompatible luminescent material 128 can be any one of a variety of suitable long-persistent luminescent (LPL) materials, which include tetramethylbenzidine (TMB), bis(diphenylphosphoryl)dibenzo[b,d]thiophene (PPT), and / or a mixture of TMB / PPT. In some embodiments, the luminescent material 128 is applied to at least a portion of the catheter fitting 66, and in such embodiments, the luminescent material 128 is provided as a biocompatible luminescent material. According to an embodiment, the entire catheter fitting 66 can be coated with the biocompatible luminescent material 128, or only the desired section of the catheter fitting 66 can be coated with the biocompatible luminescent material 128, such as coating the proximal / proximal section of the catheter fitting 66 (visible in the housing during advancement / insertion) with the biocompatible luminescent material 128, while leaving the distal / distal section of the catheter fitting 66 that enters the patient's vasculature untreated. In other embodiments, the luminescent material 128 can be applied to the housing 62 at a desired location to provide illumination of the catheter fitting 66 during operation of the blood drawing device 60.

[0072] According to some aspects of the present disclosure, to facilitate visualization of the catheter fitting 66 during operation of the instrument delivery device 60, the housing 62 can be formed as a fluorescent plastic housing. The fluorescent plastic housing 62 can be illuminated by an illumination element 116 disposed in the internal volume 76 of the housing, and can further allow visualization of the catheter fitting 66 through the housing 62.

[0073] Accordingly, in accordance with embodiments described herein, the blood draw device 60 is configured to provide optically enabled viewing of the catheter fitting 66 when the catheter fitting 66 is advanced into and through the catheter assembly and into a patient's vein. The blood draw device 60 is provided with light generating elements that are configured to generate light / illumination sufficient to view the catheter fitting 66 during operation of the blood draw device 60 such that the positioning of the catheter fitting 66 can be determined as the catheter fitting 66 is advanced and / or retracted relative to the housing 62 and into the catheter assembly 12. In some embodiments, the catheter fitting 66 is illuminated to assist with visualization of the catheter fitting 66, while in other embodiments, the background (e.g., some portions of the housing 62) can be illuminated such that the catheter fitting 66 appears black / dark against the illuminated background to assist with visualization of the catheter fitting 66.

[0074] It should be recognized that aspects of the present disclosure are not limited to Figures 1 to 12 the specific blood draw device 60 shown and described, and blood draw devices having other suitable configurations can also incorporate aspects of the present disclosure. Now referring to Figure 13 , Figure 13 FIG. shows a catheter system 10 including a blood draw device 130 in accordance with another embodiment of the present disclosure. The blood draw device 130 includes: a housing 132 having a proximal end 134 and a distal end 136; and a push member 138 that is slidably received within the housing 132 (i.e., within the internal volume 140 of the housing 132). In the illustrated embodiment, the push member 138 is provided as one or more telescoping cylinders 138a that are provided in a telescoping relationship with the housing 132 such that the push member 138 can be slidably received fully or substantially fully within the internal volume 140 of the housing 132. The push member 138 also includes a proximal end 142 and a distal end 144, and in non-limiting embodiments, the push member 138 can have a variable diameter along the length of the push member. As an example, the diameter of the distal end 144 of the push member 138 can be greater than the diameter of other portions of the push member 138 such that when the push member 138 is retracted, one or more features on the housing 132 can interact with the enlarged portion of the push member 138 to prevent the push member 138 from being fully pulled out of the housing 132. As another example, the diameter of the distal end 144 of the push member 138 can be less than the diameter of other portions of the push member 138 to hold the push member 138 in a position under a blood draw forward condition, thereby freeing the operator's hand to manipulate additional components (e.g., a vacuum tube).

[0075] The blood drawing device 130 further includes a catheter fitting 146 having a proximal end 148 and a distal end 150. The catheter fitting 146 is received within the internal volume 140 of the housing 132 and can be advanced and / or retracted relative to the housing 132 by displacement of the advancement member 138 relative to the housing 132. In some embodiments, the catheter fitting 146 may be coupled to the advancement member 138 via a fitting 152 disposed at the distal end 144 of the advancement member 138 such that displacement of the advancement member 138 relative to the housing 132 causes a corresponding displacement of the catheter fitting 146. In a non-limiting embodiment, as previously described with respect to the blood drawing device 60 and its operation, the catheter fitting 146 can be advanced from a first position in which the distal end 150 of the catheter fitting 146 is located within the housing 132 to a second position in which the distal end 150 of the catheter fitting 146 is positioned distally of the housing 132 (and also distally of the catheter 16).

[0076] The blood drawing device further includes a coupling device 154 located on the blood drawing device, and the coupling device 154 can be the same as the coupling device 64 shown and described in the Figures 1 to 12 blood drawing device. That is, the coupling device 154 is configured as a lock 80 that includes a blunt cannula 82 and a locking arm 84 for coupling to the needleless access connector 46 of the catheter assembly 12, wherein the blunt cannula 82 and the locking arm 84 form three contact points with the needleless access connector. However, it can be understood that alternative embodiments of the blood drawing device 130 may include another type of coupling device 154 for securing the blood drawing device 130 to the catheter assembly 12, and the coupling device includes a Luer connector, a clamp, a blunt plastic cannula, a blunt metal cannula, a hybrid Luer (e.g., having a cannula), and a friction fitting, etc. In accordance with aspects of the present disclosure, the auxiliary catheter 102 can be routed through the telescoping barrel 138a of the advancement member 138, wherein the auxiliary catheter 102 provides a fluid connection between the catheter fitting 146 and a coupler 112 disposed at the proximal portion 104 of the auxiliary catheter 102, and the coupler 112 is configured to mate with a collection device (not shown).

[0077] As described in detail above, the blood drawing device 130 can incorporate one or more light generating elements in the blood drawing device, the one or more light generating elements being configured to generate light sufficient to observe the catheter fitting 146 / illuminate during operation of the blood drawing device 130 such that the positioning of the catheter fitting 146 can be determined as the catheter fitting 146 is advanced and / or retracted relative to the housing 132 and into the catheter assembly 12. According to some embodiments, the LEDs 116 can be disposed within the internal volume 140 of the housing 132 (e.g., disposed on the inner surface of the housing 132 and / or on the distally facing surface of the advancement member 138), the LEDs 116 emitting light from the housing to provide visualization of the catheter fitting 146. According to other embodiments, a biocompatible luminescent material or coating (not shown) can be applied to at least a portion of the catheter fitting 146, wherein the biocompatible luminescent material emits light from the luminescent material in response to the luminescent material being exposed to ambient light.

[0078] Although the present disclosure has been described in detail for purposes of illustration based on the currently considered most practical and preferred embodiments or aspects, it is to be understood that such detail is for that purpose only 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 is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. An instrument delivery device for use with an intravenous catheter assembly, characterized in that: The device delivery device comprises: a housing having a proximal portion and a distal portion, the housing defining 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 the intravenous catheter assembly; an advancement member configured to move relative to the housing to advance a distal end of the device beyond the distal portion of the housing and into the intravenous catheter assembly; and A light generating element is at least partially disposed within the housing and is configured to generate light capable of visualizing the instrument.

2. The device delivery device according to claim 1, wherein: The light generating element includes an illumination element positioned adjacent to the distal portion or the proximal portion of the housing.

3. The device delivery device according to claim 2, wherein: The instrument delivery device also includes an optical fiber extending from the illumination element and configured to transmit light along the length of the optical fiber.

4. The device delivery device according to claim 1, wherein: The light generating element comprises one or more light emitting diodes LED.

5. The device delivery apparatus according to claim 4, wherein: The one or more LEDs are secured to an inner surface of the housing.

6. The device delivery apparatus according to claim 4, wherein: The light generating element comprises a light strip including a plurality of LEDs arranged on a substrate, the light strip being fixed to an inner surface of the housing.

7. The device delivery apparatus according to claim 4, wherein: the advancement member comprising a first portion configured to move along an outer surface of the housing and a second portion connected to the first portion and positioned within the interior volume, the second portion engaging the instrument; and Wherein, the one or more LEDs are positioned on a distal end of the second portion of the advancement member such that when the advancement member moves relative to the housing, the one or more LEDs move together with the advancement member.

8. The device delivery apparatus according to claim 7, wherein: The instrument delivery device further includes a battery for powering the one or more LEDs, the battery being mounted on the second portion of the advancement member.

9. The device delivery apparatus according to claim 4, wherein: The one or more LEDs include micro-LEDs having dimensions of 1.5 mm x 1.5 mm or less.

10. The device delivery apparatus according to claim 4, wherein: The instrument delivery device further includes a power circuit having an open state and a closed state, the power circuit providing power to the light generating element when in the closed state; wherein, when the propulsion member is located at an initial position at the proximal end portion of the housing, the power circuit is in the disconnected state; and When the advancement member moves distally from the initial position, the power circuit switches from the open state to the closed state, so that the light generating element receives power from the power circuit and is caused to emit light.

11. The device delivery apparatus according to claim 10, wherein: The power circuit is configured to change a color of light output from the light generating element based on a positioning of the propulsion member.

12. The instrument delivery device of claim 1, wherein: The light generating element comprises a luminescent coating applied to at least a portion of the device, the luminescent coating generating light upon exposure to ambient light.

13. The instrument delivery device of claim 1, wherein: The housing is formed from fluorescent plastic.

14. A catheter system, characterized in that: The catheter system comprises: An intravenous catheter assembly, the intravenous catheter assembly comprising: a catheter comprising a distal end and a proximal end, the catheter defining a lumen extending between the distal end and the proximal end; and an access connector configured to provide access to the lumen of the catheter; and An instrument delivery device, the instrument delivery device being coupleable to the access connector, the instrument delivery device comprising: a housing having a proximal portion and a distal portion, the housing defining 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 the access connector of the intravenous catheter assembly; an advancement member configured to move relative to the housing to advance a distal end of the device beyond the distal portion of the housing and into the intravenous catheter assembly; and A light generating element is at least partially disposed within the housing and is configured to generate light capable of visualizing the instrument.

15. The catheter system of claim 14, wherein: The light generating element comprises: a lighting element positioned adjacent the proximal portion of the housing; and An optical fiber extends from the lighting element and is configured to transmit light along the length of the optical fiber.

16. The catheter system of claim 14, wherein: The light generating element comprises one or more light emitting diodes LED, wherein the one or more LEDs are fixed to an inner surface of the housing or to a portion of the propulsion member positioned within the inner volume of the housing.

17. The catheter system of claim 16, wherein: The one or more LEDs include micro-LEDs having a size of 1.5 mm x 1.5 mm or less, and wherein the instrument advancement device further includes a battery for powering the micro-LEDs.

18. The catheter system of claim 15, wherein: The catheter system further includes a power circuit having an open state and a closed state, the power circuit providing power to the light generating element when in the closed state; wherein, when the propulsion member is located at an initial position at the proximal end portion of the housing, the power circuit is in the disconnected state; and When the advancement member moves distally from the initial position, the power circuit switches from the open state to the closed state, so that the light generating element receives power from the power circuit and is caused to emit light.

19. The catheter system of claim 14, wherein: The light generating element comprises a luminescent coating applied to at least a portion of the device, the luminescent coating generating light upon exposure to ambient light.

20. The catheter system of claim 14, wherein: The housing is formed from fluorescent plastic.

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