Instrument advancement device with light-based 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 and defining an internal volume; an instrument movably received within the internal volume; a coupling device positioned in the distal portion of the housing and configured to connect the housing to the access connector of the intravenous catheter assembly; 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; and a photogenerating element positioned at least partially within the housing and configured to generate light that enables visualization of the instrument.

Description

Technical Field

[0001] Provided herein is an instrument advancement device for use in vascular access, particularly an instrument advancement device incorporating components for visualizing an instrument by light.

Background Art

[0002] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 468,097, filed May 22, 2023, entitled "Instrument Advancement Device with Light - Enabled Instrument Viewing", the disclosure of which is hereby incorporated by reference in its entirety.

[0003] Catheters are frequently used to administer liquids that enter and exit the body. Patients in various situations, including hospitals and home care, receive liquids, pharmaceuticals, and blood products via 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 a 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 and / or fluid administration. 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 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 can be used in many different environments and under various conditions. For example, blood sampling may be required at night or in environments with insufficient light, thereby resulting in reduced / poor visibility for the clinician operating the introducer. 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. Furthermore, if, during insertion, the tip of the instrument encounters an obstruction that requires repair or repositioning to advance normally, this need for repair / repositioning may not be apparent without visualization.

[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 (or other portion) of a catheter or other instrument as it advances due to the action of the introducer. [Overview of the Initiative]

[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 and defining an internal volume; an instrument movably received within the internal volume; a coupling device positioned in the distal portion of the housing and configured to connect the housing to the access connector of the intravenous catheter assembly; 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; and a photogenerating element positioned at least partially within the housing and configured to generate light that enables visualization of the instrument.

[0009] In some embodiments, the light-generating element comprises an illumination element positioned adjacent to the distal or proximal end portion of the housing.

[0010] In some embodiments, the fixture delivery device includes an optical fiber extending from a lighting element and configured to transmit light along the length of the optical fiber.

[0011] In some embodiments, the photogenerating element comprises one or more light-emitting diodes (LEDs).

[0012] In some embodiments, one or more LEDs are fixed to the inner surface of the housing.

[0013] In some embodiments, the photogenerating element includes a light strip of multiple LEDs arranged on a substrate, the light strip being fixed to the inner surface of the housing.

[0014] In some embodiments, the forward member includes a first portion configured to move along the outer surface of the housing and a second portion connected to the first portion and positioned within the internal volume, the second portion engaging with the fixture, and one or more LEDs positioned at the distal end of the second portion of the forward member so that one or more LEDs move with the forward member when the forward member is moved relative to the housing.

[0015] In some embodiments, the device delivery device includes a battery housed in a second portion of the forward member to supply power to the LED.

[0016] In some embodiments, one or more LEDs consist of microLEDs having dimensions of 1.5 mm × 1.5 mm or less.

[0017] In some embodiments, the housing is formed from fluorescent plastic.

[0018] In some embodiments, the instrument delivery device includes a power supply circuit having an open state and a closed state, the power supply circuit supplying power to a photogenerating element when in the closed state, the power supply circuit being in the open state at the proximal end portion of the housing when the forward member is in the home position, the power supply circuit transitioning from the open state to the closed state when the forward member is moved distally from the home position, the photogenerating element receiving power from the power supply circuit and emitting light.

[0019] In some embodiments, the power supply circuit is configured to change the color of the light output from the photogenerating element based on the positioning of the forward member.

[0020] In some embodiments, the photogenerating element includes a light-emitting coating applied to at least a portion of the fixture, the light-emitting coating generating light after being exposed to ambient light.

[0021] Furthermore, this specification provides a catheter system including an intravenous catheter assembly including a catheter having 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 also includes an instrument delivery device that can be coupled to the access connector, the instrument delivery device comprising: a housing having a proximal end portion and a distal end portion and defining an internal volume; an instrument movably received within the internal volume; a coupling device positioned in the distal end portion of the housing and configured to couple the housing to the access connector of the intravenous catheter assembly; an advancing member configured to move relative to the housing to advance the distal end of the instrument into the intravenous catheter assembly beyond the distal end portion of the housing; and a photogenerating element positioned at least partially within the housing and configured to generate light that enables visualization of the instrument.

[0022] In some embodiments, the light generating element comprises an illumination element disposed adjacent to the proximal end 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.

[0023] In some embodiments, the light generating element includes one or more light emitting diodes (LEDs), and the one or more LEDs are fixed to a part of an advancing member disposed within the inner surface of the housing or the internal volume of the housing.

[0024] In some embodiments, the one or more LEDs consist of micro-LEDs having dimensions of 1.5 mm × 1.5 mm or less, and the instrument advancing device further comprises a battery for supplying power to the micro-LEDs.

[0025] In some embodiments, the instrument delivery device includes a power circuit having an open state and a closed state. The power circuit supplies power to the light generating element when in the closed state. The power circuit is in an open state at the proximal end portion of the housing when the advancing member is in the home position. The power circuit transitions from the open state to the closed state when the advancing member is moved distally from the home position, and the light generating element receives power from the power circuit and emits light.

[0026] In some embodiments, the light generating element consists of a light emitting coating applied to at least a part of the instrument, and the light emitting coating generates light after being exposed to ambient light.

[0027] In some embodiments, the housing is formed of fluorescent plastic.

Brief Description of the Drawings

[0028] [Figure 1] FIG. 1 is a perspective view of a catheter system according to an aspect of the present disclosure. [Figure 2] FIG. 2 is a perspective view of a blood sampling device usable in the catheter system of FIG. 1 according to an aspect of the present disclosure. [Figure 3]Figure 3 is an exploded view of the blood collection device shown in Figure 2, according to an aspect of this 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 a blood collection device housing, including an illumination element provided thereon, according to an aspect of this disclosure. [Figure 6B] Figure 6B is a perspective view of a portion of a blood collection device housing, including an illumination element provided thereon, according to an aspect of this disclosure. [Figure 7A] Figure 7A is a perspective view of a portion of a blood collection device housing, including an illumination element provided thereon, according to an aspect of this disclosure. [Figure 7B] Figure 7B is a perspective view of a portion of a blood collection device housing, including an illumination element provided thereon, according to an aspect of this disclosure. [Figure 8A] Figure 8A is a perspective view of a portion of a blood collection device housing, including an illumination element provided thereon, according to an aspect of this disclosure. [Figure 8B] Figure 8B is a perspective view of a portion of a blood collection device housing, including an illumination element provided thereon, according to an aspect of this disclosure. [Figure 9] Figure 9 is an exploded view of a blood collection device according to an aspect of this disclosure. [Figure 10] Figure 10 is a perspective view of the forward member of the blood collection device shown in Figure 9. [Figure 11] Figure 11 is an exploded view of a blood collection device according to an aspect of this disclosure. [Figure 12] Figure 12 is a cross-sectional view of the catheter tube of the blood collection device of Figure 11, taken along line 12-12, with a luminescent coating on the catheter tube. [Figure 13] Figure 13 is a perspective view of a catheter system according to another aspect of this disclosure. [Modes for carrying out the invention]

[0029] 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.

[0030] 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.

[0031] As used herein, the terms “proximal” and “distal” refer to the directions closer to and farther from the user who will be bringing the device into contact with the patient, respectively. Therefore, 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.

[0032] 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.

[0033] Referring here to Figure 1, a non-limiting embodiment of a catheter system 10 for facilitating the delivery of an instrument to an indwelling catheter, which may be desirable for blood sampling (or other sensing purposes) 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 which may be 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 extending through the distal end 18 and the proximal end 20, 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.

[0034] 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.

[0035] 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-closed access port near the insertion site of the catheter 16, but it is recognized that access ports can be provided at other alternative locations sufficiently close to the insertion site to allow a blood collection catheter tube or other probe to be advanced into the indwelling catheter 16 and beyond its distal end. For example, an access port for inserting a blood collection catheter tube into the indwelling arterial catheter 16 may be located on another connector, such as the proximal connector on an extension set (described later) of the catheter assembly 12.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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). Therefore, 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. Therefore, 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.

[0040] 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, defining an internal volume 76. In some embodiments, the housing 62 may be formed from a pair of housing portions 78a, 78b 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 (e.g., fluorescent plastic) 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 the clinician, as will be described in more detail below.

[0041] 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, can be used, as long as the distal end 70 of the catheter tube 66 passes through the coupling device 64 and reaches the catheter assembly 12.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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 portion 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.

[0046] According to aspects of the present disclosure, with reference to Figures 6-12, the blood collection device 60 is configured to incorporate within it a component or element, i.e., a “photo-generating element,” which provides optical visualization of the catheter tube 66 during the operation of the device 60. That is, the photo-generating element is configured to generate enough light / illumination to see the catheter tube 66 during the operation of the blood collection device 60, and the position of the catheter tube 66 can be determined as the catheter tube 66 moves forward and / or backward relative to the housing 62 into the catheter assembly 12.

[0047] According to one embodiment, the blood collection device 60 includes one or more illumination elements 116 located within a housing 62 configured to emit light from there. According to embodiments of the present disclosure, the illumination element 116 may be configured as any of several suitable light sources, but in exemplary embodiments, the illumination element 116 may be provided as a light-emitting diode (LED) (hereinafter, "LED116").

[0048] According to some embodiments, the LED 116 may be fixed to the housing 62 within the internal volume 76, such as being fixed to the inner surface of the housing 62 at one or more of its positions. As shown by dashed lines in Figures 3, 6A, and 6B, one or more LEDs 116 may be located at the proximal end 72 of the housing 62, the distal end 74 of the housing 62, and / or at positions in the housing 62 between the proximal and distal ends.

[0049] As shown in Figures 7A and 7B, according to one aspect of the present disclosure, when an LED 116 (or LED 116) is positioned at one end of a housing 62, such as a proximal end 72, an optical fiber 118 may be provided to connect to the LED 116 (for each illuminating element 116). The optical fiber 118 is composed of one or more glass fibers of a composition and thickness that provides light transmission (from the illuminating elements 116) along its length. In some embodiments, the optical fiber 118 may be configured such that light is emitted from the optical fiber 118 along its entire length. In other embodiments, a portion of the optical fiber 118 may be surrounded by a cladding layer (not shown) consisting of one or more layers of a material having a lower refractive index than the glass fibers of the optical fiber 118, the cladding being spaced along the length of the optical fiber 118, and as a result, light is emitted from the optical fiber 118 at the locations of the cladding apertures.

[0050] As shown in Figures 8A and 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 on which the multiple LEDs 116 are arranged. In some embodiments, the LEDs 116 may be arranged at equal intervals along the length of the substrate 122, and the light strip 120 extends at least partially longitudinally along the housing 62 between its proximal end 72 and distal end 74. In other embodiments, the LEDs 116 may be arranged on the substrate 122 such that the light strip 120 illuminates certain important forward points or regions where the catheter tube 66 is most likely to bend and curve.

[0051] According to embodiments of the present disclosure, the LED 116 may be configured as a micro-LED sized to fit within the housing 62, given the small size of the blood collection device 60 (and its housing 62). The micro-LED may have dimensions of, for example, 1.5 mm × 1.5 mm (0.06 inches × 0.06 inches) to enable the LED 116 to be incorporated into the existing architecture of the blood collection device 60.

[0052] According to aspects of the present disclosure, the LED 116 may be powered by an accompanying power system, which may be provided as one or more batteries 124 that power the LED 116 in exemplary embodiments. The batteries 124 may, in non-limiting examples, be configured as coin cells or watch batteries having a reduced size (e.g., 6.8 mm (0.27 inches) in diameter) so that they can be positioned again within the housing 62.

[0053] As shown in Figures 9 and 10, in some embodiments, one or more LEDs 116 may be fixed to the forward member 68 (i.e., its second portion 88), so that the LEDs 116 move with the forward member 68 as the forward member is translated relative to the housing 62. The LEDs 116 may be located within the internal volume 76 of the housing 62, on the distal surface of the second portion 88 of the forward member 68. In some embodiments, a battery 124 may also be provided on or as part of the forward member 68. The battery 124 may be housed in a recess formed in the second portion 88, such as on the side of the second portion 88 (Figure 10), so as not to obstruct the movement of the forward member 68 relative to the housing 62.

[0054] According to some aspects of this disclosure, and as shown in Figures 9 and 10, a power supply circuit 126 is provided to an appliance delivery device 60 that selectively supplies power to the LEDs 116 from a power source (e.g., a battery 124) while the device 60 is operating. The power supply circuit 126 may be configurable between an open state and a closed state, such as via one or more switches (not shown) contained therein. Thus, the power supply circuit 126 may operate to supply / transfer power to the LED(s) 116 when it is in the closed state and to prevent power from being supplied / transferred to the LED(s) 116 when it is in the open state.

[0055] In some embodiments, the operation / configuration of the power supply circuit 126 in the open and closed states, and the switching of the power supply circuit 126 from the open to the closed state, can be controlled based on the positioning of the forward member 68 relative to the housing 62. In one embodiment, the power supply circuit 126 may be configured in the open state when the forward member 68 is in the home position at the proximal end portion 72 of the housing 62, and the power supply circuit 126 may transition from the open to the closed state in response to the forward member 68 moving distally from the home position, i.e., moving forward toward the distal end portion 74 of the housing 62, as a result the LED 116 receives power from the power supply circuit 126 and emits light. Thus, in embodiments where the LED 116 is located on the forward member 68, the LED 116 may be powered on in response to the distal movement of the forward member 68 (to advance the catheter tube 66), and the power supply circuit 126 is configured to be closed when the forward member 68 is moved distally from its home position, thereby transmitting power to the LED 116. In other embodiments, the LED 116 may be powered on when the advance of the catheter tube 66 is sufficient to consider that blood collection has begun. In such embodiments, the power circuit 126 may transition from an open to a closed state when the advance is deemed appropriate, when a feature of the catheter tube 66 is exposed to the patient's blood, or from some other signal within the catheter. In some embodiments, in addition to powering on the LED 116 by the power circuit 126, the power circuit 126 (or another associated control circuit) may control the illumination of the LED 116, such as colored light emitted from it. For example, the LED may alternate in color, with the LED 116 lighting up red for the initial advance of the catheter tube 66 and then lighting up green when the catheter tube 66 has advanced sufficiently to perform blood collection (or, if the instrument is a probe, when a reading is taken from a sensor on it). In yet another embodiment, the power circuit 126 may illuminate an indicator light when the catheter tube 66 has advanced sufficiently to perform blood collection.

[0056] Referring here to Figures 11 and 12, according to aspects of the present disclosure, the photogenerating element is provided within the blood collection device 60 in the form of a light-emitting material or coating 128 applied to one or more components within the blood collection device 60. The light-emitting material 128 is configured to emit light from there in response to exposure to ambient light. According to non-limiting examples, the biocompatible light-emitting material 128 may be any of several suitable long-lasting light-emitting (LPL) materials, including tetramethylbenzidine (TMB), bis(diphenylphosphoryl)dibenzo[b,d]thiophene (PPT), and / or mixtures of TMB / PPT. In some embodiments, the light-emitting material 128 is applied to at least a portion of the catheter tube 66, and in such embodiments, the light-emitting material 128 is provided as a biocompatible light-emitting material. In one embodiment, the entire catheter tube 66 may be coated with the biocompatible luminescent material 128, or only a desired section of the catheter tube 66 may be coated with the biocompatible luminescent material 128. For example, the distal end / section of the catheter tube 66 that enters the patient's vascular system may not be treated, while the proximal end / section of the catheter tube 66 (visible within the housing during advancement / insertion) is coated with the biocompatible luminescent material 128. In another embodiment, the luminescent material 128 may be applied to the housing 62 at a desired position to provide illumination of the catheter tube 66 during operation of the blood collection device 60.

[0057] According to some aspects of this disclosure, the housing 62 may be formed as a fluorescent plastic housing to assist in the visualization of the catheter tube 66 during the operation of the instrument delivery device 60. The fluorescent plastic housing 62 may be illuminated by an illumination element 116 provided in the internal volume 76 of the housing, which may further enable visualization of the catheter tube 66 passing through the housing 62.

[0058] Accordingly, according to embodiments described herein, the blood collection device 60 is configured to provide optical visualization of the catheter tube 66 as the catheter tube 66 advances into the catheter assembly and enters the patient's vein through the catheter assembly. A photogenerating element is configured to generate sufficient light / illumination to see the catheter tube 66 during the operation of the blood collection device 60, and the positioning of the catheter tube 66 can be determined as the catheter tube 66 advances and / or retracts relative to the housing 62 into the catheter assembly 12. In some embodiments, the catheter tube 66 is illuminated to aid in the visualization of the catheter tube 66, while in other embodiments, the background (e.g., part of the housing 62) may be illuminated such that the catheter tube 66 appears black / dark against the illuminated background to aid in the visualization of the catheter tube 66.

[0059] It is recognized that the embodiments of this disclosure are not limited to the specific blood collection device 60 shown and described in Figures 1-12, and that other blood collection devices having a suitable structure may also incorporate embodiments of this disclosure. Referring now to Figure 13, a catheter system 10 is shown that includes a blood collection device 130 according to another embodiment of this disclosure. The blood collection device 130 includes a housing 132 having a proximal end 134 and a distal end 136, and a forward member 138 slidably housed within the housing 132 (i.e., within the internal volume 140 of the housing 132). In the illustrated embodiment, the forward member 138 is provided as one or more telescopic cylinders 138a in an extension-relation relationship with the housing 132, so that the forward member 138 can be slidably housed entirely or almost entirely within the internal volume 140 of the housing 132. The forward member 138 also includes a proximal end 142 and a distal end 144, and in a non-limiting embodiment, the forward member 138 may have a variable diameter along its length. As an example, the distal end 144 of the forward member 138 may be configured to have a larger diameter than the rest of the forward member 138, so that when the forward member 138 is retracted, one or more features on the housing 132 interact with the enlarged portion of the forward member 138, preventing the forward member 138 from being completely withdrawn from the housing 132. As another example, the distal end 144 of the forward member 138 may be set to have a smaller diameter than the rest of the forward member 138. This holds the forward member 138 in place when it is in the advanced position for blood collection, freeing up one hand of the operator to manipulate additional components (e.g., a vacuuminer tube).

[0060] The blood collection device 130 further comprises a catheter tube 146 having a proximal end 148 and a distal end 150. The catheter tube 146 is housed within the internal volume 140 of the housing 132 and can be advanced and / or retracted relative to the housing 132 by the displacement of the advance member 138 relative to the housing 132. In some embodiments, the catheter tube 146 may be connected to the advance member 138 via a joint 152 provided at the distal end 144 of the advance member 138, so that the catheter tube 146 displaces in response to the displacement of the advance member 138 relative to the housing 132. In some non-limiting embodiments, the catheter tube 146 can be advanced from a first position where the distal end 150 of the catheter tube 146 is located within the housing 132 to a second position where the distal end 150 of the catheter tube 146 is located distal to the housing 132 (and distal to the catheter 16), as described above with respect to the blood collection device 60 and its operation.

[0061] The blood collection device also includes a coupling device 154 on it, which may be identical to the coupling device shown and described in the blood collection devices of Figures 1-12. That is, the coupling device 154 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 130 may include another type of coupling device 154 for securing the blood collection device 130 to the catheter assembly 12, including Luer connections, 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 138a of the forward member 138, and the secondary catheter 102 provides a fluid connection between a catheter tube 146 provided at the proximal end portion 104 of the secondary catheter 102 and a coupler 112, the coupler 112 is configured to engage with a collection device (not shown).

[0062] As described in detail above, the blood collection device 130 may incorporate one or more photogenerating elements configured to generate enough light / illumination to view the catheter tube 146 during operation of the blood collection device 130, so that the position of the catheter tube 146 can be determined as the catheter tube 146 advances and / or retracts relative to the housing 132 and enters the catheter assembly 12. According to some embodiments, the LED 116 may be located within the internal volume 140 of the housing 132 (e.g., on the inner surface of the housing 132 and / or on the distally facing surface of the advancing member 138) to provide visualization of the catheter tube 146. According to other embodiments, a biocompatible luminescent material or coating (not shown) may be applied to at least a portion of the catheter tube 146, the biocompatible luminescent material emitting light from there in response to its exposure to ambient light.

[0063] This disclosure has been described in detail for illustrative purposes based on what is currently considered to be the most practical and preferred embodiments or aspects, but such details are for that purpose only, and this disclosure is not limited to the disclosed embodiments or aspects, but rather intended to encompass modifications and equivalent arrangements that fall within the spirit and scope of the appended claims. For example, this disclosure is intended to be, wherever possible, to allow one or more features of any embodiment to be combined with one or more features of any other embodiment.

Claims

1. An instrument delivery device for use with an intravenous catheter assembly, wherein the instrument delivery device is A housing having a proximal end portion and a distal end portion, wherein the housing defines 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, A light-generating element, at least partially disposed within the housing and configured to generate light that enables visualization of the device, A device for delivering instruments, equipped with the following features.

2. The device delivery device according to claim 1, wherein the light-generating element comprises an illumination element disposed adjacent to the distal end portion or the proximal end portion of the housing.

3. The instrument delivery device according to claim 2, further comprising an optical fiber extending from the light source 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 (LEDs).

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

6. The instrument delivery device according to claim 4, wherein the light-generating element comprises a light strip including a plurality of LEDs arranged on a substrate, and the light strip is fixed to the inner surface of the housing.

7. The forward member comprises a first portion configured to move along the outer surface of the housing, and a second portion connected to the first portion and located within the internal volume, the second portion engaging with the device. Equipped with, The instrument delivery device according to claim 4, wherein the one or more LEDs are positioned at the distal end of the second portion of the forward member such that when the forward member is moved relative to the housing, the one or more LEDs move together with the forward member.

8. The instrument delivery device according to claim 7, further comprising a battery housed in the second portion of the forward member for supplying power to the LED.

9. The device delivery device according to claim 4, wherein one or more of the LEDs consist of microLEDs having dimensions of 1.5 mm x 1.5 mm or less.

10. The power supply circuit further comprises an open state and a closed state, wherein the power supply circuit supplies power to the photogenerating element when in the closed state. When the forward member is in the home position, the power supply circuit is in the open state at the proximal end portion of the housing. The device delivery device according to claim 4, wherein when the forward member is moved distal to the home position, the power supply circuit transitions from the open state to the closed state so that the light-generating element receives power from the power supply circuit and emits light.

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

12. The device delivery device according to claim 1, wherein the light-generating element comprises a light-emitting coating applied to at least a portion of the device, and the light-emitting coating generates light after being exposed to ambient light.

13. The instrument delivery device according to claim 1, wherein the housing is formed from fluorescent plastic.

14. It is a catheter system, Intravenous catheter assembly, A catheter having a distal end and a proximal end, comprising a catheter defining a lumen extending between the distal end and the proximal end, An intravenous catheter assembly comprising an access connector configured to provide access to the lumen of the catheter, A device delivery device that can be coupled to the access connector, wherein the device delivery device is A housing having a proximal end portion and a distal end portion, defining the 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, A catheter system comprising: an instrument delivery device, which includes a photogenerating element at least partially disposed within the housing and configured to generate light that enables visualization of the instrument;

15. The aforementioned photogenerating element is A lighting element positioned adjacent to the proximal end portion of the housing, The catheter system according to claim 14, comprising an optical fiber extending from the illumination element and configured to transmit light along the length of the optical fiber.

16. The catheter system according to claim 14, wherein the light-generating element comprises one or more light-emitting diodes (LEDs), and the one or more LEDs are fixed to a part of the forward member disposed on the inner surface of the housing or within the internal volume of the housing.

17. The catheter system according to claim 16, wherein one or more LEDs consist of micro-LEDs having dimensions of 1.5 mm x 1.5 mm or less, and the instrument advancement device further comprises a battery for supplying power to the micro-LEDs.

18. The power supply circuit further comprises an open state and a closed state, wherein the power supply circuit supplies power to the photogenerating element when in the closed state. When the forward member is in the home position, the power supply circuit is in the open state at the proximal end portion of the housing. The catheter system according to claim 15, wherein when the forward member is moved distally from the home position, the power supply circuit transitions from the open state to the closed state so that the light-generating element receives power from the power supply circuit and emits light.

19. The catheter system according to claim 14, wherein the light-generating element comprises a light-emitting coating applied to at least a portion of the instrument, and the light-emitting coating generates light after being exposed to ambient light.

20. The catheter system according to claim 14, wherein the housing is formed from fluorescent plastic.

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