Patent Application
20240390645
Provided herein are instrument advancement devices for use in vascular access, and, in particular, instrument advancement devices incorporating components for light-enabled instrument viewing.
Catheters are frequently utilized to administer fluids into and out of the body. Patients in a variety of settings, including in hospitals and in home care, receive fluids, pharmaceuticals, and blood products via a vascular access device (VAD) that includes such a catheter inserted into a patient's vascular system. A common VAD includes a plastic catheter that is inserted into a patient's vein, with a length of the catheter varying 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), as examples.
As known in the art, instrument advancement devices are often used in connection with an in-dwelling PIVC to facilitate blood draw and/or administering of fluids. When such instrument advancement devices are used to facilitate blood draw, the devices (i.e., “blood draw devices) have focused on the ability to reliably collect a high-quality blood sample and reduce hemolysis. The main method by which 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, with the introducer being attached to a catheter adapter of the PIVC that provide for insertion of the catheter. For example, the catheter adapter may include a needleless access connector thereon by which the catheter may be introduced to provide access to the PIVC and into the patient's vasculature. If performing a blood draw, a syringe or vacutainer may then be used to collect blood samples without needing to subject the patient to additional needle sticks.
The introducer of an instrument advancement device typically includes a housing, an instrument (i.e., a catheter or other probe, tube, or instrument) movable within the housing so as to be extendable out therefrom for advancement into the in-dwelling PIVC, and an advancement member that may 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, such that the instrument may be advanced out from the housing and into the in-dwelling PIVC.
It is recognized that instrument advancement devices may be employed in many different environments and in varying conditions. For example, blood draws may be required at night or in surroundings where there is a lack of light, thereby resulting in reduced/poor visibility for a clinician operating the introducer. Under such conditions, it may be difficult for the clinician to visualize the catheter (or other instrument) as it is advanced through the housing, such that 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 in-dwelling PIVC. Additionally, if during insertion, the tip of the instrument hits an obstruction that requires remediation or positional adjustments to successfully advance, this need for remediation/adjustments may not be obvious without visualization.
Accordingly, a need exists in the art for an instrument advancement device and introducer thereof that provides for improved visibility during operation of the device, including being able to visualize the distal end (or other portions) of a catheter or other instrument as it is advanced by operation of the introducer.
Provided herein is an instrument delivery device for use with an intravenous catheter assembly. The instrument delivery device includes a housing having a proximal end portion and a distal end portion and defining an inner volume, an instrument movably received within the inner 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 a distal end of the instrument beyond the distal end portion of the housing and into the intravenous catheter assembly, and a light generating element disposed at least partially within the housing and configured to generate light that enables visualization of the instrument.
In some embodiments, the light generating element comprises a lighting element positioned adjacent the distal end portion or the proximal end portion of the housing.
In some embodiments, the instrument delivery device includes an optical fiber extending out from the lighting element and configured to transmit light along a length of the optical fiber.
In some embodiments, the light generating element comprises one or more light emitting diodes (LEDs).
In some embodiments, the one or more LEDS are affixed to an inner surface of the housing.
In some embodiments, the light generating element comprises a light strip a plurality of LEDs arranged on a substrate, the light strip affixed to the inner surface of the housing.
In some embodiments, the advancement member comprises 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 inner volume, the second portion engaging the instrument, wherein the one or more LEDS are positioned on a distal end of the second portion of the advancement member, such that the one or more LEDS move with the advancement member when the advancement member is moved relative to the housing.
In some embodiments, the instrument delivery device includes a battery housed on the second portion of the advancement member to power the LED.
In some embodiments, the one or more LEDS comprise micro-LEDs having dimensions of 1.5 mm×1.5 mm or less.
In some embodiments, the housing is formed of a fluorescent plastic.
In some embodiments, the instrument delivery device 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 the power circuit is in the open state when the advancement member is in a home position, at the proximal end portion of the housing, and wherein the power circuit is transitioned from the open state to the closed state when the advancement member is moved distally from the home position, such that the light generating element receives power from the power circuit and is caused to emit light.
In some embodiments, the power circuit is configured to change a light color output from the light generating element based on a positioning of the advancement member.
In some embodiments, the light generating element comprises a luminescent coating applied on at least a portion of the instrument, the luminescent coating generating light after exposure to ambient light.
Also provided herein is a catheter system including an 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. The catheter system also includes an instrument delivery device coupleable to the access connector, the instrument delivery device comprising a housing having a proximal end portion and a distal end portion and defining an inner volume, an instrument movably received within the inner 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 a distal end of the instrument beyond the distal end portion of the housing and into the intravenous catheter assembly, and a light generating element disposed at least partially within the housing and configured to generate light that enables visualization of the instrument.
In some embodiments, the light generating element comprises a lighting element positioned adjacent the proximal end portion of the housing and an optical fiber extending out from the lighting element and configured to transmit light along a length of the optical fiber.
In some embodiments, the light generating element comprises one or more light emitting diodes (LEDs), with the one or more LEDS affixed to an inner surface of the housing or to a portion of the advancement member positioned within the inner volume of the housing.
In some embodiments, the one or more LEDS comprise micro-LEDs having dimensions of 1.5 mm×1.5 mm or less, and wherein the instrument advancement device further comprises a battery to power the micro-LEDs.
In some embodiments, the instrument delivery device 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 the power circuit is in the open state when the advancement member is in a home position, at the proximal end portion of the housing, and wherein the power circuit is transitioned from the open state to the closed state when the advancement member is moved distally from the home position, such that the light generating element receives power from the power circuit and is caused to emit light.
In some embodiments, the light generating element comprises a luminescent coating applied on at least a portion of the instrument, the luminescent coating generating light after exposure to ambient light.
In some embodiments, the housing is formed of a fluorescent plastic.
The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent 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 invention.
For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
As used in this specification, the words “proximal” and “distal” refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device being manipulated by the user would be the proximal end of the device.
Provided herein are devices and systems for introducing instruments through indwelling catheters, such as peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. While certain catheter assemblies are shown in the accompanying figures and described below, those of skill will appreciate that a disinfecting probe as described herein may be useful in any number of different catheter assembly configurations.
Referring now to
In some non-limiting embodiments or aspects, the catheter assembly 12 may include a first fluid conduit 30 extending from the port 22. First fluid conduit 30 may be formed of any suitable material known to those of skill in the art and may have a distal end 32 and a proximal end 34. The distal end 32 of first fluid conduit 30 is coupled to port 22, while the proximal end 34 of first fluid conduit 30 may be coupled to a connector 36. Connector 36 may be a t-connector (e.g., one side port arranged at a 90 degree angle relative to a longitudinal axis of connector 36), a y-connector (e.g., one side port arranged at a 25, a 60, or a 75 degree angle relative to a longitudinal axis of connector 36), or any other type of connector known in the art. The connector 36 may include a second lumen 38 therethrough, having any number of branches suitable for the type of connector, such as a branch extending between distal and proximal ends of connector 36 and a branch provided to a port 44 of the connector 36.
In some non-limiting embodiments or aspects, catheter assembly 12 may include a needleless access connector 46 coupled to the proximal end 42 of connector 36, with the needleless access connector 46 providing an access port to the catheter assembly 12. The needleless access connector 46 may be configured as a split-septum connector or self-healing septum connector, as examples. In the illustrated embodiment, the access port provided by needleless access connector 46 is a near-patient access port close to the insertion site of the catheter 16, but it is recognized that an access port could be provided at other alternative locations close enough to the insertion site that allow for advancement of a blood draw catheter tube or other probe into the indwelling catheter 16 and out beyond the distal tip thereof. For example, an access port that provides for advancement of a blood draw catheter tube into the indwelling arterial catheter 16 could be located on another connector, such as a proximal connector on an extension set (as described below) of the catheter assembly 12.
In some non-limiting embodiments or aspects, catheter assembly 12 may also include an extension set 48 coupled to the port 44 of the connector 36. The extension set 48 may include a second fluid conduit 50 coupled to port 44 at end 52 of the conduit 50 and a luer connection 54 at opposing end 56, with a clamp 57 provided on second fluid conduit 50 that allows for occlusion thereof.
Catheter system 10 further includes an instrument delivery device 60 that may be operated to introduce an instrument into the catheter assembly 12 and into the vasculature of the patient. In some embodiments, and as referred to hereafter, the instrument delivery device 60 may comprise a blood draw device (“blood draw device 60”) that introduces a catheter tube through the catheter assembly 12 and into the patient vasculature to obtain a blood sample from the patient. However, it is recognized that the instrument delivery device 60 could instead introduce a guidewire, probe, or other sensor into the patient vasculature, according to aspects of the disclosure, and thus it is to be understood that the below description of a blood draw device should not limit the scope of the disclosure.
As shown in
According to embodiments, the catheter tube 66 is sized to enable introduction thereof into the fluid path (i.e., into a lumen of catheter 16, lumen 24 of catheter adapter 14, and first fluid conduit 30) of catheter assembly 12 and for advancement therethrough. Accordingly, the catheter tube 66 can have an outer diameter (e.g., between a 10-gauge and a 30-gauge) that is smaller than the smallest lumen of the catheter assembly fluid path. The catheter tube 66 can have a length that is sufficient to place a distal end 70 of the catheter tube 66 in a desired position within the fluid path of the catheter system 10. Thus, in one embodiment, the catheter tube 66 may have a length sufficient to provide for advancement of the distal end 70 thereof out from the housing 62 and through the catheter assembly (i.e., through connector 36, fluid conduit 30, catheter adapter 14 and catheter 16), and all the way out past the distal tip 26 of catheter 16.
As shown in
The coupling device 64 of blood draw device 60 is provided at the distal end 74 of the housing 62, with the coupling device 64 providing for reversible coupling of the blood draw device 60 to catheter assembly 12, such as via needleless access connector 46 as shown in
The advancement member 68 of blood draw device 60 includes a first portion 86 and a second portion 88. The first portion 86 is movably disposed along an upper surface 90 of the housing 62 and the second portion 88 is movably disposed within the inner volume 76 of the housing 62. The arrangement of the advancement member 68 and the housing 62 is such that a connecting portion (not shown) of the advancement member 68 that joins the first and second portions 86, 88 is seated within a slot 92 formed in the upper surface 90 of the housing 62—the slot 92 generally extending between the proximal and distal ends 72, 74 of the housing 62. As the first and second portions 86, 88 are joined together, movement of the first portion 86 along the upper surface 90 of the housing 62 results in a corresponding movement of the second portion 88 within the inner volume 76.
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According to aspects of the disclosure, and referring now to
In accordance with one embodiment, blood collection device 60 includes one or more lighting elements 116 therein positioned within housing 62 that are configured to emit light therefrom. According to embodiments of the disclosure, lighting element(s) 116 may be configured as any of a number of suitable light sources; however, in an exemplary embodiment, lighting element(s) 116 may be provided as light emitting diodes (LEDs) (hereafter “LEDs 116”).
According to some embodiments, the LED(s) 116 may be secured to housing 62 within the inner volume 76, such as being affixed to the inner surface of the housing 62 at one or more locations thereof. As shown in phantom in
As shown in
As shown in
According to embodiments of the disclosure, the LEDs 116 may be configured as micro-LEDs sized to fit within housing 62, due to the smaller size of the blood draw device 60 (and housing 62 thereof). The micro-LEDs may have dimensions of 1.5 mm×1.5 mm (0.06 in ×0.06 in), for example, so as to allow the LEDs 116 to be incorporated into the existing architecture of the blood draw device 60.
According to aspects of the disclosure, the LEDs 116 may be powered by an accompanying power system that, in an exemplary embodiment, may be provided as one or more batteries 124 that provide power to the LED(s) 116. The battery or batteries 124 may be configured as coin cell batteries or watch batteries, as non-limiting examples, having a reduced size (e.g., 6.8 mm (0.27 in) diameter), so as to again allow for positioning thereof within housing 62.
As shown in
In accordance with some aspects of the disclosure, and as shown in
In some embodiments, operation/configuring of the power circuit 126 in the open and closed states, and switching of the power circuit 126 from the open state to the closed state, may be controlled based on positioning of the advancement member 68 relative to housing 62. In one embodiment, the power circuit 126 may be configured in the open state when the advancement member 68 is in a home position, at the proximal end portion 72 of the housing 62, and the power circuit 126 may be transitioned from the open state to the closed state responsive to the advancement member 68 being moved distally from the home position, i.e., advanced toward the distal end portion 74 of housing 62, such that the LED(s) 116 receives power from the power circuit 126 and is/are caused to emit light. Thus, in an embodiment where LED(s) 116 are positioned on the advancement member 68, the LED(s) 116 may be powered on responsive to distal movement of advancement member 68 (to advance catheter tube 66)—with the power circuit 126 being configured in the closed state when the advancement member 68 is moved distally from its home position and thereby transferring power to the LED(s) 116. In other embodiments, the LED(s) 116 may be powered on when advancement of the catheter tube 66 is adequate to consider beginning a blood draw. In such an embodiment, power circuit 126 may be transitioned from the open state to the closed state when the advancement is deemed adequate, when a feature of the catheter tube 66 is exposed to the blood of the patient, or from some other signal in the catheter. In some embodiments, in addition to powering on of the LED(s) 116 by power circuit 126, the power circuit 126 (or another associated control circuit) could control an illumination of the LED(s) 116, such as a color light output therefrom. For example, the LED(s) could alternate colors, with the LED(s) 116 illuminating in red for an initial advancement of the catheter tube 66 and illuminating in green when the catheter tube 66 has advanced adequately to perform a blood draw (or take a reading from a sensor thereon, when the instrument is a probe). In still other embodiments, the power circuit 126 could cause an indicator light to illuminate when the catheter tube 66 has advanced adequately to perform a blood draw.
Referring now to
In accordance with some aspects of the disclosure, in order to aid in visualization of the catheter tube 66 during operation of the instrument delivery device 60, the housing 62 may be formed as a fluorescent plastic housing. The fluorescent plastic housing 62 may be illuminated by lighting elements 116 provided in the inner volume 76 of the housing and may further allow for visualization of the catheter tube 66 through the housing 62.
Therefore, according to embodiments described herein, the blood draw device 60 is configured to provide for light-enabled viewing of the catheter tube 66 as the catheter tube 66 is advanced into and through a catheter assembly and into the vein of a patient. Light generating elements are provided in blood draw device 60 that are configured to generate light/illumination sufficient to view the catheter tube 66 during operation of the blood draw device 60, such that positioning of the catheter tube 66 can be determined as the catheter tube 66 is advanced and/or retracted relative to the housing 62 and into catheter assembly 12. In some embodiments, the catheter tube 66 is illuminated in order to assist in visualizing the catheter tube 66, while in other embodiments a background (e.g., parts of the housing 62) may be illuminated so that the catheter tube 66 appears black/dark against the illuminated background, to assist in visualizing the catheter tube 66.
It is recognized that aspects of the disclosure are not limited to the specific blood draw device 60 shown and described in
Blood draw device 130 further includes a catheter tube 146 having a proximal end 148 and a distal end 150. Catheter tube 146 is received within the inner volume 140 of housing 132, and may be advanced and/or retracted relative to housing 132 by displacement of the advancement member 138 relative to the housing 132. In some embodiments, the catheter tube 146 may be joined to advancement member 138 via a fitting 152 provided at the distal end 144 of advancement member 138, such that displacement of the advancement member 138 relative to the housing 132 causes a corresponding displacement of catheter tube 146. In non-limiting embodiments, catheter tube 146 may be advanced from a first positon in which distal end 150 of catheter tube 146 is within housing 132, to a second position in which a distal end 150 of catheter tube 146 is positioned distally of housing 132 (and also positioned distally of catheter 16), as previously described regarding blood draw device 60 and operation thereof.
Blood draw device also includes a coupling device 154 thereon which may be identical to the coupling device 64 shown and described in the blood draw device of
As described in detail above, blood draw device 130 may incorporate one or more light generating elements therein that are configured to generate light/illumination sufficient to view the catheter tube 146 during operation of the blood draw device 130, such that positioning of the catheter tube 146 can be determined as the catheter tube 146 is advanced and/or retracted relative to the housing 132 and into catheter assembly 12. According to some embodiments, LEDs 116 may be provided within the inner volume 140 of housing 132 (on an inner surface of housing 132 and/or on a distal-facing surface of advancement member 138, for example) that emit light therefrom to provide for visualization of the catheter tube 146. According to other embodiments, a bio-compatible luminescent material or coating (not shown) may be applied to at least a portion of the catheter tube 146, with the bio-compatible luminescent material emitting light therefrom responsive to exposure thereof to an ambient light.
Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are 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 may be combined with one or more features of any other embodiment.
The present application claims priority to U.S. Provisional Application No. 63/468,097, entitled “Instrument Advancement Device with Light-Enabled Instrument Viewing”, filed May 22, 2023, the entire disclosure of which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63468097 | May 2023 | US |
