Instrument conveying device

Abstract

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

Description

[0001] Cross - Reference to Related Applications

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

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

[0004] Catheters are often used to inject fluids into and drain 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 many 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 draws, infusions, or for sensing or other purposes. When such instrument advancement devices are used to assist with blood draws, these devices (i.e., "blood draw devices") focus on the ability to reliably collect high - quality blood samples and reduce hemolysis. The main way these instrument advancement devices work 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 guided to provide access to the PIVC and into the patient's vasculature. If a blood draw 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 so as to be able to extend from 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 so that the instrument moves correspondingly relative to the housing, enabling the instrument to 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, for various reasons, it may be necessary or desirable to draw blood at night or in a low-light environment (e.g., for the health of the patient, such as to enable them to sleep), which results in reduced visibility for the clinician operating 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. In some cases, it should be recognized that the instrument (i.e., the catheter or probe) may bend during its advancement (such as when encountering an obstacle or other resistance), and it is important to be able to observe such possible bending during advancement to prevent kinking of the probe, which may cause damage to the instrument and / or make it difficult to draw blood.

[0008] Accordingly, there is a need in the art for an instrument propulsion device and its introducer that provide improved visibility during operation of the device, including being able to visualize the distal end of the catheter or other instrument as it is 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, wherein the housing includes a first housing portion and a second housing portion that are arranged side by side and coupled together to define an internal volume. The instrument delivery device further includes: 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 a access connector of the intravenous catheter assembly; and 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. The housing includes a visualization aid configured to improve the visibility of the instrument within the internal volume of the housing.

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

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

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

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

[0014] In some embodiments, the visualization aid includes the side regions of each of the first housing portion and the second housing portion.

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

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

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

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

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

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

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

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

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

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

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

[0026] The present disclosure also provides an instrument delivery device for use with an intravenous catheter assembly. The instrument delivery device includes a housing having a proximal portion and a distal portion, wherein the housing includes a first housing portion and a second housing portion that are arranged side by side and coupled together to define an internal volume. The instrument delivery device further includes: 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 a access connector of the intravenous catheter assembly; and 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. The instrument includes a visualization aid configured to improve visibility of the instrument within the internal volume of the housing.

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

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

[0029] In some embodiments, the visualization aid includes a positioning of the instrument within the internal volume of the housing, the instrument being positioned eccentrically relative to a centerline of the internal volume that extends longitudinally between the proximal portion and the distal portion of the housing. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0031] Figure 2 is a perspective view of a blood drawing device capable of being used with Figure 1 the catheter system of;

[0032] Figure 3 is a Figure 2 exploded view of the blood drawing device of;

[0033] Figure 4 is Figure 2 a side view of the blood drawing device of, showing the catheter fitting in a first retracted position;

[0034] Figure 5 is Figure 2 a side view of the blood drawing device of, showing the catheter fitting in a second extended position;

[0035] Figure 6A and Figure 6B is a perspective view of each part of a blood drawing device housing of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assistance element provided thereon; Figure 2

[0036] Figure 7 Figure 2 is a perspective cross-sectional view of a blood drawing device of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assistance element provided thereon;

[0037] Figure 8A Figure 8B Figure 2 and is a perspective view of each part of a blood drawing device housing of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assistance element provided thereon;

[0038] Figure 9 Figure 2

[0039] is a perspective cross-sectional view of a blood drawing device of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assistance element provided thereon; Figure 10 Figure 2

[0040] Figure 11 is a perspective cross-sectional view of a blood drawing device of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assistance element provided thereon; Figure 2

[0041] Figure 12 Figure 2 is a cross-sectional view of a blood drawing device of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assistance element provided thereon;

[0042] Figure 13 Figure 2 is a cross-sectional view of a blood drawing device of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assistance element provided thereon;

[0043] Figure 14 Figure 2

[0044] is a cross-sectional view of a blood drawing device of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assistance element provided thereon; Figure 15 Figure 2

[0045] ​​​​​​​​​​​​Figure 16 is a cross-sectional perspective view of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assisting element disposed thereon; Figure 2

[0046] Figure 17 is a side perspective view of a part of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assisting element disposed thereon; Figure 2

[0047] Figure 18 is a perspective view of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assisting element disposed thereon; Figure 2

[0048] Figure 19 is a perspective view of a first housing part of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assisting element disposed thereon; Figure 2

[0049] Figure 20A is a perspective view of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assisting element disposed thereon; Figure 2

[0050] Figure 20B is Figure 20A a cross-sectional perspective view of the blood drawing device taken along line 20B - 20B;

[0051] Figure 21 is an exploded view of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assisting element disposed thereon; Figure 2

[0052] Figure 22 is a cross-sectional perspective view of a blood drawing device according to one aspect of the present disclosure, the blood drawing device including a visualization assisting element disposed thereon; and Figure 2

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

[0054] The following description is provided to enable a person skilled in the art to make and use embodiments contemplated for implementing the present utility model. However, various modifications, equivalents, variations, and alternatives will still be apparent to a person 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.

[0055] ​​​​​​​In the following text, for purposes of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and derivatives thereof shall relate to the present utility model as oriented in the accompanying drawings. However, it should be understood that the present utility model may adopt various alternative variations unless specifically stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the present utility model. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered restrictive.

[0056] As used in this specification, the terms "proximal" and "distal" refer respectively to the direction closer to the user who places the device in contact with the patient and the direction away from that 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 that is operated by the user will be the proximal end of the device.

[0057] Provided herein are devices and systems for guiding an instrument through an indwelling catheter, such as a peripheral intravenous catheter (PIVC), a peripherally inserted central catheter (PICC), a central venous catheter (CVC), and a midline catheter. 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.

[0058] Now referring to Figure 1 , Figure 1 A non-limiting embodiment of a catheter system 10 is shown that is configured to facilitate delivery of an instrument into an indwelling catheter, such as when it may be desirable to draw blood from a patient. The catheter system 10 may include a catheter assembly 12 having a catheter adapter 14 and an associated catheter 16. The catheter adapter 14 may include a distal end 18 and a proximal end 20. In some embodiments, the catheter adapter 14 may include an additional adapter port 22 that 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 that extends 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 the patient's vasculature, where the distal end or tip 26 of the catheter 16 is appropriately positioned within a vein to enable blood to be drawn from the patient.

[0059] In some non-limiting embodiments or aspects, the catheter assembly 12 may include a first fluid conduit 30 that extends from the adapter port 22. The first fluid conduit 30 may be formed of any suitable material known to those skilled in the art and may have a distal end 32 and a proximal end 34. The distal end 32 of the first fluid conduit 30 is coupled to the adapter port 22, 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 an angle of 25 degrees, 60 degrees, or 75 degrees relative to the longitudinal axis of the connector 36), or any other type of connector known in the art. The connector 36 includes a second lumen 38 therethrough, 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 provided to the port 44 of the connector 36.

[0060] In some non-limiting embodiments or aspects, the catheter assembly 12 may also include a needleless access connector 46 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 may be configured as a slit 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 near the insertion site of the catheter 16, but it can be appreciated that the access port may be provided at other alternative locations sufficiently close to the insertion site, which allows the blood draw catheter tubing to be advanced into the indwelling catheter 16 and beyond the distal end of the indwelling catheter. For example, the access port provided for advancing the blood draw catheter tubing into the indwelling catheter 16 may be located on another connector, such as a proximal connector on an extension kit (described below) of the catheter assembly 12.

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

[0062] 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 a patient's vasculature. In some embodiments, as described below, the instrument delivery device 60 can include a blood sampling device (“blood sampling device 60”) that guides a catheter tube through the catheter assembly 12 and into the patient's vasculature to obtain a blood sample from the patient. However, it should be recognized that, 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 sampling device should not limit the scope of the present disclosure.

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

[0064] According to an embodiment, the catheter tube 66 is sized to enable its introduction 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 propulsion through the fluid path. Thus, the catheter tube 66 can have an outer diameter that is less than the minimum lumen of the catheter assembly fluid path (e.g., between 10 gauge and 30 gauge). The catheter tube 66 can have a length sufficient to place the distal end 70 of the catheter tube 66 at a desired location within the fluid path of the catheter system 10. Thus, in one embodiment, the catheter tube 66 can have a sufficient length such that the distal end of the catheter tube is advanced 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 out of the distal end 26 of the catheter 16.

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

[0066] The coupling device 64 of the blood drawing device 60 is provided 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 via, for example, a needleless access connector 46 as Figure 1 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 understand that any connector or coupling (e.g., a Luer connector) can be used as long as the distal end 70 of the catheter fitting 66 can reach the catheter assembly 12 through the coupling device.

[0067] The advancing 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 advancing member 68 and the housing 62 are arranged such that a connecting portion (not shown) of the advancing member 68 that couples the first portion 86 and the second portion 88 is seated within a slot 92 formed in the upper surface 90 of the housing 62, and the slot generally extends between the proximal end 72 and the distal end 74 of the housing 62. When the first portion 86 and the second portion 88 are coupled together, movement of the first portion 86 along the upper surface 90 of the housing 62 causes the second portion 88 to move correspondingly within the internal volume 76.

[0068] As Figures 1 to 5As shown, a 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 lower side 94b that contacts an outer surface (e.g., upper surface 90) of the housing 62. In such an embodiment, the upper surface 90 of the housing 62 can include a track 96 (e.g., a set of ribs, a set of ridges, a set of protrusions, and / or a set of grooves, etc.), and when the user engages the advancement member 68, the lower side 94b of the lug or protrusion advances along this 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.

[0069] As Figure 3 shown, a second portion 88 includes an opening 98 extending therethrough, and the opening 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 interior volume 76 of the housing 62 as desired, for example, when the blood drawing device 60 has been coupled to the catheter assembly 12 and a blood sample is to be collected, advancing the distal end 70 of the catheter fitting 66 out of the housing 62.

[0070] Further as Figures 1 to 5 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 within the housing 62, wherein the distal portion 106 is coupled to the second portion 88 of the advancement member 68. In some embodiments, the auxiliary catheter 102 can have a diameter larger than the diameter of the catheter fitting 66, and this larger diameter can serve to limit, reduce, and / or substantially prevent hemolysis of a quantity of blood when that quantity of blood flows through the catheter fitting 66 and the auxiliary catheter 102. According to embodiments of the present disclosure, the proximal portion 104 of the auxiliary catheter 102 is coupled to and / or otherwise includes a coupler 112 that is configured to mate with a collection device (not shown) that can be used with the blood drawing device 60 to collect a blood sample for subsequent analysis. According to some embodiments, the coupler 112 can be configured as a Luer connector (i.e., a female Luer connector) that is configured to mate with a corresponding Luer connector (i.e., a male Luer connector) of the collection device.

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

[0072] According to some embodiments, as Figure 6A , Figure 6B and Figure 7 shown, at least one of the housing portions 78a, 78b of the housing 62 includes a paint, finish, or coating 120 (hereinafter referred to as "coating 120") applied thereto that enables improved viewing of the catheter fitting 66. In such an embodiment, each of the housing portions 78a, 78b is formed of a transparent or translucent material 121 that provides at least partial visibility of its internal volume 76, but at least one of the housing portions 78a, 78b includes a coating 120 applied thereto, where the coating 120 is preferably applied to the inner surface 122 of the housing 62, but it should be appreciated that the coating may alternatively be applied to the outer surface 124 of the housing 62.

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

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

[0075] In Figure 7 an embodiment, an opaque coating 120 is applied to the inner surface 122 of the housing 62 along some surfaces of the top region 128 and the bottom region 130 of the housing portions 78a, 78b. When the coating 120 is applied to some surfaces of the top region 128 and the bottom region 130 of the housing portions 78a, 78b, the opaque coating 120 serves to prevent any light from entering the internal volume 76 where the catheter fitting 66 is located. In some embodiments, the opaque coating 120 applied to the inner surface 122 of the housing 62 may have a matte finish, which is used to further diffuse light within the internal volume 76 of the housing 62.

[0076] According to some embodiments, as Figures 8A to 17 shown, the structure of the housing 62 and / or one or more materials that make up the housing 62 enable improved observation of the catheter fitting 66 within the housing 62.

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

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

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

[0080] Now referring to Figures 11 to 15 , in some embodiments, the shape of the side regions 126 is controlled to improve the visualization of the conduit fitting 66 within the interior of the housing 62.

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

[0082] In one embodiment, and as Figure 12 and Figure 13 shown, the inner surface 122 of one or both of the side regions 126 has a different shape from its outer surface 124. In one configuration, and as Figure 12 shown, the inner surface 122 of one or both of the side regions 126 has a convex shape to add a magnifying effect for the visibility of the catheter fitting 66 to facilitate visualization. In another configuration, and as Figure 13 shown, the inner surface 122 of one or both of the side regions 126 has a flat shape (while the outer surface 124 remains curved) to again add a magnifying effect for the visibility of the catheter fitting 66 to facilitate visualization. Further as Figure 13 shown, a flat surface can also be provided on the side of the advancement member 68. In yet another configuration, and as Figure 14 shown, the outer surface 124 of the side region can be curved with a smaller radius than the radius of the inner surface 122, where the smaller radius reduces the glare of light from wider lines to smaller lines and also adds a magnifying effect for the visibility of the catheter fitting 66.

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

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

[0085] In some embodiments, and as Figure 17 shown, instead of being formed as a co-molded part having a side window 132 formed of a different material, the housing 62 may be formed such that a side window disposed therein is initially formed as an open slot or side slot 134. The open side slot 134 may be formed along all or part of the length of the housing 62 and may have a transparent material 136 (e.g., glass, a translucent plastic insert, or a translucent plastic film) inserted into the open side slot, and the transparent material provides visibility of the internal volume 76 of the housing 62 to enable visualization of the catheter fitting 66.

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

[0087] Reference Figure 18, according to one embodiment, the sticker 138 can be provided together with the blood drawing device 60. The sticker can be applied to the housing 62 (by a clinician) when using the blood drawing device 60 to achieve improved visualization of the catheter fitting 66. The sticker 138 can be configured to be white (or other light color), and the sticker can be applied to the side region of the housing 62 (applied to any one of the housing parts 78a, 78b) to provide a white background that contrasts with the catheter fitting 66, thereby improving the visualization of the catheter fitting. In one embodiment, the sticker 138 can be initially provided separately from the housing 62, such that the sticker 138 can be selectively applied to the desired housing part 78a, 78b, allowing the clinician to choose which side to apply the sticker to and allowing the clinician to use the sticker 138 only when needed. In another embodiment, multiple stickers 138 can be pre-applied to both sides of the housing 62, and then the clinician can remove one of the stickers 138 from the desired side of the housing 62 to provide visualization of the catheter fitting 66 through the desired side of the housing 62. In some embodiments, lugs 141 can be provided on the sticker 138 to make it easier to remove the sticker from the housing 62.

[0088] Reference Figure 19 , according to another embodiment, the sleeve 140 can be provided separately from the housing 62. The sleeve can be snapped onto the housing 62 (by a clinician) when using the blood drawing device 60 to achieve improved visualization of the catheter fitting 66. The sleeve 140 can be snapped onto the side region of any one of the housing parts 78a, 78b ( Figure 19 the first housing part 78a therein), thereby enabling the right or left hand use of the blood drawing device 60. The sleeve 140 can be configured as a white (or other light color) sleeve 140, and the white (or other light color) sleeve provides a light background that contrasts with the darker catheter fitting 66 to improve the visualization of the catheter fitting. Alternatively, the sleeve 140 can be configured as a darker color sleeve 140, and the darker color sleeve provides a dark background that contrasts with the white or other light color catheter fitting 66 to improve the visualization of the catheter fitting.

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

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

[0091] According to some embodiments, to provide improved observation of the catheter fitting 66 within the housing 62, as Figure 22As shown, the catheter fitting 66 can be eccentrically positioned within the internal volume 76 of the housing 62 (relative to the centerline 146 of the housing 62 that extends longitudinally along the housing). That is, it should be recognized that when the catheter fitting 66 is centered within the internal volume 76, the catheter fitting 66 can be positioned in a region of the internal volume 76 where optical glare from the housing 62 has a negative impact on the visualization of the catheter fitting 66. Thus, in a region where the optical glare is reduced, the catheter fitting 66 can be eccentrically positioned within the internal volume 76 of the housing 62 relative to the centerline 146, thereby making the visualization of the catheter fitting 66 within the housing 62 easier.

[0092] Accordingly, in accordance with the embodiments described herein, the blood drawing device 60 is configured to provide improved observation of the catheter fitting 66 as the catheter fitting 66 is advanced into the catheter assembly and through the catheter assembly into a patient's vein. A visualization assist element is provided in the blood drawing device 60 that is configured to improve the visibility of the internal volume 76 of the housing and the catheter fitting 66 therein during operation of the blood drawing device 60 such that the condition (e.g., bending or twisting) and 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.

[0093] It should be recognized that aspects of the present disclosure are not limited to Figures 1 to 22 the specific blood drawing device 60 shown and described, and blood drawing devices having other suitable configurations can also incorporate aspects of the present disclosure. Now referring to Figure 23 , Figure 23Illustrated is a catheter system 10 that includes a blood drawing device 150 according to another embodiment of the present disclosure. The blood drawing device 150 includes a housing 152 and a propulsion member 158. The housing has a proximal end 154 and a distal end 156, and the propulsion member is slidably received within the housing 152 (i.e., within an internal volume 160 of the housing 152). In the illustrated embodiment, the propulsion member 158 is provided as one or more telescoping cylinders 158a that are provided in a telescoping relationship with the housing 152 such that the propulsion member 158 can be fully or nearly fully slidably received within the internal volume 160 of the housing 152. The propulsion member 158 also includes a proximal end 162 and a distal end 164. In a non-limiting embodiment, the propulsion member 158 can have a variable diameter along its length. As an example, the distal end 164 of the propulsion member 158 can have a greater diameter than other portions of the propulsion member 158 such that when the propulsion member 158 is retracted, one or more features on the housing 152 can interact with the enlarged portion of the propulsion member 158 to prevent the propulsion member 158 from being fully pulled out of the housing 152. As another example, the diameter of the distal end 164 of the propulsion member 158 can be less than the diameter of other portions of the propulsion member 158 to hold the propulsion member 158 in a position under a blood draw forward condition, thus freeing the operator's hand to manipulate additional components (e.g., a vacuum blood collection tube).

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

[0095] The blood drawing device further includes a coupling device 174 located thereon that can be coupled with Figures 1 to 12is the same as the coupling device 64 shown and described in the blood drawing device. That is, the coupling device 174 is configured as a lock 80, which 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 should be understood that an alternative embodiment of the blood drawing device 150 may include another type of coupling device 174 for fixing the blood drawing device 150 to the catheter assembly 12. Another type of coupling device includes a Luer connector, a clip, a blunt plastic cannula, a blunt metal cannula, a hybrid Luer (e.g., with a cannula) friction fitting, etc. According to aspects of the present disclosure, the auxiliary catheter 102 may pass through the telescopic cylinder 158a of the advancing member 158 along a path, wherein the auxiliary catheter 102 provides fluid communication between the catheter fitting 166 and a coupler 112 provided at the proximal portion 104 of the auxiliary catheter 102, and wherein the coupler 112 is configured to mate with a collection device (not shown).

[0096] As described in detail above, the blood drawing device 150 may incorporate one or more visualization assisting elements therein, which are configured to improve the visibility of the catheter fitting 166 during the operation of the blood drawing device 150, such that when the catheter fitting 166 is advanced and / or retracted relative to the housing 152 and into the catheter assembly 12, the condition (e.g., bending / twisting) and positioning of the catheter fitting 166 can be determined. According to aspects of the present disclosure, the visibility of the catheter fitting 166 can be improved by modifying the housing 152 (e.g., modifying the structure of the housing 152, the material forming the housing 152, and / or applying one or more coatings to the housing 152), adding components to the housing 152, and / or by moving / modifying the catheter fitting 166 within the housing 152. According to embodiments, any visualization assisting element shown in the embodiments of Figures 6A to 22 can be incorporated into Figure 23 the blood drawing device 150 of

[0097] 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 should be understood that such details are for this purpose only, and the present disclosure is not limited to the disclosed embodiments or aspects. On the contrary, the present disclosure is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Images