Instrument delivery device and vascular access system

Abstract

The utility model relates to instrument conveying device and vascular access system. Provide an instrument conveying device for introducing instrument into the vascular system of patient via the catheter assembly including main catheter. The instrument conveying device includes: extension pipe spare, the extension pipe spare includes proximal end, distal end and the outer pipe spare wall of defining pipe spare inner chamber and the distal connector that is positioned at the distal end of the extension pipe spare. Instrument is arranged in the pipe spare inner chamber and includes proximal end and distal end, the instrument can be moved to the advance position in the pipe spare inner chamber, in the advance position, the distal end of the instrument extends into the main catheter or beyond the distal end of the main catheter. The proximal end of the instrument includes the holding feature, and the first outer diameter of the holding feature is greater than the second outer diameter of the distal end of the instrument, and the holding feature includes the reinforcing structure that prevents the holding feature from being deformed.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Patent Application No. 18 / 781,177, filed July 23, 2024, entitled “Vascular Access System with Secondary Catheter Having Reinforced Proximal EndRetention Feature,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to a vascular access system with a secondary catheter, and more specifically to a secondary catheter with improved proximal enhancement and delivery features that enable the secondary catheter to be advanced into an indwelling catheter. Background Technology

[0004] Catheters are frequently used to administer and remove fluids from the body. In a variety of settings, including hospital and home care, patients receive fluids, medications, and blood products via a vascular access device (VAD), which includes such a catheter inserted into the patient's vascular system. For example, a common VAD consists of a plastic catheter inserted into a patient's vein, with the length varying from a few centimeters when the VAD is a peripheral intravenous catheter (PIVC) to several centimeters when the VAD is a central venous catheter (CVC).

[0005] Recent developments in the field of PIVC have spurred the development of techniques designed to facilitate fluid delivery and / or blood collection using indwelling PIVCs and accompanying instrument delivery devices. The primary method of operation for these devices is the insertion of a secondary catheter, probe, tube, or other instrument (collectively referred to below as “secondary catheter”) through the lumen of the PIVC, with a delivery device attached to a catheter adapter of the PIVC for insertion and advancement of the secondary catheter into the indwelling PIVC and into the patient’s vascular system. The secondary catheter can be advanced through the indwelling PIVC and into the patient’s vascular system a short distance (e.g., for blood sample collection) or a longer distance (e.g., as a multi-lumen midline catheter).

[0006] It is recognized that various types of delivery devices exist that can be used to insert and advance accessory catheters, probes, fittings, or other instruments into and through the lumen of a PIVC. For example, some delivery devices include an extension fitting housing within which the accessory catheter is positioned. In some embodiments, the accessory catheter may be advanced distally from the extension fitting housing using a flush-in-place method, wherein the accessory catheter is advanced distally as a saline flushing solution is injected into the PIVC through the guide. In other embodiments, the accessory catheter may be advanced distally from the extension fitting housing using a non-contact or direct-contact advancement member, wherein the advancement member advances the accessory catheter as it moves distally relative to the extension fitting housing. In any of these embodiments, the proximal end of the accessory catheter may include an enlarged or tapered region, meaning that a portion of the accessory catheter is retained within the guide as it is advanced distally within the guide.

[0007] In each of the aforementioned delivery device configurations, it is recognized that there are disadvantages associated with the method of advancing the accessory catheter and / or with the construction of the accessory catheter itself. One potential disadvantage of “in-situ flushing” type guides is that the accessory catheter may separate from the extension housing during flushing, for example, due to collapse / deformation of the enlarged area (i.e., it may be flushed out from the extension housing through the distal connector of the extension housing), and this may result in the accessory catheter being flushed into the patient's vascular system, requiring surgical intervention to remove it. Another potential disadvantage of “in-situ flushing” type delivery devices is the unreliability / inconsistency of the flushing advancement itself, as multiple flushing attempts and large flush volumes may be required to advance the accessory catheter the desired amount. A potential disadvantage of delivery devices with non-contact advancement members is that the proximal end of the enlarged accessory catheter may potentially deform / collapse when pressure is applied by the advancement member, which in turn may result in the accessory catheter potentially being able to exit the extension housing (through the distal connector of the extension housing).

[0008] Therefore, it is desirable to provide a secondary conduit for use with a delivery device, wherein the secondary conduit is reinforced to prevent deformation and to prevent potential separation from the extension fitting housing of the guide. The reinforced proximal end of the secondary conduit is sized to prevent it from protruding through the distal connector of the extension fitting housing. Utility Model Content

[0009] A device delivery device is provided for introducing a device into a patient's vascular system via a catheter assembly including a main tubing. The device delivery device includes an extension tubing having a proximal end, a distal end, and an outer tubing wall defining an inner lumen. The device delivery device also includes a device disposed within the inner lumen of the tubing and including a proximal end and a distal end, the device being movable within the inner lumen to an advance position in which the distal end of the device extends into or beyond the distal tip of the main tubing. The proximal end of the device includes a retaining feature having a first outer diameter greater than a second outer diameter of the distal end of the device, the retaining feature including a reinforcing structure to prevent deformation of the retaining feature.

[0010] In one aspect or embodiment, the device includes a secondary catheter defining a catheter lumen extending between the proximal and distal ends of the secondary catheter.

[0011] In one aspect or embodiment, the retaining feature includes a tapered portion that expands radially outward from the second outer diameter to the first outer diameter, wherein the increased wall thickness of the tapered portion is greater than the wall thickness of the remainder of the secondary conduit, thereby forming the reinforcing structure.

[0012] In one aspect or embodiment, the tapered portion having the increased wall thickness forms a funnel structure that defines a shaped opening leading to the lumen of the conduit.

[0013] In one aspect or embodiment, the reinforcing structure includes a reinforcing member formed of a reinforcing material having a stiffness greater than that of the material forming the secondary conduit.

[0014] In one aspect or embodiment, the reinforcing member is fixed to the secondary conduit via adhesive bonding, welding, or swaging.

[0015] In one aspect or embodiment, the retaining feature includes a tapered portion that expands radially outward from the second outer diameter to the first outer diameter, and wherein the reinforcing member is positioned within the lumen of the catheter and within the tapered portion.

[0016] In one aspect or embodiment, the reinforcing member defines an opening into the lumen of the catheter, the opening having a reduced opening area compared to the opening area defined by the tapered portion.

[0017] In one aspect or embodiment, the reinforcing member is formed as one of a wedge-shaped reinforcing member, an annular reinforcing member, and a truncated conical reinforcing member.

[0018] In one aspect or embodiment, the reinforcing component is positioned around the secondary conduit.

[0019] In one aspect or embodiment, at least one of the retaining feature and the reinforcing member is tipped at the end to provide a radius or chamfer at the end of the at least one of the retaining feature and the reinforcing member.

[0020] In one aspect or embodiment, the instrument delivery device further includes a distal connector positioned at the distal end of the extension fitting to connect the extension fitting to the catheter assembly.

[0021] In one aspect or embodiment, the instrument delivery device further includes a proximal connector positioned at the proximal end of the extension tube, the proximal connector being configured to engage a fluid delivery device that delivers fluid to the catheter assembly via the secondary conduit.

[0022] In one aspect or embodiment, the device is configured to move between a retracted position and an advanced position in response to the injection of flushing fluid through the proximal connector.

[0023] In one aspect or embodiment, the instrument delivery device further includes a translation handle coupled to the outer surface of the outer tube wall, wherein the translation handle is configured to move along the outer surface of the outer tube wall between a proximal position and a distal position to translate the distal end of the instrument between a retracted position and an advanced position.

[0024] In one aspect or embodiment, the translation handle engages the retaining feature via the outer tube wall to allow the instrument to move between the retracted position and the advance position.

[0025] A vascular access system is also provided, comprising a catheter assembly including: a catheter adapter including a distal adapter port, a proximal adapter port, and a lateral adapter port; a main tube coupled to the distal adapter port and configured for insertion into a patient's vascular system; and a proximal patient connector coupled to the lateral adapter port via a first fluid conduit, the proximal patient connector including a distal connector port, a proximal connector port, and a lateral connector port. The vascular access system also includes a device delivery device, wherein an extension of the device delivery device is coupled to the proximal patient connector at the proximal connector port.

[0026] In one aspect or embodiment, the vascular access system further includes an extension kit that is integrated with the proximal patient connector at the side connector port, the extension kit including a second fluid conduit for supplying fluid to the catheter assembly.

[0027] In one aspect or embodiment, the extension fitting is integrated with the near-patient connector at the proximal connector port.

[0028] In one aspect or embodiment, the extension fitting is connected at the proximal connector port to the near-patient connector via one of a Luer connector and a locking element, the locking element comprising a blunt sleeve and a pair of locking arms. Attached Figure Description

[0029] The above and other features and advantages of this disclosure, and their implementations, will become more apparent and the disclosure itself will be better understood by referring to the following description of embodiments of this disclosure in conjunction with the accompanying drawings, in which:

[0030] Figure 1 A perspective view of a vascular access system according to one aspect or embodiment of this application, showing the retracted position of the accessory catheter;

[0031] Figure 2 for Figure 1 A three-dimensional diagram of the vascular access system, showing the protrusion position of the accessory catheter;

[0032] Figure 3 for Figure 2 A three-dimensional diagram of the instrument delivery device of the vascular access system, showing the retracted position of the auxiliary catheter;

[0033] Figure 4 for Figure 3 A cross-sectional view of the instrument delivery device;

[0034] Figure 5 for Figure 3 A perspective view of the instrument delivery device, showing the protrusion position of the auxiliary catheter;

[0035] Figure 6 for Figure 5 A cross-sectional view of the instrument delivery device;

[0036] Figure 7 A perspective view of a vascular access system according to one aspect or embodiment of this application, showing the retracted position of the accessory catheter;

[0037] Figure 8 for Figure 7 A three-dimensional diagram of the vascular access system, showing the protrusion position of the accessory catheter;

[0038] Figure 9 for Figure 7 A three-dimensional diagram of the vascular access system, showing the instrument delivery device disconnected from the catheter assembly, and the retracted position of the accessory catheter;

[0039] Figure 10 for Figure 7 A three-dimensional diagram of the vascular access system, showing the instrument delivery device disconnected from the catheter assembly, and the extended position of the accessory catheter;

[0040] Figure 11 for Figure 7 A cross-sectional view of the instrument delivery device in the vascular access system, showing the retracted position of the auxiliary catheter;

[0041] Figure 12 for Figure 7 A cross-sectional view of the instrument delivery device in the vascular access system, showing the extended position of the accessory catheter;

[0042] Figure 13 A perspective view of a vascular access system according to one aspect or embodiment of this application, showing the retracted position of the accessory catheter;

[0043] Figure 14 for Figure 13 A three-dimensional diagram of the vascular access system, showing the protrusion position of the accessory catheter;

[0044] Figure 15 A cross-sectional view of the proximal end of a secondary catheter included in an instrument delivery device according to one aspect or embodiment of this application;

[0045] Figure 16 for Figure 15 A three-dimensional view of the proximal end of the accessory catheter;

[0046] Figure 17 According to one aspect or embodiment of this application Figure 15 Side view of the proximal end of the accessory catheter;

[0047] Figure 18 According to one aspect or embodiment of this application Figure 15 An end view of the proximal end of the accessory catheter;

[0048] Figure 19 According to one aspect or embodiment of this application Figure 15 An end view of the proximal end of the accessory catheter;

[0049] Figure 20 A side view of the proximal end of a secondary catheter included in an instrument delivery device according to one aspect or embodiment of this application;

[0050] Figure 21 A side view of the proximal end of a secondary catheter included in an instrument delivery device according to one aspect or embodiment of this application;

[0051] Figure 22A side view of the proximal end of a secondary catheter included in an instrument delivery device according to one aspect or embodiment of this application;

[0052] Figure 23 According to one aspect or embodiment of this application Figures 20 to 22 An end view of the proximal end of the accessory catheter in any of the figures;

[0053] Figure 24 According to one aspect or embodiment of this application Figures 20 to 22 An end view of the proximal end of the accessory catheter in any of the figures;

[0054] Figure 25 A cross-sectional view of the proximal end of a secondary catheter included in an instrument delivery device according to one aspect or embodiment of this application;

[0055] Figure 26 A cross-sectional view of the proximal end of a secondary catheter included in a device delivery device according to one aspect or embodiment of this application; and

[0056] Figure 27 This is a cross-sectional view of the proximal end of a secondary conduit of an instrument delivery device positioned within an extension tube and engaging with a translation handle of the instrument delivery device, according to one aspect or embodiment of this application. Detailed Implementation

[0057] Spatial or directional terms, such as “left,” “right,” “inner,” “outer,” “up,” “down,” etc., should not be considered as limitations, as this utility model can adopt various alternative orientations.

[0058] In the following description, for descriptive purposes, the terms “above,” “below,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the present invention as oriented as shown in the accompanying drawings. However, it should be understood that the present invention may take various alternative variations unless explicitly stated to the contrary. It should also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary aspects of the present invention.

[0059] Unless otherwise stated, all ranges or ratios disclosed herein should be understood to include the starting and ending values, as well as any and all subranges or subratios contained therein. For example, the range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between the minimum value 1 and the maximum value 10 (inclusive); that is, all subranges or subratios starting from the minimum value 1 or greater and ending at the maximum value 10 or less.

[0060] The terms “first”, “second”, etc., do not refer to any specific order or sequence, but rather to different conditions, characteristics, or elements.

[0061] As used herein, “at least one of…” is synonymous with “one or more of…”. For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of two or more of A, B, or C. For example, “at least one of A, B, and C” includes only one or more of A; or only one or more of B; or only one or more of C; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or all or one or more of A, B, and C.

[0062] In this disclosure, the distal end of a component or device refers to the end of the component or device that is furthest from the user's hand (closest to the patient's body) when the component or device is in the use position, while the proximal end of a component or device refers to the end of the component or device that is closest to the user's hand when the component or device is in the use position.

[0063] This disclosure relates to device delivery devices and associated vascular access systems, including such device delivery devices and catheter assemblies that provide access to a patient's vascular system. The device delivery device is configured to advance a device (e.g., a secondary catheter) into the catheter assembly and through the distal tip of an indwelling primary catheter to facilitate fluid delivery and / or blood aspiration. The proximal end of the secondary catheter includes a retaining feature thereon for holding the proximal end of the secondary catheter within the device delivery device during advancement, and the retaining feature includes a reinforcing structure that prevents deformation of the retaining feature, thereby ensuring such retention of the secondary catheter.

[0064] refer to Figure 1 and Figure 2 This illustration shows a non-limiting embodiment of a vascular access system 10 that facilitates blood draws and / or fluid administration to a patient. The vascular access system 10 typically includes a catheter assembly 12 and a device delivery device 60 that can be connected to the catheter assembly 12 to introduce devices (e.g., accessory catheters). The connection of the device delivery device 60 to the catheter assembly 12 provides the vascular access system 10 with added functionality, including extending the extension of the main tube (of the catheter assembly 12) into the patient's vascular system to meet short-term needs (e.g., blood sample collection) and / or long-term needs (e.g., converting a shorter peripheral intravenous catheter (PIVC) assembly into a multi-lumen midline catheter).

[0065] In the illustrated embodiment, catheter assembly 12 is configured / arranged as an integrated catheter assembly including an integrated proximal patient connector and an extension kit, as described in further detail below. However, it should be appreciated that, according to additional aspects of this disclosure, catheter assembly 12 may have another suitable configuration.

[0066] like Figure 1 and Figure 2 As shown, the catheter assembly 12 includes a catheter adapter 14 and an associated (main) catheter 16. The catheter adapter 14 may include a distal adapter port or distal end 18 and a proximal adapter port or proximal end 20, as well as an additional adapter port or "side" adapter port 22 that may be disposed between the distal end 18 and 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 catheter 16 extends from the distal end 18 of the catheter adapter 14 and may be configured to be placed in a patient's vein at the point of implantation of a PIVC, wherein the distal end or tip of the catheter 16 is properly positioned within the vein to enable blood draw from the patient. As those skilled in the art will appreciate, the catheter 16 may be formed of any suitable material and may have any useful length.

[0067] Still referencing Figure 1 and Figure 2 In some non-limiting embodiments or aspects, the catheter assembly 12 may include a first fluid conduit 26 extending from the side adapter port 22, wherein the first fluid conduit 26 is integrated with the side adapter port 22. The first fluid conduit 26 may be formed of any suitable material known to those skilled in the art and may have a distal end and a proximal end. The distal end of the first fluid conduit 26 is coupled to the side adapter port 22, while the proximal end of the first fluid conduit 26 may be coupled to a proximal patient connector or a "proximal port" connector 32 (hereinafter referred to as "connector 32").

[0068] like Figure 1 and Figure 2As shown, according to an exemplary aspect of this disclosure, connector 32 includes a distal connector end or distal port 34 and a proximal connector end or proximal port 36 located thereon. Connector 32 also includes a side connector port 38 located thereon, disposed between the distal port 34 and the proximal port 36. According to embodiments, connector 32 can be configured as a T-type connector (e.g., a side port arranged at a 90-degree angle relative to the longitudinal axis of connector 32) or a Y-type connector (e.g., a side port arranged at an angle of 15 to 85 degrees relative to the longitudinal axis of connector 32). Connector 32 includes a (second) cavity 40 located therein, wherein the cavity 40 has any number of branches suitable for the connector type, such as branches extending between the distal port 34 and the proximal port 36 and branches disposed to the side connector port 38.

[0069] According to some embodiments or aspects, a needleless access connector 42 (which may be configured as a split diaphragm valve) is disposed in the proximal port 36 of connector 32. The needleless access connector 42 provides a proximal patient access port to catheter assembly 12, via which external devices (e.g., a device delivery device 60 that can introduce instruments into the catheter assembly) can be connected to catheter assembly 12, as explained in further detail below.

[0070] In some non-limiting embodiments or aspects, the conduit assembly 12 further includes an extension kit 44 coupled to a side connector port 38 of the connector 32. The extension kit 44 may include a second fluid conduit 46 having a distal end 48 and a proximal end 50. The distal end 48 of the second fluid conduit 46 may be coupled to the side connector port 38 of the connector 32, while the proximal end 50 of the second fluid conduit 46 may include a proximal connector or proximal port 52, i.e., a "far port connector" 52. In some embodiments, the far port connector 52 may include a Luer connector to which a fluid delivery device may be connected.

[0071] As a non-limiting example, extension kit 44 can be used to provide a fluid path for catheter assembly 12 to enable fluid or drug delivery. In some embodiments, as a non-limiting example, the fluid delivery device can be coupled to distal connector 52 to perform intravenous infusion via gravity dripping, syringe push, or saline flushing.

[0072] like Figure 1 and Figure 2As shown, the device delivery device 60 is connected to the catheter assembly 12 via connector 32 (i.e., via needleless access connector 42 in the proximal port 36). The device delivery device 60 is operable to introduce and advance device 62 into the catheter assembly 12. According to embodiments, device 62 may include a secondary catheter, probe, guidewire, or other device; for simplicity, device 62 is generally referred to hereinafter as “secondary catheter 62”. In the case where device 62 is a secondary catheter, secondary catheter 62 may be constructed of soft or flexible materials to facilitate its smooth placement within the patient’s vascular system with little or no damage to the vascular system. In some embodiments, secondary catheter 62 may be constructed of silicone, polyimide, latex, polyurethane, nylon, polyethylene, or other suitable materials.

[0073] According to various aspects of this disclosure, the instrument delivery device 60 includes a housing 64, such as Figure 1 and Figure 2 As shown and in more detail as Figures 3 to 6 As shown, the housing can be configured as an extension tube (hereinafter referred to as "extension tube 64"). Extension tube 64 includes a cylindrical outer wall (also referred to as "outer tube wall") 66 defining an inner tube lumen 68. In some embodiments, a distal connector 70 is disposed at the distal end of extension tube 64, and a proximal connector 72 is disposed at the proximal end of extension tube 64. In the illustrated embodiment, the distal connector 70 is a Luer connector (e.g., a male Luer connector): this Luer connector is configured to engage the needleless access connector 42 to connect the instrument delivery device 60 to the catheter assembly 12; however, the distal connector 70 may be another suitable type of connector. The proximal connector 72 may also include a Luer connector (e.g., a female Luer connector), and in some embodiments, the proximal connector may include a needleless access connector 74 coupled thereto to control access to the inner tube lumen 68 of the instrument delivery device 60.

[0074] like Figures 3 to 6 As shown, the accessory catheter 62 includes a distal end 76 and a proximal end 78, wherein the catheter lumen 80 extends through the accessory catheter 62 for the length between the distal end 76 and the proximal end 78. As explained in further detail below, the proximal end 78 may include an enlargement (or retaining feature) thereon for preventing the accessory catheter 62 from disengaging from the instrument delivery device 60 (i.e., exiting through the distal connector 70) and / or entering / passing through the catheter assembly 12.

[0075] The secondary conduit 62 is housed within the inner cavity 68 of the extension fitting 64 and is not attached to the extension fitting 64. The secondary conduit 62 has a retracted position. Figure 3 and Figure 4 ) and the position of the extension ( Figure 5 and Figure 6In the retracted position, the distal end 76 of the auxiliary catheter 62 is positioned within the extension fitting 64 and / or the distal connector 70. In the extended position, the distal end 76 of the auxiliary catheter 62 extends from the extension fitting 64, through the catheter assembly 12, and beyond the distal end 81 of the main catheter 16. As previously described, the auxiliary catheter 62 is configured to extend the extension range of the vascular access system 10 (and the extension range of the main catheter 16) into the patient's vasculature to meet both short-term needs (e.g., blood sample collection) and long-term needs (e.g., providing multi-lumen midline catheter capability). The vascular access system 10 is configured to utilize the auxiliary catheter 62 for blood aspiration and / or drug administration, while also providing the option of simultaneous fluid infusion via the extension kit 44 and the device delivery device 60.

[0076] In the illustrated embodiment, the device delivery device 60 is configured to inject flushing fluid into the device delivery device 60 via the proximal connector 72, moving the secondary catheter 62 from its retracted position to its extended position. That is, a pre-filled syringe 83 can be attached to the device delivery device 60 via the proximal connector 72, and the secondary catheter 62 can move from its retracted position to its extended position in response to pressure generated by the depressurization of the plunger of the pre-filled syringe. In some embodiments, the flushing performed to advance the secondary catheter 62 can be referred to as an "in-situ flushing" technique because the main catheter 16 can remain in place within the patient's vascular system when flushing occurs. In some embodiments, as the secondary catheter 62 moves from its retracted position to its extended position to advance the secondary catheter 62, the distal end 76 of the secondary catheter 62 can be moved distally via one or more of the following non-torsional fluid paths: the distal connector 70, the proximal patient connector 32, the first fluid conduit 26, the side adapter port 22, the distal adapter port 18, and the main catheter 16.

[0077] Figures 1 to 6 The vascular access system 10 is configured to function similarly to a standard integrated peripheral intravenous catheter, enabling infusion via the distal connector 50 of the extension kit 44 and the proximal connector 72 of the device delivery device 60. As fluid flushes through the proximal connector 72 of the device delivery device 60, fluid flows through the extension fitting 64 and the auxiliary catheter 62 to ensure that the corresponding lumens (i.e., the fitting lumen 68 and the catheter lumen 80) remain flushed. When the auxiliary catheter 62 is in the extended position, it can be used to deliver corrosive medications. Further downstream delivery of medication in the patient's vein from the distal end 81 of the main catheter 16 allows for faster blood dilution and reduces the risk of chemical phlebitis at the location of the main catheter 16.

[0078] Now for reference Figures 7 to 12 This illustrates an instrument delivery device 82 according to another embodiment of the present disclosure. Figures 7 to 12The instrument delivery device 82, in its retracted position, uses a non-contact translation handle 84 disposed on the instrument delivery device 82, instead of via the fluid flushing technique described above with the instrument delivery device 60. Figure 7 , Figure 9 and Figure 11 ) and the position of the extension ( Figure 8 , Figure 10 and Figure 12 The auxiliary conduit 62 moves between the extension fitting 64 and the extension fitting 64. The translation handle 84 is configured to move along the outer surface of the extension fitting 64, and the translation handle 84 is fully positioned outside the extension fitting 64. Figure 11 and Figure 12 As shown, the translation handle 84 may include a body 86 having a gripping surface 88 that engages the outer surface of the extension tube 64. In one aspect or embodiment, the gripping surface 88 may include protrusions, such as cylindrical or spherical protrusions, that engage the outer surface of the extension tube 64. The gripping surface 88 may engage the proximal end 78 of the secondary conduit 62 via the extension tube 64 (i.e., the retention feature at the proximal end 78, as described in further detail below). Distal or proximal movement of the translation handle 84 causes the gripping surface 88 to engage the proximal end 78 of the secondary conduit 62, and the extension tube 64 is pressed down and positioned between the gripping surface 88 and the proximal end 78 of the secondary conduit 62, thereby allowing the secondary conduit 62 to move together with the translation handle 84.

[0079] like Figures 7 to 12 As can be seen, the instrument delivery device 82 may include a distal connector 92 configured as a locking element that engages the connector of the catheter assembly 12. The locking-type distal connector 92 may therefore include a blunt cannula 94 that engages with the needleless access connector 42, and a pair of locking arms 96 that facilitate securing the instrument delivery device 82 to the proximal patient connector 32. In other embodiments, the distal connector 92 of the instrument delivery device 82 may include, for example, a device designed for... Figures 1 to 6 The instrument delivery device 60 shown and the Luer connector described therein.

[0080] According to additional aspects of this disclosure, it is recognized that vascular access systems with various other configurations can be provided. For example, such as Figure 13 and Figure 14 The illustrated vascular access system 10 can be configured such that its device delivery device 100 is integrated with the catheter assembly 12. That is, the distal end of the extension fitting 64 can be permanently connected (i.e. integrated) to the proximal patient connector 32 at the proximal connector port, for example by bonding, adhesive, or other suitable arrangement. The device delivery device 100 in the vascular access system 10 can be configured to be delivered via any of a variety of suitable means (e.g., via a previously installed...). Figures 1 to 6The in-situ flushing method described in the system embodiments, or via previously described Figures 7 to 12 The non-contact translation handle 84 described in the system embodiment is used to advance the secondary conduit 62.

[0081] Based on all aspects of this disclosure, for Figures 1 to 14 In any of the embodiments shown, the proximal end 78 of the secondary conduit 62 can be configured to prevent the secondary conduit 62 from separating from the extension fitting. For Figures 1 to 6 and / or Figure 13 and Figure 14 The instrument delivery devices 60 and 100 mean that during the injection of flushing fluid to advance the accessory catheter 62 distally into / through the catheter assembly 12, the proximal end 78 of the accessory catheter 62 is prevented from being flushed out through the extension fitting 64 (and the distal connector 70 for the instrument delivery device 60). Figures 7 to 12 The instrument delivery device 82, which means that after the auxiliary catheter is advanced distally via actuation of the translation handle 84, prevents the proximal end 78 of the auxiliary catheter 62 from passing through the extension fitting 64 and the distal connector 92. To prevent the auxiliary catheter 62 from separating from and exiting the extension fitting, the proximal end 78 of the auxiliary catheter 62 includes a retaining feature 110, the (first) outer diameter of which is larger than the (second) outer diameter of the distal end of the auxiliary catheter 62, the retaining feature being a radially enlarged portion. The (first) outer diameter of the retaining feature 110 is also larger than the (third) diameter of the openings in the distal connector 70 of the instrument delivery device 60 and the distal connector 92 of the instrument delivery device 82. In some embodiments, the radially enlarged retaining feature 110 may include an outwardly tapered portion 112 that increases the size / diameter of the proximal end 78 of the auxiliary catheter 62, while in other embodiments, the radially enlarged retaining feature 110 may have a stepped configuration.

[0082] According to various aspects of this disclosure, in order to prevent collapse or deformation of the retaining feature 110 that may occur during in-situ flushing or mechanical advancement of the secondary catheter 62 (thus allowing the secondary catheter 62 to separate from the extension fitting 64), the retaining feature 110 includes a reinforcing structure 114 that prevents the retaining feature 110 from collapsing / deforming. The reinforcing structure 114 disposed in / on the retaining feature 110 increases the structural rigidity and robustness of the retaining feature 110, such that the retaining feature 110 functions to retain the proximal end 78 of the secondary catheter 62 within the instrument delivery devices 60, 82, 100 and prevent the proximal end of the secondary catheter 62 from entering / passing through the catheter assembly 12.

[0083] According to some embodiments, such as Figure 15 and Figure 16As shown, the reinforcing structure 114 in / on the retaining feature 110 is provided by forming a retaining feature 110 with increased inherent rigidity (i.e., the reinforcing structure 114 is integral with the remainder of the accessory catheter 62). For example, in an embodiment where the retaining feature 110 is configured as an outwardly tapered portion 112 of the accessory catheter 62, the reinforcing structure 114 is provided in the form of a tapered portion 112 having an increased wall thickness greater than the wall thickness of the remainder of the accessory catheter 62. Thus, the tapered portion 112 with the increased wall thickness can form a reinforced funnel structure 114a that resists collapse or other deformation that may occur during in-situ flushing or mechanical advancement of the accessory catheter 62. In some embodiments, according to various embodiments, the funnel structure 114a may be configured to present a shaped opening 116 leading to the catheter lumen 80 of the accessory catheter 62, wherein exemplary shaped openings are configured in Figure 17 and Figure 18 As shown in the figure. In other embodiments, the funnel structure 114a may be configured to present a circular opening 116 leading to the catheter lumen 80 of the secondary catheter 62, such as Figure 19 As shown.

[0084] According to other embodiments, the reinforcing structure 114 disposed in / on the retaining feature 110 is configured as a material / component separate from the secondary conduit 62. In such embodiments, the reinforcing structure 114 includes a reinforcing member 114b that is fixed / connected to or integrated with the secondary conduit 62. The reinforcing member 114b may be formed of a reinforcing material, which may include a rigid polymeric material, a metal, or a composite material with increased hardness and rigidity compared to the material forming the secondary conduit 62 (e.g., silicone, polyimide, latex, polyurethane, nylon, polyethylene, etc., so that the conduit is flexible / bendable). Depending on the configuration of the reinforcing member 114b, the reinforcing member 114b may be formed, bonded, tipped, glued, ultrasonically welded, forged, or otherwise connected to the retaining feature 110 on the secondary conduit 62.

[0085] In some embodiments, while retaining feature 110 as the outwardly tapering portion 112 of the secondary conduit 62, the reinforcing member 114b may be disposed within the internal volume defined by the tapering portion 112, such that the reinforcing member 114b is located within the tapering portion 112. For example... Figures 20 to 22 As shown, as a non-limiting example, the reinforcing member 114b can be formed as a wedge-shaped reinforcing member. Figure 20 ), ring-shaped reinforcing member ( Figure 21 ) or truncated conical reinforced member ( Figure 22 In such an embodiment, the reinforcing member 114b may extend to or past the proximal end of the tapered portion 112 (e.g., Figure 20 Alternatively, the tapered portion 112 may extend proximally through the reinforcing member 114b to form a "tubing tip" (e.g., Figure 22 ).

[0086] In one aspect or embodiment, when the reinforcing member 114b is positioned within the internal volume defined by the tapered portion 112, the reinforcing member 114b defines an opening 118 leading to the conduit lumen 80, which has a reduced opening area compared to the opening area defined by the tapered portion 112. In some embodiments, the opening 118 may include a circular opening, for example... Figure 23 A circular opening is shown. In other embodiments, the opening may include a shaped opening, such as... Figure 24 The shaped opening is shown in the figure.

[0087] In some embodiments, the reinforcing member 114b may be positioned around at least a portion of the retaining feature 110 (i.e., around the outer surface of at least a portion of the retaining feature 110), such as Figure 25 and Figure 26 As shown. For example, the reinforcing member 114b may be positioned on / around the outer surface of the tapered portion 112, such that the reinforcing member 114b has a frustoconical shape. The reinforcing member 114b may cover the entire tapered portion 112. Figure 25 ) or only cover a portion of the tapered section 112 ( Figure 26 ).

[0088] In some embodiments, depending on the structure, arrangement, and / or assembly method of the retaining feature 110 and the reinforcing member 114b, at least one of the retaining feature 110 and the reinforcing member 114b is end-angled to provide a rounded corner or chamfer at the end of the at least one of the retaining feature 110 and the reinforcing member 114b. As an example, such as Figure 25 As shown, the reinforcing member 114b is positioned around the outer surface of the retaining feature 110, and the reinforcing member 114b is end-sloped at its proximal edge.

[0089] Now for reference Figure 27 In embodiments where the instrument delivery device 82 includes a translation handle 84 for distally advancing the auxiliary catheter 62 through the extension fitting 64, the reinforcing member 114b may specifically be configured and formed to engage with the translation handle 84 (through the extension fitting 64). For example, in Figure 27In one embodiment, the reinforcing member 114b can be configured as a wedge-shaped reinforcing member extending proximally through the proximal end 78 of the secondary conduit 62, for example, extending through the tapered portion 112, such that the reinforcing member 114b provides an engagement surface with which the gripping surface 88 of the translation handle 84 can mate. The proximal end of the reinforcing member 114b can be shaped (via the extension tube 64) to directly mate with the gripping surface 88, or an additional cap 120 can be applied to the proximal end of the reinforcing member 114b to mate with the gripping surface 88 (via the extension tube 64), wherein the cap 120 is formed of a rigid or flexible material.

[0090] Advantageously, embodiments of this disclosure therefore provide a device delivery device and an associated vascular access system, the vascular access system including such a device delivery device and a catheter assembly that provides access to a patient's vascular system. The device delivery device is configured to advance a device (e.g., a secondary catheter) into the catheter assembly and through the distal end of an indwelling primary catheter to facilitate fluid delivery and / or blood aspiration. The proximal end of the secondary catheter includes a retaining feature thereon for holding the proximal end of the secondary catheter within the device delivery device during advancement, and the retaining feature includes a reinforcing structure that prevents deformation of the retaining feature, thereby ensuring such retention of the secondary catheter.

[0091] Although this disclosure has been described in detail based on embodiments or aspects currently considered to be most practical and preferred for illustrative purposes, it should be understood that such detail is for that purpose only, and this disclosure is not limited to the disclosed embodiments or aspects. Rather, this 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 this 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. A medical device conveying device, characterized in that, The device delivery device is used to introduce a device into a patient's vascular system via a catheter assembly including a main tubing, the device delivery device comprising: Extension fitting, the extension fitting including a proximal end, a distal end, and an outer fitting wall defining the inner cavity of the fitting; and An instrument disposed within the cavity of the fitting and including a proximal end and a distal end, the instrument being movable within the cavity of the fitting to an advance position, wherein, in the advance position, the distal end of the instrument extends into or beyond the distal end of the main tube; The proximal end of the device includes a retaining feature, the first outer diameter of which is larger than the second outer diameter of the distal end of the device, and the retaining feature includes a reinforcing structure to prevent deformation of the retaining feature.

2. The instrument conveying device according to claim 1, characterized in that, The device includes a secondary catheter that defines a catheter lumen extending between the proximal and distal ends of the secondary catheter.

3. The instrument conveying device according to claim 2, characterized in that, The retaining feature includes a tapered portion that expands radially outward from the second outer diameter to the first outer diameter, wherein the increased wall thickness of the tapered portion is greater than the wall thickness of the rest of the secondary conduit, thereby forming the reinforcing structure.

4. The instrument conveying device according to claim 3, characterized in that, The tapered portion having the increased wall thickness forms a funnel structure that defines a shaped opening leading to the lumen of the catheter.

5. The instrument conveying device according to claim 2, characterized in that, The reinforcing structure includes a reinforcing member formed of a reinforcing material, the stiffness of which is greater than the stiffness of the material forming the secondary conduit.

6. The instrument conveying device according to claim 5, characterized in that, The reinforcing component is fixed to the secondary conduit by one of adhesive bonding, welding, or forging.

7. The instrument conveying device according to claim 5, characterized in that, The retaining feature includes a tapering portion that expands radially outward from the second outer diameter to the first outer diameter, and wherein the reinforcing member is positioned within the lumen of the catheter and within the tapering portion.

8. The instrument conveying device according to claim 7, characterized in that, The reinforcing member defines an opening leading to the lumen of the catheter, the opening having a reduced opening area compared to the opening area defined by the tapered portion.

9. The instrument conveying device according to claim 7, characterized in that, The reinforcing component is formed as one of a wedge-shaped reinforcing member, an annular reinforcing member, and a truncated conical reinforcing member.

10. The instrument conveying device according to claim 5, characterized in that, The reinforcing component is positioned around the secondary conduit.

11. The instrument conveying device according to claim 5, characterized in that, At least one of the retaining feature and the reinforcing member is end-sloped to provide a rounded or chamfered end to the at least one of the retaining feature and the reinforcing member.

12. The instrument conveying device according to claim 2, characterized in that, The instrument delivery device further includes a distal connector positioned at the distal end of the extension tube to connect the extension tube to the catheter assembly.

13. The instrument conveying device according to claim 2, characterized in that, The instrument delivery device further includes a proximal connector positioned at the proximal end of the extension fitting, the proximal connector being configured to engage a fluid delivery device that delivers fluid to the catheter assembly via the secondary catheter.

14. The instrument conveying device according to claim 13, characterized in that, The device is configured to move between a retracted position and an advanced position in response to the injection of flushing fluid through the proximal connector.

15. The instrument conveying device according to claim 1, characterized in that, The instrument delivery device further includes a translation handle connected to the outer surface of the outer tube wall, wherein the translation handle is configured to move along the outer surface of the outer tube wall between a proximal position and a distal position to translate the distal end of the instrument between a retracted position and an advanced position.

16. The instrument conveying device according to claim 15, characterized in that, The translation handle engages the retaining feature via the outer tube wall to allow the instrument to move between the retracted position and the advance position.

17. A vascular access system, characterized in that, The vascular access system includes: The catheter assembly includes: A catheter adapter, the catheter adapter including a distal adapter port, a proximal adapter port and a lateral adapter port; A main tube, which is coupled to the distal adapter port and configured for insertion into the patient's vascular system; and A near-patient connector, the near-patient connector being connected to the side adapter port via a first fluid conduit, the near-patient connector including a distal connector port, a proximal connector port, and a side connector port; and According to claim 1, the instrument delivery device, wherein the extension tube is coupled to the near-patient connector at the proximal connector port.

18. The vascular access system according to claim 17, characterized in that, The vascular access system also includes an extension kit that is integrated with the proximal patient connector at the side connector port, the extension kit including a second fluid conduit for supplying fluid to the catheter assembly.

19. The vascular access system according to claim 17, characterized in that, The extension tube is integrated with the near-patient connector at the proximal connector port.

20. The vascular access system according to claim 17, characterized in that, The extension fitting is connected to the near-patient connector at the proximal connector port via one of a Luer connector and a locking element, the locking element comprising a blunt sleeve and a pair of locking arms.

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