Instrument delivery device with curved, nested housing
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- BECTON DICKINSON & CO
- Filing Date
- 2023-08-31
- Publication Date
- 2026-07-06
Smart Images
Figure 00000000_0000_ABST
Abstract
Description
[Technical Field]
[0001] This application claims priority to U.S. Patent Application No. 17 / 901,026, filed September 1, 2022, entitled "Instrument Delivery Device with Curved Nested Housing," the entire disclosure of which is incorporated herein by reference in its entirety.
[0002] The present disclosure relates to medical devices for use with catheters, and more particularly to device delivery devices for improving the delivery of devices within a catheter or through an intravenous (IV) catheter to the vascular system. [Background technology]
[0003] When used with an indwelling catheter, instrument delivery devices, including those used to withdraw blood, can include a movable instrument that can be advanced into and / or beyond the tip of the indwelling catheter. As a movable instrument advances, it often encounters obstacles that can cause the instrument to deflect. Examples of obstacles include friction from seals within the delivery device, tortuous paths within the integrated catheter, pinching of the catheter tubing as the catheter extends into the skin, thrombus, fibrin, and valves. Furthermore, instrument delivery can be complicated by instrument exchanges and the necessary lengths required to deploy such instruments. Therefore, there is a need in the art for an instrument delivery device that enables reliable delivery and performance of instruments introduced into a catheter and / or the vascular system. [Prior art documents] [Patent documents]
[0004] [Patent Document 1] International Publication No. 2023076195 Summary of the Invention
[0005] The present invention is directed to a medical device including an instrument having a proximal end and a distal end, and an introducer configured to movably receive the instrument. The introducer includes an outer housing having proximal and distal ends and a sidewall between the proximal and distal ends that define a passageway, and an inner housing having proximal and distal ends and a sidewall between the proximal and distal ends that define an interior volume. The passageway of the outer housing may be curved, and the outer housing may also be curved. The inner housing is slidably received within the outer housing. The distal end of the introducer is configured to couple the introducer to an intravenous line, and the inner housing is movable relative to the outer housing to move the instrument between a first position in which the instrument is disposed within the outer housing and a second position in which the distal end of the instrument is disposed beyond the distal end of the outer housing such that at least a portion of the instrument is disposed within the intravenous line when the introducer is coupled to the intravenous line.
[0006] The curvature of the passageway of the outer housing may follow an arc of a circle. The curvature of the outer housing may also follow an arc of a circle. The inner housing may be straight, or the inner housing may be curved along an arc of a circle. The inner housing may extend along an arc of a circle corresponding to the arc of the circle through which the outer housing extends. The inner and outer housings may extend along substantially equal arcs of a circle. When the inner housing is in the first position, the combined inner and outer housings may extend around a partial circle, a full circle, or more than one circle.
[0007] The passageway in the outer housing may be coiled with at least one turn extending around one circle.
[0008] The outer housing may be tubular or may be a coil of concentric turns having a set shape imparted by the material of the outer housing. The concentric turns of the outer housing may be attached to one another along all or part of the contact area between the concentric turns. The outer housing may be tubular and the concentric turns of the outer housing may be attached to one another by at least one connector.
[0009] The outer housing may be a single or multi-part housing defining a coiled passageway. The exterior of the outer housing may have a shape other than a coiled shape, and the passageway defined within the outer housing is coiled. The outer housing may be an assembly of two or more parts connected in a clamshell configuration.
[0010] The inner housing may be straight. The inner housing may be coiled and have a diameter larger than the diameter of the outer housing and surround the outer housing, or the outer housing may be coiled and the inner housing may be coiled and have a diameter smaller than the diameter of the outer housing and may be positioned within the middle of the outer housing. The inner housing may be coiled and positioned adjacent to the outer housing. The inner housing may include any number of full and / or partial turns.
[0011] The length of the inner housing may be approximately equal to the length of the outer housing.
[0012] The present invention is further directed to a system including a catheter assembly and the medical device described above. The catheter assembly includes a catheter adapter and a catheter extending distally from the catheter adapter. The catheter adapter includes a distal end, a proximal end, a lumen extending between the distal and proximal ends, and a side port disposed between the distal and proximal ends, the side port being in fluid communication with the lumen. A medical device is attached to the side port, and the catheter is in fluid communication with the lumen.
[0013] The medical device may be coupled to the side port by a fluid conduit having a proximal end coupled to the side port and a distal end coupled to the medical device.
[0014] The device may be one or more of a catheter, a guidewire, an occluder, a wire, an electrical wiring, a probe, a light pipe, and a sensor. [Brief explanation of the drawings]
[0015] [Figure 1A] FIG. 1A shows a top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 1B] FIG. 1B shows a top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 2A] FIG. 2A shows a top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 2B] FIG. 2B shows a top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 3A] FIG. 3A shows a top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 3B] FIG. 3B shows a top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 4A] FIG. 4A shows a top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 4B] FIG. 4B shows a top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 5A] FIG. 5A shows a schematic top view of the outer and inner housings of an instrument delivery device according to a non-limiting embodiment described herein. [Figure 5B]FIG. 5B shows a schematic top view of the outer and inner housings of an instrument delivery device according to a non-limiting embodiment described herein. [Figure 5C] FIG. 5C shows a schematic top view of the outer and inner housings of an instrument delivery device according to a non-limiting embodiment described herein. [Figure 6] FIG. 6 shows a top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 7] FIG. 7 shows a partial top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 8] FIG. 8 shows a partial top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 9] FIG. 9 shows a perspective view of an instrument delivery device according to a non-limiting embodiment described herein. [Figure 10] FIG. 10 shows a partial top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 11A] FIG. 11A shows a partial view of an instrument delivery device according to a non-limiting embodiment described herein. [Figure 11B] FIG. 11B shows a partial view of an instrument delivery device according to a non-limiting embodiment described herein. [Figure 11C] FIG. 11C shows a partial view of an instrument delivery device according to a non-limiting embodiment described herein. [Figure 12A] FIG. 12A shows a partial view of an instrument delivery device according to a non-limiting embodiment described herein. [Figure 12B] FIG. 12B shows a partial view of an instrument delivery device according to a non-limiting embodiment described herein. [Figure 13] FIG. 13 shows a perspective view of an instrument delivery device according to a non-limiting embodiment described herein. DETAILED DESCRIPTION OF THE INVENTION
[0016] The following description is provided to enable any person skilled in the art to make and use the described embodiments intended to practice the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, equivalents, variations, and alternatives are intended to be within the spirit and scope of the present invention.
[0017] Hereinafter, for purposes of explanation, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and their derivatives will refer to the invention as oriented in the drawings. However, it will be understood that the invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings, and described in the following specification, are merely exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting.
[0018] It should be understood that any numerical range recited herein is intended to include all subranges subsumed therein. For example, a range of "1 to 10" is intended to include all subranges between (and including) the recited minimum of 1 and the recited maximum of 10, i.e., ranges having a minimum of 1 or more and a maximum of 10 or less.
[0019] Provided herein are devices and systems for delivering devices through an indwelling catheter, such as a peripheral intravenous catheter (PIVC). While particular devices (e.g., blood collection devices) are described below with respect to devices that may be used with a PIVC and may be illustrated in the accompanying drawings, one skilled in the art will understand that any number of different devices for introducing devices may be used within the scope of this disclosure, including devices ranging from tubing, probes, sensors (e.g., pressure sensors, pH sensors, lactate sensors, glucose sensors, etc.), wiring, fiber optics, guidewires, etc.
[0020] 1A-4B illustrate non-limiting embodiments of a system including a catheter assembly 10 and an instrument delivery device 110. Suitable catheter assemblies for use with the instrument delivery device 110 described herein are commercially available, for example, from Becton, Dickinson and Company under the trade name Nexiva. The catheter assembly 10 may include a catheter adapter 12, which may include a distal end 14 and a proximal end 16. In some embodiments, the catheter adapter 12 may include one or more additional ports 18. In some embodiments, the additional ports 18 may be disposed between the distal end 14 and the proximal end 16 of the catheter adapter 12. In some embodiments, more than one port 18 may be disposed between the distal end 14 and the proximal end 16 of the catheter adapter 12. In some embodiments, the additional ports 18 may be disposed at the proximal end 16 of the catheter adapter 12. In some embodiments, the catheter adapter 12 may include a first lumen 20 extending through the distal end 14 and the proximal end 16 of the catheter adapter 12. The first lumen 20 may be sealed at the proximal end 16 of the catheter adapter 12 .
[0021] In some non-limiting embodiments, the catheter assembly 10 may include a catheter 22 extending from the distal end 14 of the catheter adapter 12. The catheter 22 may be any catheter suitable for accessing a patient's vascular system, including, but not limited to, a peripheral venous catheter, a midline catheter, an arterial catheter, a peripherally inserted centrally inserted catheter (PICC), or a central venous catheter (CVC) access device (VAD), including integrated or non-integrated vascular access devices. The catheter 22 may be formed of any suitable material and of any useful length, as known to those skilled in the art. In some non-limiting embodiments, the catheter assembly 10 may include a first fluid conduit 24 extending from the port 18. The first fluid conduit 24 may be formed of any suitable material known to those skilled in the art and may have a distal end 26 and a proximal end 28. The first fluid conduit 24 may be coupled to the port 18 at its distal end 26. In some non-limiting embodiments, a connector 30 may be coupled to the proximal end 28 of the first fluid conduit 24. Connector 30 may be a connector (e.g., one side port positioned at a 90 degree angle relative to the longitudinal axis of connector 30), a y-connector (e.g., one side port positioned at a 25 degree, 60 degree, or 75 degree angle relative to the longitudinal axis of connector 30), or any other type of connector known in the art, and may include a second lumen therethrough with any number of branches appropriate to the type of connector 30.
[0022] The catheter assembly 10 may include a needleless access connector 32 and / or a second fluid conduit 34. Suitable needleless access connectors 32 may include any separate septum connector and / or those with direct fluid pathway access. Needleless access connectors 32 are known to those skilled in the art and are commercially available, for example, from Becton, Dickinson and Company under the trade names Q-SYTE and Smart Site. While the non-limiting embodiment of FIGS. 1A-4B shows a needleless access connector disposed on a connector 30, those skilled in the art will understand that a suitable needleless access connector may also be disposed on a Luer connection 36. In a non-limiting embodiment, the needleless access connector 32 includes a septum (not shown), such as a self-healing septum. In a non-limiting embodiment, the septum is a slit-type septum. As described below, an instrument delivery device 110 is reversibly coupleable to the needleless access connector 32, and one or more portions of the instrument delivery device 110 may penetrate the septum and access the patient's vasculature via the catheter 22.
[0023] In some non-limiting embodiments, the catheter assembly 10 can include an extension set (integrated with or removably connectable to the catheter adapter 12, connector 30, and / or needleless access connector 32) that includes a second fluid conduit, such as second fluid conduit 34. Extension sets are known to those skilled in the art and are commercially available, for example, from Becton, Dickinson and Company. In some non-limiting embodiments, the second fluid conduit 34 can include a Luer connection 36 at its end. In some non-limiting embodiments, the extension set can include a clamp 40 that allows for occlusion of the second fluid conduit 34. The clamp 40 and the second fluid conduit 34 can be formed of any suitable material known to those skilled in the art. In non-limiting embodiments, the second lumen (e.g., within the connector 30) has an inner diameter substantially equal to the inner diameter of the first fluid conduit 24 and / or the second fluid conduit 34.
[0024] 1A-4B , instrument delivery device 110 includes outer housing 116 having a proximal end, a distal end, and a sidewall that define passageway 120, and inner housing 118 having a proximal end, a distal end, and a sidewall that define an interior volume that is slidably received within outer housing 116. In a non-limiting embodiment, inner housing 118 and outer housing 116 are nested together such that inner housing 118 can be slidably received completely or nearly completely within outer housing 116. In a non-limiting embodiment, inner housing 118 can have a variable diameter along its length, for example, a distal end of inner housing 118 can be larger in diameter than other portions of inner housing 118.
[0025] The outer housing 116 defines a curved passageway 120 that receives the inner housing 118. In one non-limiting embodiment, the curvature of the passageway 120 of the outer housing 116 may follow at least a circular arc. The curvature of the passageway 120 of the outer housing 116a may have a curved arch shape (large radius arc) as shown in FIGS. 4A and 4B, the outer housing 116b may extend around a substantial portion of a circle ( FIGS. 5A and 5B), or the outer housing 116c may take the form of at least one coil that extends around a complete circle ( FIGS. 1A-3B). The coiled outer housing 116c may include any number of full and / or partial turns, e.g., at least one full circular turn of the coil ( FIGS. 1A and 1B ), or more than one full circular turn of the coil ( FIGS. 2A-3B ).
[0026] In one non-limiting embodiment (FIGS. 1A and 1B), the outer housing 116c can be tubular and can be coiled with concentric turns of the coiled outer housing 116c in a set shape provided by the material of the outer housing 116c. The concentric turns of the outer housing 116c can be separated from one another (FIGS. 1A and 1B) or attached to one another along all or part of the contact area between the concentric turns.
[0027] In another non-limiting embodiment (FIGS. 2A and 2B), outer housing 116 a may be tubular with a concentric rotation of outer housing 116 c attached to one another by at least one connector 122 .
[0028] In yet another non-limiting embodiment (FIGS. 3A and 3B), the outer housing 116c can be a single or multiple housing that defines a coiled passageway 120 in which the inner housing 118 is received. While the exterior of the outer housing 116c can have a coiled shape as shown in FIGs. 3A and 3B, the exterior of the outer housing 116c can have any shape so long as the passageway 120 defined within the outer housing 116c is coiled. The outer housing 116c can be an assembly of two or more parts connected in a clamshell configuration.
[0029] The outer housing 116 can be rigid, semi-flexible, or flexible. For example, the outer housing 116 can be made from any suitable material, including plastic. For example, the outer housing 116 can be made from polyurethane, polycarbonate, and / or polypropylene. The material of the outer housing 116 can be transparent, i.e., clear or translucent.
[0030] The inner housing 118a, 118b may be straight (not shown), or the inner housing 118a, 118b may be curved along at least an arc (FIGS. 1A-4B). In a non-limiting embodiment, the inner housings 118a, 118b may be rigid or semi-rigid tubes that extend along an arc of a circle corresponding to the arc of the circle along which the outer housings 116a, 116b extend (FIGS. 4A-5C). The inner housings 118a, 118b and the outer housings 116a, 116b may extend along substantially equal arcs of a circle. When the inner housing 118b is in a first position extending from the outer housing 116b, the combined inner housing 118b and outer housing 116b may extend around a partial circle (FIGS. 4A, 4B, and 5A), a complete circle (FIG. 5B), or more than a complete circle (FIG. 5C).
[0031] In another non-limiting embodiment, the inner housing 118c can be coiled with concentric rotations of the inner housing 118c in a set shape provided by the material of the inner housing 118c (FIGS. 1A-3B). Alternatively, the inner housing 118c can be flexible such that the inner housing 118c bends as it enters the outer housing 116.
[0032] In a further non-limiting embodiment, the inner housing 118c may be coiled, have a diameter larger than the diameter of the coiled outer housing 116c, and may surround the coiled outer housing 116c (FIGS. 2A-3B). The inner housing 118c may be coiled, have a diameter smaller than the diameter of the coiled outer housing 116c, and may be disposed within a central region of the coiled outer housing 116c (FIGS. 1A and 1B). The inner housing 118c may be coiled, have the same or a different diameter than the coiled outer housing 116c, and may be disposed adjacent to the coiled outer housing 116c. The coiled inner housing 118c may include any number of full and / or partial turns, e.g., at least one full circular turn of the coil, or multiple full circular turns of the coil.
[0033] Inner housing 118 may be made of any suitable material that minimizes potential buckling of inner housing 118, including, for example, polymeric and elastomeric materials such as polyethylene, polypropylene, nylon, polyurethane, and metallic materials. Those skilled in the art will appreciate that a variety of materials may be suitable as long as they minimize potential buckling of inner housing 118.
[0034] In a non-limiting embodiment, the length of the inner housing 118 is approximately equal to the length of the outer housing 116 .
[0035] In a non-limiting embodiment, the instrument delivery apparatus 110 can include a fastener 130 at its distal end for attaching the instrument delivery device 110 to the catheter 22 or catheter adapter 12. In a non-limiting embodiment, the fastener 130 can be a nose 132 coupled to a locking arm 134. The nose 132 is configured to provide a fluid-tight seal with the catheter assembly 10, for example, by having a diameter that closely matches the diameter of the catheter adapter 12 and / or needleless access connector 32, thereby limiting the ability of fluid to leak between the outer wall of the nose 132 and the inner wall of the catheter adapter 12 and / or needleless access connector 32. While the securement device 130 is illustrated in Figures 1A-4B and 6-8 as a nose 132 and locking arms 134, those skilled in the art will appreciate that any type of suitable connector may be used to secure the device delivery device 110 to the indwelling catheter 22 or catheter assembly 10, including a luer connection, a clip, a blunt plastic cannula, a blunt metal cannula, a hybrid luer (e.g., with a cannula), a friction fit, etc.
[0036] Instrument delivery device 110 further includes instrument 150, illustrated in the drawings as a catheter or fluid conduit having a proximal end and a distal end 152. As previously discussed and as would be understood by one of ordinary skill in the art, the instrument may be any medical device that can be delivered to a patient's vascular system via catheter assembly 10, such as one or more of a fluid conduit, catheter, guidewire, obturator, wire, electrical wiring, probe, light pipe, and sensor. Instruments useful in instrument delivery device 110 described herein may be formed of any useful material; for example, instrument 150 may be a fluid conduit formed of a polymer, such as a polyimide-containing material, nylon, polyurethane, or another suitable polymeric material.
[0037] Instrument 150 is slidably received within outer housing 116 and may be advanced and / or retracted relative to outer housing 116 by displacement of inner housing 118 relative to outer housing 116. Figures 1A, 2A, 3A, and 4A show instrument delivery device 110 in a first state, with distal end 152 of instrument 150 in a first position and received within outer housing 116 and / or fastener 130, and inner housing 118 in the first position and extending proximally from outer housing 116. Figures 1B, 2B, 3B, and 4B show instrument delivery device 110 in a second state, with distal end 152 of instrument 150 in a second position and extending distally from outer housing 116 and / or fastener 130, and inner housing 118 in the second position and received within outer housing 116.
[0038] The length of outer housing 116 and inner housing 118 of instrument delivery device 110 in a first position in which inner housing 118 extends from outer housing 116 should be substantially longer than instrument 150 to be inserted into the vascular system, typically twice the length of instrument 150. Thus, if straight outer and inner housings were provided, instrument delivery device 110 could be cumbersome and difficult to use. In instrument delivery device 110 of the present invention, curved outer housing 116 and inner housing 118, particularly coiled outer housing 116c and inner housing 118c, reduces the overall length of instrument delivery device 110, making instrument delivery device 110 more compact and easier to use, particularly when outer housing 116 and / or inner housing 118 are coiled.
[0039] Additionally, the curved instrument delivery device 110, having an arcuate outer housing 116a and inner housing 118a, allows the user to preselect a curve orientation to better access the intravenous catheter by allowing the instrument delivery device 110 to curve around the patient's arm, the patient's bed, or other obstacles. For example, when the instrument delivery device 110 is being used on the patient's left arm, the selected curve orientation of the instrument delivery device 110 may be different than when the instrument delivery device 110 is being used on the patient's right arm. Or, when the patient's arm is in a position in bed with a handrail, the curved instrument delivery device 110 allows the instrument delivery device 110 to be adjusted for more ergonomic use. The pre-curved instrument 150 within the curved housings 116a, 118a also allows the user to guide the instrument 150 as it passes through the catheter adapter 12 and the vasculature. This can be accomplished by rotating the instrument delivery device 110 to orient the curve and position the instrument 150 in the desired advancement direction.
[0040] In a non-limiting embodiment, inner housing 118 is coupled to or interacts with instrument 150 such that when inner housing 118 is advanced distally to the second position, for example, by a user grasping grip 182 and applying a distal force to inner housing 118, instrument 150 moves to the second position and distal end 152 of instrument 150 extends beyond outer housing 116, anchor 130 (if present), and / or catheter 22. Grip 182 is disposed at the proximal end of inner housing 118 and may be located at or near clamp 180 suitable for occluding fluid flow through inner housing 118 and / or instrument 150, as described in more detail below. Grip 182 may be formed of an ergonomic material to provide comfort for a user while gripping instrument delivery device 110 and may include features, for example, to increase grip strength and prevent slippage while inner housing 118 is advanced / retracted. Clamp 180 can be, for example, a slide clamp as shown in FIGS. 1A-4B, or a pinch clamp as shown in FIG.
[0041] As mentioned above, the distal portion of the inner housing 118 can be larger in diameter than the remainder of the inner housing 118, such that when the inner housing 118 is retracted, one or more features of the outer housing 116 can interact with the enlarged portion of the inner housing 118 to prevent the inner housing 118 from being completely pulled from the outer housing 116. The enlarged distal portion of the inner housing 118 may include a vent to allow air to pass therethrough, thereby reducing the force required to advance / retract the inner housing 118 within the outer housing 116, and, as described below, a lubricant 190 can be applied to the enlarged distal portion of the inner housing 118 to reduce friction between the inner housing 118 and the outer housing 116.
[0042] In a non-limiting embodiment, any portion of instrument delivery device 110 can be flexible to allow freedom of pivoting and / or rotation when instrument delivery device 110 is in use.
[0043] As described below and shown in the accompanying drawings, instrument delivery device 110 can include a number of features to provide a more robust system for accessing a patient's vascular system. With continued reference to FIGS. 1A and 1B and 7, in a non-limiting embodiment, joint 113 can be included at the distal end of outer housing 116, for example, between outer housing 116 and fixation device 130. Suitable joints 113 can include swivel and revolute joints. Such joints 113 can increase the ease of use of instrument delivery device 110, for example, by allowing greater access in terms of distance from the patient's skin and by allowing fixation of the indwelling catheter by avoiding excessive manipulation of catheter assembly 10 during instrument delivery and associated medical procedures.
[0044] In a non-limiting embodiment, the nose 132 of the fixture 130 is formed of a flexible material to similarly allow freedom to swivel and / or rotate to avoid over-manipulation of the catheter assembly 10 .
[0045] The inner housing 118 may include a connector 170 at its proximal end that allows various medical devices to be attached to the inner housing 118, thereby providing, for example, an instrument 150 that can be advanced relative to a patient's vascular system to inject compositions into the vascular system and / or receive fluids withdrawn from the vascular system. Suitable connectors 170 include luer connectors, luer lock access devices, needleless access connectors, and the like, known to those skilled in the art. The connector 170 may also include an electrical connector, an optical connector, or a combination thereof.
[0046] 1A , 2A , 3A , and 4A , and 6 , in a non-limiting embodiment, the inner housing 118 can include one or more indicia 184, 186 disposed on its exterior surface. Suitable indicia can be visual and / or tactile, for example, to indicate the length and / or position of the device relative to the indwelling catheter 22. In a non-limiting embodiment, the one or more indicia 186 are provided on the inner housing 118, and the outer housing 116 can be formed of a material that is at least partially transparent to allow visualization of the indicia 186 throughout the transition of the inner housing 118 from a first position in which the inner housing 118 is substantially outside the outer housing 116 to a second position in which the inner housing 118 is substantially within the outer housing 116. In a non-limiting embodiment, separate indicia in the form of tactile stops 184 can be included at one or more locations along the inner housing 118 to provide a tactile indication to the user of a particular threshold. For example, tactile catch 184 may indicate that instrument 150 has nearly reached its full extension, may indicate that instrument 150 cannot be extended any further (e.g., as shown in FIG. 1B), and / or may indicate that instrument 150 is approaching the patient's vasculature.
[0047] Alternatively, or in addition to the indicia 184 , 186 provided on the inner housing 118 , indicia such as those described above may be provided on the outer housing 118 .
[0048] 9 and 13, one or more septa 200 and one or more seals 205, 207 may be disposed about a portion of instrument 150 and may be movable with instrument 150 through outer housing 116. Sealings 205, 207 may be located at the proximal end of instrument 150 or at any suitable location along instrument 150. Sealings 205, 207 and septa 200 may include venting mechanisms to facilitate advancement and retraction of instrument 150.
[0049] 1A-4B and Figures 6, 8, and 9, in a non-limiting embodiment, lubricant 190 may be applied to one or more locations on or within one or more components of instrument delivery device 110. For example, lubricant 190 may be applied to the exterior surface of the distal portion (e.g., nose 132) of outer housing 116 of instrument delivery device 110 that is inserted into an indwelling catheter 22, such as catheter assembly 10, to reduce the force required to couple the devices together. Adding lubricant 190 to nose 132 facilitates connection of instrument delivery device 110 to catheter assembly 10 despite their similar diameters. Lubricant 190 may be applied to one or more locations within outer housing 116, such as one or more exterior surfaces of inner housing 118 or one or more exterior surfaces of instrument 150. Lubricant 190 may be applied to the exterior surfaces of one or more of seals 205, 207. Lubricant 190 may also, or alternatively, be provided around the opening through septum 200 through which instrument 150 may pass. Suitable lubricants are known to those skilled in the art and may include silicone-based lubricants.
[0050] 1A-4B, 6, and 10, in a non-limiting embodiment, instrument delivery device 110 includes one or more supports 210 disposed within outer housing 116 to limit and / or prevent buckling of inner housing 118 and / or instrument 150 as inner housing 118 and / or instrument 150 advance distally therethrough. Support 210 may include a narrowed portion of passageway 120 of outer housing 116 with one or more washers and / or the like disposed around inner housing 118 and / or instrument 150 to reduce the effective buckling length and / or buckling mode shape of inner housing 118 and / or instrument 150. Suitable supports are also described in U.S. Patent Application Publication No. 2021 / 0129994, filed October 29, 2021, the contents of which are incorporated herein by reference in their entirety.
[0051] 1A-4B and 11A-11C, in a non-limiting embodiment, for example, when device 150 is a fluid conduit, a fluid, such as blood, may be transferred to or from a patient's vascular system in which a catheter, such as catheter 22, may be placed. In a non-limiting embodiment as shown in FIGS. 1A, 2A, 3A, 4A, and 11B, fluid conduit device 150 may be coupled at junction 163 to a separate fluid conduit 166 that passes through inner housing 118. Separate fluid conduit 166 may extend beyond the proximal end of inner housing 118 and, optionally, be coupled to connector 170 via adapter 172, as shown in FIG. 11B, for example. In a non-limiting embodiment, fluid conduit device 150 is long enough to pass directly through inner housing 118, optionally through adapter 172, to couple to connector 170. 11A and 11C, for example, the inner housing 118 itself forms a fluid conduit in fluid communication with the fluid conduit fitting 150. In the embodiment of FIG. 11C, a separate fluid tube 173 is provided at the proximal end of the inner housing 118, optionally via an adapter 172, to fluidly couple the inner housing 118 to the connector 170. In any of the described embodiments, an adapter 172 can be provided to fluidly couple the fluid conduit 166, the inner housing 118, and / or the fluid conduit fitting 150 to the connector 170 as described hereinabove.
[0052] With regard to the connector 170 described above, with reference to FIGS. 12A and 12B, various non-limiting configurations of the connector 170 are illustrated. As shown in FIG. 12A, the connector 170 can be coupled to a fluid conduit (e.g., a fluid conduit instrument 150 or a fluid conduit 166) with a clamp 180 and a grip 182 disposed distally of the connector 170. The connector 170 can be a luer connector, a luer lock access device, a needleless access connector, or the like, as described above, known to those skilled in the art. As shown in FIG. 12B, the outer housing 118 can include an angled portion at its proximal end, for example, such that the connector 170 is positioned not parallel to the longitudinal axis of the outer housing 116. In any embodiment, the connector 170 can be coupled to the inner housing 118 and / or the fluid conduit (e.g., a fluid conduit instrument 150 or a fluid conduit 166) via an adapter 172.
[0053] With further reference to the figures, in a non-limiting embodiment, the inner housing 118 and the outer housing 116, together with the clamp 180, can be configured to draw blood through the fluid line device 150 when the fluid line device 150 is in a second position in which the distal end 152 of the fluid line device 150 is disposed within the patient's vasculature. In a non-limiting embodiment, while the clamp 180 is in the first configuration, blood can be drawn into the fluid line device 150, preventing fluid flow to the connector 170. With that fluid path occluded, blood can flow, for example, through one or more openings in the fluid line device 150 and / or the fluid conduit 166, filling a volume within the outer housing 116, for example, between the outer housing 116 and the inner housing 118, and / or between the outer surface of the fluid line device 150 and / or the fluid conduit 166 and the inner surface of the inner housing 118. After the volume is filled, the clamp 180 can be reoriented to a second configuration in which fluid flow to the connector 170 is unimpeded. Once the volume between the outer surface of the fluid line device 150 and / or fluid line 166 and the inner surface of the inner housing 118 is already filled, a fresh blood sample can be drawn through the connector 170 to any medical device coupled thereto.
[0054] While the present disclosure has been described in detail for purposes of illustration based on what are presently considered to be the most practical and preferred embodiments or aspects, it should be understood that such detail is for that purpose only, and that the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary 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. It is a medical device, An instrument having a proximal end and a distal end, An introducer configured to movably receive the aforementioned device, An outer housing having a proximal end, a distal end, and a side wall between the proximal end and the distal end that define a passage, wherein the passage is curved, An inner housing having a proximal end, a distal end, and a side wall between the proximal and distal ends, wherein the inner housing is slidably received within the outer housing, An introducer having, Equipped with, A medical device comprising: a distal end of the introducer configured to connect the introducer to a venous line; an inner housing movable relative to the outer housing, and moving the instrument between a first position in which the instrument is positioned within the outer housing and a second position in which the distal end of the instrument is positioned beyond the distal end of the outer housing such that at least a portion of the instrument is positioned within the venous line when the introducer is connected to a venous line.
2. The medical device according to claim 1, wherein the outer housing is curved.
3. The medical device according to claim 1, wherein the curvature of the passage in the outer housing follows the arc of a circle.
4. The medical device according to claim 1, wherein the curvature of the outer housing follows the arc of a circle.
5. The medical device according to claim 1, wherein the inner housing is straight.
6. The medical device according to claim 1, wherein the inner housing is curved along the arc of a circle.
7. The medical device according to claim 1, wherein the inner housing extends along the arc of a circle corresponding to the arc of the circle on which the outer housing extends.
8. The medical device according to claim 1, wherein the inner housing and the outer housing extend along an arc of substantially equal circles.
9. The medical device according to claim 6, wherein when the inner housing is in the first position, the combined inner housing and outer housing extend around a partial circle.
10. The medical device according to claim 6, wherein when the inner housing is in the first position, the combined inner housing and outer housing extend around a circle of one revolution.
11. The medical device according to claim 6, wherein when the inner housing is in the first position, the combined inner housing and outer housing extend around a circle of more than one rotation.
12. The medical device according to claim 1, wherein the passage of the outer housing is coil-shaped and has at least one rotating portion extending around a circle of one revolution.
13. The medical device according to claim 12, wherein the outer housing is tubular and has a coil shape of a concentric rotating part having a set shape given by the material of the outer housing.
14. The medical device according to claim 12, wherein the concentric rotating parts of the outer housing are mounted to one another along all or part of the contact area between the concentric rotating parts.
15. The medical device according to claim 12, wherein the outer housing is tubular, and the concentric rotating portions of the outer housing are attached to each other by at least one connector.
16. The medical device according to claim 11, wherein the outer housing is one or more partial housings defining a coiled passage.
17. The medical device according to claim 16, wherein the outer surface of the outer housing has a shape other than a coil shape, and the passage defined within the outer housing is coil-shaped.
18. The medical device according to claim 16, wherein the outer housing is an assembly of two or more parts connected in a clamshell structure.
19. The medical device according to claim 11, wherein the inner housing is straight.
20. The medical device according to claim 11, wherein the inner housing is coil-shaped and has a diameter larger than the outer housing's diameter, surrounding the outer housing.
21. The medical device according to claim 11, wherein the outer housing is coil-shaped, the inner housing is coil-shaped, and the inner housing has a diameter smaller than the diameter of the outer housing and is positioned in the middle of the outer housing.
22. The medical device according to claim 11, wherein the inner housing is coil-shaped and is arranged adjacent to the outer housing.
23. The medical device according to claim 20, wherein the inner housing includes any number of one-turn rotations and / or partial rotations.
24. The medical device according to claim 1, wherein the length of the inner housing is approximately equal to the length of the outer housing.
25. A catheter assembly, A catheter adapter, The distal end and The proximal end and A lumen extending between the distal end and the proximal end, A side port located between the distal end and the proximal end, the side port having fluid communication with the lumen, Catheter adapters including A catheter assembly comprising, A catheter extending distally from the catheter adapter and communicating fluidly with the lumen, The medical device according to claim 1, coupled to the side port, A system that includes this.
26. The system according to claim 25, wherein the medical device is connected to the side port by a fluid tube having a proximal end connected to the side port and a distal end connected to the medical device.
27. The system according to claim 25, wherein the instrument is one or more of a catheter, a guidewire, an occluder, a wire, electrical wiring, a probe, a light pipe, and a sensor.