Instrument carrier with telescoping housing

Abstract

Provided herein is an instrument delivery device for advancing an instrument into a vascular access device. The instrument delivery device includes an outer housing, a connector coupled to the outer housing and including a protruding member for mating with the vascular access device, and an inner housing positioned within the outer housing and having a distal end for engaging a proximal end of an instrument. The inner housing is movable relative to the outer housing such that the distal movement moves the instrument from a first position to a second position, with the distal end of the instrument moving from within the outer housing and past the distal end of the protruding member. A fluid flow prevention seal disposed within or adjacent to the connector prevents fluid movement between the vascular access device and the interior volume of the outer housing.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Application No. 17 / 901,005, filed September 1, 2022, entitled "Instrument Delivery Device with Nested Housing," the entire disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] Background of the Invention FIELD OF THE INVENTION FIELD OF THE DISCLOSURE The present disclosure relates generally to an instrument delivery device for use with intravenous (IV) catheters, and more particularly to an instrument delivery device for improving performance in terms of accessing the vascular system.

[0003] 2. Description of Related Art Vascular access devices (VADs) are used in medicine to access a patient's peripheral vasculature for the purposes of infusion therapy and / or blood withdrawal. Common types of VADs include over-the-needle peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. VADs may be left in place for short-term (days), intermediate-term (weeks), or long-term (months to years).

[0004] Instrument delivery devices are often used with VADs to deliver instruments into an indwelling intravenous catheter, with the instrument delivery device advancing the instrument beyond the tip of the indwelling catheter. When the instrument delivery device is used to collect blood, by way of example, the instrument may be in the form of a flexible tube or catheter; however, in other embodiments, the instrument may be a guidewire, obturator, wire, electrical wiring, probe, or sensor(s). As the instrument is advanced, it often encounters obstacles that can result in the instrument deflecting. Examples of obstacles include friction of seals within the delivery device, tortuous paths within an integrated catheter, pinching of the catheter tubing as it penetrates skin, clots, fibrin, and valves. Furthermore, instrument delivery can be complicated by instrument exchange, the length required to deploy such instruments, and fluid leakage between the VAD and the instrument delivery device. Thus, there is a need in the art for an instrument delivery device that enables robust performance of the delivered instrument. Summary of the Invention

[0005] Provided herein is an instrument delivery device for advancing an instrument into a vascular access device. The instrument delivery device includes an outer housing defining an interior volume and having proximal and distal ends, and a connector positioned at the distal end of the outer housing and including a protruding member protruding from the outer housing configured to mate with an access connector of the vascular access device. The instrument delivery device also includes an inner housing having proximal and distal ends, the distal end positioned within the interior volume for engagement with the proximal end of an instrument, the inner housing configured to move relative to the outer housing such that distal movement of the inner housing moves the instrument from a first position where the distal end of the instrument is disposed within the outer housing to a second position where the distal end of the instrument is disposed beyond the outer housing and the distal end of the protruding member. The instrument delivery device further includes a fluid flow prevention seal disposed within or adjacent to the connector and configured to prevent fluid transfer between the vascular access device and the interior volume of the outer housing.

[0006] In some embodiments, the fluid flow prevention seal is a flexible sealing member positioned adjacent the proximal end of the connector between the connector and the outer housing, the flexible sealing member including an opening formed therein through which an instrument passes, the opening having a diameter smaller than a diameter of the instrument, and the opening configured to expand when an instrument passes therethrough.

[0007] In some embodiments, a seal lubricant is applied around the opening in the flexible seal member.

[0008] In some embodiments, the fluid flow prevention seal is a telescoping seal formed between the inner diameter of the lumen formed through the projection member and the outer diameter of an instrument advanced through the projection member when moved to the second position.

[0009] In some embodiments, the projection member is a blunt cannula, and the blunt cannula is one of a molded plastic cannula, a metal cannula, or a metal cannula overmolded with plastic.

[0010] In some embodiments, an instrument lubricant is applied to the outer surface of the instrument, at least along the portion of the instrument that may be advanced through the fluid flow prevention seal when the instrument is moved from the first position to the second position.

[0011] In some embodiments, the device includes a base material and a low-friction coating applied to an outer surface of the base material, the low-friction coating having a lower coefficient of friction than the base material.

[0012] Also provided herein is an instrument delivery device for advancing an instrument into a vascular access device. The instrument delivery device includes an outer housing defining an interior volume and having proximal and distal ends, and a connector positioned at the distal end of the outer housing configured to mate with the access connector of the vascular access device. The instrument delivery device also includes an inner housing having proximal and distal ends, the distal end positioned within the interior volume and configured to engage the proximal end of an instrument, the inner housing configured to move relative to the outer housing such that distal movement of the inner housing moves the instrument from a first position where the distal end of the instrument is disposed within the outer housing to a second position where the distal end of the instrument is disposed beyond the distal end of the outer housing. The instrument delivery device further includes one or more instrument supports positioned within the interior volume of the outer housing and configured to support the instrument as it is moved from the first position toward the second position to prevent buckling of the instrument, the one or more instrument supports being held in a fixed position within the interior volume until the inner housing is moved distally into contact therewith.

[0013] In some embodiments, each of the one or more instrument supports is a support washer or support cylinder having an opening formed therein through which the instrument passes.

[0014] In some embodiments, each of the one or more instrument supports is held in a fixed position within the interior volume of the housing via a friction fit or detent feature.

[0015] In some embodiments, each of the one or more instrument supports includes a tether member attached to an end or ends thereof, the tether member holding the instrument support in a fixed position within the interior volume.

[0016] In some embodiments, the inner housing slides one or more instrument supports distally as it contacts and continues to move distally, and the tether member is configured to return the instrument supports to their original positions within the internal volume as the inner housing is retracted proximally.

[0017] In some embodiments, a lubricant is applied to at least one of the instrument and the one or more instrument supports to reduce friction between the instrument and the one or more instrument supports.

[0018] In some embodiments, the inner diameter of the outer housing is configured to limit and / or prevent buckling of the device as the inner housing is advanced through the outer housing.

[0019] Also provided herein is an instrument delivery device for advancing an instrument into a vascular access device. The instrument delivery device includes an inner housing having proximal and distal ends and a connector positioned at the distal end of the inner housing configured to mate with the access connector of the vascular access device. The instrument delivery device also includes an outer housing defining an interior volume and having proximal and distal ends, the proximal end of the inner housing being positioned at its distal end within the interior volume of the outer housing, the outer housing configured to move relative to the inner housing such that distal movement of the outer housing moves the instrument from a first position where the distal end of the instrument is disposed within the inner housing to a second position where the distal end of the instrument is disposed beyond the distal end of the inner housing. Upon distal movement of the outer housing relative to the inner housing, the outer housing is advanced over the inner housing, and the inner housing is received within the interior volume of the outer housing.

[0020] In some embodiments, one or more instrument supports are positioned within the interior volume of the outer housing configured to support the instrument to prevent buckling of the instrument when the outer housing is moved distally over the inner housing and when the instrument advances from the first position toward the second position.

[0021] In some embodiments, the inner diameter of the inner housing is configured to limit and / or prevent buckling of the device when the outer housing is distally advanced over the inner housing.

[0022] Also provided herein is an instrument delivery device for advancing an instrument into a vascular access device. The instrument delivery device includes an outer housing defining an interior volume and having proximal and distal ends, and a connector positioned at the distal end of the outer housing configured to mate with the access connector of the vascular access device. The instrument delivery device also includes an inner housing having proximal and distal ends, the distal end positioned within the interior volume and configured to engage the proximal end of an instrument, the inner housing configured to move relative to the outer housing such that distal movement of the inner housing moves the instrument from a first position where the distal end of the instrument is disposed within the outer housing to a second position where the distal end of the instrument is disposed beyond the distal end of the outer housing and within the vascular access device. The instrument delivery device further includes a first position marker provided on the inner housing adjacent its distal end and a second position marker provided on the outer housing adjacent its distal end, wherein the first position marker is aligned with the second position marker when the instrument is in the second position extending within the vascular access device.

[0023] In some embodiments, the first position marker is an indicia located on the top surface of the inner housing and the second position marker is a window formed in the top surface of the outer housing, and the indicia are visible through the window when the instrument is in the second position.

[0024] In some embodiments, the indicator is one of a colored region, text, or a symbol. [Brief explanation of the drawings]

[0025] [Figure 1A] FIG. 1A is a side view of a catheter assembly and an associated instrument delivery device usable therewith, according to a non-limiting embodiment described herein, with the instrument delivery device in a first configuration. [Figure 1B] FIG. 1B is a side view of the catheter assembly and associated instrument delivery device of FIG. 1A, with the instrument delivery device in a second configuration. [Figure 2]FIG. 2 is a perspective view of the instrument delivery device of FIGS. 1A and 1B. [Figure 3] 3 is a partial cross-sectional view of the instrument delivery device of FIG. 1A taken along line aa, showing a connector according to an embodiment described herein. [Figure 4] 4 is an exploded view of a sealing member included in the connector of FIG. [Figure 5] FIG. 5 is an isolated view of an instrument support included in the instrument carrier of FIG. 1A, according to an embodiment described herein. [Figure 6] FIG. 6 is an isolated view of an instrument support included in the instrument carrier of FIG. 1A according to another embodiment described herein. [Figure 7A] FIG. 7A is a side view of a catheter assembly and an associated instrument delivery device usable therewith, according to another non-limiting embodiment described herein, the instrument delivery device being in a first configuration. [Figure 7B] FIG. 7B is a side view of the catheter assembly and associated instrument delivery device of FIG. 7A, with the instrument delivery device in a second configuration. [Figure 8] FIG. 8 is a perspective view of the instrument delivery device of FIGS. 7A and 7B. DETAILED DESCRIPTION OF THE INVENTION

[0026] Description of the Invention The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. All such modifications, equivalents, variations, and alternatives are intended to be within the spirit and scope of the invention.

[0027] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and derivatives thereof, shall refer to the present invention as oriented in the drawing figures. It should be understood, however, that the present invention may contemplate 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 present invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting.

[0028] As used herein, the terms "proximal" and "distal" refer to directions closer to and further from a user who brings the device into contact with a patient, respectively. Thus, for example, the end of a device that first contacts a patient's body is the distal end, while the opposite end of the device that is manipulated by the user is the proximal end of the device.

[0029] Terms such as "first," "second," etc. are not intended to refer to a particular order or chronology, but rather to different conditions, characteristics, or elements.

[0030] As used herein, "at least one" is synonymous with "one or more." For example, the phrase "at least one of A, B, and C" means any one of A, B, and C, or any two or more combinations of A, B, and C. For example, "at least one of A, B, and C" includes one or more As alone, or one or more Bs alone, or one or more Cs alone, or one or more As and one or more Bs, or one or more As and one or more Cs, or one or more Bs and one or more Cs, or all one or more of A, B, and C.

[0031] It should be understood that the numerical ranges set forth herein are intended to include all values ​​and subranges subsumed therein. For example, a range of "1 to 10" is intended to include all subranges between (and including) the implied minimum of 1 and the implied maximum of 10, i.e., subranges having minimum values ​​equal to or greater than 1 and maximum values ​​equal to or less than 10.

[0032] Provided herein are devices and systems for delivering instruments through an indwelling catheter, such as a peripheral intravenous catheter (PIVC). While particular devices (e.g., blood suction devices) are described below and illustrated in the accompanying drawings in terms of devices that may be used with a PIVC, one skilled in the art will understand that any number of different devices for introducing instruments 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.

[0033] 1A and 1B, shown are non-limiting embodiments of a system including a catheter assembly 10 and an instrument delivery device 110. Catheter assemblies suitable for use with the instrument delivery devices 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. The port 18 may be located between the distal end 14 and the proximal end 16, or multiple ports 18 may be located between the distal end 14 and the proximal end 16. The port 18 may alternatively be located at the proximal end 16. In some embodiments, the first catheter adapter 12 may include a first lumen 20 extending through the distal end 14 and the proximal end 16. The first lumen 20 may be sealed at the proximal end 16 of the catheter adapter 12.

[0034] In some non-limiting embodiments or aspects, the catheter assembly 10 may include a catheter 22 extending from the distal end 14. The first catheter 22 may include a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter. The catheter 22 may be formed of any suitable material and may be of any useful length, as known to those of skill in the art. In some non-limiting embodiments or aspects, 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 of skill in the art and may have a distal end 26 and a proximal end 28, and the first fluid conduit 24 may be coupled to the port 18 at its distal end 26. In some non-limiting embodiments or aspects, a connector 30 may be coupled to the proximal end 28 of the first fluid conduit 24. Connector 30 may be a t-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 an angle of 15 to 165 degrees relative to the longitudinal axis of connector 30), or any other type of connector known in the art, and may include a second lumen therein with any number of branches appropriate for the type of connector.

[0035] In some non-limiting embodiments or aspects, the catheter assembly 10 may include an extension set (integral to or removably connectable to the catheter adapter 12, connector 30, and / or needleless access connector 32) that includes a second fluid conduit, such as the second fluid conduit 34. Extension sets are known to those skilled in the art and are commercially available, for example, from Becton, Dickinson & Co. In some non-limiting embodiments or aspects, the second fluid conduit 34 may include a luer connection 36 at its end. The extension set may also include a clamp 40 to enable occlusion of the second fluid conduit 34. The clamp 40 and the second fluid conduit 34 may 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.

[0036] 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 split 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 tradenames Q-SYTE and SMARTSITE. While the non-limiting embodiment of FIGS. 1A and 1B 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 36. In a non-limiting embodiment, the needleless access connector 32 includes a septum (not shown), such as a slit-type self-healing septum. As described below, an instrument delivery device 110 may be reversibly connectable to the needleless access connector 32, such that one or more portions of the instrument delivery device may puncture the septum to access the patient's vasculature through the catheter 22.

[0037] 1A and 1B, and now also referring to FIG. 2, instrument delivery device 110 includes an outer housing 116 having a proximal end 120 and a distal end 122, and an inner housing 118 slidably received within outer housing 116. In a non-limiting embodiment, inner housing 118 and outer housing 116 have a telescoping relationship such that inner housing 118 can be slidably received entirely or nearly entirely within outer housing 116. Inner housing 118 also includes a proximal end 124 and a distal end 126, and in a non-limiting embodiment, the inner housing may have a variable diameter along its length. By way of example, distal end 126 of inner housing 118 may have a larger diameter than other portions of inner housing 118 to provide more localized stiffness or sliding feature(s) and limit friction or binding. As another example, distal end 126 of inner housing 118 may have a smaller diameter than the remainder of inner housing 118 and may be positioned to maintain inner housing 118 in place in the blood-drawing advanced state, freeing the operator's hands to manipulate additional components (e.g., a vacutainer tube). Instrument delivery device 110 further includes an instrument 150 having a proximal end 152 and a distal end 154. While instrument 150 is illustrated in the drawings as a catheter or fluid conduit, those skilled in the art will understand that instrument 150 may be any medical instrument capable of being delivered through catheter assembly 10 to a patient's vascular system, such as a guidewire, obturator, wire, electrical wiring, probe, sensor, or the like.

[0038] Instrument 150 is 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. In non-limiting embodiments, instrument 150 may be advanced from a first position, as shown in FIG. 1A , where distal end 154 of instrument 150 is within instrument delivery device 110, e.g., outer housing 116 and / or connector 130 (which, for example, secures instrument delivery device 110 to needleless access connector 32), to a second position, as shown in FIG. 1B , where distal end 154 of instrument 150 is located at the distal end of connector 130 and, in embodiments where instrument delivery device 110 is coupled to catheter assembly 10, optionally at the distal end of catheter 22. Although connector 130 is illustrated as a lock (hereinafter "lock 130") including a blunt cannula 132 and an arm 134, those skilled in the art will understand that any type of suitable connection for securing instrument delivery device 110 to an indwelling catheter such as catheter assembly 10 may be used, 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, or the like.

[0039] The instrument 150 useful with the instrument delivery device 110 described herein may be formed from any useful material. In a non-limiting embodiment, the instrument 150 is a fluid conduit formed from a polymer, such as a polyimide-containing material, nylon, polyurethane, or other suitable polymeric material. In other embodiments, the instrument 150 includes a base material and a low-friction coating applied to the outer surface of the base material, the low-friction coating having a lower coefficient of friction than the base material. Furthermore, the inner housing 118 may be formed from any suitable material, including polymeric materials, elastomeric materials, metallic materials, and combinations thereof, so long as the material has sufficient rigidity to reduce buckling. In a non-limiting embodiment, the inner housing 118 is formed from a material that provides resistance to buckling, such as polyethylene, polypropylene, nylon, or polyurethane.

[0040] As can be seen, Figure 1A shows the instrument delivery device in a first condition, with the instrument 150 in a first position received within the outer housing 116 and the inner housing 118 in a first position extending proximally from the outer housing. In a non-limiting embodiment, the inner housing 118 is coupled to or otherwise interacts with the instrument 150 such that the inner housing 118 is advanced distally to a second position, as shown in Figure 1B, and the instrument 150 is moved to the second position where the distal end 154 of the instrument 150 extends beyond the outer housing 116, lock 130 (if present), and / or catheter 22.

[0041] In a non-limiting embodiment, inner housing 118 may be distally advanced relative to outer housing 116 by a user grasping grip 182 and applying a distally directed force to 118. Grip 182 may be located at the proximal end of inner housing 118 and may be located at or near a 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 while a user is gripping instrument delivery device 110 and may include features, for example, to enhance grip and prevent slippage while inner housing 118 is being advanced / retracted.

[0042] As mentioned above, the distal end of the inner housing 118 may be larger in diameter than the remainder of the inner housing 118, and when the inner housing 118 is retracted, one or more features on the outer housing 116 may interact with the enlarged portion of the inner housing 118 to prevent the inner housing 118 from being fully withdrawn from the outer housing 116. The enlarged distal portion of the inner housing 118 may include vents to allow air to pass therethrough, reducing the force required to advance / retract the inner housing 118, and, as described below, a lubricant 190 may be applied to the enlarged portion of the inner housing 118 to reduce friction between the inner housing 118 and the outer housing 116.

[0043] Inner housing 118 may include a connector 170 at its proximal end 124 to allow various medical devices to be attached to inner housing 118, for example, to provide a device that can be advanced into a patient's vascular system, to inject compositions into the vascular system, and / or to receive fluids withdrawn from the vascular system. Suitable connectors 170 include those known to those skilled in the art, including luer connectors, luer lock access devices, needleless access connectors, electrical connectors, optical connectors, and any combination of the foregoing connector types.

[0044] In a non-limiting embodiment in which device 150 is a fluid conduit, fluid (e.g., blood) may be transported into or out of the vascular system of a patient in which a catheter, such as catheter 22, is placed. As shown in FIGS. 1A and 1B and 2 , fluid conduit 150 may be joined to inner housing 118 at fitting 164. According to a non-limiting embodiment, fluid conduit 150 may be joined at fitting 164 to a separate fluid tube 166 that passes through inner housing 118 and is connected to connector 170. In other non-limiting embodiments, fluid conduit 150 may be joined to inner housing 118 at fitting 164, with inner housing 118 itself forming a fluid conduit in fluid communication with connector 170 (i.e., inner housing 118 functions as a fluid conduit in place of separate fluid tube 166). In any of the above-described embodiments, a fluid control component 180 may be provided at the proximal end 124 of the inner housing 118 suitable for occluding fluid flow through the inner housing 118 and / or the fluid conduit 150. Although the fluid control component 180 is illustrated as a clamp (e.g., a slide clamp or a pinch clamp), the component 180 may instead be a valve (e.g., a stopcock) according to the embodiment.

[0045] In a non-limiting embodiment, the inner housing 118 and the outer housing 116 may include position markers 186, 188 to indicate the length and position of the device relative to the indwelling catheter 22. In a non-limiting embodiment, a first position marker 186 on the inner housing 118 may be provided as an indicia 186 such as a colored area, text, or symbol, and a second position marker 188 may be provided on the outer housing 116 as a window 188 formed at least partially from a transparent material. The indicia 186 may be provided on the top surface (or the entire outer surface) of the inner housing 118 adjacent its distal end 126, and the window 188 may similarly be provided on the top surface of the outer housing 116 adjacent its distal end 122. The indicia 186 and window 188 allow an operator to identify the positioning of the inner housing 118, and therefore the positioning of the device 150, relative to the outer housing 116. In particular, the indicia 186 and the window 188 allow the operator to identify when the instrument 150 is extended within the catheter assembly 10 and is in a second position in which the instrument 150 extends into or beyond the indwelling catheter 22. When the instrument 150 is in the second position, the inner housing 118 is advanced within the outer housing 116 so that the indicia 186 is aligned with and visible through the window 188. The indicia 186 being visible within the window 188 reminds the operator that the instrument 150 needs to be retracted toward the first position before it can be fully advanced and the instrument delivery device 110 removed from the catheter assembly 10.

[0046] While the position markers 186, 188 are described above as indicia 186 and window 188, additional embodiments may include a second position marker 188 in the form of an additional indicia provided on the top surface of the outer housing 116. In such embodiments, the top surface of the outer housing 116 may be formed of a material that is at least partially transparent along the length of the outer housing 116 to allow visualization of the indicia 186 throughout the transition from the first position of the inner housing 118 to the second position of the inner housing 118. The additional indicia may be provided beneath this transparent material at the distal end 122 of the outer housing. When the inner housing 118 is advanced into the outer housing 116 to move the instrument 150 to the second position, the indicator 186 on the inner housing 118 aligns with the additional indicator on the outer housing 116 (both visible through the transparent top surface of the outer housing 116), indicating to the operator that the instrument 150 has been advanced sufficiently and must be retracted toward the first position before the instrument delivery device 110 can be removed from the catheter assembly 10.

[0047] According to embodiments, the instrument delivery device 110 may include any of a number of features to prevent unwanted fluid transfer between the catheter assembly 10 and the instrument delivery device 110, e.g., to prevent blood or other fluids from leaking out of or entering the blood flow path other than through the intended ports. That is, various anti-fluid flow seals may be provided within or adjacent to the lock 130 of the instrument delivery device 110 configured to prevent undesired transfer of fluid between the catheter assembly 10 and the interior volume 192 (FIG. 2) of the outer housing 116.

[0048] 1A and 1B, and now with reference to FIG. 3, lock 130 of instrument delivery device 110 is configured to be physically and fluidly coupled to outer housing 116 and configured to couple instrument delivery device 110 to an access device, such as needleless access connector 32, of catheter assembly 10. Lock 130, as shown in FIG. 3, includes a coupling portion 194, a blunt cannula 132, and a pair of arms 134. Lock 130 further defines a lumen 196 extending through coupling portion 194 and blunt cannula 132. Coupling portion 194 is configured to couple lock 130 to an end coupling portion 198 of outer housing 116. Specifically, in this embodiment, coupling portion 194 includes and / or forms one or more protrusions configured to selectively engage threads defined and / or formed in end coupling portion 198 of outer housing 116, thereby forming a threaded connection.

[0049] The blunt cannula 132 extends from the linkage 194 and is disposed between the pair of arms 134. The blunt cannula 132 may be of any suitable structure, shape, size, and / or configuration. In some embodiments, the blunt cannula 132 may be configured as a molded plastic cannula, a metal cannula, or a metal cannula overmolded with plastic, with the lumen 196 thus defined by the molded plastic or metal cannula (itself or overmolded with plastic). The blunt cannula 132 may have a length sufficient to extend at least through the needleless access connector 32 and into the connector 30 of the catheter assembly 10. In embodiments, as described further below, the dimensional tolerances of the lumen 196 may be tightly controlled in manufacturing the lock 130 / cannula 132 in order to control the clearance between the outer surface of the instrument 150 and the inner surface of the lumen 196.

[0050] In some embodiments, a fluid flow prevention seal is formed within lock 130 based on the size of lumen 196 of blunt cannula 132 relative to the size of instrument 150. That is, lumen 196 can have an inner diameter 202 (i.e., the diameter of the surface at least partially defining lumen 196) that is similar to or slightly larger than the outer diameter 204 of a portion of instrument 150 (e.g., within 0.5 mm), such that when the instrument is moved to the second position, a mating seal is formed between inner diameter 202 of lumen 196 within blunt cannula 132 and outer diameter 204 of instrument 150 as the instrument is advanced through blunt cannula 132. By minimizing the space between inner diameter 202 of lumen 196 and outer diameter 204 of instrument 150, the space through which fluid can flow is reduced, thereby slowing or stopping the flow of such fluid if the space is small enough to balance the pressure and surface tension of the fluid.

[0051] In some embodiments, a lubricant 190 (e.g., a silicone-based lubricant) can be added to the lumen 196 of the blunt cannula 132 or to the outer surface of the instrument 150 to reduce friction between the instrument 150 and the blunt cannula 132. In addition to reducing friction, the lubricant 190 can also fill any remaining gap between the inner diameter 202 of the lumen 196 and the outer diameter 204 of the instrument 150, further helping to prevent fluid flow through this gap.

[0052] In some embodiments, a fluid flow prevention seal is formed adjacent lock 130 by providing a flexible septum or seal member 200. Flexible seal member 200 may be positioned adjacent a proximal end of lock 130, such as between coupling portion 194 and end coupling portion 198 of outer housing 116, and may seat in a groove 206 formed in end coupling portion 198 to be held in place when coupling portion 194 is coupled thereto (e.g., via a threaded engagement or a snap fit). Flexible seal member 200, according to one embodiment, may be formed from a flexible elastomeric material and includes an opening 208 formed therein through which instrument 150 passes. As shown in FIG. 4 , opening 208 has a diameter 210 that is smaller than the outer diameter 204 of instrument 150, and is configured so that opening 208 expands as instrument 150 passes therethrough. Based on the size of the opening, a seal is formed between seal member 200 and instrument 150 when an instrument is advanced through the opening when the conduit is moved to the second position. In some embodiments, a lubricant 190 (e.g., a silicone-based lubricant) can be added to the opening 208 of the seal member 200 or to the outer surface of the instrument 150 to reduce friction between the instrument 150 and the seal member 200.

[0053] According to embodiments, instrument delivery device 110 may also include any of a number of features that provide a more robust system for accessing a patient's vasculature, such as limiting and / or preventing bowing and buckling of instrument 150. That is, various support, restraining, and guiding features may be provided on instrument delivery device 110 that function to minimize bowing or buckling of instrument 150 as it advances through outer housing 116.

[0054] 1A, 1B, and 2, and now FIGS. 5 and 6, instrument delivery device 110 includes one or more instrument supports 212 disposed within interior volume 192 of outer housing 116 to limit and / or prevent buckling of instrument 150 as inner housing 118 and / or instrument 150 are advanced distally through outer housing 116. In some embodiments, multiple instrument supports 212 are provided and positioned at optimal locations between proximal end 120 and distal end 122 of outer housing 116 determined to provide the necessary support for instrument 150 as it is advanced distally by instrument delivery device 110, such as at locations where instrument 150 encounters greatest drag and / or resistance. Instrument supports 212 effectively divide the single long strut of instrument 150 into multiple shorter struts, each of which has a much higher buckling strength than a single long strut.

[0055] 5 and 6, each of the instrument supports 212, according to an embodiment, includes a body 214, which may be configured as a washer or cylindrical structure, or may have another cross-sectional shape based at least in part on the cross-sectional shape of the outer housing 116. The body 214 defines a passageway 216, which is sized and shaped to allow the instrument 150 to pass freely therethrough while at least partially receiving and preventing excessive movement of the instrument 150 within the interior volume 192 of the outer housing 116.

[0056] According to embodiments, the body 214 of each instrument support portion 212 may include features sized and / or included to help hold the instrument support portion 212 in place within the outer housing 116. In one embodiment, the outer diameter of the body 214 of the instrument support portion 212 approximates the inner diameter of the outer housing 116, such that a friction fit is provided between the instrument support portion 212 and the outer housing 116 to hold the instrument support portion 212 in place. In another embodiment, the body 214 of the instrument support portion includes detents 218 formed on its outer surface that interact with the inner surface of the outer housing 116 to hold the instrument support portion 212 in place. Through any of these features described above, the instrument support portion 212 may be held in place within the outer housing 116 until operation of the instrument delivery device 110 causes the inner housing 118 to move distally within the outer housing 116 and contact the instrument support portion 212. Upon contacting the instrument support portions 212 and continuing to move distally, the inner housing 118 causes the instrument support portion(s) 212 to slide distally within the outer housing 116 .

[0057] In some embodiments, each instrument support body 212 may have one or more tether members 220 secured thereto and extending between the body 214 and the outer housing 116. The tether members 220 may be configured as flexible, rigid, or semi-rigid members. According to embodiments, each instrument support 210 may have a single tether member 220 coupled to one end of the body 214, or two tether members 220 coupled to opposite ends of the body 214. The tether members 220 function to return the instrument support 212 to its original position within the interior volume 192 (i.e., reset the position of the instrument support 212) after the inner housing 118 slides the instrument support 212 distally within the outer housing 116, as the tether members 220 pull the instrument support 212 back to its original position as the inner housing 118 is retracted toward the proximal end 120 of the outer housing 116.

[0058] To further reduce the chance of warping or buckling of the instrument 150, friction-reducing materials or coatings may be utilized on various components of the instrument carrier 110. In some embodiments, the various components of the instrument carrier 110, such as the instrument 150, the instrument support 212, the seal 200, and the lock 130 (or portions thereof), may be formed from low-friction materials such as, by way of example, polyethylene, polypropylene, or PTFE. In other embodiments, one or more of the above components may have a low-friction coating applied to the outer surface of the component's base material, where the low-friction coating has a lower coefficient of friction than the base material. The coating may be provided, by way of example, as PTFE or Parylene. In still other embodiments, a suitable lubricant 190 (e.g., silicone oil) may be applied to one or more of the above components, all of which will reduce friction and aid in the advancement and insertion of the instrument 150.

[0059] In some embodiments, the outer housing 116 may be configured to limit the amount of bowing and buckling experienced by the instrument 150 as it is advanced through the outer housing 116. To reduce the amount that the instrument 150 may bow or buckle during advancement, the inner diameter 222 of the outer housing 116 may be reduced to reduce the available space into which the instrument 150 may deflect as it is advanced, thereby controlling the shape and amount that the instrument 150 bows. As the instrument 150 begins to bow under compressive forces, it will contact the smaller inner diameter 222 of the outer housing 116, thereby preventing the instrument 150 from bowing or buckling further.

[0060] 7A, 7B, and 8, another embodiment of an instrument delivery device 230 is shown. The instrument delivery device 230 includes an outer housing 232 and an inner housing 234 in a telescoping relationship, but may be generally described as an "inverted nesting housing" device due to its inverted arrangement compared to the inner housing 118 and outer housing 116 of the instrument delivery device 110—i.e., the inner housing 234 is positioned distally and adjacent to the catheter assembly 10 connected thereto, while the outer housing 232 is positioned proximally away from the catheter assembly 10. The inner housing 234 includes a proximal end 236 and a distal end 238, and the outer housing 232 includes a proximal end 240 and a distal end 242. The outer housing 232 is advanced distally through interaction therewith by an operator such that the outer housing 232 slides over the inner housing 234, and the inner housing 234 may be received wholly or nearly wholly within the outer housing 232.

[0061] The device delivery device 230 further includes a device 150, which is illustrated in the drawings as a catheter or fluid conduit having a proximal end 152 and a distal end 154, but may be any medical device capable of being delivered to a patient's vascular system through the catheter assembly 10, as previously described and as will be understood by those skilled in the art. In embodiments in which the device 150 is a fluid conduit, the fluid conduit may be joined at a fitting 164 to a separate fluid tube 166 that passes through the outer housing 232 and connects to a connector 170.

[0062] The instrument 150 is received within the inner housing 234 and may be advanced and / or retracted relative to the inner housing 234 by displacement of the outer housing 232 relative to the inner housing 234. In a non-limiting embodiment, the instrument 150 may be advanced from a first position, as shown in FIG. 7A , where the distal end 154 of the instrument 150 is within the inner housing 234 and / or the instrument delivery device 230, for example, within the lock 130 (e.g., securing the instrument delivery device 230 to the needleless access connector 32), to a second position, as shown in FIG. 7B , where the distal end 154 of the instrument 150 is positioned at the distal end of the connector 130, and optionally at the distal end of the catheter 22 in embodiments where the instrument delivery device 230 is coupled to the catheter assembly 10.

[0063] In some embodiments, outer housing 232 may be distally advanced relative to inner housing 234 by a user grasping grip 182 and applying a distally directed force to outer housing 232. Grip 182 may be located at proximal end 240 of outer housing 232 and may be formed of an ergonomic material to provide comfort while a user is gripping instrument delivery device 230, and may include features to increase grip and prevent slippage while outer housing 232 is being advanced / retracted, for example.

[0064] By positioning the smaller diameter inner housing 234 closer to the catheter assembly 10 and the patient, the inner housing 234 may limit the amount of bowing and buckling that the device 150 experiences as it is advanced therethrough. That is, because the inner housing 234 has a smaller inner diameter than the outer housing 232, the inner housing 234 reduces the available space into which the device 150 can deflect as it is advanced, thereby controlling the shape and amount that the device 150 bows. As the device 150 begins to bow under compressive forces, it will contact the smaller inner diameter of the inner housing 234, thereby preventing the device 150 from bowing or buckling further.

[0065] In some embodiments, one or more instrument supports 212 may be disposed within outer housing 232 to limit and / or prevent buckling of instrument 150 as the instrument is distally advanced through inner housing 234 (in response to distal movement of outer housing 232). In some embodiments, multiple instrument supports 212 are provided and positioned at optimal locations between proximal end 240 and distal end 242 of outer housing 232, such as locations where instrument 150 encounters greatest drag and / or resistance, as determined to provide the necessary support for instrument 150 as it is distally advanced by instrument delivery device 230. Instrument supports 212 effectively divide the single long strut of instrument 150 into multiple shorter struts, each with a much higher buckling strength than a single long strut.

[0066] 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 can be combined with one or more features of any other embodiment.

Claims

1. 1. An instrument delivery device for advancing an instrument within a vascular access device, the instrument delivery device comprising: an outer housing defining an interior volume and having a proximal end and a distal end; a connector positioned at a connector distal end of the connector outer housing and including a protruding member protruding from the outer housing configured to mate with an access connector of the vascular access device; an inner housing having a proximal end and a distal end, the distal end positioned within the interior volume for engagement with the proximal end of the instrument, the inner housing configured to move relative to the outer housing such that distal movement of the inner housing moves the instrument from a first position where the distal end of the instrument is disposed within the outer housing to a second position where the distal end of the instrument is disposed beyond the outer housing and the distal end of the projection member; and a fluid flow prevention seal disposed within or adjacent to the connector and configured to prevent fluid movement between the vascular access device and the interior volume of the outer housing; An instrument transport device comprising:

2. 2. The instrument delivery device of claim 1, wherein the fluid flow prevention seal comprises a flexible sealing member positioned adjacent the proximal end of the connector between the connector and the outer housing, the flexible sealing member including an opening formed therein through which the instrument passes, the opening having a diameter smaller than a diameter of the instrument, and the opening configured to expand when the instrument passes therethrough.

3. The instrument delivery device of claim 2 further comprising a seal lubricant applied around the opening in the flexible seal member.

4. 2. The instrument delivery device of claim 1, wherein the fluid flow prevention seal comprises a mating seal formed between an inner diameter of a lumen formed through the projection member and an outer diameter of the instrument advanced through the projection member when moved to the second position.

5. The instrument delivery device of claim 1 , wherein the protruding member comprises a blunt cannula, the blunt cannula being one of a molded plastic cannula, a metal cannula, or a metal cannula overmolded with plastic.

6. 10. The instrument delivery device of claim 1, further comprising an instrument lubricant applied to an outer surface of the instrument along at least a portion of the instrument that may be advanced through the fluid-flow prevention seal when the instrument is moved from the first position to the second position.

7. 10. The instrument delivery device of claim 1, wherein the instrument comprises a base material and a low-friction coating applied to an outer surface of the base material, the low-friction coating having a lower coefficient of friction than the base material.

8. 1. An instrument delivery device for advancing an instrument within a vascular access device, the instrument delivery device comprising: an outer housing defining an interior volume and having a proximal end and a distal end; a connector positioned at the distal end of the outer housing and configured to mate with an access connector of the vascular access device; an inner housing having a proximal end and a distal end, the distal end positioned within the interior volume and engaged with the proximal end of the instrument, the inner housing configured to move relative to the outer housing such that distal movement of the inner housing moves the instrument from a first position where the distal end of the instrument is disposed within the outer housing to a second position where the distal end of the instrument is disposed beyond the distal end of the outer housing; and one or more instrument supports positioned within the interior volume of the outer housing and configured to support the instrument and prevent buckling of the instrument as the instrument is moved from a first position toward a second position, the one or more instrument supports being held in a fixed position within the interior volume until the inner housing is moved distally into contact therewith; An instrument transport device comprising:

9. 9. An instrument carrier according to claim 8, wherein each of the one or more instrument supports comprises a support washer or support cylinder having an opening formed therein through which the instrument passes.

10. The instrument transport device of claim 8 , wherein each of the one or more instrument supports is held in the fixed position within the interior volume of the housing via a friction fit or detent feature.

11. 9. The instrument delivery device of claim 8, wherein each of the one or more instrument supports includes a tether member attached to an end or both ends thereof, the tether member holding the instrument support in the fixed position within the interior volume.

12. 12. The instrument delivery device of claim 11, wherein the inner housing continues to slide the one or more instrument support portions distally upon contact therewith, and the tether member is configured to return the instrument support portions to their original positions within the internal volume when the inner housing is retracted proximally.

13. 9. An instrument delivery device according to claim 8, wherein a lubricant is applied to at least one of the instrument and the one or more instrument supports to reduce friction between the instrument and the one or more instrument supports.

14. 9. The instrument delivery device of claim 8, wherein the inner diameter of the outer housing is configured to limit and / or prevent buckling of the instrument as the inner housing is advanced through the outer housing.

15. 1. An instrument delivery device for advancing an instrument into a vascular access device, the instrument delivery device comprising: an inner housing having a proximal end and a distal end; a connector positioned at the distal end of the inner housing configured to mate with an access connector of the vascular access device; and an outer housing defining an interior volume and having a proximal end and a distal end, the proximal end of the inner housing being positioned at the distal end within the interior volume of the outer housing, the outer housing being configured to move relative to the inner housing such that distal movement of the outer housing moves the instrument from a first position where the distal end of the instrument is disposed within the inner housing to a second position where the distal end of the instrument is disposed beyond the distal end of the inner housing; When the outer housing is moved distally relative to the inner housing, the outer housing is advanced over the inner housing and the inner housing is received within the interior volume of the outer housing. Instrument transport device.

16. 16. The instrument transport device of claim 15, further comprising one or more instrument supports positioned within the internal volume of the outer housing and configured to support the instrument and prevent buckling of the instrument as the outer housing is moved distally on the inner housing and as the instrument advances from the first position toward the second position.

17. 16. The instrument delivery device of claim 15, wherein the inner diameter of the inner housing is configured to limit and / or prevent buckling of the instrument when the outer housing is advanced distally over the inner housing.

18. 1. An instrument delivery device for advancing an instrument within a vascular access device, the instrument delivery device comprising: an outer housing defining an interior volume and having a proximal end and a distal end; a connector positioned at the distal end of the outer housing and configured to mate with an access connector of the vascular access device; an inner housing having a proximal end and a distal end, the distal end positioned within the interior volume and engaged with the proximal end of the instrument, the inner housing configured to move relative to the outer housing such that distal movement of the inner housing moves the instrument from a first position where the distal end of the instrument is disposed within the outer housing to a second position where the distal end of the instrument is disposed beyond the distal end of the outer housing within the vascular access device; and a first position marker disposed on the inner housing adjacent a distal end thereof; and a second position marker disposed on the outer housing adjacent its distal end; Equipped with the first position marker aligns with the second position marker when the instrument is extended within the vascular access device at the second position. Instrument transport device.

19. 19. The instrument delivery device of claim 18, wherein the first position marker comprises an index disposed on a top surface of the inner housing and the second position marker comprises a window formed in the top surface of the outer housing, the index being visible through the window when the instrument is in the second position.

20. 20. The instrument delivery device of claim 19, wherein the indicia comprises one of a colored area, text, or a symbol.

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