Instrument delivery device having a linearly compressible housing

Abstract

Provided herein is a medical device including an introducer and an instrument having a proximal end and a distal end, the introducer configured to movably receive the instrument, an outer housing having a proximal end, a distal end, and a sidewall defining an interior space therebetween, and an inner housing having a proximal end, a distal end, and a sidewall therebetween, the outer housing being slidably received within the inner housing, the distal end of the introducer configured to couple the introducer to an intravenous line. The inner and / or outer housings are configured to move relative to one another to move the instrument between a first position and a second position and reduce the effective length of the device.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical devices for use with intravenous (IV) catheters, and more particularly to medical devices having features for improving performance with respect to access to the vascular system. [Background technology]

[0002] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Patent Application No. 17 / 901,034, filed September 1, 2022, entitled "Instrument Delivery Device Having a Linearly Compressible Housing," which is incorporated herein by reference in its entirety.

[0003] Description of Related Art When used with an indwelling IV catheter, an instrument delivery device, including an instrument used for blood collection, can include a displaceable instrument that is advanced beyond the tip of the indwelling catheter. Often, the displaceable instrument encounters obstacles as it advances, potentially resulting in deflection of the instrument. Examples of obstacles include friction of seals within the delivery device, tortuous paths within the integrated catheter, constriction of the catheter tube as it is inserted through the skin, thrombus, fibrin, and valves. Furthermore, instrument delivery can be complicated by instrument exchanges and the lengths required to deploy such instruments. Summary of the Invention [Problem to be solved by the invention]

[0004] Therefore, there is a need in the art for an instrument delivery device that allows for robust performance of the delivered instrument. [Means for solving the problem]

[0005] In this specification, an instrument having a proximal end and a distal end; an introducer configured to movably receive the instrument, the introducer including an outer housing having a proximal end, a distal end, and a sidewall defining an interior space therebetween, and an inner housing having a proximal end, a distal end, and a sidewall therebetween; A medical device comprising: a distal end of the introducer configured to couple the introducer to an venous line; the inner housing and the outer housing are displaceable relative to one another to move the device between a first position (where the device is disposed within the outer housing) and a second position (where the device is disposed beyond the distal end of the outer housing and at least a first portion of the device is disposed within the IV line when the introducer is connected to the IV line); The length of the inner housing and the outer housing is longer when the device is in the first position than when the device is in the second position; A medical device is provided. [Brief explanation of the drawings]

[0006] [Figure 1] FIG. 1 is a top view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 2] FIG. 1 is a perspective view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 3A] FIG. 1 is a perspective view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 3B] 1 is a cross-sectional view of an instrument delivery device and system according to a non-limiting embodiment described herein. [Figure 4] FIG. 1 is a perspective view of an instrument delivery device and system according to a non-limiting embodiment described herein. DETAILED DESCRIPTION OF THE INVENTION

[0007] 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 present invention.

[0008] In the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and derivatives thereof, refer to the present invention as oriented in the drawings. However, it should be understood that the present invention contemplates 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 related to the embodiments disclosed herein are not to be considered limiting.

[0009] It should be understood that numerical ranges recited 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 stated minimum value of 1 and the stated maximum value of 10, i.e., subranges having a minimum value of 1 or greater and a maximum value of 10 or less.

[0010] US Patent Application No. 17 / 570,554 is incorporated herein by reference in its entirety.

[0011] Provided herein are devices and systems for delivering certain devices through an indwelling catheter, such as a peripheral intravenous catheter (PIVC). Certain devices (e.g., blood collection devices) are described below and illustrated in the accompanying drawings in terms of devices that may be used with a PIVC. However, those skilled in the art will understand that any number of different types of 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.

[0012] Referring to FIG. 1 , a non-limiting embodiment of a system including a catheter assembly 10 and an instrument delivery device 110 is shown. 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. In some embodiments, the port 18 may be located between the distal end 14 and the proximal end 16. In some embodiments, two or more ports 18 may be located between the distal end 14 and the proximal end 16. In some embodiments, the port 18 may be located at the proximal end 16. In some embodiments, the first catheter adapter 12 may include a first lumen 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.

[0013] In some non-limiting embodiments or aspects, the catheter assembly 10 may include a catheter 22 extending from the distal end 14. In some embodiments, the first catheter 22 may include a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter. As known to those skilled in the art, the catheter 22 may be formed of any suitable material and may have any useful length. 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 skilled in the art and may have a distal end and a proximal end. 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., with one side port disposed at a 90-degree angle relative to the longitudinal axis of connector 30), a Y-connector (e.g., with one side port disposed 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. Connector 30 may include a second lumen extending therethrough with any number of branches appropriate for the type of connector.

[0014] In some non-limiting embodiments or aspects, the catheter assembly 10 may include an extension set (integrated with or detachably 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 and Company. In some non-limiting embodiments or aspects, the second fluid conduit 34 may include a Luer connection 36 at its end. In some non-limiting embodiments or aspects, the extension set may 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.

[0015] 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 a connector with direct fluid line 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 SMARTSITE. The non-limiting embodiment of FIG. 1 shows a needleless access connector disposed on a connector 30. However, one 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, such as a self-healing septum. In a non-limiting embodiment, the septum is a slit-type septum. As described below, the instrument delivery device 110 may be reversibly connectable to the needleless access connector 32, and one or more portions of the instrument delivery device may pierce the septum to access the patient's vasculature.

[0016] 1 and 2, instrument delivery device 110 includes an outer housing 116 having a proximal end and a distal end, and an inner housing. Throughout the illustrated embodiments, it will be apparent to those skilled in the art that the intended effect of the instrument delivery devices described herein is that when an instrument is delivered (e.g., when the instrument moves from a first configuration (in which the instrument does not extend beyond the distal end of outer housing 116) to a second configuration (in which the instrument extends beyond the distal end of outer housing 116)), the overall length of the housing of the instrument delivery device is shorter than when the instrument is not delivered. Assuming a shorter length when the instrument is delivered can reduce errors associated with site manipulation.

[0017] As shown in the non-limiting embodiment of FIGS. 1 and 2 , the inner housing can include multiple telescoping sections, such as telescoping sections 117 and 118. In a non-limiting embodiment, the first telescoping section 118 is slidably received within the second telescoping section 117. In a non-limiting embodiment, the second telescoping section 117 can be slidably received within the outer housing 116, such that the inner housing is slidably received completely or nearly completely within the outer housing 116. Each section of the inner housing includes a proximal end and a distal end, and in a non-limiting embodiment, the inner housing sections 117 and 118 can have variable diameters to enable the telescoping relationship. The device delivery device 110 further includes a device, which is illustrated in the drawings as a catheter or fluid conduit 150 having a proximal end and a distal end 152. However, based on the above description and as would be understood by one of ordinary skill in the art, the device can be any medical device that can be delivered to a patient's vascular system through the catheter assembly 10. The fluid conduit 150 is slidably received within the outer housing 116 and can be advanced and / or retracted relative to the outer housing 116 by displacement of the inner housing relative to the outer housing 116 .

[0018] In a non-limiting embodiment, the fluid conduit 150 may be advanced from a first position to a second position. In the first position, the distal end 152 of the fluid conduit 150 is within the instrument delivery device 110, e.g., the outer housing 116 and / or the lock 130. In the second position, the distal end 152 of the fluid conduit 150 is located distal to the lock 130, and, in embodiments in which the instrument delivery device 110 is coupled to the catheter assembly 10, optionally distal to the catheter 22. In FIGS. 1 and 2, the lock 130 is illustrated as a proboscis 132 and arms. However, one skilled in the art will appreciate that any type of suitable connection may be used to secure the instrument delivery device to an indwelling catheter (such as the catheter assembly 10). The connection may include 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. In some embodiments, instrument delivery device 110 may further include a connector 170 disposed at the proximal end of fluid conduit 150 to allow various medical instruments to be attached to inner housing 118, a clamp 180 to occlude flow through fluid conduit 150, and / or a grip 182 to assist in displacement of inner housing 118. Clamp 180 may be, for example, a slide clamp as shown in FIG. 1 or a pinch clamp. Suitable connectors 170 include luer connectors, luer lock access devices, needleless access connectors, etc., known to those skilled in the art.

[0019] Continuing with reference to Figures 1 and 2, and not limited to the illustrated embodiments, in a non-limiting embodiment, various portions 117, 118, and / or 119 of the inner housing may include lubricants between them, and / or between portions of the inner housing and outer housing 116, and / or between an instrument and inner portions 117, 118, and / or 119 and / or outer housing 116 to reduce the force required to advance an instrument (such as fluid conduit 150).

[0020] 3A-4, various embodiments of instrument delivery device 110 are shown in which outer housing 116 and / or inner housing 117 are collapsible. By "collapsible," we mean that the housing (or a portion of the housing) can be collapsed along the longitudinal axis from a first (longer) length to a second (shorter) length. Suitable collapsible materials, including plastic materials such as polyethylene, polypropylene, polyvinyl chloride, and elastomeric materials such as thermoplastic elastomers such as silicone and rubber (natural and synthetic), as well as arrangements such as accordion arrangements, are known to those skilled in the art. With reference to FIGS. 3A and 3B, an embodiment of an instrument delivery device is shown in which outer housing 116 is collapsible and inner housings 117, 118, 119 are rigid. Outer housing 116 may optionally be collapsible from a first extended configuration to a second collapsed configuration during advancement of an instrument (e.g., fluid conduit 150) by advancing inner housings 117, 118, 119 relative to outer housing 116. As shown in FIG. 3A , inner housings 117, 118, 119 may be telescopic, and the process of advancing the instrument involves nesting first housing portion 119 into second housing portion 118, which in turn nests into third housing portion 117. Outer housing 116 may be collapsed during or after instrument advancement to reduce the overall effective length of instrument delivery device 110. While FIG. 3A shows a telescopic inner housing, those skilled in the art will understand that inner housings 117, 118, 119 may include more or fewer telescopic portions or may be a unitary housing.

[0021] 4, an embodiment is shown in which outer housing 116 is a rigid housing and inner housing 117 is a collapsible housing. As mentioned above, the housings may optionally be collapsible from a first extended configuration to a second collapsed configuration during advancement of the instrument (e.g., fluid conduit 150) by advancing inner housing 117 relative to outer housing 116.

[0022] 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, however, that these details are for illustrative purposes 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. an instrument having a proximal end and a distal end; An introducer configured to movably receive an instrument, comprising: an outer housing having a proximal end, a distal end, and a sidewall defining an interior space therebetween; an inner housing having a proximal end, a distal end, and a sidewall therebetween; an introducer having A medical device comprising: a distal end of the introducer configured to couple the introducer to an venous line; the inner housing and the outer housing are displaceable relative to one another to move the instrument between the first and second positions; In the first position, the instrument is disposed within the outer housing; In the second position, the device is positioned beyond the distal end of the outer housing, and at least a first portion of the device is positioned within the IV line when the introducer is connected to the IV line; The length of the inner housing and the outer housing is longer when the device is in the first position than when the device is in the second position; A medical device characterized by:

2. 10. The medical device of claim 1, wherein the inner housing includes a plurality of telescoping portions, at least one of the telescoping portions configured to be received within the interior space of the outer housing.

3. 3. The medical device of claim 2, wherein the inner housing includes at least three telescopic sections, a first telescopic section being slidably received within a second telescopic section, and the second telescopic section being slidably received within a third telescopic section.

4. The medical device of claim 3 , wherein the third telescopic section is slidably received within the outer housing.

5. 10. The medical device of claim 1, wherein the inner housing is rigid and the outer housing is longitudinally collapsible between the first and second configurations, the length of the outer housing in the first configuration being greater than the length of the outer housing in the second configuration.

6. 10. The medical device of claim 1, wherein the outer housing is rigid and the inner housing is longitudinally collapsible between the first and second configurations, the length of the inner housing in the first configuration being greater than the length of the inner housing in the second configuration.

7. 10. The medical device of claim 1, wherein the outer housing includes a lock at a distal end thereof, the lock configured to couple the introducer to an intravenous line.

8. 10. The medical device of claim 1, wherein the instrument is one or more of a catheter, a guidewire, an obturator, a wire, an electrical wiring, a probe, a light pipe, and a sensor.

9. 10. The medical device of claim 1, wherein the instrument is a catheter including a proximal end and a distal end.

10. 10. The medical device of claim 9, further comprising a clamp disposed at a proximal end of the catheter and configured to selectively block fluid flow through the catheter.

11. 10. The medical device of claim 9, wherein the catheter includes a connector at its proximal end.

12. 10. The medical device of claim 1, further comprising a lubricant disposed between the inner housing and the outer housing.

13. The medical device of claim 1 , further comprising a lubricant between the instrument and the inner housing and / or the outer housing.

14. 10. A system comprising a catheter assembly and the medical device of claim 1, wherein the catheter assembly comprises: A catheter adapter, a distal end; the proximal end; a lumen extending between the distal end and the proximal end; a side port disposed between the distal end and the proximal end and in fluid communication with the lumen; a catheter adapter including: a catheter secured to a distal end of the catheter adapter and extending distally from the catheter adapter; a fluid conduit having a proximal end coupled to the side port and a distal end, the fluid conduit being in fluid communication with the side port; Contains A system comprising:

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