A vascular access system having an integrated catheter, integrated catheter septum access, stabilization features, and an extension set providing direct probe access

Abstract

A vascular access system for use with a blood aspiration or probe delivery device includes a catheter adapter having a proximal end portion and a distal end portion, the catheter extending from the distal end portion of the catheter adapter, and an extension set. The extension set includes a stabilization platform, a catheter adapter interface configured to secure the proximal end portion of the catheter adapter, and a probe access portion. The probe access portion includes a needleless connector configured to receive a distal connector portion of the blood aspiration or probe delivery device, the probe access portion being arranged in series with the catheter adapter and providing a direct fluid path for a tube or probe of the blood aspiration or probe delivery device to advance through the probe access portion, the catheter adapter, and the catheter.

Description

Technical Field

[0001] Cross - reference to related applications This application claims the priority of Indian Provisional Application No. 202211028612, filed on May 18, 2022, entitled "Vascular Access System with an Integrated Catheter, Integrated Catheter Septum Access, Stabilizing Features, and Extension Set Providing Direct Probe Access", the entire disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Background of the Invention Field of the Invention This disclosure generally relates to vascular access systems, such as, for example, peripheral intravenous catheters (PIVCs). More particularly, this disclosure relates to vascular access systems optimized for compatibility with blood aspiration and / or probe delivery devices.

[0003] Description of the Related Art Catheters are commonly used to inject fluids into a patient's vasculature. For example, catheters are used to inject normal saline, various pharmaceuticals, or total parenteral nutrition. Additionally, catheters may also be used to withdraw blood from a patient.

[0004] The catheter may be an over - the - needle peripheral intravenous catheter (PIVC). In this case, the catheter may be placed over an introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter and the bevel of the needle faces upward away from the patient's skin. The catheter and the introducer needle are generally inserted at a shallow angle from the skin into the patient's vasculature. After proper placement of the needle, the operator may temporarily occlude the flow in the vasculature, remove the needle, and leave the catheter in place (i.e., "indwell") for future blood withdrawal and / or infusion.

[0005] For the purpose of completing blood aspiration from a PIVC having an indwelling catheter, a blood aspiration device has been developed that is configured to overcome previous problems associated with blood aspiration via a PIVC, such as the possibility of catheter collapse and a reduction in blood flow due to debris accumulated on or within the catheter. One such device, the PIVO™ from Velano Vascular, is configured as a single-use device that is temporarily attached to a PIVC to aspirate a blood sample. Using an existing peripheral venous line as a conduit into the vascular system, the PIVO™ device advances a probe in the form of a flexible internal flow tube through the PIVC and beyond the catheter tip into the blood vessel to collect a blood sample. This flow tube is designed to reach a blood vessel location where the blood flow is optimal for aspiration, beyond the suboptimal blood aspiration conditions around the indwelling line. When blood collection is complete, the flow tube is retracted and the device is removed from the PIVC and discarded.

[0006] In addition to blood aspiration devices such as the PIVO™ device described above, similar devices for advancing a probe (e.g., a nitinol wire, a guide wire, an instrument, an obturator, a rod, a wire with a fluid path, and / or a sensor) through an indwelling catheter into a patient's vascular system have also been developed. However, existing vascular access devices generally are not optimized for compatibility with these blood aspiration and / or probe delivery devices, and as a result, manipulation of the catheter access site is increased when using the probe, thus increasing the risk of catheter dislodgment due to connection, disconnection, and / or use of the blood aspiration or probe delivery device(s). SUMMARY OF THE INVENTION

[0007] In accordance with one aspect of the present disclosure, a vascular access system for use with a blood aspiration or probe delivery device is disclosed. The system includes a catheter adapter having a proximal end portion and a distal end portion, with a catheter extending from the distal end portion of the catheter adapter, and an extension set. The extension set includes a stabilization platform, a catheter adapter interface configured to secure the proximal end portion of the catheter adapter, and a probe access portion including a needleless connector configured to receive a distal connector portion of the blood aspiration or probe delivery device, the probe access portion being positioned in-line with the catheter adapter to provide a direct fluid path for the blood aspiration or probe delivery device's tube or probe to advance through the probe access portion, the catheter adapter, and the catheter.

[0008] In some embodiments, the catheter adapter interface extends from the top surface of the stabilization platform.

[0009] In some embodiments, the probe access portion is coupled to the top surface of the stabilization platform.

[0010] In some embodiments, the extension set further includes a septum access cannula extending distally from the catheter adapter interface.

[0011] In some embodiments, the septum access cannula includes a blunt cannula.

[0012] In some embodiments, the catheter adapter further includes an integral catheter septum disposed within its proximal end portion, the integral catheter septum being configured to receive the septum access cannula therein.

[0013] In some embodiments, the stabilization platform is angled such that the septum access cannula is angled toward the patient's skin surface.

[0014] In some embodiments, the catheter adapter interface is configured to removably secure the proximal end portion of the catheter adapter.

[0015] In some embodiments, the catheter adapter interface includes a plurality of snap features for securing the proximal end portion of the catheter adapter.

[0016] In some embodiments, the extension set further includes an intermediate tube disposed between the proximal end portion of the catheter adapter and the probe access portion.

[0017] In some embodiments, the extension set further includes a proximal extension tube extending distally from the side surface of the probe access portion to the needleless connector.

[0018] In some embodiments, the proximal extension tube extends from the side surface of the probe access portion at an angle of 30° to 150° with respect to the longitudinal axis of the probe access portion.

[0019] In some embodiments, the probe access portion includes at least one of an offset side port through which the proximal extension tube extends and a vortex feature within the fluid path of the probe access portion for directing fluid through the proximal extension tube toward the needleless connector.

[0020] According to another aspect of the present disclosure, an extension set for use with a vascular access device is disclosed. The extension set includes a stabilization platform, a catheter adapter interface configured to secure a proximal end portion of a catheter adapter of the vascular access device, a septum access cannula extending distally from the catheter adapter interface, and a probe access portion including a needleless connector configured to receive a distal connector portion of a blood aspiration or probe delivery device, the probe access portion being arranged in series with the septum access cannula.

[0021] In some embodiments, the catheter adapter interface extends from a top surface of the stabilization platform.

[0022] In some embodiments, the probe access portion is coupled to a top surface of the stabilization platform.

[0023] In some embodiments, the stabilization platform is angled such that the septum access cannula is angled toward the patient's skin surface.

[0024] In some embodiments, the extension set further includes an intermediate tube disposed between the proximal end portion of the catheter adapter and the probe access portion.

[0025] In some embodiments, the extension set further includes a proximal extension tube extending from a side surface of the probe access portion to the distal side of the needleless connector.

[0026] In some embodiments, the probe access portion includes at least one of an offset side port through which the proximal extension tube extends and a vortex feature within a fluid path of the probe access portion for directing fluid directed through the proximal extension tube toward the needleless connector.

[0027] Further details and advantages of the present invention will become apparent upon reading the following detailed description in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0028]

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Modes for Carrying Out the Invention

[0029] Description of Preferred Embodiments The following description is provided to enable a person of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to a person of ordinary skill in the art. All such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.

[0030] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and their derivatives shall relate to the invention as oriented in the drawings. However, it is to be understood that the present invention may assume various alternative variations, unless explicitly specified to the contrary. Also, it is to 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, the specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be regarded as limiting.

[0031] In the present disclosure, the distal end of a component or device means the end that is furthest from the user's hand when the component or device is in the use position, i.e., when the user is holding the blood aspiration or probe delivery device during preparation for use or during use, and the proximal end means the end that is closest to the user's hand. Similarly, in the present application, the terms "distally" and "distal to" mean the direction towards the connector portion of the fluid transfer device, and the terms "proximally" and "proximal to" mean the direction opposite to the direction of the connector.

[0032] Embodiments of the present disclosure are mainly described in the context of a vascular access system including an integrated peripheral IV catheter (PIVC). However, the embodiments of the present disclosure equally extend to use with other catheter devices.

[0033] Referring to FIG. 1, a vascular access system 10 according to one aspect of the present disclosure is illustrated. The vascular access system 10 includes an extension set 12 coupled to an integrated catheter adapter 14, and the catheter adapter 14 has a catheter 16 configured to extend therefrom distally and be inserted into a patient's vasculature. The extension set 12 includes a stabilization platform 18 and a catheter adapter interface 20 extending vertically upward from the top surface of the stabilization platform 18. A septum access cannula 22 extends distally from the catheter adapter interface 20, and the septum access cannula 22 is configured to penetrate an integrated catheter septum 24 of the catheter adapter 14 to provide fluid communication between the catheter 16 and the septum access cannula 22. In some embodiments, the septum access cannula 22 is a blunt metal or plastic cannula, which may be formed separately from the catheter adapter interface 20 or may be integrated with the catheter adapter interface 20. Further, in some embodiments, the septum access cannula 22 may have side holes (not shown) positioned distally relative to the distal surface of the catheter septum for improved cleaning of the catheter adapter 14. In other embodiments, the septum access cannula 22 may be a sharp cannula and / or the septum access cannula may be initially covered with a cannula cover prior to connection to the catheter adapter 14.

[0034] The vascular access system 10 further includes a probe access portion 28, and the probe access portion 28 includes a needleless connector 30. In some embodiments, the needleless connector 30 is configured as a split septum type needleless connector. However, in other embodiments, any suitable connector may be used, including other forms of needleless connectors (integral or removable type), needle connectors (e.g., PRN connectors), etc. The needleless connector 30 is connected to the catheter adapter interface 20 via an intermediate tube 26 such that the needleless connector 30 is in fluid communication with the septum access cannula 22 and is generally aligned with the septum access cannula 22 as a whole.

[0035] The probe access portion 28 further includes a proximal extension tube 32 extending from a side portion of the needleless connector 30. The proximal extension tube 32 is in fluid communication with the needleless connector 30 and thus is also in fluid communication with the intermediate tube 26 and the septum access cannula 22. A proximal luer adapter 36 may be connected to the proximal end portion of the proximal extension tube 32, and a clamp device 34 may be placed in series on the proximal extension tube 32 to enable selective occlusion of the proximal extension tube 32. It should be understood that the proximal luer adapter 36 shown in FIG. 1 is only a single port adapter, but the proximal luer adapter 36 may include more than one port. The proximal luer adapter 36 is configured to receive various devices for fluid administration and flushing of the vascular access system 10, for example.

[0036] In some embodiments, the catheter adapter 14 includes a side branch 38, and has a tube set 42 extending from the side branch 38 and a connector portion 40 at the proximal end portion of the tube set 42. The connector portion 40 may be any suitable connector configuration that can be attached to a fluid administration device or a flushing device. However, in some embodiments, the side branch 38 and the tube set 42 may be omitted, and only the catheter adapter 14 may be fluidly connected to the probe access portion 28.

[0037] Referring next to FIG. 2, the vascular access system 10 is shown together with a blood aspiration device 50 coupled thereto. More specifically, the distal connector portion 52 of the blood aspiration device 50 is configured to releasably couple the blood aspiration device 50 to the needleless connector 30 of the probe access portion 28. In the embodiment shown in FIG. 2, the blood aspiration device 50 includes a flexible tube 54, which passes through the intermediate tube 26, the septum access cannula 22, the catheter adapter 14, and beyond the distal tip of the catheter 16 and is selectively advanced so that a blood sample may be aspirated by the blood aspiration device 50 into a suitable sample collection container (not shown). However, it should be understood that the vascular access system 10 is not limited to use with the blood aspiration device 50 and may instead be used with any device capable of advancing an elongate tube or probe (e.g., a nitinol wire, a guide wire, an instrument, an obturator, a rod, a wire having a fluid path and / or a sensor, etc.).

[0038] Referring to FIG. 3, the extension set 12 of the vascular access system 10 is shown in more detail. In particular, the stabilization platform 18 is angled such that the septum access cannula 22 is oriented at an angle optimized for the patient's skin. In this way, when the catheter adapter 14 is coupled to the catheter adapter interface 20, the catheter 16 enters the patient's vasculature at an optimized angle. Further, the angle of the stabilization platform 18 also provides an angle optimal for the advancement of a tube or probe (e.g., tube 54 shown in FIG. 2) through the vascular access system 10. In some embodiments, the stabilization platform 18 is integrally formed with the catheter adapter interface 20 (e.g., an overmolded elastomeric material). In other embodiments, the stabilization platform 18 may be formed separately from the catheter adapter interface 20. In some embodiments, the stabilization platform 18 may include an adhesive incorporated thereon to improve its fixation to the patient's skin. Alternatively, in other embodiments, the stabilization platform 18 may rely only on the top dressing for fixation to the patient's skin. Additionally and / or alternatively, other aspects of the extension set 12 may include stabilization features such as wings. Such stabilization features may be provided, for example, on the catheter adapter 14, the catheter adapter interface 20, the needleless connector 30, etc. Alternatively, in other embodiments, the extension set 12 may not have any stabilization features(s).

[0039] Shown with reference to FIGS. 1-3, the features of the vascular access system 10 described above may provide direct and substantially axial access to the catheter 16 by a probe device (e.g., blood suction device 50) through the intermediate tube 26 and the probe access portion 28, thereby minimizing the overall height of the system, providing flexibility to the system, and thereby reducing manipulation at the catheter insertion site. Further, since the stabilization platform 18 is disposed under the catheter adapter 14, the risk of manipulation of the access site and / or movement or dislodgment of the catheter is also reduced. Further, the vascular access system 10 enables easier fixation of the extension set 12 with a dressing, while the probe access portion 28 and the proximal extension tube 32 provide a proximal slot for exiting the dressing for access via a probe device, fluid injection device, etc., while minimizing obstruction to the catheter access site.

[0040] In some embodiments, the catheter adapter interface 20 is configured to non-removably secure the catheter adapter 14 when disposing the integral catheter septum 24 over the septum access cannula 22. Alternatively, in other embodiments, the catheter adapter interface 20 and / or the catheter adapter 14 may be configured such that the catheter adapter 14 is removably secured to the catheter adapter interface 20.

[0041] Further, in some embodiments, each internal junction of each component of the vascular access system 10 may have the same (or increasing) inner diameter in the distal direction (i.e., the direction from the needleless connector 30 towards the catheter 16), thereby allowing a tube or probe advanced, for example, by the blood suction device 50 to avoid snagging or decelerating the tube or probe as it moves distally through the system by avoiding steps or ridges.

[0042] Further, in some embodiments, the probe access portion 28 includes a series backflow prevention valve (not shown) disposed at the end of the needleless connector 30, and the backflow prevention valve may be a separate component from the needleless connector 30 or may be integrally formed with the needleless connector 30. Additionally and / or alternatively, the needleless connector 30 may include features for improving the cleaning of the system, as will be described in more detail below.

[0043] Next, referring to FIG. 4, an extension set 60 according to another aspect of the present disclosure is shown. The extension set 60 is substantially similar to the extension set 12 described above with respect to FIGS. 1 - 3, and thus like reference numerals are used throughout. However, unlike the extension set 12, the extension set 60 does not include an intermediate tube of a certain length between the probe access portion 28 and the catheter adapter interface 20. Since the probe access portion 28 (and thus the needleless connector 30) is directly connected to the catheter adapter interface 20, the extension set 60 provides a shorter path through the system that, for example, a probe or tube of a blood aspiration device must travel. In such a configuration, the stabilization platform 18 may be a platform that is connected to the catheter adapter interface 20 (as shown in FIG. 4) or that is connected to and extends beneath the probe access portion 28.

[0044] Next, referring to FIG. 5, an extension set 70 according to another aspect of the present disclosure is shown. Unlike the above-described extension sets 10, 60, the extension set 70 includes a probe access portion 72 that is coupled to a stabilization platform 74, and the stabilization platform 74 extends below the probe access portion 72 (and thus the needleless connector 30). The intermediate tube 26 extends from the needleless connector 30 to the end, and the catheter adapter interface 20 and the septum access cannula 22 extend from the intermediate tube 26 to the end. Thus, the catheter adapter interface 20 is movable relative to the probe access portion 72, but the stabilization platform 74 still provides a stabilized extension set for reducing manipulation of the catheter access site when a device such as the blood suction device 50 shown in FIG. 2 is coupled to the needleless connector 30.

[0045] Next, referring to FIGS. 6A and 6B, an extension set 80 according to another aspect of the present disclosure is shown. As described above, in some embodiments, the catheter adapter interface may be configured to fixedly attach the catheter adapter in a non-removable or removable manner when disposing the integral catheter septum 24 onto the septum access cannula 22. To secure the catheter adapter, the extension set 80 includes a catheter adapter interface 82 having a plurality of snap features 84A, 84B that provide a secure and non-removable connection of a catheter adapter (not shown) to the catheter adapter interface 82. In some embodiments, the snap features 84A, 84B are internal structures that can hold the proximal end portion of the catheter adapter. Additionally and / or alternatively, other securing features such as, for example, a threaded connection or a slip ring connection may be used to secure the proximal end portion of the catheter adapter to the catheter adapter interface.

[0046] Next, referring to FIGS. 7A - 7C, a probe access portion 90 according to another aspect of the present disclosure is shown. The probe access portion 90 can be used with the various extension sets described above with respect to FIGS. 1 - 6B and may include features for improving the cleaning of the probe access portion 90 and portions of the extension set connected thereto. The probe access portion 90 includes, for example, a needleless connector 92 having a proximal end portion 91 configured to connect to a probe device such as a blood aspiration device. The needleless connector 92 defines a fluid path 100 that extends between the proximal end portion 91 and the distal end portion 94, and the distal end portion 94 can be connected to, for example, an intermediate tube.

[0047] The probe access portion 90 also includes a side port 96, which may be connected to, for example, a proximal extension tube for fluid injection, cleaning, etc. In some embodiments, the side port 96 may be offset from the center of the fluid path 100 as shown in FIG. 7C. The offset of the side port 96 is configured to cause the fluid entering the probe access portion 90 through the side port 96 to enter along the inner surface of the fluid path 100 and create a vortex, or otherwise redirect the fluid proximally within the probe access portion 90 to assist in cleaning the needleless connector 92. In some embodiments, the probe access portion 90 further includes an internal structure 98 configured to create a vortex or otherwise redirect the fluid when the fluid enters the needleless connector probe access portion 90 through the side port 96. In some embodiments, the offset and vortex - creating features are the same as or similar to the cleaning features shown in U.S. Patent Application Publication No. 2021 / 0220548, which is hereby incorporated by reference in its entirety.

[0048] The body of the probe access portion 90 defines a longitudinal axis extending between a proximal end portion 91 and a distal end portion 94, and the side port 96 extends from the body at an angle θ of, for example, 30° to 150° with respect to the longitudinal axis of the body. In one embodiment, the side port 96 extends from the body at an angle of 60° with respect to the longitudinal axis of the body. The side port 96 extends at an angle θ toward the distal end portion 94, although other suitable arrangements may be utilized. Further, in some embodiments, the probe access portion 90 is formed as a single piece. However, in other embodiments, the probe access portion may be formed from more than one piece.

[0049] Although several embodiments of the vascular access system and / or extension set have been described in the foregoing detailed description, those skilled in the art can make modifications and changes to these embodiments without departing from the scope and spirit of the present invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The present invention described herein is defined by the appended claims, and all changes to the present invention that fall within the meaning and scope of equivalence of the claims are included within its scope.

Claims

1. A vascular access system for use with a blood aspiration or probe delivery device, the system comprising: A catheter adapter having a proximal end portion and a distal end portion, with a catheter extending from the distal end portion of the catheter adapter, and An extension set, the extension set comprising: A stabilization platform, A catheter adapter interface configured to secure the proximal end portion of the catheter adapter, and A probe access portion comprising a needleless connector configured to receive a distal connector portion of the blood aspiration or probe delivery device, the probe access portion being positioned in series with the catheter adapter to provide a direct fluid path for a tube or probe of the blood aspiration or probe delivery device to advance through the probe access portion, the catheter adapter, and the catheter, An extension set comprising the above, A system comprising the above.

2. The system of claim 1, wherein the catheter adapter interface extends from a top surface of the stabilization platform.

3. The system of claim 1, wherein the probe access portion is connected to a top surface of the stabilization platform.

4. The system of claim 1, wherein the extension set further comprises a septum access cannula extending distally from the catheter adapter interface.

5. The system of claim 4, wherein the septum access cannula comprises a blunt cannula.

6. The system of claim 4, wherein the catheter adapter further comprises an integral catheter septum disposed within its proximal end portion, the integral catheter septum being configured to receive the septum access cannula therein.

7. The system of claim 4, wherein the stabilization platform is angled such that the septum access cannula is angled toward the patient's skin surface.

8. The system of claim 1, wherein the catheter adapter interface is configured to removably fix the proximal end portion of the catheter adapter.

9. The system of claim 8, wherein the catheter adapter interface comprises a plurality of snap features for fixing the proximal end portion of the catheter adapter.

10. The system of claim 1, wherein the extension set further comprises an intermediate tube disposed between the proximal end portion of the catheter adapter and the probe access portion.

11. The system of claim 1, wherein the extension set further comprises a proximal extension tube extending distally from a side surface of the probe access portion to the needleless connector.

12. The system of claim 11, wherein the proximal extension tube extends from the side surface of the probe access portion at an angle of 30° to 150° with respect to the longitudinal axis of the probe access portion.

13. The system of claim 11, wherein the probe access portion includes at least one of an offset side port from which the proximal extension tube extends and a vortex feature within a fluid path of the probe access portion for directing fluid directed through the proximal extension tube toward the needleless connector.

14. An extension set for use with a vascular access device, the extension set comprising: a stabilization platform, a catheter adapter interface configured to fix a proximal end portion of a catheter adapter of the vascular access device, a septum access cannula extending distally from the catheter adapter interface, and a probe access portion comprising a needleless connector configured to receive a distal connector portion of a blood aspiration or probe delivery device, the probe access portion being positioned in series with the septum access cannula. An extension set comprising.

15. The extension set of claim 14, wherein the catheter adapter interface extends from a top surface of the stabilization platform.

16. The extension set according to claim 14, wherein the probe access portion is connected to the top surface of the stabilization platform. **Claim 17** The extension set according to claim 14, wherein the stabilization platform is angled such that the septum access cannula is angled towards the patient's skin surface. **Claim 18** The extension set according to claim 14, further comprising an intermediate tube disposed between the proximal end portion of the catheter adapter and the probe access portion. **Claim 19** The extension set according to claim 14, further comprising a proximal extension tube extending distally from the side surface of the probe access portion to the needleless connector. **Claim 20** The extension set according to claim 19, wherein the probe access portion includes at least one of an offset side port through which the proximal extension tube extends and a vortex feature within the fluid path of the probe access portion for directing fluid directed through the proximal extension tube towards the needleless connector.

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