Integrated safety iv catheter system with port for attachment of blood collection device

Abstract

An integrated catheter system is provided that includes a catheter and a catheter adapter having an adapter body with distal, proximal and side ports thereon, with the catheter proximal end secured to the distal port and the side port. A first extension tube is connected to the proximal adapter port, with a near-patient connector coupled to an opposite end of the first extension tube, the near-patient connector comprising distal, proximal, and side connector ports, with an access valve provided in the proximal connector port. An extension set is coupled to the side connector port, with the extension set comprising a second extension tube having a connecting port provided thereon. The first extension tube, the near-patient connector, and the extension set are integrated with the catheter adapter.

Description

INTEGRATED SAFETY IV CATHETER SYSTEM WITH PORT FOR ATTACHMENT OF BLOOD COLLECTION DEVICECROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Patent Application No. 63 / 564,732 entitled “Integrated Safety IV Catheter System with Port for Attachment of Blood Collection Device” filed March 13, 2024, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present invention is directed to an integrated safety IV catheter system used for insertion of an indwelling catheter, with a near-patient connector provided to facilitate the connection of external devices such as a blood collection device and / or fluid delivery device.Background of the Invention

[0003] Vascular access devices (VADs) are used in the medical field to access peripheral vasculature of a patient for purposes of infusion therapy and / or blood withdrawal. A common type of VAD is an over-the-needle peripheral intravenous catheter (PIVC). As its name implies, the “over-the-needle” PIVC may be mounted over an introducer needle having a sharp distal tip. The sharp distal tip may be used to pierce skin and the vasculature of the patient. Insertion of the PIVC into the vasculature may follow the piercing of the vasculature by the needle. The needle and the PIVC are generally inserted at a shallow angle through the skin into the vasculature of the patient with a bevel of the needle facing away from the skin of the patient. Once placement of the needle within the vasculature has been confirmed, a clinician may temporarily occlude flow in the vasculature and withdraw the needle, leaving the PIVC in place for future fluid infusion and / or blood withdrawal.

[0004] An integrated PIVC is a PIVC having an integrated extension set. Such extension sets typically consist of extension tubing that is integrated at one end into the catheter adapter and that includes an access port (e.g., a luer connector) coupled to the other end. Integrated PIVCs are oftentimes used to draw blood. For example, after inserting the catheter of the integrated PIVC into the patient's vasculature, a clinician may allow blood to flow into the extension set up to the access port and / or to a clamp positioned along the extension tubing.Once the blood has flowed up to the access port (or clamp), the clinician may attach a blood collection set (e.g., a vacuum tube adapter) and the blood can then be collected.

[0005] Known integrated PIVC catheter systems include the Becton, Dickinson and Company (“BD”) Pegasus® safety integrated IV catheter system, which is shown in FIG. 1A, and the BD Intima II® integrated IV catheter system, which is shown in FIG. IB. Each of these catheter systems 1 includes a catheter adapter 2 with a catheter 3 secured thereto and extending out distally therefrom. A needle subassembly 4 is provided at a proximal port of the catheter adapter 2. The needle subassembly 4 may operate to provide for introduction and advancement of a needle 5 into the vasculature of a patient, and for subsequent withdrawal of the needle 5 out from the catheter 3 and out through the catheter adapter 2. An extension tube 6 may be integrally provided with the catheter adapter 2, with the extension tube 6 extending out from a side port 7 of the adapter 2. An access port 8 is provided at a proximal end of the extension tube 6, via which a blood collection set (e.g., a vacuum tube adapter) or other external device may be connected to the catheter system 1.

[0006] After collection of an initial blood sample, such as via a blood collection set coupled to the access port 8, the PIVC that is left in place may be used for a future fluid infusion and / or blood withdrawal, with it recognized that such fluid infusion and / or blood withdrawal may be performed via an external device or system useable with the PIVC to aid in fluid infusion and / or blood withdrawal directly from the indwelling catheter of the PIVC. For example, a blood draw device known as PIVO™ from Becton, Dickinson and Company, is configured as a single-use device which temporarily attaches to a PIVC to draw a blood sample. Using an existing peripheral intravenous line as a conduit to the vasculature, the PIVO™ device advances a flexible, internal probe or flow tube through the PIVC to (or beyond) the catheter tip to collect a blood sample. This flow tube is designed to extend beyond the suboptimal draw conditions around the indwelling line to reach vein locations where blood flow is optimal for aspiration. Once blood collection is complete, the flow tube is retracted, and the device is removed from the PIVC and discarded.

[0007] While IV catheter systems such as the BD Pegasus® and BD Intima II® catheter systems 1 described above are capable of use with external devices / systems that aid in fluid infusion and / or blood withdrawal directly from the indwelling catheter of the PIVC (e.g., the BD PIVO™), it is recognized that there are limitations and / or drawbacks associated with the current configuration of such catheter systems. As one example, the configuration of the catheter system (e.g., the length of extension tube 6), may inhibit or otherwise increase thedifficulty of advancing a flow tube of a blood draw device into and through the catheter adapter 2.

[0008] Accordingly, a need exists for a catheter system that facilitates the connection of a blood draw device thereto and enables advancement of a flow tube into the indwelling catheter. The catheter system would provide one or more additional ports or connections, whereby a blood draw device and / or fluid delivery device could be coupled to the catheter system.SUMMARY OF THE INVENTION

[0009] Provided herein is An integrated catheter system that includes a catheter comprising a catheter distal end and a catheter proximal end, and a catheter adapter comprising an adapter body including a distal adapter port, a proximal adapter port, and a side adapter port, the adapter body defining a lumen therein extending between the distal adapter port and the proximal adapter port, wherein the catheter proximal end is secured to the distal adapter port, and wherein the side adapter port is in fluid communication with the lumen. The catheter system also includes a first extension tube comprising a distal end and a proximal end, the distal end of the extension tube connected to the proximal adapter port, and a near-patient connector comprising a distal connector port, a proximal connector port, and a side connector port, the distal connector port connected to the proximal end of the first extension tube, with the near-patient connector comprising an access valve provided in the proximal connector port. The catheter system further includes an extension set coupled to the side connector port, the extension set comprising a second extension tube comprising a distal end and a proximal end, the distal end coupled to the side connector port, and a connecting port provided at the proximal end of the second extension tube. The first extension tube, the near-patient connector and the extension set are integrated with the catheter adapter.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIGS. 1A and IB are perspective views of catheter systems, as known in the prior art:

[0011] FIG. 2 is a perspective view of an integrated catheter system including a catheter adapter and integrated near-patient connector, in accordance with an aspect of the disclosure;

[0012] FIG. 3 illustrates the catheter system of FIG. 2, with an instrument delivery device (e.g., blood draw device) connected thereto, in accordance with an aspect of the disclosure;

[0013] FIG. 4 is a cross-sectional view of a catheter adapter included in the catheter system of FIG. 2, in accordance with an aspect of the disclosure;

[0014] FIG. 5 illustrates the catheter system of FIG. 2, with a fluid delivery device connected thereto, in accordance with an aspect of the disclosure;

[0015] FIG. 6 illustrates the catheter system of FIG. 2, with additional features incorporated into the catheter adapter, in accordance with an aspect of the disclosure; and

[0016] FIG. 7 illustrates the catheter system of FIG. 2, with a blood collection set connected thereto, in accordance with another aspect of the disclosure.DESCRIPTION OF THE INVENTION

[0017] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0018] As used in this specification, the words "proximal" and "distal" refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device (e.g., the end of the device being manipulated by the user) would be the proximal end of the device,

[0019] Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, are not to be considered as limiting as the invention can assume various alternative orientations.

[0020] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention.

[0021] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

[0022] Referring to FIG. 2, shown is a non-limiting embodiment of a system 10 for facilitating blood draw and / or administering of fluids for a patient. As shown in FIG. 1, system10 may include a catheter assembly 12 that provides access to the vasculature of a patient. According to embodiments of the disclosure, the catheter assembly 12 is constructed / arranged as an integrated catheter assembly that includes an integrated near-patient connector and extension set, as described in further detail below.

[0023] As shown in FIG. 2, the catheter assembly 12 includes a catheter adapter 14 and associated catheter 16. The catheter adapter 14 may include an adapter body 17 having a distal adapter port or end 18 and a proximal adapter port or end 20, as well as an additional or “side” adapter port 22 that may be disposed between the distal end 18 and the proximal end 20. The catheter adapter 14 may include a (first) lumen 24 extending through the distal end 18 and the proximal end 20. The catheter 16 extends from the distal end 18 of catheter adapter 14 and may be configured as a PIVC that is placed into a vein of the patient, with a distal end or tip of the catheter 16 positioned appropriately within the vein to enable a blood draw from the patient. Catheter 16 may be formed of any suitable material and may be of any useful length, as known to those of skill in the art.

[0024] Provided at the proximal end 20 of the catheter adapter 14 is a needle subassembly 28 including a needle 30 that extends through the catheter adapter 14 (i.e., through lumen 24 thereof) and into the catheter 16, in a catheter-over-needle arrangement, for example. The needle subassembly 28 may comprise the needle 30 and a body 32 that includes a connector portion 34 and a wing 36. The connector portion 34 may engage the proximal end 20 of the catheter adapter 14, while the wing 36 may be configured to flex or deflect in order to control movement of the needle 30 relative to the catheter 16 and / or catheter adapter 14, including during insertion of the needle 30 into the vasculature of a patient and during a subsequent withdrawal of the needle 30 out from the catheter 16 and out through the catheter adapter 12.

[0025] In some embodiments, and as shown in FIG. 2, needle subassembly 28 may include a shielding feature 38 that provides shielding to the needle 30 after withdrawal thereof out from the catheter 16 and the catheter adapter 12, such as provided in a BD Pegasus® catheter system. In other embodiments, needle subassembly 28 may be configured to not provide such shielding.

[0026] In some non-limiting embodiments or aspects, the catheter assembly 12 may include a first fluid conduit 40 extending from the side port 22, with the first fluid conduit 40 integrated with the side port 22. First fluid conduit 40 may be formed of any suitable material known to those of skill in the art and may have a distal end 42 and a proximal end 44. The distal end 42 of first fluid conduit 40 is coupled to port 22, while the proximal end 44 of first fluid conduit 40 may be coupled to a near-patient connector 46 (hereafter “connector 46”).

[0027] According to an exemplary aspect of the disclosure, connector 46 includes a distal connector end or port 48, a proximal connector end or port 50, and a side connector port 52 disposed between the distal and proximal ports 48, 50. According to embodiments, the connector 46 may be configured as a t-connector (e.g., one side port arranged at an 80 degree angle relative to a longitudinal axis of connector 46) or a y-connector (e.g., one side port arranged at a 15-85 degree angle relative to a longitudinal axis of connector 46). The connector 46 includes a (second) lumen 54 therethrough, having any number of branches suitable for the type of connector, such as a branch extending between distal and proximal ports 48, 50 of connector 46 and a branch provided to the side port 52 of the connector 46. In some embodiments, the connector 46 may comprise a NearPort™ connector from Becton, Dickinson and Company.

[0028] In accordance with some embodiments or aspects, an access valve 56 may be provided in and coupled to the proximal port 50 of connector 46. The access valve 56 may be provided as a needleless access connector (hereafter “needleless access connector 56”) that, according to embodiments, may be configured as a split- septum connector or self-healing septum connector, as examples. The needleless access connector 56 provides a near-patient access port to the catheter assembly 12, via which external devices may be connected to catheter assembly 12, as explained in further detail below.

[0029] In some embodiments, connector 46 may include one or more features (e.g., valves, internal formations / contours, etc.) that provide flushability, flow diversion, and the like. Exemplary connector features are described in U.S. Patent Application Serial Nos. 17 / 898,617 and 17 / 994,920, to Becton, Dickinson and Company, which are incorporated herein by reference in their entirety.

[0030] In some non-limiting embodiments or aspects, catheter assembly 12 may also include an extension set 58 coupled to the side port 52 of connector 46. The extension set 58 may include a second fluid conduit 60 having a distal end 62 and a proximal end 64. The distal end 62 of the second fluid conduit 60 may be coupled to side port 52 of connector 46, while the proximal end 64 of the second fluid conduit 60 may include a proximal connection or port 66 (e.g., a luer connection). In some embodiments, a needleless access connector 68 may be provided on the proximal connection or port 66. A clamp 70 may be provided on the second fluid conduit 50, at a location between the ends 62, 64 thereof, that allows for occlusion thereof. The extension set 58 may be used to provide a fluid path to or from the catheter assembly 12 to enable fluid or medication delivery, blood aspiration, or connection to an ex-vivohemodynamic monitoring device that monitors blood pressure, heart rate, and / or pulse contour of a patient, as non-limiting examples.

[0031] According to aspects of the disclosure, the first fluid conduit 40, near-patient connector 46, and extension set 58 may be considered to be collectively integrated with the catheter adapter 14, to provide an integrated catheter assembly 12. As explained in further detail below, with a connector 46 integrated into the catheter assembly 12, additional functionality and versatility is provided to catheter assembly 12 regarding the connection of external devices thereto, such as by facilitating a blood collection from a patient and / or administering of fluids to the patient.

[0032] According to an aspect of the disclosure, and as shown in FIG. 3, system 10 may further include an instrument delivery device 72 that may be operated to introduce an instrument (e.g., catheter tubing or a sensing probe, as non-limiting examples) into the vasculature of the patient, with such an instrument enabling a blood draw or blood gas analysis, for example. As shown in FIG. 3 according to a non-limiting embodiment, the delivery device 72 is configured as a blood draw device that includes at least a housing 74, a coupling device or “lock” 76, a catheter tubing 78, and an advancement member 80. The catheter tubing 78 is moveable within the housing 74 so as to provide for advancement thereof from a first or retracted position inside the housing 74 to a second or advanced position outside of the housing 74, such that a distal end thereof may be routed into the catheter assembly 12 and into or out past the indwelling catheter 16.

[0033] As shown in FIG. 3, the lock 76 of the blood draw device 72 is configured to couple the blood draw device 72 to the catheter system 10, such as by lock 76 engaging with needleless access connector 56 provided on connector 46. In some embodiments, the lock 76 has a blunt cannula 82 and a pair of locking arms 84. In addition, the lock 76 defines a lumen (not shown) extending therethrough. The blunt cannula 82 is disposed between the pair of locking arms 84 and may have a length that is sufficient to extend through at least a portion of the connector 46 (i.e., through the needleless access connector 56 therein).

[0034] As described above, at least a portion of the catheter tubing 78 is movably disposed within the housing 74. A proximal end of the catheter tubing 78 is coupled to the advancement member 80 such that, when advancement member 80 is moved relative to the housing 74, the catheter tubing 78 may be moved between a first position, in which the catheter tubing 78 is disposed within the housing 74 (e.g., the entire catheter tubing 78 is disposed within the housing 74 or within the housing 74 and the lock 76) and a second position, in which the distal end portion of the catheter tubing 78 is at least partially disposed in a position distal to the lock76 and distal to the catheter adapter 14 (e.g., within catheter 16 or out past a distal tip of catheter 16, as is shown in FIG. 3).

[0035] In some embodiments, and in order to better accommodate usage of blood draw device 72 with catheter system 10, an internal geometry of the catheter adapter 14 (e.g., of the lumen 24) may be configured to improve feeding of the catheter tubing 78 from the blood draw device 72 and into and through the catheter adapter 14 and catheter 16. As shown in FIG. 4, an inner surface 86 of the adapter body 17 that defines the lumen 24 may be configured as a smoothed surface that prevents snagging of a distal tip of the catheter tubing 78 thereon. The inner surface 86 of the catheter adapter 14 may thus function to provide guidance to the catheter tubing 78 as it is advanced through the catheter adapter 14.

[0036] According to another aspect of the disclosure, and as shown in FIG. 5, system 10 may further include a fluid delivery device 88 that may be operated to dispense / inject a fluid into the catheter adapter 14. As shown in FIG. 5, according to a non-limiting embodiment, fluid delivery device 88 is provided as pre-filled syringe 88. The syringe 88 may include a luer connection 90 at the distal tip thereof that is configured to mate with the proximal connector port 50 and / or with needleless access connector 56. With a plunger 91 of the syringe 88 in an initial partially retracted position, the syringe 88 may be actuated to force a fluid (e.g., flushing fluid) out from the syringe 88 and into the catheter adapter 14, such as for purposes of performing a fluid flushing thereof (e.g., to flush residual blood out from adapter 14).

[0037] Beneficially, the configuration of the catheter assembly 12 as described above - with an integrated near-patient connector 46 having a proximal port (with a needleless access connector 56 retained therein) allows for the connection of additional external devices to the catheter assembly 12. That is, the connector 46 provides a dedicated port for connection of a blood draw device 72 thereto for collection of a blood sample from a patient and / or for connection of a fluid delivery device 88 for flushing of the catheter adapter 14.

[0038] Referring now to FIG. 6, another embodiment of the system 10 may introduce further features to the catheter assembly 12 that provide improved functionality and / or operability (i.e., operability with blood draw device 72 and / or fluid delivery device 88.

[0039] In some embodiments, and as shown in FIG. 6, catheter adapter 14 may further include a support wing or stabilization platform 92 formed / positioned on the adapter body 17 and configured to enable placement and securing of the catheter adapter 14 onto the skin of a patient, as well as a soft / pliable nose or “strain relief’ feature 94 adjacent the distal end / port 18 of the adapter 14. The stabilization platform 92 and strain relief feature 94 may improve the stabilityand / or comfort of the catheter adapter 14, when left in-place on the skin of a patient during indwelling of the catheter 16.

[0040] In some embodiments, removable or non-removable connectors, such as needle-free connectors, PRN connectors / adapters, split septum connectors, and / or a combination needle- free connector and removable PRN, may also be provided at the side port 52 of connector 46 and / or at the proximal port 66 of extension set 58.

[0041] Referring now to FIG. 7, another embodiment of the system 10 may include a blood draw assembly 96 that is coupled to connector 46 and in fluid communication therewith. The blood draw assembly 96 includes an adapter-connector arrangement 98 that may attach to connector 46, and a blood collection set 100 coupled to the adapter-connector arrangement 98. The adapter-connector arrangement 98 may include a distal end that is connected to connector 46 and a proximal end configured to receive the blood collection set 100. Some embodiments of the blood collection set 100 may include a needle assembly 102 and a housing 104. While not shown in detail in FIG. 7, it is recognized that, as known in the art, the needle assembly 102 of the blood collection set 100 may include a body, a sharp needle extending proximally from the body, and an elastomeric sheath covering a sharp proximal tip of the sharp needle.

[0042] While not shown in FIG. 7, it is recognized that the blood collection set 100 may be configured to receive a blood collection device such as a blood collection tube, for example. The blood collection device may be connected to the blood collection set 100 via needle assembly 102, such as by the blood collection device pushing a sheath distally towards the body so that the sharp needle pierces the sheath and the sharp proximal tip of the needle assembly 102 may be inserted into the blood collection device. In some embodiments, inserting the sharp proximal tip into the blood collection device may couple the blood collection device to the blood collection set 100, with blood flowing into the blood collection device due to a pressure differential between the vasculature and the blood collection device.

[0043] Beneficially, embodiments of the disclosure thus provide an integrated (safety) IV catheter system that facilitates the connection of an instrument delivery device (e.g., blood draw device) and / or fluid delivery device (e.g., syringe) thereto and enables advancement of an instrument into the indwelling catheter. The catheter system integrates a near-patient connector therein that provides one or more additional ports or connections, whereby such a blood draw device and / or fluid delivery device could be coupled to the catheter system.

[0044] Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferredembodiments or aspects, it is to be understood that such detail is solely for that purpose 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 that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

THE INVENTION CLAIMED IS1. An integrated catheter system comprising: a catheter comprising a catheter distal end and a catheter proximal end; a catheter adapter comprising an adapter body including a distal adapter port, a proximal adapter port, and a side adapter port, the adapter body defining a lumen therein extending between the distal adapter port and the proximal adapter port, wherein the catheter proximal end is secured to the distal adapter port, and wherein the side adapter port is in fluid communication with the lumen; a first extension tube comprising a distal end and a proximal end, the distal end of the extension tube connected to the proximal adapter port; a near-patient connector comprising a distal connector port, a proximal connector port, and a side connector port, the distal connector port connected to the proximal end of the first extension tube, with the near-patient connector comprising an access valve provided in the proximal connector port; and an extension set coupled to the side connector port, the extension set comprising: a second extension tube comprising a distal end and a proximal end, the distal end coupled to the side connector port; and a connecting port provided at the proximal end of the second extension tube; wherein the first extension tube, the near-patient connector and the extension set are integrated with the catheter adapter.

2. The catheter system of claim 1, further comprising a needle subassembly coupled to the catheter adapter, the needle subassembly comprising a needle housed within the lumen of the catheter adapter and extending into and through the catheter in a catheter-over-needle arrangement.

3. The catheter system of claim 2, wherein the needle subassembly comprises a shielding feature that shields the needle after disconnecting of the needle subassembly from the catheter adapter and withdrawal of the needle out from the catheter and the catheter adapter.

4. The catheter system of claim 1, wherein the access valve of the nearpatient connector comprises a needleless access connector.

5. The catheter system of claim 4, further comprising an instrument delivery device configured to couple with and engage the needleless access connector, the instrument delivery device comprising an instrument configured to be advanced distally out from the instrument delivery device and through the first catheter adapter and into the catheter.

6. The catheter system of claim 5, wherein the instrument delivery device comprises: an introducer having a proximal end and a distal end, and defining an inner volume configured to movably receive the instrument; an actuator movably coupled to the introducer, the actuator configured to move relative to the introducer to move a distal end of the instrument from a position within the introducer to a position outside the introducer housing and past a catheter distal end of the catheter; and a coupler positioned at the distal end of the introducer and configured to engage the needleless access connector, the coupler comprising a blunt cannula and a pair of locking arms.

7. The catheter system of claim 5, wherein the instrument delivery device comprises a blood draw device, with the instrument comprising a flow tube.

8. The catheter system of claim 5, wherein the adapter body comprises an inner surface defining the lumen, the inner surface comprising a smoothed surface that prevents snagging of a distal tip of the instrument thereon, so as to improve feedability of the instrument from the instrument delivery device and into and through the catheter adapter and catheter.

9. The catheter system of claim 1, further comprising a fluid delivery device connected to the proximal connector port of the near-patient connector and engaging the access valve, the fluid delivery device configured to dispense / inject a fluid.

10. The catheter system of claim 9, wherein the fluid delivery device comprises a pre-filled syringe including a luer connection at the distal tip thereof coupleable with the proximal connector port of the near-patient connector.

11. The catheter system of claim 1 , further comprising a blood collection set connected to the proximal connector port of the near-patient connector, the blood collection set configured to receive a blood collection tube thereon, with a needle of the blood collection set engaging a seal of the blood collection tube to provide a fluid connection thereto.

12. The catheter system of claim 1, wherein the catheter adapter comprises a stabilization platform positioned on the adapter body and configured to enable placement and securing of the catheter adapter onto the skin of a patient.

13. The catheter system of claim 1, wherein the catheter adapter comprises a compliant nose or strain relief feature adjacent the distal adapter port.

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