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 a distal port, a proximal port, and a side port, wherein a catheter proximal end is secured to the distal port and the side port. A first extension tube is connected to the proximal adapter port, wherein a proximal patient connector is coupled to an opposite end of the first extension tube, the proximal patient connector including a distal connector port, a proximal connector port, and a side connector port, wherein a pass-through valve is disposed in the proximal connector port. An extension set is coupled to the side connector port, wherein the extension set includes a second extension tube having a connection port disposed thereon. The first extension tube, the proximal patient connector, and the extension set are integrated with the catheter adapter.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 564,732, filed March 13, 2024, entitled “Integrated Safety IV Catheter System with Port for Attachment of Blood Collection Device,” the disclosure of which is incorporated herein by reference in its entirety.

[0002] Background of the Invention Field of the Invention This invention relates to an integrated safety IV catheter system for inserting an indwelling catheter, wherein a patient-proximity connector is provided for connecting external devices (e.g., blood collection devices and / or fluid delivery devices).

[0003] Background of the Invention Vascular access devices (VADs) are used in the medical field to access a patient's peripheral vascular system for infusion therapy and / or blood draws. A common type of VAD is the over-the-needle peripheral intravenous catheter (PIVC). As the name suggests, an over-the-needle PIVC is mounted on an introducer needle with a sharp distal tip. The sharp distal tip is used to puncture the patient's skin and vascular system. With the needle puncturing the vascular system, the PIVC can be inserted into the vascular system. The needle and PIVC are typically inserted into the patient's vascular system through the skin at a small angle, with the bevel of the needle facing away from the patient's skin. Once the needle is confirmed to be in place within the vascular system, the clinician can temporarily block flow in the vascular system and withdraw the needle, leaving the PIVC in place for future fluid infusions and / or blood draws.

[0004] An integrated PIVC is a PIVC with an integrated extension kit. This extension kit typically includes an extension tube, one end of which is integrated into a catheter adapter, and the extension tube includes a access port (e.g., a Luer connector) that connects to the other end. Integrated PIVCs are frequently used for blood collection. For example, after inserting the catheter of the integrated PIVC into a patient's vascular system, the clinician can allow blood to flow into the extension kit up to the access port and / or a clamp positioned along the extension tube. Once the blood has flowed up to the access port (or clamp), the clinician can attach a blood collection kit (e.g., a vacuum tube adapter) and then collect the blood.

[0005] Known integrated PIVC catheter systems include the Pegasus® Safety Integrated IV Catheter System from Becton, Dickinson and Company (“BD”). Figure 1A (as shown in the image), and BD's Intima II® integrated IV catheter system (which is shown in...) Figure 1B (As shown in the diagram). Each of these catheter systems 1 includes a catheter adapter 2 to which a catheter 3 is attached and extends distally from the catheter adapter. A needle assembly 4 is located at a proximal port of the catheter adapter 2. The needle assembly 4 is operable to introduce and advance a needle 5 into the patient's vascular system and to subsequently withdraw the needle 5 from the catheter 3 and through the catheter adapter 2. An extension tube 6 may be integrally disposed with the catheter adapter 2, wherein the extension tube 6 extends from a side port 7 of the adapter 2. A access port 8 is located at the proximal end of the extension tube 6, through which a blood collection kit (e.g., a vacuum tube adapter) or other external device may be connected to the catheter system 1.

[0006] After the initial blood sample is collected, for example via a blood collection kit connected to access port 8, the PIVC left in place can be used for future fluid infusions and / or blood draws. It should be recognized that such fluid infusions and / or blood draws can be performed via an external device or system that can be used with the PIVC to assist in direct fluid infusions and / or blood draws from the indwelling catheter of the PIVC. For example, a blood draw device from Becton Dickinson, known as PIVO™, is configured as a disposable device for short-term attachment to the PIVC to draw blood samples. The PIVO™ device uses an existing peripheral venous line as a conduit to the vascular system, allowing a flexible internal probe or flow tube to advance through the PIVC to (or beyond) the catheter tip to collect a blood sample. This flow tube is designed to extend beyond the suboptimal aspiration environment around the indwelling line to reach a venous location where blood flow is most suitable for aspiration. Once blood collection is complete, the flow tube is withdrawn, 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 described above 1) can be used with external devices / systems (e.g., BD's PIVO™) that assist in fluid infusion and / or blood draw directly from an indwelling catheter in the PIVC, it should be recognized that there are limitations and / or disadvantages associated with the current configuration of such catheter systems. As an example, the configuration of the catheter system (e.g., the length of the extension tube 6) may inhibit the advancement of the flow tube of the blood draw device into and through the catheter adapter 2, or otherwise increase its difficulty.

[0008] Therefore, there is a need for a catheter system that facilitates the connection of a blood collection device to the catheter system and enables the advancement of the flow tube into the indwelling catheter. The catheter system will provide one or more additional ports or connections whereby the blood collection device and / or fluid delivery device can be coupled to the catheter system. Summary of the Invention

[0009] This document provides an integrated catheter system comprising: a catheter including a distal end and a proximal end; and a catheter adapter including an adapter body including a distal adapter port, a proximal adapter port, and a lateral adapter port, the adapter body defining a lumen extending between the distal adapter port and the proximal adapter port, wherein the proximal end of the catheter is secured to the distal adapter port, and wherein the lateral adapter port is in fluid communication with the lumen. The catheter system further includes: a first extension tube including a distal end and a proximal end, the distal end of the extension tube being connected to the proximal adapter port; and a near-patient connector including a distal connector port, a proximal connector port, and a lateral connector port, the distal connector port being connected to the proximal end of the first extension tube, the near-patient connector including an access valve disposed in the proximal connector port. The catheter system also includes an extension kit that is coupled to the side connector port. The extension kit includes: a second extension tube comprising a distal end and a proximal end, the distal end of which is coupled to the side connector port; and a connection port located at the proximal end of the second extension tube. The first extension tube, the proximal patient connector, and the extension kit are integrated with the catheter adapter. Attached Figure Description

[0010] Figure 1A and Figure 1B A perspective view of a catheter system as known in the prior art; Figure 2A perspective view of an integrated catheter system according to one aspect of this disclosure, the integrated catheter system including a catheter adapter and an integrated proximal patient connector; Figure 3 This illustrates one aspect of the disclosure. Figure 2 A catheter system having an instrument delivery device (e.g., a blood collection device) connected thereto. Figure 4 For the purposes of this disclosure Figure 2 A cross-sectional view of the catheter adapters included in the catheter system; Figure 5 This illustrates one aspect of the disclosure. Figure 2 A conduit system having a fluid delivery device connected thereto; Figure 6 This illustrates one aspect of the disclosure. Figure 2 A catheter system having the additional feature of incorporating a catheter adapter; and Figure 7 This illustrates another aspect of the disclosure. Figure 2 The catheter system has a blood collection kit that is connected to it. Detailed Implementation

[0011] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all of these modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0012] As used in this specification, the terms “proximal” and “distal” refer to the direction closer to and further away from the user who places the device in contact with the patient, respectively. Thus, for example, the end of the device that first contacts the patient’s body will be the distal end, while the opposite end of the device (e.g., the end of the device that is manipulated by the user) will be the proximal end of the device.

[0013] Spatial or directional terms (such as “left,” “right,” “inner,” “outer,” “up,” and “down”, etc.) should not be considered limiting, as the invention can take various alternative orientations.

[0014] In the following text, for descriptive purposes, the terms “above,” “below,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the present invention as oriented as shown in the accompanying drawings. However, it will be understood that the invention may take various alternative variations unless explicitly stated otherwise. It will also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary aspects of the invention.

[0015] The terms “first” and “second” are not intended to refer to any particular order or sequence, but rather to different conditions, properties or elements.

[0016] refer to Figure 2 , Figure 2 A non-limiting embodiment of a system 10 facilitating blood draws and / or infusions for patients is shown. As shown in FIG1, system 10 may include a catheter assembly 12 that provides access to a patient's vascular system. According to embodiments of the present disclosure, catheter assembly 12 is configured / arranged as an integrated catheter assembly including an integrated proximal patient connector and an extension kit, as described in further detail below.

[0017] like Figure 2 As shown, the catheter assembly 12 includes a catheter adapter 14 and an associated catheter 16. The catheter adapter 14 may include an adapter body 17 having a distal adapter port or distal end 18 and a proximal adapter port or proximal end 20, and an additional port or adapter “side” 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 the catheter adapter 14 and may be configured for placement in a patient’s vein at the point of implantation of a PIVC, wherein the distal or distal tip of the catheter 16 is properly positioned within the vein to allow blood to be drawn from the patient. As those skilled in the art will appreciate, the catheter 16 may be formed of any suitable material and may have any useful length.

[0018] A needle assembly 28 is provided at the proximal end 20 of the catheter adapter 14. This needle assembly includes a needle 30 that extends through the catheter adapter 14 (i.e., through its lumen 24) and into the catheter 16, for example, in the form of a catheter sheath arrangement. The needle assembly 28 may include the needle 30 and a body 32, the body 32 including a connector portion 34 and wings 36. The connector portion 34 may engage the proximal end 20 of the catheter adapter 14, while the wings 36 may be configured to bend or deflect to control the movement of the needle 30 relative to the catheter 16 and / or the catheter adapter 14, including during insertion of the needle 30 into the patient's vascular system and during subsequent withdrawal of the needle 30 from the catheter 16 and from the catheter adapter 14.

[0019] In some embodiments, and as Figure 2 As shown, needle assembly 28 may include a shielding feature 38 that provides shielding for needle 30 after the needle has been withdrawn from catheter 16 and catheter adapter 12, such as the shielding feature provided in the BD Pegasus Catheter System®. In other embodiments, needle assembly 28 may be configured not to provide such shielding.

[0020] In some non-limiting embodiments or aspects, the catheter assembly 12 may include a first fluid conduit 40 extending from a side port 22, the first fluid conduit 40 being integrated with the side port 22. The first fluid conduit 40 may be formed of any suitable material known to those skilled in the art and may have a distal end 42 and a proximal end 44. The distal end 42 of the first fluid conduit 40 is coupled to port 22, while the proximal end 44 of the first fluid conduit 40 may be coupled to a proximal patient connector 46 (hereinafter referred to as "connector 46").

[0021] According to an exemplary aspect of this disclosure, connector 46 includes a distal connector end or distal port 48, a proximal connector end or proximal port 50, and a side connector port 52 disposed between the distal port 48 and the proximal port 50. According to embodiments, connector 46 may be configured as a T-connector (e.g., one side port is arranged at an 80-degree angle relative to the longitudinal axis of connector 46) or a Y-connector (e.g., one side port is arranged at an angle of 15 to 85 degrees relative to the longitudinal axis of connector 46). Connector 46 includes a (second) lumen 54 passing through it, the lumen having any number of branches suitable for the connector type, such as branches extending between the distal port 48 and the proximal port 50 of connector 46, and branches provided to the side port 52 of connector 46. In some embodiments, connector 46 may include NearPort from Becton Dickinson Corporation. TM Connector.

[0022] According to some embodiments or aspects, a access valve 56 may be provided in the proximal port 50 of connector 46 and coupled to the proximal port. The access valve 56 may be configured as a needleless access connector (hereinafter referred to as "needleless access connector 56"), which, according to embodiments, may be configured as, for example, a split diaphragm connector or a self-healing diaphragm connector. The needleless access connector 56 provides a patient access port to catheter assembly 12 through which external devices may be connected to catheter assembly 12, as explained in further detail below.

[0023] In some embodiments, connector 46 may include one or more features (e.g., valves, internal structures / profiles, etc.) that provide flushability, diversion, etc. Exemplary connector features are described in U.S. Patent Application Serials 17 / 898,617 and 17 / 994,920 of Becton Dickinson, Inc., which are incorporated herein by reference in their entirety.

[0024] In some non-limiting embodiments or aspects, the catheter assembly 12 may further include an extension kit 58 coupled to a side port 52 of the connector 46. The extension kit 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 the side port 52 of the connector 46, while the proximal end 64 of the second fluid conduit 60 may include a proximal connector or proximal port 66 (e.g., a Luer connector). In some embodiments, a needleless access connector 68 may be disposed on the proximal connector or proximal port 66. A clamp 70 may be disposed on the second fluid conduit 50, located between the ends 62, 64 of the second fluid conduit, thereby allowing its occlusion. As a non-limiting example, the extension kit 58 may be used to provide a fluid path in and out of the catheter assembly 12 for fluid or drug delivery, blood aspiration, or connection to an extracorporeal hemodynamic monitoring device that monitors a patient's blood pressure, heart rate, and / or pulse profile.

[0025] According to various aspects of this disclosure, the first fluid conduit 40, the patient proximity connector 46, and the extension kit 58 can be considered as integrally integrated with the catheter adapter 14 to provide an integrated catheter assembly 12. As explained in further detail below, with the connector 46 integrated into the catheter assembly 12, the connection of external devices to the catheter assembly 12 provides additional functionality and versatility to the catheter assembly 12, for example, by facilitating the collection of blood from and / or the administration of fluids to the patient.

[0026] According to one aspect of this disclosure, and as Figure 3As shown, system 10 may also include an instrument delivery device 72, which can be operated to introduce an instrument (e.g., a catheter fitting or a sensing probe, as a non-limiting example) into a patient's vascular system, wherein the instrument is capable of, for example, drawing blood or performing blood gas analysis. Figure 3 As shown, according to a non-limiting embodiment, the delivery device 72 is configured as a blood-drawing device, which includes at least a housing 74, a coupling device or "lock" 76, a catheter fitting 78, and a propulsion member 80. The catheter fitting 78 is movable within the housing 74 to advance from a first or retracted position within the housing 74 to a second or forward position outside the housing 74, such that the distal end of the catheter fitting can enter the catheter assembly 12 and enter or exit the indwelling catheter 16.

[0027] like Figure 3 As shown, the lock 76 of the blood-drawing device 72 is used to connect the blood-drawing device 72 to the catheter system 10, for example, by engaging the lock 76 with the needleless access connector 56 disposed on the connector 46. In some embodiments, the lock 76 has a blunt sleeve 82 and a pair of locking arms 84. Furthermore, the lock 76 defines a lumen (not shown) extending therethrough. The blunt sleeve 82 is disposed between the pair of locking arms 84 and may have a length sufficient to extend through at least a portion of the connector 46 (i.e., through the needleless access connector 56 therethrough).

[0028] As described above, at least a portion of the conduit fitting 78 is movably disposed within the housing 74. The proximal end of the conduit fitting 78 is coupled to the propulsion member 80 such that, as the propulsion member 80 moves relative to the housing 74, the conduit fitting 78 can move between a first position and a second position. In the first position, the conduit fitting 78 is disposed within the housing 74 (e.g., the entire conduit fitting 78 is disposed within the housing 74 or within the housing 74 and the lock 76). In the second position, the distal portion of the conduit fitting 78 is at least partially disposed distal to the lock 76 and distal to the conduit adapter 14 (e.g., within the conduit 16 or beyond the distal end of the conduit 16, such as...). Figure 3 (As shown).

[0029] In some embodiments, to better accommodate the use of the blood-drawing device 72 and the catheter system 10, the internal geometry of the catheter adapter 14 (e.g., lumen 24) can be configured to improve the insertion and delivery of the catheter fitting 78 from the blood-drawing device 72 through the catheter adapter 14 and the catheter 16. Figure 4As shown, the inner surface 86 of the adapter body 17 defining the lumen 24 can be configured as a smooth surface that prevents the distal end of the catheter fitting 78 from snagging thereon. The inner surface 86 of the catheter adapter 14 can therefore be used to guide the catheter fitting 78 as it advances through the catheter adapter 14.

[0030] According to another aspect of this disclosure, and as Figure 5 As shown, system 10 may also include a fluid delivery device 88, which can be operated to dispense / inject fluid into catheter adapter 14. Figure 5 As shown, according to a non-limiting embodiment, the fluid delivery device 88 is provided as a pre-filled syringe 88. The syringe 88 may include a Luer connector 90 at its distal end, configured to mate with a proximal connector port 50 and / or a needleless access connector 56. With the plunger 91 of the syringe 88 in an initial partially retracted position, the syringe 88 can be actuated to force fluid (e.g., flushing fluid) out of the syringe 88 and into the catheter adapter 14, for example, to perform fluid flushing (e.g., flushing residual blood from the adapter 14).

[0031] Advantageously, the configuration of the catheter assembly 12 described above (with an integrated proximal patient connector 46 having a proximal port (where a needleless access connector 56 is retained)) allows for the connection of additional external devices to the catheter assembly 12. That is, connector 46 provides a dedicated port for connecting a blood collection device 72 to the connector to collect blood samples from the patient and / or for connecting a fluid delivery device 88 to flush the catheter adapter 14.

[0032] Now for reference Figure 6 Another embodiment of system 10 may introduce more functional and / or operable features (i.e., operability of blood collection device 72 and / or fluid delivery device 88) into catheter assembly 12.

[0033] In some embodiments, and as Figure 6 As shown, the catheter adapter 14 may further include: a support wing or stabilizing platform 92 formed / positioned on the adapter body 17 and configured to place and secure the catheter adapter 14 to the patient's skin; and a soft / flexible nose or "strain relief" feature 94 adjacent to the distal / distal port 18 of the adapter 14. The stabilizing platform 92 and the strain relief feature 94 can improve the stability and / or comfort of the catheter adapter 14 when it remains in the appropriate position on the patient's skin during catheter 16 indwelling.

[0034] In some embodiments, detachable or non-detachable connectors (e.g., pinless connectors, PRN connectors / adapters, split diaphragm connectors, and / or combined pinless connectors and detachable PRNs) may also be provided at the side port 52 of connector 46 and / or the proximal port 66 of extension kit 58.

[0035] Now for reference Figure 7 Another embodiment of system 10 may include a blood-drawing assembly 96 coupled to and in fluid communication with connector 46. The blood-drawing assembly 96 includes an adapter-connector device 98 attachable to connector 46, and a blood collection kit 100 coupled to the adapter-connector device 98. The adapter-connector device 98 may include a distal end connected to connector 46 and a proximal end configured to receive blood collection kit 100. Some embodiments of blood collection kit 100 may include a needle assembly 102 and a housing 104. Although in Figure 7 Not shown in detail, but it will be appreciated that, as is known in the art, the needle assembly 102 of the blood collection kit 100 may include a body, a sharp needle extending proximally from the body, and an elastic sheath covering the sharp proximal tip of the needle.

[0036] Although Figure 7 Although not shown, it will be understood that the blood collection kit 100 can be configured to receive a blood collection device (e.g., a blood collection tube). The blood collection device can be connected to the blood collection kit 100 via a needle assembly 102, for example, by pushing the sheath distally toward the body through the blood collection device, such that a sharp needle pierces the sheath and the sharp proximal end of the needle assembly 102 can be inserted into the blood collection device. In some embodiments, inserting the sharp proximal end into the blood collection device can connect the blood collection device to the blood collection kit 100, allowing blood to flow into the blood collection device due to the pressure difference between the vascular system and the blood collection device.

[0037] Advantageously, embodiments of this disclosure provide an integrated (safe) IV catheter system that facilitates connection of instrument delivery devices (e.g., blood collection devices) and / or fluid delivery devices (e.g., syringes) to the catheter system and enables the advancement of instruments into an indwelling catheter. The catheter system integrates a patient proximity connector that provides one or more additional ports or connections whereby such blood collection devices and / or fluid delivery devices can be connected to the catheter system.

[0038] Although this disclosure has been described in detail based on embodiments or aspects currently considered to be most practical and preferred for illustrative purposes, it will be understood that such detail is merely for that purpose, and this disclosure is not limited to the disclosed embodiments or aspects, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it will be understood that this disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. An integrated catheter system, the integrated catheter system comprising: The catheter includes a distal end and a proximal end; A catheter adapter includes an adapter body comprising a distal adapter port, a proximal adapter port, and a lateral adapter port, wherein the adapter body defines a lumen extending between the distal adapter port and the proximal adapter port, wherein the proximal end of the catheter is secured to the distal adapter port, and wherein the lateral adapter port is in fluid communication with the lumen. A first extension tube, the first extension tube including a distal end and a proximal end, the distal end of the extension tube being connected to the proximal adapter port; A patient-friendly connector, comprising a distal connector port, a proximal connector port, and a lateral connector port, wherein the distal connector port is connected to the proximal end of the first extension tube, and the patient-friendly connector includes a passage valve disposed in the proximal connector port; and Extension kit, which is connected to the side connector port, includes: A second extension tube including a distal end and a proximal end, the distal end being coupled to the side connector port; and A connection port is provided at the proximal end of the second extension tube; The first extension tube, the near-patient connector, and the extension kit are integrated with the catheter adapter.

2. The catheter system of claim 1, further comprising a needle assembly coupled to the catheter adapter, the needle assembly comprising a needle received within the lumen of the catheter adapter and inserted into and through the catheter in a catheter-needle arrangement.

3. The catheter system according to claim 2, wherein, The needle assembly includes a shielding feature that shields the needle after the needle assembly is disconnected from the catheter adapter and the needle is withdrawn from the catheter and the catheter adapter.

4. The catheter system according to claim 1, wherein, The access valve of the near-patient connector includes a needleless access connector.

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

6. The catheter system according to claim 5, wherein, The instrument delivery device includes: A guide having a proximal end and a distal end and defining an internal volume configured to movably receive the instrument; An actuator movably coupled to the guide, the actuator being configured to move relative to the guide to move the distal end of the instrument from a position within the guide to a position outside the housing of the guide, and through the distal end of the catheter; and A connector, located at the distal end of the guide and configured to engage the pinless access connector, the connector comprising a blunt sleeve and a pair of locking arms.

7. The catheter system according to claim 5, wherein, The instrument delivery device includes a blood drawing device, and the instrument includes a flow tube.

8. The catheter system according to claim 5, wherein, The adapter body includes an inner surface defining the lumen, the inner surface including a smooth surface that prevents the distal end of the instrument from obstructing it, thereby improving the deliverability of the instrument from the instrument delivery device into and through the catheter adapter and the catheter.

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

10. The catheter system according to claim 9, wherein, The fluid delivery device includes a pre-filled syringe with a Luer connector at its distal end, the Luer connector being capable of engaging with the proximal connector port of the proximal patient connector.

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

12. The catheter system according to claim 1, wherein, The catheter adapter includes a stabilizing platform located on the adapter body, the stabilizing platform being configured to place and secure the catheter adapter to the patient's skin.

13. The catheter system according to claim 1, wherein, The catheter adapter includes a compliant nasal or strain relief feature adjacent to the distal adapter port.

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