Integrated Midline Catheter System

Abstract

The integrated midline catheter system includes a catheter adapter including a catheter, a body for receiving the catheter, and a side port in fluid communication with the catheter, a patient-proximal access port in fluid communication with the side port of the catheter adapter, the patient-proximal access port including a connector portion configured to be coupled with a peripheral probe device, and a catheter insertion device including a housing, an introducer needle extending distally from the housing, and a guidewire advancement tab movable relative to the housing for advancing a guidewire through the introducer needle. The catheter adapter is configured to be advanced distally relative to the housing.

Description

[Technical Field]

[0001] The present disclosure relates to an integrated midline catheter system. [Background technology]

[0002] This application claims priority to U.S. Application No. 17 / 893,825, filed August 23, 2022, entitled "Integrated Midline Catheter System," the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] Midline catheters are commonly used for parenteral nutrition, intravenous fluids, and / or the administration of pain medications and antibiotics. Midline catheters are inserted at the bedside using sterile technique and can be left in place for several weeks. Insertion (venipuncture) is performed above or below the antecubital fossa, into the basilic vein, or into a bronchial vein. The length and gauge of the catheter can vary, but the tip of the catheter terminates in the axilla and below the proximal central vein.

[0004] Potential benefits of midline catheters include reduced frequency of repeat venipuncture for testing / restart, reduced incidence of catheter-associated infections, extended implantation / indwelling periods, improved clinical outcomes, patient satisfaction, and associated cost savings. Placing the catheter tip in a larger vein rather than a small vein in the upper arm improves drug delivery therapy and hemodilution. Midline catheters can also be used to inject contrast media at higher flow rates than is typically achieved with other catheters, such as peripheral intravenous catheters (PIVCs).

[0005] However, an advantage of vascular access devices such as PIVCs over midline catheters is the recent development of systems that support blood sampling and / or intravenous digital measurements directly through the indwelling catheter of the vascular access device. For example, a blood sampling device known as PIVO™ from Becton, Dickinson & Company is configured as a disposable device that temporarily attaches to a PIVC to collect a blood sample. Using an existing peripheral venous line as a conduit to the blood vessel, the PIVO™ device advances a flexible internal probe or flow tube through the PIVC to (or beyond) the tip of the catheter to collect a blood sample. This flow tube is designed to overcome the suboptimal sampling conditions around the indwelling line and reach a location in the venous system where blood flow is optimal for aspiration. Once blood sampling is complete, the flow tube is retracted, and the device is removed from the PIVC and discarded. An example of such a blood sampling device is shown and described in U.S. Patent No. 5,629,499, the entire contents of which are incorporated herein by reference. Similarly, devices configured to insert probes, wires, fibers, guidewires, sensors, etc. directly into a patient's vasculature through a PIVC for intravenous digital measurements have also been developed. On the other hand, conventional midline catheter systems lack the access architecture necessary for compatibility with such blood sampling devices and / or intravenous digital measurement devices. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 10,300,247 [Patent Document 2] U.S. Patent Application Publication No. 20200001051 Summary of the Invention

[0007] In one aspect or embodiment, an integrated midline catheter system includes a catheter adapter including a catheter, a body for receiving the catheter, and a side port in fluid communication with the catheter, a patient-proximal access port in fluid communication with the side port of the catheter adapter, the patient-proximal access port including a connector portion configured to be coupled with a peripheral probe device, and a catheter insertion device including a housing, an introducer needle extending distally from the housing, and a guidewire advancement tab movable relative to the housing for advancing a guidewire through the introducer needle. The catheter adapter is configured to advance distally relative to the housing.

[0008] The guidewire advancement tab may be positioned closer to the proximal end of the catheter insertion device housing than to the distal end of the catheter insertion device housing. The catheter insertion device may include a handle. The patient-proximal access port may further include a secondary port, which may be coupled to the integrated extension set. The system may further include a proximal access port coupled to the proximal end of the extension set. The proximal access port may be color-coded and provide a flow rate indication. The proximal access port may include indicia indicating at least one of the length and gauge of the catheter. The connector portion of the patient-proximal access port may be a needleless connector.

[0009] The catheter adapter may include a stabilizing platform, which may be a pair of stabilizing wings.

[0010] The catheter insertion device may be detachable from the catheter adapter after insertion of the catheter into the patient's vasculature. The catheter may include a reinforced tip. The catheter adapter may include a strain relief.

[0011] The handle may be located closer to the distal end of the housing of the catheter insertion device than to the proximal end of the housing of the catheter insertion device. The handle may be grasped between the thumb and index finger of a clinician. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 is a perspective view of an integrated midline catheter system according to one aspect or embodiment of the present application. [Figure 2] 2 is a perspective view of the integrated midline catheter, stabilizer, and patient-proximal access port of FIG. 1. [Figure 3] FIG. 3 is a perspective view of an integrated midline catheter according to a further aspect or embodiment of the present application. [Figure 4] FIG. 4 is a perspective view of an integrated midline catheter system according to a further aspect or embodiment of the present application.

[0013] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations presented herein illustrate exemplary embodiments of the present disclosure, and such illustrations are not to be construed as limiting the scope of the present disclosure in any way. DETAILED DESCRIPTION OF THE INVENTION

[0014] The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present disclosure.

[0015] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall refer to the present invention as oriented in the drawings. However, it should be understood that the present invention may contemplate various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings, and described in the following specification, are merely exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0016] In this disclosure, the distal end of a component or device means the end farthest from the user's hand when the component or device is in the use position, i.e., when the user is holding the catheter insertion device while preparing or using it, and the proximal end means the end closest to the user's hand. Similarly, in this application, the terms "distal direction" and "distally" mean the direction toward the distal end of the needle or catheter of the system, and the terms "proximal direction" and "proximally" mean the direction opposite to the direction of the distal end of the needle or catheter.

[0017] Although embodiments of the present disclosure are described primarily in the context of devices for use with integrated midline catheters, embodiments of the present disclosure extend to use with other catheter devices as well.

[0018] 1 and 2 , in one aspect or embodiment, an integrated midline catheter system 10 includes a catheter adapter 12, a patient-proximal access port 14, and a catheter insertion device 16. The catheter adapter 12 includes a catheter 18, a body 20 that receives the catheter 18, and a side port 22 in fluid communication with the catheter 18. The patient-proximal access port 14 is in fluid communication with the side port 22 of the catheter adapter 12. The patient-proximal access port 14 includes a connector portion 24 configured to be coupled to a peripheral probe device. The catheter insertion device 16 includes a housing 26, an introducer needle 28 extending distally from the housing 26, and a guidewire advancement tab 30 movable relative to the housing 26 for advancing a guidewire through the introducer needle 28. The catheter adapter 12 is configured to be advanced distally relative to the housing 26. The integrated midline catheter system 10 is configured to provide complete midline catheter functionality and an integrated proximal-patient access port architecture, providing a closed-system midline capable of delivering instruments, tubing, and probes into the patient's vasculature through the proximal-patient access port 14. The system 10 can be used for peripheral vascular access, IJ, EJ, and / or arterial access for blood sampling or intravenous digital measurements.

[0019] Referring to FIG. 1 , the guidewire advancement tab 30 is disposed at the proximal end 32 of the housing 26 of the catheter insertion device 16. The catheter insertion device 16 also includes a handle 34 for a clinician to hold steadily during operation of the catheter insertion device 16. The handle 34 is configured to allow a clinician to hold the handle 34 between the thumb and index finger of one hand and manipulate the guidewire to advance the catheter with the other hand. The guidewire advancement tab 30 is disposed on a surface of the housing 26 and configured to move substantially linearly along a slot 36 formed in the housing 26. Although not shown in FIG. 1 , the guidewire advancement tab 30 is operably coupled to a guidewire, which is sized and configured to selectively pass through (and past) the introducer needle 28 when the guidewire advancement tab 30 is advanced distally along the slot 36 and, conversely, to retract through the introducer needle 28 when the guidewire advancement tab 30 is retracted proximally by the clinician. The guidewire may include a blunt, atraumatic tip to substantially prevent vascular injury. In some embodiments, a polymer rod or tube with an atraumatic tip may replace the guidewire.

[0020] 2 and 4 , in some aspects or embodiments, the catheter adapter 12 or system 10 includes a stabilization platform formed by one or more stabilization wings, which may include opposing stabilization wings 40, 42. As shown in FIG. 4 , the catheter adapter 12 is at least partially disposed within the housing 26 such that the stabilization wings 40, 42 extend outward from opposite sides of the housing 26. The catheter adapter 12 is configured to linearly move distally along the housing 26 so that the catheter 18 can be selectively advanced beyond the introducer needle 28 into the patient's vasculature. The catheter 18 may be of any length and gauge suitable for use as a midline catheter. For example, the catheter 18 may be 8 cm to 10 cm long and may be any of 16 GA, 18 GA, 20 GA, or 22 GA. However, it is understood that the catheter 18 is not limited to the above-mentioned lengths and / or gauges. Additionally, the catheter 18 may be formed of a suitable material, such as polyurethane. The catheter 18 may have a reinforced tip 44 that may be configured to substantially prevent the tip of the catheter from collapsing and / or to aid in the deployment and positioning of the catheter 18.

[0021] Referring to FIG. 3, in some aspects or embodiments, the catheter adapter 12 does not include a stabilizing platform.

[0022] Utilizing the system 10 to place a catheter 18 within a patient's blood vessel is now described in accordance with an embodiment of the present disclosure. First, a clinician identifies an appropriate insertion site and cleans and prepares the insertion site according to facility policy. Next, the clinician grasps and advances the entire catheter insertion device 16 to insert the introducer needle 28 into the appropriate venous or other vascular access site in the patient. Although not shown, the system 10 may include magnetic needle guidance to ensure proper insertion of the introducer needle 28. Magnetic needle guidance may be used in conjunction with ultrasound placement systems and methods, such as, for example, Becton, Dickinson & Company's Cue™ needle tracking system. With the introducer needle 28 in place, the clinician can advance the guidewire advancement tab 30 distally along the slot 36 such that a guidewire (not shown) operably coupled to the guidewire advancement tab 30 is simultaneously advanced through the introducer needle 28, thereby providing an extended guide path for deployment of the catheter 18.

[0023] With the guidewire in the advanced position, the clinician can then advance the catheter adapter 12 distally along the housing 26, thereby also advancing the catheter 18 over the introducer needle 28 and guidewire, and moving the catheter 18 to a desired location within the patient's vasculature. To advance the catheter adapter 12 distally, the clinician can grasp or otherwise manipulate one or both of the stabilizing wings 40, 42. Additionally and / or alternatively, the clinician can utilize the side port 22 extending from the catheter adapter 12 to assist in the advancement of the catheter adapter 12 and catheter 18.

[0024] With the catheter 18 and catheter adapter 12 in the desired position, the clinician may separate the catheter insertion device 16 from the catheter adapter 12. In doing so, the introducer needle 28 and guidewire (not shown) are also withdrawn from the catheter 18 and through the self-sealing proximal connector portion 46 of the catheter adapter 12. Thus, even when the catheter insertion device 16 is removed, the catheter adapter 12 remains in place at the insertion site in the configuration shown in FIG. 2, with the stabilization wings 40, 42 configured to stabilize the catheter adapter 12. In some embodiments, a strain relief feature 50 may be provided between the catheter adapter 12 and the catheter 18. In one aspect or embodiment, the catheter insertion device 16 is the same as or similar to the catheter insertion device 16 shown and described in U.S. Patent Application Publication No. 2007 / 0122990 to Huang et al., which is incorporated herein by reference in its entirety.

[0025] 1 and 2, the patient-proximal access port 14 is configured to provide catheter access to peripheral devices, such as, for example, a blood sampling device (e.g., PIVO™ from Becton, Dickinson & Company) or a vascular access probe (VAP) for intravenous digital measurement of patient data, such as temperature, pH, lactate, and / or other blood-based measurements. In some embodiments, the patient-proximal access port 14 is coupled to the side port 22 of the catheter adapter 12 via intermediate tubing 58. However, in other embodiments, the patient-proximal access port 14 may be directly coupled to the side port 22 or connected via another intermediate member.

[0026] The patient-proximal access port 14 includes a connector portion 24, which in some embodiments is configured to be compatible with peripheral devices, such as blood sampling devices and / or vascular access probes. The connector portion 24 may include an interface for securely coupling a peripheral device to the connector portion 24. In some embodiments, the connector portion 24 is configured as a needleless connector (NFC) configured to accept, for example, a blunt introducer of a blood sampling device. More specifically, the connector portion 24 may be configured as a split-septum NFC with direct probe access, such as, for example, a Becton, Dickinson & Company Q-Syte™ or SmartSite™ NFC, or any other suitable split-septum NFC. Alternatively, in other embodiments, the connector portion 24 may be formed with a non-split-septum NFC. Additionally, in some embodiments, the patient-proximal access port 14 may include antibacterial and / or flush-facilitating features. For example, the patient-proximal access port 14 may include one or more of offset tube port vortex generating features, proximal flow diverting features, antimicrobial NFC lubricants, antimicrobial eluting surface coatings or inserts, and the like.

[0027] With the patient-proximal access port 14 fluidly connected to the catheter adapter 12 via the side port 22, the system 10 provides access to a probe (or tube) from a peripheral probe device through an indwelling catheter 18. Because the catheter 18 is a midline catheter and is generally long in length (e.g., a PIVC), the length of the probe or tube of the peripheral probe device may be modified and / or optimized for use with a midline catheter, such that the probe or tube may extend beyond the reinforced tip 44 of the catheter 18 when deployed.

[0028] Patient-proximal access port 14 further includes a secondary port 62 disposed near its distal end. In some embodiments, secondary port 62 is coupled to an integrated extension set 70, which is further coupled at its proximal end to a proximal portion 72. Integrated extension set 70 is provided with a clamp 74 configured to selectively restrict flow through integrated extension set 70. In some embodiments, clamp 74 may be color-coded to indicate the type and / or infusion compatibility of integrated extension set 70.

[0029] In some embodiments, the proximal portion 72 may include a proximal access port 76 and a proximal connector 78. The proximal connector 78 may be removably or non-removably coupled to the proximal access port 76, and the proximal connector 78 may be configured to allow fluid infusion through the catheter 18 via the patient-proximal access port 14. In some embodiments, the proximal access port 76 may be color-coded and / or include indicia indicating catheter length, catheter gauge, high-pressure infusion compatibility, etc. In other embodiments, the proximal connector 78 may be replaced with, for example, a removable vent plug during insertion of the catheter 18 into the patient's vasculature. In some embodiments, the proximal access port 76 may be a non-split septum connector and may include antibacterial and / or flushable features. While only a single proximal access port 76 is shown, it is understood that the proximal portion 72 may be configured to include multiple access ports.

[0030] 1 through 4, the secondary port 62 of the patient-proximal access port 14 is configured as an angled port, resulting in the patient-proximal access port 14 being a y-adapter. However, in other embodiments, the secondary port 62 may be configured as a t-adapter such that the secondary port 62 enters the patient-proximal access port 14 at an approximately 90-degree angle. Additionally, although the secondary port 62 is shown pointing toward the center of the device, it will be understood that the secondary port 62 may be oriented away from the device.

[0031] Thus, the above-described integrated midline catheter system 10 provides a midline catheter system with a patient-proximal access port that accommodates instruments, probes, and / or tubing delivered through the midline catheter into the patient's vasculature, which is not provided in conventional integrated midline catheter systems.

[0032] While several embodiments of an integrated midline catheter system with a patient-proximal access port for access to a peripheral probe device have been described in the foregoing detailed description, those skilled in the art may make modifications and variations to these embodiments without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative, not limiting. The above-described invention is defined by the appended claims, and all changes to the invention that come within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

1. a catheter adapter including a catheter, a body for receiving the catheter, and a side port in fluid communication with the catheter; a patient-proximal access port in fluid communication with the side port of the catheter adapter, the patient-proximal access port including a connector portion configured to couple with a peripheral probe device; a catheter insertion device including a housing, an introducer needle extending distally from the housing, and a guidewire advancement tab movable relative to the housing for advancing a guidewire through the introducer needle, the catheter adapter being configured to be advanced distally relative to the housing; 1. An integrated midline catheter system comprising:

2. the guidewire advancement tab is positioned closer to the proximal end of the housing of the catheter insertion device than to the distal end of the housing of the catheter insertion device. The system of claim 1 .

3. The catheter insertion device comprises a handle. The system of claim 1 .

4. the patient-proximal access port further comprises a secondary port, the secondary port being coupled to an integrated extension set; The system of claim 1 .

5. a proximal access port coupled to a proximal end of the extension set; The system of claim 4.

6. the proximal access port is color coded to provide a flow rate indication; The system of claim 5.

7. the proximal access port includes indicia indicating at least one of a catheter length and gauge; The system of claim 5.

8. the connector portion of the patient-proximal access port is a needleless connector. The system of claim 1 .

9. the catheter adapter includes a stabilizing platform. The system of claim 1 .

10. the stabilizing platform comprises a pair of stabilizing wings; The system of claim 9.

11. the catheter insertion device is detachable from the catheter adapter after insertion of the catheter into the patient's vasculature. The system of claim 1 .

12. The catheter comprises a reinforced tip. The system of claim 1 .

13. the catheter adapter includes a strain relief; The system of claim 1 .

14. the handle is positioned closer to the distal end of the housing of the catheter insertion device than to the proximal end of the housing of the catheter insertion device. The system of claim 3.

15. The handle is grasped between the clinician's thumb and index finger. The system of claim 14.

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