Indwelling catheter assembly

Abstract

An indwelling catheter assembly with a hub having a proximal end and a distal end. The hub can have an opening through the proximal end and one or more coupling bands positioned on the hub exterior. A catheter can be in fluid communication with the hub and extend from the hub distal end. A valve with a resealable septum can be positioned within the hub and configured to seal the distal interior of the hub from the proximal opening. An extension set including a tube extending between a luer and an extension port in fluid communication with the hub distal interior can provide for a flow of blood for blood draws. Alternatively, blood draws can be performed by a device coupled to the hub proximal end through the valve.

Description

INDWELLING CATHETER ASSEMBLYCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 666,090, titled “INDWELLING CATHETER ASSEMBLY,” filed June 28, 2024, which is herein incorporated by reference in its entirety.INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.FIELD

[0003] The present invention relates generally to methods and systems for performing vascular access. More particularly, the present invention provides a catheter and needle assembly with an integrated gu4ide element or structure for transcutaneous insertion of the catheter into a patient's arterial or venous vasculature.BACKGROUND

[0004] Vascular access can be necessary for blood draws or administration of therapeutics to a patient. Indwelling catheters are often used to reduce the number of needle sticks when repeated vascular access is needed.

[0005] Generally, indwelling catheters have a catheter extending from a simple hub with a luer coupling for blood draws or therapeutic administration. These devices are limited in their capability to engage with different types or styles of medical devices as they have a standard luer connection requiring a corresponding connector of a peripheral device being coupled thereto. As the coupling mechanisms of medical devices have changed to include various coupling mechanisms, it is often required to use a matched pair catheter for the device being used. This creates a physical and financial burden on the patient and healthcare systems that are required to purchase and use the specific matched pair of devices and catheter for a given procedure.

[0006] Further, standard catheters and matched pair catheters are often open systems that rely on clamps between the portion of the catheter inserted into the patient and any accessible port. While sterilization is vitally important for indwelling catheters, the additional sterilization process for standard catheters or open systems introduces risk of contamination.

[0007] Certain catheter systems attempting to address issues with open catheter systems introduce a tube for a vacutainer assembly that limits vascular access exclusively through the tube without any option or availability of access through the catheter after it has been placed. The inability to access the catheter in a more axially aligned manner fails to address the limited capabilities even in recent modified catheter systems.

[0008] For these reasons, it would be desirable to provide improved systems, and tools for intravascular access using a closed system indwelling catheter assembly with valves allowing for access through the catheter hub. It would be particularly desirable to provide an indwelling catheter assembly with universal coupling capabilities and access that is more axially aligned with the catheter lumen through the hub which increases efficacy, capability, and reduces potential for contamination during use. At least some of these objectives will be met by the various embodiments that follow.SUMMARY OF THE DISCLOSURE

[0009] In one aspect, there is provided an indwelling catheter assembly with a hub having a proximal end and a distal end. The hub can have an opening through the proximal end and one or more coupling bands positioned on the hub exterior. A catheter can be in fluid communication with the hub and extend from the hub distal end. A valve with a resealable septum can be positioned within the hub and configured to seal the distal interior of the hub from the proximal opening. An extension set including a tube extending between a luer and an extension port in fluid communication with the hub distal interior can provide for a flow of blood for blood draws. Alternatively, blood draws can be performed by a device coupled to the hub proximal end through the valve.

[0010] In some examples, the indwelling catheter assembly can further comprise a notch in the distal end of the catheter configured to communicate with a guide element when the catheter assembly is being inserted into a vessel. A stabilizing element can be coupled to the distal end of the hub.

[0011] The valve may be configured to provide vascular access from a device coupled to the proximal side of the hub. For example, the septum can be configured to be traversed by a blood draw device coupled to the distal end of the hub. The catheter assembly can further comprise a luer coupling at the proximal end of the hub to couple with the device at the proximal side for blood draws or other vascular access. The catheter assembly may comprise one or more coupling regions such as a proximal coupling region and a distal coupling regionpositioned around the hub exterior and configured to retain a blood draw device in communication with the hub.

[0012] In general, a method of accessing a blood vessel using an indwelling catheter may comprise the steps of coupling a blood draw device to one or more coupling bands on a proximal portion of the hub or to a threaded portion of the proximal portion of the hub. Advancing a blood draw catheter through a valve in a proximal portion of the hub and into an indwelling catheter lumen. Continuing to advance the blood draw catheter until a distal end portion of the blood draw catheter is in a blood vessel beyond the distal most end of the in dwelling catheter.

[0013] In this and any other example described herein may further include one or more of the following. The step of advancing the blood draw catheter through the valve may cause the valve to open along a central longitudinal axis that is substantially aligned to a central longitudinal axis of the in dwelling catheter.

[0014] In general, an indwelling catheter can comprise a hub comprising a lumen extending therethrough from a proximal end and a distal end, and one or more coupling regions positioned around the hub exterior between the hub proximal end and hub distal end. A catheter having a lumen can extend from the hub distal end and in fluid communication with the hub lumen. A resealable valve can be positioned within the hub lumen and configured to seal a distal interior of the hub lumen. A port can be in fluid communication with the distal interior of the hub lumen, and a luer operably coupled to the port.

[0015] In this and any other example described herein may further include one or more of the following. A notch in the distal end of the catheter, the notch can be configured to communicate with a guide element. A stabilizer can be coupled to the hub. The resealable valve can have a septum configured to be traversed by a blood draw device coupled to the distal end of the hub. A first coupling region and a second coupling region, the first coupling region can be positioned proximal to the second coupling region. The first coupling region can be larger than the second coupling region. The one or more coupling regions can be configured to engage a blood draw device, vascular access device, or an infusion device. A fluid container can be in fluid communication with the port, wherein the catheter is configured to direct a flow of fluid between the catheter lumen and the fluid container. The hub may comprise a threaded proximal region at the hub proximal end.

[0016] The indwelling catheter can be configured to be placed within a vessel by a vascular access device comprising a handle configured to couple with the hub proximal end, and an access needle extending from the vascular access device through the resealable valve and catheter lumen, wherein a guide element at the distal end of a guide wire extends fromthe vascular access device and along the needle exterior through the catheter lumen. The indwelling catheter can be configured to be placed within a vessel by an vascular access device comprising a handle configured to couple with the hub proximal end, and an access needle extending from the vascular access device through the resealable valve and catheter lumen, wherein a guide element at the distal end of a guide wire extends from the vascular access device and along the needle exterior through the catheter lumen to engage the notch in the distal end of the catheter.BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0018] FIG. l is a side elevation view of an indwelling catheter assembly with a catheter extending from a catheter hub and an extension set in fluid communication with the catheter hub interior space distal to a valve separating the distal hub interior from a proximal access and coupling bands.

[0019] FIG. 2 is a perspective view of the catheter assembly in FIG. 1 from the distal end showing details of hub coupling regions positioned on the catheter hub exterior and the extension luer coupled to the catheter hub with an extension set tube.

[0020] FIG. 3 is a detailed side elevation view showing a close-up of the catheter assembly from FIG. 2 with coupling regions positioned on the catheter hub exterior and a proximal access provided proximal to a valve located inside of the catheter hub.

[0021] FIG. 4 is a distal end perspective view of a catheter assembly including a stabilizer coupled to the catheter hub with a catheter extending distally beyond the stabilizer and an extension set in fluid communication with the hub interior distal to the valve positioned therein.

[0022] FIG. 5 is a side elevation view of the catheter assembly from FIG. 4 showing another side of the catheter assembly and alignment of the valve positioned within the hub interior.

[0023] FIG. 6 is a cross-section view of the catheter assembly exposing a fluid path through the catheter and into the catheter hub distal to the valve for fluid communication to the extension set or a peripheral device configured to couple with the proximal end of the catheter hub.

[0024] FIG. 7 is a detailed view of the cross section shown in FIG. 6 providing additional detail of the valve and proximal access through the catheter hub as an optional flow path for accessing or drawing of fluid from the catheter.

[0025] FIG. 8 is a schematic view of the catheter assembly hub including an example of a fluid path flowing through the catheter into the catheter hub and on through the extension port of the catheter hub to a vacutainer or other device configured to engage the extension set luer.

[0026] FIG. 9 is another exemplary schematic view of the catheter assembly hub from FIG. 9 showing an alternative flow path of fluid through the catheter and catheter hub when the valve is accessed from the proximal end of the hub.

[0027] FIG. 10 is a side elevation view of a catheter assembly with a blood draw device coupled to the proximal end of the hub and engaged with the coupling bands on the hub exterior.

[0028] FIG. 11 is another view of the catheter assembly with coupled blood draw device from FIG. 10 now with a cannula extending from the blood draw device through the catheter as it may configured to draw blood when the catheter is positioned in a blood vessel through the blood draw device with the catheter assembly facilitating access to the vessel.

[0029] FIG. 12 is a detailed view of the blood draw device coupled to the catheter assembly shown in a transparent manner to expose the arrangement of the distal end of the blood draw device interacting with the catheter hub interior and an exemplary flow path when blood is being drawn through the blood draw device using the indwelling catheter assembly.

[0030] FIGS. 13A, 13B and 13C illustrate exemplary coupling configurations for a variety of different peripheral devices including a catheter assembly, as described herein, with peripheral devices as they may be adapted to communicate with one another during use by engagement with a proximal end portion (FIG. 13 A), a first proximal hub portion (FIG. 13B) or a second proximal hub portion (FIG. 13C).DETAILED DESCRIPTION

[0031] The catheter assemblies described herein provide a closed system of vascular access through the indwelling catheter assembly. The catheter assemblies described herein comprise a catheter hub with an integrated extension set in fluid communication with an interior distal space and a valve positioned within the hub proximal to the distal space sealing the distal space while allowing access from the proximal end of the catheter hub through the valve. The catheter hub and valve can be configured to provide fluid communication or vascular access through the extension set and / or the proximal end of the catheter hub.Coupling bands of the hub can be configured to engage or otherwise communicate with any coupler, luer, or connection mechanism of a peripheral device.

[0032] FIG. 1 shows a catheter assembly 100 including hub 105 having a proximal opening 123 and a catheter 150 extending from the hub distal end 155 to the catheter distal end 160. An extension set including a lure 140 is coupled to the extension port 125 of the hub 105 via a length of tube 135 with a clamp 145 disposed on the tube 135 configured to open and close a flow path from inside the hub 105 to the luer 140 and device coupled thereto (e.g., vacutainer; not shown). A valve 130 is locatable within the hub 105 and seals an interior volume of the hub 105 from the proximal opening 123.

[0033] The hub 105 can be configured to couple with any peripheral device at the proximal end of the hub for vascular access. In FIG. 1, a threaded coupler 122 is shown at the proximal section of the hub 105 with raised elements such as helical threads for engaging a luer-style coupler. Additional examples of coupling features are illustrated including a proximal coupling band 110 and a distal coupling band 115 positioned on the exterior of the hub 105.

[0034] FIG. 2 is a perspective view of the catheter assembly 100 in FIG. 1 from the catheter distal end 160 showing additional detail of the distal coupling band 115 and the proximal coupling band 110 around the hub 105. The coupling bands 110 and 115 can be configured to provide the hub 105 a universal coupling capacity for peripheral devices that may have coupling mechanisms to engage a catheter. The luer coupler region 122 at the proximal end of the hub 105 may be configured to engage or couple to devices having a luer or threaded-style coupling mechanism. The distal coupling band 115 is shown in FIG. 2 as a segment of the hub exterior that is elevated or having a greater circumference than the hub perimeter. The distal coupling band 115 may have a distal facet 116 configured to communicate with peripheral device coupling mechanisms when the device is advanced onto the proximal end of the hub 105 and the peripheral device coupling mechanism communicated with the distal coupling band 115 and / or facet 116 to retain a connection between the catheter assembly and the peripheral device. Similarly, the proximal coupling band 110 is shown with a circumference greater than that of the distal coupling band 115 and including a distal facet 111 similarly configured as facet 116 to communicate with a peripheral device coupling mechanism. The facets 111 and 116 may be positioned on the hub exterior and adapted to communicate with clips or features of a peripheral device when the peripheral device is advanced onto the catheter hub 105. For example, a peripheral device may comprise coupling mechanisms configured to receive more of a proximal segment of the hub 105 such that the peripheral device may engage the distal facet 116. In some examples,the catheter hub 105 may also comprise one or more tabs 120 adapted to support the manipulation and placement or positioning of the catheter assembly. For example, tab 120 may be adapted to contact from a user for support in separating a peripheral device from the catheter assembly.

[0035] In some examples, the catheter distal tip 160 may also comprise a notch 165 in the catheter distal end 160. Notch 165 can be adapted to receive a guide element that can be positioned at the catheter distal end 160 through the catheter lumen. The notch 165 can be adapted to receive a portion of the guide element and form a tapered distal end to facilitate insertion and placement of the catheter into a patient. In some examples, the guide element may be at the distal end of a guide wire extending through the catheter lumen to support placement of the catheter in a vessel. The guide element may be advanceable from notch 165 when the catheter has been inserted into a vessel to guide the catheter further into the vessel for placement. For example, a catheter assembly described herein may be placed with a peripheral device which includes a housing or handle having mechanism for advancing a guide structure or guide element which carries the catheter where the handle is adapted to automatically retract both the access needle and the guide structure or guide element from the catheter after the placement procedure is complete, a button activated automatic needle and guide withdrawal assembly are described in PCT Application No. PCT / US2023 / 086107, which is incorporated herein by reference in their entirety.

[0036] The catheter hub 105 can be configured to provide universal coupling ability for any peripheral medical device used in combination with a catheter. FIG. 3 shows a side elevation view of the catheter assembly 100 with some examples of the coupling features (e.g., coupling bands, threaded coupler, luer coupler, etc.) identified as segments positioned on the hub exterior. Segment 106 may be a length or region of hub 105 comprising the proximal most coupling feature, the threaded coupler 122. Region 106 can be configured to engage a luer or other threaded- style coupling of a peripheral device engaging the hub 105. In some examples, the threaded coupler 122 may also be adapted to coupled to a clip, clamp or friction fit coupler of a peripheral medical device. Hub segment 107 shows an exemplary position of coupling band 110 illustrated as a section of the hub 105 with a larger exterior diameter providing a raised portion of the hub 105. Segment 108 highlights an example of another section or region of the hub 105 with the distal coupling band 115 having a diameter greater than the hub 105, but smaller than the proximal coupling band 110. Then, segment 109 distinguishes and example of a distal portion of the hub 105 including the interior distal space 121 where fluid from the catheter 150 may be accessible from the port 125 and to a vacutainer in communication with the tube 135. In some other examples, fluid in the distalspace 121 may be accessible by a blood draw peripheral device coupled to the hub 105 and with a cannula extending through the valve 130 to access the hub distal space 121.

[0037] The hub interior space 121 is sealed distally from the valve 130. The transparent view in FIG. 3 exposes the valve 130 and a septum 131 through the valve 130 to the hub distal space 121. The septum 131 can provide resealable access for blood draws through the catheter by a peripheral device having a cannula or other feature configured to penetrate the septum 131 to access the catheter 150 or distal hub space 121. In some examples, the septum 131 may be penetrable by the distal end of a vascular access device or blood draw device adapted to couple to the hub 105 and support the placement of the catheter assembly 100 into a vessel, draw blood through the catheter assembly 100, administer a medication or substance through the catheter assembly, etc.

[0038] FIG. 4 is a distal end perspective view of a catheter assembly including a stabilizer 180 positioned on the distal end of the hub 105 with the catheter 150 extending therethrough. The stabilizer 180 can be adapted to contact the patient and stabilize the catheter assembly to reduce rotational displacement of the catheter assembly during use. The stabilizer distal end 175 has a lumen for the catheter 150 to pass through. In some examples, the stabilizer 180 may be coupled to the catheter assembly or integrated into the assembly (e.g., the hub).

[0039] The distal coupling band, 115, proximal coupling band 110 and threaded coupler 122 can be engaged by a peripheral medical device when the hub 105 comprises the stabilizer 180 as the position and orientation of the stabilizer leaves the coupling bands exposed to communicate with a coupling mechanism of a peripheral medical device.

[0040] The view in FIG. 4 also exposes examples of draw paths or vascular access through either the extension port 125 or through the proximal opening 123 when a blood draw device cannula extends through the valve 130 and the catheter 150. In some examples, there may be peripheral devices having a cannula configured to access the catheter 150 or hub interior space 121 through the luer 140 and tube 135 into the hub 105 through the extension port 125. In some examples, when the peripheral medical device is coupled to the threaded coupler 122, the stabilizer 180 can reduce or prevent rotation of the catheter hub 105 as the peripheral device is rotated onto the threads at the hub proximal end.

[0041] FIG. 5 is a side elevation view of the catheter assembly from FIG. 4 still shown in a transparent manner to expose to the hub distal end 155 and the catheter 150 position through the stabilizer 180. In this view, a flow path through the catheter assembly can be appreciated and may include an alignment of the proximal opening 123 with the septum 131 and through the catheter 150. In some other examples, another flow path may comprise thelumen through the luer 140 and tube 135 coupled to the extension port 125 then into the hub distal interior and out of the catheter 150. The flow path can be selectively established from the catheter 150 to the proximal opening 123 and / or the extension port 125. Access via the proximal opening 123 of the hub 105 includes engagement between the peripheral device and the coupling features (e.g., distal band 115, proximal band 110, threaded coupler 122, etc.) to establish an axial alignment through the catheter assembly. With the catheter assembly described herein, the access through the proximal end of the hub 105 is not limited to initial placement or position of the catheter in a vessel.

[0042] In some examples, the valve 130 can be configured for repeat access through the hub 105 with a sealable septum 131 adapted to allow a cannula, needle, or other elongate member of a peripheral medical device penetrate and pass through the valve to access blood through the catheter 150 or within the hub interior distal to the valve 130. The transparent view of stabilizer 180 shows the catheter 150 passing through the stabilizer distal end 175 where the stabilizer may be bonded or otherwise affixed around the catheter extending therethrough.

[0043] FIG. 6 is a cross-section view of the catheter assembly exposing interior details of the hub 105 including the valve 130 and access 131 through the valve 130. The valve 130 is seated within hub 105 and retained in position within the hub interior separating the hub distal space 121 from the proximal opening 123. The proximal opening 123 then extends from the proximal end of the valve 130 through the proximal opening 123. The distal hub interior 121 can be in fluid communication with the catheter lumen 151 and the extension port 125 with the extension tube distal end 135a positioned in the port 125 and configured to direct a flow of fluid (e.g., blood) through the catheter 150 and to a vacutainer or other component engaged to the luer (not shown). When a blood draw or fluid access from the proximal end of the hub is necessary, the valve septum 131 can be traversed and fluid communication with the hub distal interior 121 or through the catheter 150 can be established. When fluid communication through the proximal end 123 is complete, the valve 130 and septum 131 can reseal the hub distal interior 121 to prevent inadvertent fluid flow from the hub interior.

[0044] The detailed view of the hub 105 in FIG. 7 shows the proximal side of the valve 130 includes the septum 131 extending from the valve or septum proximal side 13 la to the valve distal side 131b (e.g., distal hub interior 121). Accordingly, when a peripheral device such as those described in PCT Application No. PCT / US2023 / 086107 are used to initially insert and place the catheter 150 into a vessel, the peripheral placement devices can be separated from the hub 105 to leave the assembly 100 in place. Additionally, peripheraldevices such as blood draw devices can access the hub interior space 121 and through the catheter lumen 151 to clear catheter occlusions or draw blood through the catheter 150 when a cannula of the peripheral device is advanced through the hub interior and catheter lumen 151 into a vessel.

[0045] In some examples, the extension port 125 may have a lumen 134 in communication with the hub distal interior 121 allowing fluid to flow from the catheter through tube 135 when the clamp is released. When the clamp is engaged to seal the tube, fluid may remain in the hub distal interior 121. The catheter lumen 151 is also seen in communication with the hub distal interior 121 to direct a flow of fluid from the vessel to the hub 105.

[0046] FIG. 7 also includes an example of features, elements or compositions of the catheter assembly configured to be bacterioci die, antimicrobial, or otherwise configured to prevent, reduce, stop, eliminate or otherwise disrupt any bacteria or microorganisms. In the example illustrated in FIG. 7, element 155a is shown in a position at or near the proximal end of the catheter, which is also at or near the distal end of the catheter hub. In this example, antimicrobial element 155a is shown as circumferentially engaged to the catheter and may be embedded into the catheter material, positioned around the exterior of the catheter. It may be positioned around the interior of the catheter, may be positioned in and throughout the catheter, or a combination thereof. The antimicrobial element may be any material that is configured to have antimicrobial (e.g., bacterioci die) properties.

[0047] FIG. 7 is also an example of a hub housing and valve design that enables simplified manufacturing and design variations. The section view of FIG. 7 shows how the distal end portion 112 can have an interior shoulder 112a to receive the distal end of the valve 130 as well as a proximal facing shoulder 112b to couple to the proximal end 114. Advantageously this two-part housing allows for a wide variety of longitudinally sealing valves to be accommodated depending on different clinical requirements or use scenarios. Still further, the proximal end 114 while shown with a threaded proximal end 122 and coupling band 110, may also me modified to have different or additional external features to allow different kinds of coupling or releasable attachment designs without altering the design envelope for the valve or the distal end of the housing. As a result, the hub embodiment of FIG. 7 enables a wide range of innovative closed system designs having proximal sealed and resealable vascular access via the indwelling catheter.

[0048] Examples of a flow path or fluid communication through the catheter assembly are illustrated in FIG. 8 and FIG. 9. Referring to FIG. 8, the hub 105 is shown in a detailed side elevation view with directional arrows 200 and 205 representing the direction of fluidthrough the hub 105 through the extension port 125 into the tube 135. Here, valve 130 maintains a sealed hub distal interior 121 against proximal flow through septum 131 and promoting a fluid flow through the extension port 125. Although not shown, the luer at the end of the tube 135 can be coupled to a vacutainer assembly allowing blood draws to vacutainer tubes that can be in fluid communication with the hub distal interior 121. When the clamp is released, blood can flow through the catheter 150 as indicated by arrows 200 and into the distal hub interior 121. The flow then proceeds through the extension set port 125 through the distal end of the tube 135a and through the tube on to the vacutainer.

[0049] When fluid flows through the catheter 150, and into the hub at the catheter proximal end 155, it may flow through the extension port 125, as indicated by arrows 200 and 205. When septum 131 has been penetrated by a peripheral device coupled to the proximal opening 123, the fluid may then flow to the peripheral device through the valve 130. For example, the fluid may flow through a cannula or other portion of the peripheral device extending through the valve 130. Examples of this other flow path are shown in FIG. 9, with the flow path through the hub 105 is shown as if the septum 131 had been traversed or opened by a peripheral device coupled to the proximal end of the hub 105. Here, arrow 200 still indicated the flow of fluid from the catheter 150 to the distal hub interior 121. However, arrows 210 show the flow of fluid through the proximal opening of the hub as if a peripheral device were coupled thereto. Accordingly, there is not an indication of a flow through the extension port 125 or tube 135. In some examples, the extension port 125 may be closed by a peripheral device extending into the distal hub interior 121. In some examples, flow may not proceed through the extension port as the peripheral device may comprise a cannula configured to extend through the catheter and restrict any flow other than through the cannula (e.g., restrict any flow from advancing to the extension port 125).

[0050] FIG. 10 and FIG. 11 show examples of a peripheral blood draw device coupled to the hub 105 with the cannula 305 transitioning from the stowed position in FIG. 10 to the deployed configuration in FIG. 11. Referring to FIG. 10 the catheter assembly 100 is coupled to a blood draw device 300. The distal end of this blood draw device has a coupler 310 with coupling arms 311 that are engaged with the proximal coupling band 110 on the exterior of the hub 105. The blood draw device has a cannula 305 configured to extend through the valve 130 and septum supported by a protrusion extending out of the distal end of the blood draw device 300 configured to traverse the valve 130. Cannula 305 can be extended through the catheter 150 and out of the catheter distal end 160 into the vessel to draw blood through the cannula 305 and device.

[0051] In some examples, the distal end of the peripheral device 300 may have a feature extendable through the septum 131 and adapted to close or block flow from the catheter to the extension port 125. In some examples, the cannula 305 may be extendable through the catheter 150 such that flow is directed through the cannula 305 instead of the catheter 150 to the hub interior space 121.

[0052] FIG. 11 shows the combined blood draw device 300 and catheter assembly from FIG. 10 now with the cannula 305 extended through the catheter 150 as it may be during use and extended into the blood vessel. The extension set including the tube 135 may be closed off or otherwise not in fluid communication with the hub interior with the blood draw device cannula 305 drawing directly, and / or with the blood draw device traversing the valve 130 and closing off the extension port 125. With the cannula 305 deployed, fluid may be directed from the vessel through the cannula 305 deployed therein instead of the catheter 150. In this way, the flow of blood may be from the vessel to the peripheral device 300 using the catheter assembly as a conduit for access to the vessel.

[0053] FIG. 12 further details the arrangement of the blood draw device 300 and catheter assembly from FIG. 11 showing a flow of blood indicated by arrows 225 through the cannula 305 that is extending through the catheter assembly and through the catheter 150. In this example, the cannula 305 is shown extending through the catheter lumen 151 to allow for blood to flow through the cannula 305 directly to the blood draw device 300. The transparent view provides further details including no blood flow to the tube 135 through extension port 125 as it may be closed off from cannula 305 or flow from the vessel may not proceed through the catheter lumen 151 outside of cannula 305. Even though the blood flow is through the cannula 305, the clamp on the tube 135 may be further adapted to provide an air lock or seal to reduce or prevent any inadvertent flow from the hub through the extension set.

[0054] FIG. 12 also provides further detail of an exemplary coupling between the blood draw device and the catheter assembly including the engagement of arms 310 with the coupling band 110 around the hub exterior. In this exemplary engagement, the peripheral device 300 is adapted to receive a proximal portion of the catheter hub 105 such that the coupling arms 310 are positioned to engage with the coupling bands on the hub 105. Although not shown here, it may be appreciated where the hub 105 is further received by a peripheral device, the distal ban 115 may be similarly engaged by a coupling mechanism of the peripheral device.

[0055] In some examples, the catheter assemblies, described herein, can be adapted to couple with, engage, or otherwise communicate with medical devices used in combination with an in-dwelling catheter. For example, catheter placement devices, vascular accessdevices, blood draw devices, infusion devices, etc. may be used with the catheter assembly and the catheter assembly hub can be configured for universal coupling of one or more medical devices.

[0056] In FIGS. 13A, 13B and 13C, there are three examples of coupling configurations between different medical devices as they may be adapted to engage the coupling bands (e.g., coupling regions, features, etc.) based on the coupler of the medical device. In FIG. 13 A, a first example shows medical device 325 engaging the threaded coupler 122 at the proximal end of the hub. In this example, the device 325 has a distal extension 326 that can be inserted into the catheter hub of the catheter assembly 100 as the device is threadedly coupled to the proximal end. The proximal coupling band 130 and distal coupling band 115 are not engaged by the device 325, as the device distal end has threads 326 configured to complement and engage with the threads 122a of the threaded coupler 122 of the catheter assembly. In FIG. 13B, an example of the coupler 310 of the medical device (e.g., blood draw device) previously illustrated in FIG. 10. Here, the threaded coupler 122 is generally ingested or received within the device coupler 310 as the catheter assembly 100 is engaged at the proximal coupling band 130. In this example, the coupler arms 310a are contacting the distal facet 111 of the proximal coupling band. Similarly, in FIG. 13C, device 311 is coupled to the catheter assembly 100, shown in a rotated view compared to FIG. 13B to highlight the engagement between the coupler arms 31 la of the device with the distal facet 116 of the distal coupling band 115. In this example, the device 311 is adapted to receive more of the catheter assembly within the coupler 311. For example, the proximal coupling band 130 and the threaded coupler (not shown) are substantially positioned within the coupler 311 as the coupling arms are able to engage the distal coupling band 115.

[0057] In any example, the coupling features (e.g., coupling band, coupling region, coupling segment, threaded coupler, etc.) may have dimensions configured as a type of universal coupler to engage with any of a wide range of different medical device. Advantageously, the coupling features may have a length and outer diameter that are configured to allow for engagement with any of several different kinds of devices. It is believed that this universal coupler capability would allow a catheter device so configured to engage with and provide access to several different kinds of vascular access devices. This kind of compatibility would reduce or eliminate the need for medical staff to find the “right kind” of access device when such universality is not provided. For example, the length of a proximal coupling band (e.g., coupling band 130) may have a length adapted to receive and engage with the distal end of a device while the distal coupling band (e.g., coupling band 115) is unused and the threaded coupler (e.g., threaded coupler 122) is ingested or otherwisereceived by the device. Another examples, as shown in FIG. 13C, the distal coupling band may have a smaller diameter compared to the proximal coupling band allowing for the proximal band to be received into the device and coupling engagement then is between the distal coupling band and the coupler of the device. In some examples, the proximal coupling band may have a greater diameter than a proximal coupling band. In some examples, the proximal coupling band may have a diameter greater than a distal coupling band. In any example, the catheter assembly is configured to receive any medical device adapted for use with an in-dwelling catheter assembly.

[0058] Additional aspects of the construction and operation of a catheter placement device which includes a housing or handle having mechanism for advancing a guide structure or guide element which carries the catheter where the handle is adapted to automatically retract both the access needle and the guide structure or guide element from the catheter after the placement procedure is complete, a button activated automatic needle and guide withdrawal assembly are described in U.S. Patent Publication US 2008 / 0300574 and US Patent 9,522,254, each of which is incorporated herein by reference in their entirety.

[0059] Still other details of representative intravascular catheter insertion devices and methods are described in U.S. Pat. Nos. 5,704,914 and 5,800,395 and in U.S. Patent Publications US 2010 / 0094310; US 2010 / 0210934; and US 2012 / 0197200, the full disclosure of each of these are incorporated herein by reference in their entirety.

[0060] There may be one or more variations, alternatives, constructions, compositions, and / or components described herein that can be used to modify an element, component, device, system, process, etc. of a guide element, intravascular access device and / or an associated structure or process. Accordingly, any variation, description, example, element, component, process, method, method step, etc. described herein can be used as a modification, variation, and / or alternative to any element, device, system, composition, example, component, process, method, method step, etc. described in co-pending U.S. Provisional Patent Application Ser. No. 63 / 328,732 filed on April, 7 2022 entitled “INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE”; and / or PCT application number PCT / US21 / 54046 filed on October 7, 2021 entitled “INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE” the entireties of which are incorporated herein.

[0061] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

[0062] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0063] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “ / ”.

[0064] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The devicemay be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0065] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0066] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0067] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, andranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0068] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMSWhat is claimed is:

1. An indwelling catheter assembly comprising: a hub comprising an opening through a proximal end, a threaded coupler adjacent to the hub proximal end and at least a first coupling band distal to the threaded coupler and positioned circumferentially around the hub with a diameter greater than a diameter of the threaded coupler; a catheter extending from the hub distal end with a lumen in fluid communication with a distal interior of the hub; a valve having a resealable septum, the valve positioned within the hub and configured to seal a distal interior of the hub; an extension assembly comprising a tube extending between a luer and an extension port in fluid communication with the distal interior of the hub.

2. The indwelling catheter assembly of claim 1, further comprising a second coupling band distal to the first coupling band and positioned circumferentially around the hub.

3. The indwelling catheter assembly of claim 2, wherein a diameter of the second coupling band is less than the diameter of the first coupling band.

4. The indwelling catheter assembly of claim 2, wherein a diameter of the second coupling band is greater than the threaded coupler.

5. The indwelling catheter assembly of claim 3 or claim 4, wherein the diameter of the second coupling band is less than the diameter of the first coupling band and greater than the diameter of the threaded coupler.

6. The indwelling catheter assembly of claim 1, further comprising a notch in the distal end of the catheter, the notch configured to communicate with a guide element when the catheter assembly is being inserted into a vessel.

7. The indwelling catheter assembly of claim 1, further comprising a stabilizing element coupled to the distal end of the hub.

8. The indwelling catheter assembly of claim 1, wherein the septum is configured to be traversed by a blood draw device coupled to the distal end of the hub.

9. The indwelling catheter assembly of claim 1, further comprising a proximal coupling region and a distal coupling region positioned around the hub exterior and configured to retain a blood draw device in communication with the hub.

10. The indwelling catheter assembly of claim 1, further configured to direct a flow of blood from the catheter to a fluid container in communication with the extension assembly.

11. The indwelling catheter assembly of claim 1, further configured to receive a cannula through the septum for a blood draw through the catheter to a peripheral device coupled to the hub proximal end.

12. The indwelling catheter assembly of claim 1, further comprising a threaded coupler positioned on a proximal end of the hub, the threaded coupler configured to engage a peripheral device coupled to the proximal end of the hub.

13. The indwelling catheter assembly of claim 1, further configured to be placed within a vessel by an intravascular access device comprising a handle with an access needle extending from the distal end of the handle and through the catheter, wherein a guide element at the distal end of a guide wire extending from the intravascular access device may be positioned within the catheter lumen and the guide element can be in communication with a notch at the distal end of the catheter.

14. An indwelling catheter assembly comprising: a hub having a proximal end and a distal end, the hub comprising an opening through the proximal end and one or more coupling bands positioned on an exterior of the hub; a catheter extending from the hub distal end with a lumen in fluid communication with a distal interior of the hub; a valve having a resealable septum, the valve positioned within the hub and configured to seal the distal interior of the hub from the proximal opening; an extension assembly comprising a tube extending between a luer and an extension port in fluid communication with the hub distal interior, wherein the catheter is configured to be inserted into a blood vessel by an intravascular access device coupled to the proximal end of the hub, the intravascular access device comprising an access needle and a guide wire extending through the catheter, the access needle configured to penetrate tissue to introduce the catheter into the vessel.

15. A method of accessing a blood vessel using an indwelling catheter of any of the above claims comprising:Coupling a blood draw device to one or more coupling bands on a proximal portion of the hub or to a threaded portion of the proximal portion of the hub;Advancing a blood draw catheter through a valve in a proximal portion of the hub and into an indwelling catheter lumen; andContinuing to advance the blood draw catheter until a distal end portion of the blood draw catheter is in a blood vessel beyond the distal most end of the in dwelling catheter.

16. The method of claim 15, wherein the step of advancing the blood draw catheter through the valve causes the valve to open along a central longitudinal axis that is substantially aligned to a central longitudinal axis of the in dwelling catheter.

17. An indwelling catheter comprising: a hub comprising a lumen extending therethrough from a proximal end and a distal end, and one or more coupling regions positioned around the hub exterior between the hub proximal end and hub distal end; a catheter having a lumen extending from the hub distal end and in fluid communication with the hub lumen; a resealable valve positioned within the hub lumen and configured to seal a distal interior of the hub lumen; a port in fluid communication with the distal interior of the hub lumen, and a luer operably coupled to the port.

18. The indwelling catheter of claim 17, further comprising a notch in the distal end of the catheter, the notch configured to communicate with a guide element.

19. The indwelling catheter of claim 17, further comprising a stabilizer coupled to the hub.

20. The indwelling catheter of claim 17, wherein the resealable valve has a septum configured to be traversed by a blood draw device coupled to the distal end of the hub.

21. The indwelling catheter of claim 17, further comprising a first coupling region and a second coupling region, the first coupling region positioned proximal to the second coupling region.

22. The indwelling catheter of claim 21, wherein the first coupling region is larger than the second coupling region.

23. The indwelling catheter of claim 17 or claim 21, wherein the one or more coupling regions are configured to engage a blood draw device, vascular access device, or an infusion device.

24. The indwelling catheter of claim 17, wherein a fluid container is in fluid communication with the port, wherein the catheter is configured to direct a flow of fluid between the catheter lumen and the fluid container.

25. The indwelling catheter of claim 17, the hub further comprising a threaded proximal region at the hub proximal end.

26. The indwelling catheter of claim 17, further configured to be placed within a vessel by a vascular access device comprising a handle configured to couple with the hub proximal end, and an access needle extending from the vascular access device through the resealable valve and catheter lumen, wherein a guide element at the distal end of a guide wire extends from the vascular access device and along the needle exterior through the catheter lumen.

27. The indwelling catheter of claim 18, further configured to be placed within a vessel by an vascular access device comprising a handle configured to couple with the hub proximal end, and an access needle extending from the vascular access device through the resealable valve and catheter lumen, wherein a guide element at the distal end of a guide wire extends from the vascular access device and along the needle exterior through the catheter lumen to engage the notch in the distal end of the catheter.

Images