Extension set

Abstract

An extension set comprising a body having a distal protrusion and a proximal coupling segment with a lumen extending from a proximal end of the body through the distal protrusion. An extension port provided on the body with a fluid container coupler in fluid communication with an interior of the body, the fluid container coupler at a distal end of tubing in communication with the extension port. A collar positioned proximal to the distal protrusion. A coupling mechanism configured to couple the body to a catheter hub.

Description

EXTENSION SETCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 689,522, titled “EXTENSION SET,” filed August 30, 2024, which is 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 an extension set and catheter assembly for access 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 device 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.- 1 -SG Docket No.: 14842-721.600

[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 increase efficacy, capability, and reduce 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, an extension set may comprise a body having a distal protrusion and a proximal coupling segment with a lumen extending from a proximal end of the body through the distal protrusion. An extension port provided on the body with a fluid container coupler in fluid communication with an interior of the body, the fluid container coupler at a distal end of tubing in communication with the extension port. A collar positioned proximal to the distal protrusion. A coupling mechanism configured to couple the body to a catheter hub.

[0010] In this and any other example described herein may further comprise one or more of the following. The coupling mechanism can be configured to couple the body to a catheter assembly comprising a catheter extending distally from the catheter hub. An activable valve positioned within the catheter hub proximally adjacent to the catheter proximal end, wherein the collar is configured to contact the valve and advance a distal surface of the activatable valve against the interior of the catheter hub to activate the valve and provide a lumen from the catheter to the interior of the extension set body. The valve comprises a circumferential channel around a valve body, the channel configured to engage a raised portion of the catheter hub interior while the valve is in a first position, wherein the channel is configured to disengage the raised portion of the catheter hub interior when the collar distally advances the valve in the catheter hub. The coupling mechanism can be configured to advance the collar against a valve positioned within the catheter hub until the collar activates the valve to open. A valve can be positioned within the catheter hub and configured to be activated to an open configuration when distally advanced from a first position to a second position. The coupling- 2 -SG Docket No.: 14842-721.600mechanism can be configured to threadingly engage the catheter hub and advance the collar against the valve from the first position to the second position. The collar can be configured to distally advance a valve from a first position to a second position within a catheter hub.

[0011] The extension set may further comprise a valve positioned at the proximal end of the body, the valve providing sealable access to the body interior. The lumen through the extension set body can be configured to axially align with a catheter hub at the distal end and a blood draw device coupled to the proximal end.

[0012] In one aspect, an extension set can comprise a body having a distal protrusion and a proximal coupling segment with a lumen extending from a proximal end of the body through the distal protrusion. An extension port provided on the body with tubing extending to a fluid coupler. A coupling mechanism configured to couple the body to a catheter, wherein the distal protrusion is configured to transition a valve within the catheter between a closed configuration and an open configuration.

[0013] In this and any other example described herein may further comprise one or more of the following. The catheter comprises a catheter hub, a catheter extending from the catheter hub, and a valve having a distal segment separated from a proximal segment with a central lumen configured to transition between an open configuration and a close configuration. The catheter comprises a valve with a distal segment separated from a proximal segment by a central portion, the central portion having a diameter less than the distal segment and the proximal segment. The distal protrusion can be configured to advance the central portion against the distal segment to open a sealable lumen through the valve. An interior diameter of the proximal segment decreases distally. The extension set may further comprise a conical interior geometry through the proximal segment configured to direct a cannula of a blood draw device through a longitudinal axis of the valve.

[0014] In one aspect, an extension set can comprise a body having a distal protrusion and a proximal coupling segment with a lumen extending from a proximal end of the body through the distal protrusion. An extension port provided on the body with a fluid container coupler in fluid communication with an interior of the body, the fluid container coupler at a distal end of tubing in communication with the extension port. A coupling mechanism configured to couple the body to a catheter, the catheter comprising a sealable valve having a proximal body separated from a distal body by a central portion, the valve positioned within a catheter hub and a catheter defining a lumen from the catheter hub through the length of the catheter, wherein the valve is configured to provide a lumen through the central portion of the valve when the proximal valve body distally biases the central portion against the distal valve body.- 3 -SG Docket No.: 14842-721.600

[0015] In one aspect, a catheter can comprise a catheter extending distally from a catheter hub, with a lumen extending through the catheter and catheter hub. An actuatable valve configured to seal the catheter hub proximal to the valve, wherein the valve is actuated when at least a portion of the valve is distally advanced in the catheter hub.

[0016] In this and any other examples described herein may further comprise one or more of the following. The hub further comprises a proximal end and a distal end, wherein an interior of the proximal end is sealed from the distal end until a force is provided against the proximal end. The valve comprises a central portion having a distal side, proximal side, and at least one slit extending through the central portion, the distal side comprising a plurality of supports positioned around the at least one slit and configured to bias the slit in a closed configuration. The slit can be configured to open when a proximal end of the valve is distally advanced.

[0017] The proximal end of the valve can be configured to advance the central portion without advancing a distal end of the valve. A proximal end of the catheter protrudes proximally into the interior of the catheter hub, and wherein the valve is configured to provide a lumen through the valve when the valve is distally advanced against the proximal end of the catheter. The catheter may further comprise a raised portion of the catheter hub interior configured to engage a channel positioned around a circumference of the valve. The valve is configured to disengage the raised portion of the catheter hub interior when distally advanced in the catheter hub. The valve comprises a distal surface and a plurality of flaps configured to be biased proximally into the valve when the distal surface is advanced against the distal interior of the catheter hub. The valve can be an active blood control valve.

[0018] In general, a blood control valve can comprise a valve body having a distal body segment and a proximal body segment, and a resealable slit axially aligned with the valve body and configured to transition between a closed configuration and an open configuration when contacted by the distal end of a blood draw device, wherein the valve is configured to be positioned within a catheter hub.

[0019] In this and any other examples described herein may further comprise one or more of the following. The distal body includes a distal interior and a proximal interior, wherein the resealable slit separates the distal interior and the proximal interior. The resealable slit can be configured to open when the proximal valve body is advanced towards the distal valve body. The blood control valve can further comprise a collar section separating the distal valve body and the proximal valve body, the collar section comprising an outer diameter less than the outer diameter of the proximal valve body, wherein the collar section is adapted to be advanced distally to the distal valve body. The resealable slit can be positioned through a - 4 -SG Docket No.: 14842-721.600collar section between the distal valve body and the proximal valve body, wherein a plurality of ribs can be arranged around the resealable slit in the distal interior, wherein each of the plurality of ribs can be configured to open the resealable slit when the proximal valve body is advanced towards the distal valve body. A proximal end of the distal valve body can be flexible and adapted to be distally depressed when the proximal valve body is advanced against the distal valve body.BRIEF DESCRIPTION OF THE DRAWINGS

[0020] 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:

[0021] FIG. l is a side elevation view of a catheter assembly including an extension set coupled to the proximal end and providing a proximal end configured to receive a blood draw device and an extension port and tube that can receive a fluid collection container.

[0022] FIG. 2A is a side elevation view of the extension set from FIG. 1 with the catheter hub aligned as it may be ready to receive the distal end of the extension set within the catheter hub and the collar configured to engage and couple with the catheter hub.

[0023] FIG. 2B shows the same side elevation view from FIG. 2A in a longitudinal crosssection to reveal the position of a valve in the proximal segment of the extension set and a valve positioned in the catheter hub.

[0024] FIG. 2C is another side elevation view of the catheter assembly from FIG. 2A now with the extension set in communication with the catheter hub.

[0025] FIG.2D is the same catheter assembly from FIG. 2A including a cross-section view of the assembly to reveal the arrangement of the extension set distal end in communication with the catheter hub valve and the catheter hub valve transitioned into an open configuration from the distal displacement provided by the extension set distal end.

[0026] FIG. 3 A is a perspective view from the distal end of the extension set in alignment with the proximal end of the catheter hub.

[0027] FIG. 3B is a perspective view of the extension set in FIG. 3 A from the proximal side showing the extension set in alignment with the catheter hub and the valve positioned in the proximal end of the extension set body in a closed configuration as it may be when coupling to the catheter hub.- 5 -SG Docket No.: 14842-721.600

[0028] FIG. 4A to 4E are various views of a catheter hub valve that may be positioned within a catheter hub and configured to be activated whereby the flaps on the distal valve face can be biased towards the valve body interior to open a lumen through the length of the valve from the catheter proximal end.

[0029] FIG. 5A is a distal perspective of the valve from FIG. 4A now in an activated and opened configuration whereby the flaps are biased towards the interior of the valve body and a lumen extends through the valve body from the proximal opening to the activated distal face.

[0030] FIG. 5B is a cross section of the valve illustrated in FIG. 5A with the valve flaps still in an open and activated configuration as they may be biased towards the valve interior when the valve is activated against the catheter hub interior geometry and proximal end of the catheter.

[0031] FIG. 5C is another cross section view of the valve from FIG. 5A in a side elevation position providing further detail of the valve flaps in an open and activated configuration.

[0032] FIG. 6A is a detailed cross section view of the valve from FIG. 4A positioned within the valve body and proximal to the catheter hub interior surrounding the proximal end of the catheter as it may be prior to transitioning to an activated configuration.

[0033] FIG. 6B is a cross section view of the catheter assembly from FIG. 6A now with the distal portion of the extension set inserted into the catheter hub and having distally displaced or advanced the valve against the catheter interior surrounding the proximal end of the catheter such that the valve is activated and the flaps are biased towards the valve body interior providing for a lumen through the catheter, passed the valve distal face and on to the interior space of the extension set.

[0034] FIG. 7A to 7G are various views of another valve that may be positioned within the extension set body at the proximal end to seal the extension set proximal end until the valve slit is activated or bypassed by a peripheral medical device such as a blood draw device.

[0035] FIG. 8 is a cross section of a proximal perspective view of the catheter assembly including the extension set body showing the position of the extension set valve at the proximal end of the extension set body and the arrangement of the extension set distal end within the catheter hub after having advanced the catheter hub valve distally to open the valve distal face in an activated configuration.- 6 -SG Docket No.: 14842-721.600

[0036] FIG. 9A is an exemplary arrangement of the catheter assembly, extension set, and a blood draw device as they may be aligned for coupling with the extension set positioned between the catheter hub and the distal end of the blood draw device handle.

[0037] FIG. 9B is a cross section of the component arrangement from FIG. 9A that reveals the interior orientation and configuration of the components before they are coupled together.

[0038] FIG. 10 is a side elevation view of the catheter assembly now coupled with the extension set with the blood draw device still aligned with the extension set proximal end as it may be when the extension set is coupled to the catheter assembly prior to coupling the blood draw device.

[0039] FIG. 11 A is yet another exemplary arrangement of the catheter assembly, extension set, and blood draw device as it has progressed from the arrangement illustrated in FIG. 9 A then FIG. 10, now with the blood draw device coupled to the proximal end of the extension set a it may be during a blood draw or fluid transfer procedure.

[0040] FIG. 1 IB is a cross section of the view illustrated in FIG. 11 A to reveal the arrangement of the interior components of the catheter assembly, extension set, and blood draw device as they may be configured to engage one another during use and provide a lumen or passage for a cannula to extend from the blood draw device through the extension set and then through the distal end of the catheter to facilitate a blood draw.

[0041] FIG. 12 is a side elevation view of the extension set alone, showing a prominent distal protrusion configured to be inserted into the catheter hub and activate the valve by distally advancing the valve against the proximal end of the catheter.

[0042] FIG. 13 is a cross section of the extension set from FIG. 12 revealing the interior geometry of the extension set and the extension port with tubing providing a fluid coupling between the vacutainer luer and the extension set interior volume.

[0043] FIG. 14 is a detailed view of the extension set shown in FIG. 12 zoomed in on the extension set body to further detail the interior geometry and valve position within the extension set body proximal end.

[0044] FIG. 15 is a detailed cross section view of the catheter hub from a distal perspective showing the extension set distal end within the catheter hub and the catheter hub valve in an activated configuration with the valve flaps biased towards an interior of the valve body.

[0045] FIG. 16A is a side elevation view of another exemplary extension set now with a shortened distal protrusion as it may be configured to be used with an alternative catheter hub valve illustrated in FIG. 19A to 19H.- 7 -SG Docket No.: 14842-721.600

[0046] FIG. 16B is a cross section of the extension set shown in FIG. 16A with the distal end now provided without a collar and including a shortened distal protrusion as it may be configured for use with the valve illustrated in FIG. 19A to 19H, as well as the extension set valve positioned in the proximal end of the extension set body.

[0047] FIG. 17 is a detailed cross section of the extension set body from FIG. 16B to provide additional details of the extension set body interior geometry, shortened distal end and position of the valve in the proximal end.

[0048] FIG. 18A and 18B are detailed cross section views of the extension set shown in FIG. 16A now coupled with the catheter hub including the catheter hub valve further detailed in FIG. 19A to 19H and shown here in an activated configuration with the distal tip of the extension set having contacted the proximal end of the catheter hub valve to activate the valve flaps into an open configuration providing a lumen through the catheter and on to the extension set body interior.

[0049] FIG. 19A to 19H are various views of another exemplary catheter hub valve as an alternative to the valve illustrated in FIG. 4A now having a distal body segment and a proximal body segment separated from one another by a collar segment wherein the valve flaps may transition between a closed position to an activated or open configuration when the proximal valve body segment is distally advanced towards the distal valve body segment and the collar section supports the opening of the valve slit therebetween.

[0050] FIG. 20 is a detailed cross section of a side elevation view of the valve from FIG. 19A now positioned within a catheter hub and adjacent to the proximal end of the catheter in a closed configuration.

[0051] FIG. 21 A shows the catheter assembly, extension set, and a blood draw device as they may be in alignment for coupling with one another during use.

[0052] FIG. 2 IB is a cross section of FIG. 21 A revealing the position and arrangement of the catheter hub valve from FIG. 19A, the extension set valve, and the distal end of the blood draw device.

[0053] FIG. 22A is a progression of the arrangement illustrated in FIG. 21 A now with the catheter assembly, extension set, and blood draw device coupled with one another as they may be during use.

[0054] FIG. 22B is a cross section of FIG. 22 A showing the distal end of the extension set coupled to the catheter hub assembly and having activated the valve to open the valve slit and provide a lumen whereby the cannula of the blood draw device extends through the extension set valve, through the activated catheter hub valve and on through the catheter such- 8 -SG Docket No.: 14842-721.600that the distal end of the cannula is extending beyond the catheter distal tip as it may be during a blood draw procedure.

[0055] FIG. 23 is a detailed cross sectional view of the catheter assembly, extension set, and a blood draw device as it may be arranged during use with the extension set valve slit opened and bypassed by the blood draw device distal tip such that he blood draw device is extended through the extension set, catheter hub valve, and then through the catheter.DETAILED DESCRIPTION

[0056] The extension sets described herein can be configured to provide an extension port in fluid communication with a fluid receptacle (e.g., vacutainer) and one or more valves to control fluid communication between an in-dwelling catheter to the vacutainer or proximal access through the extension set body. Valves configured to be positioned in the catheter hub can be transitioned from a closed state to an open state. In some cases, the valves can transition from an open state to a closed state after use to reseal or reestablish a fluid seal in the catheter hub. Additionally, valves positioned within the extension set body can provide a fluid seal to a proximal opening of the extension set body that may be accessible by a medical device such as a fluid transfer (e.g., blood draw) device.

[0057] FIG. 1 is a side elevation view of a catheter assembly 100 including an extension set 200 coupled to the proximal end and providing a proximal end configured to receive a blood draw device and an extension port 220 and tube 221 that can receive a fluid collection container. The catheter assembly 100 is illustrated with a catheter 101 extending distally from a catheter hub 105 to a catheter tip 101a. In some examples, the catheter assembly may have a stabilizer 106 to provide stability for the catheter assembly 100 when it is placed and positioned within a patient.

[0058] The extension set 200 is coupled to the catheter assembly 100 with a coupling mechanism 215 providing a connection between the extension set 200 and the catheter hub 105. The extension set body 205 is shown in this example having one or more segments or regions including a proximal engagement region 210, a first coupling region 208, a distal coupling region 207 and a central portion 206. In some examples, the coupling regions may provide features configured to engage with a peripheral medical device such as a blood draw device. The extension port 220 is in communication with tubing 221 extending to a luer 223 configured to receive a fluid container such as a vacutainer assembly. A clip 222 is provided on the tubing in operable communication to control a flow of fluid (e.g., blood) from the extension set body 205 to the luer 223.- 9 -SG Docket No.: 14842-721.600

[0059] FIG. 2A is a side elevation view of the extension set 200 from FIG. 1 with the catheter hub 105 aligned as it may be ready to receive the extension set distal end (e.g., distal protrusion 230) within the catheter hub 105 and the collar 235 configured to engage and couple with the catheter hub 105. Here, additional details of the catheter assembly include an engagement feature 107 position on the catheter hub 105 and configured to facilitate manipulation and positioning of the catheter assembly. Coupling tabs 110 are shown at the catheter hub proximal end 105b and configured to engage the coupler 215 of the extension set. The coupling tabs 110 may be tabs positioned around the catheter hub proximal opening 105b. In some examples, the tabs 110 may be a threaded feature, circumferential raised feature or otherwise configured to engage a coupling mechanism (e.g., coupler 215) of an extension set.

[0060] FIG. 2B shows the same side elevation view from FIG. 2A in a longitudinal crosssection to reveal the position of a valve 250 in the proximal segment of the extension set 200 and a valve 150 positioned in the catheter hub 105. The valve 250 in the extension set body provides a sealed proximal opening of the extension set with a slit 265 that can be accessible by a blood draw device or other medical device with a distal end configured to traverse the slit 265 and access the extension set body interior volume. The valve 150 is shown in a closed configuration positioned proximal to the catheter proximal end in the catheter hub 105. The alignment of the distal protrusion 230 with the catheter hub 105 shows an arrangement as it may be during installation of the extension set. The distal protrusion can be inserted into the catheter hub 105 and be positioned within the proximal end of the valve 150. The collar (e.g., collar segment or portion) 235 is proximal to the protrusion and adapted to contact the proximal perimeter of valve 150 to advance the valve to an open configuration, when the extension set in coupled to the catheter hub 105.

[0061] In FIG. 2C the extension set is now coupled with the catheter assembly as initially shown in FIG. 1. Here, the coupler 215 is engaged with the coupling tabs (not visible) to retain the extension set body 205 to the catheter hub 105. The cross section in FIG.2D is the same catheter assembly from FIG. 2C including a cross-section view of the extension set body 205 coupled with the catheter hub 105 now with the valve 150 in an open position as the collar 235 has advanced the valve 150 against the distal interior of the catheter hub 105 to provide a flow path or lumen open through the catheter 101 through the distal protrusion 230 and into the extension set interior which is sealed by valve 250 at the extension set proximal end.

[0062] In some examples, the extension set is coupled with the catheter hub and provides an axial alignment and lumen through the catheter continuing into the extension set body for- 10 -SG Docket No.: 14842-721.600fluid extraction from the extension set port. In some examples, the extension set port may be configured to receive medications, other catheters, etc.

[0063] The perspective views in FIGS. 3A and 3B illustrate additional details of an alignment between the extension set and catheter assembly as it may be when the extension set is installed (e.g., coupled) to the catheter hub 105. Referring to FIG. 3 A the distal perspective shows the lumen through the distal protrusion 230 from the distal protrusion tip 230a and continuing into the extension set body. From this distal perspective, details of a distal face 207a and distal face 208a of the coupling regions 207 and 208, respectively, can be seen. These coupling regions (e.g., 208 and 207) can provide the surfaces 208a and 207a to a clip, clamp, or other coupling mechanism of a device configured to engage the extension set proximal side during use. The collar segment distal end 235 can also been seen with a larger diameter than the distal protrusion 230, which is adapted to allow the distal protrusion 230 to be positioned within a valve in the hub 105 and the collar 235 to then contact a proximal end of the valve to activate the valve.

[0064] FIG. 3B is another perspective view of the extension set 200 and catheter assembly 100 now from the proximal side to reveal details of the valve 250 sealing the extension set proximal end 210b. The slit 265 is configured to receive an elongate member therethrough while maintaining a seal of the extension set interior. The slit 265 may then reseal after engagement with a peripheral medical device to maintain and re-establish a seal of the extension set interior. This proximal perspective also reveals additional details o the coupling mechanism 215 having teeth 217 at a proximal end configured to engage the extension set body 205. The teeth 217 can allow for rotation of this coupling mechanism 215 when the extension set engages the catheter hub 105. The distal protrusion 230 is aligned with the catheter hub interior 120. Also seen here, similar to FIG. 2A is the opening 224 in the luer 223. Accordingly, the extension sets described herein can provide fluid access to a vessel through the catheter and through the extension set via the extension port 220 and / or the proximal end 210b through the valve 250.

[0065] Details of an exemplary catheter hub valve are shown in FIG. 4A to 5C. Referring to FIG. 4A, a side elevation view of a valve 150 alone, which may be positioned within the catheter hub. The valve 150 is shown with a proximal valve body 160 and a distal valve body 155. A channel 165 is positioned around the circumference of the valve 150 between the distal body portion 155 and proximal body portion 160. The channel 165 can be adapted to receive a corresponding raised feature within the catheter hub to retain the valve in position within the hub until the valve is actuated by distal advanced to disengage the channel 165 from the catheter hub interior allowing the valve 150 to advance and open against the- 11 -SG Docket No.: 14842-721.600proximal end of the catheter pressing against the valve distal end 150a. The proximal end 150b can be configured to contact the collar of an extension set. FIG. 4B is a cross-section view of the valve 150 from FIG. 4A revealing a slit 175 having a proximal side 175b within the valve interior 170 and a distal side 175a position at the valve distal face 155a. Flaps 180 are provided on either side of the slit 175 and are configured to be biased towards the valve interior 170. The distal surface 170a of the valve interior 170 may be sufficiently flexible allowing the flaps 180 to bend or bias from the closed position (as shown) to an open position providing a lumen though the valve 150. The interior geometry may comprise a taper 170b providing a larger interior diameter in the distal body portion 155 and distal to the channel 165. In some examples, this taper 170b may provide for a thinner valve wall through the distal body portion 155 configured to accommodate the displacement of the flaps 180 and facilitate the repositioning of the valve 150 as it is distally advanced in the catheter hub. In some examples, the thicker valve wall in the proximal body portion 160 may be configured to increase structural integrity of the valve as a force is supplied to the proximal end 150b by an extension set when the valve is to be activated to an open position.

[0066] The additional views in FIG. 4C and 4D illustrate additional details of the distal valve face 150a now with two intersecting slits 175 that provide a plurality of flaps 180. As described above, the flaps 180 can be configured to flex or open towards the valve interior 170 when the valve is distally advanced against a protrusion (e.g., the distal end of the catheter hub interior and / or the proximal end of the catheter). FIG. 4E is a proximal end view centered on the interior distal surface showing the intersecting slit 175, flaps 180, and an additional conical feature 185 extending distally into the interior distal surface. This conical feature 185 can be configured to support valve activation against the catheter proximal end and prevent inadvertent contact with a cannula that can be extended through the extension set and catheter assembly during a blood draw procedure.

[0067] FIGS. 5 A to 5C show the valve 150 now in an open configuration with the flaps 180 biased towards the valve interior 170. FIG. 5 A is a distal perspective of the valve 150 now in an activated and opened configuration whereby the flaps 180 are biased towards the interior of the valve body and a lumen extends through the valve body from the proximal opening to the activated distal face.

[0068] FIG. 5B and 5C provide cross section views of the valve 150 illustrated in FIG. 5 A with the valve flaps 180 still in an open and activated configuration as they may be biased towards the valve interior 170 when the valve is activated against the catheter hub interior geometry and proximal end of the catheter. In some examples, the valve distal face 150a may have a region 151 configured to circumferentially engage a protrusion or proximal catheter- 12 -SG Docket No.: 14842-721.600end within the catheter hub. Accordingly, the activated valve can provide a lumen through t valve 150 and then through a catheter, while maintaining a fluid seal for the valve interior 170 such that blood may be prevented from flowing anywhere other than through the valve interior 170 or through a cannula that may be extended through the valve and through the catheter.

[0069] FIG. 6A is a detailed view of the valve 150 now positioned within the catheter hub 105. As described above, the valve 150 has a channel 165 engaged with the catheter interior 111 as the valve is in the closed configuration proximal to the catheter proximal end 101b ready to be activated. The interior volume 170 of the valve is open to the proximal end 150a, which is also open to the catheter hub proximal end 105b. The slit 175 is axially aligned with the catheter 101 and lumen 102 extending therethrough. At the hub interior distal end 120a, there is a space between the catheter hub interior distal end 120a and the valve distal end 105a. As will be further illustrated in FIG. 6B, the valve 150 can be distally displaced into the space 120a and as the flaps 180 are advanced against the catheter proximal end 101b and hub protrusion 120c around the catheter proximal end 101b to open the valve 150. Also, in this view, the hub distal end 105a is positioned within the stabilizer 106.

[0070] Now, in FIG. 6B, the valve 150 has been distally advanced in the catheter hub 105 by the extension set collar 235 contacting the valve proximal end 150b to disengage the channel 165 and distally advance the valve distal face 150a against the catheter proximal end 101b to open the flaps 180. The valve 150 has been advanced a sufficient distance into the catheter hub interior distal end 120a to sufficiently open the valve such that the extension set distal protrusion 230a is in alignment and proximally positioned to the catheter proximal end and lumen 102 therethrough. Accordingly, the catheter lumen 102 now continues into the extension set interior 229 allowing blood draw through the extension port (not visible) or through the extension set proximal end with a blood draw device.

[0071] Advancing the extension set collar 235 against the valve 150 to open the valve 150 can be facilitated by the coupling mechanism 215. The detailed view in FIG. 6 reveals the threads 216 of the coupling mechanism 215 that can engage the tabs 110 of the catheter hub 105. As the coupling mechanism is threaded onto the hub 105, the distal protrusion 230, collar 235 and extension set body are distally advanced against the valve 150. For example, the extension set body distal end (e.g., 230) may initially be inserted into the catheter hub 105 until the coupling mechanism 215 engages the hub 105 and is then threaded onto the hub providing sufficient force to displace the valve towards the hub distal interior 120a. For example, each rotation of the coupling mechanism 215 may further advance the collar 235- 13 -SG Docket No.: 14842-721.600against the valve proximal end 150b and correspondingly translate the valve 150 further distal in the hub 105 to open the flaps 180 as illustrated.

[0072] Reference has been made to a valve locatable in the extension set body. FIG. 7A to 7G illustrate various views of an extension set body valve 250. The valve 250 generally has a valve body 255 which may comprise a plurality of regions of segments from a proximal end 255b to a proximal neck region 260 configured to extend through a proximal opening in the extension set body providing a seal to the interior of the extension set body. A tapered segment 259 extends proximally from the neck 260 with an exterior geometry that can be complementary to the interior geometry of the extension set proximal end further supporting a seal of the extension set interior, segment 258 is a regio of reduced diameter relative to section 257. The proximal end of section 275b can be configure to engage an interior of the extension set to lock or retain the valve 250 in position within the extension set body. Similarly, section 256 as a distal collar comprises a larger diameter than the distal side of section 257 with a proximal face 256b that can also contact or engage an interior of the extension set body to support a static position and placement of the valve 250 in the extension set.

[0073] The proximal perspective shown in FIG. 7B now reveals the valve slit 256 on the proximal end 255b. This slit can be traversed by a medical device such as a blood draw device with a distal protrusion configured to be inserted through slit 256 to be disposed through the valve 250 to extend or deploy a cannula through the lumen of the extension set body, through the distal protrusion, and though the catheter lumen to access a blood vessel through the catheter and draw blood therefrom. This proximal perspective also highlights the characteristics of the proximal face 257b and 256b having different circumferences and configured to engage an interior of the extension set body. The distal perspective in FIG. 7C now reveals opening 270 into the hollow interior of the valve 250. This opening 270 can be open to the interior of the extension set body.

[0074] The cross-section views in FIG. 7D to 7F illustrate additional details of the hollow interior and examples of the different body segment geometries configured to accommodate and complement the interior of the extension set body where the valve is positioned. The slit 265 can be seen extending through the neck segment 260 and into the interior 270. This slit can be re-sealable such that it may accommodate a device (e.g., a blood draw device extended therethrough, then transition back to a sealed configuration after the device is withdrawn from the extension set.

[0075] Now in FIG. 7G, the slit 265 is open to the valve interior 270 as it may be when the distal end of a blood draw device is inserted therethrough. The neck portion 260 can be- 14 -SG Docket No.: 14842-721.600configured to seal around the portion of the blood draw device extending through the slit 265 in the open configuration. From this configuration illustrated in FIG. 7G, the slit 265 may then transition back to a closed configuration as illustrated in FIG. 7B.

[0076] FIG. 8 shows the extension set from FIG. 1 coupled to the catheter hub 105 with the distal protrusion 230 proximal to the catheter proximal end 101b including the coupling mechanism 215 engaged to the catheter hub tabs 107 such that the collar 235 has contacted the valve proximal end 150b to distally advance the valve 150 into an open configuration with the distal valve side 150a providing the flaps 180 biased proximally to expose the catheter lumen that continues through the extension set body 205 until the valve 250 sealing the extension set proximal end 210b. The valve slit 265 can be seen in the closed configuration with the proximal valve face 255b ready to receive a blood draw device through the slit 265.

[0077] In this view, an additional feature of the extension set body can be seen including a coupler retention feature 209a which the coupling mechanism 215 may be in communication with to advance the extension set body 205 into the catheter hub 105. Further details, the valve distal side 255a is seen contacting and seated against a proximal face 207c of extension set segment 207 such that the valve 250 is prevented from distal advancement within the extension set body 205. Similarly, proximal face 257b of the valve is also in communication with the extension set body interior to further retain the valve 250 in position.

[0078] As described herein, the extension sets and catheter assemblies may provide access for a blood draw device to engage the extension set and draw blood from the vessel vias the catheter positioned therein. FIG. 9A to 1 IB provide an exemplary arrangement and configuration for interaction and compatibility of the extension set to receive a blood draw device. Referring to FIG. 9 A, an exemplary arrangement of the catheter assembly 100, extension set (e.g., extension set body 205), and a blood draw device 500 as they may be aligned prior to coupling during use. The illustrated arrangement highlights an example of an axial alignment between the catheter, extension set and blood draw device. For example, the blood draw device has a handle 505 with coupling arms 506 configured to receive the extension set proximal end 210 as the blood draw device distal end 507 and distal tip 507a inserted in and through the valve within the extension set housing 205. The cross section of FIG. 9 A shown in FIG. 9B further details this arrangement. Starting with the catheter assembly 100, the catheter 101 extends from the hub 105 with the valve 150 positioned proximally to the catheter proximal end 101b. The valve proximal end 150b is arranged towards the proximal end of the hub 105 ready to receive the distal protrusion 230 of the extension set body 205 as well as the collar 235 that can be configured to distally advance the- 15 -SG Docket No.: 14842-721.600valve into an activated or actuated open configuration. The extension set interior 229 is generally axially aligned with the catheter 101 with the valve slit 265 of the extension set valve 250 also in axial alignment with the extension set and catheter 101. At the proximal side of the extension set body, there is at least one coupling region 208 that may provide an engagement portion for the handle 505. As illustrated here, the extension set proximal end 210 is configured to engage and be positioned in the coupling arms 506 of the blood draw device. The cross section of the handle 505 reveals a cannula 510 configured to be distally advanced from the device distal end 507 then through the extension set interior 229 and finally through the catheter 101 into the vessel to facilitate a blood draw through the cannula to a vacutainer or fluid container in communication with the handle extension port 515. Also seen here is a valve 509 positioned at a distal end of the handle interior to seal the handle interior from any flow of fluid outside of the cannula 510.

[0079] FIG. 10 illustrates a progression in the configuration of the catheter 100, extension set body 205 and blood draw device 500 when the extension set body205 is coupled to the catheter hub 105 with the coupler 215. For example, this arrangement has been detailed in FIG. 8. The blood draw device distal end 507 is still in axial alignment with the extension set proximal end 210 and in position to be inserted through the extension set proximal surface 210a.

[0080] Finally, FIG. 11 A and 1 IB progress yet further from FIG. 10 with the blood draw device 500 now coupled to the proximal side of the hub 105 such that the distal end 507 is inserted through the slit 265 and into the extension set interior 229. Referring to FIG. 11 A, the coupling arms 506 are in communication with the luer or threaded engagement ar the extension set proximal segment 210. Although the proximal end of the blood draw device 500 is not shown, it can be understood that the blood draw device is further transitioned to a cannula deployed state with the cannula 510 shown extending beyond the catheter distal tip 101a as the cannula is extending through the catheter lumen 102 and beyond the catheter 101. Referring to FIG. 1 IB, the details of the activated valve 150 can be seen as it has been advanced by the collar 235 against the proximal end of the catheter 101b.

[0081] Looking to the extension set body interior, the exemplary geometry provides a progressively reduced taper through the various body segments that may be adapted to direct the cannula 510 through the extension set body and to maintain or support an axial alignment of the cannula 510 from the blood draw device distal tip 507a through the extension set distal protrusion 230, passed the valve 150 and through the catheter 101. In this deployed configuration, the distal portion of a plunger 520 within the handle 505 can be seen with the cannula proximal end 520a open through the plunger 250 and in fluid communication with- 16 -SG Docket No.: 14842-721.600the extension port 515 then on through tubing 516 that may be coupled to a vacutainer or other fluid receptacle.

[0082] FIG. 12 is a side elevation view of the extension set including the extension set body 205 extending from a proximal end 210b to a distal end 230a at the distal tip of the protrusion 230. Proximally positioned is the collar region 235 separated from the distal tip 235a by a length 230c of the distal protrusion 230. As previously illustrated, the distal protrusion 230 is adapted to be inserted into a valve within a catheter hub while the collar provides a larger diameter and raised distal collar to contact the proximal end of a valve and displace the valve into an open configuration. The length 230c can be adapted to position the distal tip 235a adjacent to the proximal end of a catheter. Also as described herein, when the extension set is used with a blood draw device providing an extendable cannula configured to be extended through the catheter, the extension set can provide support for reducing the distance between the distal tip 235a to the proximal opening of the catheter lumen thereby reducing any misalignment of the cannula when it is deployed.

[0083] The cross section of FIG. 12 illustrated in FIG. 13 provides further details of the extension set interior geometry including one or more tapered regions with a distally decreasing diameter that may also be adapted to direct the passage of a cannula therethrough. For example, a first tapered region 229b may be distal to the distal tip of a blood draw device positioned within the extension set body 205. Accordingly, if the extendable cannula is flexible or deflected to contact the interior surface of the extension set, region 229b can guide the cannula towards the central axis of the extension set. Additionally, region 229a comprises a further taper that may be adapted to further direct the cannula to the central axis of the extension set body 205 and towards the distal opening through the distal protrusion 230.

[0084] Further interior detail of the extension set body 205 is illustrated in FIG. 14 to provide details of the engagement between the extension set valve 250 seated in a proximal end of the extension set body. Here, the valve distal end 255a is open to the extension set interior with a perimeter of the valve seated in communication with the interior face 207c of the extension set. This point of contact can be adapted to prevent distal displacement or movement of the valve when a medical device engaged the slit and inserted distally through the valve. Similarly, proximal face 208c of the extension set interior is in contact with the valve 250 to prevent proximal displacement or movement of the valve. For example, when the medical device is withdrawn proximally through slit 265. In this example, the valve body has a proximally increasing taper of the valve body to provide the contact with the extension set interior face 208c.- 17 -SG Docket No.: 14842-721.600

[0085] The distal perspective view in FIG. 15 shows additional detail of the distal protrusion 230 position relative to the proximal end of the catheter 101b. As previously described, the distal protrusion tip 230a is adapted to be positioned adjacent to the proximal catheter opening 101b and reduce the distance a cannula extending through the extension set body 205 may need to traverse before passing into and through the catheter 101. The valve flaps 180 are open here and as the distal valve face 150a is pressed against the catheter interior distal end 120c, the flaps 180 are biased proximally and retract away from the central axis of the catheter and extension set to provide a lumen through the catheter 101 and the extension set body 205. In this detailed view, additional examples of engagement between the coupling mechanism 215 and the catheter hub proximal end 105b can be seen with the threads 216 rotatable engage the catheter hub 105 to secure and advance the extension set body 205 relative to the catheter hub 105.

[0086] FIG. 16A is a side elevation view of another exemplary extension set 400 now with a shorted distal protrusion 430 as it may be configured to be used with an alternative catheter hub valve illustrated in FIG. 19A to 19H. The extension set body 405 may be provided without a collar section as seen in extension set 200 as the extension set 400 may be adapted for use with a different valve. The extension set proximal end 410b may also have a coupling region 410 configured to receive a medical device. Additional engagement regions (e.g., region 408) may still be provided on the body as any of the extension sets described herein may be universally configured to engage or couple with any style of medical device for fluid transfer, or other styles of injectables (e.g., power injectables, needles, etc.). The extension set 400 also include extension port 420 with tubing 421 extending to the luer connector 424.

[0087] FIG. 16B is a cross section of the extension set shown in FIG. 16A. The cross section reveals a similar interior geometry to extension set 200. However, the extension set body 405 now has the distal protrusion extending from the extension set body with the coupling mechanism 415 circumferentially positioned around the distal protrusion that is shortened or abbreviated compared to distal protrusion 230 of extension set 200. The valve 250 is still positionable in the proximal end of extension set body 405 with slit 265 similarly positioned and configured as described with extension set 200.

[0088] FIG. 17 provides further details of the extension set 400 including the interior 429 with the tapered interior regions 429a and 429b similarly configured to direct a cannula through the extension set body 405, if necessary. The distal protrusion 430 now extends at length 430c which is less than the length 230c of extension set 200. The different distal end- 18 -SG Docket No.: 14842-721.600configuration of the extension sets may provide for compatibility with a different catheter hub valve.

[0089] FIG. 18A and 18B are detailed cross section views of the extension set shown in FIG. 16A now coupled with the catheter hub including the catheter hub valve further detailed in FIG. 19A to 19H. Valve 300 is shown in an open configuration with a central lumen 320 open as the extension set body 405 and particularly the distal protrusion 430 has contacted the proximal side of the valve 300 such that the contact and proximal pressure on the valve 300 is sufficient to open the lumen 320 to the catheter 101. As seen here, the extension set 400 provides an axial alignment through the extension set interior to the proximal end with valve slit 265 then distally through the catheter assembly and catheter 101. In FIG. 18B, additional detail of the distal protrusion 430 arrangement relative to the valve 300 and catheter hub 105 are shown. The distal tip 430a of the extension set is in contact with the valve proximal end to advance a proximal valve body 310 distally to activate and open the valve 300 where the flaps 325 are biased into an open position. In this view, the distal end of the valve 305a is positioned in the distal end of the catheter hub interior 120a. In this example, the distal end of the valve 305a fills the distal catheter hub interior 120a such that the distal valve body is statically positioned within the hub 105.

[0090] FIG. 19A to 19H are various views of another exemplary catheter hub valve 300 as an alternative to the valve 150 illustrated in FIG. 4A now having a distal body segment 305 and a proximal body segment 310 separated from one another by a collar segment 315 wherein the valve flaps may transition between a closed position to an activated or open configuration when the proximal valve body segment 310 is distally advanced towards the distal valve body segment 305 and the collar section 315 supports the opening of the valve slit therebetween. In some examples, the valve in FIG. 19A is an active blood control valve as it may transition between an open configuration and a closed configuration such that the extension set can couple and may be uncoupled from the catheter hub and the valve 300 can maintain a fluid seal for the catheter.

[0091] Referring still to FIG. 19A, the proximal end of the distal valve body 305b is shown with compression zones 305c that can be adapted to compress distally when pressure is supplied to the proximal valve body 310 to advance the collar segment 315 into the distal valve body 305. In this way, the compression zones 305c may provide for increased flexibility of the proximal face 305b of the distal valve body 305 to activate the flaps into an open configuration.

[0092] FIG. 19B is a view through the distal opening 340a to show a slit 320 with flaps 325a on either side of the slit 320. Ribs 330 are positioned around the slit and configured to- 19 -SG Docket No.: 14842-721.600support the activation of the slit 320 to an open configuration when pressure is supplied to the proximal valve body 310. Ribs 330 may also be configured to bias the valve in a closed position without pressure supplied to the proximal valve body 305. In some examples, the ribs 330 may provide a spring boas or spring force to the slit and require sufficient force supplied to the proximal valve body 305 to activate the slit 320 into an open configuration by overcoming the spring bias of the ribs 330. In this view, there may also be a region 306 on the distal valve end configured to contact the proximal end of the cannula or the proximal interior of the catheter hub around the catheter proximal end providing a seal around the proximal end of the cannula.

[0093] FIG. 19C is a view through the proximal opening of the valve from FIG. 19B. The proximal end of the slit 320 is visible as it is extending from the distal valve body to the proximal valve body. Flaps 325b now seen on the proximal side of the valve are identified in this exemplary configuration where the flaps may separate as the valve (e.g., slit) is opening when the proximal body portion is advanced towards the distal body portion. From this proximal view, the ribs 330 are not visible on the proximal side of the valve body interior as they may be configured to support function of the valve on the distal dise of the slit when the valve is activated during use.

[0094] FIG. 19D to 19F now shows a cross section of valve 300 with the collar segment 315 having a length 315c. As previously described, when force is supplied to the proximal valve body 310, the collar region may be advanced into or towards the distal valve body 305. The length 315c of the collar segment 315 may provide a distance of travel for the collar portion 315 to be biased into the distal valve body. The slit 320 can be seen extending between the distal valve interior 340a and the proximal valve interior 340b. At the proximal end, an opening 341 (e.g., proximal opening) may be open to the extension set distal tip 430a. The interior geometry of the valve 300 at the distal end of the proximal interior 340b is shown as having a taper or distally decreasing diameter to the slit 365. Accordingly, the configuration of the valve interior may be adapted to support guiding or directing the cannula through the slit 320 and thereby axially aligned with the catheter lumen.

[0095] The interior geometry of the valve 300 adjacent to the proximal side of the slit 320b may also be configured to support the opening of the slit 320 in response to a proximal force on the valve segment 310. For example, the collar segment 315 may translate the proximal force initially towards the center of the slit 320 where the ribs may respond by outwardly curling or biasing the distal flaps 325 to open providing a lumen through the collar segment 315.- 20 -SG Docket No.: 14842-721.600

[0096] In FIG. 19G and 19H, the slit 320 is now open with the lumen 340c extending through the lumen between the proximal interior 340b and the distal interior 340a thereby providing a lumen that can continue through the catheter lumen. In FIG. 19G, the compressed collar segment 315d is translating the force from the proximal side 305 through the flaps 325 and to the ribs 330 that pull the distal end of the flips outward and open. The arrows 355 in FIG. 19H show the direction of the translated force from the proximal end indicated by arrow 350 as the ribs 330 pull or bias the slit 320 open and provide lumen 340c through the collar portion now linking the distal interior and the proximal interior 340b of the valve.

[0097] FIG. 20 shows valve 300 in a closed or inactive configuration within the catheter hub 105 and proximally adjacent to the catheter proximal end 101b. The slit 320 is axially aligned with the catheter lumen. Now, the distal end of the valve 305a is positioned within the distal end of the catheter interior 120a. As illustrated here, the valve fills the distal catheter interior which can be adapted to support a static position of the distal valve body 305 such that the distal valve body may not be displaced of moved in response to a force on the proximal valve body 310. The opening 120b at the proximal end of the catheter 105 is still configured to receive the distal protrusion of an extension set. With this valve 300, the catheter may be adapted for use with extension set 400 or with any other blood draw device or medical device having a catheter engagement and configured to insert a distal portion of the device into the catheter hub sufficiently to contact and activate the valve 300 to an open configuration.

[0098] FIG. 21 A and 21B illustrate a similar arrangement previously described in FIG. 9A with the extension set 400 positioned between a blood draw device 500 and the catheter assembly 100. Arrows are provided to indicate the direction of each component with which they are to be coupled together in use. The distal protrusion 430 is aligned with the catheter hub proximal side 100b and the distal end 507 of the blood draw device handle is similarly axially aligned with the extension set body proximal end 410. In FIG. 2 IB, the cross section further reveals an exemplary alignment of the catheter 100, extension set 400 and blood draw device 500, now with the active blood control valve positioned in the catheter hub 105 ready to be activated by the distal protrusion 430 of the extension set.

[0099] The cross-section view in FIG. 2 IB also illustrates an exemplary arrangement including dimensions of the catheter 100, extension set 400 and blood draw device 500. In some examples, dimensions of one or more features, elements, regions, segments, etc. of any of the components may be optimized or otherwise configured to optimal compatibility. Referring to the catheters described here, the hub 105 may have a length, circumference, or geometry optimally configured to engage or communicate with the distal end of the extension - 21 -SG Docket No.: 14842-721.600set 400 and / or the distal protrusion of the blood draw device 500. For example, where the extension set distal end if elongated, the catheter hub may be longer to accommodate the extension set without impeding any interaction between the extension set and valve(s) within the catheter hub. Alternatively, the catheter hub may be shorter where the distal end of the extension set is shorter to accommodate the positioning, alignment and function of engagement between the catheter and the extension set, accordingly. Similarly, the proximal end of the extension set may be sized or otherwise configured to optimally communicate with the distal end of a blood draw device. In FIG. 2 IB, the blood draw device distal end 507 is elongated and generally configured to engage the proximal end of the extension set. In some examples, the coupling between the extension set and the blood draw device may also include one or more valves, as described herein. In any example, the distal end of the blood draw device may have a length, circumference, or geometry to optimally engage with the extension set without impeding the function of the extension set to seal the interior while allowing the blood draw device to properly communicate therewith. In some examples, the blood draw device distal end (e.g., protrusion 507) may be shortened to engage with the proximal end of the extension set and / or the proximal end of the catheter.

[0100] FIG. 22A and 22B illustrate a progression in the arrangement of components from FIG. 21 A. Now, with the extension set 400 coupled to the catheter hub 105 with the coupling mechanism 415 engaged to the hub proximal end, the distal protrusion 430 is placed in communication with the valve 300 and providing sufficient force to the proximal valve body 310 to activate the slit 320 and open the lumen further cannula 510 to be extended through. At the proximal end of the extension set body 405, the blood draw device 500 is coupled as previously described herein. In some examples, the extension set 400 is configured to supply the force to the proximal valve body 310 to transition the valve 300 into an active configuration.

[0101] FIG. 23 further details the arrangement in an activate configuration for the extension set 400 with the valve 300 in the catheter hub 105. In this detailed view, the blood draw device distal end 507 is extending through the valve 250 with the coupling arms 506 engaged to the extension set body proximal end 410 and the cannula 510 is deployed from the blood draw device 500 then extending through the extension set interior through te distal protrusion 430, through the valve 300 and valve slit 320 that is open by the proximal force supplied by the distal protrusion tip 430a contacting the proximal side of the valve 310b to advance the collar portion 315 against the distal valve body proximal face to open or activate the valve. The distal valve body 305 is statically positioned in the catheter hub interior distal end 120a as it may not be moved or displaced in response to the force from the distal- 22 -SG Docket No.: 14842-721.600protrusion 430. The cannula 510 is axially aligned with the catheter 101 and extending therethrough in this open configuration. When the extension set 400 and distal protrusion 430 are retracted or withdrawn from the catheter hub, the proximal valve body 305 can then be proximally biased base to an inactive configuration with the slit 320 returning to a close configuration and closing the lumen to re-establish the fluid seal of the catheter. For example, after a blood draw procedure, the cannula 510 may be retracted to the blood draw device 500, the blood draw device may be retracted, withdrawn or otherwise disengage the extension set valve 300 which can re-establish a seal of the extension set interior. Then, the extension set may be uncoupled from the catheter hub 105 which will decrease and remove any force supplied by contact between the valve 300 and the distal protrusion 430. The proximal valve body may then be biased proximally. For example, the collar portion may provide a spring bias to proximally shift the proximal valve body 305 to an inactive position and the ribs may return the slit 320 to a close position re-establishing the fluid seal to the catheter.

[0102] In any of the examples described herein, the length of a distal end (e.g., distal protrusion) or any other portion of the extension set body may be configured with any length for use, arrangement, or orientation described herein. For example, the length of the distal protrusion may be less than 1mm, 1mm, or greater than one 1mm. In any of the examples, the distal protrusion may extend from the distal end to the central portion of the extension set body. In any of the examples described herein, the distal protrusion may extend to the collar segment or region. In any of the examples described herein, the distal end may be configured with a length for use with the catheter hub depending on the valve (e.g., valve 150, valve 300, or other valve) positioned within the catheter hub.

[0103] 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.

[0104] 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.

[0105] There may be one or more variations, alternatives, constructions, compositions, and / or components described herein that can be used to modify an element, component,- 23 -SG Docket No.: 14842-721.600device, 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.

[0106] 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 understood that 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.

[0107] 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.

[0108] 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 - 24 -SG Docket No.: 14842-721.600context 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 “ / ”.

[0109] 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 device may 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.

[0110] 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.

[0111] 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.

[0112] 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 - 25 -SG Docket No.: 14842-721.600the 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, and ranges 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.

[0113] 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 - 26 -SG Docket No.: 14842-721.600intending 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.- 27 -SG Docket No.: 14842-721.600

Claims

CLAIMSWhat is claimed is:

1. An extension set comprising: a body having a distal protrusion and a proximal coupling segment with a lumen extending from a proximal end of the body through the distal protrusion; an extension port provided on the body with a fluid container coupler in fluid communication with an interior of the body, the fluid container coupler at a distal end of tubing in communication with the extension port; a collar positioned proximal to the distal protrusion; and a coupling mechanism configured to couple the body to a catheter hub.

2. The extension set of claim 1, wherein the coupling mechanism is configured to couple the body to a catheter assembly comprising: a catheter extending distally from the catheter hub; an activable valve positioned within the catheter hub proximally adjacent to the catheter proximal end, wherein the collar is configured to contact the valve and advance a distal surface of the activatable valve against the interior of the catheter hub to activate the valve and provide a lumen from the catheter to the interior of the extension set body.

3. The extension set of claim 2, wherein the valve comprises a circumferential channel around a valve body, the channel configured to engage a raised portion of the catheter hub interior while the valve is in a first position, wherein the channel is configured to disengage the raised portion of the catheter hub interior when the collar distally advances the valve in the catheter hub.

4. The extension set of claim 1, wherein the coupling mechanism is configured to advance the collar against a valve positioned within the catheter hub until the collar activates the valve to open.

5. The extension set of claim 1, wherein a valve is positioned within the catheter hub and configured to be activated to an open configuration when distally advanced from a first position to a second position.- 28 -SG Docket No.: 14842-721.6006. The extension set of claim 5, wherein the coupling mechanism is configured to threadingly engage the catheter hub and advance the collar against the valve from the first position to the second position.

7. The extension set of claim 1, wherein the collar is configured to distally advance a valve from a first position to a second position within a catheter hub.

8. The extension set of claim 1, further comprising a valve positioned at the proximal end of the body, the valve providing sealable access to the body interior.

9. The extension set of claim 1, wherein the lumen through the extension set body is configured to axially align with a catheter hub at the distal end and a blood draw device coupled to the proximal end.

10. An extension set comprising: a body having a distal protrusion and a proximal coupling segment with a lumen extending from a proximal end of the body through the distal protrusion; an extension port provided on the body with tubing extending to a fluid coupler; and a coupling mechanism configured to couple the body to a catheter, wherein the distal protrusion is configured to transition a valve within the catheter between a closed configuration and an open configuration.

11. The extension set of claim 10, wherein the catheter comprises a catheter hub, a catheter extending from the catheter hub, and a valve having a distal segment separated from a proximal segment with a central lumen configured to transition between an open configuration and a close configuration.

12. The extension set of claim 10, wherein the catheter comprises a valve with a distal segment separated from a proximal segment by a central portion, the central portion having a diameter less than the distal segment and the proximal segment.

13. The extension set of claim 12, wherein the distal protrusion is configured to advance the central portion against the distal segment to open a sealable lumen through the valve.- 29 -SG Docket No.: 14842-721.60014. The extension set of claim 11, wherein an interior diameter of the proximal segment decreases distally.

15. The extension set of claim 11, further comprising a conical interior geometry through the proximal segment configured to direct a cannula of a blood draw device through a longitudinal axis of the valve.

16. An extension set comprising: a body having a distal protrusion and a proximal coupling segment with a lumen extending from a proximal end of the body through the distal protrusion; an extension port provided on the body with a fluid container coupler in fluid communication with an interior of the body, the fluid container coupler at a distal end of tubing in communication with the extension port; a coupling mechanism configured to couple the body to a catheter, the catheter comprising a sealable valve having a proximal body separated from a distal body by a central portion, the valve positioned within a catheter hub and a catheter defining a lumen from the catheter hub through the length of the catheter, wherein the valve is configured to provide a lumen through the central portion of the valve when the proximal valve body distally biases the central portion against the distal valve body.

17. A catheter comprising: a catheter extending distally from a catheter hub, with a lumen extending through the catheter and catheter hub; and an actuatable valve configured to seal the catheter hub proximal to the valve, wherein the valve is actuated when at least a portion of the valve is distally advanced in the catheter hub.

18. The catheter of claim 17, wherein the hub further comprises a proximal end and a distal end, wherein an interior of the proximal end is sealed from the distal end until a force is provided against the proximal end.

19. The catheter of claim 17, wherein the valve comprises a central portion having a distal side, proximal side, and at least one slit extending through the central- 30 -SG Docket No.: 14842-721.600portion, the distal side comprising a plurality of supports positioned around the at least one slit and configured to bias the slit in a closed configuration.

20. The catheter of claim 19, wherein the slit is configured to open when a proximal end of the valve is distally advanced.

21. The catheter of claim 20, wherein the proximal end of the valve is configured to advance the central portion without advancing a distal end of the valve.

22. The catheter of claim 17, wherein a proximal end of the catheter protrudes proximally into the interior of the catheter hub, and wherein the valve is configured to provide a lumen through the valve when the valve is distally advanced against the proximal end of the catheter.

23. The catheter of claim 17, further comprising a raised portion of the catheter hub interior configured to engage a channel positioned around a circumference of the valve.

24. The catheter of claim 23, wherein the valve is configured to disengage the raised portion of the catheter hub interior when distally advanced in the catheter hub.

25. The catheter of claim 23, wherein the valve comprises a distal surface and a plurality of flaps configured to be biased proximally into the valve when the distal surface is advanced against the distal interior of the catheter hub.

26. The catheter of any of claims 17 to 25, wherein the valve is an active blood control valve.

27. A blood control valve comprising: a valve body having a distal body segment and a proximal body segment; a resealable slit axially aligned with the valve body and configured to transition between a closed configuration and an open configuration when contacted by the distal end of a blood draw device, wherein the valve is configured to be positioned within a catheter hub.- 31 -SG Docket No.: 14842-721.60028. The blood control valve of claim 27, wherein the distal body includes a distal interior and a proximal interior, wherein the resealable slit separates the distal interior and the proximal interior.

29. The blood control valve of claim 28, wherein the resealable slit is configured to open when the proximal valve body is advanced towards the distal valve body.

30. The blood control valve of claim 28, further comprising a collar section separating the distal valve body and the proximal valve body, the collar section comprising an outer diameter less than the outer diameter of the proximal valve body, wherein the collar section is adapted to be advanced distally to the distal valve body.

31. The blood control valve of claim 28, wherein the resealable slit is positioned through a collar section between the distal valve body and the proximal valve body, wherein a plurality of ribs are arranged around the resealable slit in the distal interior, wherein each of the plurality of ribs are configured to open the resealable slit when the proximal valve body is advanced towards the distal valve body.

32. The blood control valve of claim 28, wherein a proximal end of the distal valve body is flexible and adapted to be distally depressed when the proximal valve body is advanced against the distal valve body.- 32 -SG Docket No.: 14842-721.600

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