Catheter assembly and catheter system

Abstract

The present disclosure relates to a catheter assembly and a catheter system configured to selectively isolate a blood fluid path from a priming solution fluid path. The catheter assembly can include a catheter adapter that can include a distal end, a proximal end, and a lumen extending therethrough. A catheter can extend from the distal end, and a side port can be disposed between the distal end and the proximal end. A septum can be positioned within the lumen and aligned with the side port. The septum can provide a seal between the side port and the catheter in the distal position. The septum can be configured to slide from the distal position to a proximal position proximal to the side port. In the proximal position, the side port can be in fluid communication with the catheter. The catheter assembly can increase the likelihood of obtaining a quick and clear indication of backflow to confirm proper catheter placement.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to catheter assemblies and catheter systems. BACKGROUND

[0002] Catheters are commonly used to infuse fluids into a patient's vasculature. For example, catheters can be used to infuse normal saline solution, various medicaments, or total parenteral nutrition. Catheters can also be used to withdraw blood from a patient.

[0003] In either case, an over-the-needle peripheral intravenous ("IV") catheter can be installed on an introducer needle, which can include a sharp distal tip. The catheter and introducer needle can be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the bevel of the needle facing away from the patient's skin. The catheter and introducer needle are typically inserted into the patient's vasculature at a shallow angle.

[0004] However, prior to introducing the catheter into the patient's vasculature, air present in the catheter system is removed to prevent air from entering the patient's bloodstream. For example, this "priming" process can be performed by flushing the catheter system with saline. Then, to verify proper placement of the introducer needle and / or catheter in the blood vessel, the clinician typically confirms "flashback" of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the clinician can temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or infusion.

[0005] Unfortunately, the presence of the priming solution in the catheter system can easily compromise continuous blood flow through the catheter, hindering the ability to obtain a quick and clear indication of flashback. This can result in confusion or uncertainty as to whether the catheter has been properly inserted into the patient's vasculature. As a result, proper catheter insertion can be delayed, resulting in prolonged exposure of the catheter to the priming solution. This in turn can result in softening of the catheter material, reducing catheter tip stiffness and column strength. During insertion, the catheter material can get stuck outside the vein, causing the catheter to peel back and possibly damage the vein.

[0006] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein can be practiced. SUMMARY

[0007] The present disclosure relates generally to intravenous catheter assemblies and related devices, systems, and methods. In some embodiments, the catheter assemblies can increase the likelihood of obtaining a quick and clear flashback indication to confirm proper catheter placement. In some embodiments, the catheter assemblies can thereby avoid delays in catheter insertion caused by clinician confusion or uncertainty regarding proper catheter placement.

[0008] In some embodiments, the catheter assemblies can also prevent the catheter from being exposed to the priming solution for an extended period of time. Some embodiments of the catheter assemblies can thereby reduce one or more of the following risks: catheter material softening, catheter tip stiffness reduction, and reduced burst strength. Reducing the catheter’s exposure to the priming solution for an extended period of time can also reduce the risk of catheter back peeling and / or causing venous injury.

[0009] In some embodiments, the catheter assembly can include a catheter adapter, a catheter, and a septum. In some embodiments, the catheter adapter can include a distal end, a proximal end, and a lumen extending therethrough. In some embodiments, a side port can be disposed between the distal end and the proximal end of the catheter adapter, and the catheter can extend from the distal end. In some embodiments, the septum can be disposed within the lumen at a distal position aligned with the side port. In the distal position, the septum can provide a seal between the side port and the catheter.

[0010] In some embodiments, the septum can be configured to slide from the distal position to a proximal position proximal to the side port. In the proximal position, the side port can be in fluid communication with the catheter. In this manner, the catheter assembly can isolate the blood fluid path from the priming solution fluid path and also facilitate selective retraction of the needle septum to subsequently join the blood fluid path and the priming solution fluid path.

[0011] In some embodiments, a puller element can be disposed within the lumen of the catheter adapter. In some embodiments, the puller element can include a distal end coupled to the septum and a proximal end configured to be coupled to a blood collection set. In some embodiments, the catheter adapter can include a slot that can include a stop at a proximal end thereof. In some embodiments, the puller element can include an extension that extends through the slot and is configured to contact the stop when the septum slides from the distal position to the proximal position. In some embodiments, the extension can be coupled to a push tab.

[0012] In some embodiments, the catheter adapter can include a vent. In some embodiments, an outer surface of the septum can include an annular groove. In some embodiments, in response to the septum being in the distal position, the side port can be in fluid communication with the annular groove and the vent. In some embodiments, a stop can be disposed within the lumen of the catheter adapter. In some embodiments, the stop can be formed by the vent.

[0013] In some embodiments, a catheter system can include a catheter assembly and / or a needle assembly. In some embodiments, a needle assembly can include a needle hub coupled to a proximal end of a catheter adapter. In some embodiments, a needle assembly can include a guide needle that can include a sharp distal tip, a proximal end, and a needle feature, such as a bump, disposed between the sharp distal tip and the proximal end. In some embodiments, the proximal end of the guide needle can be fixed within the needle hub.

[0014] In some embodiments, the guide needle can be withdrawn from the catheter adapter in a proximal direction by a first amount. In response, the needle feature can be configured to contact the septum and slide the septum from the distal position to the proximal position such that the side port can be in fluid communication with the catheter and the stopper can contact the septum. In some embodiments, withdrawing the guide needle in the proximal direction beyond the first amount can cause the needle feature to move proximally relative to the septum.

[0015] In some embodiments, an outer surface of the septum can include an annular groove. In response to the septum being in the distal position, the side port can be in fluid communication with the annular groove and the vent.

[0016] In some embodiments, a method can include pre-charging a catheter system with a pre-charging solution. In some embodiments, the vent can extend through a wall of the catheter adapter.

[0017] In some embodiments, a needle assembly can include a guide needle that can include a sharp distal tip, a proximal end, and a notch. After pre-charging the catheter system, the guide needle and the catheter can be inserted into the vasculature. In response, blood can flow into the sharp distal tip of the guide needle, through the notch into a space between the guide needle and the catheter, and proximate to the septum. In some embodiments, the blood can be isolated such that it is not in fluid communication with the pre-charging solution.

[0018] In some embodiments, a needle assembly can include a flashback chamber. In some embodiments, in response to the guide needle being inserted into the vasculature, blood can flow through the guide needle to the flashback chamber.

[0019] In some embodiments, a guide needle can include a needle feature, such as a bump, disposed between a sharp distal tip and a proximal end of the guide needle. In some embodiments, after the guide needle and the catheter are inserted into the vasculature, the guide needle can be withdrawn in a proximal direction by a first amount such that the needle feature contacts the septum and slides the septum from the distal position to the proximal position.

[0020] In some embodiments, the guide needle can be withdrawn in the proximal direction beyond the first amount after the guide needle is withdrawn in the proximal direction by the first amount. This can cause the needle feature to move proximally relative to the septum. In some embodiments, the needle feature can contact the septum and slide the septum from the distal position to the proximal position in response to the guide needle being withdrawn in the proximal direction by the first amount.

[0021] In some embodiments, the catheter assembly can further include a puller element disposed within the lumen. In some embodiments, the puller element can include a distal end coupled to the septum and a proximal end configured to be coupled to a blood collection set. In some embodiments, the catheter adapter can further include a slot. In some embodiments, a proximal end of the slot can include a stop. In some embodiments, the puller element can further include an extension that extends through the slot and is configured to contact the stop in response to the septum sliding from the distal position to the proximal position.

[0022] Some embodiments of the method can include removing the needle assembly from the catheter system. In some embodiments, a distal end of a housing of the blood collection set can be coupled to a proximal end of the puller element. In some embodiments, the housing can include one or more of: a distal end, a proximal end, a slot, and a sleeve that can include a wing that extends through the slot. In some embodiments, the sleeve seat can slide relative to the housing between a retracted position and an advanced position, and the sleeve can extend distally from the sleeve seat. In some embodiments, the blood collection set can further include an extension tube that can include a distal end coupled to a proximal end of the sleeve seat. In some embodiments, a blood collection device can be coupled to a proximal end of the extension tube. In some embodiments, the blood collection device can include a syringe, an evacuated blood collection tube, a micro sample collection device, or another suitable blood collection device.

[0023] In some embodiments, after coupling the distal end of the housing of the blood collection set to the proximal end of the puller element, the method can include grasping the wing to slide the sleeve seat from the retracted position to the advanced position. In some embodiments, in response to the sleeve seat being in the retracted position, the sleeve can be disposed within the housing. In some embodiments, in response to the sleeve seat being in the advanced position, the sleeve can extend through the distal end of the housing, the puller element, and the septum.

[0024] In some embodiments, after grasping the wing to slide the sleeve seat from the retracted position to the advanced position, the method can include collecting a blood sample within the blood collection set.

[0025] In some embodiments, the method can further include, after collecting the blood sample within the blood collection set, grasping the wing to slide the sleeve seat from the advanced position to the retracted position.

[0026] In some embodiments, after the blood sample is collected within the blood collection set, the housing can be moved proximally until the extension contacts the stop. In some embodiments, in response to moving the housing proximally, the septum can slide from the distal position to the proximal position. In some embodiments, in response to the extension contacting the stop, the housing can be decoupled from the puller element.

[0027] In some embodiments, the extension can be coupled to the tab. In these embodiments, moving the housing proximally until the extension contacts the stop can include grasping the housing and the tab.

[0028] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application, as claimed. It should be understood that various embodiments are not limited to the arrangements and instrumentalities shown in the attached drawings. It should also be understood that the embodiments can be combined or other embodiments utilized, and structural changes made, without departing from the scope of the various embodiments of the present application. Accordingly, the following detailed description is not to be considered limiting. BRIEF DESCRIPTION OF DRAWINGS

[0029] The exemplary embodiments will be described in additional detail and explained with the use of the accompanying drawings in which:

[0030] Figure 1 is a top perspective view of an exemplary catheter system according to some embodiments;

[0031] Figure 2 is an exploded view of the catheter system of Figure 1 according to some embodiments;

[0032] Figure 3 is a top perspective view of another exemplary catheter system according to some embodiments, showing a needle with a needle feature and a septum in a distal position aligned with a side port;

[0033] Figure 4 is a cross-sectional view of the catheter system of Figure 3 according to some embodiments, showing the septum in a proximal position proximal to the side port;

[0034] Figure 5 is a top perspective view of an exemplary catheter assembly of the catheter system of Figure 3 according to some embodiments, showing the septum in a proximal position proximal to the side port;

[0035] Figure 6 is a cross-sectional view of the catheter assembly of Figure 5 according to some embodiments, showing the septum in a proximal position proximal to the side port;

[0036] Figure 7 is a cross-sectional view of an exemplary catheter assembly of the catheter system ofFigure 1 The upper perspective view of an exemplary catheter assembly of a catheter system shows a puller element and a diaphragm in a distal position aligned with the side port.

[0037] Figure 8 According to some embodiments Figure 7 A cross-sectional view of the catheter assembly, showing an exemplary blood collection kit coupled to a retractor element and a septum in a distal position;

[0038] Figure 9 According to some embodiments Figure 7 The upper perspective view of the catheter assembly shows the diaphragm located in a proximal position near the side port;

[0039] Figure 10 According to some embodiments Figure 9 A cross-sectional view of the catheter assembly, showing the septum in a proximal position;

[0040] Figure 11A This is a top perspective view of an exemplary catheter system according to some embodiments, illustrating the pre-inflation step;

[0041] Figure 11B According to some embodiments Figure 11A A three-dimensional view of the upper part of the catheter system, showing the blood return procedure;

[0042] Figure 11C According to some embodiments Figure 11A The upper perspective view of the catheter system shows the engagement of the blood collection kit;

[0043] Figure 11D According to some embodiments Figure 11A The upper perspective view of the catheter assembly of the catheter system shows the blood collection procedure;

[0044] Figure 11E According to some embodiments Figure 11A Catheter components of the catheter system and Figure 11D A cross-sectional view of the blood collection procedure;

[0045] Figure 11F According to some embodiments Figure 11A A top perspective view of the catheter assembly of the catheter system, illustrating the infusion procedure; and

[0046] Figure 11G This is a top perspective view of an exemplary blood collection kit according to some embodiments. Detailed Implementation

[0047] Now for reference Figure 1 and Figure 2In some embodiments, to introduce catheter 110 into a patient's vasculature, catheter 110 can be mounted on a hollow bore guide needle 112, which can include a sharp distal tip 202. In some embodiments, the inner surface of catheter 110 can be in close engagement with the outer surface of guide needle 112 to prevent catheter 110 from stripping back and to facilitate insertion of catheter 110 into a blood vessel or vein. In some embodiments, the sharp distal tip 202 of guide needle 112 can extend beyond the distal tip of catheter 110 to facilitate insertion of catheter 110 at a shallow angle through a patient's skin and into a vein.

[0048] In some embodiments, catheter system 100 can include a catheter assembly 101. In some embodiments, catheter assembly 101 can include a catheter adapter 102, which can include a lumen 108 extending longitudinally between a distal end 104 and a proximal end 106 thereof. In some embodiments, the inner diameter of lumen 108 can be at least slightly larger than the outer diameter of over-the-needle catheter 110. In some embodiments, catheter 110 can be coupled to distal end 104 of catheter adapter 102. In some embodiments, catheter 110 can be secured to and mechanically sealed to catheter adapter 102 by, for example, a threaded connection, a press fit, a wedge, or by any other means known to those skilled in the art.

[0049] In some embodiments, the inner diameter of lumen 108 can increase between distal end 104 and proximal end 106 of catheter adapter 102. In some embodiments, the inner diameter of catheter adapter 102 at distal end 104 can substantially match the outer diameter of the associated catheter 110 to snugly engage guide needle 112 therein. This can prevent stripping back of catheter 110 during insertion of catheter 110 into a blood vessel. On the other hand, in some embodiments, proximal end 106 of catheter adapter 102 can include a much larger inner diameter to receive and / or engage a blood collection set or other peripheral device.

[0050] In some embodiments, a side port 132 can extend from catheter adapter 102 and be in communication with lumen 108. In this manner, side port 132 can provide an independent fluid path between catheter 110 and an infusion set or other infusion device coupled to side port 132. In some embodiments, an infusion set can be coupled to needleless access connector 136, or directly to an adapter disposed at the proximal end of an extension tube extending from side port 132.

[0051] In some embodiments, the side port 132 can be used to provide an independent fluid path for dispensing a priming fluid or solution, such as saline or a medication intended for infusion, for priming the catheter system 100. Similarly, in some embodiments, the side port 132 can provide an independent fluid path for inputting fluid into the vasculature of a patient. The fluid can include, for example, saline solution, various medications, total parenteral nutrition, etc.

[0052] In some embodiments, the septum 114 can be disposed within the lumen 108 of the catheter adapter 102. In some embodiments, the septum 114 can include a substantially resilient and fluid-impermeable material to facilitate creating an effective fluid seal between the side port 132 and the lumen 108. In some embodiments, the septum 114 can include a material such as silicone, foam, rubber, composite, etc. In some embodiments, the material can be configured to expand or otherwise substantially occupy the interior space or volume of the lumen 108. In some embodiments, the septum 114 and / or the lumen 108 can include a coating or lubricant to facilitate the ability of the septum 114 to slide within the lumen 108 and / or seal the fluid path between the lumen 108 and the side port 132.

[0053] Further, in some embodiments, the septum 114 can include a size sufficient to selectively obstruct and seal the fluid path between the side port 132 and the lumen 108. In some embodiments, the septum 114 can include a generally circular cross-section having a diameter that substantially matches the diameter of the lumen 108 of the catheter adapter 102. The septum 114 can also include a length and height sufficient to plug the distal opening 138 of the side port 132. Of course, the septum 114 can include any shape and / or size for sealing the fluid path between the side port 132 and the lumen 108.

[0054] As discussed in greater detail below, in some embodiments, the septum 114 can be configured to slide and / or otherwise move within the lumen 108 between a distal position and a proximal position. In some embodiments, in the distal position, the septum 114 can be substantially aligned with the side port 132 such that the septum 114 provides a seal between the side port 132 and the catheter 110. In this manner, the fluid path between the distal end 104 and the proximal end 106 of the catheter adapter 102 can be isolated to prevent contamination of the current or residual fluid in the side port 132. On the other hand, in the proximal position, the septum 114 can form a path between the side port 132 and the catheter adapter 102 to facilitate the side port 132 being in fluid communication with the catheter 110.

[0055] In some embodiments, manipulating the position of the diaphragm 114 in this manner can prevent one fluid from contaminating or diluting another fluid. In some embodiments, a prefill solution can be dispensed via the side port 132 to prefill the catheter system 100. In some embodiments, the fluid path for dispensing the prefill solution can be sealed relative to the lumen 108 of the catheter adapter 102. This allows pure or undiluted blood to be drawn from a blood collection kit (e.g., see [link to blood collection kit]) that is coupled to the proximal end 106 of the catheter adapter 102. Figure 8 The blood sample is withdrawn from the cannula of the blood collection kit 801. In some embodiments, after blood sample collection, the diaphragm 114 can be moved from a distal position to a proximal position within the lumen 108, thereby creating a fluid path for the fluid used for infusion through the catheter 110 and the side port 132. In this way, undiluted blood can be withdrawn from the catheter 110, which can be the same catheter used for prefilling and infusion, and the risk of cross-contamination between any of the various fluids is minimal or nonexistent. In some embodiments, the catheter 110 may include a peripheral intravenous catheter (“PIVC”), a midline catheter, or a peripherally inserted central venous catheter (“PICC”).

[0056] Of course, those skilled in the art will recognize that the embodiments of this disclosure are not limited to any particular number or orientation of fluids and / or fluid paths, as any number and / or orientation of all fluids and fluid paths is contemplated herein. For example, the length of the diaphragm 114 may be extended, or the dimensions of the diaphragm 114 may be modified to seal more than one side port 132 simultaneously. In other embodiments, the orientation of the side ports 132 may be varied to create any number of fluid paths. For example, two or more side ports 132 may be positioned on opposite sides of the conduit adapter 102 such that translation of the diaphragm 114 within the lumen 108 may expose more than one side port 132 at a time.

[0057] In some embodiments, the retractor element 116 may be disposed within the lumen 108 such that the distal end 118 of the retractor element 116 is positioned substantially adjacent to the proximal end of the diaphragm 114. In some embodiments, the proximal end 120 of the retractor element 116 may be configured to be coupled to, for example, a needle hub 134 and / or a blood collection kit. In other embodiments, the distal end 118 of the retractor element 116 may be integral with or coupled to the proximal end of the diaphragm 114. In some embodiments, the retractor element 116 and the diaphragm 114 may be integrally formed as a single unit. In some embodiments, the distal end 118 of the retractor element 116 may be positioned substantially adjacent to the proximal end of the diaphragm 114.

[0058] In some embodiments, the catheter adapter 102 can include a slot 124 to receive at least a portion of the puller element 116. For example, in some embodiments, the puller element 116 can include an extension 126 that extends through the slot 124. In some embodiments, the push tab 130 can be coupled to an end of the extension 126, enabling the puller element 116 to be manually translated through the wall of the catheter adapter 102.

[0059] In some embodiments, a proximal end of the slot 124 can include a stop 128, such as a narrowing, edge, ridge, or any other suitable feature that is integral with or coupled to the slot 124. In some embodiments, the stop 128 can contact the extension 126 as the septum 114 is moved from the distal position to the proximal position.

[0060] Referring now to Figures 3 to 6 some embodiments of the catheter system 100 can include a needle assembly 200 that can include a needle hub 134 coupled to the proximal end 106 of the catheter adapter 102. In some embodiments, a proximal end 206 of the guide needle 112 can be secured within the needle hub 134 by, for example, a threaded connection or a press fit. Alternatively, in some embodiments, the guide needle 112 can be secured within the needle hub 134 by any means known to those of skill in the art. In some embodiments, the guide needle 112 can include a sharp distal tip 202 and a needle feature 204 disposed between the sharp distal tip 202 and the proximal end 206. In some embodiments, at least a portion of the length of the guide needle 112 can extend through the septum 114 and / or the puller element 116.

[0061] As shown in Figure 3 and Figure 4 some embodiments, the sharp distal tip 202 of the guide needle 112 can be disposed distal to the septum 114 and / or the puller element 116. In some embodiments, the septum 114 can include a slit through which the guide needle 112 can extend. In some embodiments, the needle feature 204, such as a bump, curl, or other suitable feature, can be disposed distal to the septum 114.

[0062] In certain embodiments, the vent 304 can be integral with or coupled to a hole in the outer surface of the catheter adapter 102 to facilitate the flow of air between the lumen 108 of the catheter adapter 102 and the external environment. Some embodiments of the vent 304 can include a hydrophobic membrane to avoid any interference with the pre-priming fluid or any other fluid or solution. In some embodiments, the hydrophobic membrane can be air permeable but impermeable to the pre-priming fluid or any other fluid or solution.

[0063] In some embodiments, the outer surface of the septum 114 can include an annular groove 306 disposed between its distal end and its proximal end. This design can mitigate frictional forces as the septum 114 translates between the distal position and the proximal position. In some embodiments, the annular groove 306 can also create a distal edge 308 at the distal end of the septum 114 and a proximal edge 310 at the proximal end of the septum 114. In some embodiments, the side port 132 can be in fluid communication with the annular groove 306 and the vent 304 when the septum 114 is in the distal position. In certain embodiments, the vent 304 can form a stop to contact the proximal edge 310 of the septum 114 within the lumen 108. In some embodiments, the stop can fix the position of the septum 114 relative to the septum and prevent the septum 114 from translating further in the distal direction.

[0064] In some embodiments, the needle feature 204 can be configured to capture on the distal end of the septum 114. In some embodiments, withdrawing the guide needle 112 from the catheter adapter 102 in the proximal direction can push the needle feature 204 onto the distal end of the septum 114. In some embodiments, the withdrawal force exerted on the guide needle 112 in the proximal direction can in turn cause the needle feature 204 to passively force the septum 114 to slide or otherwise move from the distal position to the proximal position.

[0065] In some embodiments, as shown in FIGS. 1 and 2, the needle feature 204 can include a needle tip 206 and a needle shaft 208. In some embodiments, the needle shaft 208 can be configured to passively force the septum 114 to slide or otherwise move from the distal position to the proximal position when the guide needle 112 is withdrawn from the catheter adapter 102 in the proximal direction. Figure 5 and Figure 6 In some embodiments, the side port 132 can be in fluid communication with the catheter 110 in the proximal position. Further, in some embodiments, the vent 304 can form a stop to contact the distal edge 308 of the septum 114 within the lumen 108. This can ensure the position of the septum 114 relative to the stop and prevent the septum 114 from translating further in the proximal direction.

[0066] In some embodiments, the withdrawal force exerted on the guide needle 112 in the proximal direction can exceed the force required to move the septum 114 to the proximal position, causing the needle feature 204 to continue to move proximally through the septum 114. In this manner, the needle feature 204 can translate through the proximal end of the septum 114, enabling the guide needle 112 to be removed from the catheter adapter 102.

[0067] Referring now to FIG. 3, in some embodiments, the catheter adapter 102 can include a puller element 116. In some embodiments, the puller element 116 can be configured to facilitate translation of the septum 114 between the distal position and the proximal position. Figures 7 to 10 In some embodiments, the puller element 116 can be coupled to the septum 114 to facilitate translation of the septum 114 between the distal position and the proximal position. In some embodiments, the puller element 116 can be coupled to the proximal end of the septum 114 by a press fit, an interference fit, or another suitable coupling mechanism.

[0068] In some embodiments, the puller element 116 can be positioned adjacent to the septum 114 within the lumen 108. In some embodiments, the housing or actuator 800 of the blood collection set 801 can engage a proximal end of the puller element 116 and thereby push the puller element 116 in a distal direction in response to a force applied by a clinician in a proximal direction. In some embodiments, in response to the pushing of the puller element 116 in the distal direction, a distal end of the puller element 116 coupled to a proximal end of the septum 114 can cause the septum 114 to automatically slide proximally, such as to a proximal position.

[0069] In some embodiments, a proximal end of the puller element 116 can include a male or female connector portion, and a distal end of the actuator 800 can include a male or female connector portion. In some embodiments, a proximal end of the septum 114 can include a male or female connector portion, and a distal end of the puller element 116 can include a male or female connector portion. As shown, for example, a proximal end of the puller element 116 can include a female connector portion, and a distal end of the actuator 800 can include a male connector portion. Also as shown, for example, a proximal end of the septum 114 can include a female connector portion, and a distal end of the puller element 116 can include a male connector portion.

[0070] In some embodiments, in operation, the actuator 800 can be inserted into the proximal end 106 of the catheter adapter 102 such that the male connector portion of the actuator 800 engages the female connector portion of the puller element 116. In some embodiments, the actuator 800 can then be pushed in a distal direction, causing the male connector portion of the puller element 116 to engage the female connector portion of the septum 114. In some embodiments, continuing to push the actuator in the distal direction in this manner can cause the septum 114 to slide from the proximal position to the distal position. In some embodiments, as Figure 9 and Figure 10 shown, once engaged, the actuator 800 can be moved in a proximal direction. This can cause the septum 114 to be passively slid from the distal position to the proximal position, creating a fluid path between the side port 132 and the catheter 110.

[0071] Referring now to Figure 11A -E, a method can include pre-charging the catheter system 100 with a pre-charging fluid or solution to purge air present from the catheter system 100 prior to inserting the catheter 110 into a patient. As Figure 11A shown, the pre-charging solution (such as saline or a medication for infusion) can be administered through the side port 132 via the extension tube 1100.

[0072] In some embodiments, the septum 114 can be initially positioned in a distal position to facilitate a pre-priming process to reduce or eliminate air from the catheter assembly 101. In some embodiments, in the distal position, the septum 114 can occlude the lumen 108 such that the pre-priming solution cannot enter or prime the lumen 108 or contact the guide tube 110. In some embodiments, the guide tube 110 is prevented from exposure to the pre-priming fluid in this manner, which can prevent softening of the guide tube 110 during insertion. However, in some embodiments, the septum 114 can include an annular groove 306 to allow the pre-priming fluid to flow from the side port 132 across the annular groove 306 to prime a distal portion of the lumen 108 corresponding to the annular groove 306. In some embodiments, the pre-priming fluid can also prime a portion of the vent 304 exposed to the lumen 108. In some embodiments, the vent 304 can include a hydrophobic membrane or other suitable vent to seal the pre-priming fluid within the lumen 108.

[0073] Referring now to Figure 11B After pre-priming the catheter assembly 101, the introducer needle 112 and the guide tube 110 can be inserted into the vasculature of a patient. In some embodiments, to verify proper placement of the introducer needle 112 and the guide tube 110 in the blood vessel, the clinician can confirm the presence of “flashback” of blood along the guide tube 110 and / or in a flashback chamber 1102 disposed within the catheter assembly 101 and / or the needle hub 134. In some embodiments, the blood flashback 1104 can flow into the sharp distal tip 202 of the introducer needle 112, through the notch into the space 1108 between the introducer needle 112 and the guide tube 110, and proximate to the septum 114. Advantageously, in some embodiments, the blood can be prevented from being in fluid communication with the pre-priming solution in response to the septum 114 being in the distal position. In some embodiments, the catheter assembly 101 can facilitate minimal resistance and a quick clear indication of the blood flashback 1104 within the guide tube 110 and / or an indication of the blood flashback 1104 at the flashback chamber 1102.

[0074] Referring now to Figure 11C In some embodiments, after inserting the guide tube 110 into the vein, the clinician can remove the introducer needle 112 from the catheter system 100. In some embodiments, the clinician can then couple the actuator 800 of the blood collection set 801 to the proximal end of the puller element 116 to facilitate continued entry into the blood vessel through the catheter for blood collection.

[0075] Referring now to Figure 11D and Figure 11GIn some embodiments, the blood collection kit 801 may include an actuator 800, which may include a distal end, a proximal end, and a slot 1110. In some embodiments, the blood collection kit 801 may include a cannula 1115, which may be coupled to a wing 1116 extending through the slot 1110. In some embodiments, the cannula 1115 may be retained within the actuator when the cannula or needle hub 134 is in the retracted position. In some embodiments, the cannula 1115 may slide between a retracted position and an advanced position such that, in the advanced position, the cannula 1115 may extend through one or more of the following: the distal end of the actuator 800, the retractor element 116, and the diaphragm 114. In some embodiments, the distal end of the cannula 1115 may be disposed within a lumen 108 or a catheter 110. In some embodiments, the wing 1116 may be gripped to facilitate sliding of the cannula between the retracted and advanced positions. In some embodiments, in response to the cannula 1115 extending through the diaphragm 114, blood samples can be collected via the blood collection kit 801.

[0076] In some embodiments, the blood collection kit 801 may include an extension tube 1117 (e.g., see...). Figure 11G In some embodiments, the extension tube 1117 may be coupled to the proximal end of the cannula 1115, and the blood collection device 1118 may be coupled to the proximal end of the extension tube 1117. In some embodiments, the blood collection device 1118 may include a syringe, an emptied blood collection tube, a small sample collection device, or another suitable blood collection device.

[0077] In some embodiments, the blood collection device 1118 may include a needle enclosed in an elastomeric sheath, such as, for example... Figure 11G As shown. In some embodiments, the blood collection device 1118 may include a blood collection device purchased from Becton Dickinson and Company, Franklin Lakes, New Jersey. Or another suitable device.

[0078] In some embodiments, after a blood sample is collected in the blood collection device 1118 or blood collection kit 801, the wing 1116 can be grasped and moved along the slot 1110 to allow the cannula 1115 to slide between an advance position and a retracted position. In some embodiments, in response to the cannula 1115 being in the retracted position, the distal end of the cannula 1115 can be positioned within the actuator 800.

[0079] Now for reference Figure 11E and Figure 11FAfter a sufficient amount of blood has been collected, and / or the cannula 1115 is slid to the retracted position, the actuator 800 can be removed from the puller element 116. In some embodiments, the actuator 800 can be removed by applying a force in the proximal direction such that the puller element 116 contacts the stop 128 of the slot 124 of the catheter adapter 102. Continued force on the actuator 800 in the proximal direction can cause the actuator 800 to disengage from the puller element 116. Additionally, now referring to FIG. 10, the actuator 800 can be removed from the catheter adapter 102. Figure 11E In some embodiments, proximal movement of the actuator 800 in this manner can cause the septum 114 to be passively slid from the distal position to the proximal position, thereby opening the fluid path comprising the catheter 110, a portion of the lumen 108, the side port 132, and the extension tube 1100, as shown in FIG. 10. Figure 11F

[0080] All examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the present application and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions.​

Claims

1. A catheter assembly (101) comprising: a catheter adapter (102) comprising a distal end (104), a proximal end (106), a lumen (108) extending between the distal end and the proximal end, and a side port (132) positioned between the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter (110) extending from the distal end (104) of the catheter adapter (102); and a septum (114) disposed within the lumen (108) at a distal position in alignment with the side port (132), wherein, when the septum (114) is at the distal position, the septum (114) comprises a resilient, fluid impermeable material and provides a seal between the side port (132) and the catheter (110), characterized in that the catheter assembly (101) further comprises a puller element (116) disposed within the lumen (108); the catheter adapter (102) comprises a slot (124) having a proximal end provided with a stop (128); the puller element (116) comprises a distal end (118) connected to the septum (114), a proximal end (120) configured to be connected to a blood collection set (801), and an extension (126) extending through the slot (124) configured to contact the stop (128) when the septum is slid from the distal position to a proximal position; and the septum (114) is configured to be slid from the distal position to the proximal position proximal to the side port (132), wherein, when the septum (114) is at the proximal position, the side port (132) is in fluid communication with the catheter (110). the extension (126) is coupled to a pusher tab (130).

2. The catheter assembly (101) according to claim 1, characterized in that the catheter adapter (102) comprises a vent (304), wherein an outer surface of the septum (114) comprises an annular groove (306), wherein, when the septum is at the distal position, the side port (132) is in fluid communication with the annular groove (306) and the vent (304).

3. The catheter assembly (101) according to claim 1, characterized in that 4. A catheter system (100) comprising: a catheter assembly (101) according to any one of claims 1 to 3; and a needle assembly (200) comprising: a needle hub (134) coupled to the proximal end (106) of the catheter adapter (102); a guide needle (112) comprising a sharp distal tip (202), a proximal end (206), and a needle feature (204) disposed between the sharp distal tip (202) of the guide needle and the proximal end (206) of the guide needle, wherein the proximal end (206) of the guide needle (112) is fixed within the needle hub (134), characterized in that the needle feature (204) of the guide needle (112) is configured to be connected to a blood collection set (801). ​ the needle feature (204) contacts the septum (114) and slides the septum (114) from the distal position to the proximal position as the introducer needle (112) is withdrawn a first amount in the proximal direction; the side port (132) is in fluid communication with the catheter (110) and the stopper (128) contacts the septum (114) when the septum (114) is in the proximal position; and the needle feature (204) moves proximally relative to the septum (114) as the introducer needle (112) is withdrawn further in the proximal direction beyond the first amount.

5. The catheter system (100) according to claim 4, characterized in that the needle feature (204) comprises a protuberance.

6. Catheter system (100) according to claim 4 or 5, characterized in that the catheter adapter (102) comprises a vent (304), wherein an outer surface of the septum (114) comprises an annular groove (306), wherein the side port (132) is in fluid communication with the annular groove (306) and the vent (304) when the septum is in the distal position.

7. The catheter system (100) according to claim 6, characterized in that the vent (304) forms the stopper (128).

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