Catheter assemblies with sliding septums and related systems and methods

Abstract

A catheter assembly configured to selectively isolate a blood fluid path from a priming solution fluid path. The catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending therethrough. The catheter may extend from the distal end, and a side port may be disposed between the distal end and the proximal end. A septum may be disposed within the lumen and aligned with the side port. The septum may provide a seal between the side port and the catheter at a distal position. The septum may be configured to slide from the distal position to a proximal position proximal to the side port. At the proximal position, the side port may be in fluid communication with the catheter. The catheter assembly may increase the likelihood of obtaining a rapid and clear indication of flashback to confirm proper placement of the catheter.

Description

Technical Field

[0001] The present disclosure generally relates to intravenous catheter assemblies, as well as related devices, systems, and methods.

Background Art

[0002] Background Catheters are generally used to inject fluids into a patient's vascular system. For example, a catheter can be used to inject normal saline, various pharmaceuticals, or parenteral total nutrition. Also, a catheter can be used to draw blood from a patient.

[0003] In either case, an over-the-needle peripheral intravenous (IV) catheter can be mounted on an introducer needle that can include a sharp distal tip. The catheter and the introducer needle can be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter, and the bevel of the needle faces away from the patient's skin. The catheter and the introducer needle are generally inserted at a shallow angle through the skin into the patient's vascular system.

[0004] However, before introducing the catheter into the patient's vascular system, air present within the catheter system is removed to prevent air from entering the patient's bloodstream. This "priming" process can be performed, for example, by flushing the catheter system with saline.

[0005] Next, to confirm proper placement of the introducer needle and / or catheter within the blood vessel, a clinician generally checks for the presence of a "flashback" of blood within the flashback chamber of the catheter assembly. Once the needle placement is confirmed, the clinician can temporarily occlude the flow within the vascular system, remove the needle, and leave the catheter in place for future blood withdrawal or fluid injection.

Summary of the Invention

Problems to be Solved by the Invention

[0006] Unfortunately, the presence of priming solution within the catheter system tends to impair continuous blood flow through the catheter, thereby hindering the ability to obtain quick and clear indications of flashback. This can lead to confusion or uncertainty regarding whether the catheter is properly inserted into the patient's vascular system. As a result, proper catheter insertion may be delayed, leading to prolonged exposure of the catheter to the priming solution. This, in turn, can lead to softening of the catheter material, thereby reducing the hardness and columnar strength of the catheter tip. During insertion, the catheter material may become immobile outside the vein, potentially leading to catheter detachment and vein damage. [Means for solving the problem]

[0007] The subject matter claimed herein is not limited to embodiments that solve any defects or embodiments that operate only in the environment described above. Rather, this background is provided solely to illustrate an example of a technical area in which some embodiments described herein may be put into practice.

[0008] This disclosure generally relates to intravenous catheter assemblies, as well as related devices, systems, and methods. In some embodiments, the catheter assemblies may increase the likelihood of obtaining quick and clear instructions for flashback to confirm proper catheter placement. Thus, in some embodiments, the catheter assemblies may avoid delays in catheter insertion caused by clinician confusion or uncertainty regarding proper catheter placement.

[0009] In some embodiments, the catheter assembly can also prevent prolonged exposure of the catheter to the priming solution. Some embodiments of the catheter assembly can therefore reduce one or more risks of softening of the catheter material, reduced catheter tip stiffness, and reduced column strength. Reducing prolonged exposure of the catheter to the priming solution can also reduce the risk of catheter detachment and / or resulting vein damage.

[0010] In some embodiments, the catheter assembly may include a catheter adapter, a catheter, and a septum. In some embodiments, the catheter adapter may include a distal end, a proximal end, and a lumen extending through it. In some embodiments, a side port may be located between the distal and proximal ends of the catheter adapter, and the catheter may extend from the distal end. In some embodiments, the septum may be located within the lumen at a distal position aligned with the side port. At the distal position, the septum may provide a seal between the side port and the catheter.

[0011] In some embodiments, the septum may be configured to slide from a distal position to a proximal position near the side port. At the proximal position, the side port can be in fluid communication with the catheter. In this way, the catheter assembly can isolate the blood fluid pathway from the priming solution fluid pathway and facilitate the selective retraction of the needle septum to later connect the blood fluid pathway and the priming solution fluid pathway.

[0012] In some embodiments, the puller member may be positioned within the lumen of the catheter adapter. In some embodiments, the puller member may include a distal end coupled to the septum and a proximal end configured to couple to a blood collection set. In some embodiments, the catheter adapter may include a slot, the slot may include a stop at its proximal end. In some embodiments, the puller member may include an extension extending through the slot and configured to contact the stop as the septum slides from the distal to the proximal position. In some embodiments, the extension may be coupled to a push tab.

[0013] In some embodiments, the catheter adapter may include a vent. In some embodiments, the outer surface of the septum may include an annular groove. In some embodiments, in response to the distal position of the septum, the side port may be in fluid communication with the annular groove and the vent. In some embodiments, a stopper may be located within the lumen of the catheter adapter. In some embodiments, the stopper may be formed by a vent.

[0014] In some embodiments, the catheter system may include a catheter assembly and / or a needle assembly. In some embodiments, the needle assembly may include a needle hub coupled to the proximal end of the catheter adapter. In some embodiments, the needle assembly may include a guide needle, which may include a sharp distal tip, a proximal end, and a needle structure such as a ridge positioned between the sharp distal tip and the proximal end. In some embodiments, the proximal end of the guide needle may be fixed within the needle hub.

[0015] In some embodiments, the guide needle may be withdrawn proximal to the catheter adapter by a first amount. In response, the needle structure may be configured to contact the septum and slide the septum from a distal to a proximal position, so that the side port can be in fluid communication with the catheter and the stop portion can be in contact with the septum. In some embodiments, withdrawal of the guide needle proximal to the septum by more than the first amount may result in the needle feature moving proximal to the septum.

[0016] In some embodiments, the outer surface of the septum may include an annular groove. Depending on the distal position of the septum, a side port may be in fluid communication with the annular groove and the air vent.

[0017] In some embodiments, the method may include priming the catheter system with a priming solution. In some embodiments, an air vent may extend through the wall of the catheter adapter.

[0018] In some embodiments, the needle assembly may include a guide needle having a sharp distal tip, a proximal end, and a notch. After priming the catheter system, the guide needle and catheter may be inserted into the vascular system. In response, blood may flow into the sharp distal tip of the guide needle, through the notch, and into the space between the guide needle and the catheter, close to the septum. In some embodiments, the blood may be isolated so as not to be in fluid communication with the priming solution.

[0019] In some embodiments, the needle assembly may include a flush chamber. In some embodiments, blood may flow through the guide needle into the flush chamber in response to the guide needle being inserted into the vascular system.

[0020] In some embodiments, the guide needle may include a needle structure, such as a ridge, positioned between the sharp distal tip and the proximal end of the guide needle. In some embodiments, after the guide needle and catheter are inserted into the vascular system, the guide needle may be withdrawn proximal by a first amount, so that the needle structure contacts the septum and slides the septum from a distal to a proximal position.

[0021] In some embodiments, after the guide needle is withdrawn proximal by a first amount, the guide needle may be withdrawn proximal by more than the first amount. This may result in the needle structure moving proximal to the septum. In some embodiments, in response to the guide needle being withdrawn proximal by a first amount, the needle structure may come into contact with the septum and slide the septum from a distal to a proximal position.

[0022] In some embodiments, the catheter assembly may further include a puller member positioned within the lumen. In some embodiments, the puller member may include a distal end coupled to the septum and a proximal end configured to coupled to a blood collection set. In some embodiments, the catheter adapter may further include a slot. In some embodiments, the proximal end of the slot may include a stopper. In some embodiments, the puller member may further include an extension extending through the slot and configured to contact the stopper in response to the septum sliding from a distal to a proximal position.

[0023] Some embodiments of this method may include removing the needle assembly from the catheter system. In some embodiments, the distal end of the housing of the blood collection set may be coupled to the proximal end of a puller member. In some embodiments, the housing may include one or more of a distal end, a proximal end, a slot, and a cannula, the cannula may include wings extending through the slot. In some embodiments, the cannula hub may be slidable with respect to the housing between a retracted position and an advanced position, and the cannula may extend distally from the cannula hub. In some embodiments, the blood collection set may also include an extension tube, the extension tube may include a distal end coupled to the proximal end of the cannula hub. In some embodiments, the blood collection device may be coupled to the proximal end of the extension tube. In some embodiments, the blood collection device may include a syringe, a vacuum blood collection tube, a small sample collection device, or another suitable blood collection device.

[0024] In some embodiments, after coupling the distal end of the blood collection set housing to the proximal end of the puller member, the method may include grasping the wings and sliding the cannula hub from a retracted position to an advanced position. In some embodiments, in response to the cannula hub being in the retracted position, the cannula may be positioned within the housing. In some embodiments, in response to the cannula hub being in the advanced position, the cannula may extend through the distal end of the housing, the puller member, and the septum.

[0025] In some embodiments, after gripping the wing portion and sliding the cannula hub from the retracted position to the advanced position, the method may include collecting a blood sample within the blood collection set. In some embodiments, the method may further include, after collecting a blood sample within the blood collection set, gripping the wing portion and sliding the cannula hub from the advanced position to the retracted position.

[0026] In some embodiments, after collecting a blood sample within the blood collection set, the housing may be moved proximally until the extension contacts the stop. In some embodiments, in response to moving the housing proximally, the septum may slide from the distal position to the proximal position. In some embodiments, in response to the extension contacting the stop, the housing may be detached from the pluer member.

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

[0028] It will be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and instruments shown in the drawings. Also, it is understood that embodiments may be combined or other embodiments may be utilized and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Accordingly, the following detailed description should not be taken in a limiting sense.

[0029] Exemplary embodiments are described with further specificity and detail through the use of the accompanying drawings.

Brief Description of the Drawings

[0030] [Figure 1]This is a top-view perspective of an exemplary catheter system according to several embodiments. [Figure 2] Figure 1 shows an exploded perspective view of the catheter system according to several embodiments. [Figure 3] This is a top fluoroscopic view of another exemplary catheter system according to several embodiments, showing a needle having a needle structure and a septum located distally aligned with a side port. [Figure 4] Figure 3 is a cross-sectional view of the catheter system according to several embodiments, showing the septum at the distal position. [Figure 5] Figure 3 is an overhead perspective view of an exemplary catheter assembly of the catheter system according to several embodiments, showing the septum located proximal to the side port. [Figure 6] Figure 5 is a cross-sectional view of a catheter assembly according to several embodiments, showing the septum located in the proximal position. [Figure 7] Figure 1 is an overhead perspective view of an exemplary catheter assembly of the catheter system according to several embodiments, showing a puller member and a distally positioned septum aligned with the side port. [Figure 8] Figure 7 is a cross-sectional view of a catheter assembly according to several embodiments, showing an exemplary blood collection set coupled to a puller member and a septum located distally. [Figure 9] Figure 7 is a top-view perspective of a catheter assembly according to several embodiments, showing a septum positioned proximal to the side port. [Figure 10] Figure 9 is a cross-sectional view of a catheter assembly according to several embodiments, showing the septum located in the proximal position. [Figure 11A] This is a top-view fluoroscopic diagram of an exemplary catheter system according to several embodiments, showing the priming process. [Figure 11B]Figure 11A is a top fluoroscopic view of the catheter system according to several embodiments, and shows the flashback process. [Figure 11C] Figure 11A is a top-view perspective of the catheter system according to several embodiments, showing the engagement of the blood collection set. [Figure 11D] Figure 11A is a top perspective view of the catheter assembly of the catheter system according to several embodiments, and shows the blood collection process. [Figure 11E] Figure 11A shows a cross-sectional view of the catheter assembly of the catheter system according to several embodiments, and Figure 11D shows the blood collection process. [Figure 11F] Figure 11A is a top-view perspective of the catheter assembly of the catheter system according to several embodiments, and shows the injection process. [Figure 11G] This is an overhead perspective view of an exemplary blood collection set according to several embodiments. [Modes for carrying out the invention]

[0031] Referring here to Figures 1 and 2, in some embodiments, the catheter 110 may be mounted on a hollow guide needle 112, which may include a sharp distal tip 202, in order to introduce the catheter 110 into the patient's vascular system. In some embodiments, the inner surface of the catheter 110 may firmly engage with the outer surface of the guide needle 112, preventing the catheter 110 from detaching and facilitating the insertion of the catheter 110 into a blood vessel or vein. In some embodiments, the sharp distal tip 202 of the guide needle 112 may extend beyond the distal tip of the catheter 110, facilitating the insertion of the catheter 110 at a shallow angle through the patient's skin into a vein.

[0032] In some embodiments, the catheter system 100 may include a catheter assembly 101. In some embodiments, the catheter assembly 101 may include a catheter adapter 102, which may include a lumen 108 extending longitudinally between its distal end 104 and proximal end 106. In some embodiments, the lumen 108 may have an inner diameter at least slightly larger than the outer diameter of the catheter 110, which may be over-the-needle. In some embodiments, the catheter 110 may be coupled to the distal end 104 of the catheter adapter 102. In some embodiments, the catheter 110 may be fixed to the catheter adapter 102 and mechanically sealed, for example, using a screw connection, press-fit, wedge, or any other means known to those skilled in the art.

[0033] In some embodiments, the inner diameter of the lumen 108 may increase between the distal end 104 and the proximal end 106 of the catheter adapter 102. In some embodiments, the inner diameter of the catheter adapter 102 at the distal end 104 may substantially match the outer diameter of the associated catheter 110, securely engaging the guide needle 112 therewith. This can prevent the catheter 110 from detaching during insertion into the blood vessel. In some embodiments, the proximal end 106 of the catheter adapter 102 may have a substantially larger inner diameter to receive and / or engage a blood collection set or other peripheral device.

[0034] In some embodiments, the side port 132 may extend from the catheter adapter 102 and communicate with the lumen 108. Thus, the side port 132 may provide an independent fluid pathway between the catheter 110 and an infusion set or other infusion device coupled to the side port 132. In some embodiments, the infusion set may be coupled to a needleless access connector 136 or directly to an adapter located at the proximal end of an extension tube extending from the side port 132.

[0035] In some embodiments, the side port 132 may be used to provide an independent fluid pathway for distributing a priming fluid or solution, such as saline solution or a drug intended for infusion, in order to prime the catheter system 100. Similarly, in some embodiments, the side port 132 may provide an independent fluid pathway for infusing fluid into the patient's vascular system. The fluid may include, for example, saline solution, various pharmaceuticals, parenteral complete nutrition, etc.

[0036] In some embodiments, the septum 114 may be located within the lumen 108 of the catheter adapter 102. In some embodiments, the septum 114 may comprise a substantially resilient, fluid-impermeable material to facilitate the formation of an effective fluid seal between the side port 132 and the lumen 108. In some embodiments, the septum 114 may comprise a material such as silicone, foam, rubber, composite, or the like. In some embodiments, the material may be configured to expand into or otherwise substantially occupy the internal space or volume of the lumen 108. In some embodiments, the septum 114 and / or the lumen 108 may comprise a coating or lubricant to facilitate the ability of the septum 114 to slide within the lumen 108 and / or to seal the fluid path between the lumen 108 and the side port 132.

[0037] Furthermore, in some embodiments, the septum 114 may include dimensions sufficient to selectively occlude and seal the fluid path between the side port 132 and the lumen 108. In some embodiments, the septum 114 may include a substantially circular cross-section having a diameter substantially matching the diameter of the lumen 108 of the catheter adapter 102. The septum 114 may further include a length and height sufficient to occlude the distal opening 138 of the side port 132. Of course, the septum 114 may include any shape and / or dimensions for sealing the fluid path between the side port 132 and the lumen 108.

[0038] As will be discussed in more detail below, in some embodiments, the septum 114 may be configured to slide within the lumen 108 and / or move in other ways between a distal and proximal position. In some embodiments, at the distal position, the septum 114 may be substantially aligned with the side port 132, thereby providing a seal between the side port 132 and the catheter 110. In this way, the fluid path between the distal end 104 and the proximal end 106 of the catheter adapter 102 may be isolated to prevent contamination from flow or residual fluid in the side port 132. On the other hand, at the proximal position, the septum 114 may form a passage between the side port 132 and the catheter adapter 102 to facilitate fluid communication between the side port 132 and the catheter 110.

[0039] In some embodiments, manipulating the position of the septum 114 in this way can prevent one fluid from contaminating or diluting another. In some embodiments, the priming solution can be distributed via the side port 132 to prime the catheter system 100. In some embodiments, the fluid pathway used to distribute the priming solution can be sealed against the lumen 108 of the catheter adapter 102. This can allow pure, undiluted blood to be drawn from a cannula of a blood collection set (see, for example, blood collection set 801 in Figure 8) which can be coupled to the proximal end 106 of the catheter adapter 102. In some embodiments, after collecting a blood sample, the septum 114 can be moved from a distal to a proximal position within the lumen 108 to form a fluid pathway for the fluid intended for injection, passing through the catheter 110 and the side port 132. In this way, undiluted blood can be collected from the catheter 110, which may be the same catheter used for priming and injection, with little or no risk of cross-contamination with any of the various fluids. In some embodiments, the catheter 110 may include a peripheral venous catheter (PIVC), a midline catheter, or a peripherally inserted central catheter (PICC).

[0040] Of course, those skilled in the art will recognize that all fluids and any number and / or orientation of fluid paths are contemplated herein, and therefore embodiments of the present disclosure are not limited to any particular fluid and / or any number or orientation of fluid paths. For example, the length of the septum 114 may be extended, or the dimensions of the septum 114 may be changed to allow multiple side ports 132 to be sealed simultaneously. In other embodiments, the orientation of the side ports 132 may be changed to form any number of fluid paths. For example, two or more side ports 132 may be positioned on opposite sides of the catheter adapter 102, so that translating the septum 114 within the lumen 108 may expose multiple side ports 132 at once.

[0041] In some embodiments, the puller member 116 may be positioned within the lumen 108 such that the distal end 118 of the puller member 116 is positioned substantially adjacent to the proximal end of the septum 114. In some embodiments, the proximal end 120 of the puller member 116 may be configured to connect, for example, to a needle hub 134 and / or a blood collection set. In other embodiments, the distal end 118 of the puller member 116 may be integrated with or connected to the proximal end of the septum 114. In some embodiments, the puller member 116 and the septum 114 may be formed monolithically as a single unit. In some embodiments, the distal end 118 of the puller member 116 may be positioned substantially adjacent to the proximal end of the septum 114.

[0042] In some embodiments, the catheter adapter 102 may include a slot 124 for receiving at least a portion of the puller member 116. For example, in some embodiments, the puller member 116 may include an extension 126 extending through the slot 124. In some embodiments, a push tab 130 may be coupled to the end of the extension 126, allowing manual translation of the puller member 116 through the wall of the catheter adapter 102.

[0043] In some embodiments, the proximal end of the slot 124 may include a stopper 128, such as a constriction, edge, protrusion, or any other suitable structure integrated with or coupled to the slot 124. In some embodiments, the stopper 128 may contact the extension 126 when the septum 114 is moved from the distal to the proximal position.

[0044] Referring here to Figures 3-6, some embodiments of the catheter system 100 may include a needle assembly 200, which may include a needle hub 134 coupled to the proximal end 106 of the catheter adapter 102. In some embodiments, the proximal end 206 of the guide needle 112 may be fixed within the needle hub 134, for example, by screw connection or press-fit. Alternatively, in some embodiments, the guide needle 112 may be fixed within the needle hub 134 by any means known to those skilled in the art. In some embodiments, the guide needle 112 may include a sharp distal tip 202 and a needle structure 204 positioned 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 may extend through the septum 114 and / or puller member 116.

[0045] As shown in Figures 3 and 4, in some embodiments, the sharp distal tip 202 of the guide needle 112 may be located distal to the septum 114 and / or puller member 116. In some embodiments, the septum 114 may include a slit through which the guide needle 112 may extend. In some embodiments, a needle structure 204, such as a ridge, crimp, or another suitable structure, may be located distal to the septum 114.

[0046] In certain embodiments, the air vent 304 may be integrated with or coupled to an opening on the outer surface of the catheter adapter 102, facilitating the flow of air between the lumen 108 of the catheter adapter 102 and the external environment. Some embodiments of the air vent 304 may include a hydrophobic membrane to avoid any interference with the priming fluid or any other fluid or solution. In some embodiments, the hydrophobic membrane may be permeable to air but impermeable to the priming fluid or any other fluid or solution.

[0047] In some embodiments, the outer surface of the septum 114 may include an annular groove 306 positioned between its distal end and its proximal end. This design can mitigate frictional forces when the septum 114 is translated between its distal and proximal positions. In some embodiments, the annular groove 306 may also form 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, when the septum 114 is in its distal position, the side port 132 may be in fluid communication with the annular groove 306 and the air vent 304. In certain embodiments, the air vent 304 may form a stopper for contact with the proximal edge 310 of the septum 114 within the lumen 108. In some embodiments, the stopper can fix the position of the septum 114 relative to it and prevent further translation of the septum 114 distally.

[0048] In some embodiments, the needle structure 204 may be configured to catch on the distal end of the septum 114. In some embodiments, pulling the guide needle 112 out of the catheter adapter 102 in the proximal direction may press the needle structure 204 against the distal end of the septum 114.

[0049] In some embodiments, the pulling force applied to the guide needle 112 in the proximal direction may, in turn, cause the needle structure 204 to passively push the septum 114, sliding it from a distal position to a proximal position or moving it in other ways.

[0050] In some embodiments, as shown in Figures 5 and 6, the side port 132 can be in fluid communication with the catheter 110 at a proximal position. Furthermore, in some embodiments, the air vent 304 may form a stopper that contacts the distal edge 308 of the septum 114 within the lumen 108. This can fix the position of the septum 114 relative to the stopper and prevent further translation of the septum 114 in the proximal direction.

[0051] In some embodiments, the pulling force applied to the guide needle 112 in the proximal direction may exceed the force required to move the septum 114 to its proximal position, resulting in the needle structure 204 continuing to move proximal through the septum 114. In this way, the needle structure 204 can be translated through the proximal end of the septum 114, thereby allowing the guide needle 112 to be removed from the catheter adapter 102.

[0052] Referring here to Figures 7-10, in some embodiments, the puller member 116 may be coupled to the septum 114 to facilitate the translation of the septum 114 between its distal and proximal positions. In some embodiments, the puller member 116 may be coupled to the proximal end of the septum 114 by press-fit, interlocking, or another suitable coupling mechanism.

[0053] In some embodiments, the puller member 116 may 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 engages with the proximal end of the puller member 116, thereby allowing the puller member 116 to be pressed distally in response to a force applied proximal by a clinician. In some embodiments, in response to the distal pressing of the puller member 116, the distal end of the puller member 116 coupled to the proximal end of the septum 114 may automatically slide the septum 114 proximal, such as to a proximal position.

[0054] In some embodiments, the proximal end of the puller member 116 may include a male or female connector portion, and the distal end of the actuator 800 may include a male or female connector portion. In some embodiments, the proximal end of the septum 114 may include a male or female connector portion, and the distal end of the puller member 116 may include a male or female connector portion. As shown in the figure, for example, the proximal end of the puller member 116 may include a female connector portion, and the distal end of the actuator 800 may include a male connector portion. Also, as shown in the figure, for example, the proximal end of the septum 114 may include a female connector portion, and the distal end of the puller member 116 may include a male connector portion.

[0055] In some embodiments, during operation, the actuator 800 may be inserted into the proximal end 106 of the catheter adapter 102, so that the male connector portion of the actuator 800 engages with the female connector portion of the puller member 116. In some embodiments, the actuator 800 may then be pressed distally, causing the male connector portion of the puller member 116 to engage with the female connector portion of the septum 114. In some embodiments, continuing to press the actuator distally in this manner may cause the septum 114 to slide from its proximal position to its distal position. In some embodiments, as shown in Figures 9 and 10, once engaged, the actuator 800 may be moved proximal. This may cause the septum 114 to passively slide from its distal position to its proximal position, thereby forming a fluid path between the side port 132 and the catheter 110.

[0056] Referring here to Figures 11A-11E, the method may include priming the catheter system 100 with a priming fluid or solution to remove any air present in the catheter system 100 before inserting the catheter 110 into the patient. As shown in Figure 11A, the priming solution, such as saline solution or the drug to be injected, may be administered through the extension tube 1100 via the side port 132.

[0057] In some embodiments, the septum 114 may be initially positioned distally to facilitate a priming process for reducing or removing air from the catheter assembly 101. In some embodiments, at the distal position, the septum 114 may occlude the lumen 108, as a result, the priming solution cannot enter the lumen 108, prime the lumen 108, or come into contact with the catheter 110. In some embodiments, preventing the catheter 110 from being exposed to the priming fluid in this way can prevent the catheter 110 from softening during insertion. However, in some embodiments, the septum 114 may include an annular groove 306, allowing the priming fluid to flow from the side port 132 across the annular groove 306 and prime the distal portion of the lumen 108 corresponding to the annular groove 306.

[0058] In some embodiments, the priming fluid may also prime a portion of the air vent 304 exposed to the lumen 108. In some embodiments, the air vent 304 may include a hydrophobic membrane or other suitable air vent to seal the priming fluid within the lumen 108.

[0059] Referring here to Figure 11B, after priming the catheter assembly 101, the guide needle 112 and catheter 110 can be inserted into the patient's vascular system. In some embodiments, to confirm proper placement of the guide needle 112 and catheter 110 into the blood vessel, the clinician may check for the presence of “flashback” blood in a flashback chamber 1102 located along the catheter 110 and / or within the catheter assembly 101 and / or needle hub 134. In some embodiments, the blood flashback 1104 may flow into the sharp distal tip 202 of the guide needle 112, through the notch, and into the space 1108 between the guide needle 112 and the catheter 110, close to the septum. Advantageously, in some embodiments, in response to the distal position of the septum 114, the blood may be prevented from fluidizing with the priming solution. In some embodiments, the catheter assembly 101 can provide minimal resistance and facilitate rapid and clear visualization of blood flashback 1104 within the catheter 110 and / or visualization of blood flashback 1104 in the flashback chamber 1102.

[0060] Referring here to Figure 11C, in some embodiments, after inserting the catheter 110 into a vein, the clinician may remove the guide needle 112 from the catheter system 100. In some embodiments, the clinician may then connect the actuator 800 of the blood collection set 801 to the proximal end of the puller member 116 to facilitate continued access to the blood vessel through the catheter for blood collection.

[0061] Referring here to Figures 11D and 11G, in some embodiments the blood collection set 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 set 801 may include a cannula 1115 which may be coupled to a wing portion 1116 extending through the slot 1110. In some embodiments the cannula 1115 may be held within the actuator when the cannula or needle hub 134 is in a retracted position. In some embodiments the cannula 1115 may be slidable between a retracted position and an advanced position, and in the advanced position the cannula 1115 may extend through one or more of the distal end of the actuator 800, the puller member 116, and the septum 114. In some embodiments the distal end of the cannula 1115 may be located within the lumen 108 or catheter 110. In some embodiments, the wing portion 1116 may be gripped to facilitate sliding the cannula between a retracted position and an advanced position. In some embodiments, in response to the cannula 1115 extending through the septum 114, a blood sample may be collected through the blood collection set 801.

[0062] In some embodiments, the blood collection set 801 may include an extension tube 1117 (see, for example, 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, a vacuum blood collection tube, a miniature sample collection device, or another suitable blood collection device. In some embodiments, the blood collection device 1118 may include a needle housed in an elastomer sheath, for example, as shown in Figure 11G. In some embodiments, the blood collection device 1118 may include the VACUTAINER®, available from Becton Dickinson & Company, Franklin Lake, New Jersey, or another suitable device.

[0063] In some embodiments, after a blood sample has been collected in the blood collection device 1118 or set 801, the wing portion 1116 may be grasped and moved along the slot 1110 to slide the cannula 1115 between an advanced position and a retracted position. In some embodiments, the distal end of the cannula 1115 may be positioned within the actuator 800 in response to the cannula 1115 being in the retracted position.

[0064] Referring here to Figures 11E and 11F, after a sufficient amount of blood has been collected and / or after the cannula 1115 has been slid to the retracted position, the actuator 800 can be removed from the puller member 116. In some embodiments, the actuator 800 can be removed by applying a force in the proximal direction, causing the puller member 116 to contact the stop 128 of the slot 124 of the catheter adapter 102. A sustained force applied to the actuator 800 in the proximal direction may result in the actuator 800 being disengaged from the puller member 116. Furthermore, referring here to Figure 11E, in some embodiments, such proximal movement of the actuator 800 may passively slide the septum 114 from the distal position to the proximal position, opening the flow path including the catheter 110, a portion of the lumen 108, the side port 132, and the extension tube 1100, as shown in Figure 11F.

[0065] All examples and conditional statements described herein are intended for educational purposes to help the reader understand the concepts to which the inventors have contributed to advance the invention and the art, and should be construed as not being limited to such specifically described examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made with respect to them without departing from the spirit and scope of the invention.

Claims

1. A catheter assembly, wherein the catheter assembly is A catheter adapter comprising a distal end, a proximal end, a lumen extending through the distal end and the proximal end, and a side port between the distal end and the proximal end of the catheter adapter, A catheter extending from the distal end of the catheter adapter, A catheter assembly comprising: a septum disposed in the lumen at a distal position aligned with the side port, wherein, in response to the septum being at the distal position, the septum provides a seal between the side port and the catheter; the septum is configured to slide from the distal position to a proximal position proximal to the side port; and, in response to the septum being at the proximal position, the side port is in fluid communication with the catheter.

2. A catheter assembly according to claim 1, further comprising a puller member disposed within the lumen, wherein the puller member comprises a distal end coupled to the septum and a proximal end configured to be coupled to a blood collection set.

3. A catheter assembly according to claim 2, wherein the catheter adapter includes a slot, the proximal end of the slot includes a stopper, and the puller member further includes an extension that extends through the slot and is configured to contact the stopper in response to the septum sliding from the distal position to the proximal position.

4. A catheter assembly according to claim 3, wherein the extension portion is connected to a push tab.

5. A catheter assembly according to claim 1, wherein the catheter adapter includes an air vent, the outer surface of the septum includes an annular groove, and the side port is in fluid communication with the annular groove and the air vent in response to the septum being in the distal position.

6. A catheter system, wherein the catheter system is A catheter assembly, wherein the catheter assembly is A catheter adapter comprising a distal end, a proximal end, a lumen extending through the distal end and the proximal end, and a side port between the distal end and the proximal end of the catheter adapter, A catheter extending from the distal end of the catheter adapter, The stop portion within the lumen, A catheter assembly comprising: a septum positioned distally to the side port and located within the lumen, wherein, in response to the septum being in the distal position, the septum provides a seal between the side port and the catheter; and A needle assembly, wherein the needle assembly is A needle hub coupled to the proximal end of the catheter adapter, A catheter system comprising a needle assembly, the guide needle, the guide needle comprising a sharp distal tip, a proximal end, and a needle structure positioned between the sharp distal tip and the proximal end, wherein the proximal end of the guide needle is fixed within the needle hub, and the needle structure is configured to contact the septum in response to a first amount of proximal withdrawal of the guide needle, causing the septum to slide from the distal to the proximal position, the side port is in fluid communication with the catheter in response to the septum being in the proximal position, the stop portion is in contact with the septum, and the needle structure is configured to move proximal with respect to the septum in response to a first amount or more of proximal withdrawal of the guide needle.

7. A catheter system according to claim 6, wherein the needle structure includes a protrusion.

8. A catheter assembly according to claim 1, wherein the catheter adapter includes an air vent, the outer surface of the septum includes an annular groove, and the side port is in fluid communication with the annular groove and the air vent in response to the septum being in the distal position.

9. A catheter assembly according to claim 8, wherein the air vent forms a stopper.

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