Introducer components, assemblies and methods thereof

Abstract

The introducer assembly includes a syringe (102) and a needle assembly (104) fluidly connected thereto. The needle assembly includes a needle having a needle shaft (140) and an access guidewire advancement mechanism (162) mounted on a proximal straight portion of the needle shaft of the needle. The needle shaft includes an S-shaped portion (146) between the distal and proximal straight portions of the needle shaft and a port (148) at the transition from the S-shaped portion to the distal straight portion of the needle shaft. An access guidewire (106) can be loaded into both the access guidewire advancement mechanism and the needle shaft lumen in the distal straight portion of the needle shaft in the ready-to-deploy state of the introducer assembly. In this manner, the access guidewire can be immediately advanced into the vessel lumen upon establishing a needle pathway therewith using the needle.

Description

[Technical field]

[0001] The present invention relates to introducer components, assemblies and methods thereof. [Background technology]

[0002] A guidewire is typically placed into a blood vessel with an introducer assembly prior to inserting a central venous catheter ("CVC") or the like over the guidewire into the vessel. The introducer assembly typically includes a needle connected to a syringe. When accessing a vessel with the needle, the needle must be removed from the syringe so that a guidewire can be inserted into the needle through the needle hub and then into the vessel. Removing the needle from the syringe as well as inserting the guidewire into the needle carries the risk of over-manipulating the needle and puncturing the back wall of the vessel, losing access to the vessel, or both. What is needed is an introducer assembly that does not require removing the needle from the syringe in order to insert a guidewire into the vessel.

[0003] Disclosed herein are introducer components, assemblies, and methods that address the foregoing. Summary of the Invention

[0004] Disclosed herein, in some embodiments, is an introducer assembly including a syringe, a needle assembly fluidly connected to the syringe, and an access guidewire. The needle assembly includes a needle and an access guidewire advancement mechanism. The needle includes a needle shaft and a needle hub. The needle shaft includes an S-shaped section between a distal straight section and a proximal straight section, and a port at the transition from the S-shaped section of the needle shaft to the distal straight section of the needle shaft. The needle hub is located on the proximal straight section of the needle shaft. The access guidewire advancement mechanism is attached to the proximal straight section of the needle shaft distal to the needle hub. An access guidewire is loaded into both the access guidewire advancement mechanism and the needle shaft lumen in the distal straight section of the needle shaft in the ready-to-deploy state of the introducer assembly.

[0005] In some embodiments, the access guidewire extends along the barrel wall of the syringe, through the access guidewire advancement mechanism, through a port in the needle shaft, and into the needle shaft lumen in the distal straight portion of the needle shaft without appreciably bending, the distal end of the access guidewire being positioned just proximal to the needle tip in the distal straight portion of the needle shaft in the ready-to-deploy state of the introducer assembly.

[0006] In some embodiments, the access guidewire comprises a "J" shaped guidewire tip that is straight in the ready to deploy state of the introducer assembly and that is curved as the guidewire tip advances beyond the distal end of the needle shaft in the deployed state of the introducer assembly.

[0007] In some embodiments, the access guidewire includes a bare wire portion and a wound portion proximal to the bare wire portion, the bare wire portion extending distally through the port in at least a ready-to-deploy state of the introducer assembly.

[0008] In some embodiments, the access guidewire includes a proximal portion that extends proximally from the access guidewire advancement mechanism in the ready-to-deploy state of the introducer assembly, The proximal portion of the access guidewire is disposed within a sterile barrier configured to maintain sterility of the access guidewire.

[0009] In some embodiments, the port includes a valve configured to form a fluid-tight seal around the access guidewire. In some embodiments, the valve includes a split septum compressed within the port.

[0010] In some embodiments, the access guidewire advancement mechanism includes a thumbwheel device configured to advance the access guidewire when the access guidewire is pressed into the thumbwheel and the thumbwheel is rotated.

[0011] In some embodiments, the needle hub further comprises a needle hub connector, the needle hub connector comprising a needle hub bore in a proximal portion of the needle hub, and a syringe tip of the syringe disposed in the needle hub bore, thereby fluidly connecting the needle to the syringe.

[0012] Also disclosed herein, in some embodiments, is a needle assembly including a needling having a needle shaft and a needle hub covering the needle shaft. The needle shaft includes an S-shaped portion between a distal straight portion and a proximal straight portion, and a port at the transition from the S-shaped portion of the needle shaft to the distal straight portion of the needle shaft. The needle hub is located on the proximal straight portion of the needle shaft.

[0013] In some embodiments, the needle assembly further includes an access guidewire advancement mechanism located on a proximal straight portion of the needle shaft distal to the needle hub.

[0014] In some embodiments, the port includes a valve configured to form a fluid-tight seal around the access guidewire. In some embodiments, the valve includes a split septum compressed within the port.

[0015] In some embodiments, the access guidewire advancement mechanism includes a thumbwheel device configured to advance the access guidewire when the access guidewire is pressed into the thumbwheel and the thumbwheel is rotated.

[0016] Also disclosed herein is a method for obtaining access to a blood vessel. The method, in some embodiments, includes an introducer assembly obtaining step, a needle path establishing step, and an access guidewire advancing step. The introducer assembly obtaining step includes obtaining an introducer assembly. The introducer assembly includes a syringe and a needle assembly fluidly connected to the syringe. The needle assembly includes a needle and an access guidewire advancement mechanism. The needle includes an S-shaped portion between a distal straight portion and a proximal straight portion, and a port at a transition from the S-shaped portion of the needle shaft to the distal straight portion of the needle shaft. The access guidewire advancement mechanism is attached to the proximal straight portion of the needle shaft distal to the needle hub for advancing the access guidewire into the patient's blood vessel lumen. The needle path establishing step includes establishing a needle path from the area of ​​skin to the blood vessel lumen with the needle. The access guidewire advancing step includes advancing at least a guidewire tip of the access guidewire into the blood vessel lumen to obtain access to the blood vessel.

[0017] In some embodiments, the method further includes an introducer assembly adjustment step, which includes adjusting the introducer assembly such that the introducer assembly is in a ready-to-deploy state in which a guidewire tip of the access guidewire is positioned just proximal to the needle tip of the distal straight portion of the needle shaft for performing the access guidewire advancement step immediately following establishment of the needle path in the needle path establishment step.

[0018] In some embodiments, the access guidewire extends along the barrel wall of the syringe, through the access guidewire advancement mechanism, through a port in the needle shaft, and into the needle shaft lumen in the distal straight portion of the needle shaft without appreciably bending in the ready-to-deploy state of the introducer assembly.

[0019] In some embodiments, the access guidewire advancing step includes rotating a thumbwheel of the access guidewire advancement mechanism while the access guidewire is pressed against the thumbwheel.

[0020] In some embodiments, the access guidewire advancement step can cause the guidewire tip of the access guidewire to transition from a straight shape within the needle shaft to a curved shape within the vessel lumen.

[0021] In some embodiments, the method further includes a plunger withdrawal step that involves withdrawing the plunger from the barrel of the syringe and creating a slight vacuum prior to reaching the blood vessel lumen in the needle pathway establishment step, where the slight vacuum causes blood to flow back into at least the syringe tip, confirming the establishment of the needle pathway.

[0022] In some embodiments, the method further includes a blood aspirating step, which includes aspirating blood with a syringe to confirm establishment of a needle pathway, and a valve disposed within the port configured to form a fluid-tight seal around the bare portion of the access guidewire to maintain a vacuum during the blood aspirating step.

[0023] In some embodiments, the method further comprises a needle withdrawal step, which comprises withdrawing the needle from the patient while leaving the access guidewire within the vessel lumen.

[0024] In some embodiments, the needle withdrawal step includes holding the access guidewire in a fixed position at or near the area of ​​skin containing the needle path while withdrawing the needle over a proximal portion of the access guidewire in the needle withdrawal step.

[0025] In some embodiments, the method further comprises a syringe and needle separation step, the syringe and needle separation step comprising separating the needle from the syringe prior to performing the needle withdrawal step.

[0026] In some embodiments, the method further includes an air-bleeding step, which includes pushing the access guidewire toward the port to expel air toward the port while performing the needle withdrawal step. Exhausting air into the port eliminates the need to separate the needle from the syringe.

[0027] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and following description, which disclose in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0028] [Figure 1] FIG. 1 shows a side view of an introducer assembly, according to some embodiments. [Diagram 2] FIG. 2 shows an exploded view of an introducer assembly, according to some embodiments. [Diagram 3] FIG. 3 shows a detailed view of a needle assembly of the introducer assembly, according to some embodiments. [Figure 4] FIG. 4 shows a longitudinal cross-sectional view of a needle assembly, according to some embodiments. [Diagram 5] FIG. 5 illustrates a portion of an introducer assembly according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other embodiments disclosed herein.

[0030] With regard to the terms used herein, it should also be understood that these terms are intended to describe some particular embodiments, and that these terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide serial or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. In addition, any of the aforementioned features or steps may further include one or more features or steps, unless otherwise indicated. Designations such as "left," "right," "up," "down," "front," "rear," etc. are for convenience and do not imply, for example, a particular fixed position, direction, orientation, etc. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0031] For example, with reference to the "proximal," "proximal portion," or "proximal end portion" of a catheter, this includes the portion of the catheter that is intended to be near the clinician when the catheter is used with a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be near the clinician when the catheter is used with a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be near the clinician when the catheter is used with a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter. However, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0032] For example, with reference to the "distal," "distal portion," or "distal end portion" of a catheter, this includes the portion of the catheter that is intended to be near or within the patient when the catheter is used with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be near or within the patient when the catheter is used with the patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be near or within the patient when the catheter is used with the patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter. However, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0033] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As discussed above, a guidewire is typically placed into a blood vessel with an introducer assembly prior to inserting a CVC or the like over the guidewire into the vessel. The introducer assembly typically includes a needle connected to a syringe. When using the needle to access a vessel, the needle must be removed from the syringe so that the guidewire can be inserted through the needle hub into the needle and then into the vessel. Not only removing the needle from the syringe, but also inserting the guidewire into the needle, carries the risk of puncturing the back wall of the vessel or losing access to the vessel due to overhandling the needle, or both. What is needed is an introducer assembly that does not require the needle to be removed from the syringe in order to insert the guidewire into the vessel.

[0034] Disclosed herein are introducer components, assemblies, and methods that do not require disconnecting the needle from the syringe to insert the guidewire into the vessel as in typical introducer assemblies. Such introducer components, assemblies, and methods are advantageous in that they do not have the same risk of puncturing the back wall of the vessel or losing access to the vessel due to overhandling. In one example, an introducer assembly is disclosed that includes a syringe and a needle assembly fluidly connected to the syringe. The needle assembly may include a needle and an access guidewire advancement mechanism mounted on a proximal straight portion of the needle shaft of the needle. The needle shaft may include an S-shaped portion between the distal straight portion and the proximal straight portion of the needle shaft, and a port at the transition from the S-shaped portion to the distal straight portion of the needle shaft. An access guidewire may be loaded into both the access guidewire advancement mechanism and the needle shaft lumen in the distal straight portion of the needle shaft in the ready-to-deploy state of the introducer assembly. In another example, a method is disclosed for securing vascular access with the aforementioned introducer assembly. Moreover, these and other features will become more apparent in view of the accompanying drawings and the following description, which set forth certain embodiments in more detail.

[0035] Introducer Assembly 1 and 2 show various views of an introducer assembly 100 according to some embodiments.

[0036] As shown, introducer assembly 100 includes a syringe 102 and a needle assembly 104 that is fluidly connected to syringe 102 at least in the ready-to-deploy state of introducer assembly 100. In addition, introducer assembly 100 may include an access guidewire 106 that is slidably disposed within introducer assembly 100 in the ready-to-deploy state of introducer assembly 100. Indeed, as described in more detail below, access guidewire 106 is loaded into both an access guidewire advancement mechanism (e.g., thumbwheel device 162) and a needle shaft lumen 150 within a distal straight portion 152 of needle shaft 140 in the ready-to-deploy state of introducer assembly 100. When so loaded into the introducer assembly 100, the access guidewire 106 extends along the barrel wall 120 of the syringe 102, through or over the access guidewire advancement mechanism, through a port 148 in the needle shaft 140, and into a needle shaft lumen 150 in a distal straight portion 152 of the needle shaft 140 just proximal to the needle tip 142, without any appreciable bending. In this manner, the access guidewire 106 can be advanced immediately and linearly into the patient's vascular lumen as the needle 138 is used to establish a needle pathway to the patient's vascular lumen.

[0037] Syringe 102 includes a syringe hub 108, a barrel 110, and a plunger 112 that is disposed within barrel 110 in at least the ready-to-deploy state of introducer assembly 100.

[0038] The syringe hub 108 includes a syringe tip 114 that extends from a distal portion (e.g., the distal end) of the barrel 110. Additionally, the syringe hub 108 can include a threaded collar 116 that extends from the distal portion (e.g., the distal end) of the barrel 110 and around the syringe tip 114.

[0039] The syringe tip 114 is configured for insertion into a needle hub bore 160 in the needle hub 144 to fluidly connect the syringe 102 to the needle 138. In practice, the syringe tip 114 may have a luer taper (e.g., a 6% taper) configured for insertion into the needle hub bore 160, which is complementarily configured as described below.

[0040] The threaded collar 116 includes internal threads 118 that are configured to threadably mate with an optional needle hub flange of the needle hub 144, described below. In this case, the threaded collar 116 of the syringe hub 108 advantageously provides a so-called luer lock type connection with the needle hub flange of the needle hub 144, providing greater security against inadvertent disconnection than a luer slip type connection.

[0041] The barrel 110 includes a barrel wall 120, a barrel chamber 122 defined by the barrel wall 120, a barrel flange 124 extending outwardly from a proximal portion (e.g., a proximal end) of the barrel 110 or barrel wall 120 that is configured to actuate the syringe 102 in conjunction with a plunger flange 130, a plunger collar, etc., described below.

[0042] The barrel chamber 122 is configured to receive the plunger 112 inserted therein. In effect, the barrel chamber 122 extends from the distal end of the barrel 110, which is the closed end of the barrel 110 (excluding the syringe tip 114), to the proximal end of the barrel 110, which is the open end of the barrel 110 into which the plunger 112 can be inserted.

[0043] The plunger 112 includes an integral plunger shaft 126, a piston 128 fitted onto a distal portion (e.g., distal end) of the plunger shaft 126, a plunger flange 130 extending outwardly from a proximal portion (e.g., proximal end) of the plunger 112 configured to actuate the syringe 102 in conjunction with the barrel flange 124, barrel collar, etc.

[0044] The plunger shaft 126 may include orthogonal struts 132 that meet along their longitudinal edges at a central axis of the plunger shaft 126. However, the plunger shaft 126 may take other forms, and thus the plunger shaft 126 is not limited to orthogonal struts 132.

[0045] The piston 128 may be a one-piece resilient piston and includes one or more rings configured to respectively form one or more seals with the barrel wall 120. The one or more rings include at least a forward ring 134 configured to form a seal with the barrel wall 120. The one or more rings may also include a rearward ring 136, as shown in FIG. 2. Similar to the forward ring 134, the rearward ring 136 is configured to form a seal with the barrel wall 120. In fact, the rearward ring 136, if present, provides a backup seal with the barrel wall 120. The forward ring 134 and the rearward ring 136 together ensure that the seal between the piston 128 and the barrel wall 120 (e.g., the seal provided by the forward ring 134, the rearward ring 136, or both the forward ring 134 and the rearward ring 136) remains intact during actuation of the syringe 102, thereby allowing the syringe 102 to continue to aspirate liquid, such as blood, as the plunger 112 is withdrawn from the barrel 110.

[0046] 3 and 4 show various views of the needle assembly 104 according to some embodiments. Needle assembly 104 includes a needle 138 and an access guidewire advancement mechanism, such as a thumbwheel device 162 described below.

[0047] The needle 138 includes a needle shaft 140, a needle tip 142 on a distal straight portion 152 of the needle shaft 140, and a needle hub 144 on a proximal straight portion 154 of the needle shaft 140, which will be described below.

[0048] The needle shaft 140 includes an S-shaped portion 146 , a port 148 , and a needle shaft lumen 150 that extends from an opening in the needle tip 142 to the proximal end of the needle shaft 140 . The S-shaped portion 146 of the needle shaft 140 is located between a distal straight portion 152 of the needle shaft 140 and a proximal straight portion 154 of the needle shaft 140. The S-shaped portion 146 is configured to offset the central axis of the syringe 102 from the central axis of the distal straight portion 152 of the needle shaft 140 such that the access guidewire 106 can extend along the barrel wall 120 of the syringe 102, through or over an access guidewire advancement mechanism (e.g., a thumbwheel device 162 described below), through a port 148 in the needle shaft 140, and into a needle shaft lumen 150 in the distal straight portion 152 of the needle shaft 140 without appreciably bending. In this manner, the access guidewire 106 can be advanced linearly into the patient's vascular lumen when establishing a needle pathway with the needle 138 to the patient's vascular lumen.

[0049] The port 148 is located within the S-shaped portion 146 of the needle shaft 140 or within the transition from the S-shaped portion 146 to the distal straight portion 152. The port 148 includes a valve 156, which may be a septum or a split septum disposed within the port 148. The valve 156 is configured to form a fluid-tight seal around the access guidewire 106 (e.g., the bare portion 172 of the access guidewire 106) as it passes through the port 148 and into the needle shaft lumen 150 of the needle shaft 140.

[0050] The needle hub 144 includes a needle-hub connector 158 at a proximal portion of the needle hub 144. The needle-hub connector 158 in turn includes a needle-hub bore 160 and an optional needle-hub flange about the needle-hub connector 158.

[0051] The needle hub bore 160 is configured to receive the syringe tip 114 therein to fluidly connect the needle 138 to the syringe 102. In practice, the needle hub bore 160 can have a luer taper (e.g., a 6% taper) configured to receive the syringe tip 114 therein, with the syringe tip 114 being complementarily configured as described above.

[0052] Although not shown, the optional needle hub flange is configured to threadably mate with the internal threads 118 of the threaded collar 116 of the syringe hub 108. In this case, the needle hub flange advantageously provides a so-called luer lock type connection with the internal threads 118 of the threaded collar 116 of the syringe hub 108, providing increased security against inadvertent disconnection as compared to a luer slip type connection.

[0053] The access guidewire advancement mechanism may include, but is not limited to, a thumbwheel device 162. The thumbwheel device 162 may include a thumbwheel 164 mounted on an axis 166 between the arms of a thumbwheel chassis 168, which in turn is mounted on the proximal straight portion 154 of the needle shaft 140 distal to the needle hub 144. Such a thumbwheel device 162 is configured to advance the access guidewire 106 when the access guidewire 106 is pressed into the thumbwheel 164 and the thumbwheel 164 is rotated.

[0054] Additionally, introducer assembly 100 may include an access guidewire 106 that is slidably disposed within introducer assembly 100 in its ready-to-deploy state. Indeed, access guidewire 106 is loaded into both the access guidewire advancement mechanism (e.g., thumbwheel device 162) and into needle shaft lumen 150 in the distal straight portion 152 of needle shaft 140 in its ready-to-deploy state. When so loaded into introducer assembly 100, access guidewire 106 extends along barrel wall 120 of syringe 102, through or over the access guidewire advancement mechanism, through port 148 in needle shaft 140 or its valve 156, and into needle shaft lumen 150 in the distal straight portion 152 of needle shaft 140 just proximal to needle tip 142 without any appreciable bending. In this manner, the access guidewire 106 may be advanced immediately and linearly into the patient's vessel lumen as the needle 138 is used to establish a needle pathway into the patient's vessel lumen.

[0055] The access guidewire 106 may include a guidewire tip 170 in the form of a "J" shaped guidewire tip configured to prevent puncturing the posterior wall of a blood vessel, which is straight in the ready-to-deploy state of the introducer assembly 100 and curved as the guidewire tip 170 advances beyond the needle tip 142 in the deployed state of the introducer assembly 100.

[0056] The access guidewire 106 may further include a bare wire portion 172 and a wound wire portion 174 distal to the bare wire portion 172, proximal to the bare wire portion 172, or both. The bare wire portion 172 extends distally through the port 148 or its valve 156 in at least a ready-to-deploy state of the introducer assembly 100 to form a fluid-tight seal. Indeed, the bare wire portion 172 may extend further distally through the port 148 or its valve 156 in one or more deployed states of the introducer assembly 100 to maintain a fluid-tight seal even when a distal portion of the access guidewire 106 advances into the vessel lumen. Notably, the access guidewire 106 need not have the bare wire portion 172 and the wound wire portion 174. At least the aforementioned bare wire portion 172 may instead be a flat-wound or ground-wound portion of the access guidewire 106, where the flat-wound portion includes windings of tape instead of round wire, and the ground-wound portion includes windings of round wire that have been ground to make the windings flat.

[0057] In particular, access guidewire 106 includes a proximal portion that extends proximally from the access guidewire advancement mechanism (e.g., thumbwheel device 162) in the ready-to-deploy state of introducer assembly 100. Although not shown, the proximal portion of access guidewire 106 can be disposed within a sterile barrier, such as an elongated bag or guidewire dispensing device, which is configured to maintain the sterility of access guidewire 106.

[0058] method The method includes at least a method of obtaining vascular access, the method including one or more steps selected from the steps of obtaining an introducer assembly, adjusting an introducer assembly, establishing a needle path, withdrawing a plunger, aspirating blood, advancing an access guidewire, separating a syringe and needle, venting air, and withdrawing a needle.

[0059] The introducer assembly obtaining step includes obtaining an introducer assembly 100. As described above, the introducer assembly 100 includes a syringe 102 and a needle assembly 104 fluidly connected to the syringe 102. The needle assembly 104 includes a needle 138 and an access guidewire advancement mechanism (e.g., a thumbwheel device 162). The needle 138 includes an S-shaped portion 146 between a distal straight portion 152 and a proximal straight portion 154, and a port 148 located at the transition of the needle shaft 140 from the S-shaped portion 146 to the distal straight portion 152 of the needle shaft 140. The access guidewire advancement mechanism is attached to the proximal straight portion 154 of the needle shaft 140 distal to the needle hub 144 for advancing the access guidewire 106 into the patient's vascular lumen.

[0060] The introducer assembly adjusting step includes adjusting the introducer assembly 100 so that the introducer assembly 100 is in its ready-to-deploy state if the introducer assembly obtaining step has not yet been performed. Furthermore, in the ready-to-deploy state of the introducer assembly 100, the guidewire tip 170 of the access guidewire 106 is located just proximal to the needle tip 142 of the distal straight portion 152 of the needle shaft 140 for performing the access guidewire advancement step immediately following needle path establishment in the needle path establishment step. The remaining portion of the access guidewire 106 extends along the barrel wall 120 of the syringe 102, through or over the access guidewire advancement mechanism (e.g., thumbwheel device 162), through the port 148 of the needle shaft 140, and into the needle shaft lumen 150 within the distal straight portion 152 of the needle shaft 140 without appreciable bending of the access guidewire 106.

[0061] The needle pathway establishment step involves establishing a needle pathway with needle 138 from an area of ​​the patient's skin to the lumen of the blood vessel. The plunger withdrawal step involves withdrawing the plunger 112 from the barrel 110 of the syringe 102 to create a slight vacuum before reaching the blood vessel lumen in the needle path establishment step. The slight vacuum causes blood to flow back into at least the syringe tip 114, confirming the establishment of the needle path in the needle path establishment step.

[0062] The blood withdrawal step includes aspirating blood with the syringe 102 to confirm establishment of the needle path in the needle path establishment step. The valve 156 disposed within the port 148 is configured to form a fluid-tight seal around the bare portion 172 of the access guidewire 106 to maintain a vacuum during the blood withdrawal step.

[0063] FIG. 5 illustrates the access guidewire advancement step of a method according to some embodiments. The step of advancing the access guidewire includes rotating the thumbwheel 164 of the thumbwheel device 162 as an access guidewire advancement mechanism while the access guidewire 106 is pressed against the thumbwheel 164 to advance at least the guidewire tip 170 of the access guidewire 106 into the vessel lumen to gain access to the blood vessel. The access guidewire advancement step allows the guidewire tip 170 of the access guidewire 106 to transition from a straight state within the needle shaft lumen 150 of the needle shaft 140 to a curved state within the vessel lumen.

[0064] The syringe and needle separation step includes a step of separating the needle 138 from the syringe 102 before performing the needle withdrawal step. However, if the air removal step is performed, it is not necessary to perform the syringe and needle separation step.

[0065] The needle withdrawal step involves withdrawing the needle 138 from the patient while leaving the access guidewire 106 within the vessel lumen. The needle withdrawal step can include holding the access guidewire 106 in place at or near the area of ​​the skin that includes the needle track while withdrawing the needle 138 over a proximal portion of the access guidewire 106.

[0066] The air purge step includes pushing the access guidewire 106 toward the port 148 against the valve 156 to expel air toward the port 148 while the needle retraction step is being performed. However, in some embodiments, the needle hub 144 includes a push button purge valve on another side of the needle hub 144 for the air purge step. By expelling the air into the port 148, a separation step of separating the needle 138 from the syringe 102 is not required. However, in some embodiments, both the syringe and needle separation step and the air purge step may be performed.

[0067] Some specific embodiments are disclosed herein, and although the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concept provided herein. Additional adaptations or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations or modifications. Thus, one may deviate from the specific embodiments disclosed herein without departing from the scope of the concept provided herein.

Claims

1. An introducer assembly comprising: a syringe; a needle assembly fluidly connected to the syringe; an access guide wire; wherein the needle assembly includes a needle and an access guide wire advancement mechanism; the needle comprising: a needle shaft having a S-shaped portion between a distal straight portion and a proximal straight portion; a port at a transition from the S-shaped portion of the needle shaft to the distal straight portion of the needle shaft; a needle hub positioned over the proximal straight portion of the needle shaft; wherein the access guide wire advancement mechanism is attached to the proximal straight portion of the needle shaft distal to the needle hub; the access guide wire being loaded within both the access guide wire advancement mechanism and a needle shaft lumen within the distal straight portion of the needle shaft in a ready-to-deploy state of the introducer assembly.

2. The access guide wire extends along the barrel wall of the syringe, through the access guide wire advancement mechanism, through the port in the needle shaft, and into the needle shaft lumen within the distal straight portion of the needle shaft without perceptible bending, and a distal end of the access guide wire is disposed immediately proximal to a needle tip within the distal straight portion of the needle shaft in the ready-to-deploy state of the introducer assembly. The introducer assembly according to claim 1.

3. The access guide wire is straight in the ready-to-deploy state of the introducer assembly and curved in a deployed state of the introducer assembly when a guide wire tip advances beyond a distal end of the needle shaft, the introducer assembly according to claim 1, comprising a "J"-shaped guide wire tip.

4. The access guide wire includes a bare wire portion and a coiled wire portion proximal to the bare wire portion, the bare wire portion extending distally through the port at least in the ready-to-deploy state of the introducer assembly. The introducer assembly according to claim 1.

5. The access guide wire includes a proximal portion that extends proximally from the access guide wire advancement mechanism in the state where the deployment of the introducer assembly is ready, and the proximal portion of the access guide wire is disposed within a sterile barrier configured to maintain the sterility of the access guide wire. The introducer assembly according to claim 1.

6. The port includes a valve configured to form a liquid-tight seal around the access guide wire. The introducer assembly according to claim 1.

7. The valve includes a split septum compressed within the port. The introducer assembly according to claim 6.

8. The access guide wire advancement mechanism includes a thumb wheel device configured to advance the access guide wire when the access guide wire is pushed into the thumb wheel and the thumb wheel is rotated. The introducer assembly according to claim 1.

9. The needle hub further includes a needle hub connector including a needle hub hole at a proximal portion of the needle hub, and a tip of the syringe is disposed in the needle hub hole, thereby fluidly connecting the needle to the syringe. The introducer assembly according to any one of claims 1 to 8.

10. A needle assembly, comprising a needle, the needle includes a needle shaft and a needle hub, the needle shaft includes an S-shaped portion between a distal straight portion and a proximal straight portion, and a port at a transition portion from the S-shaped portion of the needle shaft to the distal straight portion of the needle shaft. The needle hub is located on the proximal straight portion of the needle shaft. The needle assembly.

11. The needle assembly according to claim 10, further comprising an access guide wire advancement mechanism located on the proximal straight portion of the needle shaft distal to the needle hub.

12. The port includes a valve configured to form a liquid-tight seal around the access guide wire. The needle assembly according to claim 10.

13. The valve includes a split septum compressed within the port. The needle assembly according to claim 12.

14. The access guide wire advancement mechanism includes a thumb wheel device configured to advance the access guide wire when the access guide wire is pushed into the thumb wheel and the thumb wheel is rotated, the needle assembly according to any one of claims 10 to 13.

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