Introducer assembly and method thereof

Abstract

An introducer assembly and method are disclosed. For example, the introducer assembly may include a syringe and a needle fluidly connected to the syringe. The syringe may include a barrel and a plunger disposed within the barrel. The plunger may include an integral plunger shaft and a piston fitted onto a distal end of the plunger shaft. The plunger shaft may include a longitudinal plunger shaft passageway extending from a distal end of the plunger shaft. The piston may include a piston throughbore that together with the plunger shaft passageway forms a portion of the access guidewire passageway of the introducer assembly. The needle may include a needle shaft and a needle hub covering a proximal portion of the needle shaft. In another embodiment, a method for obtaining vascular access using the introducer assembly described above is disclosed.

Description

[Technical field]

[0001] The present disclosure relates to an introducer assembly and method thereof. [Background technology]

[0002] A guidewire is typically placed into a blood vessel using an introducer assembly prior to inserting a central venous catheter ("CVC") or the like over the guidewire into the blood vessel. The introducer assembly typically includes a needle connected to a syringe. Once the blood vessel is accessed with the needle, the needle must be disconnected from the syringe so that a guidewire can be inserted into the needle through the needle hub of the needle and subsequently into the blood vessel. Disconnecting the needle from the syringe as well as inserting the guidewire into the needle carries the risk of puncturing the back wall of the blood vessel due to excessive handling of the needle, losing access to the blood vessel, or both. What is needed is an introducer assembly that does not require disconnecting the needle from the syringe to insert the guidewire into the blood vessel.

[0003] Disclosed herein is an introducer assembly and method that addresses the above. Summary of the Invention

[0004] Disclosed herein, in some embodiments, is an introducer assembly including a syringe and a needle fluidly connected to the syringe. The syringe includes a barrel and a plunger disposed within the barrel. The plunger includes a one-piece plunger shaft and a piston fitted onto a distal end of the plunger shaft. The plunger shaft includes a longitudinal plunger shaft passageway extending from a distal end of the plunger shaft. The piston includes a piston throughbore that together with the plunger shaft passageway forms a portion of the access guidewire passageway of the introducer assembly. The needle includes a needle shaft and a needle hub covering a proximal portion of the needle shaft.

[0005] In some embodiments, the introducer assembly further includes an access guidewire slidably disposed within the access guidewire passage. A needle lumen of the needle forms another portion of the access guidewire passage.

[0006] In some embodiments, the access guidewire includes a "J" shaped guidewire tip at a distal portion of the access guidewire, the distal end of the access guidewire being positioned proximal to the needle tip in the ready-to-deploy state of the introducer assembly such that the guidewire tip assumes a straightened configuration in the ready-to-deploy state of the introducer assembly.

[0007] In some embodiments, the access guidewire includes a bare wire portion and a wrapped wire portion proximal to the bare wire portion, the bare wire portion extending distally from at least the piston throughbore in a deployed state of the introducer assembly.

[0008] In some embodiments, the piston includes at least a leading ring, the leading ring including a gasket about an inner circumference of the piston throughbore, the gasket configured to form a seal around the access guidewire.

[0009] Also disclosed herein, in some embodiments, is an introducer assembly including a syringe and a needle fluidly connected to the syringe. The syringe includes a syringe hub, a barrel, and a plunger disposed within the barrel. The barrel includes a syringe tip extending from a distal portion of the barrel. The syringe tip includes a syringe tip lumen extending from a distal end of the syringe tip into a barrel chamber of the barrel. The plunger includes an integral plunger shaft and a piston fitted onto a distal end of the plunger shaft. The plunger shaft includes a longitudinal plunger shaft passage extending from a distal end of the plunger shaft. The piston includes a piston throughbore. The needle includes a needle shaft and a needle hub covering a proximal portion of the needle shaft. The needle shaft includes a needle tip at a distal portion of the needle shaft. The needle shaft also includes a needle shaft lumen extending from an opening in the needle tip to a proximal end of the needle shaft. The needle hub includes a needle hub lumen extending from a proximal end of the needle shaft lumen to a proximal end of the needle hub. The needle shaft lumen, the needle hub lumen, the syringe tip lumen, any intervening portions of the barrel chamber between the syringe tip and the piston, the piston throughbore, and the plunger shaft passage are aligned to form an access guidewire passage configured to slidably receive an access guidewire therein.

[0010] In some embodiments, the introducer assembly further includes an access guidewire slidably disposed within the access guidewire passageway, the distal end of the access guidewire being proximal to the needle tip in the ready-to-deploy state of the introducer assembly.

[0011] In some embodiments, the access guidewire includes a "J" shaped guidewire tip at a distal portion of the access guidewire. In a ready-to-deploy state of the introducer assembly, the guidewire tip assumes a straightened state. In a deployed state of the introducer assembly, the guidewire tip assumes a curved state when the guidewire tip is advanced beyond the needle tip.

[0012] In some embodiments, the access guidewire includes a bare wire portion and a wrapped wire portion proximal to the bare wire portion, the bare wire portion extending distally from at least the piston throughbore to a distal end of the access guidewire in a ready-to-deploy state of the introducer assembly.

[0013] In some embodiments, the piston includes at least a leading ring, the leading ring including a gasket about an inner circumference of the piston throughbore, the gasket configured to form a seal around the access guidewire.

[0014] In some embodiments, the gasket includes one or more integral "O" rings. In some embodiments, the plunger shaft includes orthogonal struts that meet along their longitudinal edges at a central axis of the plunger shaft.

[0015] In some embodiments, the plunger shaft passage extends from the distal end of the plunger shaft no more than about ½ the length of the plunger shaft. In some embodiments, the plunger shaft passage extends from the distal end of the plunger shaft no more than about ⅓ of the length of the plunger shaft.

[0016] In some embodiments, the plunger shaft passage extends from the distal end of the plunger shaft no more than about ¼ of the length of the plunger shaft. In some embodiments, the syringe hub further includes a threaded collar extending from the distal portion of the barrel around the syringe tip, the threaded collar including internal threads configured to threadably mate with a needle hub flange of the needle hub.

[0017] Also disclosed herein, in some embodiments, is a syringe including a syringe hub, a barrel, and a plunger disposed within the barrel. The barrel includes a syringe tip extending from a distal portion of the barrel. The syringe tip includes a syringe tip lumen extending from a distal end of the syringe tip into a barrel chamber of the barrel. The plunger includes an integral plunger shaft and a piston fitted onto a distal end of the plunger shaft. The plunger shaft includes a longitudinal plunger shaft passage extending from a distal end of the plunger shaft. The piston includes a piston throughbore. The syringe tip lumen, any intervening portions of the barrel chamber between the syringe tip and the piston, the piston throughbore, and the plunger shaft passage are aligned to form an access guidewire passage. The access guidewire passage is configured to slidably receive an access guidewire therein.

[0018] In some embodiments, the piston includes at least a leading ring, the leading ring including a gasket about an inner circumference of the piston throughbore, the gasket configured to form a seal around the access guidewire.

[0019] In some embodiments, the gasket includes one or more integral "O" rings. In some embodiments, the plunger shaft includes orthogonal struts that meet along their longitudinal edges at a central axis of the plunger shaft.

[0020] In some embodiments, the plunger shaft passage extends from the distal end of the plunger shaft no more than about ½ the length of the plunger shaft. In some embodiments, the plunger shaft passage extends from the distal end of the plunger shaft no more than about ⅓ of the length of the plunger shaft.

[0021] In some embodiments, the plunger shaft passage extends from the distal end of the plunger shaft no more than about ¼ of the length of the plunger shaft. In some embodiments, the syringe hub further includes a threaded collar extending from the distal portion of the barrel around the syringe tip, the threaded collar including internal threads configured to threadably mate with a needle hub flange of the needle hub.

[0022] Also disclosed herein is a plunger for a syringe. The plunger, in some embodiments, includes an integral plunger shaft and a piston fitted onto a distal end of the plunger shaft. The plunger shaft includes a longitudinal plunger shaft passageway extending from the distal end of the plunger shaft. The piston includes a piston throughbore. The piston throughbore and the plunger shaft passageway are aligned to form an access guidewire passageway. The access guidewire passageway is configured to slidably receive an access guidewire therein.

[0023] In some embodiments, the piston includes at least a leading ring, the leading ring including a gasket about an inner circumference of the piston throughbore, the gasket configured to form a seal around the access guidewire.

[0024] In some embodiments, the gasket includes one or more integral "O" rings. In some embodiments, the plunger shaft includes orthogonal struts that meet along their longitudinal edges at a central axis of the plunger shaft.

[0025] In some embodiments, the plunger shaft passage extends from the distal end of the plunger shaft no more than about ½ the length of the plunger shaft. In some embodiments, the plunger shaft passage extends from the distal end of the plunger shaft no more than about ⅓ of the length of the plunger shaft.

[0026] In some embodiments, the plunger shaft passage extends from the distal end of the plunger shaft no more than about ¼ of the length of the plunger shaft. Also disclosed herein is a method for securing vascular access. The method, in some embodiments, includes the steps of obtaining an introducer assembly, establishing a needle path, and advancing an access guidewire. The obtaining an introducer assembly includes obtaining an introducer assembly. The introducer assembly includes a syringe, a needle fluidly connected to the syringe, and an access guidewire slidably disposed within an access guidewire passage of the introducer assembly. The syringe includes a barrel and a plunger disposed within the barrel. The needle includes a needle shaft and a needle hub covering a proximal portion of the needle shaft. The access guidewire passage is formed from at least a needle lumen of the needle, a piston through-hole of a piston fitted onto a distal end of a plunger shaft of the plunger, and a plunger shaft passage extending from a distal end of the plunger shaft. The establishing a needle path includes establishing a needle path from an area of ​​the patient's skin to a blood vessel lumen with the needle. The advancing an access guidewire includes advancing an access guidewire into the blood vessel lumen for securing vascular access.

[0027] In some embodiments, the method further includes an introducer assembly adjusting step, which includes adjusting the introducer assembly such that the introducer assembly is in its ready-to-deploy state, where a distal end of the access guidewire is positioned proximal to a needle tip of a needle for performing an access guidewire advancement step immediately following establishment of the needle path in the needle path establishing step.

[0028] In some embodiments, the access guidewire advancement step allows the "J" shaped guidewire tip of the distal portion of the access guidewire to transition from a straight state within the access guidewire passage to a curved state within the blood vessel lumen.

[0029] In some embodiments, the method further includes a blood aspirating step, which includes aspirating blood with a syringe to confirm establishment of the needle path in the needle path establishing step. The piston throughbore includes a gasket on an inner periphery of the piston throughbore, the gasket configured to form a seal around the bare wire portion of the access guidewire to maintain a vacuum during the blood aspirating step.

[0030] In some embodiments, the method further comprises the step of withdrawing the needle, the step of withdrawing the needle from the patient, leaving the access guidewire within the vessel lumen.

[0031] 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 following description and accompanying drawings, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0032] [Figure 1] 1 illustrates a side view of an introducer assembly in a ready-to-deploy state, according to some embodiments. [Diagram 2] 1 illustrates a side view of an introducer assembly in a deployed state, according to some embodiments. [Diagram 3] 1 illustrates a top view of an introducer assembly in a deployed state, according to some embodiments. [Figure 4] 1 illustrates an exploded view of an introducer assembly, according to some embodiments. [Diagram 5] FIG. 13 shows a side view of a plunger of a syringe of the introducer assembly, according to some embodiments. [Figure 6]1 illustrates a longitudinal cross section of a plunger according to some embodiments. [Figure 7] 13 shows a cross section of a distal portion of a plunger according to some embodiments. [Figure 8] 13 shows a cross section of a proximal portion of a plunger according to some embodiments. [Figure 9] 13A shows a detailed view of a distal portion of the plunger, including a longitudinal plunger shaft passageway of the plunger shaft of the plunger and a piston throughbore of the piston of the plunger, according to some embodiments. [Figure 10] 13A shows a detailed view of a distal portion of the plunger, including a longitudinal plunger shaft passageway and an access guidewire disposed within the piston throughbore, according to some embodiments. [Figure 11] 1 shows a detailed longitudinal cross-sectional view of an introducer assembly having an access guidewire positioned within the access guidewire passage of the introducer assembly, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Before some specific embodiments are disclosed 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 can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0034] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain embodiments, and that the 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 sequential or numerical limitations. For example, the "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 used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "the" also include plural references unless the context clearly dictates otherwise.

[0035] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a catheter includes a portion of the catheter that is intended to be near a clinician when the catheter is used with a patient. Similarly, for example, a "proximal length" of a catheter includes a length of the catheter that is intended to be near a clinician when the catheter is used with a patient. For example, a "proximal end" of a catheter includes an end of the catheter that is intended to be near a clinician when the catheter is used with a patient. Although a proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, a proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise indicated by context, a proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or terminal length of a catheter.

[0036] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter includes a portion of a catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of a catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, a "distal end" of a catheter includes an end of a catheter that is intended to be near or within a patient when the catheter is used with a patient. Although a distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0037] 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 mentioned above, a guidewire is typically placed into a blood vessel using an introducer assembly prior to inserting a central venous catheter ("CVC") or the like over the guidewire into the blood vessel. The introducer assembly typically includes a needle connected to a syringe. Once the blood vessel is accessed with the needle, the needle must be disconnected from the syringe so that a guidewire can be inserted into the needle through the needle hub of the needle and subsequently into the blood vessel. Disconnecting the needle from the syringe and inserting the guidewire into the needle carries the risk of puncturing the back wall of the blood vessel due to excessive handling of the needle, losing access to the blood vessel, or both. What is needed is an introducer assembly that does not require disconnecting the needle from the syringe to insert the guidewire into the blood vessel.

[0038] Disclosed herein is an introducer assembly and method that does not require disconnecting a needle from a syringe as in typical introducer assemblies to insert a guidewire into a blood vessel. Such introducer assemblies and methods are advantageous in that they do not have the same risk of puncturing the rear wall of the vessel or losing access to the vessel due to excessive handling. In one example, an introducer assembly is disclosed that includes, in some embodiments, a syringe and a needle fluidly connected to the syringe. The syringe includes a barrel and a plunger disposed within the barrel. The plunger includes an integral plunger shaft and a piston fitted onto a distal end of the plunger shaft. The plunger shaft includes a longitudinal plunger shaft passageway extending from a distal end of the plunger shaft. The piston includes a piston throughbore that, together with the plunger shaft passageway, forms a portion of the access guidewire passageway of the introducer assembly. The needle includes a needle shaft and a needle hub that covers a proximal portion of the needle shaft. In another example, a method is disclosed for obtaining vascular access using the introducer assembly described above. Again, these and other features will become more apparent upon consideration of the accompanying drawings and the following description, which set forth certain embodiments in more detail.

[0039] Introducer Assembly 1-4 and 11 show various views of an introducer assembly 100 according to some embodiments.

[0040] As shown, the introducer assembly 100 includes at least a syringe 102 and a needle 104 fluidly connected to the syringe 102. In addition, the introducer assembly 100 may include an access guidewire 106 slidably disposed within an access guidewire passage 108 of the introducer assembly 100. Such an introducer assembly having the access guidewire 106 pre-loaded within the access guidewire passage 108 is advantageous in obviating any difficulties associated with loading the access guidewire 106 within the introducer assembly 100 as well as reducing procedure time commensurate with loading the access guidewire 106 within the introducer assembly 100. Notwithstanding the aforementioned advantages, the introducer assembly 100 need not include the access guidewire 106 pre-loaded within the access guidewire passage 108 in some embodiments.

[0041] The syringe 102 includes a syringe hub 110 , a barrel 112 , and a plunger 114 disposed within the barrel 112 . The syringe hub 110 includes a syringe tip 116 extending from a distal portion (e.g., the distal end) of the barrel 112. Additionally, the syringe hub 110 can include a threaded collar 118 extending from the distal portion (e.g., the distal end) of the barrel 112 and around the syringe tip 116.

[0042] The syringe tip 116 is configured to be inserted into a needle hub 154, described below, to fluidly connect the syringe 102 and the needle 104. In practice, the syringe tip 116 may have a luer taper (e.g., a 6% taper) configured for insertion into the needle hub 154, which is complementarily configured, as described below.

[0043] The syringe tip 116 includes a syringe tip lumen 120 that extends from a distal end of the syringe tip 116 into a barrel chamber 126 of the barrel 112, described below. Notably, the syringe tip lumen 120 and the barrel chamber 126, individually and collectively, form a portion of the access guidewire passageway 108 of the introducer assembly 100. Considered collectively, the syringe tip lumen 120 and the barrel chamber 126 form a hub-barrel portion of the access guidewire passageway 108 of the introducer assembly 100.

[0044] The threaded collar 118 includes internal threads 122 configured to threadably mate with a needle hub flange 160 of the needle hub 154, described below. The threaded collar 118 of the syringe hub 110, when present, advantageously provides a so-called luer lock type connection with the needle hub flange 160 of the needle hub 154 to provide greater security against inadvertent disconnection between the syringe hub 110 and the needle hub 154 than would otherwise be provided by a luer slip type connection.

[0045] The barrel 112 includes a barrel wall 124, a barrel chamber 126 defined by the barrel wall 124, and a barrel flange 128, barrel collar, etc. extending outwardly from a proximal portion (e.g., a proximal end) of the barrel 112 or barrel wall 124 configured to actuate the syringe 102.

[0046] The barrel chamber 126 is configured to receive the plunger 114 when inserted therein. In fact, the barrel chamber 126 extends from the distal end of the barrel 112, which is the closed end of the barrel 112 (excluding the syringe tip 116), to the proximal end of the barrel 112, which is the open end of the barrel 112 into which the plunger 114 may be inserted. Again, the syringe tip lumen 120 and the barrel chamber 126 (specifically, any intervening portions of the barrel chamber 126 between the syringe tip 116 and the piston 132, described below) individually and collectively form a portion of the access guidewire passage 108 of the introducer assembly 100, specifically the hub-barrel portion of the access guidewire passage 108. That said, any remaining portion of the barrel chamber 126 between the piston 132 and the barrel flange 128, barrel collar, etc. may also be considered part of the access guidewire passage 108 of the introducer assembly 100, albeit as a less constrained portion of the access guidewire passage 108 as shown in Figures 1-4 and 11.

[0047] 5-10 show various views of the plunger 114 of the syringe 102 of the introducer assembly 100 according to some embodiments. As shown, the plunger 114 includes an integral plunger shaft 130, a piston 132 fitted onto a distal portion (e.g., the distal end) of the plunger shaft 130, and a plunger flange 134, plunger collar, etc. extending outward from a proximal portion (e.g., the proximal end) of the plunger 114 that is configured to actuate the syringe 102.

[0048] The plunger shaft 130 includes orthogonal struts 136 that meet along their longitudinal edges at the central axis of the plunger shaft 130, except for a distal portion of the plunger shaft 130 that includes a longitudinal plunger shaft passageway 138 extending from the distal end of the plunger shaft 130. The plunger shaft passageway 138 extends from the distal end of the plunger shaft 130 about ½ or less of the length of the plunger shaft 130, including from the distal end of the plunger shaft 130 about ⅓ or less of the length of the plunger shaft 130, for example about ¼ or less of the length of the plunger shaft 130. Notably, the plunger shaft passageway 138 is configured individually and collectively with a piston throughbore 140, described below, to form a portion of the access guidewire passageway 108 of the introducer assembly 100. Collectively, the plunger shaft passageway 138 and the piston throughbore 140 form the plunger portion of the access guidewire passageway 108 of the introducer assembly 100 .

[0049] Although not shown, the plunger shaft 130 may alternatively be configured as an open cylinder, such as the barrel 112, or a closed cylinder, such as a rod, with the proximal end of such a plunger shaft being open or closed, respectively. If the alternative plunger shaft is configured as an open cylinder, the distal end of the plunger shaft includes a plunger shaft through-hole (otherwise closed) that is configured to pass the access guidewire 106 through the plunger shaft through-hole, into the internal cavity or chamber of the plunger shaft defined by the plunger shaft wall, and out the proximal end of the alternative plunger shaft. If the alternative plunger shaft is configured as a closed cylinder, the alternative plunger shaft may be either hollow or solid. For an alternative plunger shaft configured as a hollow closed cylinder, the distal end of the alternative plunger shaft includes a distal plunger shaft through-hole (otherwise closed). Similarly, the proximal end of the alternative plunger shaft includes a proximal plunger shaft through-hole (otherwise closed). Such an alternative plunger shaft is configured to pass the access guidewire 106 through the distal plunger shaft through-hole, into the internal cavity or chamber of the alternative plunger shaft defined by the plunger shaft wall, and out of the distal plunger shaft through-hole. In the case of an alternative plunger shaft configured as a solid closed cylinder, the alternative plunger shaft includes both the distal and proximal plunger shaft through-holes described above. However, the distal and proximal plunger shaft through-holes of an alternative plunger shaft configured as a solid closed cylinder are connected by a plunger shaft lumen through the alternative plunger shaft, rather than an internal chamber or cavity of an alternative plunger shaft configured as a hollow closed cylinder. Nevertheless, as described above, the alternative plunger shaft remains a one-piece plunger shaft having a plunger shaft passageway.

[0050] The piston 132, which may be a one-piece elastomeric piston, includes a piston through-bore 140, one or more rings 142 each configured to form one or more seals with the barrel wall 124, and one or more gaskets 144 each configured to form one or more seals around the access guidewire 106.

[0051] The piston throughbore 140 is configured, individually and collectively with the plunger shaft passage 138, to form a portion of the access guidewire passage 108 of the introducer assembly 100. Considered collectively, the piston throughbore 140 and the plunger shaft passage 138 form a plunger portion of the access guidewire passage 108 of the introducer assembly 100. Notably, the plunger portion and the hub-barrel portion of the access guidewire passage 108 collectively form a syringe portion of the access guidewire passage 108 of the introducer assembly 100. The syringe portion of the access guidewire passage 108, along with a needle portion of the access guidewire passage 108, described below, collectively form the access guidewire passage 108 of the introducer assembly 100.

[0052] The one or more rings 142 include at least one leading ring 146 configured to form a seal with the barrel wall 124. The one or more rings 142 may also include a trailing ring 148, as illustrated in FIGS. 5-10. Like the leading ring 146, the trailing ring 148 is configured to form a seal with the barrel wall 124. In fact, the trailing ring 148, if present, provides a backup seal with the barrel wall 124. Together, the leading ring 146 and the trailing ring 148 enable the syringe 102 to consistently aspirate liquid, such as blood, when the plunger 114 is withdrawn from the barrel 112 by ensuring that the seal between the piston 132 and the barrel wall 124 (e.g., the seal provided by the leading ring 146, the trailing ring 148, or both the leading ring 146 and the trailing ring 148) remains intact while the syringe 102 is actuated.

[0053] One or more gaskets 144 can be disposed within the piston throughbore 140 to cover a distal end of the piston 132 around the piston throughbore 140, to cover a middle portion of the piston 132 around the piston throughbore 140, or a combination thereof, to form a seal around the access guidewire 106 (e.g., a bare wire portion 166 of the access guidewire 106, described below). The one or more gaskets 144 can include one or more integral "O" rings, which are molded into the piston 132 at the time the piston 132 is molded. In the example shown in FIG. 9, one gasket is configured as an integral "O" ring disposed within the piston throughbore 140. In effect, the leading ring 146 of the piston 132 includes a gasket on the inner circumference of the piston throughbore 140 to form a seal around the access guidewire 106.

[0054] 1-4 show various views of a needle 104 as part of an introducer assembly 100, according to some embodiments. As shown, the needle 104 includes a needle shaft 150 , a needle tip 152 within a distal portion of the needle shaft 150 , and a needle hub 154 covering a proximal portion of the needle shaft 150 .

[0055] The needle shaft 150 includes a needle shaft lumen 156 that extends from an opening in the needle tip 152 to the proximal end of the needle shaft 150. Notably, the needle shaft lumen 156 and a needle hub lumen 162, described below, individually and collectively form a portion of the access guidewire passage 108 of the introducer assembly 100. Considered collectively, the needle shaft lumen 156 and the needle hub lumen 162 form the needle portion of the access guidewire passage 108 of the introducer assembly 100.

[0056] The needle hub 154 is configured to receive the syringe tip 116 therein for fluidly connecting the needle 104 and the syringe 102. In fact, the bore 158 of the needle hub 154 can have a luer taper (e.g., a 6% taper) configured to receive the syringe tip 116 therein, which is complementarily configured as described above. In addition, the needle hub 154 can include a needle hub flange 160 configured to threadably mate with the internal threads 122 of the threaded collar 118 of the syringe hub 110. The needle hub flange 160 of the needle hub 154, if present, advantageously provides a so-called luer lock type connection with the internal threads 122 of the threaded collar 118 of the syringe hub 110 to provide greater security against inadvertent disconnection between the needle hub 154 and the syringe hub 110 than would otherwise be provided by a luer slip type connection.

[0057] The needle hub 154 includes a needle hub lumen 162 that extends from the distal end of the needle hub 154 to the proximal end of the needle hub 154. However, with the needle hub 154 covering the proximal portion of the needle shaft 150, the needle hub lumen 162 actually extends from the proximal end of the needle shaft lumen 156 to the proximal end of the needle hub 154. Again, the needle shaft lumen 156 and the needle hub lumen 162 individually and collectively form a portion of the access guidewire passage 108 of the introducer assembly 100, specifically the needle portion of the access guidewire passage 108.

[0058] To summarize the above description of the access guidewire passage 108, the access guidewire passage 108 of the introducer assembly 100 includes both the syringe and needle portions of the access guidewire passage 108 when the syringe 102 and needle 104 are fluidly connected to one another. The syringe portion of the access guidewire passage 108 includes both the hub-barrel and plunger portions of the access guidewire passage 108 when the plunger 114 is disposed within the barrel 112, with the syringe tip lumen 120 and barrel chamber 126 forming the hub-barrel portion of the access guidewire passage 108 and the piston throughbore 140 and plunger shaft passage 138 forming the plunger portion of the access guidewire passage 108. The needle portion of the access guidewire passage 108 includes both the needle shaft lumen 156 and the needle hub lumen 162. Thus, the needle shaft lumen 156, the needle hub lumen 162, the syringe tip lumen 120, any intervening portions of the barrel chamber 126 between the syringe tip 116 and the piston 132, the piston throughbore 140, and the plunger shaft passageway 138 form an access guidewire passageway 108 of the introducer assembly 100 when the introducer assembly 100 is aligned in its fluidly connected, ready-to-deploy state, for example. The access guidewire passageway 108 is configured to slidably receive the access guidewire 106 therein.

[0059] 1-4 show various views of an access guidewire 106 as part of an introducer assembly 100, according to some embodiments. As shown, the access guidewire 106 is slidably disposed within the access guidewire passage 108 of the introducer assembly 100 in an assembled state of the introducer assembly 100, such as in the ready-to-deploy state of the introducer assembly 100. Indeed, in the ready-to-deploy state of the introducer assembly 100 shown in FIG. 1, the distal end of the access guidewire 106 is just proximal to the needle tip 152 such that, once a needle pathway to the blood vessel has been established, the access guidewire 106 may be immediately advanced one centimeter or less into the blood vessel lumen to obtain vascular access. The remainder of the access guidewire 106 in the ready-to-deploy state of the introducer assembly 100 extends proximally along the access guidewire passage 108 and exits through the barrel flange 128, barrel collar, etc.

[0060] The access guidewire 106 may include a "J" shaped guidewire tip 164 at a distal portion of the access guidewire 106. The guidewire tip 164 is configured to assume a straightened state in a ready-to-deploy state of the introducer assembly 100, where again the distal end of the access guidewire 106 is just proximal to the needle tip 152. However, the guidewire tip 164 is configured to assume a curved state or "J" shape when the guidewire tip 164 is advanced beyond the needle tip 152 in a deployed state of the introducer assembly 100, such as when establishing a needle pathway to a blood vessel and then advancing the access guidewire 106 into a blood vessel lumen to secure vascular access.

[0061] The access guidewire 106 may also include a bare wire portion 166 and a wrapped wire portion 168 distal to the bare wire portion 166, proximal to the bare wire portion 166, or both. The bare wire portion 166, if present, extends distally from at least proximal to the piston throughbore 140 to a more distal portion of the access guidewire 106 in a ready-to-deploy state of the introducer assembly 100. Indeed, the bare wire portion 166 also extends distally from at least proximal to the piston throughbore 140 to a more distal portion of the access guidewire 106 in the previously described deployed state of the introducer assembly 100 in which the access guidewire 106 is advanced into the vascular lumen. Such bare wire portion of the access guidewire 106 may enable one or more gaskets 144 of the piston 132 to consistently form one or more seals around the access guidewire 106. That said, the wound wire portion 168, which provides structural integrity to the access guidewire 106, may extend through the piston throughbore 140 in one or more operative states of the introducer assembly 100, or in some embodiments may extend throughout the entirety of the access guidewire 106. In such embodiments, the windings of the wound wire portion 168 of the access guidewire 106 are advantageously as tight as possible to minimize any air leakage gaps between adjacent windings that may prevent the formation of one or more seals around the access guidewire 106 with one or more gaskets 144. Although air leakage gaps for any portion of the wound wire portion 168 of the access guidewire 106 configured to extend through the piston throughbore 140 can be minimized using a small diameter wound wire around a core wire of the access guidewire 106, the aforementioned wound wire portion 168 of the access guidewire 106 may alternatively be a flat-wound or ground-wound portion of the access guidewire 106.

[0062] Although not shown, when the introducer assembly 100 is in a ready-to-deploy state, the access guidewire 106 exiting through the barrel flange 128, barrel collar, etc. may be placed within a sterile barrier, such as a sterile bag, to maintain the sterility of the access guidewire 106 prior to deployment of the access guidewire 106.

[0063] method Methods of the introducer assembly 100 include methods of obtaining vascular access using the introducer assembly 100. For example, the method of obtaining vascular access includes one or more steps selected from an introducer assembly obtaining step, an introducer assembly adjusting step, a needle path establishing step, a blood aspiration step, an access guidewire advancing step, and a needle withdrawal step.

[0064] The introducer assembly obtaining step includes obtaining an introducer assembly 100. As described above, the introducer assembly 100 includes a syringe 102, a needle 104 fluidly connected to the syringe 102, and an access guidewire 106 slidably disposed within an access guidewire passage 108 of the introducer assembly 100 at least in a ready-to-deploy state of the introducer assembly 100. The syringe 102 includes a barrel 112 and a plunger 114 disposed within the barrel 112. The needle 104 includes a needle shaft 150 and a needle hub 154 covering a proximal portion of the needle shaft 150. The access guidewire passage 108 is formed at least from a needle lumen of the needle 104, a piston through-hole 140 of a piston 132 fitted onto a distal end of a plunger shaft 130 of the plunger 114, and a plunger shaft passage 138 extending from the distal end of the plunger shaft 130.

[0065] The introducer assembly adjustment step includes adjusting the introducer assembly 100 so that the introducer assembly 100 is in a ready-to-deploy state if the introducer assembly 100 is not already in a ready-to-deploy state in which the distal end of the access guidewire 106 is immediately proximal to the needle tip 152 of the needle 104 for the access guidewire advancement step to occur immediately after needle path establishment in the needle path establishment step.

[0066] The needle pathway establishment step involves establishing a needle pathway from an area of ​​the patient's skin to the blood vessel lumen with the needle 104. Of note, blood reflux is often observed immediately upon establishing the needle pathway due to the annular space between the inner diameter of the needle shaft 150 and the outer diameter of the access guidewire 106 (specifically, the bare wire portion 166 of the access guidewire 106 or the corresponding wire winding portion of the access guidewire 106 that is configured with minimal or no air leakage gaps between adjacent windings).

[0067] The blood drawing step includes drawing blood with the syringe 102 to confirm establishment of the needle path in the needle path establishing step. As mentioned above, the piston throughbore 140 may include a gasket on an inner periphery of the piston throughbore 140. The gasket is configured to form a seal around at least the bare wire portion 166 of the access guidewire 106 to maintain a vacuum during the blood drawing step. Notably, blood is drawn into the introducer assembly 100 along with the access guidewire 106.

[0068] The access guidewire advancement step involves advancing the access guidewire 106 into the vessel lumen to gain vascular access. The access guidewire advancement step allows the "J" shaped guidewire tip 164 of the distal portion of the access guidewire 106 to transition from a straightened state within the access guidewire passage 108 to a curved state within the vessel lumen.

[0069] The needle withdrawal step involves withdrawing the needle 104 from the patient, leaving the access guidewire 106 within the vessel lumen. Although some specific embodiments are disclosed herein and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations or modifications may become apparent to those skilled in the art, and the broader aspects of the invention encompass these adaptations or modifications as well. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. An introducer assembly, comprising a syringe, comprising a barrel, and a plunger disposed within the barrel, the plunger comprising a one-piece plunger shaft including a longitudinal plunger shaft passage extending from a distal end of the plunger shaft, and a piston fitted onto the distal end of the plunger shaft, the piston including a piston through-hole that forms a part of an access guide wire passage of the introducer assembly together with the plunger shaft passage, and a plunger including the above, and a syringe including the above, and a needle fluidly connected to the syringe, the needle comprising a needle shaft, and a needle hub covering a proximal portion of the needle shaft, and a needle including the above, the introducer assembly comprising the above.

2. The introducer assembly according to claim 1, further comprising an access guide wire slidably disposed within the access guide wire passage, and a needle lumen of the needle forming another part of the access guide wire passage.

3. The introducer assembly according to claim 2, wherein the access guide wire includes a "J"-shaped guide wire tip at a distal portion of the access guide wire, and a distal end of the access guide wire is disposed proximal to a needle tip at a distal portion of the needle shaft in the ready-for-deployment state of the introducer assembly such that the guide wire tip is straight in the ready-for-deployment state of the introducer assembly.

4. The introducer assembly according to claim 2 or 3, wherein the access guide wire includes a bare wire portion and a coiled wire portion proximal to the bare wire portion, and the bare wire portion extends distally at least from the piston through-hole in the deployed state of the introducer assembly.

5. The introducer assembly according to claim 2 or 3, wherein the piston includes at least a leading ring, and the leading ring includes a gasket configured to form a seal around the access guide wire on an inner circumference of the piston through-hole.

6. An introducer assembly, comprising a syringe, comprising a barrel, and A syringe hub including a syringe tip extending from a distal portion of the barrel, the syringe tip including a syringe tip lumen extending from a distal end of the syringe tip into the barrel chamber of the barrel, the syringe hub; A plunger disposed within the barrel, the plunger; An integral plunger shaft including a longitudinal plunger shaft passage extending from a distal end of the plunger shaft, the plunger shaft; A piston fitted onto the distal end of the plunger shaft, the piston including a piston through hole, the piston; The plunger including; The syringe including; A needle fluidly connected to the syringe, the needle; A needle shaft including a needle tip at a distal portion of the needle shaft, the needle shaft including a needle shaft lumen extending from an opening of the needle tip to a proximal end of the needle shaft, the needle shaft; A needle hub covering a proximal portion of the needle shaft, the needle hub including a needle hub lumen extending from a proximal end of the needle shaft lumen to a proximal end of the needle hub, the needle hub; The needle including; and comprising The needle shaft lumen, the needle hub lumen, the syringe tip lumen, any intervening portion of the barrel chamber between the syringe tip and the piston, the piston through hole, and the plunger shaft passage are aligned to form an access guide wire passage, the access guide wire passage being configured to slidably receive an access guide wire therein, an introducer assembly. Claim 7 The introducer assembly according to claim 6, further comprising an access guide wire slidably disposed within the access guide wire passage, a distal end of the access guide wire being proximal to the needle tip in a state where deployment of the introducer assembly is ready. Claim 8 The access guide wire includes a "J"-shaped guide wire tip at a distal portion of the access guide wire, and in the state where the preparation for deployment of the introducer assembly is completed, the guide wire tip is in a straight state, and in the deployed state of the introducer assembly, when the guide wire tip is advanced beyond the needle tip, it takes a curved state. The introducer assembly according to claim 7.

9. The access guide wire includes a bare wire portion and a wound wire portion proximal to the bare wire portion. The bare wire portion extends at least from the piston through-hole to the distal end of the access guide wire in the state where the preparation for deployment of the introducer assembly is completed. The introducer assembly according to claim 7 or 8.

10. The piston includes at least a leading ring, and the leading ring includes a gasket configured to form a seal around the access guide wire on the inner circumference of the piston through-hole. The introducer assembly according to any one of claims 6 to 8.

11. The gasket includes one or more integrated "O" rings. The introducer assembly according to claim 10.

12. The plunger shaft includes an orthogonal support, and the orthogonal support intersects along the longitudinal edge of the orthogonal support on the central axis of the plunger shaft. The introducer assembly according to any one of claims 6 to 8.

13. The plunger shaft passage extends only about 1 / 2 or less of the length of the plunger shaft from the distal end of the plunger shaft. The introducer assembly according to any one of claims 6 to 8.

14. The plunger shaft passage extends only about 1 / 3 or less of the length of the plunger shaft from the distal end of the plunger shaft. The introducer assembly according to any one of claims 6 to 8.

15. The plunger shaft passage extends only about 1 / 4 or less of the length of the plunger shaft from the distal end of the plunger shaft. The introducer assembly according to any one of claims 6 to 8.

16. The syringe hub further includes a threaded collar extending from the distal portion of the barrel around the syringe tip, the threaded collar including an internal thread configured to threadedly engage a needle hub flange of the needle hub, the introducer assembly according to any one of claims 6-8.

17. A syringe, comprising a barrel, and a syringe hub including a syringe tip extending from a distal portion of the barrel, the syringe tip including a syringe tip lumen extending from a distal end of the syringe tip into the barrel chamber of the barrel, a plunger disposed within the barrel, the plunger comprising an integral plunger shaft including a longitudinal plunger shaft passage extending from a distal end of the plunger shaft, a piston fitted onto the distal end of the plunger shaft, the piston including a piston through-hole, a plunger, comprising, the syringe tip lumen, any intervening portion of the barrel chamber between the syringe tip and the piston, the piston through-hole, and the plunger shaft passage are aligned to form an access guide wire passage, the access guide wire passage being configured to slidably receive an access guide wire therein, the syringe.

18. The piston includes at least a leading ring, the leading ring including a gasket configured to form a seal around the access guide wire on an inner circumference of the piston through-hole, the syringe according to claim 17.

19. The gasket includes one or more integrated "O" rings, the syringe according to claim 18.

20. The plunger shaft includes an orthogonal strut, the orthogonal strut intersecting along a longitudinal edge of the orthogonal strut at a central axis of the plunger shaft, the syringe according to any one of claims 17-19.

21. The plunger shaft passage extends from the distal end of the plunger shaft by no more than about 1 / 2 of the length of the plunger shaft, the syringe according to any one of claims 17-19.

22. The plunger shaft passage extends from the distal end of the plunger shaft by not more than about one-third of the length of the plunger shaft, the syringe according to any one of claims 17 to 19.

23. The plunger shaft passage extends from the distal end of the plunger shaft by not more than about one-fourth of the length of the plunger shaft, the syringe according to any one of claims 17 to 19.

24. The syringe hub further includes a threaded collar extending from the distal portion of the barrel around the syringe tip, the threaded collar including an internal thread configured to engage a needle hub flange of a needle hub, the syringe according to any one of claims 17 to 19.

25. A plunger for a syringe, An integral plunger shaft including a longitudinal plunger shaft passage extending from a distal end of the plunger shaft, a plunger shaft, and A piston fitted on the distal end of the plunger shaft, the piston including a piston through hole, a piston, and The piston through hole and the plunger shaft passage are aligned to form an access guide wire passage, the access guide wire passage being configured to slidably receive an access guide wire therein, a plunger.

26. The piston includes at least a leading ring, the leading ring including a gasket configured to form a seal around the access guide wire on an inner circumference of the piston through hole, the plunger according to claim 25.

27. The gasket includes one or more integrated "O" rings, the plunger according to claim 26.

28. The plunger shaft includes an orthogonal support, the orthogonal support intersecting along a longitudinal edge of the orthogonal support at a central axis of the plunger shaft, the plunger according to any one of claims 25 to 27.

29. The plunger shaft passage extends from the distal end of the plunger shaft by not more than about one-half of the length of the plunger shaft, the plunger according to any one of claims 25 to 27.

30. The plunger shaft passage extends from the distal end of the plunger shaft by no more than about one-third of the length of the plunger shaft, the plunger according to any one of claims 25 to 27.

31. The plunger shaft passage extends from the distal end of the plunger shaft by no more than about one-fourth of the length of the plunger shaft, the plunger according to any one of claims 25 to 27.

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