Introducer adapter and introducer assembly

Abstract

An introducer adapter and introducer assembly are disclosed. In one example, the introducer assembly may include a syringe (106), a needle (104), and an introducer adapter (102) fluidly connected between the syringe and the needle. The introducer adapter may include a main conduit (112), a secondary conduit (114) extending from a side of the main conduit, and a valve (128) including an elastomeric septum (136) that seals a proximal portion of the main conduit or secondary conduit. Optionally, an access guidewire (110) is loaded into the introducer adapter and sealed inside the introducer adapter by the valve.

Description

[Technical field]

[0001] The present disclosure relates to an introducer adapter and an introducer assembly. [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. When using the introducer assembly to access a blood vessel, the needle must be disconnected from the syringe so that the guidewire can be inserted through the needle hub of the needle and subsequently placed into the blood vessel. Both disconnecting the needle from the syringe and inserting the guidewire into the needle hub carry the risk of puncturing the back wall of the blood vessel, losing access to the blood vessel, or both due to excessive manipulation of the needle. What is needed is an adapter that does not require disconnecting the needle from the syringe to place a guidewire into the blood vessel.

[0003] SUMMARY OF THE DISCLOSURE Disclosed herein are introducer adapters, introducer assemblies, and methods that address the above. Summary of the Invention

[0004] In some embodiments, disclosed herein is an introducer assembly including a syringe, a needle, and an introducer adapter that fluidly couples the syringe and needle together. The introducer adapter includes a main conduit, a secondary conduit extending from a side of the main conduit, and a valve including an elastomeric septum that seals a proximal portion of the main conduit or the secondary conduit. Optionally, an access guidewire is loaded into the introducer adapter and sealed inside the introducer adapter by the valve.

[0005] In some embodiments, the valve is a non-elastomeric cylindrical or conical insert, the insert comprising a septum sealing an opening of the insert, the valve being disposed within a proximal portion of the main or secondary conduit.

[0006] In some embodiments, the valve is an elastomeric grommet with a septum integral therewith that seals a cavity in the grommet. The valve is disposed within a proximal portion of the main or secondary conduit.

[0007] In some embodiments, the septum is recessed in the proximal portion of the main or secondary conduit. In some embodiments, the valve seals a proximal portion of the secondary conduit.

[0008] In some embodiments, the valve seals a proximal portion of the main conduit. In some embodiments, the introducer adaptor hole in the proximal portion of the main conduit includes a luer taper that is complementary to a luer taper of the syringe tip of the syringe.

[0009] In some embodiments, the introducer adaptor hole in the proximal portion of the secondary conduit includes a luer taper that is complementary to a luer taper of the syringe tip of the syringe. In some embodiments, the introducer adapter tip at the distal portion of the introducer adapter includes a luer taper that is complementary to a luer taper of a needle hub bore of a needle hub of the needle.

[0010] In some embodiments, the introducer assembly further includes a guidewire management device including an access guidewire. The guidewire management device is optionally coupled to the introducer adapter.

[0011] In some embodiments, the guidewire management device further includes a handle and a guidewire conduit. The handle includes a proximal sleeve, a distal sleeve, and a gap between the proximal and distal sleeves configured to provide access to the access guidewire for manipulation of the access guidewire. The guidewire conduit is coupled to the proximal sleeve. The guidewire conduit is configured to provide sterile storage of the access guidewire within the guidewire conduit.

[0012] In some embodiments, the distal portion of the distal sleeve includes an integral septum piercing tip configured to pierce the septum of the valve and deliver an access guidewire through the valve.

[0013] In some embodiments, the guidewire management device further includes a septum piercing tip coupled to a distal portion of the distal sleeve, the septum piercing tip configured to pierce a septum of the valve and deliver an access guidewire through the valve.

[0014] In some embodiments, the access guidewire includes a bare wire portion around which a septum seals. In some embodiments, the access guidewire comprises a wrapped wire section that terminates in an atraumatic "J" shaped guidewire tip.

[0015] Also disclosed herein, in some embodiments, is an introducer adapter that includes a main conduit, a secondary conduit extending from a side of the main conduit, and a valve that includes an elastomeric member for sealing a proximal portion of the main conduit or the secondary conduit.

[0016] In some embodiments, the valve is a non-elastomeric cylindrical or conical insert having an elastomeric septum for sealing an opening of the insert, the valve being disposed in a proximal portion of the main or secondary conduit.

[0017] In some embodiments, the valve is an elastomeric grommet with an elastomeric septum integral therewith for sealing a cavity in the grommet. The valve is disposed in a proximal portion of the main or secondary conduit.

[0018] In some embodiments, the septum is recessed in the proximal portion of the main or secondary conduit. In some embodiments, the valve is a one-piece Touhy-Borst valve that includes an elastomeric "O" ring to seal the valve. The valve is integrated into the proximal portion of the main or secondary conduit.

[0019] In some embodiments, the valve is a Touhy-Borst adapter that includes an elastomeric "O" ring to seal the valve. The adapter is coupled to a proximal portion of the main or secondary conduit.

[0020] In some embodiments, the valve is for sealing a proximal portion of the secondary conduit. In some embodiments, the valve is for sealing a proximal portion of the main conduit. In some embodiments, the introducer adaptor hole in the proximal portion of the main conduit includes a luer taper that is complementary to a luer taper of the syringe tip of the syringe.

[0021] In some embodiments, the introducer adaptor hole in the proximal portion of the secondary conduit includes a luer taper that is complementary to a luer taper of the syringe tip of the syringe. In some embodiments, the introducer adapter tip at the distal portion of the introducer adapter includes a luer taper that is complementary to a luer taper of a needle hub bore of a needle hub of the needle.

[0022] Also disclosed herein is a method for obtaining 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, and an introducer adapter that fluidly couples the syringe and the needle together. The introducer adapter includes a main conduit, a secondary conduit extending from a side of the main conduit, and a valve including an elastomeric septum that seals a proximal portion of the main conduit or the secondary conduit. The establishing a needle path includes establishing a needle path from an area of ​​the patient's skin to the vessel lumen with a needle. The establishing a needle path. The advancing an access guidewire includes advancing at least a guidewire tip of an access guidewire into the vessel lumen to obtain vascular access.

[0023] 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 its ready-to-deploy state, where the guidewire tip of the access guidewire is immediately proximal to the needle tip at the distal portion of the needle shaft of the needle, allowing the access guidewire to be advanced into the vessel lumen immediately upon establishing the needle pathway.

[0024] In some embodiments, the method further includes a septum puncturing step, the septum puncturing step including puncturing the septum with an integrated septum puncturing tip of a distal portion of a distal sleeve of the guidewire management device, the septum puncturing step being performed prior to the introducer assembly adjusting step.

[0025] In some embodiments, the method further includes a septum puncturing step, the septum puncturing step including puncturing the septum with a septum puncturing tip coupled to a distal portion of the distal sleeve of the guidewire management device, the septum puncturing step being performed prior to the introducer assembly adjusting step.

[0026] In some embodiments, the access guidewire advancement step allows the guidewire tip to transition from a straight state within the needle to a curved state in the vessel lumen.

[0027] In some embodiments, the method further includes withdrawing the guidewire management device, which includes withdrawing the guidewire management device from the introducer adapter after the access guidewire advancing step, leaving a septum to seal around the bare wire portion of the access guidewire.

[0028] In some embodiments, the method further comprises a blood aspirating step, which comprises aspirating blood with a syringe to confirm establishment of a needle pathway, wherein sealing of the septum around the bare wire portion of the access guidewire is sufficient to maintain a vacuum during the blood aspirating step.

[0029] In some embodiments, the method further includes a needle withdrawal step that includes withdrawing the needle from the patient but leaving the access guidewire in the vessel lumen, and that includes withdrawing both the introducer adapter and the needle over a proximal portion of the access guidewire until the proximal end of the access guidewire exits the needle.

[0030] 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 both the introducer adapter and the needle over the proximal portion of the access guidewire.

[0031] In some embodiments, the method further comprises a syringe disconnection step, which comprises disconnecting the syringe prior to the needle withdrawal step, thereby preventing the creation of a vacuum during the needle withdrawal step.

[0032] 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 describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0033] [Figure 1] 1 illustrates an introducer assembly including an introducer adapter that couples together a needle, a syringe, and a guidewire management device in a ready-to-deploy state of the introducer assembly, according to some embodiments. [Diagram 2] 2 illustrates the introducer assembly of FIG. 1 with the guidewire management device partially withdrawn from the introducer adapter, according to some embodiments. [Diagram 3] 2 shows a detailed longitudinal cross-sectional view of the introducer assembly of FIG. 1 according to some embodiments. [Figure 4] 3 shows a detailed longitudinal cross-sectional view of the introducer assembly of FIG. 2 according to some embodiments. [Diagram 5] 3 shows another detailed view of the longitudinal cross section of the introducer assembly of FIG. 2 according to some embodiments. [Figure 6] 1 shows a detailed longitudinal cross-sectional view of an introducer assembly with an integrated septum piercing tip of a guidewire management device passing through the septum of the insert section of an introducer adapter, according to some embodiments. [Figure 7]1 shows a detailed longitudinal cross-sectional view of an introducer assembly with a septum piercing tip coupled to a guidewire management device ready to pass through the septum of the insert section of the introducer adapter, according to some embodiments. [Figure 8] 1 shows a detailed view of a longitudinal cross section of an introducer adaptor, according to some embodiments. [Figure 9A] 1 illustrates a first valve according to some embodiments. [Figure 9B] 1 illustrates a second valve according to some embodiments. [Figure 9C] 1 illustrates a third valve, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] 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 may have features that can be easily separated from the specific embodiment and can be combined or substituted in any way with any of the other several embodiments disclosed herein.

[0035] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain particular 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 sequentiality or numerical limitations. For example, the "first," "second," and "third" features or steps need not appear in that order, nor need a particular embodiment that includes such features or steps be limited to those three features or steps. In addition, any of the features or steps described above can further include one or more features or steps, unless otherwise indicated. Designations such as "left," "right," "top," "bottom," "front," "rear," and similar terms are used for convenience and are not intended to imply, for example, a particular fixed position, orientation, direction, etc. Rather, such designations are used to reflect, for example, a relative position, orientation, direction, etc. The singular forms "a," "an," and "the" include plural references unless the context clearly indicates a singular number.

[0036] For example, reference to the "proximal," "proximal portion," or "proximal section" of a catheter includes the portion or section of the catheter that is intended to be located near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be located near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be located near the clinician when the catheter is used on a patient. The proximal portion, section, or length of a catheter may include the proximal end of the catheter. However, the proximal portion, section, or length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, section, or length of a catheter is not the terminal portion or length of the catheter.

[0037] For example, reference to the "distal," "distal portion," or "distal section" of a catheter includes the portion or section of the catheter that is intended to be located near or within the patient when the catheter is used on a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be located near or within the patient when the catheter is used on a patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be located near or within the patient when the catheter is used on a patient. The distal portion, section, or length of a catheter may include the distal end of the catheter. However, the distal portion, section, or length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, section, or length of a catheter is not the terminal portion or length of the catheter.

[0038] Unless defined otherwise, all technical or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0039] As discussed above, a guidewire is typically placed into a blood vessel using an introducer assembly prior to inserting a CVC or the like over the guidewire into the blood vessel. The introducer assembly typically includes a needle connected to a syringe. When accessing a blood vessel using the introducer assembly, the guidewire must be inserted through the needle hub of the needle and then disconnected from the syringe so that the guidewire can be placed into the blood vessel. Both disconnecting the needle from the syringe and inserting the guidewire into the needle hub carry the risk of puncturing the back wall of the vessel, losing access to the vessel, or both due to excessive manipulation of the needle. What is needed is an adapter that does not require disconnecting the needle from the syringe to place the guidewire into the blood vessel.

[0040] Disclosed herein are introducer adapters, introducer assemblies, and methods that do not require disconnecting the needle from the syringe to place a guidewire in the vessel as in a typical introducer assembly. Such introducer adapters, introducer 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 over-manipulation. In one embodiment, the introducer assembly can include a syringe, a needle, and an introducer adapter that fluidly couples the syringe and the needle together. The introducer adapter can include a main conduit, a secondary conduit extending from a side of the main conduit, and a valve including an elastomeric septum that seals a proximal portion of the main conduit or the secondary conduit. Optionally, an access guidewire is loaded into the introducer adapter and sealed inside the introducer adapter by the valve. In another embodiment, a method can include a method for obtaining vascular access using the introducer assembly described above. Such a method may include obtaining an introducer assembly, establishing a needle pathway using a needle from an area of ​​the patient's skin to a vessel lumen, and advancing an access guidewire, at least a guidewire tip of the access guidewire, into the vessel lumen to gain vascular access. Again, these and other features will become more apparent in view of the accompanying drawings and the following description, which describe certain embodiments in more detail.

[0041] Introducer Assembly 1 and 2 show different views of an introducer assembly 100, according to some embodiments. In fact, Fig. 1 shows the introducer assembly 100 including an introducer adapter 102 coupling together a needle 104, a syringe 106, and a guidewire management device 108 including an access guidewire 110, in a ready-to-deploy state of the introducer assembly 100. Fig. 2 shows the introducer assembly 100 with the guidewire management device 108 partially withdrawn from the introducer adapter 102.

[0042] The introducer assembly 100, in its ready-to-deploy state, includes at least a syringe 106 (or another vacuum generating device), a needle 104, and an introducer adapter 102 that fluidly couples together the syringe 106 (or another vacuum generating device) and the needle 104. Neither the access guidewire 110 nor the guidewire management device 108 that provides the access guidewire 110 in some embodiments may be present in the ready-to-deploy state of the introducer assembly 100. This is because the access guidewire 110 may be optionally inserted into the introducer assembly 100 using the guidewire management device 108 and subsequently advanced into the patient's vascular lumen when the needle 104 is used to establish a needle pathway to the patient's vascular lumen. However, a ready-to-deploy state of the introducer assembly 100 including the access guidewire 110 is advantageous when the access guidewire 110 is loaded into the introducer adapter 102 and needle 104 combination and sealed therein by the valve 116 of the introducer adapter 102. In fact, as shown, the access guidewire 110 may be loaded into the needle lumen of the needle 104 such that the guidewire tip 192 of the access guidewire 110 is located just proximal to the needle tip 180 of the needle 104. In this manner, the access guidewire 110 is available for advancement immediately and directly into the patient's vascular lumen upon establishing a needle pathway, without the need for further manipulation of the introducer assembly 100 to insert the access guidewire 110.

[0043] 3-8 show different views of the introducer assembly 100 and its introducer adapter 102 in different longitudinal sections. As shown, the introducer adapter 102 includes a main conduit 112, a secondary conduit 114 extending from a side of the main conduit 112 at an angle (e.g., a 30° angle formed between the axis of the main conduit 112 and the axis of the secondary conduit 114), and a valve 116 including an elastomeric member as described below for sealing a proximal portion of the main conduit 112 or the secondary conduit 114.

[0044] In particular, the introducer adapter 102 can have a primary configuration for fluidly connecting the syringe 106 to the main conduit 112, as shown, or a secondary configuration for fluidly connecting the syringe 106 to the secondary conduit 114. Correspondingly, the primary configuration of the introducer adapter 102 is for inserting the access guidewire 110 into the secondary conduit 114, as shown, while the secondary configuration of the introducer adapter 102 is for inserting the access guidewire 110 into the main conduit 112, with insertion of the access guidewire 110 into either the secondary conduit 114 or the main conduit 112, optionally using a guidewire management device 108. In accordance with the primary configuration of the introducer adapter 102, when the syringe 106 is fluidly coupled to the main conduit 112 and the access guidewire 110 is inserted into the secondary conduit 114, the syringe 106 is axially aligned with the needle 104 through the main conduit 112, thereby ensuring timely and visible blood flashback into at least the syringe tip 152 when the needle 104 is used to establish a needle pathway to the blood vessel lumen. In accordance with the secondary configuration of the introducer adapter 102, when the syringe 106 is fluidly coupled to the secondary conduit 114 and the access guidewire 110 is inserted into the main conduit 112, the syringe 106 is not axially aligned with the needle 104 through the main conduit 112, thereby potentially compromising such timely and visible blood flashback. That said, the sub-configuration of the introducer adapter 102 advantageously allows the access guidewire 110 to be advanced straight through the main conduit 112 and into the vascular lumen without bending, thereby facilitating advancement of the access guidewire 110 into the vascular lumen.

[0045] The main conduit 112 includes a main channel 118 extending through both the proximal and distal ends of the main conduit 112. In the main configuration of the introducer adapter 102, the main conduit 112 or a proximal portion of its main channel 118 includes an introducer adapter bore 120 having a luer taper (e.g., a 6% taper) complementary to the luer taper of the syringe tip 152 of the syringe 106. Optionally, the proximal portion of the main conduit 112 also includes a main introducer adapter flange 122 configured to threadably mate with the internal threads 156 of the threaded collar 154 of the syringe hub 146. However, in the secondary configuration of the introducer adapter 102, the main conduit 112 or a proximal portion of its main channel 118 instead includes a valve 116 disposed therein. Alternatively, the proximal portion of the main conduit 112 instead includes a valve 116 coupled thereto. For example, the valve 116 may be a Touhy-Borst adapter, described below, in which the female threads of the adapter hub 142 are threadedly engaged with the primary introducer adapter flange 122. Whether the introducer adapter 102 is in its primary or secondary configuration, the distal portion of the introducer adapter 102 or its main conduit 112 includes an introducer adapter tip 124 having a luer taper (e.g., a 6% taper) that is complementary to the luer taper of the needle hub bore 190 of the needle hub 178 of the needle 104. Although not shown, the introducer adapter tip 124 optionally includes a threaded collar having female threads, such as the female threads of the syringe 106, described below, and the threaded collar around the introducer adapter tip 124 is configured to form a so-called luer lock connection with the optional needle hub flange of the needle hub 178 of the needle 104, as described below.

[0046] The secondary conduit 114 includes a secondary channel 126 that extends through a proximal end of the secondary conduit 114 and into an intermediate portion of the main channel 118 of the main conduit 112. In the primary configuration of the introducer adapter 102, the secondary conduit 114 or a proximal portion of its secondary channel 126 includes a valve 116 disposed therein. Alternatively, the proximal portion of the secondary conduit 114 includes the valve 116 coupled thereto. For example, the valve 116 may be a Touhy-Borst adapter, described below, in which the female threads of the adapter hub 142 are threadedly engaged with a secondary introducer adapter flange (not shown) similar to the primary introducer adapter flange 122. However, in the secondary configuration of the introducer adapter 102, the proximal portion of the secondary conduit 114 or its secondary channel 126 instead includes an introducer adapter bore 120 having a luer taper (e.g., a 6% taper) that is complementary to the luer taper of the syringe tip 152 of the syringe 106. Optionally, the proximal portion of the secondary conduit 114 also includes a secondary introducer adapter flange that is also configured to threadably mate with the internal threads 156 of the threaded collar 154 of the syringe hub 146.

[0047] 9A-9C show valves 128, 130, and 132 for sealing proximal portions of the main conduit 112 or the secondary conduit 114, according to some embodiments. It should be understood that the valves 128, 130, and 132 are types of the valve 116 described above.

[0048] 9A, the valve 128 is a cylindrical or conical insert 134 with a septum 136 disposed within or on the insert 134 to seal an opening in the insert 134. The insert 134 may be formed of a relatively rigid non-elastomeric material, such as polyethylene, polypropylene, poly(methyl methacrylate), polyvinyl chloride, acrylonitrile butadiene styrene, or polycarbonate, while the septum 136 may be formed of an elastomeric material, such as silicone rubber, natural rubber, synthetic rubber, or combinations thereof, such as red rubber, which is a blend of natural rubber and styrene butadiene rubber. Although the septum 136 is shown intact and thus configured to be pierced by the septum piercing tip 210 or 212 of the guidewire management device 108, the septum 136 may alternatively include a slit, multiple cross slits, or a through hole having an inner diameter smaller than the outer diameter of the access guidewire 110 through which the distal portion of the distal sleeve 204 of the guidewire management device 108 may be used to deliver the access guidewire 110. The valve 128 is disposed within a proximal portion of the secondary conduit 114 in the primary configuration of the introducer adapter 102, or within a proximal portion of the main conduit 112 in the secondary configuration of the introducer adapter 102, and notably, the septum 136 is recessed in the proximal portion of the secondary conduit 114 or main conduit 112.

[0049] 9B, the valve 130 is a grommet with an integral septum 138 that seals the opening of the grommet, thereby forming a sealed cavity of the grommet. The grommet and its septum 138 may be formed of an elastomeric material, such as silicone rubber, natural rubber, synthetic rubber, or combinations thereof, e.g., red rubber. As with the description of septum 136, septum 138 is shown intact and thus configured to be pierced by septum piercing tip 210 or 212 of guidewire management device 108, although septum 138 may alternatively include a slit, multiple cross slits, or a through hole having an inner diameter smaller than the outer diameter of the access guidewire 110, through which a distal portion of distal sleeve 204 of guidewire management device 108 may be used to deliver the access guidewire 110. The valve 130 is disposed in the proximal portion of the secondary conduit 114 in the primary configuration of the introducer adapter 102, or in the proximal portion of the main conduit 112 in the secondary configuration of the introducer adapter 102, and in particular, the septum 138 is recessed in the proximal portion of the secondary conduit 114 or the main conduit 112.

[0050] 9C, the valve 132 is a Touhy-Borst adapter with an elastomeric "O" ring for sealing the Touhy-Borst adapter when compressed between an adapter nut 140 and an adapter hub 142, which are threaded with respective internal threads (not shown) and external threads 144. Although not shown, the adapter hub 142 includes internal threads, like the syringe hub 146, configured to threadably mate with a proximal portion of the secondary conduit 114 in the primary configuration of the introducer adapter 102, or a proximal portion of the primary conduit 112 in the secondary configuration of the introducer adapter 102.

[0051] Although not shown, the valve 132 may alternatively be integrated into the proximal portion of the secondary conduit 114 or into the proximal portion of the main conduit 112. In fact, the valve 132 may alternatively be an integral Touhy-Borst valve that includes an elastomeric "O" ring for sealing the Touhy-Borst valve when compressed between a valve nut (see, e.g., adapter nut 140) and the proximal portion of the secondary conduit 114 or the proximal portion of the main conduit 112 (see, e.g., adapter hub 142) that are threaded with the female threads of the valve nut and the male threads of the proximal portion of the secondary conduit 114 or the proximal portion of the main conduit 112. Such a valve is integrated into the proximal portion of the secondary conduit 114 in the primary configuration of the introducer adapter 102, or into the proximal portion of the main conduit 112 in the secondary configuration of the introducer adapter 102.

[0052] Notably, because the sealing portion of the valve 132 is not a septum 136 or 138 but rather an "O" ring or the like that is compressed between the adapter nut 140 and the adapter hub 142 when screwed together, and the septum puncture tip 210 or 212 or the like of the guidewire management device 108 is configured to deliver the access guidewire 110 through the "O" ring, the access guidewire 110 can be used directly with the valve 132 without the guidewire management device 108.

[0053] 3-7 show different views through different longitudinal sections of the introducer assembly 100 and its syringe 106, but reference is also made to FIGS. 1 and 2 which also show different views of the introducer assembly 100 and its syringe 106.

[0054] As shown, the syringe 106 includes a syringe hub 146, a barrel 148, and a plunger 150 that is disposed within the barrel 148 at least in the ready-to-deploy state of the introducer assembly 100.

[0055] The syringe hub 146 includes a syringe tip 152 extending from a distal portion (e.g., the distal end) of the barrel 148. Additionally, the syringe hub 146 can include a threaded collar 154 extending from the distal portion (e.g., the distal end) of the barrel 148 and around the syringe tip 152.

[0056] The syringe tip 152 is configured for insertion into an introducer adapter bore 120 in a proximal portion of the main conduit 112 or the secondary conduit 114 to fluidly connect the syringe 106 with the introducer adapter 102. In practice, the syringe tip 152 may have a luer taper (e.g., a 6% taper) configured for insertion into the introducer adapter bore 120, which is complementarily configured as described above.

[0057] The threaded collar 154 includes internal threads 156 configured to threadably mate with the primary introducer adapter flange 122 or the secondary introducer adapter flange (not shown) of the introducer adapter 102, each of which is optional as described above. The threaded collar 154 of the syringe hub 146, if present, advantageously provides a so-called luer lock-style connection with the primary introducer adapter flange 122 or the secondary introducer adapter flange of the introducer adapter 102 to provide greater security against accidental disconnection than would otherwise be provided by a luer slip-style connection.

[0058] The barrel 148 includes a barrel wall 158, a barrel chamber 160 defined by the barrel wall 158, and a barrel flange 162 extending outwardly from a proximal portion (e.g., a proximal end) of the barrel 148 or barrel wall 158, a barrel collar, etc., configured to actuate the syringe 106 in conjunction with a plunger flange 168, a plunger collar, etc., described below.

[0059] Barrel chamber 160 is configured to receive plunger 150 when plunger 150 is inserted therein. In practice, barrel chamber 160 extends from the distal end of barrel 148, which is the closed end of barrel 148 (excluding syringe tip 152), to the proximal end of barrel 148, which is the open end of barrel 148 into which plunger 150 may be inserted.

[0060] The plunger 150 includes an integral plunger shaft 164, a piston 166 fitted onto a distal portion (e.g., the distal end) of the plunger shaft 164, and a plunger flange 168 extending outwardly from a proximal portion (e.g., the proximal end) of the plunger 150, which is configured to actuate the syringe 106 together with the barrel flange 162, barrel collar, etc.

[0061] The plunger shaft 164 may include orthogonal struts 170 that meet along longitudinal edges at a central axis of the plunger shaft 164. However, the plunger shaft 164 may take other forms, and thus the plunger shaft 164 is not limited to orthogonal struts 170.

[0062] The piston 166, which may be a unitary elastomeric piston, includes one or more rings each configured to form one or more seals with the barrel wall 158. The one or more rings include at least one leading ring 172 configured to form a seal with the barrel wall 158. The one or more rings may also include a trailing ring 174, as shown in FIG. 4. Like the leading ring 172, the trailing ring 174 is configured to form a seal with the barrel wall 158. In effect, the trailing ring 174, when present, provides a secondary seal with the barrel wall 158. Together, the leading ring 172 and the trailing ring 174 ensure that the seal between the piston 166 and the barrel wall 158 (e.g., the seal provided by the leading ring 172, the trailing ring 174, or both the leading ring 172 and the trailing ring 174) remains intact while the syringe 106 is actuated, thereby allowing the syringe 106 to steadily aspirate liquid, such as blood, as the plunger 150 is withdrawn from the barrel 148.

[0063] 3-7 show different views through different longitudinal sections of the introducer assembly 100 and its needle 104, but reference is also made to FIGS. 1 and 2 which also show different views of the introducer assembly 100 and its needle 104.

[0064] As shown, the needle 104 includes a needle shaft 176 and a needle hub 178 that covers a proximal portion of the needle shaft 176, including the proximal end of the needle shaft 176. The needle shaft 176 includes a needle tip 180 at a distal portion of the needle shaft 176 and a needle shaft lumen 182 that extends the entirety of the needle shaft 176. Among other things, the needle shaft lumen 182 and a needle hub lumen 188, described below, together form the needle lumen.

[0065] The needle hub 178 includes a neck 184 and a needle hub connector 186 at a proximal portion of the needle hub 178 . The neck 184 includes a neck portion of a needle hub lumen 188 that extends entirely through the needle hub 178. The remainder of the needle hub lumen 188 is defined by a needle hub bore 190, specifically that portion not occupied by the syringe tip 152 in the ready-to-deploy state of the introducer assembly 100. Among other things, the needle hub lumen 188 and the needle shaft lumen 182, described above, together form the needle lumen.

[0066] The needle hub connector 186 includes a needle hub bore 190 configured to receive the syringe tip 152 therein to fluidly connect the needle 104 with the introducer adapter 102. In practice, the needle hub bore 190 may have a luer taper (e.g., a 6% taper) configured to receive the introducer adapter tip 124 therein, which is complementarily configured as described above.

[0067] Although not shown, the needle hub 178 may include a needle hub flange, such as the primary introducer adapter flange 122, configured to threadably mate with the female threads of an optional threaded collar around the introducer adapter tip 124. The needle hub flange, if present, advantageously provides a so-called luer lock style connection with the female threads of the threaded collar of the introducer adapter tip 124 to provide greater security against accidental disconnection than would otherwise be provided by a luer slip style connection.

[0068] 3-7 show different views through different longitudinal sections of the introducer assembly 100 and its access guidewire 110, but reference is also made to FIGS. 1 and 2 which also show different views of the introducer assembly 100 and its syringe 106.

[0069] Again, the introducer assembly 100 may include an access guidewire 110 that is loaded therein when the introducer assembly 100 is in a ready-to-deploy state. When loaded into the introducer assembly 100 in a ready-to-deploy state, the access guidewire 110 is loaded into the introducer adapter 102 and needle 104 combination and sealed therein by the valve 116 of the introducer adapter 102. In practice, as shown, the access guidewire 110 may be loaded into the needle lumen of the needle 104 such that the guidewire tip 192 of the access guidewire 110 is located just proximal to the needle tip 180 of the needle 104. In this manner, the access guidewire 110 is available for advancement immediately and directly into the patient's vascular lumen upon establishing a needle pathway, without the need for further manipulation of the introducer assembly 100 to insert the access guidewire 110.

[0070] The access guidewire 110 may include a guidewire tip 192 in the form of an atraumatic "J" shaped guidewire tip configured to prevent puncturing the posterior wall of a blood vessel. Such a guidewire tip is configured to assume a straight state within the needle 104 or needle lumen thereof, and to assume a curved state when the guidewire tip 192 is advanced beyond the needle tip 180 of the needle 104 in the deployed state of the introducer assembly 100, such as when the guidewire tip 192 is advanced into a blood vessel lumen.

[0071] The access guidewire 110 may further include a bare wire portion 194 and a wrapped wire portion 196 distal to the bare wire portion 194, proximal to the bare wire portion 194, or both. When the wrapped wire portion 196 of the access guidewire 110 is distal to the bare wire portion 194, the wrapped wire portion 196 terminates at the guidewire tip 192. The bare wire portion 194 of the access guidewire 110 extends distally through the valve 116 of the introducer adapter 102 in some configurations of the introducer assembly 100 such that the septum 136 or 138 or an “O” ring forms a fluid-tight seal around the bare wire portion 194 of the access guidewire 110. For example, the bare wire portion 194 of the access guidewire 110 extends distally through the valve 116 of the introducer adapter 102 to maintain a fluid-tight seal even when the guidewire tip 192 advances into the vessel lumen in the deployed state of the introducer assembly 100. Notably, the access guidewire 110 need not have a bare wire portion 194 and a wrapped wire portion 196. At least said bare wire portion 194 of the access guidewire 110 can instead be a flat-wrapped or ground-wrapped portion of the access guidewire 110, around which the septum 136 or 138 or an "O" ring can also form a fluid-tight seal. The flat-wrapped portion of the access guidewire 110, if present, includes a wrap of tape instead of a round wire. The ground-wrapped portion of the access guidewire 110, if present, includes a wrapped round wire that has been crushed to flatten the wraps.

[0072] Notably, if the access guidewire 110 is not provided by the guidewire management device 108, the access guidewire 110 includes a proximal portion that extends proximally from the valve 116 in at least the ready-to-deploy state of the introducer assembly 100. Although not shown, the proximal portion of the access guidewire 110 can be disposed within a sterile barrier (e.g., a sterile bag) configured to maintain the sterility of the access guidewire 110.

[0073] 1 and 2 show different views of the introducer assembly 100 and its guidewire management device 108. As shown, guidewire management device 108 includes a handle 198 , a guidewire conduit 200 , and an access guidewire 110 spanning between the handle 198 and the guidewire conduit 200 .

[0074] The handle 198 includes a proximal sleeve 202 , a distal sleeve 204 , and a gap 206 between the proximal sleeve 202 and the distal sleeve 204 . The proximal sleeve 202 of the handle 198 includes a bore at a proximal portion thereof that includes a distal end of the guidewire conduit 200 inserted therein, thereby coupling the guidewire conduit 200 to the handle 198. Notably, the handle 198 further includes a guidewire conduit clip 208 on the opposite side of the gap 206, which further couples the guidewire conduit 200 to the handle 198.

[0075] The distal sleeve 204 of the handle 198 may include an integral septum piercing tip 210, or a separate septum piercing tip 212 coupled to a distal portion of the distal sleeve 204, configured to pierce the septum 136 or 138 of the valve 128 or 130 and deliver the access guidewire 110 therethrough. That said, if the septum 136 or 138 is not intact (i.e., if the septum 136 or 138 includes a slit, multiple cross slits, or through holes as described above), the distal portion of the distal sleeve 204 of the handle 198 may be used to deliver the access guidewire 110 therethrough. Notably, the distal sleeve 204 of the handle 198 may further include one or more "O" rings or the like therein configured to seal the access guidewire 110 within the distal sleeve 204. One or more "O" rings sealing the access guidewire 110 within the distal sleeve 204 allow a vacuum to be easily established and maintained using the syringe 106 during the blood aspiration step described below, even when the septum puncture tip 210 or 212 or the distal portion of the distal sleeve 204 is positioned through the septum 136 or 138.

[0076] A gap 206 between the proximal sleeve 202 and the distal sleeve 204 of the handle 198 is configured to provide access to the access guidewire 110 at the gap 206 for manipulation of the access guidewire 110. In practice, the gap 206 allows the access guidewire 110 to be advanced into the introducer adapter 102, needle 104, blood vessel, etc. by grasping the access guidewire 110 between the thumb and one or more fingers of a hand and pushing it into the proximal opening of the distal sleeve 204. Alternatively, the access guidewire 110 can be pressed with the thumb against the segmented crescent shaped thumb pad 214 and, while continuing to push, the access guidewire 110 can be slid across the thumb pad 214 and into the proximal opening of the distal sleeve 204 while supporting the handle 198 with one or more fingers of the same hand. Similarly, the gap 206 allows the access guidewire 110 to be grasped between the thumb and one or more fingers of a hand and pulled out of the proximal opening of the distal sleeve 204, thereby withdrawing it from the introducer adapter 102, needle 104, blood vessel, etc. Alternatively, the access guidewire 110 can be pressed with the thumb against the thumb pad 214 and, while continuing to press, slid across the thumb pad 214 and out of the proximal opening of the distal sleeve 204, while supporting the handle 198 with one or more fingers of the same hand.

[0077] Guidewire conduit 200 is configured to provide sterile storage therein of access guidewire 110. In effect, the tubular wall of guidewire conduit 200 provides a sterile barrier configured to maintain the sterility of access guidewire 110 for as long as access guidewire 110 is disposed therein.

[0078] method The method includes at least a method for obtaining vascular access, the method including one or more steps selected from the steps of obtaining an introducer assembly, puncturing or penetrating a septum, adjusting an introducer assembly, establishing a needle path, withdrawing a plunger, aspirating blood, advancing an access guidewire, withdrawing a guidewire management device, disconnecting a syringe, venting air, and withdrawing a needle.

[0079] The introducer assembly obtaining step includes obtaining an introducer assembly 100. As described above, the introducer assembly 100 includes at least a syringe 106, a needle 104, and an introducer adapter 102 that fluidly couples together the syringe 106 and the needle 104. The introducer adapter 102 includes a main conduit 112, a secondary conduit 114 extending from a side of the main conduit 112, and a valve 116 that, in some embodiments, includes an elastomeric septum 136 or 138 that seals a proximal portion of the main conduit 112 or secondary conduit 114.

[0080] The septum puncturing step involves puncturing the septum 136 or 138 with an integral septum puncturing tip 210 on the distal portion of the distal sleeve 204 of the handle 198, or a septum puncturing tip 212 coupled to the distal portion of the distal sleeve 204 of the handle 198. The septum piercing step involves penetrating the septum 136 or 138 with the distal portion of the distal sleeve 204 of the handle 198 if the septum 136 or 138 includes a slit, multiple cross slits, or piercing holes as described above. The septum puncturing or piercing step may be performed prior to the introducer assembly adjustment step or after the needle path establishment step, such as after the blood aspiration step or during the access guidewire advancement step as described below.

[0081] Notably, the access guidewire 110 may be used directly, without the guidewire management device 108, if the introducer adapter 102 includes the valve 132. In such an embodiment, the method may include an access guidewire insertion step in lieu of the septum puncturing or penetration step. The access guidewire insertion step includes inserting the access guidewire 110 into the introducer adapter 102 through the valve 132 when it is open, followed by closing the valve 132 either immediately after inserting the access guidewire 110 through the valve 132, or at some point prior to the blood aspiration step, if a blood aspiration step is performed.

[0082] The introducer assembly adjusting step includes adjusting the introducer assembly 100 so that the introducer assembly 100 is in its ready-to-deploy state when the introducer assembly obtaining step is performed, if the introducer assembly 100 is not already in its ready-to-deploy state. In the ready-to-deploy state of the introducer assembly 100, the guidewire tip 192 of the access guidewire 110 is immediately proximal to the needle tip 180 at the distal portion of the needle shaft 176 of the needle 104. This allows the access guidewire 110 to be advanced into the vessel lumen as soon as the needle pathway is established.

[0083] The needle pathway establishment step involves establishing a needle pathway with needle 104 from an area of ​​the patient's skin to a blood vessel lumen. The plunger withdrawal step involves withdrawing the plunger 150 from the barrel 148 of the syringe 106 to create a slight vacuum before reaching the blood vessel lumen in the needle path establishment step. The slight vacuum ensures blood flashback into at least the syringe tip 152 to confirm establishment of the needle path in the needle path establishment step.

[0084] The blood aspiration step involves aspirating blood with the syringe 106 to confirm establishment of a needle track. A seal such as a septum 136 or 138 around the distal portion of the distal sleeve 204 of the handle 198 or around the bare wire portion 194 of the access guidewire 110 is sufficient to maintain a vacuum during the blood aspiration step, particularly if the distal sleeve 204 includes one or more "O" rings or the like disposed therein.

[0085] The access guidewire advancement step includes advancing at least the guidewire tip 192 of the access guidewire 110 into the vessel lumen to gain vascular access. However, in some embodiments, a septum puncture or penetration step is performed during the access guidewire advancement step. In practice, the septum puncture or penetration step can be performed after advancing the access guidewire 110 or its guidewire tip 192 several centimeters into the vessel lumen to eliminate any friction against the access guidewire 110 by the septum 136 or 138, making the remaining access guidewire advancement steps easier to perform. In any case, advancing the access guidewire 110 into the vessel lumen includes grasping the access guidewire 110 between the thumb and one or more fingers of a hand and pushing it into the proximal opening of the distal sleeve 204. Alternatively, the access guidewire 110 can be pressed with the thumb against the thumb pad 214 in the gap 206 of the handle 198 and, while continuing to press, slid the access guidewire 110 across the thumb pad 214 and into the proximal opening of the distal sleeve 204 while supporting the handle 198 with one or more fingers of the same hand. Among other things, the access guidewire advancement step allows the guidewire tip 192 to transition from a straight state within the needle 104 to a curved state in the blood vessel lumen.

[0086] The guidewire management device withdrawal step involves withdrawing the guidewire management device 108 from the introducer adapter 102 (if a guidewire management device 108 is used in the method) after the access guidewire advancement step. The guidewire management device withdrawal step leaves the septum 136 or 138 to seal around the bare wire portion 194 of the access guidewire 110.

[0087] The syringe disconnection step includes disconnecting the syringe 106 prior to the needle retraction step, thereby preventing the creation of a vacuum during the needle retraction step. However, the air purge step may not require a syringe disconnection step, since the air purge step includes purge air into the valve 116 while performing the needle retraction step. Purge air into the valve 116 may include pressing the access guidewire 110 against the side of the valve 128 or 130 to deform the septum 136 or 138. However, in some embodiments, the introducer adapter 102 includes a push button air purge valve for the air purge step. Notwithstanding the above, in some embodiments of the method, both the syringe disconnection step and the air purge step may be performed.

[0088] The needle withdrawal step involves withdrawing the needle 104 from the patient but leaving the access guidewire 110 in the blood vessel lumen. The needle withdrawal step involves withdrawing both the introducer adapter 102 and the needle 104 over the proximal portion of the access guidewire 110 until the proximal end of the access guidewire 110 exits the needle 104. In particular, the needle withdrawal step involves holding the access guidewire 110 in a fixed position at or near the area of ​​the skin that includes the needle track while withdrawing both the introducer adapter 102 and the needle 104 over the proximal portion of the access guidewire 110.

[0089] 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. Additional improvements or modifications may be apparent to those skilled in the art, and the broader aspects of the present invention encompass these improvements or modifications as well. Thus, one may depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. An introducer assembly comprising: A syringe and a needle including a needle shaft and a needle tip at a distal portion of the needle shaft; an introducer adapter fluidly connecting the syringe and the needle together, The main pipe and a secondary conduit extending from a side of the main conduit; a valve including an elastomeric septum sealing a proximal portion of the main conduit or the secondary conduit; an introducer adapter including: An introducer assembly comprising: an access guidewire that is loaded into the introducer adapter and sealed inside the introducer adapter by the valve when the introducer assembly is in a ready-to-deploy state, and wherein when the introducer assembly is in the ready-to-deploy state, the guidewire tip of the guidewire is located on the needle shaft just proximal to the needle tip and the septum that seals around the bare wire portion of the access guidewire.

2. 2. The introducer assembly of claim 1, wherein the valve is a non-elastomeric cylindrical or conical insert with the septum sealing an opening of the insert, the valve being disposed within the proximal portion of the main conduit or the secondary conduit.

3. 2. The introducer assembly of claim 1, wherein the valve is an elastomeric grommet having a septum integral with the elastomeric grommet sealing a cavity of the grommet, the valve being disposed within the proximal portion of the main conduit or the secondary conduit.

4. The introducer assembly of claim 2 , wherein the septum is recessed in the proximal portion of the main conduit or the secondary conduit.

5. The introducer assembly of claim 1 , wherein the valve seals the proximal portion of the secondary conduit.

6. The introducer assembly of claim 1 , wherein the valve seals the proximal portion of the main conduit.

7. The introducer assembly of claim 1 , wherein the introducer adapter bore in the proximal portion of the main conduit includes a luer taper complementary to a luer taper of a syringe tip of the syringe.

8. The introducer assembly of claim 1 , wherein the introducer adapter bore in the proximal portion of the secondary conduit includes a luer taper complementary to a luer taper of a syringe tip of the syringe.

9. The introducer assembly of claim 1 , wherein an introducer adapter tip at a distal portion of the introducer adapter includes a luer taper complementary to a luer taper of a needle hub bore of a needle hub of the needle.

10. The introducer assembly of claim 1 , further comprising a guidewire management device including the access guidewire, the guidewire management device optionally coupled to the introducer adapter.

11. the guidewire management device a handle including a proximal sleeve, a distal sleeve, and a gap between the proximal sleeve and the distal sleeve configured to provide access to the access guidewire for manipulation of the access guidewire; 11. The introducer assembly of claim 10, further comprising: a guidewire conduit coupled to the proximal sleeve and configured to provide sterile storage of the access guidewire within the guidewire conduit.

12. The introducer assembly of claim 11 , wherein a distal portion of the distal sleeve includes an integral septum piercing tip configured to pierce the septum of the valve and deliver the access guidewire through the valve.

13. 12. The introducer assembly of claim 11, wherein the guidewire management device further includes a septum piercing tip coupled to a distal portion of the distal sleeve, the septum piercing tip configured to pierce the septum of the valve and deliver the access guidewire through the valve.

14. The introducer assembly of claim 1 , wherein the access guidewire includes a wrapped wire portion terminating in an atraumatic "J" shaped guidewire tip.

Images