Introducer needle and method for manufacturing the same

Abstract

The introducer needle (104) includes a needle shaft (144), a sheath (142), and a needle hub (146). The needle shaft includes a needle slot (150) that extends from a proximal portion of the needle shaft to the distal needle tip. The sheath is placed over the needle shaft and fixed in position on the needle shaft. The sheath can seal the needle slot below the sheath except for a sheath opening at the proximal portion of the sheath. The needle hub can be around at least a proximal portion of the needle shaft. The introducer needle can be manufactured by forming a needle slot in the needle shaft, such as by grinding or polishing the needle slot, placing the sheath over the needle shaft, and fixing the sheath onto the needle shaft.

Description

[Background technology]

[0001] Central venous catheters (CVCs) are typically introduced into a patient's body and advanced through the patient's vasculature by the Seldinger technique. The Seldinger technique involves many steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Seldinger technique is effective, many of the steps are time consuming and the handling of multiple medical devices is cumbersome, all of which may cause trauma to the patient. In addition, there is a relatively high chance of contamination through contact, as many medical devices need to be replaced during the Seldinger technique. Therefore, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient's body and advancing the catheter through its vasculature.

[0002] Disclosed herein is an introducer sheath and method for an introducer needle, which may be used separately or in conjunction with a Rapidly Insertable Central Catheter (RICC), to address the aforementioned needs. Summary of the Invention

[0003] Disclosed herein, in some embodiments, is an introducer needle including a needle shaft, a sheath, and a needle hub. The needle shaft includes a needle slot extending from a proximal portion of the needle shaft to a distal needle tip. The sheath is disposed over the needle shaft and fixed in position at least on the needle shaft. The sheath seals the needle slot below the sheath, except for a sheath opening at a proximal portion of the sheath. The needle hub is around at least a proximal portion of the needle shaft.

[0004] In some embodiments, the sheath is adhered to the needle shaft with an intervening adhesive. In some embodiments, the adhesive is a pressure sensitive adhesive.

[0005] In some embodiments, the adhesive is a cured epoxy resin. In some embodiments, the adhesive is a cured tie layer resin.

[0006] In some embodiments, the sheath is laser welded to the needle shaft. The sheath is transparent to at least one wavelength or range of wavelengths of the laser used to laser weld the sheath to the needle shaft.

[0007] In some embodiments, the sheath is translucent to visible light, allowing a user to visualize blood spurting into the needle shaft as the introducer needle makes a percutaneous puncture through the sheath that seals the needle slot below.

[0008] In some embodiments, the needle shaft includes one or more outwardly projecting protrusions on a proximal portion of the needle shaft proximal to the needle slot, on a proximal portion of the needle shaft distal to the needle slot, on a distal portion of the needle shaft proximal to the needle tip, or a combination thereof. The one or more protrusions are configured to limit the sliding of the sheath over the needle shaft.

[0009] In some embodiments, the one or more protrusions are one or more posts, respectively. In some embodiments, the one or more protrusions are each one or more arcuate ridges, each of the one or more arcuate ridges extending along at least a portion of the circumference of the needle shaft.

[0010] In some embodiments, the sheath includes one or more through holes configured to accommodate the one or more protrusions, the one or more protrusions of the needle shaft being disposed within the one or more through holes of the sheath, respectively.

[0011] In some embodiments, a proximal portion of the needle shaft proximal to the needle slot includes a flared portion configured to limit proximal sliding of the sheath over the needle shaft.

[0012] In some embodiments, a proximal portion of the needle shaft proximal to the needle slot includes a stepped portion configured to limit proximal sliding of the sheath over the needle shaft.

[0013] In some embodiments, the needle shaft includes a recess between a proximal portion of the needle shaft and the tip configured to limit sliding of the sheath over the needle shaft in a proximal or distal direction, the sheath being disposed in the recess in the needle shaft flush with the remainder of the needle shaft.

[0014] In some embodiments, the sheath includes an inwardly projecting protrusion at a proximal portion of the sheath that is configured to reside within the needle slot and abut the proximal end of the needle slot to limit the sheath from sliding proximally over the needle shaft.

[0015] In some embodiments, the sheath includes an inwardly projecting longitudinal ridge extending from a proximal portion of the sheath to a distal portion of the sheath, the ridge being configured to reside within the needle slot and abut a proximal end of the needle slot to limit proximal sliding of the sheath over the needle shaft.

[0016] In some embodiments, the sheath is disposed over the needle shaft with an engineered fit selected from a transition fit and an interference fit. In some embodiments, the outer surface of the needle shaft is textured or roughened.

[0017] In some embodiments, the sheath has a sheath wall thickness of about 0.001 inch (about 0.025 mm) to about 0.003 inch (about 0.076 mm). In some embodiments, the sheath has a sheath wall thickness of about 0.003 inches (about 0.076 mm) to about 0.006 inches (about 0.15 mm).

[0018] In some embodiments, the sheath has a sheath wall thickness of about 0.006 inches (about 0.15 mm) to about 0.008 inches (about 0.20 mm). Also disclosed herein is an introducer needle, which in some embodiments includes a needle shaft, a longitudinal strip, and a needle hub. The needle shaft includes a needle slot extending from a proximal portion of the needle shaft to a distal tip. The strip is adhered to the needle shaft and seals the lower needle slot except for a proximal portion of the needle slot, thereby creating an opening in the side of the introducer needle. The needle hub surrounds at least a proximal portion of the needle shaft.

[0019] Also disclosed herein is a method of manufacturing an introducer needle. The method, in some embodiments, includes a needle slot forming step, a sheath placement step, a sheath fixing step, and a needle hub fixing step. The needle slot forming step includes forming a needle slot in the needle shaft. The needle slot extends from a proximal portion of the needle shaft to a distal needle tip. The sheath placement step includes placing a sheath over the needle shaft. The sheath fixing step includes fixing the sheath to the needle shaft. The sheath seals the needle slot below the sheath. The needle hub fixing step includes fixing the needle hub around at least a proximal portion of the needle shaft.

[0020] In some embodiments, the needle slot forming step comprises cutting or grinding the needle slot into the needle shaft. In some embodiments, the sheath positioning step includes inserting a needle shaft into the sheath.

[0021] In some embodiments, the sheath securing step includes adhering the sheath to the needle shaft with an adhesive selected from a pressure sensitive adhesive, an epoxy, and a tie layer resin. In some embodiments, the sheath securing step includes laser welding the sheath to the needle shaft, the sheath being transparent to at least one wavelength or range of wavelengths of the laser used for laser welding.

[0022] In some embodiments, the sheath fixing step includes welding one or more outwardly projecting protrusions onto the needle shaft, cutting one or more through holes in the sheath, and placing the sheath over the needle shaft such that the one or more protrusions are respectively disposed within the one or more through holes.

[0023] In some embodiments, the sheath fixation step includes recessing a portion of the needle shaft between a proximal portion of the needle shaft and the needle tip to form a recess in the needle shaft, and then positioning the sheath over the needle shaft in the recess in the needle shaft, with the sheath flush with the remaining portion of the needle shaft.

[0024] In some embodiments, the method further includes a sheath opening forming step, which includes forming a sheath opening in the sheath by laser cutting after the sheath positioning step, the sheath sealing the needle slot below the sheath except for the sheath opening in a proximal portion of the sheath.

[0025] 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 the following description, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0026] [Figure 1] 1 illustrates a RICC insertion assembly according to some embodiments. [Diagram 2] 1 illustrates a sealing module of a coupler of a RICC insertion assembly, according to some embodiments. [Diagram 3] 1 illustrates a RICC of a RICC insertion assembly, according to some embodiments. [Figure 4] 1 shows a detailed view of a distal portion of a catheter tube of a RICC, according to some embodiments. [Diagram 5] FIG. 1 shows a cross-sectional view of a distal portion of a catheter tube according to some embodiments. [Figure 6] 13 shows another cross-sectional view of a distal portion of a catheter tube according to some embodiments. [Figure 7] 1 shows a longitudinal cross-sectional view of a distal portion of a catheter tube according to some embodiments. [Figure 8] 1 illustrates a top view of an introducer needle, according to some embodiments. [Figure 9] 1 illustrates a sheath for an introducer needle, according to some embodiments. [Figure 10] 1 illustrates a needle shaft of an introducer needle having a needle slot extending along at least a portion of the top of the needle shaft, according to some embodiments. [Figure 11] 13A shows a detailed view of a distal portion of an introducer needle, with a sheath adhered to the needle shaft with an intervening adhesive, according to some embodiments. [Figure 12] 13A shows a cross-sectional view of a proximal portion of an introducer needle with a sheath glued to the needle shaft, according to some embodiments. [Figure 13] 13A shows a longitudinal cross-sectional view of a distal portion of an introducer needle with a sheath glued to the needle shaft according to some embodiments. [Figure 14] 13A shows a detailed view of a distal portion of an introducer needle, where the sheath is laser welded to the needle shaft, according to some embodiments. [Figure 15] 13A shows a detailed view of a needle shaft having one or more protrusions projecting outward at a proximal portion of the needle shaft, according to some embodiments. [Figure 16] 13A shows a detailed view of a proximal portion of an introducer needle having a needle shaft including a stepped portion, according to some embodiments. [Figure 17] 1 illustrates an introducer needle having a needle shaft that includes a recess, according to some embodiments. [Figure 18] 1 illustrates an introducer needle having a needle shaft including a flared portion, according to some embodiments. [Figure 19] 13A shows a detailed view of a proximal portion of an introducer needle having a needle shaft including a flared portion, according to some embodiments. [Figure 20] 13A shows a detailed view of a proximal portion of an introducer needle having a sheath that is within a needle slot of a needle shaft and includes an inwardly protruding protuberance or ridge, according to some embodiments. [Figure 21] 13A is a cross-sectional view of an introducer needle having a sheath that is within a needle slot of a needle shaft and includes an inwardly protruding protuberance or ridge, according to some embodiments. [Figure 22] 1 illustrates a detailed view of a distal portion of an introducer needle having a relatively thin sheath, according to some embodiments. [Figure 23] 1 illustrates a distal end view of an introducer needle having a relatively thin sheath, according to some embodiments. [Figure 24]13A shows a detailed view of a distal portion of an introducer needle having a relatively thick sheath, according to some embodiments. [Diagram 25] 1 illustrates a distal end view of an introducer needle having a relatively thick sheath, according to some embodiments. [Figure 26] 13A shows a detailed view of a distal portion of an introducer needle having a longitudinal strip covering the needle slot and adhered to the needle shaft, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] 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.

[0028] 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. Labels such as "left," "right," "upper," "lower," "front," "rear," etc. are used for convenience and do not imply a particular fixed position, orientation, or direction, for example. Instead, such designations are used to reflect a relative position, orientation, or direction, for example. The singular forms "one," "one," and "said" include plural references unless the context clearly dictates otherwise.

[0029] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a catheter includes the portion of the catheter intended to be near the clinician when the catheter is used with a patient. Similarly, for example, a "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used with a patient. For example, the "proximal end" of a needle includes the end of the catheter intended to be near the 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 suggested 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.

[0030] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter includes a portion of the 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 the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, the "distal end" of a needle includes the end of the 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.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As discussed above with respect to the Seldinger technique, the many steps are time consuming and the handling of numerous medical devices is cumbersome, all of which can be traumatic for the patient. In addition, the large number of medical devices that need to be replaced during the Seldinger technique increases the likelihood of contamination through contact. There is therefore a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient's body and advancing the catheter through its vasculature.

[0032] Disclosed herein is an introducer sheath for an introducer needle, which can be used separately or together with a RICC or even other CVC. For example, the introducer needle can include a needle shaft, a sheath, and a needle hub. The needle shaft can include a needle slot extending from a proximal portion of the needle shaft to a distal needle tip. The sheath can be disposed over the needle shaft and fixed in position at least on the needle shaft. The sheath can seal the needle slot below the sheath, except for a sheath opening at a proximal portion of the sheath. The needle hub can be around at least a proximal portion of the needle shaft. A method of manufacturing the introducer needle is also disclosed.

[0033] The above and other features of the introducer sheath, introducer needle, RICC, and method disclosed herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in detail certain of the above-mentioned embodiments, beginning with a RICC insertion assembly. However, it should be understood that the RICC of this RICC insertion assembly is only one type of catheter that can be used with an introducer needle and incorporated into a catheter insertion assembly such as that disclosed herein. Indeed, other CVCs, peripherally inserted central catheters (PICCs), dialysis catheters, and the like, can also be used with an introducer needle and incorporated into a catheter insertion assembly.

[0034] RICC Insertion Assembly FIG. 1 illustrates a RICC insertion assembly 100 according to some embodiments. As shown, the RICC insertion assembly 100 includes a RICC 102, an introducer needle 104, an access guidewire 106, and a coupler 108 that couples the RICC 102, the introducer needle 104, and the access guidewire 106 together in a ready-to-operate state of the RICC insertion assembly 100. As described in more detail below, in the ready-to-operate state of the RICC insertion assembly 100, a proximal end of the access guidewire 106 is coupled to the coupler 108 and a distal end of the access guidewire 106 is disposed within the needle lumen 158 of the introducer needle 104. This causes a loop 110 to be formed in the access guidewire 106 over which it is disposed in the ready-to-operate state of the RICC insertion assembly 100, maintaining the RICC insertion assembly 100 in a relatively compact configuration.

[0035] The RICC insertion assembly 100 may further include a syringe 112 fluidly coupled to the introducer needle 104 in a ready-to-operate state of the RICC insertion assembly 100. As described below, the sealing module of the coupler 108 seals around a proximal portion of the introducer needle 104 and a distal portion of the access guidewire 106 when the sealing module insert 198 is compressed within the sealing module cavity 178 of the coupler housing 172 in one or more states of the RICC insertion assembly 100. Specifically, the sealing module seals over a sheath opening 162 of the sheath 142 that is open to a needle slot 150 of the needle shaft 144. Outside of the sealing module, the sheath 142 seals the needle slot 150 of the needle shaft 144. Such a seal allows the syringe 112 to aspirate blood.

[0036] FIG. 3 illustrates a RICC 102 of a RICC insertion assembly 100, according to some embodiments. As shown, the RICC 102 includes a catheter tube 114 , a catheter hub 116 , one or more extension legs 118 , and one or more extension leg connectors 120 .

[0037] 4-7 show various views of the catheter tube 114 of the RICC 102, according to some embodiments. The catheter tube 114 includes a first section 122 at a distal portion of the catheter tube 114, a second section 124 at a distal portion of the catheter tube 114 proximal to the first section 122, and a tapered junction 126 between the first section 122 and the second section 124 of the catheter tube 114.

[0038] The first section 122 of the catheter tube 114 includes a catheter tip 128 having a relatively short taper from an outer diameter of a distal portion of the first section 122 distal to the junction 126 to an outer diameter of the distal end of the first section 122. The taper of the catheter tip 128 is configured to immediately dilate tissue surrounding the puncture path established by the introducer needle 104 to the outer diameter of the distal portion of the first section 122 of the catheter tube 114. As best shown in FIG. 7, the first section 122 of the catheter tube 114 also includes a proximal portion that is disposed within a bore distal to the junction 126 and fixedly coupled thereto, such as by solvent bonding, adhesive bonding, or heat welding.

[0039] The second section 124 of the catheter tube 114 includes a consistent outer diameter along its length, from the distal end of the second section 124 to the proximal end of the second section 124. The consistent diameter of the second section 124 of the catheter tube 114 is configured for smooth insertion into the puncture tract and target vasculature following expansion by the first section 122 of the catheter tube 114 and the junction 126. The distal end of the second section 124 of the catheter tube 114 has a flat surface that is flush with the flattened proximal end of the junction 126 and is fixedly joined thereto, such as by solvent bonding, adhesive bonding, or heat welding.

[0040] The junction 126 includes a taper over its length from the proximal end of the junction 126 to the distal end of the junction 126. The taper of the junction 126 is configured to immediately expand the tissue surrounding the puncture path from the outer diameter of the proximal portion of the first section 122 of the catheter tube 114 to the outer diameter of the second section 124 of the catheter tube 114. The abluminal surface of the junction 126 transitions smoothly from the abluminal surface of the first section 122 of the catheter tube 114 to the abluminal surface of the second section 124 of the catheter tube 114 and does not have edges that may catch on the skin as the catheter tube 114 is inserted into the puncture path. In addition to having minimal or negligible edges, the edges may include a solvent interdiffusion polymeric material of the multiple polymeric materials forming the catheter tube 114, which provides a smooth transition from the first section 122 of the catheter tube 114 to the junction 126 and from the junction 126 to the second section 124 of the catheter tube 114. Notably, the junction 126 has a length that is approximately equal to the length of the exposed portion of the first section 122 of the catheter tube 114 or a length between the lengths of the exposed portions of the first section 122 and the second section 124 of the catheter tube 114. As such, the length of the exposed portion of the first section 122 of the catheter tube 114 is less than the length of the junction 126 and is at most approximately equal to the length of the junction 126.

[0041] The first section 122 of the catheter tube 114 is formed from a first polymeric material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer hardness. The second section 124 of the catheter tube 114 is formed from a second polymeric material (e.g., polyvinyl chloride, polyethylene, another polyurethane, or silicone) having a second durometer hardness less than the first durometer hardness. For example, the first section 122 of the catheter tube 114 can be formed from a first polyurethane having a first durometer, and the second section 124 of the catheter tube 114 can be formed from a second, different polyurethane having a second durometer less than the first durometer (e.g., the same or different diisocyanates or triisocyanates reacted with different diols or triols, different diisocyanates or triisocyanates reacted with the same or different diols or triols, the same diisocyanates or triisocyanates reacted with the same diols or triols under different conditions or with different additives, etc.). Indeed, polyurethanes are advantageous for the catheter tube 114 in that they are relatively stiff at room temperature, but may become more flexible in vivo at body temperature, thereby reducing irritation to the vessel wall and phlebitis. Polyurethanes are also advantageous in that they may be less thrombogenic than some other polymers. The joint 126 is formed from a second polymeric material or from a third polymeric material (e.g., yet another polyurethane) having a third durometer hardness less than the first durometer hardness and greater than, approximately equal to, or less than the second durometer hardness.

[0042] It should be understood that the first durometer hardness of the first polymeric material, the second durometer hardness of the second polymeric material, and the third durometer hardness of the third polymeric material may be on different scales (e.g., Type A or Type D). With this understanding, the second durometer hardness of the second polymeric material or the third durometer hardness of the third polymeric material may not be numerically less than the first durometer hardness of the first polymeric material if the second durometer hardness or the third durometer hardness is less than the first durometer hardness. In fact, the hardness of the second polymeric material or the third polymeric material may still be less than the hardness of the first polymeric material. This is because the different scales, each ranging from 0 to 100, are designed to characterize separate materials within a group of materials having similar hardness.

[0043] With the first section 122 of the catheter tube 114, the second section 124 of the catheter tube 114, and the junction 126 between the first section 122 and the second section 124 of the catheter tube 114 described above, the catheter tube 114 has sufficient buckling strength to prevent buckling of the catheter tube 114 when inserted into a needle tract established by an introducer needle 104, described below, optionally in combination with an access guidewire 106. The buckling strength of the catheter tube 114 is also sufficient to prevent buckling of the catheter tube 114 when advanced through a patient's vasculature without pre-dilating the tissue surrounding the needle tract or any vessels in the vasculature with a separate dilator.

[0044] The catheter tube 114 includes one or more catheter tube lumens extending therethrough. However, typically in a multi-lumen RICC (e.g., a two-lumen RICC, a three-lumen RICC, a four-lumen RICC, a five-lumen RICC, a six-lumen RICC, etc.), there is only one catheter tube lumen extending from the proximal end of the catheter tube 114 to the distal end of the catheter tube 114. (See FIGS. 4-7.) Indeed, the first section 122 of the catheter tube 114 typically includes a single lumen, as shown in FIGS. 4 and 7.

[0045] A catheter hub 116 is coupled to a proximal portion of the catheter tube 114. The catheter hub 116 includes one or more catheter hub lumens corresponding to the number of the one or more catheter tube lumens. The one or more catheter hub lumens extend entirely through the catheter hub 116 from the proximal end of the catheter hub 116 to the distal end of the catheter hub 116.

[0046] Each of the one or more extension legs 118 is coupled by its distal portion to the catheter hub 116. Each of the one or more extension legs 118 includes one or more extension leg lumens, the number of which corresponds to the number of the one or more catheter hub lumens. Each of the one or more extension leg lumens extends entirely through the extension leg from a proximal end of the extension leg to a distal end of the extension leg.

[0047] Each of the one or more extension leg connectors 120 covers a proximal portion of one of the one or more extension legs 118. For example, each of the one or more extension leg connectors 120 can be a luer connector that covers a proximal portion of one of the one or more extension legs 118. Through such an extension leg connector, a corresponding extension leg and its extension leg lumen can be connected to another medical device and its lumen. However, in the ready-to-operate state of the RICC insertion assembly 100, at least one extension leg connector (e.g., an extension leg connector including a portion of the primary lumen 130 of the RICC 102) is indirectly connected to the access guidewire connection side arm 174 of the coupler 108 via the intervening access guidewire hub 218, realizing a loop 110 on the access guidewire 106 and the RICC 102 covering it.

[0048] As shown, the RICC 102 is a tri-lumen RICC including a set of three lumens. However, the RICC 102 is not limited to the set of three lumens described above. The set of three lumens includes a primary lumen 130, a secondary lumen 132, and a tertiary lumen 134, which are formed from fluidly connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens. The primary lumen 130 has a primary lumen aperture 136 at the distal end of the first section 122 of the catheter tube 114, which corresponds to the distal end of the catheter tube 114 and the distal end of the RICC 102. The secondary lumen 132 has a secondary lumen aperture 138 on the side of the distal portion of the catheter tube 114. The tertiary lumen 134 has a tertiary lumen aperture 140 on a side of the distal portion of the catheter tube 114 proximal to the secondary lumen aperture 138 .

[0049] Figure 8 shows a top view of the introducer needle 104 of the RICC insertion assembly 100, according to some embodiments. Figure 9 shows the sheath 142 of the introducer needle 104, according to some embodiments. Figure 10 shows the needle shaft 144 of the introducer needle 104, according to some embodiments.

[0050] As shown, the introducer needle 104 includes a needle shaft 144, a sheath 142 that covers the needle shaft 144, and a needle hub 146 at a proximal portion of the introducer needle 104, the needle hub covering or surrounding at least a proximal portion of the needle shaft 144, including the proximal end of the needle shaft 144. At least in the ready-to-operate state of the RICC insertion assembly 100, the needle shaft 144 and sheath 142 extend from the needle hub 146, through a sealing module of the coupler 108, and out the distal end of the coupler housing 172.

[0051] The needle shaft 144 includes a tip 148 at a distal portion of the needle shaft 144 and a longitudinal needle slot 150 that extends from a proximal portion of the needle shaft 144 to the tip 148 .

[0052] The needle tip 148 includes a bevel having a tip bevel, or secondary bevel 152, and a primary bevel 154 proximal to the tip bevel 152, which terminates in a proximal heel. The tip bevel angle of the tip bevel 152 is greater than the primary bevel angle of the primary bevel 154 such that the bevel provides a smooth transition across the needle tip 148. Such a needle tip is thus configured to establish a needle pathway from an area of ​​the patient's skin into a blood vessel lumen. Notably, the top of the needle shaft 144 includes the bevel heel, the bottom of the needle shaft 144 includes the bevel tip bevel 152, and the sides of the needle shaft 144 are between the bevel heel and the tip bevel 152.

[0053] The needle slot 150 extends from the proximal portion of the needle shaft 144 to the needle tip 148, thereby forming a needle channel 156 along most of the length of the needle shaft 144, as opposed to a needle lumen that extends through the needle shaft.

[0054] The needle slot 150 can extend linearly along at least a portion of the needle shaft 144, such as from a small portion of the top of the needle shaft 144 to a majority of the top of the needle shaft 144, but less than the proximal end of the needle shaft 144 (e.g., by about 0.2-0.3 inches (5.1-7.6 mm)). The needle slot 150 can also extend along the entire top of the needle shaft 144, including the proximal end of the needle shaft 144. As shown in FIG. 10, for example, the needle slot 150 extends along a majority of the top of the needle shaft 144 from the proximal portion of the needle shaft 144, across the heel of the bevel, to the tip 148, excluding the proximal end of the needle shaft 144. When the needle slot 150 crosses the heel of the bevel, for example, there is greater bending strength of the needle shaft 144 along the top and bottom of the needle shaft 144 about at least a distal portion of the needle shaft 144, as compared to needle slots on the sides of the needle shaft 144, which configurations may also be made. This can be important because the introducer needle 104 is typically bent at the top or bottom of the needle shaft 144 about the distal portion of the needle shaft 144 during percutaneous puncture with the introducer needle 104 when establishing a needle pathway from an area of ​​the patient's skin to a blood vessel lumen.

[0055] The needle slot 150 has a needle slot width sized at least according to the outer diameter of the access guidewire 106, which allows the access guidewire to pass from the proximal portion of the needle shaft 144 to the needle tip 148 when the introducer needle is withdrawn along with the access guidewire 106 following percutaneous puncture. In practice, the needle slot 150 can have a constant needle slot width sized at least according to the outer diameter of the access guidewire 106, such as slightly larger than the outer diameter of the access guidewire 106. For example, the slot width can range from about 0.018 inches (about 0.46 mm) to about 0.035 inches (about 0.89 mm).

[0056] Further description of the needle shaft 144 is provided below with respect to various securing means for securing the sheath 142 to the needle shaft 144 to prevent proximal or distal movement of the sheath 142 relative to the needle shaft 144, including one or more protrusions 230 on the proximal portion of the needle shaft 144, a flared portion 234 of the needle shaft 144, a stepped portion 236 of the needle shaft 144, and a recess 238 in the needle shaft 144.

[0057] Notably, the needle shaft 144 includes a needle channel 156, while the introducer needle 104 includes a needle lumen 158. This is because the needle lumen 158 results from the combination of the needle shaft 144 and the sheath 142, with the sheath 142 covering the needle shaft 144. In effect, the sheath 142 covering the needle shaft 144 seals the needle channel 156 and forms the needle lumen 158 of the introducer needle 104, thereby allowing the syringe 112 to aspirate blood following percutaneous puncture by the introducer needle 104, which establishes a needle pathway from an area of ​​the patient's skin to the lumen of a blood vessel.

[0058] The sheath 142 includes a sheath tip 160 at a distal portion of the sheath 142 and a sheath opening 162 on a side of a proximal portion of the sheath 142 . The sheath tip 160 includes a relatively short taper from the outer diameter of the distal portion of the sheath 142 to the outer diameter of the distal end of the sheath 142 that is comparable to the outer diameter of the distal portion of the needle shaft 144 (a needle shaft 144 having a recess as specified below is contemplated). The taper has a taper angle that is less than the primary bevel angle of the primary bevel 154 of the needle tip 148, which in turn is less than the tip bevel angle of the tip bevel 152 of the needle tip 148. The sheath tip 160, including such a taper, is configured to provide a smooth transition from the needle tip 148 to the sheath body during percutaneous puncture to establish a needle pathway from an area of ​​the patient's skin to a vascular lumen.

[0059] The sheath opening 162 is open to the needle slot 150 of the needle shaft 144 to allow the access guidewire 106 to pass through the sheath opening 162 and into the needle slot 150 when the RICC insertion assembly 100 is in a ready-to-operate state. Thus, the sheath opening 162 has a width that corresponds approximately to the width of the needle slot 150 below it, which is sized according to the diameter of the access guidewire 106. The sheath opening 162 is also long enough to allow the access guidewire 106 to pass through the sheath opening 162 and into the needle slot 150. Notably, the sheath 142 covering the needle shaft 144 seals off the needle slot 150 below it, but not the needle slot below the sheath opening 162. However, the sealing module of the coupler 108 covers and seals the needle slot 150 exposed by the sheath opening 162 by sealing the needle shaft 144 and the proximal portion of the sheath 142 therein, thereby allowing the syringe 112 to aspirate blood following percutaneous puncture by the introducer needle 104, which establishes a needle pathway from an area of ​​the patient's skin to the vascular cavity.

[0060] The sheath 142 may be a cuttable or separable sheath configured to cut or separate the sheath 142 from the needle shaft 144, respectively, to allow the access guidewire 106 to exit the needle shaft 144 through the needle slot 150. If configured to cut from the needle shaft 144, the sheath 142 may be formed from a polymeric material, such as polyurethane, that allows the sheath 142 to be easily cut from the needle shaft 144. If configured to be separated from the needle shaft 144, the sheath 142 may include one or more weakened portions of the sheath 142 (e.g., a longitudinal perforation pattern, longitudinal grooves, etc.) that allow the sheath 142 to be easily separated from the needle shaft 144.

[0061] The sheath 142, or the sheath body thereof, is formed from a polymeric material configured to facilitate smooth and consistent insertion of the introducer needle 104 from an area of ​​the patient's skin into the vascular lumen. In addition, the polymeric material has sufficient mechanical properties at the sheath 142 thickness (i.e., sheath wall thickness described below) to withstand the sheath 142 from collapsing into the needle slot 150 of the needle shaft 144 when blood is aspirated through the introducer needle 104 using the syringe 112, while also facilitating cutting or separation of the sheath 142, particularly from the needle shaft 144. Such polymeric materials may include, but are not limited to, polyethylene, polypropylene, polyurethane, or polytetrafluoroethylene (PTFE). In one example, in an embodiment of the RICC insertion assembly 100 in which the sheath 142 is cut from the needle shaft 144, the sheath 142 can be polyurethane. As another example, in embodiments of the RICC insertion assembly 100 in which the sheath 142 is separated from the needle shaft 144, the sheath 142 can be PTFE or even expanded PTFE (ePTFE). If the sheath 142 is ePTFE, for example, the sheath 142 does not need to include one or more weakened portions of the sheath 142 to separate it from the needle shaft 144, since the ePTFE itself facilitates separation of the sheath 142 from the needle shaft 144 due to the longitudinal orientation of the polymer chains in ePTFE.

[0062] The sheath 142 can have a sheath wall thickness ranging from about 0.001 inch (about 0.025 mm) to about 0.010 inch (about 0.25 mm). In one example, the sheath wall thickness of the sheath 142 can be relatively thin, such as about 0.001 inch (about 0.025 mm) to about 0.003 inch (about 0.076 mm), e.g., about 0.001 inch (about 0.025 mm), as shown in Figures 22 and 23. With such a relatively thin sheath 142, the caliber of the introducer needle 104 is relatively small, resulting in a narrow needle path, and therefore minimizing tissue damage due to expansion when the introducer needle 104 is used to make a percutaneous puncture. In another example, the sheath 142 may have a relatively thick sheath wall thickness, such as about 0.006 inches (about 0.15 mm) to about 0.008 inches (about 0.20 mm), as shown in FIGS. 24 and 25. Such a relatively thick sheath 142 may better resist collapsing into the needle slot 150 of the needle shaft 144 when blood is aspirated through the introducer needle 104 using the syringe 112. Higher pressure injections may also be possible through the relatively thick sheath 142. In yet another example, the sheath wall thickness of the sheath 142 may be between the two sheath wall thicknesses described above, for example, about 0.003 inches (about 0.076 mm) to about 0.006 inches (about 0.15 mm).

[0063] Further description of the sheath 142 is provided below with respect to various fixing means for fixing the sheath 142 to the needle shaft 144 to prevent proximal or distal movement of the sheath 142 relative to the needle shaft 144, including the optical transparency of the sheath 142 to one or more wavelengths, one or more through holes 232 in the sheath 142, or protrusions 240 or ridges 242 in the sheath 142.

[0064] The sheath 142 may be disposed over the needle shaft 144 and may be at least fixed in position to prevent proximal movement of the sheath 142, distal movement of the sheath 142, or both proximal and distal movement of the sheath 142 relative to the needle shaft 144. Indeed, any one or more of a variety of fastening means for fastening the sheath 142 to the needle shaft 144, as shown in Figures 11-21 and 26 or described below, may be used to prevent proximal or distal movement of the sheath 142 relative to the needle shaft 144.

[0065] The sheath 142 may be a heat shrinkable material, and the sheath 142 may be heat shrunk over the needle shaft 144, thereby securing the sheath 142 to the needle shaft 144. The sheath 142 may also be secured to the needle shaft 144 using an engineering fit selected from an transition fit and an interference fit as defined in accordance with the International Organization for Standardization (ISO) (Geneva, Switzerland). It is notable that the sheath 142 does not need to be heat shrunk onto the needle shaft 144 in order for the sheath 142 to be secured to the needle shaft 144 by such an engineering fit. In fact, the sheath 142 of any introducer needle 104 disclosed herein may be disposed over the needle shaft 144 and secured thereto using an engineering fit selected from an transition fit and an interference fit.

[0066] 11-14 show various views of an introducer needle 104 having a sheath 142 adhered to a needle shaft 144 by an intervening adhesive 228, according to some embodiments.

[0067] As shown, the sheath 142 can be adhered to the needle shaft 144 using an adhesive 228, thereby securing the sheath 142 to the needle shaft 144. Such an adhesive can be a non-reactive adhesive, such as a pressure sensitive adhesive disposed between the sheath 142 and the needle shaft 144, a reactive but reacted adhesive, such as an epoxy resin that is cured between the sheath 142 and the needle shaft 144, or even an intervening tie layer of a cured tie layer resin (e.g., ethylene-acrylic acid (EAA), ethylene methacrylic (EMAA), or ethylene-methyl acrylate (EMA)) between the sheath 142 and the needle shaft 144. Notably, the outer surface of the needle shaft 144 can be textured or roughened to increase its contact area for interaction with the adhesive 228. However, such textured or roughened outer surfaces of the needle shaft 144 are not necessarily limited to embodiments of the introducer needle 104 in which the sheath 142 is bonded to the needle shaft 144. Indeed, the needle shaft 144 of any introducer needle 104 disclosed herein can include a textured or roughened outer surface. For example, the irregularities on the roughened outer surface of the needle shaft 144 can be useful for biting into the inner or luminal surface of the sheath 142, thereby further securing the sheath 142 to the needle shaft 144.

[0068] FIG. 14 shows a detailed view of a distal portion of the introducer needle 104 where the sheath 142 is laser welded to the needle shaft 144, according to some embodiments. As shown, the sheath 142 may be laser welded to the needle shaft 144, thereby securing the sheath 142 to the needle shaft 144. Such a sheath is translucent to at least one wavelength or range of wavelengths of the laser used to laser weld the sheath 142 to the needle shaft 144. However, the sheath 142 may also be translucent to visible light. Such a sheath allows a user to visualize the spurt of blood through the sheath 142 sealing the lower needle slot 150 and into the needle shaft 144 upon successful performance of a percutaneous puncture with the introducer needle 104, which establishes a needle pathway from an area of ​​the patient's skin to the vessel lumen.

[0069] FIG. 15 is a detailed view of a needle shaft 144 having one or more protrusions 230 protruding outwardly, and optionally a sheath 142 having one or more through holes 232 formed to correspond to the one or more protrusions 230, according to some embodiments.

[0070] As shown, the needle shaft 144 may include one or more protrusions 230 configured to limit the sheath 142 from sliding over the needle shaft 144, regardless of whether the sheath 142 includes one or more through holes 232. The one or more protrusions 230 may be at a proximal portion of the needle shaft 144 proximal to the needle slot 150, as shown in FIG. 15. However, the one or more protrusions 230 may alternatively be at a proximal portion of the needle shaft 144 distal to the needle slot 150, or at a distal portion of the needle shaft 144 proximal to the needle tip 148. That said, the one or more protrusions 230 may alternatively be at some combination of the foregoing, such as at a proximal portion of the needle shaft 144 proximal to the needle slot 150 and distal to the needle slot 150. Each of the one or more protrusions 230 can be one or more posts, as shown in Figure 15, or one or more arcuate ridges, where each of the one or more arcuate ridges is around at least a portion of the circumference of the needle shaft 144. However, the one or more protrusions 230 can also be a combination of posts and arcuate ridges in embodiments of the needle shaft 144 that include multiple protrusions 230.

[0071] The sheath 142 may be placed directly over one or more protrusions 230 of the needle shaft 144, thereby securing the sheath 142 to the needle shaft 144 by the one or more protrusions 230 protruding or biting into the sheath 142. Alternatively, the sheath 142 may include one or more through holes 232 formed to accommodate the one or more protrusions 230. When the sheath 142 is placed over the needle shaft 144, the one or more protrusions 230 of the needle shaft 144 are respectively positioned in the one or more through holes 232 of the sheath 142, thereby securing the sheath 142 to the needle shaft 144.

[0072] 18 and 19 show different views of an introducer needle 104 having a needle shaft 144 that includes a flared portion 234, according to some embodiments. As shown, a proximal portion of the needle shaft 144 proximal to the needle slot 150 may include a flared portion 234, thereby securing the sheath 142 to the needle shaft 144, at least with respect to its proximal position on the needle shaft 144. In effect, the flared portion 234 of the needle shaft 144 is configured to limit the sheath 142 from sliding proximally over the needle shaft 144.

[0073] FIG. 16 shows a detailed view of the introducer needle 104 having a needle shaft 144 that includes a stepped portion 236, according to some embodiments. As shown, a proximal portion of the needle shaft 144 proximal to the needle slot 150 may include a stepped portion 236, thereby securing the sheath 142 to the needle shaft 144, at least with respect to its proximal position on the needle shaft 144. In effect, the stepped portion 236 of the needle shaft 144 is configured to limit the sheath 142 from sliding proximally over the needle shaft 144.

[0074] FIG. 17 shows an introducer needle 104 having a needle shaft 144 that includes a recess 238, according to some embodiments. As shown, the needle shaft 144 can include a recess 238 between a proximal portion of the needle shaft 144 and the tip 148, thereby securing the sheath 142 to the needle shaft 144 with respect to both proximal and distal positions on the needle shaft 144. In effect, the recess 238 in the needle shaft 144 is configured to limit the sheath 142 from sliding proximally or distally over the needle shaft 144. Notably, the sheath 142 is positioned within the recess 238 in the needle shaft 144 flush with the remainder of the needle shaft 144 so as not to snag on the skin when a percutaneous puncture is made with the introducer needle 104.

[0075] 20 and 21 show different views of an introducer needle 104 having a sheath 142 that includes an inwardly projecting protrusion 240 or longitudinal ridge 242 that resides within a needle slot 150 of a needle shaft 144, according to some embodiments.

[0076] As shown, the sheath 142 can include a protrusion 240 at a proximal portion of the sheath 142 configured to reside within the needle slot 150 and abut the proximal end of the needle slot 150, thereby securing the sheath 142 to the needle shaft 144, at least with respect to its proximal position on the needle shaft 144. In effect, the protrusion 240 in combination with the proximal end of the needle slot 150 limits the sheath 142 from sliding proximally over the needle shaft 144. Alternatively, the sheath 142 can include a ridge 242 extending from the proximal portion of the sheath 142 to the distal portion of the sheath 142 (excluding the sheath opening 162). Similar to the protrusion 240, the ridge 242 is configured to reside within the needle slot 150 and abut the proximal end of the needle slot 150, thereby limiting the sheath 142 from sliding proximally over the needle shaft 144.

[0077] FIG. 26 shows a detailed view of a distal portion of the introducer needle 104 having a longitudinal strip 244 covering the needle slot 150 and adhered to the needle shaft 144, according to some embodiments.

[0078] As shown, the introducer needle 104 need not include a sheath 142. In fact, the introducer needle 104 may include a needle shaft 144, a strip 244 instead of the sheath 142, and a needle hub 146. As described herein, the needle shaft 144 includes a needle slot 150 that extends from a proximal portion of the needle shaft 144 to the distal needle tip 148. However, in embodiments such as this embodiment, the strip 244, rather than the sheath 142, seals the needle slot 150 below. In fact, the strip 244 is glued to the needle shaft 144 and seals the needle slot 150 below, except for the proximal portion of the needle slot 150, thereby creating an opening (not shown) in the side of the introducer needle 104 similar to the sheath opening 162. In such an embodiment, the needle hub 146 surrounds at least the proximal portion of the needle shaft 144, similar to that described herein.

[0079] The needle hub 146 includes an access guidewire channel 164 at a distal portion of the needle hub 146 and a needle hub connector at a proximal portion of the needle hub 146 . The access guidewire channel 164 in the needle hub 146 is configured to allow the access guidewire 106 to pass over the needle hub 146 and guide the access guidewire 106 into the sealing module of the coupler 108. The access guidewire channel 164 is open such that the access guidewire 106 is located within the access guidewire channel 164, at least in the ready-to-operate state of the RICC insertion assembly 100. Advantageously, having the access guidewire channel 164 open allows the access guidewire 106 to remain in place as the introducer needle 104 is withdrawn from the RICC insertion assembly 100.

[0080] Although not shown, the needle hub connector includes a needle hub bore and an optional needle hub flange around the needle hub connector. The needle hub bore of the needle hub connector is configured to receive the syringe tip of the syringe 112 therein to fluidly connect the introducer needle 104 to the syringe 112. In fact, the needle hub bore can have a luer taper (e.g., a 6% taper) configured to receive the syringe tip therein, and the syringe tip can be complementarily configured with the luer taper.

[0081] The needle hub flange of the needle hub connector is configured to threadably mate with the female threads of a threaded collar around the syringe tip of the syringe 112. While the threaded collar of the syringe 112 is optional, the needle hub flange advantageously provides a so-called luer lock type connection with the female threads of the threaded collar, if both are present, which provides additional security against inadvertent separation of the introducer needle 104 and the syringe 112 over and above the security provided by an otherwise luer slip type connection.

[0082] FIG. 1 illustrates a coupler 108 of a RICC insertion assembly 100, according to some embodiments. As shown, the coupler 108 includes a coupler housing 172, an access guidewire connection side arm 174, and optionally, if the RICC insertion assembly 100 also includes a keeper 220, a separable casing retaining side arm 176.

[0083] FIG. 2 shows the sealed module cavity 178 and needle hub receptacle of the coupler housing 172, according to some embodiments. As shown, the coupler housing 172 includes a sealing module cavity 178 and a needle hub receptacle proximal to the sealing module cavity 178. The coupler housing 172 also includes a longitudinal coupler housing slot 182 formed along the length of the coupler housing 172, as shown in FIG.

[0084] The encapsulation module cavity 178 is configured to retain a encapsulation module insert 198 therein, as shown in FIG. As shown in FIG. 2 , the needle hub receptacle is configured to hold therein the needle hub 146 of the introducer needle 104. In effect, the needle hub receptacle includes the needle hub 146 inserted therein in the ready-to-operate state of the RICC insertion assembly 100. Although not shown, the coupler 108 may include a needle hub lock around the needle hub receptacle configured to lock the needle hub 146 within the needle hub receptacle. In effect, a pair of locking buttons (e.g., spring-loaded locking buttons) of the needle hub lock may be distributed between opposing sides of the coupler housing 172 such that each of the locking buttons extends through the coupler housing 172 on a respective side of the coupler 108. Such locking buttons may be configured to unlock the needle hub 146 when the locking buttons are pressed into the coupler housing 172 to withdraw the introducer needle 104 from the coupler 108. Releasing the lock button immediately releases the axial compression from the distal portion of the needle hub 146 that compresses the seal module insert 198 within the seal module cavity 178 of the coupler housing 172. This allows the seal module insert 198 to relax in order to withdraw the introducer needle 104 and subsequently the access guidewire 106 from the coupler 108.

[0085] The coupler housing slot 182 is configured to allow the access guidewire 106 to exit the coupler housing 172 after the introducer needle 104 is withdrawn from the coupler 108. Indeed, when the introducer needle 104 is withdrawn from the coupler 108, the sealing module insert 198 releases the access guidewire 106 to allow the access guidewire to exit the coupler housing 172 via the coupler housing slot 182.

[0086] Notably, the coupler housing 172 can be formed into a bullet-shaped body configured to be comfortably held underhand or overhand in the left hand for left-handed percutaneous puncture (e.g., venipuncture) and in the right hand for right-handed percutaneous puncture (e.g., venipuncture) with the RICC insertion assembly 100. To further facilitate such venipuncture, the exterior of the coupler housing 172 can be textured with grip-enhancing ridges (e.g., lateral or circumferential ridges), protrusions, or the like.

[0087] An access guidewire connection side arm 174 extends from the coupler housing 172. Although not shown, the access guidewire connection side arm 174 includes a connector configured to connect around a proximal end portion of the access guidewire 106 to an access guidewire hub 218 that extends from the proximal end of the RICC 102, at least in the ready-to-operate state of the RICC insertion assembly 100. During the ready-to-operate state of the RICC insertion assembly 100, a distal portion of the access guidewire 106 is disposed within the needle shaft 144 and the access guidewire hub 218 is connected to the connector of the access guidewire connection side arm 174, thereby achieving a loop 110 in which the RICC 102 is disposed over the access guidewire 106. When both the keeper 220 and the separable casing retaining side arm 176 are present in the RICC insertion assembly 100, the distal portion of the separable casing 222 is also retained within the primary channel 190 of the separable casing retaining side arm 176, thereby achieving a loop 110 in which the RICC 102 is positioned over the access guidewire 106.

[0088] When present, the separable casing retaining side arm 176 extends from the coupler housing 172 opposite the access guidewire connecting side arm 174. The separable casing retaining side arm 176 includes a primary channel 190 and a secondary channel 192. The primary channel 190 is configured to slidably retain the separable casing 222, or the separable casing 222 and at least the longitudinal composite of the access guidewire 106 therein. The secondary channel 192 is configured to direct the access guidewire 106, separated from the separable casing 222, into the coupler 108, its separable sealing module, and the needle shaft 144 sealed therein via the needle slot 150. A branch point 194 between the primary channel 190 and the secondary channel 192 of the separable casing retaining side arm 176 is configured to separate the access guidewire 106 from the separable casing 222 when the separable casing 222 and at least the longitudinal composite of the access guidewire 106 therein are pushed therein.

[0089] FIG. 2 illustrates a sealing module of the introducer needle 108 of the RICC insertion assembly 100, according to some embodiments. The sealing module of the coupler 108 includes a sealing module cavity 178 in the coupler housing 172 and an elastomeric (e.g., silicone) sealing module insert 198 disposed therein. The sealing module insert 198 includes a Y-shaped passage therethrough that is configured to allow the access guidewire 106 to pass through a side arm of said passage and into the introducer needle 104. In effect, the side arm of the Y-shaped passage is configured to direct the access guidewire 106 from the access guidewire channel 164 in the needle hub 146 into both the sheath opening 162 in the sheath 142 and the needle slot 150 therebelow in the needle shaft 144 such that the access guidewire 106 may be disposed within the needle shaft 144 with its distal end just proximal to the needle tip 148 in the ready-to-operate state of the RICC insertion assembly 100. The sealing module insert 198 is further configured to separately seal around the access guidewire 106 and around the introducer needle 104 when the sealing module insert 198 is compressed within the sealing module cavity 178 in one or more states of the RICC insertion assembly 100 (e.g., a ready-to-operate state or one or more operational states of the RICC insertion assembly 100).

[0090] The sealing module is configured to separately seal around a proximal portion of the introducer needle 104 and a distal portion of the access guidewire 106 when the sealing module insert 198 is compressed within the sealing module cavity 178. For example, the sealing module insert 198 can be compressed both axially and radially within the sealing module cavity 178 by the distal portion of the needle hub 146. The distal portion of the needle hub 146 axially compresses the sealing module insert 198 within the sealing module cavity 178 when the needle hub 146 is placed within the needle hub receptacle, such as in the ready-to-operate state of the RICC insertion assembly 100. The axial compression of the sealing module insert 198 within the sealing module cavity 178 then radially compresses the sealing module insert 198 within the sealing module cavity 178, thereby sealing the sealing module insert 198 around the introducer needle 104 and the access guidewire 106. The needle hub 146 can be removed from the needle hub receptacle in one or more operational states of the RICC insertion assembly 100 to release both axial and radial compression and then allow the introducer needle 104 to be withdrawn from the coupler 108 so that the access guidewire 106 can exit through the coupler housing slot 182.

[0091] FIG. 1 illustrates an access guidewire 106 disposed within a RICC insertion assembly 100, according to some embodiments. The access guidewire 106 includes a proximal portion including a proximal end and a distal portion including a distal end. In the ready-to-operate state of the RICC insertion assembly 100, the proximal end of the access guidewire 106 is coupled to the access guidewire connection side arm 174 by an access guidewire hub 218 around the proximal end portion of the access guidewire 106 including the distal end. In addition, the proximal portion of the access guidewire 106 extends along the primary lumen 130 of the RICC 102. The distal portion of the access guidewire 106 also extends along the primary lumen 130 of the RICC 102, but the distal portion of the access guidewire 106 further extends from the distal end of the RICC 102 as the catheter-external portion of the access guidewire 106 into a sealing module covering the needle hub 146 by an access guidewire channel 164, through both the sheath opening 162 of the sheath 142 and the needle slot 150 of the needle shaft 144, and into the needle shaft 144, and extends along the needle lumen 158 of the introducer needle 104 in the ready-to-operate state of the RICC insertion assembly 100. As shown in FIG. 1, the distal end of the access guidewire 106 is disposed within the needle lumen 158 just proximal to the needle tip 148 in the ready-to-operate state of the RICC insertion assembly 100. Again, the proximal and distal ends of the access guidewire 106 form a loop 110 in which the RICC 102 is positioned over the access guidewire 106 when the RICC insertion assembly 100 is in a ready-to-operate state, thereby keeping the RICC insertion assembly 100 in a relatively compact configuration.

[0092] The access guidewire 106 can include a guidewire tip at a distal portion of the access guidewire 106, the guidewire tip assuming a "J" shape configured to prevent puncturing the back wall of a blood vessel. Such guidewire tip assumes a straight state in a ready-to-operate state of the RICC insertion assembly 100 and a curved state when the guidewire tip is advanced beyond the needle tip 148 (e.g., advanced into the blood vessel lumen) in one or more operational states of the RICC insertion assembly 100 in which the access guidewire 106 is deployed.

[0093] The access guidewire 106 may also include a bare wire portion and a wrapped wire portion distal to the bare wire portion, proximal to the bare wire portion, or both. Although not shown, the bare wire portion, if present, extends distally to a side arm of the Y-shaped passageway through the sealing module such that, at least in the ready-to-operate state of the RICC insertion assembly 100 of the Y-shaped passageway, the sealing module forms a fluid-tight seal around the bare wire portion of the access guidewire 106. In particular, the aforementioned bare wire portion may instead be a flatwound or groundwound portion of the access guidewire 106, where a flatwound portion includes a wrap of tape instead of a round wire, and a groundwound portion includes a wrap of round wire that has been ground to flatten the wrap.

[0094] FIG. 1 shows a keeper 220 of a RICC insertion assembly 100, according to some embodiments. As shown, the keeper 220 can include a separable casing 222 and a catheter hub holder 224 to which the proximal end of the separable casing 222 is attached.

[0095] The separable casing 222 may form a longitudinal composite with the catheter tube 114, with the access guidewire 106, or with both the catheter tube 114 and the access guidewire 106 in the RICC insertion assembly 100. For example, with respect to the RICC insertion assembly 100 of FIG. 1 , the separable casing 222 covers, and thus forms a longitudinal composite with, both the catheter tube 114 and the access guidewire 106 in the portion of the RICC insertion assembly 100 closest to the catheter hub holder 224, where the access guidewire 106 is disposed within the primary lumen 130 of the RICC 102. 1, the separable casing 222 covers and thus forms a longitudinal composite only with the access guidewire 106 in the portion of the RICC insertion assembly 100 closest to the coupler 108 or its separable casing retaining side arm 176, where the extra-catheter portion of the access guidewire 106 extends from the distal end of the RICC 102. The separable casing 222 is configured to be separated along its length, for example, as it slides over the bifurcation 194 of the separable casing retaining side arm 176 of the coupler 108, thereby first exposing the extra-catheter portion of the access guidewire 106 and then exposing the distal portion of the catheter tube 114. In this manner, the separable casing 222 is configured to keep the catheter tube 114 and at least the distal portion of the access guidewire 106 sterile until deployment.

[0096] The catheter hub holder 224 is configured to hold the catheter hub 116 therein and also to hold the separable casing 222 in place over the catheter tube 114 and the access guidewire 106, particularly the outer catheter portion of the access guidewire 106. The catheter hub holder 224 includes a peripheral wall 226 around at least a portion (e.g., a proximal portion) of the circumference of the catheter hub holder 224. The peripheral wall 226 defines a recess into which the catheter hub 116 fits with an engineered fit (e.g., a clearance fit such as a running fit, a sliding fit, or a location fit, or an intermediate fit such as a fit similar to those classified by ISO and a fixed fit), as well as one or more gaps for extending through the one or more extension legs 118. Additionally or alternatively, the catheter hub holder 224 can include wings that correspond to the suture wings of the catheter hub 116. Such wings may include posts configured for insertion into suture wing holes in the suture wing of the catheter hub 116 via an engineered fit.

[0097] method The method includes at least a method for fabricating the introducer needle 104. Such a method includes one or more steps selected from the steps of metal strip rolling, seam welding, cold working, grinding, needle slot forming, edge finishing, sheath positioning, sheath fixation, sheath opening forming, and needle hub fixation.

[0098] The metal strip rolling step includes rolling a strip of metal, such as stainless steel, into a metal tube. For example, the metal strip rolling step may include using a milling machine to roll the metal strip into a metal tube. Such a metal tube includes a longitudinal seam formed between the longitudinal side edges of the metal strip.

[0099] The seam welding step includes welding a seam formed between the side edges of the metal strip. For example, the seam welding step can include laser welding a seam formed between the side edges of the metal strip.

[0100] The cold working step involves forcing the metal tube through one or more dies one or more times, thereby reducing the outer diameter of the metal tube while simultaneously increasing the thickness of the metal tube wall of the metal tube. Following the cold working step, the metal tube may be scored to separate it into two or more smaller metal tubes and batched for the grinding step, although for ease of explanation, such further processing will be described with reference to the metal tube previously described.

[0101] The grinding step includes grinding the end of the metal tube at multiple angles to form a needle shaft 144 with a beveled needle tip 148. For example, grinding the end of the metal tube at a first angle forms a main bevel 154 that includes the heel of the bevel, and grinding the end of the metal tube at two similar but opposing second angles forms a tip bevel 152 of the bevel.

[0102] The needle slot forming step includes forming the needle slot 150 in the needle shaft 144. In one example, the needle slot forming step may include cutting the needle slot 150 in the needle shaft 144 by machining or laser cutting. The needle slot walls resulting from cutting the needle slot 150 into the needle shaft 144 face each other and are parallel to each other. In another example, the needle slot forming step may include grinding the needle slot 150 into the needle shaft 144. The needle slot walls resulting from grinding the needle slot 150 into the needle shaft 144 face in a direction that does not face the bottom of the needle slot 150. As described above, the needle slot 150 extends from a proximal portion of the needle shaft 144 to the needle tip 148.

[0103] The edge finishing step involves finishing (e.g., grinding, polishing, etc.) the edges of the needle slot walls to minimize or eliminate sharp, access guidewire-fraying edges in the needle slot 150.

[0104] The sheath placement step includes placing the sheath 142 over the needle shaft 144, where the sheath 142 seals the needle slot 150 below. Placing the sheath 142 over the needle shaft 144 may include inserting the needle shaft 144 into the sheath 142.

[0105] The sheath fixing step includes any of several methods of fixing the sheath 142 to the needle shaft 144 according to the introducer needle 104 embodiments described above. In one example, the sheath fixing step may include heat shrinking the sheath 142 over the needle shaft 144, resulting in an engineered fit selected from a transition fit and an interference fit. In another example, the sheath fixing step may include gluing the sheath 142 to the needle shaft 144 with an adhesive 228 selected from a pressure sensitive adhesive, an epoxy, and a tie layer resin. In another example, the sheath fixing step may include laser welding the sheath 142 to the needle shaft 144. Again, such a sheath 142 is transparent to at least one wavelength or range of wavelengths of the laser used for laser welding. In another example, the sheath fixing step may include welding (e.g., micro-welding, laser welding, etc.) one or more protrusions 230 onto the needle shaft 144, cutting one or more through holes 232 into the sheath 142, and placing the sheath 142 over the needle shaft 144 such that the one or more protrusions 230 are respectively disposed within the one or more through holes 232. In another example, the sheath fixing step may include recessing a portion of the needle shaft 144 between a proximal portion of the needle shaft 144 and the needle tip 148 to form a recess 238 in the needle shaft 144, and then placing the sheath 142 over the needle shaft 144 in the recess 238 in the needle shaft 144, with the sheath 142 flush with the remaining portion of the needle shaft 144.

[0106] The sheath opening forming step includes forming a sheath opening 162 in the sheath 142. Forming the sheath opening 162 in the sheath 142 may include cutting (e.g., laser cutting) the sheath opening 162 in the needle shaft 144 before or after placing the sheath 142 over the needle shaft 144 in the sheath placement step. As discussed above, the sheath 142 seals the needle slot 150 below it, except for the sheath opening 162 in a proximal portion of the sheath 142.

[0107] The needle hub fixing step includes fixing the needle hub 146 around at least a proximal portion of the needle shaft 144, thereby forming the introducer needle 104. The needle hub fixing step may include pressing the proximal portion of the needle shaft 144 into the needle hub 146 using an engineered fit selected from a transition fit and an interference fit. Additionally or alternatively, the needle hub fixing step may include gluing the needle hub 146 to the proximal portion of the needle shaft 144.

[0108] 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 needle, a needle shaft including a needle slot extending from a proximal portion of the needle shaft to a distal tip; a sheath disposed over the needle shaft and fixed in position on at least the needle shaft, the sheath sealing the needle slot below the sheath except for a sheath opening at a proximal portion of the sheath; a needle hub secured around at least a proximal portion of the needle shaft; An introducer needle comprising:

2. The introducer needle of claim 1 , wherein the sheath is adhered to the needle shaft with an intervening adhesive.

3. The introducer needle of claim 2 , wherein the adhesive is a pressure sensitive adhesive.

4. The introducer needle of claim 2 , wherein the adhesive is a cured epoxy resin.

5. The introducer needle of claim 2 , wherein the adhesive is a cured tie layer resin.

6. 2. The introducer needle of claim 1, wherein the sheath is laser welded to the needle shaft, and the sheath is transparent to at least one wavelength or range of wavelengths of a laser used to laser weld the sheath to the needle shaft.

7. 7. The introducer needle of claim 6, wherein the sheath is translucent to visible light, allowing a user to visualize blood spurting into the needle shaft through the sheath that seals the needle slot below the sheath when the introducer needle is used to make a percutaneous puncture.

8. 2. The introducer needle of claim 1, wherein the needle shaft includes one or more outwardly projecting protrusions on the proximal portion of the needle shaft proximal to the needle slot, on the proximal portion of the needle shaft distal to the needle slot, on the distal portion of the needle shaft proximal to the distal needle tip, or a combination thereof, the one or more protrusions configured to limit sliding of the sheath over the needle shaft.

9. The introducer needle of claim 8 , wherein the one or more protrusions are one or more posts, respectively.

10. 9. The introducer needle of claim 8, wherein the one or more protrusions are each one or more arcuate ridges, each arcuate ridge of the one or more arcuate ridges extending along at least a portion of the circumference of the needle shaft.

11. 9. The introducer needle of claim 8, wherein the sheath includes one or more through holes formed to accommodate the one or more protrusions, and the one or more protrusions of the needle shaft are respectively disposed within the one or more through holes of the sheath.

12. 12. The introducer needle of claim 1, wherein the proximal portion of the needle shaft proximal to the needle slot includes a flared portion configured to limit proximal sliding of the sheath over the needle shaft.

13. 12. The introducer needle of claim 1, wherein the proximal portion of the needle shaft proximal to the needle slot includes a stepped portion configured to limit proximal sliding of the sheath over the needle shaft.

14. 12. The introducer needle of claim 1, wherein the needle shaft includes a recess between the proximal portion of the needle shaft and the distal tip configured to limit sliding of the sheath over the needle shaft in a proximal or distal direction, and the sheath is positioned within the recess in the needle shaft flush with the remainder of the needle shaft.

15. 12. The introducer needle of claim 1, wherein the sheath includes an inwardly projecting protrusion at the proximal portion of the sheath, the protrusion being configured to reside within the needle slot and abut a proximal end of the needle slot to limit proximal sliding of the sheath over the needle shaft.

16. 12. The introducer needle of claim 1, wherein the sheath includes an inwardly protruding longitudinal ridge extending from the proximal portion of the sheath to the distal portion of the sheath, the ridge being within the needle slot and configured to abut a proximal end of the needle slot to limit proximal sliding of the sheath over the needle shaft.

17. The introducer needle of claim 1 , wherein the sheath is disposed over the needle shaft with an engineered fit selected from a transition fit and an interference fit.

18. 12. The introducer needle of claim 1, wherein the outer surface of the needle shaft is textured or roughened.

19. The introducer needle of any one of claims 1 to 11, wherein the sheath has a sheath wall thickness of between 0.001 inch (0.025 mm) and 0.003 inch (0.076 mm).

20. The introducer needle of any one of claims 1 to 11, wherein the sheath has a sheath wall thickness of between 0.003 inch (0.076 mm) and 0.006 inch (0.15 mm).

21. The introducer needle of any one of claims 1 to 11, wherein the sheath has a sheath wall thickness of between 0.006 inch (0.15 mm) and 0.008 inch (0.20 mm).

22. an introducer needle, a needle shaft including a needle slot extending from a proximal portion of the needle shaft to a distal tip; a longitudinal strip adhered to the needle shaft, the longitudinal strip sealing the needle slot below the longitudinal strip except for a proximal portion of the needle slot, thereby creating an opening in the side of the introducer needle; a needle hub secured around at least a proximal portion of the needle shaft; An introducer needle comprising:

23. 1. A method for manufacturing an introducer needle, comprising: forming a needle slot in the needle shaft, the needle slot extending from a proximal portion of the needle shaft to a distal tip; placing a sheath over the needle shaft and securing the sheath onto the needle shaft, the sheath sealing the needle slot below the sheath; securing a needle hub around at least a proximal portion of the needle shaft; A method comprising:

24. 24. The method of claim 23, wherein forming the needle slot comprises cutting or grinding the needle slot into the needle shaft.

25. 24. The method of claim 23, wherein positioning the sheath over the needle shaft comprises inserting the needle shaft into the sheath.

26. 26. The method of any one of claims 23 to 25, wherein securing the sheath to the needle shaft comprises adhering the sheath to the needle shaft with an adhesive selected from a pressure sensitive adhesive, an epoxy, and a tie layer resin.

27. 26. The method of any one of claims 23 to 25, wherein fixing the sheath to the needle shaft comprises laser welding the sheath to the needle shaft, the sheath being transparent to at least one wavelength or range of wavelengths of a laser used for the laser welding.

28. 26. The method of any one of claims 23 to 25, wherein securing the sheath to the needle shaft comprises welding one or more outwardly projecting protrusions onto the needle shaft, cutting one or more through holes in the sheath, and placing the sheath over the needle shaft such that the one or more protrusions are respectively positioned within the one or more through holes.

29. 26. The method of any one of claims 23 to 25, wherein securing the sheath to the needle shaft comprises recessing a portion of the needle shaft to form a recess in the needle shaft between the proximal portion of the needle shaft and the distal tip, and then positioning the sheath over the needle shaft in the recess in the needle shaft so that the sheath is flush with the remainder of the needle shaft.

30. 26. The method of any one of claims 23 to 25, further comprising, after positioning the sheath over the needle shaft, forming a sheath opening in the sheath by laser cutting, the sheath sealing the needle slot thereunder except for the sheath opening in a proximal portion of the sheath.

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