Catheterization tools

Abstract

Embodiments disclosed herein relate to an insertion tool (100) for a catheter. The insertion tool (100) engages the proximal end of an introducer (10) and includes a guide channel (106) aligned with the lumen of the introducer (10). The guide channel (106) supports the catheter (50) to maintain columnar integrity when the catheter (50) is pushed distally through a valve and into the lumen of the introducer (10). In one embodiment, an attachment structure can be inserted through the valve to define a path for the catheter. Embodiments also include an elongated opening that allows lateral entry / exit of the catheter, a segmented cylindrical shape that provides a shortened elongated opening, and an offset elongated opening that allows the catheter to be rolled into the guide channel to prevent wear of any coating disposed on the catheter.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 962,012, filed on January 16, 2020, which is incorporated by reference in its entirety into this application. Summary of the invention

[0003] In short, embodiments disclosed herein relate to an insertion tool for inserting a catheter into the lumen of an introducer. The insertion tool engages the proximal end of the introducer and includes a guide channel aligned with the lumen of the introducer. When the catheter is pushed distally, passes through a valve and enters the lumen of the introducer, the guide channel supports the catheter and maintains columnar integrity. Embodiments include an attachment structure that is inserted through a valve to limit the path that the catheter passes through. The attachment structure may include an interference fit engagement with the introducer. Embodiments also include an elongated opening that allows catheters to enter / leave laterally, a segmented cylindrical shape of a shortened elongated opening is provided, and a deflected elongated opening that allows catheters to be rolled into the guide channel to prevent any coating wear disposed on the catheter.

[0004] The present invention discloses an insertion tool for introducing a catheter into an introducer, comprising: an attachment structure configured to engage the proximal end of the introducer; and a guide channel, which is axially aligned with the inner cavity of the introducer when the attachment structure is engaged to the proximal end of the introducer, and the guide channel is configured to support a portion of the catheter to maintain the columnar integrity of the catheter during insertion of the catheter into the introducer.

[0005] In some embodiments, the guide channel defines an arcuate cross section and includes a radius of curvature comparable to the radius of curvature of the outer surface of the catheter. The guide channel extends through an arc of 30 degrees (30 °) or greater. The guide channel surrounds the portion of the catheter arranged therein. The attachment structure includes a clamp that engages with the outer surface of the connector arranged at the proximal end of the introducer. The clamp includes a first clamp arm and a second clamp arm, and the first clamp arm and the second clamp arm cooperate to at least partially surround the outer surface of the connector. The attachment structure includes a threaded portion that engages with the threaded portion arranged at the proximal end of the introducer. The attachment structure includes an opening and a recess that engages with a flange of the connector arranged at the proximal end of the introducer to prevent the longitudinal movement of the connector through the opening.

[0006] Also disclosed is a tool for inserting a catheter into an introducer, comprising: a body defining a substantially cylindrical shape; an attachment structure extending distally from a distal end of the body and configured to engage an inner surface of a connector of the introducer; and a guide channel extending from a proximal end of the body to a distal end of the attachment structure, the guide channel defining a path for the catheter and configured to maintain the columnar integrity of the catheter during insertion of the catheter into the introducer.

[0007] In some embodiments, the tool also includes an elongated opening that extends longitudinally and extends from the guide channel to the outer surface of the tool. In some embodiments, the lateral width of the elongated opening is less than the outer diameter of the conduit. In some embodiments, the transverse axis of the elongated opening is laterally offset from the central axis of the guide channel. The main body also includes a cylindrical segment shape, which includes a horizontal upper surface of the elongated opening that provides a transverse shortening. In some embodiments, the outer surface of the main body defines one of a concave or a biconcave shape. The main body includes a plurality of ribs extending radially therefrom, and the plurality of ribs define the outer periphery of the main body.

[0008] In some embodiments, the guide channel defines a tapered shape with a diameter gradually decreasing from a first diameter at a proximal end to a second diameter at a distal end. The attachment structure engages the inner surface of the connector in an interference fit, a friction fit, a press fit, or a snap fit engagement. The attachment structure includes a ridge extending radially outward from an outer surface thereof and configured to engage the inner surface of the connector in a friction fit engagement. The attachment structure includes a beveled end configured to facilitate engagement with the connector.

[0009] In some embodiments, the distal end of the attachment structure extends to a point located proximal to a valve disposed in the introducer. In some embodiments, the distal end of the attachment structure extends to a point located distal to the valve disposed in the introducer and extends into the lumen of the introducer, with the guide channel defining a path for the catheter to be advanced distally of the valve into the lumen of the introducer. In some embodiments, the attachment structure engages the valve to secure the catheter insertion tool to the introducer in a friction fit engagement. The valve is one of a slit valve or a duckbill valve.

[0010] Also disclosed is a method for inserting a catheter into the inner cavity of an introducer, comprising connecting an insertion tool to the proximal end of the introducer, the insertion tool comprising an attachment structure and a guide channel, the connection comprising axially aligning the guide channel with the inner cavity of the introducer, inserting a portion of the catheter into the guide channel of the insertion tool, advancing the catheter distally through the guide channel until the distal portion is disposed within the inner cavity of the introducer, and detaching the insertion tool from the catheter.

[0011] In some embodiments, inserting the catheter into the guide channel of the insertion tool includes inserting the catheter longitudinally into the proximal end of the insertion tool. In some embodiments, inserting the catheter into the guide channel of the insertion tool includes inserting the catheter into the guide channel perpendicular to the longitudinal axis through the elongated opening. In some embodiments, inserting the catheter perpendicular to the longitudinal axis also includes inserting the catheter using a rolling motion against the side wall of the elongated opening.

[0012] In some embodiments, the insertion tool is disengaged from the catheter and further comprises withdrawing the insertion tool proximally to disengage the insertion tool from the introducer before the insertion tool is disengaged from the catheter in a direction perpendicular to the longitudinal axis of the catheter. In some embodiments, the insertion tool is disengaged from the catheter and further comprises disengaging the tool from the introducer and the catheter simultaneously in a direction perpendicular to the longitudinal axis of the catheter.

[0013] In some embodiments, the connection also includes an outer surface of the attachment structure, which engages the inner surface of the connector of the introducer. In some embodiments, the connection also includes a ridge arranged on the outer surface of the attachment structure, which engages the inner surface of the connector of the introducer, and the distal end of the attachment structure extends to a point proximal to the valve of the introducer. In some embodiments, the connection also includes inserting the distal end of the attachment structure distally through the valve and into the inner cavity of the introducer. In some embodiments, the connection also includes an attachment structure that engages the outer surface of the connector extending proximally from the introducer. In some embodiments, the attachment structure engages the outer surface of the connector in a threaded engagement. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] A more specific description of the present disclosure will be presented by reference to specific embodiments of the present disclosure shown in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the present invention and should not be considered as limiting the scope thereof. Exemplary embodiments of the present invention will be described and explained with additional features and details through the use of the accompanying drawings, in which:

[0015] Figure 1A A perspective view of an exemplary introducer device according to embodiments disclosed herein is shown.

[0016] Figure 1B The embodiment disclosed herein is shown Figure 1A Close-up view of the connector of the introducer device.

[0017] Figure 2A Shown is a side view of an insertion tool aligned with an exemplary introducer and catheter according to embodiments disclosed herein.

[0018] Figure 2B A proximal end view of an insertion tool according to embodiments disclosed herein is shown.

[0019] Figure 2C The embodiment disclosed herein is shown Figure 2A Side view of an exemplary introducer and catheter assembly insertion tool.

[0020] Figure 3A A perspective view of an insertion tool according to embodiments disclosed herein is shown.

[0021] Figure 3B A schematic diagram of a device assembled with an exemplary introducer and catheter according to embodiments disclosed herein is shown. Figure 3A Side view of the insertion tool.

[0022] Figure 4A A perspective view of an insertion tool according to embodiments disclosed herein is shown.

[0023] Figure 4B A schematic diagram of a device assembled with an exemplary introducer and catheter according to embodiments disclosed herein is shown. Figure 4A Side view of the insertion tool.

[0024] Figure 5A A perspective view of an insertion tool according to embodiments disclosed herein is shown.

[0025] Figure 5B Shown is a distal end view of an insertion tool according to embodiments disclosed herein.

[0026] Fig. 6A A perspective view of an insertion tool according to embodiments disclosed herein is shown.

[0027] Figure 6B The embodiment disclosed herein is shown Fig. 6A A side cross-sectional view of an insertion tool.

[0028] Figure 6C The embodiment disclosed herein is shown Fig. 6A Side view of the insertion tool.

[0029] Fig.6D The embodiment disclosed herein is shown Fig. 6A Longitudinal cross-sectional view of the insertion tool.

[0030] FIG. 6E to FIG. 6G The embodiment disclosed herein is shown Fig. 6A A distal view of an insertion tool and an exemplary catheter.

[0031] Fig. 7A A perspective view of an insertion tool according to embodiments disclosed herein is shown.

[0032] Figure 7B A schematic diagram of a device assembled with an exemplary introducer and catheter according to embodiments disclosed herein is shown. Fig. 7A Side view of the insertion tool. DETAILED DESCRIPTION

[0033] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments and optionally combined with or replace the features of any one of the many other embodiments disclosed herein.

[0034] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concepts provided herein.Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide sequential or numerical restrictions.For example, "first", "second" and "third" features or steps do not need to appear in this order, and the specific embodiments including such features or steps do not need to be limited to three features or steps.For convenience, marks such as "left", "right", "top", "bottom", "front", "back" etc. are used, and these marks are not intended to imply, for example, any specific fixed position, orientation or direction.On the contrary, such marks are used to reflect, for example, relative position, orientation or direction.Singular forms of "a kind of", "one" and "the" include plural references, unless the context clearly indicates otherwise.

[0035] With respect to the "proximal side", "proximal portion" or "proximal end portion" of, for example, a catheter disclosed herein, includes the portion of the catheter intended to be close to a clinician when the catheter is used in a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be close to a clinician when the catheter is used in a patient. For example, the "proximal end" of a catheter includes the end of the catheter intended to be close to a clinician when the catheter is used in a patient. The proximal portion, proximal portion or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context otherwise suggests, the proximal portion, proximal portion or proximal length of a catheter is not the terminal portion or terminal length of a catheter.

[0036] With regard to the "distal side", "distal portion" or "distal end portion" of, for example, a catheter disclosed herein, it includes the portion of the catheter that is intended to be close to the patient or in the patient's body when the catheter is used for a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be close to the patient or in the patient's body when the catheter is used for a patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be close to the patient or in the patient's body when the catheter is used for a patient. The distal portion, distal portion or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal portion or distal length of a catheter does not need to include the distal end of the catheter. That is, unless the context otherwise suggests, the distal portion, distal portion or distal length of a catheter is not the terminal portion or terminal length of a catheter.

[0037] To help describe the embodiments described herein, Figure 1A and Figure 3A As shown, the longitudinal axis extends substantially parallel to the axial length of the introducer shaft 12. The lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal axis and the lateral axis.

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

[0039] Figure 1A to Figure 1B Various details of the introducer 10 are shown, and the introducer 10 shown in the figure is exemplary and may include various micro-introducers, dilators, split introducers, sacrificial catheters, or similar elongated devices, which define an inner cavity configured to receive a catheter or a similar second elongated medical device therein, which is to be introduced into the vascular system of the patient. The introducer 10 includes an introducer shaft 12 extending from a proximal end to a distal end along a longitudinal axis and defines an introducer lumen 24. The introducer shaft 12 includes an introducer hub ("hub") 14 disposed at the proximal end and an introducer tip ("tip") 16 disposed at the distal end.

[0040] The bushing 14 includes a first handle 18A and a second handle 18B, each extending from the bushing 14 perpendicular to the longitudinal axis. It will be understood that the handle 18 may extend laterally, transversely or at an angle therebetween without departing from the spirit of the present invention. The bushing 14 also includes a breach line 20 extending longitudinally and configured to facilitate separation of the bushing 14 and the shaft 12 when the handle 18 is pushed radially outward from the longitudinal axis. The bushing 14 also includes a connector 22 disposed at its proximal end and in fluid communication with the introducer lumen 24. The connector 22 is configured to be coupled to an additional device and may include, for example, a male threaded portion or a female threaded portion, a swivel nut, a Luer lock, a snap-fit ​​engagement, a combination thereof, and the like.

[0041] In one embodiment, the introducer hub 14 includes a valve 30 disposed within the lumen 24 and configured to prevent proximal flow, but to allow a catheter or similar second elongated medical device to be pushed distally through the valve 30 and into the lumen 24. Exemplary valves 30 include slit valves, duckbill valves, flap valves, etc. It is important to note that due to the flexible nature of the catheter, some catheters will bend or kink when pushed against the valve 30, which can prevent the catheter from successfully passing through the valve 30. This is further complicated when the catheter includes, for example, a slit valve disposed at its distal end. Thus, the columnar strength of such a device is insufficient to be pushed through the valve, and causes the catheter to kink and / or collapse.

[0042] Disclosed herein is an embodiment of an insertion tool that enables the introduction of a flexible catheter into a Figure 1A to Figure 1B in the guide shown. FIG. 2A to FIG. 2C An embodiment of an insertion tool 100 is shown. The insertion tool 100 includes a body 102 including an attachment structure 104 and a guide channel 106. The attachment structure 104 is configured to couple with the introducer bushing 14 to releasably secure the tool 100 thereto. In one embodiment, the attachment structure 104 includes a clamp, a threaded portion, an interference fit, a snap fit, a combination thereof, etc. that engages the introducer connector 22.

[0043] Figure 2B A proximal end view of the insertion tool 100 is shown. In one embodiment, the tool attachment structure 104 includes a clamp 108 including a first clamp arm 108A and a second clamp arm 108B, the second clamp arm being opposite the first clamp arm 108A. The clamp arms 108A, 108B are formed of a resilient material that allows the arms 108 to deflect to receive the introducer connector 22 therebetween.

[0044] In one embodiment, the first clamp arm 108A and the second clamp arm 108B define an opening 110 configured to receive a portion of the connector 22 therein. The clamp 108 can engage the connector 22 in an interference fit. In one embodiment, the clamp arm 108 includes a threaded portion that engages the threaded connector 22 on its axial inner surface. In one embodiment, the clamp arm includes various numbers and configurations of barbs, clamps, detents, protrusions, etc. that engage the connector 22. In one embodiment, the attachment structure 104 is configured to allow the connector 22 to enter longitudinally into the opening 110, but prevent it from exiting longitudinally. In this way, the connector 22 can be removed vertically through the channel 112.

[0045] like Figure 2BAs shown, in one embodiment, the first clamp arm 108A and the second clamp arm 108B partially extend around the circumference of the connector 22, so that the first end face 114A of the first clamp 108A and the second end face 114B of the second clamp 108B define a channel 112 therebetween. In one embodiment, the first clamp arm 108A and the second clamp arm 108B extend circumferentially around the entire connector 22, so that the first end face 114A of the first clamp 108A abuts against the second end face 114B of the second clamp 108B to define a slit therebetween. As described above, the clamp arms 108A, 108B are formed of an elastic material that allows the clamp arms to have some deflection. Therefore, the channel 112 or slit allows the clamp arms 108A, 108B to move relative to each other. In one embodiment, the connector 22 can be pushed longitudinally into the opening 110. In one embodiment, the channel 112 allows the connector 22 to enter / leave the opening 110 perpendicular to the longitudinal axis.

[0046] In one embodiment, the insertion tool 100 includes a guide channel 106 that defines an arcuate cross-sectional shape. The radius of curvature of the cross-sectional shape of the channel 106 is configured to substantially match the radius of curvature of the outer surface of the catheter 50. The guide channel 106 is configured to support the portion of the catheter 50 disposed therein to maintain the columnar integrity of the catheter 50, preventing the catheter 50 from kinking or collapsing when it is pushed distally. In one embodiment, the cross section of the guide channel 106 extends through an arc of 30° or greater. In one embodiment, the cross section of the guide channel 106 extends through an arc of 180°. In one embodiment, the guide channel 106 defines a closed channel that completely surrounds a portion of the catheter 50 disposed therein. The central axis of the channel 106 is aligned with the central axis of the opening 110. Like this, when the insertion tool 100 is connected to the introducer 10, the central axis of the guide channel 106 is aligned with the central axis of the connector 22 and the introducer lumen 24.

[0047] In an exemplary method of use, the distal end 16 of the introducer 10 is placed in the vascular system of the patient to provide access thereto. By pushing the connector 22 longitudinally into the opening 110, the insertion tool 100 is connected to the connector 22. Optionally, the connector 22 can be pushed laterally or laterally through the passage 112 into the opening 110. The distal portion of the catheter 50 is arranged in the guide channel 106, which aligns the catheter 50 with the inner cavity 24 of the introducer. As described herein, the guide channel 106 provides a columnar support for the catheter 50 to maintain the columnar integrity of the catheter 50 to prevent kinking or collapse. Then, the catheter 50 can slide distally through the guide channel 106 until its distal end engages the valve 30. Then, the catheter 50 is pushed distally through the valve 30, wherein the guide channel 106 provides a columnar support to the catheter 50 to prevent kinking or collapse. Optionally, the clinician may place a finger on the portion of the catheter 50 disposed within the channel to support the catheter 50 against the guide channel 106 and provide additional columnar support.

[0048] FIG. 3A to FIG. 3B An embodiment of an insertion tool 200 is shown. The insertion tool 200 includes a tool body 202, an attachment structure 204, and a guide channel 206. The attachment structure 204 is configured to couple with the introducer connector 22 and align the central axis of the guide channel 206 with the central axis of the introducer 10, as described herein.

[0049] In one embodiment, the insertion tool 200 defines a substantially cubic shape, including a substantially straight distal surface extending perpendicular to the longitudinal axis. The attachment structure 204 is disposed at the distal end of the tool 200 and is configured to retain a portion of the introducer connector 22 therein. In one embodiment, the attachment structure 204 includes a substantially U-shaped notch ("notch") 210 disposed in the distal surface 208 of the tool 200, which communicates with the recess 212 of the cubic shape.

[0050] In one embodiment, the recess 210 defines a radius of curvature that substantially matches the radius of curvature of the outer surface of the introducer connector 22. In one embodiment, the peripheral surface 214 of the recess 210 extends through an arc of 30° or greater. In one embodiment, the peripheral surface 214 of the recess 210 extends through an arc of 180° or greater. In one embodiment, the peripheral surface 214 defines a first protrusion 216A and a second protrusion 216B that are laterally arranged relative to each other across the central axis 80. The lateral distance between the first protrusion 216A and the second protrusion 216B is slightly less than the diameter of the introducer connector 22. In this way, a portion of the introducer connector 22 is pushed laterally downward into the tool attachment structure 204, and the protrusions 216A, 216B cooperate to fix the introducer connector 22 in the recess 210 in a snap fit or interference fit engagement.

[0051] In one embodiment, the introducer connector 22 also includes a flange structure ("flange") 28 extending radially from its outer surface. Exemplary flange structures may include threaded portions, protrusions, lugs, bayonet connectors, twist locks, or similar structures that may extend annularly around at least a portion of the connector 22. The outer diameter of the flange 28 is greater than the inner diameter of the recess 210, but less than the lateral width of the recess 212. Thus, when the connector 22 is pushed laterally downward into the recess 210, the recess 212 is configured to receive the flange 28. The flange engages the inner surface of the recess 212 and prevents the connector 22 from being axially withdrawn from the recess 210.

[0052] In one embodiment, the insertion tool 200 includes a guide channel 206 that defines an arcuate cross-section. The radius of curvature of the channel 206 is comparable to the radius of curvature of the outer surface of the catheter 50. The guide channel 206 is configured to support the portion of the catheter 50 that is arranged therein to maintain the columnar integrity of the catheter 50 and prevent the catheter 50 from kinking or collapsing when being pushed distally. In one embodiment, the cross section of the guide channel 206 extends through an arc of 30° or greater. In one embodiment, the cross section of the guide channel 206 extends through an arc of 180°. The central axis of the channel 206 is aligned with the central axis of the recess 210. Like this, when the insertion tool 200 is connected to the introducer 10, the central axis of the guide channel 206 is aligned with the central axis of the connector 22 and the introducer lumen 24.

[0053] In an exemplary method of use, the distal end 16 of the introducer 10 is placed in the vascular system of the patient to provide access thereto. The insertion tool 200 is connected to the connector 22 by pushing the connector 22 laterally downward into the attachment structure 204. A portion of the connector is received in the recess 210, wherein the protrusions 216A, 216B cooperate to keep the connector therein. The flange 28 is received in the recess 212. The distal portion of the catheter 50 is arranged in the guide channel 206, which aligns the catheter 50 with the lumen 24 of the introducer and provides columnar support for the catheter 50. The catheter 50 can then slide through the guide channel 206 distally until its distal end engages the valve 30. The catheter 50 is then pushed through the valve 30 distally, wherein the guide channel 206 provides columnar support for the catheter 50 to prevent kinking or collapse. Optionally, the clinician can place a finger on the portion of the catheter 50 disposed within the channel to support the catheter 50 against the guide channel 206 and provide additional columnar support. In one embodiment, the upper surface of the insertion tool 200 may include one or more angled surfaces to facilitate guiding the portion of the catheter 50 toward the guide channel 206.

[0054] FIG. 4A to FIG. 4B An embodiment of an insertion tool 300 is shown, including a tool body 302 defining a guide channel 306 and an attachment structure 304 extending distally from a distal surface of the tool body 302. The tool body 302 defines a substantially cylindrical shape including a circular cross-section. Figure 4B As shown, the tool body 302 also includes a concave outer side surface that is configured to guide a user to grasp the midpoint of the tool body 302 .

[0055] The guide channel 306 extends from the proximal end of the tool body 302 to the distal end of the attachment structure 304 and is configured to receive a portion of the catheter 50 therein. In one embodiment, the inner diameter of the guide channel 306 is substantially equal to or slightly larger than the outer diameter of the catheter 50 so that the catheter 50 fits tightly therein. In addition, the proximal end of the guide channel 306 may include a chamfered edge 322 to facilitate the introduction of the catheter 50 into the guide channel 306. Figure 4B As shown, the attachment structure 304 defines an outer diameter that is smaller than the inner diameter of the connector 22 and the valve 30. The attachment structure 304 defines an axial length that allows the distal tip of the attachment structure 304 to be inserted through the valve 30, thereby defining a path for inserting the catheter 50 into the introducer lumen 24.

[0056] In an exemplary method of use, the distal end 16 of the introducer 10 is placed in the vascular system of the patient to provide access thereto. The insertion tool 300 is connected to the connector 22 by pushing the attachment structure 304 longitudinally into the connector 22. In one embodiment, the distal end of the attachment structure 304 can engage the inner surface of the connector 22 to fix the insertion tool 300 to the introducer 10. The attachment structure 304 can engage the introducer 10 in one of an interference fit, a friction fit, a press fit, or a snap fit. In one embodiment, the distal end of the attachment structure 304 can extend distally through the valve 30. The friction between the engagement of the attachment structure 304 with the valve 30, the lumen 24, or a combination thereof can fix the insertion tool 300 to the introducer 10. In addition, the attachment structure 304 opens the valve 30 to provide an unobstructed path for the catheter 50 to enter the introducer lumen 24.

[0057] The distal portion of the catheter 50 is disposed within the proximal portion of the guide channel 306. In one embodiment, the catheter 50 is disposed within the guide channel 306 after the attachment structure 304 is inserted into the introducer lumen 24. In one embodiment, the catheter 50 is "preloaded" within the guide channel 306, i.e., disposed within the guide channel 306, before the attachment structure 304 is inserted into the introducer lumen 24. As previously described, the catheter 50 can provide a sliding fit within the guide channel 306 to prevent or limit proximal flow from the introducer 10 when the valve 30 is opened. In addition, the sliding fit of the catheter 50 within the guide channel 306 provides columnar support for the catheter 50 when it is pushed distally, thereby preventing kinking or collapse. Once the distal portion of the catheter 50 is disposed within the introducer lumen 24, the insertion tool 300 can be withdrawn proximally to disengage the attachment structure 304 from the introducer and withdrawn proximally from the catheter.

[0058] FIG. 5A to FIG. 5B An embodiment of an insertion tool 400 is shown, including a tool body 402 defining a guide channel 406 and an attachment structure 404 extending distally from a distal surface of the tool body 402. As described herein, the tool body 402 defines a substantially cylindrical shape including a circular cross-section, and also includes a concave outer side surface. The guide channel 406 extends from the proximal end of the tool body 402 to the distal end of the attachment structure 404, and is configured to receive a portion of the catheter 50 therein. In one embodiment, the inner diameter of the guide channel 406 is substantially equal to or slightly larger than the outer diameter of the catheter 50, so that the catheter 50 fits tightly therein.

[0059] The insertion tool 400 also includes an elongated opening 412 that extends longitudinally and extends from the guide channel 406 to the outer surface of the insertion tool 400. The elongated opening is configured to allow the catheter 50 to enter or exit the channel 406 perpendicular to the longitudinal axis. Figure 5BAs shown, the lateral width of the elongated opening 412 is less than the outer diameter of the catheter 50. In this way, the catheter 50 is slightly deformed in order to pass through the elongated opening, and then allowed to recover its undeformed shape when placed in the guide channel 406. Similarly, during exit, the catheter 50 must be slightly deformed to be pushed through the elongated opening 412. In some embodiments, the catheter 50, the elongated opening 412, or a combination thereof, is slightly deformed to allow the catheter 50 to pass through the elongated opening 412, enter or exit the channel 406. Advantageously, the lateral width of the elongated opening so configured keeps a portion of the catheter 50 within the channel 406. In addition, during insertion, when the catheter 50 is pushed distally, its columnar strength is maintained.

[0060] In an exemplary method of use, the attachment structure 404 is engaged with the connector 22 and the valve 30. The catheter 50 is inserted into the proximal end of the passage 406 and advanced past the valve 30 into the introducer lumen 24 as described herein. The insertion tool 400 can be removed from the introducer 10 by withdrawing the tool 400 proximally, disengaging the attachment structure 404 from the valve 30 and the introducer connector 22. The tool 400 can then be removed from the catheter 50 by pushing the catheter through the elongated opening 412 perpendicular to the longitudinal axis. Advantageously, the insertion tool 400 can be removed from the catheter 50 when a proximal feature such as a catheter hub prevents the insertion tool from being removed proximally from the catheter 50.

[0061] FIG. 6A to FIG. 6G An embodiment of an insertion tool 500 is shown, including a tool body 502 defining a guide channel 506 and an attachment structure 504 extending distally from a distal surface of the tool body 502. The distal end of the attachment structure 504 includes one or more chamfered edges, a beveled tip, or a combination thereof, such as a beveled tip 524, to facilitate insertion of the distal end of the attachment structure 504 through the valve 30 without damaging the valve. The tool body 502 defines a substantially horizontal cylindrical segment shape having a cylindrical lower portion and a flat horizontal upper surface 508. Figure 6B Shows Fig. 6A A side cross-sectional view of the insertion tool 500, and Figure 6C Shows Fig. 6A 500. As shown, the tool body 502 also includes a plurality of ribs 520 extending radially from the outer surface of the tool body 502. In one embodiment, each rib 520 extends equally from the tool body 502 to define a substantially cylindrical outer periphery. In one embodiment, the ribs 520 extend at different distances from the tool body 502 to define a substantially concave outer periphery, as described herein. In one embodiment, Figure 6CAs shown, the ribs 520 extend radially to define a biconcave outer perimeter. The biconcave outer profile guides the user to grasp the first position or the second position along the outer surface of the insertion tool 500. Advantageously, the ribs 520 also provide an improved grip for the user grasping the tool 500, as well as reducing the amount of material required to form the tool 500, thereby reducing costs while maintaining structural integrity.

[0062] Fig.6D Shows Fig. 6A A longitudinal cross-sectional view of the insertion tool 500. FIG. 6E to FIG. 6G Shows Fig. 6A 504. A guide channel 506 extends from the proximal end of the tool body 502 to the distal end of the attachment structure 504 and is configured to receive a portion of the catheter 50 therein. In one embodiment, the guide channel 506 defines a tapered shape, wherein the inner diameter of the proximal end of the guide channel 506 defines a first diameter (x), and the inner diameter of the distal end defines a second diameter (y). The second diameter (y) is smaller than the first diameter (x), extends between them, and gradually decreases from the first diameter (x) to the second diameter (y). In one embodiment, the first diameter (x) defines an opening larger than the outer diameter of the catheter 50 to facilitate insertion of the catheter 50 into the guide channel 506. In one embodiment, the proximal end of the channel 506 may include a chamfered entrance to further facilitate insertion of the catheter 50 into the guide channel 506. In one embodiment, the second diameter (y) is substantially equal to or slightly smaller than the outer diameter of the catheter 50 so that the catheter 50 fits tightly therein. Advantageously, the catheter 50 may be easily inserted proximally into the guide channel, and then as the catheter 50 is advanced distally, the diameter of the channel 506 gradually decreases to the second diameter (y), thereby providing increased columnar support.

[0063] like FIG. 6A to FIG. 6B and FIG. 6E to FIG. 6G As shown, the insertion tool 500 also includes an elongated opening 512, which extends longitudinally and extends from the guide channel 506 to the outer surface of the insertion tool 500. The elongated opening is configured to allow the catheter 50 to enter or exit from the channel 506 perpendicular to the longitudinal axis. The segmented cylindrical cross-section of the insertion tool 500 provides a shortened elongated opening 512 through which the catheter 50 passes. The shortened elongated opening 512 reduces the amount of friction between the catheter 50 and the sidewall 514 of the elongated opening during entry and exit. This in turn reduces the wear on the outer surface of the catheter 50, which can remove any coating disposed thereon, thereby reducing the efficacy of the coating.

[0064] like FIG. 6E to FIG. 6G As shown, the lateral width of the elongated opening 512 is less than the outer diameter of the catheter 50 to retain the portion of the catheter 50 within the passage 506. Fig. 6FAs shown, the catheter 50 is slightly deformed to pass through the elongated opening and then allowed to recover its undeformed shape when positioned in the guide channel 506, as shown in FIG. Figure 6G Similarly, during exit, the catheter 50 is slightly deformed to be pushed through the elongated opening 512. This facilitates retaining the catheter 50 within the guide channel 506, as described herein.

[0065] Also like FIG. 6E to FIG. 6G As shown, the transverse axis of the elongated opening 512 is laterally offset from the central axis of the guide channel 506. This allows the catheter 50 to be inserted into the channel 506 using a rolling motion against the first side wall 514A of the elongated opening 512. For example, Fig. 6E As shown, during the passage of the catheter 50 into the channel 506, the catheter 50 can be placed at the entrance of the elongated opening 512. Fig. 6F As shown, the side wall of the conduit 50 at position (a) can be deformed inwardly and downwardly, passing the second side wall 514B of the elongated opening 512. In this way, the opposite side wall of the conduit 50 at position (b) causes the first side wall 514A of the elongated opening 512 to roll downwardly. Figure 6G As shown, the catheter 50 then returns to its original, undeformed shape within the guide channel 506 .

[0066] Advantageously, the offset configuration of the elongated opening 512 allows rolling motion of the catheter into / out of the channel 506. This in turn prevents friction of the catheter with the sidewalls 514A, 514B of the elongated opening, which could remove any coating disposed thereon, such as a lubricious coating, antimicrobial coating, etc.

[0067] FIG. 7A to FIG. 7B An embodiment of a catheter insertion tool 600 is shown, which includes a tool body 602 defining a guide channel 606 and an attachment structure 604 extending distally from a distal surface of the tool body 602. The tool body 602 includes an elongated longitudinal opening 612 that allows the catheter 50 to enter / leave the channel 606, as described herein. The distal end of the attachment structure 604 includes one or more chamfered edges, beveled ends, or a combination thereof, such as a beveled end 624, to facilitate engagement of the distal end of the attachment structure 604 with the connector 22.

[0068] In one embodiment, the longitudinal length (d1) of the attachment structure 604 can be less than the longitudinal length (d2) between the proximal surface of the introducer hub 14 and the valve 30. In this way, the attachment structure 604 can engage the inner surface of the connector 22 in an interference fit, but does not interact with the valve 30. In other words, when the tool 600 engages the connector 22, the distal end of the attachment structure 604 can extend to a point proximal to and near the valve 30, but does not interact with the valve 30. Advantageously, the attachment structure 604 can secure the insertion tool 600 to the introducer 10 while still allowing the valve 30 to control proximal fluid flow. In addition, the tool 600 can provide columnar support to the catheter 50 until the point of interaction with the valve 30, thereby alleviating any kinking or bending of the catheter 50 between the attachment structure 604 and the valve 30.

[0069] In one embodiment, the attachment structure 604 includes a ridge 626 extending radially outward from the outer surface of the attachment structure 604 and extending longitudinally. The attachment structure 604 may include a first ridge 626A arranged on a first side of the attachment structure 604 across the longitudinal axis and a second ridge 626B arranged on a second side of the attachment structure 604 opposite the first side. The ridge 626 may be formed of an elastic material and may engage the inner surface of the connector 22 to provide an interference fit or friction fit engagement between the attachment structure 604 and the introducer 10. It will be understood that the attachment structure 604 may include various numbers or configurations of ridges 626 without departing from the spirit of the present invention. In one embodiment, the attachment structure 604 may include one or more protrusions, detents, barb structures, etc., extending from the attachment structure and configured to engage the inner surface of the connector in a snap-fit ​​engagement.

[0070] Although some specific embodiments have been disclosed herein, and although specific embodiments have been disclosed in considerable detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations and / or modifications are also encompassed. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. An insertion tool for introducing a catheter into an introducer, comprising: an attachment structure configured to engage a proximal end of the introducer; and A guide channel is axially aligned with the lumen of the introducer when the attachment structure is engaged to the proximal end of the introducer, the distal end of the guide channel extending to a point proximal to a valve disposed within the lumen of the introducer, the guide channel being configured to support a portion of the catheter to maintain the columnar integrity of the catheter during insertion of the catheter through the valve and into the introducer. 2 . The insertion tool of claim 1 , wherein the guide channel defines an arcuate cross-section and includes a radius of curvature comparable to a radius of curvature of an outer surface of the catheter.

3. The insertion tool of claim 2, wherein the guide channel extends through an arc of thirty degrees (30°) or greater. The insertion tool according to claim 2 , wherein the guide channel surrounds a portion of the catheter disposed in the guide channel.

5. The insertion tool according to any one of claims 1 to 4, wherein the attachment structure includes a clamp that engages an outer surface of a connector disposed at the proximal end of the introducer.

6. The insertion tool of claim 5, wherein the clamp comprises a first clamp arm and a second clamp arm that cooperate to at least partially surround an outer surface of the connector.

7. The insertion tool of claim 1, wherein the attachment structure includes a threaded portion that engages a threaded portion disposed at a proximal end of the introducer.

8. The insertion tool according to any one of claims 1 to 4, wherein the attachment structure includes an opening and a recess, the recess engaging with a flange of a connector arranged at the proximal end of the introducer to prevent longitudinal movement of the connector through the opening.

9. A tool for inserting a catheter into an introducer, comprising: a body defining a substantially cylindrical shape; an attachment structure extending distally from a distal end of the body and configured to engage an inner surface of a connector of the introducer, a distal tip of the attachment structure extending to a point proximal to a valve disposed within the introducer; and A guide channel extends from a proximal end of the body to a distal tip of the attachment structure, the guide channel defining a path for the catheter and configured to maintain the cylindrical integrity of the catheter during insertion of the catheter through the valve and into the introducer.

10. The catheter insertion tool of claim 9, further comprising an elongated opening extending longitudinally and extending from the guide channel to an outer surface of the tool.

11. The catheter insertion tool of claim 10, wherein a lateral width of the elongated opening is less than an outer diameter of the catheter.

12. The catheter insertion tool of claim 10 or 11, wherein a transverse axis of the elongated opening is laterally offset from a central axis of the guide channel.

13. The catheter insertion tool of claim 10, wherein the body further comprises a cylindrical segment shape including a horizontal upper surface providing a laterally shortened elongated opening.

14. The catheter insertion tool of claim 9, wherein an outer surface of the body defines one of a concave shape or a bi-concave shape.

15. The catheter insertion tool of claim 9, wherein the body includes a plurality of ribs extending radially therefrom, the plurality of ribs defining an outer perimeter of the body.

16. The catheter insertion tool of claim 9, wherein the guide channel defines a tapered shape having a diameter that gradually decreases from a first diameter at a proximal end to a second diameter at a distal end.

17. The catheter insertion tool of claim 9, wherein the attachment structure engages the inner surface of the connector with an interference fit, a friction fit, a press fit, or a snap fit engagement.

18. The catheter insertion tool of claim 9, wherein the attachment structure includes a ridge extending radially outward from an outer surface of the attachment structure and configured to engage an inner surface of the connector in a friction fit engagement.

19. The catheter insertion tool of claim 9, wherein the attachment structure includes a beveled tip configured to facilitate engagement with the connector.

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