Catheter insertion device assembly

Abstract

The present application relates to a catheter insertion device assembly that unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, an insertion tool comprises: a housing in which at least a portion of a conduit is initially disposed; a hollow needle extending distally from the housing with at least a portion of the catheter pre-disposed over the needle; and a guidewire pre-disposed within the needle. The insertion tool also includes a guidewire advancement assembly for selectively advancing the guidewire distally past the distal end of the needle in preparation for distally advancing the catheter. The insertion tool also includes a catheter advancement assembly for selectively advancing the catheter into the patient. The catheter advancement assembly includes a mechanical gain mechanism coupled between a slide of the insertion tool and the catheter.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. patent application No. 18 / 202,702, filed May 26, 2023, which is incorporated by reference in its entirety into this application. Technical Field

[0003] The present invention relates to the field of medical devices, and more particularly to catheter insertion device assemblies. Background Art

[0004] The prior art does not teach the catheterization device assembly described in the disclosure of this application. Utility Model Content

[0005] According to some embodiments, disclosed herein is a catheter insertion device assembly comprising a catheter having a catheter tubing defining a catheter lumen extending between a distal end of the catheter and a catheter hub at a proximal end of the catheter, wherein the catheter hub is disposed within a housing. The assembly further comprises a needle configured to be inserted into a patient's body between a skin surface and a blood vessel, wherein the needle defines a needle lumen extending between a distal end of the needle and a proximal end of the needle, the proximal end of the needle being coupled to the housing, and wherein the needle is pre-arranged within the catheter lumen such that the distal end of the needle extends beyond the distal end of the catheter and the proximal end of the needle extends proximally beyond the catheter hub. The assembly further comprises a guidewire extending between a distal end of the guidewire and a proximal portion of the guidewire, wherein the guidewire is pre-arranged within the needle lumen such that the distal end of the guidewire is positioned proximal to the distal end of the needle and the proximal portion of the guidewire extends proximally beyond the proximal end of the needle. The assembly further comprises a slider capable of shifting along an exterior of the housing, wherein the slider is coupled to the proximal portion of the guidewire such that displacement of the slider causes displacement of the guidewire. The assembly also includes a mechanical advantage mechanism coupled between the slider and the catheter hub such that the slider provides an input force to the mechanical advantage mechanism and the mechanical advantage mechanism provides an output force to the catheter hub in response to the input force, wherein the output force is greater than the input force.

[0006] In some embodiments, the input force and the output force are each directed distally, and in some embodiments, the output force is twice the input force.

[0007] In some embodiments, displacement of the slider results in displacement of the catheter and simultaneous displacement of the guidewire, and in some embodiments, the displacement of the catheter is less than the simultaneous displacement of the guidewire.

[0008] In some embodiments, the mechanical advantage mechanism comprises a lever, and in some embodiments, the lever comprises an opening, wherein the needle passes through the opening.

[0009] In some embodiments, the lever includes: (i) a first end coupled to the slider; (ii) a second end defining a fulcrum with the bottom housing portion; and (iii) an intermediate point coupled to the catheter hub. In such embodiments, distal displacement of the slider relative to the bottom housing portion causes distal displacement of the catheter relative to the bottom housing portion.

[0010] In some embodiments, the lever includes: (i) a first end coupled to the slider; (ii) a second end defining a fulcrum with the needle hub; and (iii) an intermediate point coupled to the catheter hub. In such embodiments, distal displacement of the slider relative to the bottom housing portion causes distal displacement of the catheter relative to the needle.

[0011] In some embodiments, the lever includes: (i) a first end coupled to the slider; (ii) a second end coupled to the needle hub; and (iii) an intermediate point defining a fulcrum with the catheter hub. In such embodiments, distal displacement of the slider relative to the bottom housing portion causes distal displacement of the catheter relative to the needle.

[0012] In some embodiments, the lever includes: (i) a first end slidably coupled to the cam surface of the slider; (ii) a second end coupled to the catheter hub; and (iii) an intermediate point adjacent to the curved portion of the lever, the intermediate point defining a fulcrum with the needle hub. In such embodiments, distal displacement of the slider relative to the bottom housing portion results in lateral displacement of the first end, which in turn results in distal displacement of the catheter relative to the needle.

[0013] In some embodiments, the mechanical advantage mechanism includes a tension member having: (i) a first end coupled to the slider; (ii) a second end coupled to the bottom housing portion; and (iii) a ring portion coupled to the catheter hub. In such embodiments, distal displacement of the slider relative to the bottom housing portion causes the ring portion to distally displace the catheter relative to the bottom housing portion.

[0014] In some embodiments, the mechanical advantage mechanism includes: (i) a first rack coupled to the slider; (ii) a second rack coupled to the bottom housing portion; and (iii) a pinion gear coupled to the catheter hub, wherein the pinion gear meshes with the first rack and the second rack. In such embodiments, distal displacement of the slider relative to the bottom housing portion causes the pinion gear to rotate and displace distally along the bottom housing portion, thereby causing the catheter and the pinion gear to be displaced distally together relative to the bottom housing portion.

[0015] In some embodiments, the assembly further comprises a safety assembly configured to cover the distal tip of the needle when the needle is withdrawn from the catheter, wherein the safety assembly is coupled between the catheter hub and the mechanical advantage mechanism. In such embodiments, distal displacement of the slider causes distal displacement of the safety assembly, which in turn causes distal displacement of the catheter.

[0016] In some embodiments, the slider is configured to shift a first distance and subsequently shift a second distance, wherein shifting the slider the first distance causes the guidewire to shift distally relative to the needle by the first guidewire distance, and wherein subsequently shifting the slider the second distance causes: (i) the guidewire to shift distally relative to the needle by the second guidewire distance, and (ii) the catheter to shift distally relative to the needle by the first catheter distance, wherein the first catheter distance is less than the second guidewire distance.

[0017] According to some embodiments, the present invention also discloses a method for placing a catheter within a blood vessel, comprising inserting a needle of a catheter insertion device assembly through the skin of a patient so that the distal end of the needle is disposed within the blood vessel, wherein: (i) the needle is pre-disposed within the lumen of a catheter of the catheter insertion device assembly; and (ii) a guidewire of the catheter insertion device assembly is pre-disposed within the lumen of the needle. The method further comprises: advancing the guidewire distally along the lumen of the needle so that the guidewire extends beyond the distal end of the needle; and advancing the catheter distally along the needle a catheter distance so that the distal end of the catheter is displaced from a position proximal to the distal end of the needle to a position distal to the distal end of the needle, wherein distally advancing the catheter comprises displacing a slider of the catheter insertion device assembly distally by a slider distance relative to a housing of the catheter insertion device assembly, and wherein the slider distance is greater than the catheter distance.

[0018] In some embodiments of the method, displacing the slider distally includes applying a first distally-directed force on the slider, and advancing the catheter distally includes applying a second distally-directed force on the catheter, wherein the second force is greater than the first force.

[0019] In some embodiments of the method, displacing the slider distally includes rotating a lever about a fulcrum, wherein the fulcrum is coupled with a hub of the catheter, a hub of the needle, or a housing.

[0020] In some embodiments of the method, the catheter insertion device includes a tension member having: (i) a first end coupled to a slider; (ii) a second end coupled to a housing; and (iii) a ring portion coupled to a catheter. In such embodiments, distal displacement of the slider relative to the housing causes the ring portion to displace the catheter distally along the needle.

[0021] In some embodiments of the method, the catheter insertion device includes: (i) a first rack coupled to a slider; (ii) a second rack coupled to a housing; and (iii) a pinion coupled to the catheter, wherein the pinion meshes with the first rack and the second rack. In such embodiments, distal displacement of the slider relative to the housing causes the pinion to rotate and displace distally along the housing, thereby causing the catheter to displace distally along the needle.

[0022] These and other features of embodiments of the invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the embodiments of the invention as set forth hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] A more specific description of the disclosure will be presented by reference to specific embodiments of the disclosure illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the disclosure and, therefore, should not be considered as limiting the scope of the disclosure. Exemplary embodiments of the disclosure will be described and explained with additional particularity and detail through the use of the accompanying drawings, in which:

[0024] Figure 1A and Figure 1B are various views of a catheter insertion device according to one embodiment;

[0025] Figure 2A and Figure 2B yes Figure 1A and Figure 1B Various exploded views of catheter insertion devices;

[0026] Figure 3A and Figure 3B According to one embodiment, Figure 1A and Figure 1B Various views of a catheter insertion device during one phase of use;

[0027] Figure 4A and Figure 4B According to one embodiment, Figure 1A and Figure 1B Various views of a catheter insertion device during one phase of use;

[0028] Figure 5A and Figure 5B According to one embodiment, Figure 1A and Figure 1B Various views of a catheter insertion device during one phase of use;

[0029] Figure 6A and Figure 6B According to one embodiment, Figure 1A and Figure 1B Various views of a catheter insertion device during one phase of use;

[0030] Figure 7A and Figure 7B According to one embodiment, Figure 1A and Figure 1B Various views of a catheter insertion device during one phase of use;

[0031] Figure 8 According to one embodiment, Figure 1A and Figure 1B a stage of use of a catheter insertion device;

[0032] Figure 9 According to one embodiment, Figure 1A and Figure 1B a stage of use of a catheter insertion device;

[0033] Figures 10A to 10C Various views of a needle safety component and environment for a catheter insertion device are shown according to one embodiment;

[0034] 11A to 11D are various views of a catheter insertion device according to one embodiment;

[0035] Figure 12A and Figure 12B yes 11A to 11D various views of a portion of a catheterization device;

[0036] Figure 13A and Figure 13B yes 11A to 11D various views of a portion of a catheterization device;

[0037] 14A to 14F According to one embodiment, 11A to 11D The various stages of use of catheterization devices;

[0038] Figure 15 is an exploded view of a catheter insertion device according to one embodiment;

[0039] Figure 16 is a perspective view of a portion of a guidewire lever according to one embodiment;

[0040] Figure 17A and Figure 17B yes Figure 15 a cross-sectional view of a proximal portion of a catheter insertion device;

[0041] Figure 18 yes Figure 15 a perspective view of a proximal portion of a top housing portion of a catheter insertion device;

[0042] Figure 19 yes Figure 15 a cross-sectional view of a proximal portion of a catheter insertion device;

[0043] Figure 20A and Figure 20B are various views of a needle safety component according to one embodiment;

[0044] 21A to 21D yes Figure 20A and Figure 20B Various views of the needle safety component and accompanying bracket;

[0045] Figure 22A and Figure 22B According to an embodiment Figure 15 a cross-sectional view of a proximal portion of a catheter insertion device;

[0046] 23A to 23D According to an embodiment Figure 15 a cross-sectional side view of a portion of a device showing various embodiments of a mechanical advantage mechanism having a lever;

[0047] Figure 23E According to an embodiment Figure 15 a cross-sectional side view of a portion of an apparatus showing another embodiment of a mechanical advantage mechanism having a tension member;

[0048] Figure 23F According to an embodiment Figure 15 a cross-sectional side view of a portion of an apparatus showing another embodiment of a mechanical advantage mechanism having a pinion gear disposed between opposing racks;

[0049] Figure 24 is a block diagram of a method of placing a catheter within a blood vessel, according to some embodiments. DETAILED DESCRIPTION

[0050] Reference will now be made to the accompanying drawings, in which like structures will be provided with like reference numerals. It should be understood that the accompanying drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention and are neither limiting nor necessarily drawn to scale.

[0051] For the sake of clarity, it should be understood that the word "proximal" refers to a direction relatively closer to a clinician using the device described herein, while the word "distal" refers to a direction relatively further away from the clinician. For example, the end of a catheter placed inside a patient's body is considered the distal end of the catheter, while the end of the catheter remaining outside the body is the proximal end of the catheter. In addition, as used herein (including the claims), the words "comprising," "having," and "containing" shall have the same meaning as the word "including."

[0052] The phrases "connected to," "coupled with," and "in communication with" refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components can be coupled to each other even if they are not in direct contact with each other. For example, two components can be coupled to each other through an intermediate component.

[0053] Any method disclosed herein includes one or more steps or actions for performing the described method. These method steps and / or actions can be interchangeable with each other. In other words, unless the proper operation of the embodiment requires a specific order of steps or actions, the order and / or use of specific steps and / or actions can be modified. In addition, a subroutine or only a portion of the method described herein can be a separate method within the scope of the disclosure. In other words, some methods can include only a portion of the steps described in the more detailed method. In addition, all embodiments disclosed herein are combinable and / or interchangeable, unless otherwise stated, or such combination or interchange will be contrary to the operability of any embodiment.

[0054] The embodiment of the present invention as a whole relates to a kind of instrument for helping to place catheter or other tubular medical devices into patient's body.For example, catheter of various lengths is usually placed in patient's body, so that the access to patient's vascular system is established, and makes it possible to infuse medicine or aspirate body fluid.The catheter insertion tool described herein promotes the placement of such catheter.It should be noted that although the following discussion focuses on placing the catheter of specific type and relatively short length, catheter of various types, sizes and lengths can be inserted via this device, including the intermediate or extended resident catheter of peripheral IV, PICC, central venous catheter etc. In one embodiment, a catheter of length between about 2.5 inches and about 4.5 inches can be placed, but many other lengths are also possible.In another embodiment, a catheter of length of about 3.25 inches can be placed.

[0055] First reference Figure 1A to Figure 1B and Figures 2A to 2B, which depicts various details regarding a catheter insertion tool ("insertion tool"), generally depicted as 10, according to one embodiment. As shown, the insertion tool 10 includes a housing 12, which in turn includes a top housing portion 12A that detachably mates with a bottom housing portion 12B. A needle hub 14 supporting a hollow needle 16 is interposed between the housing portions 12A and 12B. The needle 16 extends distally from the needle hub 14 so as to extend through the body of the insertion tool 10 and extend beyond the distal end of the housing 12. In another embodiment, the needle is at least partially hollow while still being able to achieve the functionality described herein.

[0056] A notch 18 is defined through the wall of the needle near the distal end of the needle 16. Once access to the patient's vasculature is achieved during the catheterization procedure, the notch 18 enables blood to flow back out of the lumen defined by the hollow needle 16. Thus, blood exiting the notch 18 can be observed by the clinician to confirm proper placement of the needle in the vasculature, as will be explained further below.

[0057] Insertion tool 10 also includes a guidewire advancement assembly 20 for advancing a guidewire 22 through needle 16 and into the patient's vasculature once needle entry has been achieved. Guidewire 22 is pre-positioned within the lumen of needle 16 with the proximal end of the guidewire positioned proximal to the proximal end of needle hub 14, as shown in FIG. Figure 1B and Figure 2A The guidewire advancement assembly 20 includes a guidewire lever 24 that selectively advances the guidewire in a distal direction during use of the insertion tool 10 so that a distal portion of the guidewire extends beyond the distal end of the needle 16. The guidewire lever 24 includes a lever tab 26 that engages the proximal end of the guidewire 22 to push the guidewire through the lumen of the needle 16.

[0058] Guidewire propulsion assembly 20 also comprises the slide 28 that is slidably attached to top housing part 12A.Two tabs 24A of guidewire lever 24 are operably attached to slide 28, make the user cause the corresponding movement of lever 24 to the selectivity of slide, and by extension, this causes the corresponding movement of guidewire 22.The engagement of lever tab 24A and slide 28 also maintains the attachment of slide and housing 12. Certainly, also can adopt other engagement schemes that user input is transformed into guidewire movement.In top housing part 12A, comprise the suitable track that is used to realize the sliding movement of slide 28 and lever 24, comprise the track 34 that extends to the far-end of housing 12.

[0059] The slide 28 includes two arms 30 that partially surround a guide rail 32 defined by the housing 12. Specifically, during initial distal advancement of the slide 28, the arms 30 slide on the bottom housing guide rail 32A, as shown in FIG. Figure 5BDuring further distal advancement of the slide 28, the arm 30 slides past the bottom housing rail 32A and onto the top housing rail 32B, as shown in FIG. Figure 2A and Figure 3A With the arms 30 of the slide 28 no longer engaged with the bottom housing rails 32A, the two housing portions 12A and 12B can be separated, as will be described further below.

[0060] The guidewire lever 24 includes a resiliently arranged locking arm 36 so as to spring up and engage an extension 36A defined in the interior of the top housing portion 12A when the slider 28 has been fully slid distally. This prevents the guidewire 22 from being inadvertently retracted once distally extended, which could otherwise cause the distal tip of the needle 16 to accidentally cut the distal portion of the guidewire during the insertion procedure. Note that, in one embodiment, the engagement of the locking arm 36 with the extension 36A can provide tactile and / or audible feedback to the user to indicate full distal extension of the guidewire 22.

[0061] The insertion tool 10 further includes a catheter advancement assembly 40 for selectively advancing a catheter 42 in a distal direction, the catheter being pre-arranged in the housing 12 and comprising a catheter tube 44 and a hub 46 at its proximal end. Figure 1A and Figure 1B As seen in FIG, catheter 42 is initially partially pre-positioned within the volume defined by housing 12 such that the lumen of catheter tubing 44 is positioned over needle 16, which in turn is positioned over guidewire 22, as described above.

[0062] Specifically, the catheter advancement assembly 40 includes a handle 48 defining a base 48A and two arms 50 extending from the handle base. Each arm 50 defines a gripping surface 50A, a finger grip 50B, and one of two teeth 50C. The gripping surface 50A and the finger grip 50B enable a user to grip or contact the handle to selectively advance the catheter 42 in a distal direction during use of the insertion tool 10 to insert the catheter into a patient. The teeth 50C engage corresponding raised surfaces on the hub 46 to removably connect the handle 48 to the catheter 42.

[0063] Additional components are included in connection with the handle 48 of the catheter advancement assembly 40. A plug or valve 52 is interposed between the handle base 48A and the catheter hub 46 to prevent spillage of blood when the catheter is first introduced into the patient's vasculature. A safety housing 54, which includes a needle safety component 56, is removably attached to the handle 48 between the arms 50. Specifically, a protrusion 60 on the inner surface of the handle arms 50 engages with a corresponding recess 62 ( Figure 10A) engage to removably secure the safety housing to the handle 48. The cap 58 supports the needle safety component 56 and covers the end of the safety housing 54. Figure 1B As shown, the needle 16 is initially Figure 2B The sequence shown extends through the aforementioned components. Further details regarding the operation of these components are given below. The cap 58, safety housing 54 and needle safety component 56 can be combined to define a safety assembly.

[0064] Note that in one embodiment, the outer diameter of the needle 16 and catheter tubing 44 are lubricated with silicone or other suitable lubricant to enhance sliding of the catheter tubing relative to the needle and to aid in inserting the catheter into the patient.

[0065] The insertion tool 10 also includes a support structure 70 for stabilizing the needle 16 near the point at which it exits the housing 12. In this embodiment, the support structure 70 comprises an interface 72 of the top housing portion 12A and the bottom housing portion 12B, the shape of which is designed to closely match the circular shape of the needle 16 and the catheter tubing 44. The interface 72 stabilizes the needle 16 to prevent excessive "play" in the needle, thereby improving user accuracy during initial entry into the patient's vasculature.

[0066] like Figure 2A As best seen in FIG, top housing 12A, needle hub 14, and bottom housing 12B include engagement features 68 to maintain attachment of the proximal ends of housings 12 even when the more distal portions of the housings are separated, as described below. However, it is noted that various types, sizes, and numbers of engagement features may be employed to achieve this desired functionality.

[0067] Figures 3A to 9 Various stages of use of the insertion tool 10 are depicted when placing a catheter 42 in the patient's vasculature. For clarity, the various stages are depicted without showing actual insertion into the patient. Figure 1A In the illustrated configuration, a user holding the insertion tool 10 first guides the distal portion of the needle 16 through the skin at the appropriate insertion site and into the subcutaneous vessel. Proper vascular access is visibly confirmed by a blood flash, i.e., the presence of blood between the outer diameter of the needle 16 and the inner diameter of the catheter tubing 44 as blood flows from the hollow interior of the needle out of the notch 18. Note that, in one embodiment, the presence of blood in the safety housing 54 (which, in one embodiment, is a translucent housing) can serve as a secondary blood flash indicator, as blood enters the housing from the needle 16 as the vessel is entered.

[0068] After confirming needle entry into the vessel, the guidewire advancing assembly 20 is actuated, wherein the user's finger advances the slider 28 to distally advance the guidewire 22 initially disposed within the hollow needle 16 ( Figure 3A and Figure 3B ). Note that the guidewire is advanced distally by lever 24, which is operably attached to slider 28. Note also that during distal advancement of slider 28, its sliding arm 30 travels along rails 32 on either side of housing 12: first bottom housing rail 32A, then top housing rail 32B.

[0069] The guidewire continues to be advanced distally until the slider 28 has slid its full stroke length distally, thereby causing a predetermined length of the guidewire 22 to extend past the distal end of the needle 16, as shown in FIG. Figure 4A and Figure 4B In one embodiment, further distal advancement of the slider 28 is prevented by contact of the lever tab 26 with the distal portion of the needle hub 14, as shown. Figure 4B shown. Figure 5A and Figure 5B It is shown that when the slide 28 is fully advanced distally, its slide arm 30 is no longer engaged with the bottom housing rail 32A, but is engaged only with the top housing rail 32B. This in turn enables the housing parts 12A and 12B to be separated, as will be seen further below.

[0070] like Figure 5A and Figure 5B Once the guidewire 22 has been fully extended within the patient's vasculature ( Figure 4A and Figure 4B ), the catheter advancement assembly 40 is actuated, wherein the user advances the handle 48 distally to cause the catheter tube 44 to slide over the distal portion of the needle 16 and guidewire 22 and into the patient's vasculature through the insertion site. Figure 6A and Figure 6B It is shown that when the catheter is advanced via the handle 48, the housing portions 12A and 12B readily separate to enable the catheter hub 46 to exit the distal end of the housing 12 and allow the catheter to be inserted to the appropriate extent into the patient's vasculature.

[0071] Please note that Figure 7A and Figure 7B As shown, during removal of the catheter from within the housing 12 of the insertion tool 10 , the catheter slides distally along the needle 16 until the distal needle tip is received into the safety housing 54 and engages the needle safety feature 56 . Figure 8 The insertion tool 10 is shown as being able to then be separated from the catheter 42, leaving the handle 48 still attached to the catheter hub 46. As described above, the handle 48 includes a valve 52 interposed between the catheter hub 46 and the handle 48. When the needle 16 and the safety housing 54 are removed from the catheter 42, the valve 52 occludes the catheter lumen to prevent unintentional escape of blood from the catheter hub 46. Figure 9As shown, the handle 48 can be removed from engagement with the catheter hub 46 by pulling, twisting, etc., so that the teeth 50C of the handle disengage from the hub. According to standard procedures, the extension legs can be attached to the catheter hub and the coated catheter 42. The housing 12 of the insertion tool 10 and the handle 48 can then be discarded.

[0072] Figures 10A to 10C Additional details are provided regarding the safety housing 54 and the needle safety component 56 and its interaction with the needle when isolating the distal end of the needle 16. As shown, the safety housing 54 is configured to allow the needle 16 to pass therethrough during use of the insertion tool 10, as already described, thereby exiting the housing via an extension 74 on the distal end of the housing. The cap 58 is placed in the proximal end of the safety housing 54 and is configured to support the needle safety component 56 so that the needle 16 initially passes through the safety housing, cap, and needle safety component. Note that in this embodiment, the extension 74 of the safety housing 54 extends into the valve 52 to open the valve during use of the insertion tool 10, which eliminates undesirable friction between the valve and the needle.

[0073] Figure 10C The needle safety component 56 is shown to include a curved body or engaging element 80, through which the needle initially extends, and a friction element 82. Figure 10A As seen in FIG. 4 , when the needle 16 is withdrawn from the catheter 42 ( Figure 8 ), the distal end of the needle is withdrawn proximally through the extension 74 and passes through the distal portion of the needle safety component so that the needle no longer contacts the needle safety component. This allows the friction element 82 to slightly tilt the coupling element 80, thereby coupling the needle 16 in place and preventing it from moving further relative to the safety housing 54, and isolating the distal end of the needle within the housing to prevent inadvertent needle sticks. In this embodiment, the friction element 82 includes an O-ring of appropriate size. Suitable O-rings can be obtained, for example, from Apple Rubber Products (Lancaster, New York). It should be noted that further details about the needle safety component, its operating principles, and similar devices are disclosed in U.S. Patents Nos. 6,595,955, 6,796,962, 6,902,546, 7,179,244, 7,611,485, and 7,618,395, each of which is incorporated herein by reference in its entirety. Of course, other needle safety devices can also be used to isolate the distal end of the needle.

[0074] Now refer to 11A to 13B , which describes a catheter insertion tool 110 according to one embodiment. Note that in the embodiment and subsequent embodiments, various features are similar to those already described in connection with the above embodiments. Therefore, only selected aspects of each embodiment will be described.

[0075] Insertion tool 110 includes a housing 112 defined by a top housing portion 112A and a bottom housing portion 112B that together partially enclose catheter 42. A needle hub 114 supporting a distally extending needle 116 is included for placement within housing 112 and positioned such that catheter tubing 44 of catheter 42 is disposed over the needle. Note that in embodiments and other embodiments, partially enclosing the catheter with the insertion tool enables the clinician to manipulate the insertion tool with their hand closer to the distal end of the needle than would otherwise be possible.

[0076] Figure 13A and Figure 13B Further details are provided regarding the needle hub 114, which is attached to the top housing portion 112A. A needle holder 126, included on the distal end of the needle hub 114, receives the proximal end of the needle 116 therein. The needle 116 is secured within the needle holder 126 via adhesive, welding, or other suitable means. Extensions 128 are included on opposite sides of the needle holder 126 and are configured to be slidably received within corresponding slots 130 defined on the sides of the bottom housing portion 112B. This engagement enables the bottom housing portion 112B to slide distally relative to the top housing portion 112A.

[0077] A top guide rail 132 is included on the needle hub 114 and is configured to engage a corresponding slot 134 defined in the proximal portion of the top housing portion 112A to secure the needle hub to the top housing portion. A locking arm 136 is also included within the needle hub 114 and is positioned to engage the back plate 124 when the bottom housing portion 112B is slid distally to extend the guide wire from the needle 116, thereby preventing the guide wire from retracting. Note that the guide wire 122 initially extends distally from the back plate 124 and through the needle holder 126 and the needle 116, as shown in FIG. Figure 11D The best I've ever seen.

[0078] A guidewire advancement assembly 120 is included to selectively advance a guidewire 122 initially disposed within the lumen of the needle distally through the distal end of the needle 116. The guidewire advancement assembly 120 includes a bottom housing portion 112B to which the guidewire 122 is attached at a proximal rear plate 124 of the bottom housing portion. As will be shown, the bottom housing portion 112B is slidable distally relative to the top housing portion 112A to enable the guidewire 122 to be selectively advanced distally.

[0079] The insertion tool 110 also includes a catheter advancement assembly 140 for selectively advancing the catheter 42 over the needle 116. The advancement assembly 140 includes a handle 146 that is initially slidably disposed between the top housing 112A and the bottom housing 112B and is removably attached to the hub 46 of the catheter 42. Figure 12A and Figure 12B As best seen in FIG, handle 146 includes two arms 150 for allowing a user to selectively slide the handle to advance catheter 42. Handle 146 also includes a recess 152 in which a needle safety component 156 is positioned for isolating the distal tip of needle 116 when the needle is withdrawn from catheter 42. Additional details regarding needle safety components are disclosed in U.S. Patent Nos. 6,595,955, 6,796,962, 6,902,546, 7,179,244, 7,611,485, and 7,618,395, each of which is incorporated herein by reference.

[0080] The insertion tool 110 also includes a support structure 170 for stabilizing the needle 116 near the distal end of the housing 112. The support structure 170 in this embodiment includes two wings 172 that are hinged to the distal portion of the bottom housing portion 112B. Figure 11D and Figure 12A When closed as seen in FIG, the flaps 172 serve to stabilize the needle 116 to aid the user of the insertion tool 110 in inserting the needle into the patient. Figure 14D ), the tabs 172 provide an opening to enable the catheter hub 46 to be removed from the distal end of the housing 112, as will be described in further detail below. Before the bottom housing portion 112B is slid relative to the top housing portion 112A, the tabs 172 are arranged in tracks 174 defined by the top housing portion. Other types and configurations of support structures may also be employed. The insertion tool 110 also includes gripping surfaces 176 on either side of the housing 112 to assist in using the tool during the catheter insertion procedure, as will be described in further detail below.

[0081] Figures 14A to 14E Depicted are various stages of use of the insertion tool 110 when inserting a catheter into a patient. Figure 14A In the illustrated configuration, vascular access is achieved by the user inserting the needle 116 into the patient at the insertion site. Confirmation of vascular access may be achieved by observing blood flashback through the distal notch in the needle 116 as described in the previous embodiment, or in other suitable ways.

[0082] Once the distal portion of needle 116 is positioned within the patient's vessel, guidewire 122 is extended past the distal end of the needle and into the vessel by advancing bottom housing portion 112B distally. In this embodiment, such advancement is achieved by placing a user's finger on folded tab 172 of bottom housing portion 112B and pushing the tab distally to extend guidewire 122. Guidewire 122 is advanced until fully extended. The locking arm 136 of needle hub 114 then engages rear plate 124 of bottom housing portion 112B and prevents guidewire 122 from retracting.

[0083] At this stage, the user grasps one or both arms 150 of the handle 146 of the catheter advancement assembly 140 to advance the handle distally so as to advance the catheter 42 distally through the insertion site and into the patient's vasculature. Figure 14C , where catheter tubing 44 is shown advanced distally over needle 116 and guidewire 122.

[0084] like Figure 14D As shown, continued distal advancement of the catheter 42 causes the catheter hub 146 to push the tabs 172 open, thereby providing a suitable opening through which the hub can pass from the insertion tool housing 112. Note that the tabs 172 are shaped so that contact with the catheter hub 46 pushes each tab outwardly, as shown. Figure 14D Note also that, as a result of the guidewire 122 being fully advanced distally via the finger pressure applied to the tab 172 as described above, the tab 172 is no longer disposed within the track 174 .

[0085] Figure 14E It is shown that with the tabs no longer engaged within the tracks 174, the top housing portion 112A and the bottom housing portion 112B can be separated at their distal ends so that the handle 146, still attached to the catheter hub 46, can be separated from the housing 112. Although not shown at this stage, the needle safety feature 156 disposed in the recess 152 of the handle 146 isolates the distal end of the needle 116. The handle 146 can then be manually removed from the catheter hub 46 ( Figure 14F ), and placement and dressing of the catheter 42 can be completed. The insertion tool 110 (including the needle 116 isolated by the needle safety component 156 of the handle 146) can be safely discarded.

[0086] Now refer to Figure 15 , which depicts an exploded view of a catheter insertion device 10 according to one embodiment, the catheter insertion device includes similar components to those already described above. Therefore, only selected differences are discussed below.

[0087] Figure 15 The guidewire 22 is shown looping back upon itself in this embodiment to generally define a U-shaped configuration. Figure 17A and Figure 17B 1 and 2. The guidewire 22 is shown disposed within the housing 12 of the catheter insertion device 10. Specifically, these figures show the proximal end of the guidewire 22 being anchored to a portion of the device 10, namely, at an anchor point 982 on the top portion 12A of the housing 12. Figure 18 The guidewire 22 is shown removably extending proximally within a guide channel 984 defined on the inner surface of the top housing portion 12A. Figure 17A and Figure 17BThe middle portion of the guidewire 22 is shown looped back on itself near the proximal end of the device 10. A guide surface 980 ( Figure 16 ) constrains the flexible guide wire 22 to be in a circular, substantially U-shaped configuration. The looped middle portion of the guide wire 22 is then passed along a channel 986 (at the bottom of the housing portion 12B) defined on the inner surface of the housing 12 before it enters the hollow needle 16. Figure 19 16 (best seen in FIG. 1 ) extends toward the distal end of the device 10. The free distal end of the guide wire 22 initially resides within the needle 16.

[0088] Arrange as just described above, guide wire 22 is positioned to be selectively advanced by guide wire advancement assembly 20 so that its free distal end can extend distally from the open distal end of pin 16.In the present embodiment, this selective advancement of guide wire 22 is realized via the distal movement of the guide wire advancement slide 28 included in the device housing 12. The distal movement of guide wire advancement slide 28 causes the corresponding distal sliding movement of guide wire lever 24. When lever advances, the guide surface 980 of guide wire lever 24 pushes the curved portion of guide wire 22 distally. It should be noted that guide wire 22 is sufficiently rigid, so that it is not flexed by guide wire lever 24. In addition, guide surface 980 and guide wire 22 are configured to enable guide wire 22 to be retracted into the insertion tool housing 12 when guide wire advancement slide 28 or other suitable mechanisms slide to the proximal side.

[0089] This pushing movement of the slidable guidewire lever 24 causes the distal end of the guidewire 22 to extend distally from the open distal end of the needle 16. Due to its anchored proximal end at the anchor point 982 and its curved or looped U-shaped configuration, the guidewire 22 is advanced distally at a rate that is approximately twice the sliding rate of the guidewire advancement slider 28. Figures 1A to 9 , which results in a guidewire extension length that is approximately twice the guidewire advancement rate in the device configuration of FIG. 2 , which results in a guidewire extension length that is approximately twice the guidewire extension length when compared to the travel length of the guidewire advancement slider 28. This further advantageously results in a relatively long guidewire extension length in a vein or other patient vasculature so that the catheter 42 is more appropriately guided into the patient's body. Therefore, the guidewire and advancement assembly described herein operate as a type of "reverse pulley" system for distal guidewire advancement. It should be noted that other looped configurations of the guidewire can be included in the device 10 in addition to those configurations shown and described herein. Additionally, in other embodiments, different ratios of guidewire extension relative to advancement assembly movement are also possible.

[0090] It is noted that the looped tubing and guidewire advancement handle are merely examples of structures that may suitably perform the desired functionality described herein. In practice, other structures may be employed to implement the principles described in conjunction with the present embodiment. Furthermore, although shown and described above as being attached to the catheter insertion device housing, the proximal end of the guidewire may, for example, be attached to other structures within / on the device, such as the needle hub 14. In one embodiment, the majority of the length of the guidewire comprises a metal alloy of nickel and titanium (commonly referred to as Nitinol) that is sufficiently rigid and can be arranged in a U-shaped configuration without retaining a memory of position when the guidewire is advanced. It is noted that other suitable guidewire materials may also be employed.

[0091] Figure 20A and Figure 20B Various details of the coupling element 80 as further described above with respect to the needle safety component 56 are depicted, which is used to shield the distal end of the needle 16 once the catheter insertion is completed. As shown, the coupling element 80 (also referred to herein as a coupling member) includes a front plate 992 defining an aperture 992A, and a forked rear plate 994. A protrusion 996 extends from one of the forks of the rear plate 994. A horseshoe-shaped needle passing element 998 is also included in a spaced arrangement from the front plate 992 and defines an aperture 998A coaxially aligned with the aperture 992A of the front plate.

[0092] In this embodiment, a friction element 1000 (also referred to herein as a friction member), ie, an annular elastomeric element or O-ring 1002, is also included with the coupling element 80. Figure 21A and Figure 21B As shown, the O-ring 1002 is configured to surround both a portion of the needle 16 and the forked back plate 994. The protrusion 996 is used to help maintain the O-ring 1002 in place, as shown in FIG. Figure 21A and Figure 21B As shown. With O-ring 1002 positioned in this manner, the O-ring applies a relatively constant urging force to coupling element 80, thereby shielding the distal tip of needle 16, as will be described further below. It should be noted that the elastomeric element can take forms other than an O-ring while performing the same functionality. For example, a rod or length of elastomeric material surrounding a portion of the coupling element and the needle can also be used.

[0093] Figure 21C and Figure 21DThe coupling element 80 is shown disposed in a bracket 1008, which in turn is disposed within the safety housing 54. As shown, the bracket 1008 defines two restraining surfaces 1010 against which corresponding portions of the front plate 992 of the coupling element initially rest when the needle 16 initially extends through the bracket and the coupling element. A retaining ring 1008A, through which the needle 16 slidably passes, enables the needle to engage with the bracket 1008.

[0094] The coupling element 80 and the needle 16 are initially slidably arranged in 21A to 21D The state shown (showing the state of the coupling element before it has shielded the distal end of the needle) allows relative sliding movement between the needle and the coupling element. The passage of the needle 16 through the hole 998A of the needle passing element 998 initially restricts the tilting movement of the coupling element 80.

[0095] Needle 16 also passes through hole 992A of front plate 992 so that the needle is straddled by the prongs of forked rear plate 994. As described above, O-ring 1002 is disposed around needle 16 and rear plate 994 so that when bracket 1008 and coupling element 80 (both housed within safety housing 54) are in use of device 10, O-ring 1002 is disposed around needle 16 and rear plate 994. Figure 15 ) provides a drag force as it slides distally along the length of the needle 16. Figure 21C Viewed from the angle of the figures shown, during such distal sliding, the drag force provided by O-ring 1002 in turn exerts a rotational torque on coupling element 80 (via the force provided via contact of the coupling element with the O-ring) to urge the coupling element to rotate in a clockwise motion.

[0096] When the needle 16 is extended through the coupling element, such clockwise rotation of the coupling element 80 is prevented by the needle passing feature 998. Figure 21C As viewed from the angle of the figures shown, once the safety housing 54 containing the bracket 1008 and the binding element 80 has been slid distally a sufficient distance to allow the needle passing element 998 to slide past and away from the distal end of the needle 16, the binding element is no longer constrained, and the drag force exerted by the O-ring 1002 causes the binding element to tilt clockwise relative to the needle. This tilting locks the binding element 80 (and, by extension, the bracket 1008) from moving relative to the needle 16 by virtue of the physical engagement between the outer surface of the needle 16 and the periphery of the front plate aperture 992A, which thus serves as an engagement surface. Since the distal tip of the needle 16 is securely disposed within the locked bracket 1008, the user is protected from accidental needle sticks.

[0097] As described above, O-ring 1002 applies a relatively constant urging force to tilt coupling element 80, which keeps the coupling element tilted (after the needle distal tip is withdrawn into the bracket as described above) so as to more securely lock bracket 1008 to the distal tip of needle 16. For example, in the event that needle 16 is pushed back and forth relative to safety housing 54 / bracket 1008, the constant urging force is beneficial after the safety housing / bracket has been locked to the needle distal tip to ensure that the coupling element does not return to an orientation in which needle penetration feature 998 can reengage needle 16 and unlock needle safety component 56. Note that O-ring 1002 can be employed with needles and coupling elements that are larger or smaller than those shown and described herein.

[0098] The O-ring 1002 in the above embodiment is sufficiently compliant so that it can stretch on the aforementioned structure while applying a desired force, as described above. In one embodiment, the material of the O-ring 1002 comprises any one or more of natural or synthetic rubber, elastomer, polymer, thermoplastic, silicone, etc. In one embodiment, the material of the O-ring is selected to provide enough tear resistance, the ability to apply desired friction, and chemical compatibility. The size of the O-ring can vary according to the size and configuration of the binding element and the needle. In other embodiments, the O-ring can include other shapes, materials, and positions for placement while still providing expected functionality.

[0099] Figure 22A The guidewire lever 24 is shown to include a catheter advancement feature that enables the guidewire lever to distally advance the catheter 42 in addition to advancing the guidewire 22 as described above. In this embodiment, the catheter advancement feature includes an advancement tab 1014 disposed on the proximal portion 24A of the guidewire lever 24 and arranged to physically engage the cap 58 ( 1014 ) of the safety housing 54 when the guidewire lever 24 is moved distally via distal sliding of the slider 28 by the user. Figure 15 ).exist Figure 22B Such engagement is shown in FIG. Further distal movement of the guidewire lever 24 causes the safety can 54 and the catheter 42 ( Figure 15 ) distally. The slider 28 in this embodiment can slide to advance the catheter 42 distally a predetermined distance via the advancement tab 1014 of the guidewire lever 24. In one embodiment, the predetermined distance advances the catheter 42 until its distal end is distally advanced over the distal end of the needle 16. Further distal advancement of the catheter 42 can be achieved as needed via distal sliding of the handle 48 ( Figure 15 In another embodiment, the slider 28 is configured to distally advance the catheter via the advancement tab 1014 the full distal distance desired.

[0100] Figure 22A The position of the advancement tab 1014 is such that a staged advancement of the guidewire 22 and catheter 42 is provided. Figure 22A Distal advancement of the guidewire 22 results in immediate advancement of the guidewire, while the safety housing 54 and catheter 42 remain in place. Figure 22B Further distal advancement of the illustrated position causes the advancement tab 1014 to engage and advance the safety can 54 and catheter 42 distally, as described above, while continuing to advance the guidewire 22 distally.

[0101] Thus, in addition to distally advancing the guidewire 22 outward through the needle 16, the guidewire lever 24 can also distally advance the catheter 42 along the needle 16 and into the patient's vasculature, as further described above. Note that the specific shape and configuration of the advancement tab 1014, as well as its engagement with the safety housing and / or catheter and the amount of stroke applied to the safety housing and / or catheter, can vary from that shown and described herein.

[0102] Figure 23A A detailed cross-sectional side view of a portion of an insertion tool 10 (sometimes referred to as a catheter insertion device assembly) incorporating a first embodiment of a mechanical advantage mechanism is shown in accordance with some embodiments. The mechanical advantage mechanism 1200 is generally configured to increase the amount of force applied by the slide 28 ( Figure 1A 、 Figure 1B ) or more specifically the force applied to the catheter 42 by the guidewire lever 24 of the slider 28. More specifically, the guidewire lever 24 applies an input force 1221 to the mechanical advantage mechanism 1200, and the mechanical advantage mechanism 1200, in turn, applies an output force 1222 to the cap 58 of the safety housing 54. The cap 58, safety housing 54, catheter hub 46, and catheter 42 are coupled together such that the cap 58, safety housing 54, catheter hub, and catheter 42 are displaced distally relative to the bottom housing portion 12B as a single unit and such that the distally directed force applied to the cap 58 is transmitted to the catheter 42 ( Figure 15 ). In use, the user applies an input force 1221 to the slider 28, and the slider 28 transmits the input force 1221 to the mechanical advantage mechanism 1200 via the advancement tab 1014 of the guidewire lever 24. As a result, the mechanical advantage mechanism 1200 applies an output force 1222 to the catheter 42 to displace the catheter 42 distally along the needle 16. The mechanical advantage mechanism 1200 is generally configured such that the output force 1222 is greater than the input force 1221. In some embodiments, the output force 1222 can be two or more times the input force 1221.

[0103] Mechanical advantage mechanism 1200 includes a lever 1210. Lever 1210 defines a first end 1211, a second end 1212, and an intermediate point 1213 between first end 1211 and second end 1212. Second end 1212 and bottom housing portion 12B define a fulcrum 1215. In some embodiments, lever 1210 may include an opening 1214 configured to accommodate passage of needle 16 therethrough. Opening 1214 may include a hole or a slot.

[0104] The first end portion 1211 is coupled to the guidewire lever 24 via the advancement tab 1014 such that distal displacement of the slider 28 results in corresponding distal displacement of the first end portion 1211. In other words, the advancement tab 1014 transmits an input force 1221 to the first end portion 1211, thereby causing the first end portion 1211 to be displaced distally relative to the bottom housing portion 12B, which in turn causes the lever 1210 to rotate about the fulcrum 1215. The rotation of the lever 1210 causes the intermediate point 1213 to contact the cap 58, causing the intermediate point 1213 to apply an output force 1222 to the cap 58.

[0105] Figure 23B A detailed cross-sectional side view of a portion of the insertion tool 10 incorporating a second embodiment of a mechanical advantage mechanism is shown in accordance with some embodiments. The mechanical advantage mechanism 1300 is generally configured to increase the force applied by the guidewire lever 24 to the catheter 42. More specifically, the guidewire lever 24 applies an input force 1321 to the mechanical advantage mechanism 1300, and the mechanical advantage mechanism 1300, in turn, applies an output force 1322 to the cap 58 of the safety housing 54. The cap 58, safety housing 54, catheter hub 46, and catheter 42 are coupled together such that the cap 58, safety housing 54, catheter hub, and catheter 42 are displaced distally relative to the bottom housing portion 12B as a single unit and such that the distally directed force applied to the cap 58 is transmitted to the catheter 42. In use, a user applies the input force 1321 to the slider 28 ( Figure 1A 、 Figure 1B ), and the guidewire lever 24 of the slider 28 transmits an input force 1321 to the mechanical advantage mechanism 1300. As a result, the mechanical advantage mechanism 1300 applies an output force 1322 to the catheter 42 to displace the catheter 42 distally along the needle 16. The mechanical advantage mechanism 1300 is generally configured such that the output force 1322 is greater than the input force 1321. In some embodiments, the output force 1322 can be two or more times the input force 1321.

[0106] Mechanical advantage mechanism 1300 includes lever 1310. Lever 1310 defines a first end 1311, a second end 1312, and an intermediate point 1313 between first and second ends 1311, 1312. Second end 1312 and needle hub 14 define a fulcrum 1315. First end 1311 is coupled to guidewire lever 24 via advancement tab 1014, such that distal displacement of slider 28 results in corresponding distal displacement of first end 1311. In other words, advancement tab 1014 transmits input force 1321 to first end 1311, causing first end 1311 to be distally displaced relative to bottom housing portion 12B, which in turn causes lever 1310 to rotate about fulcrum 1315. Rotation of lever 1310 causes intermediate point 1313 to contact cap 58, causing intermediate point 1313 to apply output force 1322 to cap 58.

[0107] Figure 23C A detailed cross-sectional side view of a portion of an insertion tool 10 (sometimes referred to as a catheter insertion device assembly) incorporating a third embodiment of a mechanical advantage mechanism in accordance with some embodiments is shown. The mechanical advantage mechanism 1400 can be similar in some respects to the features and functionality of the mechanical advantage mechanisms described above. The mechanical advantage mechanism 1400 includes a lever 1410. The lever 1410 defines a first end 1411, a second end 1412, and an intermediate point 1413 between the first end 1411 and the second end 1412. The second end 1412 is engaged with the bottom housing portion 12B via an engagement feature 1418 such that distal displacement of the second end 1412 relative to the bottom housing portion 12B is limited or prevented. The engagement feature 1418 may include a tab, a slot, or any other suitable feature. The intermediate point 1413 defines a fulcrum with the cap 58. The first end 1411 is coupled to the guidewire lever 24 via a push tab 1014 such that the slider 28 ( Figure 1A 、 Figure 1B ) causes corresponding distal displacement of first end 1411. In other words, advancement tab 1014 transmits input force 1421 to first end 1411, thereby causing first end 1411 to be displaced distally relative to bottom housing portion 12B, which in turn causes lever 1410 to rotate about fulcrum 1415. Rotation of lever 1410 causes intermediate point 1413 to contact cap 58, causing intermediate point 1413 to apply output force 1422 to cap 58.

[0108] Figure 23DA detailed cross-sectional side view of a portion of an insertion tool 10 (sometimes referred to as a catheter insertion device assembly) incorporating a fourth embodiment of a mechanical advantage mechanism, according to some embodiments, is shown. Mechanical advantage mechanism 1500 can be similar in some respects to the features and functionality of the mechanical advantage mechanisms described above. Mechanical advantage mechanism 1500 includes a lever 1510. Lever 1510 defines a first end 1511, a second end 1512, and a bend 1519 at a midpoint 1513 between first end 1511 and second end 1512. Bend 1519 defines a horizontal section of lever 1510 extending between midpoint 1513 and first end 1511, and a vertical section extending between midpoint 1513 and second end 1512. Second end 1512 engages cap 58 such that distal displacement of second end 1512 causes distal displacement of cap 58. Midpoint 1513 and needle hub 14 define a fulcrum 1515. First end 1511 is slidably coupled to guidewire lever 24 such that cam surface 1507 of guidewire lever 24 causes lateral inward / downward displacement of first end 1511. This inward / downward displacement of first end 1511, in turn, causes distal displacement of second end 1512. In other words, cam surface 1507 transmits input force 1521 to first end 1511, causing first end 1511 to displace toward bottom housing portion 12B, which in turn causes lever 1510 to rotate about fulcrum 1515. Rotation of lever 1510 causes second end 1512 to contact cap 58, causing second end 1512 to apply output force 1522 to cap 58. Thus, rotation of lever 1510 separates cap 58 from needle hub 14.

[0109] Figure 23E A detailed cross-sectional side view of a portion of an insertion tool 10 (sometimes referred to as a catheter insertion device assembly) incorporating a fifth embodiment of a mechanical advantage mechanism is shown in accordance with some embodiments. The mechanical advantage mechanism 1600 can be similar in some respects to the features and functionality of the mechanical advantage mechanisms described above. The mechanical advantage mechanism 1600 includes a tension member 1610 (e.g., a wire or cable). The tension member 1610 defines a first end 1611, a second end 1612, and a loop portion 1613 between the first end 1611 and the second end 1612. The tension member 1610 is attached to the slider 28 ( Figure 1A 、 Figure 1B) of the guidewire lever 24. The tension member 1610 extends proximally along the guidewire lever 24 between the guidewire lever 24 and the safety housing 54, away from the first end 1611. The ring portion 1613 partially surrounds the cap 58 and then extends distally along the bottom housing portion 12B between the safety housing 54 and the bottom housing portion 12B. The second end 1612 is attached to the bottom housing portion 12B. Distal displacement of the slider 28 pulls the ring portion 1613 distally, causing the tension member 1610 to slide along the cap 58. The distal displacement of the ring portion 1613 pulls the cap 58 distally with it, so that the distal displacement of the cap 58 is half the distal displacement of the slider 28. In other words, the guidewire lever 24 exerts an input force 1621 on the tension member 1610 at the first end 1611, and the ring portion 1613 exerts an output force on the cap 58, wherein the output force 1622 is twice the input force 1621. The cap 58 is coupled to the catheter 42 such that distal displacement of the cap causes corresponding distal displacement of the catheter 42 relative to the bottom housing portion 12B and the needle 16. In some embodiments, when the slider 28 is in the fully retracted position, i.e., fully displaced to Figure 23E When the guide wire 22 is inserted into the guide wire 22 for a limited distance, the tension member 1610 may include some slack (i.e., it may not be tightened). In such embodiments, the guide wire lever 24 may not cause the cap 58 to shift.

[0110] Figure 23F A detailed cross-sectional side view of a portion of an insertion tool 10 (sometimes referred to as a catheter insertion device assembly) incorporating a sixth embodiment of a mechanical advantage mechanism is shown in accordance with some embodiments. The mechanical advantage mechanism 1700 can be similar in some respects to the features and functionality of the mechanical advantage mechanisms described above. The mechanical advantage mechanism 1700 includes a first rack 1711, a second rack 1712, and a pinion 1713 disposed between the first rack 1711 and the second rack 1712 such that the pinion 1713 meshes with both the first rack 1711 and the second rack 1712. The first rack 1711 is in contact with the slide 28 ( Figure 1A 、 Figure 1B) or more specifically coupled to the guidewire lever 24 (e.g., attached to or incorporated therein), and the second rack 1712 is coupled to the bottom housing portion 12B (e.g., attached to or incorporated therein). Distal displacement of the slider 28 causes the pinion 1713 to roll along the second rack 1712 (i.e., rotate and displace distally along the second rack). The pinion 1713 is coupled to the catheter 42 via the cap 58 so that the pinion 1713 and the catheter 42 are displaced distally as a single unit. The rolling of the pinion 1713 along the second rack 1712 causes the pinion 1713 to displace distally, which is half the distal displacement of the slider 28. In other words, the slider 28 applies an input force 1721 to the circumference (or top) of the pinion 1713, and the center of the pinion 1713 applies an output force to the cap 58, wherein the output force 1722 is twice the input force 1721. The cap 58 is coupled to the catheter 42 such that distal displacement of the cap 58 results in corresponding distal displacement of the catheter 42 relative to the bottom housing portion 12B and the needle 16 .

[0111] Figure 24 A block diagram of a method for placing a catheter within a blood vessel is shown, which, according to some embodiments, may include all or any subset of the following steps, actions, or processes. Method 1800 may include inserting a needle of a catheter insertion device assembly through the patient's skin (block 1810) such that the distal end of the needle is disposed within the blood vessel. The needle is pre-disposed within the lumen of a catheter of the catheter insertion device assembly, and a guidewire of the catheter insertion device assembly is pre-disposed within the lumen of the needle. Method 1800 may also include advancing the guidewire distally along the lumen of the needle (block 1820) such that the guidewire extends beyond the distal end of the needle.

[0112] The method 1800 may further include applying a first distally directed force on the slider (block 1830). The method 1800 may further include applying a second distally directed force on the catheter (block 1840), wherein the second force is greater than the first force.

[0113] Method 1800 may also include advancing the catheter distally along the needle a catheter distance (block 1850) such that the distal end of the catheter is displaced from a position proximal to the distal end of the needle to a position distal to the distal end of the needle. In some embodiments of method 1800, advancing the catheter distally includes displacing a slider of the catheter insertion device assembly distally relative to a housing of the catheter insertion device assembly by a slider distance, and wherein the slider distance is greater than the catheter distance.

[0114] In some embodiments of method 1800, displacing the slider distally comprises rotating a lever about a fulcrum, wherein the fulcrum is coupled with a hub of the catheter, a hub of the needle, or a housing.

[0115] In some embodiments of method 1800, the catheter insertion device includes a tension member having: (i) a first end coupled to a slider; (ii) a second end coupled to a housing; and (iii) a ring portion coupled to a catheter. In such embodiments, distal displacement of the slider relative to the housing causes the ring portion to displace the catheter distally along the needle.

[0116] In some embodiments of method 1800, the catheter insertion device includes: (i) a first rack coupled to a slider; (ii) a second rack coupled to a housing; and (iii) a pinion coupled to the catheter, wherein the pinion meshes with the first rack and the second rack. In such embodiments, distal displacement of the slider relative to the housing causes the pinion to rotate and displace distally along the housing, thereby causing the catheter to displace distally along the needle.

[0117] Without departing from the spirit of the disclosed text, the embodiments of the present invention may be implemented in other specific forms. The described embodiments should be considered in all respects as merely illustrative and not restrictive. Therefore, the scope of the embodiments is indicated by the appended claims rather than by the foregoing description. All changes within the meaning and range of equivalents of the claims are intended to be included within their scope.

Claims

1. A catheter insertion device assembly, characterized in that include: a catheter comprising a catheter tubing defining a catheter lumen extending between a distal end of the catheter and a catheter hub at a proximal end of the catheter, the catheter hub disposed within the housing; a needle configured for insertion into a patient between a skin surface and a blood vessel, the needle defining a needle lumen extending between a needle distal end and a needle proximal end, the needle proximal end coupled to the housing, wherein the needle is pre-positioned within the catheter lumen such that the needle distal end extends beyond the catheter distal end and the needle proximal end extends proximally beyond the catheter hub; a guidewire extending between a guidewire distal end and a guidewire proximal portion, wherein the guidewire is pre-disposed within the needle lumen such that the guidewire distal end is positioned proximal to the needle distal end and the guidewire proximal portion extends proximally beyond the needle proximal end; a slider displaceable along an exterior of the housing, the slider coupled to the guidewire proximal portion such that displacement of the slider causes displacement of the guidewire; and a mechanical advantage mechanism coupled between the slider and the catheter hub such that: The slider provides an input force to the mechanical advantage mechanism, and The mechanical advantage mechanism provides an output force to the catheter hub in response to the input force, the output force being greater than the input force.

2. The catheter insertion device assembly according to claim 1, wherein The input force and the output force are each directed distally.

3. The catheter insertion device assembly according to claim 1 or 2, characterized in that The output force is twice the input force.

4. The catheter insertion device assembly according to claim 1, wherein The displacement of the slider results in displacement of the catheter and simultaneous displacement of the guidewire.

5. The catheter insertion device assembly according to claim 4, wherein The displacement of the catheter is less than the simultaneous displacement of the guidewire.

6. The catheter insertion device assembly according to claim 1, wherein The mechanical advantage mechanism includes a lever.

7. The catheter insertion device assembly according to claim 6, wherein: The lever includes an opening, and the needle passes through the opening.

8. The catheter insertion device assembly according to claim 6, wherein: The levers include: a first end portion coupled to the sliding member; a second end portion defining a fulcrum with the bottom housing portion; and an intermediate point, which couples with the catheter hub, and Distal displacement of the slider relative to the bottom housing portion results in distal displacement of the catheter relative to the needle.

9. The catheter insertion device assembly according to claim 6, wherein: The levers include: a first end portion coupled to the sliding member; a second end portion defining a fulcrum with the needle hub; and an intermediate point, which couples with the catheter hub, and Distal displacement of the slider relative to the bottom housing portion results in distal displacement of the catheter relative to the needle.

10. The catheter insertion device assembly according to claim 6, wherein: The levers include: a first end portion coupled to the sliding member; a second end coupled to the hub of the needle; and an intermediate point coupled to the catheter hub, the intermediate point defining a fulcrum, and Distal displacement of the slider relative to the bottom housing portion results in distal displacement of the catheter relative to the needle.

11. The catheter insertion device assembly according to claim 6, wherein: The levers include: a first end slidably coupled to the cam surface of the slider; a second end portion coupled to the catheter hub; and an intermediate point adjacent to the bend of the lever defining a fulcrum with the bushing of the needle, and Distal displacement of the slider relative to the bottom housing portion results in lateral displacement of the first end, which in turn results in distal displacement of the catheter relative to the needle.

12. The catheter insertion device assembly of claim 1, wherein: The mechanical advantage mechanism includes a tension member having: a first end portion coupled to the sliding member; a second end portion coupled to the bottom housing portion; and a ring portion coupled to the catheter hub, and Distal displacement of the slider relative to the bottom housing portion causes the ring portion to distally displace the catheter relative to the needle.

13. The catheter insertion device assembly of claim 1, wherein: The mechanical advantage mechanism comprises: a first rack coupled to the sliding member; a second rack coupled to the bottom housing portion; and a pinion gear coupled to the catheter hub, the pinion gear meshing with the first rack gear and the second rack gear, and Distal displacement of the slider relative to the bottom housing portion causes the pinion to rotate and displace distally along the bottom housing portion, thereby causing the catheter and the pinion to co-displace distally relative to the needle.

14. The catheter insertion device assembly according to claim 1, wherein Also included is a safety assembly configured to cover the distal tip of the needle when the needle is withdrawn from the catheter, the safety assembly being coupled between the catheter hub and the mechanical advantage mechanism such that distal displacement of the slider causes distal displacement of the safety assembly, thereby causing distal displacement of the catheter.

15. The catheter insertion device assembly of claim 1, wherein: the slide being configured to displace a first distance and subsequently a second distance, displacement of the slider by the first distance causes the guidewire to be displaced distally relative to the needle by a first guidewire distance, and Displacing the slide by the subsequent second distance results in: the guidewire is displaced distally relative to the needle a second guidewire distance, and The catheter is displaced relative to the needle by a first catheter distance that is less than the second guidewire distance.

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