Catheterization device comprising a top-mounted propulsion component

Abstract

An insertion tool for inserting a catheter into a patient is disclosed. In one embodiment, the insertion tool includes a housing in which at least a portion of the catheter is initially disposed, a hollow needle extending distally from the housing with the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. The insertion tool includes a guidewire advancement assembly having a first finger pad for selectively advancing the guidewire distally past a distal end of the needle in preparation for advancing the catheter distally. The insertion tool also includes a catheter advancement assembly having a second finger pad for selectively advancing the catheter into the patient. The finger pads are positioned so that a user can begin advancing the second finger pad after advancing the first finger pad without substantially repositioning the user's thumb or fingers in order to advance the guidewire and catheter in succession.

Description

[0001] Division Information

[0002] This application is a divisional application of application number 201680037291.9, filed May 13, 2016, entitled "Catheter Insertion Device Including Top-Mounted Advancement Component."

[0003] Cross Reference to Related Patent Applications

[0004] This application is a continuation-in-part of U.S. Patent Application 14 / 702,580, filed May 1, 2015, entitled "Catheter Placement Device Including Guidewire and Catheter Control Elements," which claims the benefit of U.S. Provisional Patent Application 61 / 988,114, filed May 2, 2014, entitled "Catheter Placement Device Including Catheter and Guidewire Control Systems," which is a continuation-in-part of U.S. Patent Application 14 / 099,050, filed December 6, 2013, entitled "Guidewire Extension System for a Catheter Placement Device," which claims the benefit of U.S. Provisional Patent Application 61 / 771,703, filed March 13, 2013, entitled "Needle Safety and Guidewire Extension Systems for a Catheter Insertion Device," which is a continuation-in-part of U.S. Patent Application 13 / 107,781, filed May 13, 2011, entitled "Catheter Placement Device and Method," now U.S. Patent 8,932,258, which claims the benefit of the following U.S. Provisional Patent Applications: U.S. Provisional Patent Application 61 / 345,005, filed May 14, 2010, entitled "Catheter Insertion System Including an Integrated Guidewire Dilator"; U.S. Provisional Patent Application 61 / 345,022, filed May 14, 2010, entitled "Systems and Methods for Placement of an Intermediate Dwell Catheter Including a Needle Blunting System"; U.S. Provisional Patent Application 61 / 372,050, filed August 9, 2010, entitled "Catheter Insertion Tool Including Fold-out Guidewire Advancement Flaps";and U.S. Provisional Patent Application 61 / 385,844, filed September 23, 2010, entitled "Catheter Insertion Tool Including Guidewire Advancement Component." This application also claims the benefit of U.S. Provisional Patent Application 62 / 162,580, filed May 15, 2015, entitled "Catheter Placement Device Including Top-Mounted Advancement Components." Each of the above-identified applications is incorporated herein by reference in its entirety. SUMMARY

[0005] Briefly, embodiments of the present invention relate to an insertion tool for inserting a catheter or other tubular medical device into a patient. In one embodiment, the insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device to provide a simple guidewire placement procedure.

[0006] In one embodiment, the insertion tool includes a housing in which at least a portion of the catheter 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 an advancement assembly for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment, the insertion tool also includes a catheter advancement assembly for selectively advancing the catheter into the patient. Each advancement assembly can include a slider or other actuator that enables a user to selectively advance the desired component.

[0007] In one embodiment, the catheter advancement assembly also includes a handle that is initially removably attached to a hub of the catheter within the housing. The user moves the handle distally, which in turn moves the catheter distally from the housing distally. The handle can include a needle safety component for isolating and receiving a distal tip of the needle in the handle when the needle is removed from the catheter. In addition, various guidewire and catheter advancement assemblies are disclosed herein.

[0008] In another embodiment, the insertion tool includes various features, including: actuating the guidewire and catheter advancement assemblies without moving the user's grasping hand that holds the insertion tool during the catheter insertion procedure; selectively advancing one of the guidewire or catheter based on a prior advancement of the other; and a guidewire deactivation feature.

[0009] In another embodiment, the guidewire and catheter advancement assemblies each include a user engagement component configured such that a user can begin advancing the second user component after advancing the first user engagement component without substantially repositioning the user's thumb or finger for advancement.

[0010] In yet another embodiment, the catheter advancement assembly includes a handle assembly having a first wing and a second wing. A cover portion extends between the first wing and the second wing and is positioned such that advancement of the guidewire advancement assembly and the catheter advancement assembly can be accomplished by a single thumb or finger of a user.

[0011] These and other features of embodiments of the present application will become more apparent from the following description in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF DRAWINGS

[0012] A more particular description of the disclosure will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings are only illustrative and are therefore not to be considered limiting in their scope. The exemplary embodiments of the application will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0013] FIG. 1A and FIG. 1B are various views of a catheter insertion device according to an embodiment;

[0014] FIG. 2A and FIG. 2B are FIG. 1A and FIG. 1B are various exploded views of a catheter insertion device of

[0015] FIG. 3A and FIG. 3B illustrate one stage of use of a catheter insertion tool according to an embodiment, FIG. 1A and FIG. 1B are various views of one stage of use of a catheter insertion tool according to an embodiment;

[0016] FIG. 4A and FIG. 4B illustrate one stage of use of a catheter insertion tool according to an embodiment, FIG. 1A and FIG. 1B are various views of one stage of use of a catheter insertion tool according to an embodiment;

[0017] FIG. 5A and FIG. 5B illustrate one stage of use of a catheter insertion tool according to an embodiment, FIG. 1A and FIG. 1B are various views of one stage of use of a catheter insertion tool according to an embodiment;

[0018] FIG. 6A and FIG. 6B This illustrates an implementation scheme. FIG. 1A and FIG. 1B Various views of a stage in the use of catheter insertion tools;

[0019] FIG. 7A and FIG. 7B This illustrates an implementation scheme. FIG. 1A and FIG. 1B Various views of a stage in the use of catheter insertion tools;

[0020] FIG. 8 This illustrates an implementation scheme. FIG. 1A and FIG. 1B This is a stage in the use of catheter insertion tools;

[0021] FIG. 9 This illustrates an implementation scheme. FIG. 1A and FIG. 1B This is a stage in the use of catheter insertion tools;

[0022] FIG. 10A to FIG. 10C Various views of the needle safety components and environment for a catheter insertion tool according to one embodiment are shown;

[0023] FIG. 11A to FIG. 11D These are various views of a catheter insertion device according to one embodiment;

[0024] FIG. 12A and FIG. 12B yes FIG. 11A to FIG. 11D Various views of a portion of the catheter insertion device;

[0025] FIG. 13A and FIG. 13B yes FIG. 11A to FIG. 11D Various views of a portion of the catheter insertion device;

[0026] FIG. 14A to FIG. 14F This illustrates an implementation scheme. FIG. 11A to FIG. 11D The various stages of using catheter insertion tools;

[0027] FIG. 15A and FIG. 15B These are various views of a catheter insertion device according to one embodiment;

[0028] FIG. 16 Is with FIG. 15A and FIG. 15B A cross-sectional side view of an integrated guidewire / dilatator used in conjunction with a catheter insertion device;

[0029] FIG. 17A to FIG. 17C It is based on an implementation plan, and FIG. 15A andFIG. 15B Various views of a slotted needle for use with the catheterization device of

[0030] FIG. 18 is FIG. 15A and FIG. 15B Cross-sectional side view of a portion of the catheterization device of

[0031] FIG. 19 shows one stage of use of the catheterization tool of FIG. 15A and FIG. 15B

[0032] FIG. 20A and FIG. 20B shows one stage of use of the catheterization tool of FIG. 15A and FIG. 15B

[0033] FIG. 21A and FIG. 21B shows one stage of use of the catheterization tool of FIG. 15A and FIG. 15B

[0034] FIG. 22 shows one stage of use of the catheterization tool of FIG. 15A and FIG. 15B

[0035] FIG. 23 shows one stage of use of the catheterization tool of FIG. 15A and FIG. 15B

[0036] FIG. 24 shows one stage of use of the catheterization tool of FIG. 15A and FIG. 15B

[0037] FIG. 25A and FIG. 25B Various views of a needle distal tip and guidewire blunting design according to one embodiment

[0038] FIG. 26 is a perspective view of a needle distal tip design according to one embodiment

[0039] FIG. 27 is a perspective view of a catheterization tool according to one embodiment

[0040] FIG. 28 is a cutaway view of a catheterization tool according to one embodiment

[0041] ​​​​​​FIG. 29A and FIG. 29B Various views of a catheter insertion tool according to one embodiment;

[0042] FIG. 30 Perspective view of a catheter insertion tool according to one embodiment;

[0043] FIG. 31 Perspective view of a catheter insertion tool according to one embodiment;

[0044] FIG. 32A to FIG. 32I Various views of a catheter insertion tool in a configuration during use according to one embodiment;

[0045] FIG. 33A to FIG. 33C Various views of a safety needle component according to one embodiment;

[0046] FIG. 34 Exploded view of a catheter insertion device according to one embodiment;

[0047] FIG. 35 Perspective view of a portion of a guide wire rod according to one embodiment;

[0048] FIG. 36A and FIG. 36B Cross-sectional view of a proximal portion of the catheter insertion device of FIG. 34

[0049] Perspective view of a proximal portion of a top housing portion of the catheter insertion device of FIG. 37 FIG. 34 Cross-sectional view of a proximal portion of the catheter insertion device of

[0050] FIG. 38 FIG. 34 Cross-sectional view of a proximal portion of the catheter insertion device of

[0051] FIG. 39A and FIG. 39B Various views of a needle safety component according to one embodiment;

[0052] FIG. 40A to FIG. 40D Various views of a needle safety component and accompanying sled of FIG. 39A and FIG. 39B

[0053] FIG. 41A and FIG. 41B Cross-sectional view of a proximal portion of the catheter insertion device of FIG. 34

[0054] FIG. 42 Cross-sectional view of a guide wire for use with a catheter insertion tool according to one embodiment;

[0055] FIG. 43 ​​​​is partially disposed within the needle FIG. 42 a side view of the guidewire of

[0056] FIG. 44 is a cross-sectional view of a distal portion of a catheter tube including a reinforcing member according to one embodiment;

[0057] FIG. 45A and FIG. 45B illustrates various stages of manufacture of the catheter tube of FIG. 44

[0058] FIG. 46 is a cross-sectional view of a distal portion of a catheter tube including a reinforcing member according to one embodiment;

[0059] FIG. 47A and FIG. 47B illustrates a cross-sectional view of a distal portion of a catheter tube including a reinforcing member according to additional embodiments;

[0060] FIG. 48A to FIG. 48F are various views of a catheter insertion tool according to one embodiment;

[0061] FIG. 49 is an exploded view of the insertion tool of FIG. 48A to FIG. 48F

[0062] FIG. 50A and FIG. 50B illustrates various views of the insertion tool of FIG. 48A to FIG. 48F

[0063] FIG. 51 is a top view of the guidewire advancement assembly and catheter advancement assembly of FIG. 48A to FIG. 48F

[0064] FIG. 52 is a perspective view of the guidewire advancement assembly of the insertion tool of FIG. 48A to FIG. 48F

[0065] FIG. 53A to FIG. 53B illustrates details of the operation of the guidewire advancement assembly of FIG. 52

[0066] FIG. 54 is a perspective view of the insertion tool of in one state FIG. 48A to FIG. 48F

[0067] FIG. 55 is a top view of the guidewire advancement assembly of FIG. 52

[0068] FIG. 56A to FIG. 56C are various views of a portion of the catheter advancement assembly of the insertion tool of FIG. 48A to FIG. 48F

[0069] FIG. 57A and​​​​​​​​​FIG. 57B yes FIG. 48A to FIG. 48F Various views of the distal portion of the insertion tool;

[0070] FIG. 58 and FIG. 59 Show FIG. 48A to FIG. 48F Various views of the conduit advancement component of the insertion tool;

[0071] FIG. 60 yes FIG. 48A to FIG. 48F A perspective view of the conduit advancement assembly of the insertion tool;

[0072] FIG. 61 This is a perspective view of the handle of a conduit propulsion assembly according to one embodiment;

[0073] FIG. 62 yes FIG. 61 Side view of the handle;

[0074] FIG. 63 This is a perspective view of the handle of a conduit propulsion assembly according to one embodiment;

[0075] FIG. 64 This is a perspective view of the handle of a conduit propulsion assembly according to one embodiment;

[0076] FIG. 65 yes FIG. 64 Side view of the handle;

[0077] FIG. 66A to FIG. 66C These are various views of the insertion tool based on an implementation scheme;

[0078] FIG. 67A to FIG. 67F These are various views of a catheter insertion tool according to one implementation scheme;

[0079] FIG. 68 yes FIG. 67A to FIG. 67F An exploded view of the insertion tool;

[0080] FIG. 69A and FIG. 69B Show FIG. 67A to FIG. 67F Various views of the insertion tool;

[0081] FIG. 70 yes FIG. 67A to FIG. 67F Top view of the guidewire advancement assembly and the catheter advancement assembly;

[0082] FIG. 71 yes FIG. 67A to FIG. 67F A perspective view of the guide wire advancement assembly of the insertion tool;

[0083] FIG. 72A to FIG. 72B Show FIG. 71 Details of the operation of the guidewire advance assembly;

[0084] FIG. 73 in one state FIG. 67A to FIG. 67F perspective view of the insertion tool of

[0085] FIG. 74 is FIG. 71 top view of the guidewire advancement assembly of

[0086] FIG. 75A to FIG. 75C is FIG. 67A to FIG. 67F various views of the catheter advancement assembly portion of the insertion tool of

[0087] FIG. 76 show FIG. 67A to FIG. 67F catheter advancement assembly of the insertion tool of

[0088] FIG. 77 is FIG. 67A to FIG. 67F perspective view of the catheter advancement assembly of the insertion tool of

[0089] FIG. 78A and FIG. 78B various views of the catheter advancement assembly of the insertion tool of FIG. 67A to FIG. 67F

[0090] FIG. 79 is FIG. 67A to FIG. 67F perspective view of the finger pad of the insertion tool of

[0091] FIG. 80 is a perspective view of a catheter insertion tool according to an embodiment;

[0092] FIG. 81 is FIG. 80 perspective view of the catheter advancement assembly of the catheter insertion tool of

[0093] FIG. 82A and FIG. 82B side view of the guidewire advancement assembly and catheter assembly of FIG. 80

[0094] is a partial cross-sectional side view of a catheter insertion tool including a blood flash indicator according to an embodiment; FIG. 83

[0095] is a perspective view of a catheter insertion tool including a blood flash indicator according to an embodiment; and FIG. 84

[0096] is a perspective view of a catheter insertion tool including a blood flash indicator according to an embodiment. FIG. 85 DETAILED DESCRIPTION

[0097] ​​Reference will now be made to the drawings wherein like numerals refer to like components throughout the several figures. It should be understood that the drawings are diagrammatic and schematic and are not drawn to scale.

[0098] For clarity, it should be understood that the word "proximal" refers to the direction relatively closer to a clinician using the device to be described herein, while the word "distal" refers to the direction relatively away from the clinician. For example, the tip of a catheter placed within a patient is considered the distal end of the catheter, while the catheter tip remaining outside the body is the proximal end of the catheter. Additionally, the words "comprising," "having," and "including" as used herein should have the same meaning as the word "containing."

[0099] Generally, embodiments of the present application relate to a tool for assisting in the placement of a catheter or other tubular medical device into a patient. For example, catheters of various lengths are commonly placed within a patient in order to establish access to a patient's vasculature and to enable the infusion of medication or the withdrawal of bodily fluids. The catheter insertion tool to be described herein facilitates such catheter placement. It should be noted that while the discussion below focuses on the placement of a particular type and relatively short length of catheter, catheters of many types, sizes, and lengths can be inserted via the present device, including peripheral intravenous midline or extended dwell catheters, PICC catheters, central venous catheters, and the like. In one embodiment, a catheter having a length of between about 2.5 inches and about 4.5 inches can be placed, although many other lengths are possible. In another embodiment, a catheter having a length of about 3.25 inches can be placed.

[0100] Referring first to FIG. 1A to FIG. 1B and FIG. 2A to FIG. 2B various details regarding a catheter insertion tool ("insertion tool") generally indicated at 10 are shown in accordance with one embodiment. As shown, the insertion tool 10 includes a housing 12 which in turn includes a top housing portion 12A which mates with a bottom housing portion 12B. A needle hub 14 supporting a hollow needle 16 is inserted between the housing portions 12A and 12B. The needle 16 extends distally from the needle hub 14 to extend through the body of the insertion tool 10 and out the distal end of the housing 12. In another embodiment, the needle is at least partially hollow while still achieving the functionality described herein.

[0101] A notch 18 is defined through the wall of the needle 16, proximate the distal end of the needle. The notch 18 enables blood to flow back out of the lumen defined by the hollow needle 16 once the needle is within a patient's vasculature during a catheter insertion procedure. Thus, blood exiting the notch 18 can be observed by a clinician to confirm that the needle is properly placed in the vessel, as will be further explained below.

[0102] The insertion tool 10 also includes a guidewire advancement assembly 20 for advancing a guidewire 22 through the needle 16 and into the patient's vasculature once access by the needle has been achieved. The guidewire 22 is pre-positioned within the lumen of the needle 16 with the proximal end of the guidewire positioned proximal to the proximal end of the needle hub 14 as most clearly shown in FIG. 1B and FIG. 2A The guidewire advancement assembly 20 includes a guidewire rod 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 rod 24 includes rod projections 26 that engage the proximal end of the guidewire 22 so as to push the guidewire through the lumen of the needle 16.

[0103] The guidewire advancement assembly 20 also includes a slider 28 that is slidably attached to the top housing portion 12A. Two projections 24A of the guidewire rod 24 are operably attached to the slider 28 so that selective movement of the slider by a user results in corresponding movement of the rod 24 and, by extension, the guidewire 22. The engagement of the rod projections 24A with the slider 28 also maintains the attachment of the slider to the housing 12. Of course, other engagement schemes that translate user input into guidewire movement can also be used. Suitable tracks are included in the top housing portion 12A to enable the sliding movement of the slider 28 and the rod 24, including tracks 34 that extend to the distal end of the housing 12.

[0104] The slider 28 includes two arms 30 that partially wrap around the guide tracks 32 defined by the housing 12. Specifically, during the initial distal advancement of the slider 28, the arms 30 slide on the bottom housing guide tracks 32A, as most clearly shown in FIG. 5B During further distal advancement of the slider 28, the arms 30 slide past the bottom housing guide tracks 32A and continue to slide to the top housing guide tracks 32B, as most clearly shown in FIG. 2A and FIG. 3A If the arms 30 of the slider 28 are no longer engaged with the bottom housing guide tracks 32A, then the two housing portions 12A and 12B can be separated, as will be further described below.

[0105] The guidewire rod 24 includes a resiliently disposed locking arm 36 so as to pop up and engage an extension 36A defined in the interior of the top housing portion 12A when the slider 28 is fully slid distally. This prevents inadvertent retraction of the guidewire 22 distally after the guidewire has been extended distally, which would otherwise result in the distal portion of the guidewire being improperly cut off by the distal tip of the needle 16. It should be noted 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.

[0106] The insertion tool 10 also includes a catheter advancement assembly 40 for selectively advancing a catheter 42 pre-disposed within the housing 12 in a distal direction and includes a catheter tube 44 and a hub 46 at its proximal end. As FIG. 1A and FIG. 1B shown, the catheter 42 is initially partially pre-disposed within the space defined by the housing 12 such that the lumen of the catheter tube 44 is disposed over the needle 16, which in turn is disposed over the guidewire 22, as described above.

[0107] In particular, 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 finger grip 50B enable a user to hold or contact the handle for selectively advancing 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.

[0108] The handle 48 of the catheter advancement assembly 40 includes additional components. A plug or valve 52 is inserted between the handle base 48A and the catheter hub 46 to prevent blood from escaping when the catheter is first introduced into a patient's vasculature. A safety housing 54, which includes a needle safety component 56 therein, is removably attached to the handle 48 between the arms 50. In particular, raised portions 60 included on the interior surfaces of the handle arms 50 engage corresponding recessed portions 62 FIG. 10A defined in the safety housing 54 to removably secure the safety housing to the handle 48. The cap 56 supports the needle safety component 56 and covers the end of the safety housing 54. As FIG. 1B shown, the needle 16 is initially extended through the above-described components in the order shown in FIG. 2B Additional details regarding the operation of these components are provided below.

[0109] It is noted that in one embodiment, the outer diameter of the needle 16 and catheter tube 44 are lubricated with silicone or other suitable lubricant to enhance the sliding of the catheter tube relative to the needle and to facilitate the insertion of the catheter into the patient.

[0110] The insertion tool 10 also includes a support structure 70 for stabilizing the needle 16 proximate the exit point of the needle from the housing 12. In the present embodiment, the support structure 70 includes an interface 72 of the top housing portion 12A and the bottom housing 12B that is shaped to closely match the circular shape of the needle 16 and catheter tube 44. The interface 72 stabilizes the needle 16 to prevent excessive "wobble" of the needle, thereby improving user accuracy in initially entering the patient's vasculature.

[0111] As inFIG. 2A As most clearly shown, the top housing 12A, the hub 14, and the bottom housing 12B include engagement features 68 to maintain the proximal attachment of housing 12 even when more distal portions of the housing are separated, as described below. However, it should be noted that various types, sizes, and numbers of engagement features can be used to achieve this desired function.

[0112] FIG. 3A to FIG. 9 The various stages of placing the catheter 42 into the patient's blood vessel using the insertion tool 10 are illustrated. For clarity, the stages are depicted without showing actual insertion into the patient. The insertion tool 10 is in... FIG. 1A In the configuration shown, the 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 blood vessel. Proper entry into the blood vessel can be clearly confirmed by a blood flash, which occurs as blood exits from the hollow interior of the needle into the notch 18, with blood present between the outer diameter of the needle 16 and the inner diameter of the catheter body 44. It should be noted that in one embodiment, the presence of blood within the safety housing 54 (in one embodiment, the safety housing is a translucent housing) can serve as an auxiliary blood flash indicator, as blood enters the housing from the needle 16 upon entry into the blood vessel.

[0113] After confirming that the needle has entered the blood vessel, the guidewire advancement assembly 20 is actuated, wherein the slider 28 is advanced by the user's finger to advance the guidewire 22 initially positioned within the hollow needle 16 distally. FIG. 3A and FIG. 3B It should be noted that the guide wire is advanced distally by the rod 24, which is operably attached to the slide 28. It should also be noted that during the distal advancement of the slide 28, its slide arm 30 travels along the guide rail 32 on either side of the housing 12: first the bottom housing guide rail 32A, followed by the top housing guide rail 32B.

[0114] The distal guidewire advance continues until the slider 28 has slid the entire travel length distally, causing the guidewire 22 of the predetermined length to extend past the distal end of the needle 16, as shown. FIG. 4A and FIG. 4B As shown. In one embodiment, by contacting the rod protrusion 26 with the distal portion of the needle hub 14, the slide 28 is prevented from advancing further distally, as... FIG. 4B As shown. FIG. 5A and FIG. 5B As shown, after the slider 28 has been fully advanced to the distal end, its slider arm 30 no longer engages with the bottom housing guide rail 32A, but only with the top housing guide rail 32B. This, in turn, allows housing portions 12A and 12B to separate, as can be further seen below.

[0115] like FIG. 5Aand FIG. 5B As shown, once guidewire 22 has been fully extended within the patient's blood vessel ( FIG. 4A and FIG. 4B This actuates the catheter advancement assembly 40, in which the handle 48 is advanced distally by the user, causing the catheter body 44 to slide over the distal portions of the needle 16 and guidewire 22 and enter the patient's blood vessel via the insertion site. FIG. 6A and FIG. 6B As the catheter is advanced via the handle 48, the housing portions 12A and 12B can be easily separated so that the catheter hub 46 can be disengaged from the distal end of the housing 12 and the catheter can be inserted into the patient's blood vessels to the appropriate extent.

[0116] It should be noted that, such as FIG. 7A and FIG. 7B As shown, during the removal of the catheter from the housing 12 of the insertion tool 10, the catheter slides distally along the needle 16 until the distal needle tip is received in the safety housing 54 and engages with the needle safety member 56. FIG. 8 As shown, the insertion tool 10 can 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 inserted between the catheter hub 46 and the handle 48. After the needle 16 and safety housing 54 are removed from the catheter 42, the valve 52 blocks the catheter lumen to prevent accidental leakage of blood from the catheter hub 46. FIG. 9 As shown, the handle 48 can be disengaged from the catheter hub 46 by pulling, twisting, etc., so as to disengage the teeth 50C of the handle from the hub. According to standard procedure, the extension leg can be attached to the catheter hub, and the dressing on the catheter 42 can be removed. The housing 12 and handle 48 of the insertion tool 10 can then be discarded.

[0117] FIG. 10A to FIG. 10C Further details are given regarding the safety housing 54 and the needle safety member 56, and their interaction with the needle 16 to isolate its distal end. As shown, the safety housing 54 is configured such that the needle 16 can pass through the safety housing during use of the insertion tool 10, as already described, and exit the housing via an extension 74 at the distal end of the housing. A top cover 58 is placed in the proximal end of the safety housing 54 and is configured to support the needle safety member 56, thereby allowing the needle 16 to initially pass through the safety housing, top cover, and needle safety member. It should be noted 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, thereby eliminating unwanted friction between the valve and the needle.

[0118] FIG. 10C The needle safety component 56 is shown to include a curved body or connecting element 80 through which the needle initially extends, and a friction element 82. FIG. 10A As shown, when needle 16 is withdrawn from catheter 42 (FIG. 8 ), the distal tip of the needle is withdrawn proximally through the extension 74 and past the distal portion of the needle safety feature, such that the needle is no longer in contact therewith. This enables the friction element 82 to cause the link element 80 to tilt slightly, thereby linking the needle 16 in place and preventing it from further travel relative to the safety housing 54, as well as isolating the needle distal tip within the housing to prevent an inadvertent needle stick. In the present embodiment, the friction element 82 comprises an O-ring of suitable dimensions. For example, a suitable O-ring is available from Apple Rubber Products, Lancaster, NY. It is noted that additional details regarding needle safety features, their principles of operation, and similar devices are disclosed in U.S. Patents 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 be used to isolate the distal end of the needle.

[0119] Reference is now made to FIG. 1, which depicts a catheter insertion tool 110 according to one embodiment. It is noted that in this embodiment and in subsequent embodiments, various features are similar to those already described in connection with the above-described embodiments. Accordingly, only selected aspects of each embodiment will be described below. FIG. 11A to FIG. 13B

[0120] The insertion tool 110 includes a housing 112 defined by a top housing portion 112A and a bottom housing portion 112B that together partially enclose the catheter 42. A needle hub 114 is included that supports a distally extending needle 116 for disposition within the housing 112 and positioned such that the catheter tube 44 of the catheter 42 is disposed above the needle. It is noted that in this embodiment and in other embodiments, the partial enclosure of the catheter by the insertion tool enables the clinician to manipulate the insertion tool with the hand closer to the distal end of the needle than would otherwise be possible.

[0121] FIG. 13A and FIG. 13B Additional details are given 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. 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.

[0122] ​A top rail 132 is included on the needle hub 114 and is configured to engage a corresponding slot 134 defined in a 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 on 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 guidewire from the needle 116, thereby preventing it from retracting. It should be noted that the guidewire 122 is initially extended distally from the back plate 124 and through the needle holder 126 and needle 116, as most clearly shown in FIG. 11D .

[0123] A guidewire advancement assembly 120 is also included to selectively advance the guidewire 122 initially disposed within the lumen of the needle distally past the distal end of the needle 116. The guidewire advancement assembly 120 includes the bottom housing portion 112B to which the guidewire 122 is attached at a proximal back plate 124. As shown, the bottom housing portion 112B is slidable distally relative to the top housing portion 112A to enable selective distal advancement of the guidewire 122.

[0124] 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. As most clearly shown in FIG. 12A and FIG. 12B , the handle 146 includes two arms 150 that allow the user to selectively slide the handle in order to advance the catheter 42. The handle 146 also includes a recess 152 in which a needle safety feature 156 is placed for isolating the distal tip of the needle 116 when it is withdrawn from the catheter 42. Additional details regarding the needle safety feature are disclosed in U.S. Patents 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.

[0125] The insertion tool 110 also includes a support structure 170 for stabilizing the needle 116 proximate the distal end of the housing 112. The support structure 170 in the present embodiment includes two flaps 172 that are hingedly connected to a distal portion of the bottom housing portion 112B. When closed, as shown in FIG. 11D and FIG. 12A , the flaps 172 serve to stabilize the needle 116 to assist the user of the insertion tool 110 in inserting the needle into the patient. When opened, as shown in FIG. 14D) the flaps 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 further below. The flaps 172 are disposed in tracks 174 defined by the top housing portion prior to the bottom housing portion 112B being slid relative to the top housing portion 112A. Other types and configurations of support structures can also be used. The insertion tool 110 also includes gripping surfaces 176 on either side of the housing 112 to facilitate use of the tool during a catheter insertion procedure, as will be described in detail below.

[0126] FIG. 14A to FIG. 14E Various stages of using the insertion tool 110 to insert a catheter into a patient are shown. In the configuration shown, the needle 116 is used to achieve vascular access by a user inserting the needle into the patient at an insertion site. As described in the previous embodiment, confirmation of vascular access can be achieved by observing blood return via a distal notch in the needle 116, or in other suitable ways. FIG. 14A

[0127] Once the distal portion of the needle 116 is disposed within a blood vessel of the patient, the guidewire 122 is extended past the distal end of the needle and into the blood vessel by advancing the bottom housing portion 112B distally. In the present embodiment, this advancement is achieved by the user placing their fingers on the folded flaps 172 of the bottom housing portion 112B and pushing the flaps distally to extend the guidewire 122. The guidewire 122 is advanced until it is fully extended. The locking arms 136 of the needle hub 114 then engage the back plate 124 of the bottom housing portion 112B and prevent the guidewire 122 from retracting.

[0128] At this stage, the handle 146 of the catheter advancement assembly 140 is advanced distally by the user holding one or both of the arms 150 to advance the catheter 42 distally through the insertion site and into the patient's vasculature. This is shown in FIG. 14C where the catheter tube 44 is shown being advanced distally over the needle 116 and guidewire 122.

[0129] As shown in FIG. 14D the catheter 42 continues to be advanced distally causes the catheter hub 146 to force the flaps 172 open, providing a suitable opening through which the hub can be passed from the insertion tool housing 112. It is noted that the flaps 172 are shaped such that contact with the catheter hub 46 forces each flap to fold outward, as shown in FIG. 14D It is noted that the flaps 172 are no longer disposed within the tracks 174 due to the guidewire 122 being fully advanced distally via finger pressure applied to the flaps 172 as described above.

[0130] FIG. 14E ​This illustrates that, with the flap no longer engaged within the track 174, the top housing portion 112A and the bottom housing portion 112B can be separated at their distal ends, allowing the shank 146, still attached to the guide hub 46, to be separated from the housing 112. Although this stage is not shown, a needle safety member 156 provided in the recess 152 of the shank 146 isolates the distal end of the needle 116. The shank 146 can then be manually removed from the guide hub 46. FIG. 14F It can also complete the placement of catheter 42 and the application of dressings. The insertion tool 110, including the needle 116 isolated by the needle safety part 156 of the handle 146, can be safely discarded.

[0131] Now for reference FIGS. 15A-18 To describe a catheter insertion tool 210 according to one embodiment. The insertion tool 210 includes a housing 212 defined by a top housing portion 212A and a bottom housing portion 212B that together partially enclose a catheter 42. A sliding needle hub 214 supporting a distally extending hollow needle 216 is slidably attached to the housing 212. Specifically, the needle hub 214 includes a track 214A that slidably engages with corresponding guide rails 218 defined on the top housing portion 212A and the bottom housing portion 212B in a manner further described below. FIG. 15A As shown, the needle hub 214 is positioned distally relative to the housing 212, such that the needle 216 extends through the needle channel 224. FIG. 18 And through the hole defined at the distal end of the top housing portion 212A, so as to position the needle as... FIG. 15A As shown.

[0132] like FIG. 15A As shown, the housing 212 of the insertion tool 210 encloses a portion of the catheter 42. The integrated guidewire / dilatator 220 is incorporated and positioned within the lumen of the catheter body 44, as... FIG. 15B and FIG. 16 As shown. The guidewire / dilatator 220 includes a distal guidewire portion 220A and a proximal dilatator portion 220B. Constructed in this way, the guidewire / dilatator 220 serves not only as a guidewire to guide the catheter body 44 through the patient's insertion site into the accessed blood vessel, but also to dilate the insertion site as the catheter is advanced through the insertion site. In other embodiments, the guidewire / dilatator is not required. In one embodiment, it should be understood that the guidewire / dilatator 220 may extend proximally through the entire catheter 42 and includes a Luer cap on its proximal end, which may connect to a proximal Luer connector of the catheter. It should also be noted that... FIG. 15A A sterile bag 217 attached to the housing 212 is shown to cover and isolate the proximal portion of the catheter 42. For clarity, bag 217 is only... FIG. 15A As shown, but can be included in various configurations of insertion tools to protect and isolate portions of the catheter.

[0133] like FIGS. 17A-17C As shown, needle 216 includes a longitudinally extending needle slot 226 that extends from the starting point along the length of the needle to its distal end. FIG. 17B The slot 226 is shown to be optionally wider in its proximal portion than in its more distal portion. This configuration allows the needle slot 226 to be inserted into, slid relative to, and removed from the needle 216 during operation of the insertion tool 210, as described below. It should be noted that in one embodiment, the needle slot may extend the entire length of the needle.

[0134] FIG. 18 This illustrates how a guidewire / dilatator 220, according to one embodiment, enters the slot 226 of a needle 216, wherein the guidewire / dilatator extends distally along a guide groove 222 defined in the top housing portion 212A and enters the hollow needle 216 via the needle slot, the hollow needle being disposed in a needle channel 224. (Guide groove 222 is also...) FIG. 15B (As shown in the figure.) In this way, the guidewire / dilatator 220 can slide distally through the hollow needle 216 to extend beyond the distal end of the needle, while still being able to be removed from the needle via the slot 226 when the guidewire / dilatator and the needle are separated from each other, as shown in the figure.

[0135] FIG. 18 A support structure 270 for stabilizing the needle 216 is also shown, the support structure including a junction 272 defined by portions of the top housing portion 212A and the bottom housing portion 212B surrounding a hole through which the needle extends. Of course, other support structures may also be used to provide stability to the needle to facilitate insertion into a patient's blood vessel. FIG. 19 Details of the locking member 230 for the needle hub 214 included on the bottom housing portion 212B are shown to prevent further movement of the needle hub after retraction, as described below.

[0136] FIGS. 19-24 The various stages of inserting a catheter into a patient using insertion tool 210 are illustrated. Insertion tool 210 is in... FIG. 19 In the configuration shown, needle 216 is used, and the user inserts the needle into the patient's body at the insertion site to achieve blood vessel access.

[0137] Once the distal portion of needle 116 is positioned within the patient's blood vessel, the guidewire / dilator 220 is manually advanced through the hollow needle 216 to extend beyond the distal end of the needle and into the blood vessel. In this embodiment, this advancement is achieved by moving the housing 212 and catheter 42 distally together while keeping the needle hub 214 stationary. Advancing the guidewire 122 distally a suitable distance, in this embodiment, includes advancing until the distal end of the housing 212 reaches the skin insertion site.

[0138] FIG. 20A and FIG. 20B As shown, after the guidewire / dilator 220 is extended distally into the blood vessel, the needle 216 is retracted from the blood vessel by sliding the needle hub 214 proximally along the rail portion 218A disposed on the top housing portion 212A. The needle hub 214 continues to slide proximally until the hub engages the rail portion 218B of the bottom housing portion 212B and is fully slid to the proximal end of the housing 212, as shown in FIG. 21A and FIG. 21B The needle hub 214 engages the lock 230 FIG. 20B to prevent future distal movement of the needle hub or needle 216. In this position, the needle 216 is fully retracted into the insertion tool housing 212 such that the distal end of the needle is isolated from the user FIG. 21B It should be noted that the distal portion of the guidewire / dilator 220 remains in the patient's blood vessel to enable separation from the needle during retraction of the needle 216 through the needle slot 226.

[0139] At this stage, the bottom housing portion 212B FIG. 22 and the top housing portion 212A FIG. 23 are removed from the catheter 42. The catheter 42 can then be inserted through the insertion site and into the patient's blood vessel. It should be noted that the guidewire / dilator 220 remains disposed within the catheter tube 44 and the dilator portion assists the distal end of the catheter tube to enter the blood vessel by gradually enlarging the insertion site and blood vessel entry point.

[0140] As mentioned above, in one embodiment, the proximal portion of the catheter 42 including the hub 46 and attached extension legs is covered by a sterile bag that is attached to the housing 212. The sterile bag can be removed after the catheter is fully inserted into the patient's blood vessel or can be removed when the housing portions 212A and 212B are removed. In FIG. 24 the guidewire / dilator 220 is then removed from the catheter 42 and a dressing is added to the catheter and the configuration is completed for use. The guidewire / dilator 220 and other portions of the insertion tool 210 are discarded.

[0141] FIG. 25A and FIG. 25BDetails are shown regarding a needle deactivation system for isolating the distal end 316A of the hollow needle 316, in accordance with one embodiment. As shown, the needle distal end 316A includes a bevel configured such that its cutting surface is disposed at the inner diameter 318 of the needle 316. Thus, when a suitably sized guidewire 320 is extended distally past the distal end 316A of the needle 316, the cutting surface of the needle is blocked by the proximity of the guidewire, thereby safely isolating the needle end from the user. Moreover, the distal end 316A of the needle 316 is deactivated in this manner to prevent the needle end from damaging the sensitive inner wall of a blood vessel after the needle tip is inserted into the blood vessel. At this point, the distal end 44A of the catheter tube 44 can then be advanced distally over the needle 316 and guidewire 320. FIG. 26 A needle end bevel 316A is shown, in accordance with another embodiment, that includes an additional rounded component 319. Such a deactivation system can be used in one or more of the insertion tools described herein.

[0142] Reference is now made to FIG. 27 to describe a catheter insertion tool 410, in accordance with one embodiment. The insertion tool 410 includes a housing 412 that partially encloses the catheter 42. A hollow needle 416 that extends distally is disposed within the housing 412 such that the needle extends out of the distal end of the housing 412.

[0143] A guidewire advancement assembly 420 is shown for selectively advancing a guidewire 422, which includes a sled 428 that slides along a track 430 defined in the housing 412. The guidewire 422 is attached to the sled 428 and extends proximally within the housing 412 until a bend, thereby forming a guidewire bend 422A toward the distal end of the housing, and into the hollow needle 416 via its proximal end 416A, for selective distal advancement through the distal end of the needle via user actuation of the sled. When the guidewire bend 422A engages the needle proximal end 416A, the guidewire 422 stops distal advancement out of the distal end of the needle 416.

[0144] A catheter advancement assembly 440 is also shown for selectively advancing the catheter tube 44 over the needle 416, which includes a sled 448 that slides along the track 430 and a carriage 450 disposed within the housing 412 and operably connected to the sled 448. The carriage 450 is initially engaged with the catheter hub 46, such that distal sliding of the sled 448 causes the catheter to advance distally toward the distal housing end.

[0145] The insertion tool 410 also includes a support structure 470 for stabilizing the needle 416, which includes two gates 472 that are hingedly attached to the distal end of the housing 412 via a pin. The gates 472 serve to stabilize the needle 416 during insertion into the patient. Thereafter, when the catheter tube 44 and catheter hub 46 are advanced distally by the sled 448, the gates 472 open, thereby enabling the catheter 42 to pass through the gates and be separated from the insertion tool 410 by the user. In the present embodiment, a wedge feature is included on the bottom surface of the sled 428, which is configured to push the gates 472 open as the sled is slid distally, as described herein. Such a wedge or other suitable feature can also be included in other embodiments described herein.

[0146] After being separated from the insertion tool 410, the catheter 42 can then be advanced and placed in the patient by the user as desired. It should be noted that although not shown, a needle safety feature can be included for isolating the distal tip of the needle 416. In one embodiment, distal sliding of the guidewire sled 428 can partially open the gates 472 in preparation for catheter advancement.

[0147] FIG. 28 An insertion tool 410 is shown including a support structure 480 according to another embodiment, in which two half-cone gates 482 are hingedly connected to the housing 412 (via a living hinge or other suitable connection scheme) and are configured to stabilize the needle 416. FIG. 28 The sled of the insertion tool 410 in FIG. 27 is also longer than the sled in Thus, it should be understood that various different support structures and configurations can be used to stabilize the needle at or near the exit point from the insertion tool housing.

[0148] A catheter insertion tool 510 according to one embodiment is now described with reference to FIG. 29A and FIG. 29B The insertion tool 510 includes a housing 512 that partially encloses the catheter 42. A hollow needle 516 extends distally from a needle hub 514 that caps the proximal end of the housing 512, such that the needle extends out of the distal end of the housing 512.

[0149] A guidewire advancement assembly 520 is shown for selectively advancing a guidewire 522, which includes a sled 528 that slides along a track 530 defined in the housing 512. The guidewire 522 is attached to the sled 528 and extends proximally within the housing 512 and out through a top one of two holes 514A defined in the needle hub 514 via a twisted wire 524 that is attached to the proximal end of the housing 512. Near the proximal end of the twisted wire 524, the guidewire 522 is bent to form a U-shaped guidewire bend 522A and extends distally back into the housing 512 so as to enter the hollow needle 516 via a bottom one of the two needle hub holes 514A when the sled 528 is selectively actuated by the user, thereby ultimately advancing distally out the distal end of the needle. This distal advancement of the guidewire 522 out the distal end of the needle 416 stops when the guidewire bend 522A abuts the hole 514A defined in the needle hub 514.

[0150] A catheter advancement assembly 540 is also shown for selectively advancing a catheter tube 44 over the needle 516, which includes a sled 548 that slides along the track 530 and a carriage 550 disposed within the housing 512 and operably connected to the sled. The carriage 550 can initially be engaged with the catheter hub 46 such that distal sliding of the sled 548 causes the catheter to advance distally toward the distal housing end. In the present embodiment, the guidewire 522 includes a protrusion 522B thereon such that when the guidewire is advanced distally by the user actuating the (guidewire advancement) sled 528, the protrusion is advanced and engages an interior portion of the (catheter advancement) sled 548. This in turn causes the sled 548 to also be advanced, thereby causing the catheter 42 to advance distally. Thus, in one embodiment, the catheter can be advanced directly via the sled 548 or indirectly via the sled 528.

[0151] The insertion tool 510 also includes a support structure 570 for stabilizing the needle 516, which includes a plug 572 that includes a plug hole 574 defined therein and through which the needle 516 extends. The plug 572 is attached to the sled 528 via the track 530 and plugs the distal end of the housing 512, thereby serving to stabilize the needle 516 therethrough during insertion into the patient. Thereafter, when the guidewire 522 is advanced distally by the sled 528, the plug 572 is also advanced distally out of the housing 512, thereby opening the distal end of the housing and enabling the catheter 42 to pass therethrough. The catheter 42 can then be separated from the insertion tool 510 by the user and advanced to the final position by the user. It should be noted that although not shown, a needle safety assembly can be included for isolating the distal tip of the needle 516. It should also be noted that in one embodiment, the catheter tube 44 and needle 516, which are no longer constrained by the support structure plug hole 574 after the plug 572 is removed from its initial position in the housing 512, can be repositioned axially toward the center of the housing. For FIG. 30and FIG. 31 This is also true for embodiments of

[0152] Referring now to FIG. 30 A catheter insertion tool 610 according to one embodiment will now be described. The insertion tool 610 includes a housing 612 that partially encloses a catheter 42. A hollow needle 616 extends distally from a needle hub 614 that caps a proximal end of the housing 612, such that the needle extends out of a distal end of the housing 612. The needle 616 includes a longitudinally extending proximal slot 616A that extends from a proximal end of the needle 616 to a distal end 616B of the slot.

[0153] A guidewire advancement assembly 620 is shown for selectively advancing a guidewire 622, which includes a sled 628 that slides along a track 630 defined in the housing 612. The guidewire 622 is attached to the sled 628 and extends proximally within the housing 612 until a bend, forming a U-shaped guidewire bend 622A toward the distal end of the housing, and into the hollow needle 616 via its proximal slot 616A, to selectively advance distally past the distal end of the needle via user actuation of the sled. It is noted that distal advancement of the sled 628 causes the sled to decouple from the housing 612, but remains attached to the guidewire 622. The guidewire 622 stops advancing distally out of the distal end of the needle 616 when the guidewire bend 622A engages the distal end 616B of the proximal slot 616A of the needle.

[0154] A catheter advancement assembly 640 is also shown for selectively advancing a catheter tube 44 over the needle 616, which includes a carriage 650 disposed within the housing 612 and operably connected to the sled 628, such that actuation of the sled advances the guidewire 622 and the carriage 650 distally. The carriage 650 is initially not engaged with the catheter hub 46, but is engaged with the hub after a certain amount of distal advancement. This in turn causes the catheter 42 to be advanced distally toward the distal housing end.

[0155] The insertion tool 610 also includes a support structure 670 for stabilizing the needle 616, which includes a plug 672 that includes a plug bore 674 defined therein and through which the needle 616 extends. The plug 672 is attached to the sled 628 via the track 630 and occludes the distal end of the housing 612, to serve to stabilize the needle 616 therethrough during insertion into a patient. Thereafter, as the guidewire 622 is advanced distally by the sled 628, the plug 672 is also advanced distally out of the housing 612, to open the distal end of the housing and enable the catheter 42 to pass therethrough. The catheter 42 can then be decoupled from the insertion tool 610 by the user and advanced to a final position by the user. It is noted that in one embodiment, the carriage 650 can include a needle safety feature for isolating the distal end of the needle 616.

[0156] Referring now toFIG. 31 A catheter insertion tool 710 according to one embodiment is described. The insertion tool 710 includes a housing 712 that partially encloses the catheter 42. A hollow needle 716 extends distally from a needle hub 714 that caps the proximal end of the housing 712 such that the needle extends out of the distal end of the housing 712.

[0157] A pusher assembly 720 is shown for selectively advancing a guidewire 722 and the catheter 42. The pusher assembly 720 includes a wheel 730 that is selectively rotatable by a user, which is attached to a carriage 750 via a filament 726 or other suitable component. The guidewire 722 is attached to the carriage 750 and extends proximally within the housing 712 and out of one of two holes defined in the needle hub 514 (similar to the hole 514A in the needle hub 514 of FIG. 5) via a twisted wire 724 that is attached to the proximal end of the housing 712. Near the proximal end of the twisted wire 724, the guidewire 722 is bent to form a U-shaped guidewire bend 722A and extends distally back into the housing 712 so as to enter the hollow needle 716 via the other of the two holes defined in the needle hub 714 when the wheel 730 is selectively actuated by the user, ultimately advancing distally out of the distal end of the needle. This distal advancement of the guidewire 722 out of the distal end of the needle 716 stops when the guidewire bend 722A abuts the aforementioned hole defined in the needle hub 714. FIG. 29A 、 FIG. 29B The pusher assembly 720 selectively advances the catheter tube 44 over the needle 716 and includes the aforementioned carriage 750 that is disposed within the housing 712 and is operably connected to the wheel 730 via the filament 726 such that rotation of the wheel advances the carriage 750 distally. The guidewire 722 that is attached to the proximal end of the carriage 750 is also advanced distally through the needle, as described above. It is noted that, in one embodiment, the wheel 730 ensures that the guidewire 722 is only advanced distally and not proximally retracted by virtue of the non-rigid filament 726 that connects the wheel to the carriage 750.

[0158] The distal advancement of the carriage 750 causes the carriage, which is initially not engaged with the catheter hub 46, to engage with the hub after a certain amount of distal advancement. This in turn causes the catheter 42 to be advanced distally toward the distal housing end.

[0159] The distal advancement of the carriage 750 causes the carriage, which is initially not engaged with the catheter hub 46, to engage with the hub after a certain amount of distal advancement. This in turn causes the catheter 42 to be advanced distally toward the distal housing end.

[0160] The insertion tool 710 also includes a support structure 770 for stabilizing the needle 716, which includes a gate 772 hingedly attached to the distal end of the housing 712 and including a hole 774 therein for the needle 716 to pass therethrough. The gate 772 serves to stabilize the needle 716 during insertion into the patient. Thereafter, when the catheter tube 44 and catheter hub 46 are advanced distally by the wheel 730 and carriage 750, the gate 772 is pushed open by the hub, thereby enabling the catheter 42 to be separated from the insertion tool 710 by the user. The catheter 42 can then be advanced by the user for final placement in the patient. It should be noted that although not shown, a needle safety feature can be included for isolating the distal tip of the needle 716.

[0161] Referring now to FIGS. 32A-32I a catheter insertion tool 810 according to one embodiment will be described. The insertion tool 810 includes a housing 812 that at least partially encloses the catheter 42. A hollow needle 816 extends distally from a needle hub 814 included within the housing 812, such that the needle initially extends out of the distal end of the housing 812. The needle 816 includes a distal slot 816A, similar to the previously described needle slot 226 FIGS. 17A-17C ), such that a guidewire / dilator 822 similar to the previously described guidewire / dilator 220 FIG. 16 ) can be removably inserted therein. The catheter 42 is disposed over the guidewire / dilator 822.

[0162] The needle hub 814 also includes a needle retraction system 818 for selectively retracting the needle 816 into the housing 812 in order to safely isolate the distal tip of the needle from the user. The retraction system 818 includes a spring 819 or other suitable retraction device operably connected to the needle 816 to effect needle retraction.

[0163] A pusher assembly 820 is shown for selectively advancing the guidewire / dilator 822 and the catheter 42. The pusher assembly 820 includes a slide 828 that travels in a track 830 defined in the housing 812. The slide 828 is operably attached to a ratchet bar 824 that is slidably disposed within the housing 812. The ratchet bar 824 includes a plurality of upper teeth 826 for selective catheter advancement, and at least one lower tooth 826A for actuating a retraction trigger 880 of the needle retraction system 818, as will be described. A cap 834 is removably attached to the hub 46 of the catheter 42 disposed within the housing 812, which includes a pin 836 for engaging the upper teeth 826 of the ratchet bar 824.

[0164] The insertion tool 810 also includes a support structure 870 for stabilizing the needle 816, the support structure including a housing bore 872 defined by the distal end of the housing 812. The housing bore 872 is sized to provide stability for the needle 816 at the exit point where the needle leaves the housing.

[0165] FIGS. 32A-32I The various stages of inserting a catheter into a patient using insertion tool 810 are illustrated. Insertion tool 810 is in... FIG. 32A In the configuration shown, needle 816 is inserted into the patient's body by the user at the insertion site to achieve blood vessel access. Blood return can be observed through the distal slot 816A of needle 816 to confirm proper placement of the distal end of the needle within the patient's blood vessel. FIG. 32B As shown, the slider 828 slides distally to advance the guidewire / dilatator 822 distally away from the needle and into the patient's blood vessel. The distal portion of the guidewire / dilatator is pre-positioned within the needle 816 via a distal slot 816A. As shown, the guidewire / dilatator 822 is indirectly advanced by a ratchet 824, which is moved by the slider 828. Specifically, an adjacent tooth of the upper teeth 826 of the ratchet 824 engages with the insertion pin 836 of the top cap 834 mounted on the catheter hub 46. Therefore, as the slider 828 and the ratchet 824 move distally, the catheter 42 and the guidewire / dilatator 822 disposed therein also move distally, as... FIG. 32B As shown. Similar ratchet movements are also performed in successive steps.

[0166] exist FIG. 32B During the phase shown, the sliding of the slider 828 also causes the bottom tooth 826A of the ratchet 824 to engage the retraction trigger 880 of the needle retraction system 818. This, in turn, allows the spring 819 to extend and retract the needle 816 and the retraction system 818 into the housing 812, thereby isolating the distal tip of the needle from the user within the housing.

[0167] FIG. 32C The slide 828 returns to its initial position, which causes the ratchet 824 to also return to its initial position. However, because the pin 836 of the top cover 834 attached to the conduit hub 46 is angled distally, the teeth 826 of the ratchet slid past without retracting the conduit 42, thus keeping the conduit in place.

[0168] exist FIG. 32DIn this process, the slider 828 is advanced distally again, causing the adjacent upper teeth 826 of the ratchet 824 to engage the top cap needle 836 and further advancing the guidewire / dilatator 822 distally into the blood vessel. Since the catheter 42 is positioned on the guidewire / dilatator 822, the catheter is also advanced into the blood vessel in this stage or subsequent stages, depending on the catheter length, distance to the insertion site, etc. The slider 828 then retracts to its initial position, such as... FIG. 32E As shown. It should be noted that ratchet retraction can be initiated by the user or automatically by a suitable system included in the insertion tool 810.

[0169] exist FIG. 32F In this process, the slider 828 and ratchet 824 are advanced distally again, causing the housing 812 and conduit 42 of the guidewire / dilatator 822 to be advanced further distally. The slider 828 then retracts to its initial position, as... FIG. 32G As shown. In FIG. 32H In the next step, the slide 828 and ratchet 824 are advanced distally for the last time, causing the guidewire / diffuser 822 and the attached catheter 42 to be nearly completely advanced distally from the housing 812 of the insertion tool 810. At this stage, the hub 46 of the catheter 42 can be grasped and the catheter removed from the insertion tool 810, which can then be discarded. The catheter 43 can then be manually placed into the blood vessel by the user. The top cap 834 is also removed from the catheter hub 46.

[0170] FIGS. 33A-33C Details of a needle safety component for isolating the distal end 16A of a needle 16, according to one embodiment, are shown, the needle comprising as described above. FIGS. 1A-10C The distal notch 18 is described. As shown, a safety housing 954 is also included for resting on the needle 16, the safety housing including a hinged door. Two needle safety members 956 are disposed opposite each other within the safety housing 954, each resting on the needle 16. Each needle safety member includes a base 958 defining an aperture through which the needle 16 passes and a plurality of arms 960. The arms 960 extend from the base 958 and converge toward each other in a conical pattern, such that the end of each arm abuts the needle surface. The arms 960 are configured to engage the notch 18 defined in the distal portion of the needle 16 and prevent further movement of the needle 16 relative to the needle safety member 956. Specifically, each arm 960 engages the outer surface of the needle 16 in a compressive manner, such that when one arm encounters the needle notch 18, the arm will slightly descend into the notch to lock the needle 16 in place relative to the needle safety member 956. Two needle safety components 956 are disposed within the safety housing 954 to prevent further distal or proximal movement of the needle in either direction. Therefore, the distal end 16A of the needle 16 is securely isolated within the safety housing 954, as... FIGS. 33A-33Cas shown. It should be noted that the needle safety features described herein can be used to isolate the needle even while the guidewire 22 is still extending therethrough, for example, as shown in FIG. 33C

[0171] In other embodiments, only one needle safety feature as described above can be used. Thus, the needle safety features described herein serve as one example of a variety of needle safety features that can be used in conjunction with the present disclosure.

[0172] It should be appreciated that in one embodiment, the insertion tool can include a sterile sheath or bag disposed on the catheter distal portion extending distally from the insertion tool housing so as to isolate the catheter. A needle pre-disposed within the catheter and retractable into the insertion tool housing can extend from the bag so as to access the blood vessel. Thereafter, as the catheter is advanced into the vessel, the bag can be compressed toward the housing and then removed after the catheter is fully inserted. In one embodiment, the bag can include a holding wing or other means to facilitate holding the catheter or needle through the bag during insertion. It should also be noted that the insertion tools described herein can include a cap or other protective means that can be removably attached to the insertion tool prior to use to maintain the needle and catheter sterile.

[0173] Reference is now made to FIG. 34 , which illustrates an exploded view of a catheter insertion device 10 according to one embodiment, including components similar to those already described above. As such, only selected differences are discussed below.

[0174] FIG. 34 It is shown that in the present embodiment, the guidewire 22 loops back on itself to generally define a U-shaped configuration. FIG. 36A and FIG. 36B It is shown the manner in which the guidewire 22 is disposed within the housing 12 of the catheter insertion device 10. In particular, these figures show that the proximal end of the guidewire 22 is anchored to a portion of the device 10, namely, at an anchor point 982 on the top portion 12A of the housing 12. FIG. 37 It is shown that the guidewire 22 is removably extended proximally within a guide slot 984 defined on the inner surface of the top housing portion 12A. FIG. 36A and FIG. 36B It is shown that the intermediate portion of the guidewire 22 loops back on itself proximate the proximal end of the device 10. A guide surface 980 FIG. 35 ) disposed proximate the proximal end of the guidewire rod 24 constrains the flexible guidewire 22 into a looped, generally U-shaped configuration. The looped intermediate portion of the guidewire 22 then extends toward the distal end of the device 10 along a groove 986 (shown most clearly in FIG. 38 ) defined on the inner surface of the bottom housing portion 12B of the housing 12 prior to entering the hollow needle 16. The free distal end of the guidewire 22 is initially within the needle 16.

[0175] ​As described above, the guidewire 22 is arranged to be selectively advanced by the guidewire advance assembly 20, such that its free distal end can extend distally from the open distal tip of the needle 16. In this embodiment, this selective advancement of the guidewire 22 is achieved by moving the guidewire advance slide 28 included on the device housing 12 distally. Moving the guidewire advance slide 28 distally causes the guidewire rod 24 to slide distally accordingly. As the rod advances, the guide surface 980 of the guidewire rod 24 pushes the bend of the guidewire 22 distally. It should be noted that the guidewire 22 has sufficient rigidity to be advanced by the guidewire rod 24 without buckling. Furthermore, the guide surface 980 and the guidewire 22 are configured such that when the guidewire advance slide 28 or other suitable mechanism slides proximally, the guidewire 22 can retract into the insertion tool housing 12.

[0176] This movement of the sliding guide rod 24 causes the distal end of the guide wire 22 to extend distally from the open distal tip of the needle 16. Due to the anchoring proximal end at the anchoring point 982 and the curved or annular U-shaped configuration, the guide wire 22 is advanced distally at approximately twice the sliding rate of the guide wire advancing slider 28, and is FIGS. 1A-9 The guidewire advance rate in this device configuration is approximately twice that of the guidewire advance slide 28, resulting in a guidewire extension length that is approximately twice the length of the traveled guidewire. This further results in a relatively longer guidewire extension into the vein or other blood vessels of the patient, allowing for more suitable insertion of the catheter 42 into the patient's body. Therefore, the guidewire and advance assembly described herein operate as a "reverse pulley" system for distally advancing the guidewire. It should be noted that, in addition to those shown and described herein, the device 10 may also include other annular configurations of the guidewire. Furthermore, in other embodiments, the guidewire extension and advance assembly movement may also have different ratios.

[0177] It should be noted that the annular catheter and guidewire advance shank are merely exemplary structures suitable for performing the desired functions described herein. In practice, other structures can be used to achieve the principles described in conjunction with this embodiment. Furthermore, although the proximal end of the guidewire is shown and described above as being attached to the catheter insertion device housing, the proximal end of the guidewire may be attached to other structures within / on the device, such as the needle hub 14. In one embodiment, the majority of the guidewire's length comprises a nickel-titanium alloy (commonly referred to as nitinol), which has sufficient rigidity and can be configured in a U-shape without retaining positional memory as the guidewire is advanced. It should be noted that other suitable guidewire materials may also be used.

[0178] FIG. 39A and FIG. 39BVarious details are shown regarding the coupling element 80 (further described above) associated with the needle safety component 56, which is used to protect the distal tip of the needle 16 after catheterization is complete. As shown, the coupling element 80 (also referred to herein as a coupling member) includes a front plate 992 defining a hole 992A, and a forked back plate 994. A protuberance 996 extends from one of the prongs of the back plate 994. A horseshoe-shaped needle passage element 998 is also included in a spatially separate arrangement from the front plate 992, and defines a hole 998A that is coaxially aligned with the hole 992A of the front plate.

[0179] In the present embodiment, a friction element 1000 (also referred to herein as a friction member) is also included with the coupling element 80, namely a ring-shaped elastic element or O-ring 1002 as shown in FIG. 40A and FIG. 40B As shown, the O-ring 1002 is configured to wrap around the needle 16 and a portion of the forked back plate 994. The protuberance 996 serves to help maintain the O-ring 1002 in position as shown in FIG. 40A and FIG. 40B With the O-ring 1002 so arranged, the O-ring exerts a relatively constant pushing force against the coupling element 80 for protecting the distal tip of the needle 16, as will be further described below. It should be noted that the elastic element can take forms other than an O-ring, but perform the same function. For example, a length of elastic material that wraps around the coupling element and a portion of the needle can also be used.

[0180] FIG. 40C and FIG. 40D The coupling element 80 is shown disposed in a carriage 1008, which in turn is disposed within the safety housing 54. As shown, the carriage 1008 defines two restraining surfaces 1010 against which respective portions of the front plate 992 of the coupling element initially rest when the needle 16 is initially extended through the carriage and coupling element. A retaining ring 1008A through which the needle 16 slidably passes enables the needle to engage with the carriage 1008.

[0181] The coupling element 80 is initially disposed in a slidable manner with the needle 16 in the state shown in FIGS. 40A-40D , which shows the coupling element prior to the coupling element protecting the distal tip of the needle, such that relative slippage between the needle and the coupling element is permitted. The needle 16 passes through the hole 998A of the needle passage element 998, initially limiting the coupling element 80 from moving in a tilting motion.

[0182] The needle 16 also passes through the hole 992A of the front plate 992, such that the needle is pinched by the prongs of the forked back plate 994. As noted above, the O-ring 1002 is disposed around the needle 16 and the back plate 994 so as to exert a pushing force against the coupling element 80 when the carriage 1008 and coupling element 80 (both of which are housed within the safety housing 54 FIG. 34) provides resistance to sliding distally along the length of the needle 16 during use of the device 10. The resistance provided by the O-ring 1002 during such distal sliding in turn exerts a rotational torque on the link element 80 (via the force provided by the link element's contact with the O-ring) that urges the link element to rotate clockwise from FIG. 40C

[0183] When the needle 16 extends through the link element, the needle-through feature 998 can prevent the link element 80 from rotating clockwise in this manner. However, once the safety housing 54 that houses the sled 1008 and the link element 80 has been slid distally a sufficient distance for the needle-through element 998 to slide past and off the distal end of the needle 16, the link element is no longer constrained, and the resistance exerted by the O-ring 1002 causes the link element to tilt clockwise relative to the needle from FIG. 40C

[0184] As described above, the O-ring 1002 exerts a relatively constant pushing force for tilting the link element 80, and in turn for maintaining the link element tilted (after the needle distal tip has been withdrawn into the sled, as described above) so as to more securely lock the sled 1008 over the needle 16 distal tip. Such constant pushing force is advantageous, for example, in the event that the needle 16 is pushed back and forth relative to the safety housing 54 / sled 1008 after the needle has been locked over the needle distal tip, to ensure that the link element does not return to an orientation in which the needle-through feature 998 can re-engage the needle 16 and unlock the needle safety 56. It should be noted that the O-ring 1002 can be used with needles and link elements that are larger or smaller than those shown and described herein.

[0185] The O-ring 1002 in the above-described embodiments has sufficient conformability to be able to stretch over the above-described structure while exerting the required force, as described above. In one embodiment, the O-ring 1002 material includes any one or more of natural or synthetic rubber, elastomer, polymer, thermoplastic, silicone, etc. In one embodiment, the O-ring material is selected so as to provide sufficient tear resistance, ability to exert the required friction, and chemical compatibility. The size of the O-ring can vary depending on the size and configuration of the link element and needle. In other embodiments, the O-ring can include other shapes, materials, and locations, but still be able to provide the intended functionality.

[0186] FIG. 41A ​​The guidewire rod 24 is shown as including a catheter advancement feature that, in addition to advancing the guidewire 22 as described above, is also capable of causing the guidewire rod to advance the catheter 42 distally. In the present embodiment, the catheter advancement feature comprises an advancement tab 1014 disposed on the proximal portion 24A of the guidewire rod 24 and configured so as to physically engage the top cover 58 of the safety housing 54 as the guidewire rod 24 is moved distally by the user sliding the handle 48 distally through the slide 28. FIG. 34 The user slides the handle 48 distally through the slide 28, causing the guidewire rod 24 to move distally. FIG. 41B This engagement is shown. Further distal movement of the guidewire rod 24 causes the safety canister 54 and, indirectly but operatively attached thereto, the catheter 42 to advance distally. FIG. 34 The slide 28 in the present embodiment is slidable to advance the catheter 42 distally a predetermined distance via the tab 1014 of the advancing guidewire rod 24. In one embodiment, this predetermined distance advances the catheter 42 until the distal end of the catheter is advanced distally beyond the distal tip of the needle 16. The catheter 42 can be further advanced distally as desired by sliding the handle 48 distally. FIG. 34 The slide 28 in the present embodiment is slidable to advance the catheter 42 distally a predetermined distance via the tab 1014 of the advancing guidewire rod 24. In one embodiment, this predetermined distance advances the catheter 42 until the distal end of the catheter is advanced distally beyond the distal tip of the needle 16. The catheter 42 can be further advanced distally as desired by sliding the handle 48 distally.

[0187] FIG. 41A The position of the advancing tab 1014 of the present embodiment enables phased advancement of the guidewire 22 and the catheter 42. Specifically, distal advancement of the guidewire rod 24 from the position shown FIG. 41A advances the guidewire 22 immediately, while the safety housing 54 and the catheter 42 remain in place. Further distal advancement of the guidewire rod 24 to the position shown FIG. 41B advances the guidewire 22 immediately, while the safety housing 54 and the catheter 42 remain in place. Further distal advancement of the guidewire rod 24 to the position shown

[0188] Thus, the guidewire rod 24, in addition to advancing the guidewire 22 distally out through the needle 16, can also advance the catheter 42 distally along the needle 16 and into the patient's blood vessel, as further described above. It should be noted that the specific shape and configuration of the advancing tab 1014 and the manner in which it engages the safety housing and / or catheter and the magnitude of travel imparted to the safety housing and / or catheter can differ from that shown and described herein.

[0189] FIG. 42 and FIG. 43 Details of the guidewire 22, constructed in accordance with one embodiment, are shown. As FIG. 42As shown, the guidewire 22 includes an elongated core wire 1102, which includes a distal portion 1104 with a reduced diameter. An outer coil 1108 extends proximally around the core wire 1102 from its distal end 1102B. Within the distal portion 1104 with a reduced diameter, a rigid sleeve 1110 is disposed adjacent to the core wire 1102 proximally to the coil 1108. The rigid sleeve 1110 can be fixed to the core wire 1102 by gluing, welding, press fitting, or other means.

[0190] The portion of guidewire 22 including coil 1108 is designed to be relatively flexible to allow non-invasive access to a patient's vein or other blood vessel during catheter insertion using the insertion tool described herein, and to guide catheter 42 into the vein. In contrast, the portion of guidewire 22 including rigid sheath 1110 is relatively rigid. FIG. 43 As shown, the rigid sleeve 1110 is arranged such that after the guidewire 22 has been fully extended during use of the insertion tool, the rigid sleeve is positioned adjacent to the distal tip 16B of the needle 16 of the insertion tool. Together with the posterior bevel of the distal tip 16B, the rigid sleeve 1110 effectively blunts the distal tip of the needle, thereby preventing accidental puncture or severing of the catheter body 44 by the distal tip of the needle during catheter insertion into a vein. The rigid sleeve 1110 may be designed to substantially occupy the entire diameter of the needle lumen at the distal tip 16B to effectively prevent the distal tip of the needle from puncturing the catheter body 44, even if the catheter body retracts when positioned above the needle or even if the needle is reinserted into the catheter body. It should be noted that in another embodiment, the core wire itself may be used to blunt the distal tip of the needle. In one embodiment, the coil 1108 may comprise platinum, stainless steel, titanium, nitinol, or other materials with suitable tensile strength and formability. In one embodiment, the rigid sleeve 1110 comprises stainless steel, titanium, high-rigidity thermoplastic or other suitable material, and the core wire 1102 comprises nitinol, but other suitable materials may be used for these and other related components.

[0191] FIG. 42 It is also shown that the core wire 1102 of guidewire 22 may include a notch 1112 disposed proximally on the distal portion 1104 of the core wire. The notch 1112 serves as a relatively weak point, allowing the guidewire 22 to preferentially break at the notch in the event of excessive physical force. By breaking at the notch 1112, the distal segment of the broken guidewire is large enough not to embolize into the patient's blood vessels and can be easily removed from the body. The specific location of the notch on the guidewire can vary.

[0192] FIG. 44 As shown, in one embodiment, the distal end of the catheter body 44 of the insertion tool catheter 42 may include a reinforcing member 1118 generally disposed at the distal end 44A of the catheter body. For example...FIG. 44 As shown, the reinforcing member 1118 here includes an annular sheath defining the distal end 44A of the catheter body 44. The reinforcing member 1118 comprises a sufficiently rigid material, such as aromatic polyurethane, carbothane, isoplast, polyetheramide, nylon, or other suitable medical-grade thermoplastics, metals (including stainless steel, titanium, nitinol, etc.), and is arranged and designed to prevent collapse of the distal end 44A of the catheter body 44 during fluid aspiration through the lumen 1114 of the catheter body after the catheter 42 has been placed in the patient's blood vessel. In one embodiment, the reinforcing member 1118 comprises a material that does not soften at internal body temperature and has a melting temperature similar to that of the material of the catheter body 44 and is biocompatible. In one embodiment, the reinforcing member 1118 comprises a material with a Shore hardness between about 60D and about 75D, but other hardness grades are also possible. In another embodiment, the reinforcing component 1118 may include a radiation-impermeable agent (such as bismuth trioxide, barium sulfate, etc.) to enhance the radiation impermeability of the distal end 44A of the conduit body 44.

[0193] FIG. 45A and FIG. 45B The relevant implementation scheme is shown. FIG. 44 The manufacturing details of the catheter body 44 are described, but other techniques may also be used. As shown, during manufacturing, a shaped mandrel 1120 is disposed within the lumen 1114 of the catheter body 44. In this embodiment, a pre-formed annular reinforcement 1118 is disposed around the tip 1122 of the mandrel 1120 to be inserted between the mandrel and the catheter body 44 and generally co-terminated with its distal end 44A. In other embodiments, the reinforcement 1118 may also be arranged to create a finished reinforcement position that terminates proximal to, co-terminated with, or distal to the distal end 44A of the catheter body 44, to customize desired reinforcement properties or adapt to processing parameters, etc.

[0194] The sharpening die 1124 then travels slowly over the distal end of the conduit body 44 and performs a radio frequency (“RF”) sharpening process to form the distal end of the conduit body, which includes a reinforcing member 1118, such as... FIG. 44 As shown. Typically, excess material from the sharpening process forms a plug 1126, which can be discarded. Alternatively, other processes can be used to create a reinforcing structure at the distal end of the conduit body.

[0195] Other embodiments of the reinforcing structure at the distal end 44A of the catheter body 44 are also possible, such as... FIG. 46 and FIG. 47A The reinforcing component 1118 is shown. FIG. 47BAnother embodiment is shown in which the reinforcing member 1118 is disposed proximally back from the distal end of the catheter tube 44, thus illustrating that in one embodiment the reinforcing member need not be disposed at the distal end of the catheter tube. These and other reinforcing designs are thus contemplated.

[0196] FIGS. 48A-48F Various details of the insertion tool 10 according to another embodiment are shown. As shown, the insertion tool 10 includes a top housing portion 12A and a bottom housing portion 12B of a housing 12 from which the catheter 42 disposed over the needle 16 extends. The figure also shows a finger pad 1218 of the guidewire advancement assembly 20 and a portion of a handle assembly 1220 of the catheter advancement assembly 40, the finger pad being slidably disposed in a slot 1236 defined in the top housing portion 12A. The insertion tool 10 and its various details are given in greater detail below according to the present embodiment. FIG. 48A

[0197] FIGS. 48A-48F As shown, the user's fingers can slide the finger pad 1218 that is part of the guidewire advancement assembly 20 distally along the slot 1236, thereby enabling the guidewire 22 (initially disposed within the lumen of the needle 16) to be selectively pushed out and past the distal end 16B of the needle 16. As previously mentioned, the proximal end of the guidewire 22 is attached to the interior of the top housing portion 12A such that a one unit distal slide of the finger pad 1218 can result in a two unit distal advancement of the guidewire. As previously mentioned, this can be accomplished by first looping the guidewire 22 from its point of attachment on the top housing portion 12A and through a guide surface 980( FIG. 53A and FIG. 53B ) included on the guidewire rod 24, and then extending the guidewire into the lumen of the needle 16. It should be noted that in the present embodiment, the guidewire rod 24 and the finger pad 1218 of the guidewire advancement assembly 20 are integrally formed with one another, but in other embodiments they can be separately formed. It should also be noted that the guidewire 22 can be attached to other exterior or interior portions of the insertion tool 10, including the bottom housing portion 12B, the needle hub 1214, etc.

[0198] FIGS. 48A-48F The catheter advancement assembly 40 for selectively advancing the catheter 42 in a distal direction from the housing 12 of the insertion tool 10 is also shown, including a handle assembly 1220 that in turn includes two wings 1280 in addition to these components that the user's fingers grasp when the catheter is to be advanced. As will be discussed in further detail below, the wings 1280 are advanced distally via a gap 1250 defined between the top housing portion 12A and the bottom housing portion 12B.

[0199] The four tabs 1230( FIG. 48D , FIG. 49 ​The top housing portion 12A and the bottom housing portion 12B mate together with four corresponding recesses 1232 on the bottom housing portion that the top housing portion engages. Of course, other mating mechanisms and schemes can be used to join the top and bottom housing portions together.

[0200] FIG. 49 The exploded view of the insertion tool 10 in FIG. 12 shows that the handle assembly 1220 includes a head portion 1222 from which the wings 1280 extend and a tail portion 1224. Both the head portion 1222 and the tail portion 1224 are removably attached to the catheter hub 46, as will be discussed further below. The internal components of the insertion tool 10 disposed within the housing 12 through which the needle 16 passes include the valve 52, the safety housing 54 in which the sled 1008 and the needle safety component 56 are disposed, and the top cover 58 of the safety housing. This figure also shows that the safety needle component 56 includes an O-ring 1002 that, like the needle hub 1214, is secured to the proximal end of the needle 16 and is mounted to the housing 12 to secure the needle 16 in place within the insertion tool 10. In FIG. 49 It should be noted in FIG. 12 that the slot 1236 in the finger pad in which the guidewire advancement assembly 20 is disposed includes a relatively wide portion in one embodiment such that the guidewire rod 24 can be inserted through the portion to couple the guidewire advancement assembly to the housing 12.

[0201] FIG. 50A and FIG. 50B Various details regarding the stability structure 70 for supporting and stabilizing the needle 16 at the exit point of the needle from the housing 12 are shown in accordance with the present embodiment. As shown, the proximal portions of the top housing 12A and the bottom housing 12B engage one another to provide the stability structure 70 for the needle 16. The bottom housing portion 12B includes two distally disposed arms 1248 separated by a slot 1246 that enables the arms to be spread apart from one another when unconstrained. The top housing portion 12A defines a distal slot 1240 and a horseshoe feature 1242 distal to the slot. If the top housing portion 12A is bent downward (see FIG. 48C ), the slot 1240 enables the arms 1248 of the bottom housing portion 12B to protrude upward through the slot to encircle and support the needle 16, thereby stabilizing the needle. The horseshoe feature 1242 is disposed around the needle 16 at the distal ends of the bottom housing arms 1248 and acts as a collar to stabilize the needle.

[0202] The arms 1248 of the bottom housing portion 12B are configured to be spread apart from one another when unconstrained FIG. 50A and FIG. 50BThe x-y axes shown in FIGS. 1-3 move back and forth in the x-direction while remaining generally rigid in the y-direction. In contrast, the distal portion of the top housing portion 12A, including the slot 1240 and the horseshoe feature 1242, is configured to bend in the y-direction while remaining generally rigid in the x-direction, as shown in FIGS. 4-6. Thus, when the above-described components of the stability structure 70 are overlapped or otherwise engaged with one another as shown in FIGS. 1-3 FIG. 50A and FIG. 50B The x-y axes shown in FIGS. 1-3 move back and forth in the x-direction while remaining generally rigid in the y-direction. In contrast, the distal portion of the top housing portion 12A, including the slot 1240 and the horseshoe feature 1242, is configured to bend in the y-direction while remaining generally rigid in the x-direction, as shown in FIGS. 4-6. Thus, when the above-described components of the stability structure 70 are overlapped or otherwise engaged with one another as shown in FIGS. 1-3 FIG. 50A and FIG. 50B as shown in FIGS. 1-3, these components cooperate to support the needle 16 and prevent it from moving a significant amount when the housing 12 is in the configuration shown in FIGS. 4-6 (i.e., before the catheter 42 is removed from the housing 12). This in turn helps the user to accurately puncture the skin and access the patient’s blood vessel. It will be appreciated that the stability structure can include other components to stabilize the needle in addition to those explicitly described herein. FIG. 50A and FIG. 50B as shown in FIGS. 1-3, these components cooperate to support the needle 16 and prevent it from moving a significant amount when the housing 12 is in the configuration shown in FIGS. 4-6 (i.e., before the catheter 42 is removed from the housing 12). This in turn helps the user to accurately puncture the skin and access the patient’s blood vessel. It will be appreciated that the stability structure can include other components to stabilize the needle in addition to those explicitly described herein.

[0203] FIGS. 51-54 Various details regarding the catheter advancement assembly 40 and the guidewire advancement assembly 20 in accordance with the present embodiments are shown. As noted above, the catheter advancement assembly 40 includes a handle assembly 1220 which in turn includes a head portion 1222 with corresponding wings 1280 and a tail portion 1224 disposed about a portion of the catheter hub 46 and the safety housing 54. As will be discussed further below, the handle assembly 1220 is used to advance the catheter 42 distally and remove it from the insertion tool 10.

[0204] FIGS. 51-54 The finger pad 1218 and the guidewire rod 24 of the guidewire advancement assembly 20 for the present embodiments are also shown. As shown, the guidewire rod 24 extends proximally from the finger pad 1218 and includes the previously described guide surface 980 on its proximal end for guiding the guidewire 22 into a loop. The proximal end of the guidewire rod 24 also includes an actuation block 1258 near the proximal end for effecting guidewire advancement, as will be described further below. It will be noted that the specific size, shape, and other configuration of the actuation block can differ from those shown and described herein, but still have the desired functionality.

[0205] The spring arms 1260 extend downwardly from the guidewire rod 24 and are configured to be slidably retained between two guide posts 1264 of the needle hub 1214, as in FIG. 53A and FIG. 53BThe most clearly shown is the spring arm 1260, which is used to lock further movement of the guidewire advancement assembly 20 after the guidewire 22 has been fully extended distally from the insertion tool 10 and the catheter 43 has been advanced an increment. Specifically, the user slides the finger pad 1218 distally, causing the guidewire rod 24 to also move distally, thereby advancing the guidewire 22 (which internally surrounds the guide surface 980 passing through the guidewire rod 24 and into the needle cavity) distally through the cavity of the needle 16 and past the distal end 16B of the needle, as shown in the diagram. FIG. 54 As shown.

[0206] After the finger pad 1218 and guide rod 24 are fully advanced to the distal side (as... FIG. 54 As shown), the free end of the spring arm 1260 is positioned just above the recess 1266 defined between the guide pillars 1264 of the needle hub 1214, as... FIG. 53B As shown. At this stage, because the safety housing 54 is adjacent to the proximal end of the needle hub 1214 (since the guide wire 42 has not yet been advanced distally via the guide wire advancement assembly 40, the guide wire and the attached safety housing are in their initial seated position, as further described below), the free end of the spring arm 1260 cannot yet be seated in the recess 1266. However, after the guide wire 42 has advanced a certain additional distance distally, the attached safety housing 54 no longer prevents the spring arm 1260 from moving downwards, and its free end is seated in the recess 1266 of the needle hub 1214. The finger pad 1218 colliding with the distal end of the slot 1236 prevents the guide wire advancement assembly 20 from moving further distally, while the spring arm seated in the recess 1266 of the needle hub prevents it from moving proximally.

[0207] It should be noted that the finger pad 1218 includes a protrusion 1254 on its lower side near the distal end, which engages with a recess 1252 defined on the top housing portion 12A when the finger pad is fully advanced distally. This helps to keep the finger pad 1218 seated in its distal position and provides a tactile cues that the finger pad has been fully advanced distally.

[0208] It should also be noted that if the catheter advancement assembly 40 moves proximally back to its initial position (e.g., FIG. 52 (As shown), the safety housing 54 will then once again abut the needle hub 1214 and push the free end of the spring arm 1260 upward out of the recess 1266. This, in turn, allows the guidewire advance assembly 20 to move proximally and distally again, thereby allowing the guidewire 22 itself to advance proximally and distally accordingly. Therefore, in this embodiment, the locking of the guidewire advance is reversible.

[0209] In another embodiment, it is understood that the guidewire advancement assembly 20 can include a button such that after the guidewire is initially locked, the guidewire can be re-extended or retracted, such as by pressing the button to disengage the spring arms 1260 from the divots 1266 of the needle hub. These and other variations are thus contemplated.

[0210] FIGS. 55-56C It is shown that according to the present embodiment, prior to the aforementioned distal advancement of the guidewire 22, the presently described insertion tool 10 further includes locking catheter movement. In detail, FIG. 55 and FIG. 56A It is shown that the tail portion 1224 of the handle assembly 1220 of the guidewire advancement assembly 20 and the catheter advancement assembly 40 is in an initial position within the insertion tool housing 12, that is, prior to the distal advancement of the guidewire and the distal advancement of the catheter. In this position, the two spring arms 1272 of the tail portion 1224 are arranged such that both guide posts 1264 of the needle hub 1214 are seated within the respective notches 1274 of the spring arms, as most clearly shown in FIG. 56A In this position, the tail portion 1224 is prevented from moving. If the tail portion 1224 is attached to the hub 46 of the catheter 42, this also prevents the catheter or any other portion of the catheter advancement assembly 40 from advancing distally.

[0211] As shown in FIG. 56A and FIG. 56B the distal advancement of the guidewire rod 24 causes its actuation block 1258 to engage the angled surface 1276 of each spring arm 1272. As most clearly shown in FIG. 56B the continued distal movement of the guidewire rod 24 causes the actuation block 1258 to stretch the spring arms 1272, thereby disengaging the guide posts 1264 from the spring arm notches 1274. As described above in connection with FIGS. 52-54 the actuation block 1258 affects the guide posts 1264 when the guidewire 22 is fully advanced distally and the free ends of the spring arms 1260 of the guidewire rod 24 are just arranged above the divots 1266 of the needle hub 1214, as shown in FIG. 56B At this point, the spring arms 1272 of the tail portion 1224 are disengaged from the guide posts 1264 of the needle hub 1214, thereby allowing the catheter to advance distally, as shown by the distal movement of the spring arms in FIG. 56C In addition, as described above in connection with FIGS. 52-54 the distal advancement of the catheter accordingly moves the safety housing 54 attached to the catheter 42 distally. The movement of the safety housing causes the free ends of the spring arms 1260 of the distally advanced guidewire rod 24 to fall into the divots 1266 of the needle hub 1214, thereby locking further movement of the guidewire 22, excluding the return of the safety housing to the initial position adjacent to the needle hub.

[0212] Thus, it can be seen that the configuration of the insertion tool 10 of the present embodiments can prevent the catheter 42 from moving distally until the guidewire 22 is fully extended distally. Further, the guidewire 22 can be prevented from further movement as the catheter 42 is at least incrementally advanced distally from its initial proximal position. In another embodiment, distal advancement of the guidewire by an incremental amount can cause the catheter to advance.

[0213] In yet another embodiment, guidewire movement is permanently locked after full distal advancement. In one embodiment, this can be accomplished by configuring the spring arm 1260 of the guidewire rod 24 and the dimple 1266 of the needle hub 1214 to not interact with the safety housing 54. In this way, once the free end of the spring arm 1260 is seated within the dimple of the needle hub 1214, the free end is permanently retained seated within the dimple. In still another embodiment, catheter movement is locked after full distal advancement of the catheter. In still another embodiment, the guidewire and / or catheter can be advanced via a ratchet mechanism.

[0214] In another embodiment, the ability to advance the catheter is independent of guidewire advancement. In yet another embodiment, the spring arm 1260 of the guidewire rod 24 can be removed such that the guidewire advancement assembly 20 is not locked. This in turn enables the catheter advancement to be locked until the guidewire is fully advanced distally. These and other variations are thus contemplated.

[0215] FIG. 57A and FIG. 57B Various details regarding distal advancement of the catheter 42 from the insertion tool 10 are shown. As shown, once the guidewire advancement assembly 20 has advanced the guidewire 22 distally and such that the guidewire extends past the distal end 16B of the needle 16, the catheter advancement assembly 40 is free to be used to advance the catheter 42 distally out of the distal end of the insertion tool housing 12, as described above in connection with FIGS. 55-56C The user grips one or both wings 1280 of the head portion 1222 of the handle assembly 1220 and moves the wings distally, thereby advancing the catheter 42. It should be noted that the wings 1280 include ridges 1282 FIG. 50B ) to facilitate gripping of the wings by the user. Distal sliding of the wings 1280 in the gap 1250 defined between the top and bottom housing portions advances the catheter distally if the wings 1280 are attached to the head portion 1222, which in turn is attached to the hub 46 of the catheter 42.

[0216] FIG. 57A and FIG. 57BAs the catheter 42 is advanced distally, the wings 1280 also move distally so that the wings impact the top housing portion 12A and push it upward, in turn lifting the distal portion of the top housing portion, including the slot 1240 and the horseshoe feature 1242 of the stability structure 70. Lifting the slot 1240 causes the arms 1248 of the bottom housing portion 12B to disengage from the slot, thereby enabling the arms to splay apart. FIG. 57A and FIG. 57B As the catheter is advanced distally, the two struts 1286 disposed on the head portion 1222 of the handle assembly 1220 (see also FIG. 60 ) push against each arm 1248, thereby causing the arms to splay apart. The splaying apart of the arms 1248 and the lifting process created by the wings 1280 of the top housing portion enable the catheter 42 to pass through the distal end of the housing 12.

[0217] FIG. 58 and FIG. 59 The catheter 42 and catheter advancement assembly 40 are shown removed from the insertion tool housing 12, with the catheter 42, handle assembly 1220 (including the head portion 1222 and tail portion 1224), and safety housing 54 removably attached to the catheter hub 46 so as to slide distally along the needle 16 and out of the housing 12 by the user holding and advancing the wings 1280. This action can be performed, for example, after the needle 16 and guidewire 22 cooperation provides a passageway into a blood vessel, to push the catheter tube 44 into the patient's blood vessel.

[0218] FIG. 59 The catheter 42 and handle assembly 1220 are shown further separated from the housing 12 so that the safety housing 54 reaches the distal end 16B of the needle 16, at which point the needle safety component 56 FIG. 49 disposed in the safety housing engages the needle distal tip to prevent accidental needle sticks to the user, and the safety housing is laterally separated from the catheter hub 46 but still retains the needle.

[0219] FIG. 60Various features of the handle assembly 1220 are shown, including a head portion 1222 and a tail portion 1224. After the safety housing 54 and needle 16 are separated from the catheter 42 and handle assembly 1220 as described above, the head portion 1222 and tail portion 1224 remain attached to the needle hub 46 and its respective strain relief 47 via the clip arms 1300 and 1304, respectively. At this point, the user can overcome the friction fit of the clip arms 1300 with their hands to remove the head portion 1222 from the catheter hub 46 / strain relief 47. The user can also remove the tail portion 1224, including the ring 1306 disposed about the valve 52, by pulling and twisting to overcome the friction fit of the clip arms 1304 and to clear the threads of the catheter hub 46. This action will remove the valve 52 attached to the tail portion 1224 (see FIG. 49 ). In another embodiment, the tail portion ring 1306 is configured such that the valve 52 is exposed after the tail portion 1224 is removed, enabling the user to remove the valve if desired. Once the head portion 1222 and tail portion 1224 of the handle assembly 1220 have been removed from the catheter 42, a catheter dressing can be added and the catheter used as desired.

[0220] The handle assembly 1220 can be configured in other ways than those described above. FIG. 61 and FIG. 62 One example of a handle assembly 1220 is given in which the head portion and tail portion are unified in a single body 1312. As shown in FIG. 62 , this enables the safety housing 54 to be removed laterally from the handle assembly 1220, and then the catheter hub 46 can be removed vertically therefrom. FIG. 63 Similar configurations are included in the handle assembly 1220 in which the valve 52 includes oppositely disposed extensions 1316 that enable the extensions to be grasped (after the safety housing 54 is removed laterally), and the handle assembly 1220 can be removed vertically. These actions enable the valve 52 and its extensions 1316 to be attached to the hub 46 of the catheter 42, at which point the valve can be removed laterally from the hub using the extensions if desired.

[0221] In FIG. 64In this embodiment, the handle assembly 1220 includes a single body defining a living hinge 1320 disposed just distal of the ring 1306, but can be disposed elsewhere. It should be noted that the ring 1306 is used to capture the valve 52. In one embodiment, the valve 52 is integrally formed with or attached to the handle assembly body. In another embodiment, the valve 52 is separate from the handle assembly 1220 and is not affected by removal of the handle assembly 1220. The handle assembly 1220 also includes a clamp arm 1304 that is removably attached to the catheter hub 46 to secure the catheter 42 in place. The handle assembly 1220 also includes a strut 1286 as described in previous embodiments.

[0222] As shown in FIG. 128, the wings 1280 can be grasped to pull the distal portion of the handle assembly 1220 proximally, then disengage the clamp arm 1304 and the strut 1286 from the catheter hub 46, and pull the handle assembly and valve 52 laterally from the catheter hub. Other handle assembly configurations are contemplated given these and other configurations. FIG. 65

[0223] FIGS. 66A-66C Details of an insertion tool including a catheter advancement configuration are shown according to one embodiment, where the insertion tool housing 1340 includes a catheter advancement lever 1344 that engages with the guidewire advancement button such that the catheter advancement lever is initially held in a depressed position under the guidewire advancement button, thereby preventing advancement of the catheter. Upon distal movement of the guidewire advancement button 1348, the catheter advancement lever 1344 is sprung upward, thereby unlocking catheter advancement and enabling the catheter tube 44 to be advanced distally, such as by distal movement of the catheter advancement lever. It should be appreciated that one or more of a variety of internal mechanisms can be included in the housing 1340 that facilitate the functions described herein.

[0224] It should be noted that the insertion tool 10 just described above is configured such that the user's hand can grasp the tool and the tool can be used to deploy the catheter into the patient without the user having to move the hand that is grasping the device. In particular, the finger pad 1218 of the guidewire advancement assembly 20 and the wings 1280 of the catheter advancement assembly 40 are disposed distal to the position in which the user grasps the housing 12 in order to use the insertion tool 10, thus not requiring the user to move the grasping hand during advancement of the finger pad or wings.

[0225] In one embodiment, the user grasps the insertion tool housing 12 with one hand and advances at least one of the finger pad 1218 and the wings 1280 with the other hand, again without requiring movement of the hand that is grasping the insertion tool housing. In another embodiment, the user can use the fingers of the hand that is grasping the insertion tool housing to advance one or both of the finger pad 1218 and the wings 1280.

[0226] ​Reference is now made to FIGS. 67A-67F FIG. 1 shows various details regarding a catheter insertion tool ("insertion tool" or "insertion device") generally indicated at 10, in accordance with an embodiment. It should be noted that while the discussion below focuses on the placement of a particular type and relatively short length of catheter, catheters of various types, sizes, and lengths can be inserted via the present device, including peripheral midline or extended dwell catheters, PICC catheters, central venous catheters, and the like. In one embodiment, a catheter having a length of between about 2.0 inches and about 2.9 inches can be placed, although many other lengths are possible. In another embodiment, a catheter having a length of between about 2.25 inches and about 2.75 inches can be placed.

[0227] As shown, the insertion tool 10 includes a housing 12, which in turn includes a top housing portion 12A that mates with a bottom housing portion 12B. A needle 16 extends from the housing, on which is disposed a catheter 42. The figure also shows a thumb pad 1218 of the guidewire advancement assembly 20, which is slidably disposed in a slot 1236 defined in the top housing portion 12A, as well as a portion of the handle assembly 1220 of the catheter advancement assembly 40. The thumb pad 1218 is also referred to herein as a first user engagement component. The insertion tool 10 and various details thereof are presented in greater detail below in accordance with the present embodiment.

[0228] FIGS. 67A-67F As shown, the insertion tool 10 includes a housing 12, which in turn includes a top housing portion 12A that mates with a bottom housing portion 12B. A needle 16 extends from the housing, on which is disposed a catheter 42. The figure also shows a thumb pad 1218 of the guidewire advancement assembly 20, which is slidably disposed in a slot 1236 defined in the top housing portion 12A, as well as a portion of the handle assembly 1220 of the catheter advancement assembly 40. The thumb pad 1218 is also referred to herein as a first user engagement component. The insertion tool 10 and various details thereof are presented in greater detail below in accordance with the present embodiment. FIG. 72A and FIG. 72B ), and then extending the guidewire into the lumen of the needle 16. It should be noted that in the present embodiment, the guidewire rod 24 and the thumb pad 1218 of the guidewire advancement assembly 20 are integrally formed with one another, although in other embodiments they can be separately formed. It should also be noted that the guidewire 22 can be attached to other external or internal portions of the insertion tool 10, including the bottom housing portion 12B, the needle hub 1214, and the like.

[0229] FIGS. 67A-67FAlso shown is a catheter advancement assembly 40 for selectively advancing the catheter 42 out of the housing 12 of the insertion tool 10 in a distal direction, which includes a handle assembly 1220 that in turn includes, in addition to these components, a finger pad portion 1290 that is moved by the user's thumb and / or fingers when the catheter is to be advanced. As will be discussed in further detail below, the finger pad portion 1290 is advanced distally via a gap 1250 defined between the top housing portion 12A and the bottom housing portion 12B. The finger pad portion 1290 is also referred to herein as a second user engagement component, while the aforementioned finger pad 1218 of the guidewire advancement assembly 20 is also referred to herein as a second user engagement component.

[0230] The top housing portion 12A and the bottom housing portion 12B are mated together by four protrusions 1230 of the top housing portion engaging with four corresponding recesses 1232 located on the bottom housing portion. FIG. 67D 、 FIG. 68 Of course, other mating mechanisms and schemes can be used to connect the top housing portion and the bottom housing portion together.

[0231] FIG. 68 The exploded view of the insertion tool 10 in FIG. 12 shows that the handle assembly 1220 includes a head portion 1222 and a tail portion 1224, with the finger pad portion 1290 being part of the head portion. Both the head portion 1222 and the tail portion 1224 are removably attached to the catheter hub 46, as will be discussed further below. The internal components of the insertion tool 10 disposed within the housing 12 (through each of which the needle 16 passes) include the valve 52, the safety housing 54 (with the sled and needle safety components disposed therein), and the top cover 58 of the safety housing. The needle safety components can include an O-ring. The needle hub 1214, which is fixed to the proximal end of the needle 16, is mounted to the housing 12 to secure the needle 16 in place within the insertion tool 10. The needle hub 1214 is also used to secure the catheter hub 46 in place within the insertion tool 10, as will be discussed further below. FIG. 68 It should be noted in FIG. 12 that the slot 1236 in which the finger pad of the guidewire advancement assembly 20 is disposed includes a relatively wide portion or slot cavity 1236A in one embodiment, such that the guidewire rod 24 can be inserted therethrough in order to couple the guidewire advancement assembly to the housing 12, as well as to lock the guidewire movement, as shown.

[0232] FIG. 69A and FIG. 69BVarious details regarding a stability structure 70 according to the present embodiments for supporting and stabilizing the needle 16 at the exit point of the needle from the housing 12 are shown. As shown, the proximal portions of the top housing 12A and the bottom housing 12B interengage to provide the stability structure 70 for the needle 16. The bottom housing portion 12B includes two distally disposed arms 1248 separated by a slot 1246 that enables the arms to be spread apart from one another when unconstrained. The top housing portion 12A defines a distal slot 1240 and a prong 1241 adjacent the slot. If the distal portion of the top housing portion 12A is bent downward (see FIG. 67C ), the slot 1240 enables the arms 1248 of the bottom housing portion 12B to protrude upward through the slot to encircle and support the needle 16, thereby stabilizing the needle. In addition, the prong 1241 of the top housing portion 12A abuts the arms 1248 of the bottom housing portion 12B to prevent the spreading apart of the arms in the event the stability structure is mated but not yet spread out, as described below. As desired, this provides stability and support for the needle 16.

[0233] The arms 1248 of the bottom housing portion 12B are configured to move back and forth in the x-direction while remaining generally rigid in the y-direction, as shown by the x-y axes in FIG. 69A and FIG. 69B . Conversely, the distal portion of the top housing portion 12A including the slot 1240 and the prong 1241 are configured to bend in the y-direction while remaining generally rigid in the x-direction, as shown by the x-y axes in FIG. 69A and FIG. 69B . Thus, when the above-described components of the stability structure 70 are overlapped or interengaged as shown in FIG. 69A and FIG. 69B , these components cooperate to support the needle 16 and prevent large movements of the needle when the housing 12 is in the configuration shown in FIG. 69A and FIG. 69B (i.e., prior to removal of the catheter 42 from the housing 12). This in turn facilitates the user's ability to accurately puncture the skin and access the patient's blood vessel. It will be appreciated that the stability structure can include other components to stabilize the needle in addition to those explicitly described herein.

[0234] FIGS. 70-73 Various details regarding the catheter advancement assembly 40 and the advancement assembly 20 according to the present embodiments are shown. As described above, the catheter advancement assembly 40 includes a handle assembly 1220 that in turn includes a head portion 1222 with a corresponding finger pad portion 1290 and a tail portion 1224 disposed about a portion of the catheter hub 46 and the safety housing 54. As will be discussed further below, the handle assembly 1220 is used to advance the catheter 42 distally and remove it from the insertion tool 10.

[0235] FIGS. 70-73 Also shown are the finger pad 1218 and the guide wire rod 24 of the guide wire advance assembly 20 for this embodiment. As shown, the guide wire rod 24 extends proximally from the finger pad 1218 and includes the previously described guide surface 980 at its proximal end for guiding the guide wire 22 to form an annular shape. An actuating block 1258 is also included near the proximal end of the guide wire rod 24 for realizing guide wire advance, as will be further described below. It should be noted that the specific dimensions, shape, and other configurations of the actuating block may differ from those shown and described herein, but still have the desired functionality.

[0236] Spring arm 1260 extends downward from guide rod 24 (from FIGS. 70-73 (as shown in the angle), and is configured to be slidably held between the two guide pillars 1264 of the needle hub 1214, as in FIG. 72A and FIG. 72B The most clearly shown is the spring arm 1260, which is used to lock further movement of the guidewire advancement assembly 20 after the guidewire 22 has been fully extended distally from the insertion tool 10 and the catheter 43 has been advanced an increment. Specifically, the user slides the finger pad 1218 distally, causing the guidewire rod 24 to also move distally, thereby advancing the guidewire 22 (which internally surrounds the guide surface 980 passing through the guidewire rod 24 and into the needle cavity) distally through the cavity of the needle 16 and past the distal end 16B of the needle, as shown in the diagram. FIG. 73 As shown.

[0237] After the finger pad 1218 and guide rod 24 are fully advanced to the distal side (as... FIG. 73 As shown), the finger pad is pushed towards the distal end point, and the free end of the spring arm 1260 is positioned just above the recess 1266 defined between the guide pillars 1264 of the needle hub 1214, as shown. FIG. 72B As shown. Since the safety housing 54 is located adjacent to the proximal end of the needle hub 1214 at this stage (because the guide wire 42 has not yet been advanced distally via the guide wire advancement assembly 40, the guide wire and the attached safety housing are in their initial seated position, as further described below), the free end of the spring arm 1260 cannot yet be seated in the recess 1266. However, after the guide wire 42 has advanced a certain additional distance distally from the point referred to herein as the proximal starting point, the attached safety housing 54 no longer prevents the spring arm 1260 from moving downwards, and its free end is seated in the recess 1266 of the needle hub 1214. The finger pad 1218 striking the distal end of the slot 1236 prevents the guide wire advancement assembly 20 from moving further distally, while the spring arm seated in the recess 1266 of the needle hub prevents it from moving proximally.

[0238] It should be noted that in one embodiment, the finger pad 1218 may include a protrusion or extended surface 1308 on its underside near the distal end. FIG. 79), the protrusion or extension surface engages a slot cavity 1236A defined as a portion of the slot 1236 on the top housing portion 12A when the finger pad is fully advanced distally. FIG. 68

[0239] It should be noted that if the catheter advancement assembly 40 is moved proximally back to its initial position (as shown in FIG. 71 , then the safety housing 54 will once again abut the needle hub 1214 and push the free end of the spring arm 1260 up out of the recess 1266. This in turn enables the guidewire advancement assembly 20 to be unlocked and to be able to move proximally and distally again, thereby enabling the guidewire 22 itself to be advanced proximally and distally accordingly. Thus, in this embodiment, the locking of the guidewire advancement is reversible.

[0240] In another embodiment, it should be understood that the guidewire advancement assembly 20 can include a button such that after the guidewire is initially locked, the guidewire can be re-extended or retracted, such as by pressing the button to disengage the spring arm 1260 from the recess 1266 of the needle hub. These and other variations are thus contemplated.

[0241] FIGS. 74-75C It is shown that according to the present embodiment, prior to the above-described distal advancement of the guidewire 22, the presently described insertion tool 10 also includes locking catheter movement. In detail, FIG. 74 and FIG. 75A It is shown that the tail portion 1224 of the handle assembly 1220 of the guidewire advancement assembly 20 and the catheter advancement assembly 40 is in an initial position within the insertion tool housing 12, that is, prior to distal advancement of the guidewire and distal advancement of the catheter. In this position, the two spring arms 1272 of the tail portion 1224 are arranged such that both guide posts 1264 of the needle hub 1214 are seated within the respective notches 1274 of the spring arms, as most clearly shown in FIG. 75A In this position, movement of the tail portion 1224 can be prevented. If the tail portion 1224 is attached to the hub 46 of the catheter 42, this can also prevent distal advancement of the catheter or any other portion of the catheter advancement assembly 40.

[0242] As shown in FIG. 75A and FIG. 75B distal advancement of the guidewire rod 24 such that its actuation block 1258 engages the inclined surface 1276 of each spring arm 1272. As most clearly shown in FIG. 75B ​As most clearly shown, the guide rod 24 continues to move distally, causing the actuator block 1258 to extend the spring arm 1272, thereby disengaging the guide post 1264 from the spring arm recess 1274. (As illustrated above...) FIGS. 71-73 As described above, when the guide wire 22 is fully advanced distally and the free end of the spring arm 1260 of the guide wire rod 24 is positioned just above the recess 1266 of the needle hub 1214, the actuator 1258 affects the guide support 1264, such as... FIG. 75B As shown. At this time, the spring arm 1272 of the tail portion 1224 disengages from the guide post 1264 of the needle hub 1214, thereby advancing the catheter (such as by using the user to move the handle assembly 1220) distally, as in FIG. 75C As shown, the middle spring arm moves to the distal side. Furthermore, as described above... FIGS. 71-73 As the catheter is advanced distally, the safety housing 54 attached to the catheter 42 is moved distally accordingly. The movement of the safety housing causes the free end of the spring arm 1260 of the distally advanced guidewire 24 to fall into the recess 1266 of the needle hub 1214, thereby locking further movement of the guidewire 22, excluding the return of the safety housing to its initial position adjacent to the needle hub.

[0243] Therefore, it can be seen that the configuration of the insertion tool 10 in this embodiment prevents the catheter 42 from moving distally until the guidewire 22 has fully extended distally. Furthermore, as the catheter 42 is advanced distally from its initial proximal position, subsequent movement of the guidewire 22 is prevented. In another embodiment, incremental distal advancement of the guidewire allows for catheter advancement.

[0244] In yet another embodiment, guidewire movement is permanently locked after full distal advancement. In one embodiment, this is achieved by configuring the spring arm 1260 of guidewire rod 24 and the recess 1266 of needle hub 1214 to not interact with the safety housing 54. Thus, once the free end of spring arm 1260 is seated within the needle hub recess 1266, the free end remains permanently seated within the recess. In yet another embodiment, catheter movement is locked after full distal advancement of the catheter. In still another embodiment, the guidewire and / or catheter may be advanced via a ratchet mechanism.

[0245] In another embodiment, the ability to advance the catheter is independent of guidewire advancement. In yet another embodiment, the spring arm 1260 of the guidewire rod 24 can be removed, so that the guidewire advancement assembly 20 is not locked. This, in turn, allows the catheter advancement to be locked until the guidewire is fully advanced distally. Thus, these and other variations are taken into consideration.

[0246] FIG. 76Various details are shown relating to the distal advancement of the catheter 42 from the insertion tool 10. Once the guidewire advancement assembly 20 has advanced the guidewire 22 distally and caused the guidewire to extend past the distal end 16B of the needle 16, the catheter advancement assembly 40 is free (as described above in connection with FIGS. 74-75C the) to advance the catheter 42 distally out of the distal end of the insertion tool housing 12. The user engages the finger pad portion 1290 of the head portion 1222 of the handle assembly 1220 and moves the finger pad portion distally, thereby advancing the catheter 42. It should be noted that the finger pad portion 1290 includes ridges 1282 FIG. 69A 、 FIG. 69B ), to facilitate the user's grip on the finger pad portion. The finger pad portion 1290 slides distally in the gap 1250 defined between the top and bottom housing portions. The finger pad portion 1290, as part of the head portion 1222 which is in turn attached to the hub 46 of the catheter 42, slides distally to advance the catheter distally.

[0247] As the catheter 42 is advanced distally, the distal movement of the finger pad portion 1290 causes the finger pad portion to collide with and push upward on the top housing portion 12A as a portion of the head portion 1222 slides through the gap 1250. This in turn lifts the distal portion of the top housing portion 12A, including the slot 1240 and the prongs 1241 of the stability structure 70. Lifting the slot 1240 and the prongs 1241 causes the arms 1248 of the bottom housing portion 12B to disengage from the slot, thereby enabling the arms to splay apart. As the catheter is advanced distally, the two posts 1286 (see also FIG. 77 ) disposed on the head portion 1222 of the handle assembly 1220 push against each of the arms 1248, thereby causing the arms to splay apart. The splaying apart of the arms 1248 and the lifting process caused by the finger pad portion 1290 of the top housing portion enable the catheter 42 to pass through the distal end of the housing 12.

[0248] FIG. 76 The removal of the catheter 42 and the catheter advancement assembly 40 from the insertion tool housing 12 is shown, where continued distal advancement of the head portion 1222 of the handle assembly 1220 by the user engaging and advancing the finger pad portion 1290 causes the catheter 42, the handle assembly 1220 (including the head portion 1222 and the tail portion 1224), and the safety housing 54 to be removably attached to the catheter hub 46 for sliding distally along the needle 16 and out of the housing 12. This action can be performed, for example, after the needle 16 and the guidewire 22 cooperate to provide percutaneously access to a blood vessel, to advance the catheter tube 44 into the patient's blood vessel.

[0249] The catheter 42 and the handle assembly 1220 are further separated from the housing 12 such that the safety housing 54 reaches the distal end 16B of the needle 16, at which point the needle safety component disposed in the safety housing engages the needle distal tip to protect the distal tip and prevent accidental needle sticks to the user, with the safety housing being laterally separated from the catheter hub 46 but still retaining the needle.

[0250] FIG. 77 Various features of the handle assembly 1220 are shown, including a head portion 1222 and a tail portion 1224. After the safety housing 54 and the needle 16 are separated from the catheter 42 and the handle assembly 1220 as described above, the head portion 1222 and the tail portion 1224 remain attached to the needle hub 46 and its respective strain relief 47 via the clip arms 1300 and 1304, respectively.

[0251] At this point, the user can overcome the friction fit of the clip arms 1300 with their hand to remove the head portion 1222 from the catheter hub 46 / strain relief 47. The user can also overcome the friction fit of the clip arms 1304 and clear the threading of the catheter hub 46 in a pulling and twisting manner, and remove the tail portion 1224 including the ring 1306 disposed around the valve 52. This action will remove the valve 52 attached to the tail portion 1224 (see FIG. 68 ). In another embodiment, the tail portion ring 1306 is configured such that the valve 52 is exposed after the tail portion 1224 is removed, enabling the user to remove the valve if desired. Once the head portion 1222 and the tail portion 1224 of the handle assembly 1220 have been removed from the catheter 42, a catheter dressing can be added and the catheter used as desired. The handle assembly 1220 can be configured in other ways in addition to those shown and described above.

[0252] FIG. 78A and FIG. 78B Various details are shown regarding the handle assembly 1220 as part of the catheter advancement assembly 40, including the head portion 1222 and the tail portion 1224. As shown, the head portion 1222 includes a finger pad portion 1290 configured to enable a user's thumb and / or fingers to push the catheter 42 distally out of the insertion tool 10, as shown in FIG. 76 A ridge 1292 is included on the finger pad portion 1290 to help the user grip it. A rounded raised surface 1292 is included on the top surface of the finger pad portion 1290 and provides a surface on which the user can apply force to push the head portion 1222 distally.

[0253] The head portion 1222 defines a cavity 1294 within which a portion of the distal portion of the top housing portion 12A of the insertion tool housing 12 is disposed such that the head portion can slide over the distal portion of the top housing portion 12A, for example, as shown inFIG. 76 The engagement of the head portion 1222 with the proximal end of the top housing portion 12A allows the head portion to be slid distally over the distal portion of the top housing portion 12A by engagement of the user with the finger pad portion 1290, thereby pushing the catheter 42 distally out of the distal end of the insertion tool housing 12. As a result of this advancement (which separates the catheter 42 from the housing 12), the cavity 1294 of the head portion 1222 can be seen to be separated from the top housing portion 12A.

[0254] Note that, FIG. 67E , FIG. 70 and FIG. 78B The finger pad portion 1290 of the handle assembly 1220 is shown to also include a recess 1295 in which the finger pad 1218 of the guidewire rod 24 seats when the finger pad 1218 is slid distally by the user to advance the guidewire 22 distally. Thus, it can be seen that the finger pad 1218 of the guidewire advancement assembly 20 and the finger pad portion 1290 of the head portion 1222 of the catheter advancement assembly 40 cooperate to provide for single-handed advancement of the guidewire 22 and the catheter 42.

[0255] In particular, the finger pad 1218 is slid distally on the top of the housing 12 to advance the guidewire 22 until the finger pad 1218 seats in the recess 1295 of the finger pad portion 1290 of the head portion 1222. The user can then transfer the thumb and / or finger from the finger pad 1218 to the finger pad portion 1290 of the head portion 1222 adjacent its curved raised surface 1292 (without requiring substantial repositioning of the thumb and / or finger), at which point continued distal pressure can be applied to slide the finger pad portion 1290 distally and correspondingly push the catheter 42 distally out of the distal end of the insertion tool housing 12 as desired. Thus, the distal end point of the sliding finger pad 1218 of the guidewire advancement assembly 20 corresponds in position to the proximal starting point of the finger pad portion 1290 of the catheter advancement assembly 40. It will be appreciated that the finger pad 1218, the finger pad portion 1290, the ridge 1282, the raised surface 1292, etc. can also be configured in other ways.

[0256] FIG. 80 and FIG. 81 Details of the catheter insertion tool 10 are shown according to one embodiment in which the finger pad 1218 of the guidewire advancement assembly 20 is elongated in shape and includes a pair of ridges to facilitate engagement thereof by the thumb and / or finger of the user. In addition, as shown, the handle assembly 1220 of the catheter advancement assembly 40 includes a head portion 1222 and a tail portion formed as a unitary component. The head portion 1220 includes two wings 1280 similar to those described above in connection with FIGS. 48A-49 the wings for enabling the catheter 42 to be pushed distally out of the housing 12. As FIG. 80As shown, the head portion 1220 also includes a cover portion 1310 that arches over the top housing portion 12A, extending between and connecting with each of the wings 1280. So arranged, the cover portion 1310 is disposed over a portion of the finger pad 1218. A ridge or profile 1310 is included on the top surface of the cover portion 1310 to help the user engage the cover portion with the thumb and / or fingers. As can be seen, the catheter advancement assembly 40 can be used to distally advance the catheter 42 via a sliding movement by the user manually engaging either or both of the wings 1280 and / or the cover portion 1310.

[0257] FIG. 81 The head portion 1220 and the tail portion 1224 that collectively form the handle assembly 1220 in the present embodiment are shown. FIG. 82A and FIG. 82B As shown, once the handle assembly 1220 is removed from the catheter insertion tool 10 as in the previous embodiments, the handle assembly 1220 can be removed from the catheter 42 (as will occur after the catheter tube 44 thereof is inserted into a patient's blood vessel) by first bending the head portion of the handle assembly upward and proximally, as shown in FIG. 82B to disengage the clip arms 1300 and 1304 from the strain relief 47 and the catheter hub 46, respectively. The handle assembly 1220 can then be pulled proximally relative to the catheter 42 to release the engagement therebetween.

[0258] FIGS. 83-85 Various details are shown with respect to the continuous blood flash indicator 1330 that enables the user to ensure that blood or other fluid is present in the lumen of the needle 16 of the catheter insertion tool 10, and thus that the needle distal tip 16B is disposed in a patient's vein or blood vessel during placement of the catheter 42 using the insertion tool. In FIG. 83 The blood flash indicator 1330 includes an elongated channel 1332 that is in fluid communication with the lumen of the needle 16 of the insertion device 10. The channel 1332 is shaped to define a passage 1334, such as a tortuous passage, for example, along which blood present in the lumen of the needle 16 can travel after exiting the needle and entering the channel.

[0259] In more detail, FIG. 83 The channel 1332 is shown to establish fluid communication with the lumen of the needle 16 via a conduit or entry point 1336A defined through the ring 1306 of the tail portion 1224 of the handle assembly 1220, with the conduit fluidly connected with the needle 16 via a notch defined in the needle or by other suitable mode. In one embodiment, the fluid communication is established by the valve plug 52 FIG. 68) defines an entry point 1336A, which defines a bore that fluidly connects the valve plug with the conduit hub inner lumen. In another embodiment, the entry point 1336A is defined at a point that is proximal to the containment housing 54 but distal to the needle hub 1214. These and other possible locations are contemplated.

[0260] The channel 1334 is formed by a groove 1332 that extends distally from the tubing, which is defined by a portion of the handle assembly 1220, as shown. Figure 83 Here, the groove 1332 is covered by a portion of the top housing portion 12A. The thermoplastic or other material of the top housing portion 12A that covers the groove 1332 is translucent in this embodiment, enabling the user to see blood present in the groove. In another embodiment, the housing itself can define at least a portion of the groove 1332.

[0261] Figure 83 and Figure 84 In one embodiment of the blood flash indicator 1330, the groove 1332 defined by the handle assembly 1220 is fluidly connected to the finger pad portion 1290 of the head portion 1222 of the catheter advancement assembly 40 via an entry point 1336B, such that a channel 1334 is also defined on the finger pad portion. Again, in this embodiment, the portion of the finger pad portion 1290 that defines the groove 1332 is translucent, enabling the user to view blood flowing therein.

[0262] In one embodiment of the blood flash indicator 1330, the channel 1334 formed by the groove 1332 can be defined at multiple locations. Figure 85 An example of this is shown, in which a portion of the channel 1334 is included on the top housing portion 12A at a location proximal to the finger pad portion 1290 (fluid contact therewith is provided via an entry point 1336C), and another portion of the channel 1334 is included on the top housing portion at a location distal to the finger pad portion (fluid contact therewith is provided via an entry point 1336D). The entry points 1336C and 1336D are in fluid communication with another portion of the groove 1332 that extends to fluidly connect with a portion of the needle 16 (via an entry point such as the entry point 1336A, as shown) or other fluid delivery portion of the insertion device 10. Figure 83

[0263] Figure 84 and Figure 85 The channel 1334 shown forms an elongated, serpentine-shaped channel along which blood present in the inner lumen of the needle 16 can travel after exiting the needle. Figure 84 The channel 1334 shown defines a circuitous pattern that travels along the outer shape of the finger pad portion 1290, while Figure 85 ​The channels defined along the top surface of the top housing portion 12A define a reciprocating pattern. However, it is understood that various different channel designs and locations on / in the insertion device 10 can be used. In the present embodiment, the channels 1334 defined on the top housing portion 12A are formed by transparent tubes that are attached (e.g., by pressing) to the top housing portion in the illustrated pattern. In one embodiment, the transparent tubes are separated from the top housing portion when the handle assembly 1220 of the catheter advancement assembly 40 is extended distally, when the handle assembly 1220 is extended and separated from the housing 12. In another embodiment, the channels 1332 are integrally formed with the housing 12.

[0264] The user can observe the blood within the channels 1334 defined by the channels 1332 to confirm that the distal tip of the needle 16 is disposed in the vein or other desired blood vessel for delivery of blood in the patient. Because the channels 1334 are relatively long, the progress of the blood traveling in the channels 1332 enables the blood flash indicator 1330 to function as a continuous blood flash indicator, where blood is present in and advancing along the route defined by the channels 1334 as long as the needle distal tip 16B is disposed in the blood vessel (or other fluid delivery vessel in other embodiments) for delivery of blood. It is understood that the channels and grooves can be formed using one of a variety of processes, including molding, machining, etc. Note that the channels 1332 can be included on other structures in addition to those illustrated and described herein, including the hub 46 or other portions of the catheter 42, valve assemblies, other portions of the housing 12, etc.

[0265] Various channel designs are contemplated, including a trunk and branch pattern, a reciprocating pattern, a periodic crenulated pattern around the perimeter of a component, a zigzag pattern, a converging reciprocating pattern, a circular pattern, a spiral pattern, etc.

[0266] Embodiments of the application can be embodied in other specific forms without departing from the spirit of the disclosure. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the application is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning of the equivalences of the claims are intended to be embraced therein.

Claims

1. An insertion device for inserting a catheter into a patient's body, comprising: A housing, in which at least a portion of the conduit is initially disposed; A needle extending distally from the housing, at least a portion of the conduit being pre-positioned on the needle; Guide wire; A guidewire advance assembly for selectively pushing the distal end of the guidewire distally out of the distal opening of the needle in preparation for distal advancement of the catheter; and A catheter advancement assembly for selectively advancing the catheter in a distal direction, the catheter advancement assembly being located distal to the guidewire advancement assembly, the catheter advancement assembly including a handle assembly including a first wing and a second wing, and a cover portion integrally connecting the first wing to the second wing, the cover portion being positioned such that distal advancement of the guidewire advancement assembly and the catheter advancement assembly can be accomplished by a user's single thumb or a single other finger. The guidewire advancement assembly includes a spring arm designed to engage a recess in the housing to prevent proximal retraction of the guidewire after full distal advancement. The spring arm is disposed on the guide rod attached to the slide, and the recess is included in the needle hub in the housing, the proximal end of the needle being mounted to the needle hub.

2. The insertion device of claim 1, wherein the first wing and the second wing are manually graspable by the user to advance the conduit distally from the housing, the first wing and the second wing including ridges to assist the user in user engagement of the wing.

3. The insertion device of claim 2, wherein the covering portion of the handle assembly arches over the top portion of the housing.

4. The insertion device of claim 3, wherein the covering portion of the shank assembly arches over the top portion of the housing to cover a portion of the finger pad of the guidewire advance assembly.

5. The insertion device of claim 1, wherein the cover portion includes a shaped surface to assist a user in engaging the cover portion with the thumb or the other finger.

6. The insertion device of claim 1, wherein at least one of the guidewire advancement assembly and the shank assembly is configured to prevent advancement of the catheter until distal advancement of the guidewire is performed.

7. The insertion device of claim 1, wherein the shank assembly includes a head portion and a tail portion, the head portion and the tail portion being removably attached to the catheter, the tail portion being engageable with the guidewire advancement assembly to selectively advance the catheter distally.

8. The insertion device according to claim 7, wherein the head portion and the tail portion of the handle assembly are integrally formed with each other.

9. The insertion device of claim 8, wherein the catheter includes a catheter hub, the handle assembly is removably attached to the catheter hub, wherein the valve is removably included in the catheter hub, wherein a safety housing is removably disposed in the valve, the safety housing being configured to be removed in a lateral direction, and wherein the handle assembly and the catheter hub are configured to be separated from each other in a vertical direction.

10. The insertion device of claim 8, wherein the catheter includes a catheter hub, the handle assembly is removably attached to the catheter hub, the handle assembly including a movable hinge configured to selectively remove the handle assembly from the catheter hub.

11. The insertion device of claim 10, wherein the handle assembly includes a valve removably disposed in the conduit hub.

12. The insertion device of claim 1, wherein the catheter advancement assembly includes a safety housing, a needle safety component disposed within the safety housing, the safety housing being disposed adjacent to the needle hub at a first position of the shank assembly, and wherein distal movement of the safety housing allows the free end of the spring arm to sit in a recess in the needle hub after full distal advancement of the guidewire.

13. The insertion device of claim 12, wherein the catheter advancement assembly is configured such that proximal movement of the safety housing to a position adjacent to the needle hub pushes the free end of the spring arm away from the recess of the needle hub, thereby enabling the guidewire to advance and retract.

14. The insertion device of claim 1, wherein the guidewire includes an actuating block designed to engage a portion of the catheter advancement assembly after the guidewire has been fully advanced distally, and wherein engagement of the actuating block with the portion of the catheter advancement assembly enables the catheter to be advanced distally.

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