A catheter insertion device including an advancing component mounted on the upper part

Abstract

To provide an insertion tool for inserting a catheter into a patient's body.SOLUTION: The insertion tool includes: a housing in which at least a portion of a catheter 44 is initially disposed; a hollow needle distally extending from the housing with the catheter pre-disposed over the needle; and a guidewire pre-disposed within the needle. A guidewire advancement assembly with a first finger pad is included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. A catheter advancement assembly with a second finger pad is also included for selectively advancing the catheter into the patient. The finger pads are positioned such that a user can begin to advance the second finger pad after advancing the first finger pad without substantially re-positioning the thumb or a finger of the user so as to successively advance the guidewire and catheter.SELECTED DRAWING: Figure 50B

Description

Summary of the Invention

[0001] Cross - reference to related applications This application is a partial continuation of the following application: U.S. Patent Application No. 14 / 702,580, filed May 1, 2015, titled "Catheter Placement Device Including Guidewire and Catheter Control Elements". This application claims the benefit of the following application: U.S. Provisional Patent Application No. 61 / 988,114, filed May 2, 2014, titled "Catheter Placement Device Including Catheter and Guidewire Control Systems". This application is a partial continuation of the following application: U.S. Patent Application No. 14 / 099,050, filed Dec. 6, 2013, titled "Guidewire Extension System for a Catheter Placement Device". This application claims the benefit of the following application: U.S. Provisional Patent Application No. 61 / 771,703, filed Mar. 13, 2013, titled "Needle Safety and Guidewire Extension Systems for a Catheter Insertion Device". This application is a partial continuation of the following application: U.S. Patent Application No. 13 / 107,781, filed May 13, 2011, now U.S. Patent No. 8,932,258, titled "Catheter Placement Device and Method". This application claims the benefit of the following application:U.S. Provisional Patent Application No. 61 / 345,005, filed on May 14, 2010, titled "Catheter Insertion System Including an Integrated Guidewire Dilator"; U.S. Provisional Patent Application No. 61 / 345,022, filed on May 14, 2010, titled "Systems and Methods for Placement of an Intermediate Dwell Catheter Including a Needle Blunting System"; U.S. Provisional Patent Application No. 61 / 372,050, filed on August 9, 2010, titled "Catheter Insertion Tool Including Fold-out Guidewire Advancement Flaps"; and U.S. Provisional Patent Application No. 61 / 385,844, filed on September 23, 2010, titled "Catheter Insertion Tool Including Guidewire Advancement Component". This application also claims the benefit of U.S. Provisional Patent Application No. 62 / 162,580, filed on May 15, 2015, titled "Catheter Placement Device Including Top-Mounted Advancement Components". Each of the above applications is hereby incorporated by reference in its entirety.

[0002] Brief Summary Briefly summarized, embodiments of the present invention relate to an inserter for inserting a catheter or other tubular medical device into a patient's body. In one embodiment, the inserter integrates needle insertion, guidewire advancement, and catheter insertion into a single device, providing a simple catheter placement technique.

[0003] In one embodiment, the present introducer comprises a housing in which at least a portion of a catheter is initially disposed, a hollow needle extending distally from the housing, with at least a portion of the catheter being pre-disposed on the needle, and a guide wire pre-disposed within the needle. A forward assembly is also included for selectively advancing the guide wire distally beyond the distal end of the needle in preparation for distal advancement of the catheter. In one embodiment, a catheter advancement assembly for selectively advancing the catheter into a patient is also included. Each forward assembly may include a sliding portion or other actuator that enables a user to selectively advance a desired component.

[0004] In one embodiment, the catheter advancement assembly further includes a handle that is initially and removably attached to a hub of the catheter within the housing. Distal movement of the handle by the user, in turn, distally displaces the catheter in the distal direction from the housing. The handle may include a needle safety component for isolating the distal tip of the needle when the needle is removed from the catheter and the distal tip is received within the handle. Additionally, various guide wire and catheter advancement assemblies are disclosed herein.

[0005] In still other embodiments, various features are included in the introducer. For example, actuating the guide wire and catheter advancement assembly without moving the user's hand that grips the introducer during a catheter insertion procedure, selectively advancing one of the guide wire or catheter based on a previous advancement of the other, and guide wire blunting features.

[0006] In another embodiment, the guide wire and catheter advancement assemblies each include a user engagement component. The user engagement component is configured such that a user can initiate advancing a second user component after advancing a first user engagement component without substantially repositioning the thumb or finger that the user uses for advancement.

[0007] In yet other embodiments, the catheter advancement assembly includes a handle assembly that includes first and second wings. A cover portion extends between the first and second wings and is positioned such that advancement of the guidewire advancement assembly and the catheter advancement assembly can be performed by a single thumb or finger of the user.

[0008] These and other features of embodiments of the present invention will become more apparent from the following description and the appended claims, or may be learned from the practice of the embodiments of the invention described hereinafter.

Brief Description of the Drawings

[0009] This disclosure will be described in more detail by reference to the specific embodiments shown in the accompanying drawings. It is understood that these drawings show only typical embodiments of the invention and are not to be considered limiting of its scope. Exemplary embodiments of the invention will be described and explained more specifically and in detail using the following accompanying drawings.

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 5A

Figure 5B

Figure 6A

Figure 6B

Figure 7A

Figure 7B

Figure 8

Figure 9

Figure 10A

Figure 10B

Figure 10C

Figure 11A

Figure 11B

Figure 11C

Figure 11D

Figure 12A

Figure 12B

Figure 13A

Figure 13B

Figure 14A

Figure 14B

Figure 14C

Figure 14D

Figure 14E

Figure 14F

Figure 15A

Figure 15B

Figure 16

Figure 17A

Figure 17B

Figure 17C

Figure 18

Figure 19

Figure 20A

Figure 20B

Figure 21A

Figure 21B

Figure 22

Figure 23

Figure 24

Figure 25A

Figure 25B

Figure 26

Figure 27

Figure 28

Figure 29A

Figure 29B

Figure 30

Figure 31

Figure 32A

Figure 32B

Figure 32C

Figure 32D

Figure 32E

Figure 32F

Figure 32G

Figure 32H

Figure 32I

Figure 33A

Figure 33B

Figure 33C

Figure 34

Figure 35

Figure 36A

Figure 36B

Figure 37

Figure 38

Figure 39A

Figure 39B

Figure 40A

Figure 40B

Figure 40C

Figure 40D

Figure 41A

Figure 41B

Figure 42

Figure 43

Figure 44

Figure 45A

Figure 45B

Figure 46

Figure 47A

Figure 47B

Figure 48A

Figure 48B

Figure 48C

Figure 48D

Figure 48E

Figure 48F

Figure 49

Figure 50A

Figure 50B

Figure 51

Figure 52

Figure 53A

Figure 53B

Figure 54

Figure 55

Figure 56A

Figure 56B

Figure 56C

Figure 57A

Figure 57B

Figure 58

Figure 59

Figure 60

Figure 61

Figure 62

Figure 63

Figure 64

Figure 65

Figure 66A

Figure 66B

Figure 66C

Figure 67A

Figure 67B

Figure 67C

Figure 67D

Figure 67E

Figure 67F

Figure 68

Figure 69A

Figure 69B

Figure 70

Figure 71

Figure 72A

Figure 72B

Figure 73

Figure 74

Figure 75A

Figure 75B

Figure 75C

Figure 76

Figure 77

Figure 78A

Figure 78B

Figure 79

Figure 80

Figure 81

Figure 82A

Figure 82B

Figure 83

Figure 84

Figure 85

[0010] Detailed description of selected embodiments Hereinafter, reference is made to the figures showing similar structures with the same reference notations. The drawings are schematic and diagrammatic representations of representative embodiments of the present invention and are not limited to an exact scale ratio, nor is it necessary.

[0011] For clarity, it is understood that the term "proximal" refers to the direction relatively close to the physician using the device described herein, while the term "distal" refers to the direction relatively far from the physician. For example, the end of a catheter placed inside a patient's body is considered the distal end of the catheter, while the end of the catheter remaining outside the body is the proximal end of the catheter. Also, as used herein, including in the claims, the terms "comprising", "having", and "having" shall have the same meaning as the term "including".

[0012] Embodiments of the present invention generally relate to an instrument for assisting in the placement of a catheter or other tubular medical device within a patient. For example, catheters of various lengths are typically placed within a patient's body to establish access to the patient's vasculature and to enable the injection of medications or the aspiration of body fluids. The catheter introducer described herein facilitates such catheter placement. While the following description focuses on the placement of a particular type and relatively short length of catheter, it should be noted that catheters of various types, sizes, and lengths can be inserted via the present device. For example, peripheral IV, intermediate or extension dwell catheters, PICC, central venous catheters, and the like. In one embodiment, a catheter having a length of about 6.4 cm to about 11.4 cm (about 2.5 inches to about 4.5 inches) can be placed, although many other lengths are possible. In another embodiment, a catheter having a length of about 8.26 cm (about 3.25 inches) can be placed.

[0013] First, refer to FIGS. 1A - 1B and FIGS. 2A - 2B, which show various details regarding a catheter introducer (the "introducer"), generally designated 10, according to one embodiment. As shown, the introducer 10 includes a housing 12, which in turn includes an upper housing portion 12A that is detachably fitted to a bottom housing portion 12B. A needle hub 14 that supports a hollow needle 16 is interposed between the housing portions 12A and 12B. The needle 16 extends distally from the needle hub 14 so as to pass through the body of the introducer 10 and extend outside the distal end of the housing 12. In another embodiment, the needle is at least partially hollow, yet still enables the functions described herein.

[0014] A notch 18 is defined through the wall of the needle 16 proximate its distal end. The notch 18 enables blood flashback to exit the lumen defined by the hollow needle 16 when access to the patient's vasculature is achieved during the catheter insertion procedure. Thus, as further described below, the blood exiting the notch 18 can be observed by the physician to confirm proper needle placement within the vasculature.

[0015] The introducer 10 further 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 - disposed within the lumen of the needle 16, and the proximal end of the guidewire is positioned adjacent to the proximal end of the needle hub 14, as best seen in FIGS. 1B and 2A. The guidewire advancement assembly 20 includes a guidewire lever 24 for selectively advancing the guidewire distally during use of the introducer 10 such that the distal portion of the guidewire extends beyond the distal end of the needle 16. The guidewire lever 24 includes a lever tab 26 that engages the proximal end of the guidewire 22 to push the guidewire through the lumen of the needle 16.

[0016] The guidewire advancement assembly 20 further includes a slider 28 slidably attached to the upper housing portion 12A. Two tabs 24A of the guidewire lever 24 are operably attached to the slider 28 such that user - selected movement of the slider results in corresponding movement of the lever 24 and, in turn, the guidewire 22. Engagement of the lever tab 24A to the slider 28 also maintains attachment of the slider to the housing 12. Of course, other engagement schemes for converting user input into movement of the guidewire may be utilized. A track suitable for enabling sliding movement of the slider 28 and the lever 24 is included in the upper housing portion 12A and includes a track 34 that extends to the distal end of the housing 12.

[0017] The sliding portion 28 includes two arms 30 that partially cover the periphery of the rail 32 defined by the housing 12. In particular, while the sliding portion 28 is initially advancing distally, the arms 30 slide on the bottom housing rail 32A, as best seen in FIG. 5B. While the sliding portion 28 is advancing further distally, the arms 30 slide beyond the bottom housing rail 32A and onto the top housing rail 32B, as best seen in FIGS. 2A and 3A. When the arms 30 of the sliding portion 28 no longer engage the bottom housing rail 32A, the two housing portions 12A and 12B can separate, as further described below.

[0018] The guide wire lever 24 includes a locking arm 36 that is elastically disposed to spring up when the sliding portion 28 has slid fully distally and engage an expansion portion 36A defined inside the upper housing portion 12A. This prevents inadvertent retraction of the guide wire 22, which, once extended distally, could otherwise result in unintentional cutting of the distal portion of the guide wire by the distal tip of the needle 16 during the insertion procedure. Note that the engagement of the locking arm 36 with the expansion portion 36A can provide tactile and / or audible feedback to the user in one embodiment, indicating full distal extension of the guide wire 22.

[0019] The inserter 10 further includes a catheter advancement assembly 40 that is pre - disposed within the housing 12 for selectively advancing the catheter 42 in the distal direction and includes a catheter tube 44 and a hub 46 at its proximal end. As seen in FIGS. 1A and 1B, the catheter 42 is partially and initially pre - disposed within the volume defined by the housing 12, and thus, as already described, the lumen of the catheter tube 44 is disposed over the needle 16, which in turn is disposed over the guide wire 22.

[0020] In particular, the catheter advancement assembly 40 includes a handle 48 that defines a base 48A and two arms 50 extending from the handle base. Each arm 50 defines a gripping surface 50A, a finger loop portion 50B, and one of two teeth 50C. The gripping surface 50A and the finger loop portion 50B enable a user to grasp or contact the handle to selectively advance the catheter 42 distally during use of the introducer 10 for inserting the catheter into a patient's body. The tooth 50C engages a corresponding raised surface on the hub 46 to removably connect the handle 48 to the catheter 42.

[0021] Additional components associated with the handle 48 of the catheter advancement assembly 40 are included. A plug or valve 52 is interposed between the handle base 48A and the catheter hub 46 to prevent blood leakage when the catheter is first introduced into a patient's vascular structure. A safety housing 54 that includes a needle safety component 56 therein is removably attached to the handle 48 between the arms 50. Specifically, a protrusion 60 included on the inner surface of the handle arm 50 engages a corresponding recess 62 (FIG. 10A) defined in the safety housing 54 to removably secure the safety housing to the handle 48. A cap 56 supports the needle safety component 56 and covers the end of the safety housing 54. As shown in FIG. 1B, the needle 16 initially extends through the aforementioned components in the order shown in FIG. 2B. Further details regarding the operation of these components are shown below.

[0022] Note that in one embodiment, the outer diameters of the needle 16 and the catheter tube 44 are lubricated with silicone or other suitable lubricant to improve the sliding of the catheter tube relative to the needle and to assist in inserting the catheter into a patient's body.

[0023] The inserter 10 further includes a support structure 70 for stabilizing the needle 16 proximate its exit point from the housing 12. In this embodiment, the support structure 70 includes a mating surface 72 of an upper housing portion 12A and a bottom housing 12B that is formed to closely conform to the round shape of the needle 16 and the catheter tube 44. The mating surface 72 stabilizes the needle 16 to prevent excessive “play” in the needle, thus improving user accuracy when initially accessing the patient's vasculature.

[0024] As best seen in FIG. 2A, the upper housing 12A, the needle hub 14, and the bottom housing 12B include engagement features 68 to maintain attachment of the proximal end of the housing 12 even when the more distal portions of the housing are separated, as discussed below. However, note that various types, sizes, and numbers of engagement features may be utilized to achieve this desired function.

[0025] FIGS. 3A - 9 illustrate various stages of use of the inserter 10 when implanting the catheter 42 into a patient's vasculature. For clarity, the various stages are shown without depicting the actual insertion into the patient. With the inserter 10 in the configuration shown in FIG. 1A, a user gripping the inserter 10 first guides the distal portion of the needle 16 through the skin at an appropriate insertion site to access a subcutaneous vessel. Confirmation that appropriate vascular access has been achieved is evident via a blood flash, i.e., the presence of blood between the outer diameter of the needle 16 and the inner diameter of the catheter tube 44 is due to blood passing out of the hollow interior of the needle through the notch 18. Note that in one embodiment, the presence of blood in the safety housing 54, which is a translucent housing in one embodiment, can serve as a secondary blood flash indicator due to blood entering the housing from the needle 16 when the vasculature is accessed.

[0026] After access to the vessel with the needle is confirmed, the guide wire advancement assembly 20 is actuated and the sliding portion 28 is advanced distally by the user's finger to advance the guide wire 22 (Figs. 3A and 3B), which is initially disposed within the hollow needle 16, distally. Note that the guide wire is advanced distally by a lever 24 operably attached to the sliding portion 28. Also note that while the sliding portion 28 is advancing distally, its sliding portion arm 30 moves along the rails 32 on either side of the housing 12, first along the bottom housing rail 32A and then along the top housing rail 32B.

[0027] Advancement of the distal guide wire continues until the sliding portion 28 has slid distally its full travel length, resulting in a predetermined length of the guide wire 22 extending beyond the distal end of the needle 16, as shown in Figs. 4A and 4B. In one embodiment, further distal advancement of the sliding portion 28 is blocked when the lever tab 26 contacts the distal portion of the needle hub 14, as shown in Fig. 4B. Figs. 5A and 5B show that when the sliding portion 28 has advanced completely distally, its sliding portion arm 30 no longer engages the bottom housing rail 32A but rather engages only the top housing rail 32B. This in turn allows for separation of the housing portions 12A and 12B, as will be seen further below.

[0028] As seen in Figs. 5A and 5B, once the guide wire 22 has been fully extended into the patient's vessel (Figs. 4A and 4B), the catheter advancement assembly 40 is actuated and the handle 48 is advanced distally by the user to slide the catheter tube 44 over the distal portions of the needle 16 and guide wire 22 and into the patient's vascular structure through the insertion site. Figs. 6A and 6B show that when the catheter is advanced via the handle 48, the housing portions 12A and 12B are easily separated so that the catheter hub 46 can exit the distal end of the housing 12 and the catheter can be inserted an appropriate distance into the patient's vascular structure.

[0029] As shown in FIGS. 7A and 7B, note that while removing the catheter from within the housing 12 of the inserter 10, the catheter slides distally along the needle 16 until the distal needle tip is received within the safety housing 54 and engaged with the needle safety component 56. FIG. 8 shows that the inserter 10 can then be separated from the catheter 42, with the handle 48 still attached to the catheter hub 46. As previously described, the handle 48 includes a valve 52 interposed between the catheter hub 46 and the handle 48. When the needle 16 and the safety housing 54 are removed from the catheter 42, the valve 52 shields the catheter lumen to prevent inadvertent blood leakage from the catheter hub 46. As shown in FIG. 9, the handle 48 is removed from engagement with the catheter hub 46 by pulling, twisting, etc. to disengage the teeth 50C of the handle from the hub. The spreading legs can be attached to the catheter 42 with the catheter hub and dressing treated by standard techniques. The housing 12 and the handle 48 of the inserter 10 can be discarded.

[0030] FIGS. 10A - 10C show further details regarding the safety housing 54 and its interaction with the needle safety component 56 and the needle 16 when isolating the distal end of the needle 16. As shown, the safety housing 54 is configured such that during use of the inserter 10, the needle 16 can pass through the safety housing and exit the housing via the expansion portion 74 on the distal end of the housing, as has been described. The cap 58 is installed within the proximal end of the safety housing 54 and is configured to support the needle safety component 56 such that the needle 16 initially passes through the safety housing, the cap, and the needle safety component. Note that the expansion portion 74 of the safety housing 54 in this embodiment extends into the valve 52 to open the valve during use of the inserter 10, which eliminates undesirable friction between the valve and the needle.

[0031] FIG. 10C shows that the needle safety component 56 includes a curved body or coupling element 80 and a friction element 82 through which the needle initially extends. As seen in FIG. 10A, when the needle 16 is withdrawn from the catheter 42 (FIG. 8), the distal tip of the needle is withdrawn proximally through the expansion portion 74 and beyond the distal portion of the needle safety component so that the needle is no longer in contact therewith. This causes the friction element 82 to tilt the coupling element 80 slightly, thus coupling the needle 16 in place and preventing its further movement relative to the safety housing 54, isolating the distal tip of the needle within the housing to prevent inadvertent needle sticks. In this embodiment, the friction element 82 includes an appropriately sized O-ring. Suitable O-rings can be obtained, for example, from Apple Rubber Products, Lancaster, NY. Further details regarding the needle safety component, its operating principle, and similar devices are disclosed in U.S. Pat. Nos. 6,595,955, 6,796,962, 6,902,546, 7,179,244, 7,611,485, and 7,618,395, each of which is hereby incorporated by reference in its entirety. Of course, other needle safety devices can be utilized to isolate the distal end of the needle.

[0032] Referring now to FIGS. 11A - 13B, a catheter introducer 110 according to one embodiment will be described. Note that in this and subsequent embodiments, various features are similar to those already described in relation to the above embodiments. Therefore, only selected aspects of each subsequent embodiment will be described.

[0033] The inserter 110 includes a housing 112 defined by an upper housing portion 112A and a bottom housing portion 112B that together partially house the catheter 42. A needle hub 114 is included for supporting a distally extending needle 116 for placement within the housing 112, and the catheter tube 44 of the catheter 42 is positioned such that it is disposed over the needle. Note that in this and other embodiments, the partial housing of the catheter by the inserter enables the physician to manipulate the inserter with the hand closer to the distal end of the needle than would otherwise be possible by other means.

[0034] Figures 13A and 13B show further details regarding the needle hub 114 attached to the upper housing portion 112A. A needle holder 126 included on the distal end of the needle hub 114 receives the proximal end of the needle 116 therein. The needle 116 is fixed within the needle holder 126 via an adhesive, welding, or other suitable method. Extensions 128 are included on both sides of the needle holder 126 and are configured to be slidably received within corresponding slots 130 defined in the side surface of the bottom housing portion 112B. Such engagement enables the bottom housing portion 112B to slide distally relative to the upper housing portion 112A.

[0035] An upper rail 132 is included on the needle hub 114 and is configured to engage a corresponding slot 134 defined in the proximal portion of the upper housing portion 112A to fix the needle hub to the upper housing portion. A lockout arm 136 is also included with the needle hub 114 and is positioned to engage the rear plate 124 when the bottom housing portion 112B slides distally to extend a guide wire from the needle 116, thus preventing its retraction. Note that as best seen in FIG. 11D, the guide wire 122 initially extends distally from the rear plate 124 and through the needle holder 126 and the needle 116.

[0036] The guide wire advancement assembly 120 is included to selectively advance a guide wire 122 initially disposed within the lumen of a needle distally beyond the distal end of the needle 116. The guide wire advancement assembly 120 includes a bottom housing portion 112B to which the guide wire 122 is attached at its proximal rear plate 124. As can be seen, the bottom housing portion 112B is slidable distally relative to the upper housing portion 112A to enable selective distal advancement of the guide wire 122.

[0037] The introducer 110 further includes a catheter advancement assembly 140 for selectively advancing a catheter 42 over the needle 116. The advancement assembly 140 includes a handle 146 initially and slidably disposed between the upper housing 112A and the bottom 112B and removably attached to the hub 46 of the catheter 42. As best seen in FIGS. 12A and 12B, the handle 146 includes two arms 150 to enable a user to selectively slide the handle to advance the catheter 42. The handle 146 further includes a recess 152 for placement on a needle safety component 156 to isolate the distal tip of the needle 116 when the needle is withdrawn from the catheter 42. Further details regarding the needle safety component are disclosed in U.S. Pat. Nos. 6,595,955, 6,796,962, 6,902,546, 7,179,244, 7,611,485, and 7,618,395, each of which is incorporated by reference above.

[0038] The inserter 110 further includes a support structure 170 for stabilizing the needle 116 in proximity to the distal end of the housing 112. The support structure 170 in the present embodiment includes two flaps 172 that are hingedly connected to the distal portion of the bottom housing portion 112B. When closed as seen in FIGS. 11D and 12A, the flaps 172 function to stabilize the needle 116 to assist the user of the inserter 110 when inserting the needle into the patient. When opened (FIG. 14D), the flaps 172 provide an opening that allows the catheter hub 46 to be removed from the distal end of the housing 112, as will be described in more detail below. Before the bottom housing portion 112B slides relative to the top housing portion 112A, the flaps 172 are disposed within a track 174 defined by the top housing portion. Other types and configurations of the support structure can also be utilized. The inserter 110 further includes a gripping surface 176 on either side of the housing 112 to assist in the use of the inserter during the catheter insertion procedure described in more detail below.

[0039] FIGS. 14A-14E illustrate various stages of use of the inserter 110 when inserting a catheter into a patient. In the inserter 110 configured as shown in FIG. 14A, vascular access is achieved by the needle 116 via user insertion of the needle into the patient at the insertion site. Confirmation of vascular access can be achieved by confirmation of blood flashback through the distal notch of the needle 116, as described in the previous embodiment or by other suitable methods.

[0040] Once the distal portion of the needle 116 is disposed within the patient's vasculature, the guide wire 122 is advanced distally to extend beyond the distal end of the needle and into the vasculature by advancing the bottom housing portion 112B distally. Such advancement is accomplished in this embodiment by placing the user's finger on the folded flap 172 of the bottom housing portion 112B and pressing the flap distally, thereby extending the guide wire 122. The guide wire 122 is advanced until it is fully extended. Next, the lockout arm 136 of the needle hub 114 engages the rear plate 124 of the bottom housing portion 112B to prevent retraction of the guide wire 122.

[0041] At this stage, the handle 146 of the catheter advancement assembly 140 is advanced distally by the user gripping one or both of its arms 150 to advance the catheter 42 distally through the insertion site and into the patient's vascular structure. This is shown in FIG. 14C, where the catheter tube 44 advancing distally over the needle 116 and the guide wire 122 is shown.

[0042] As shown in FIG. 14D, by continuing to advance the catheter 42 distally, the catheter hub 146 prompts an opening relative to the flap 172, thus providing a suitable opening for the hub to pass through the inserter housing 112. Note that the flap 172 is formed such that contact with the catheter hub 46 prompts an outward folding of each flap, as seen in FIG. 14D. Also note that the flap 172 is no longer disposed within the track 174 due to the full distal advancement of the guide wire 122 by the finger pressure applied to the flap 172 as described above.

[0043] FIG. 14E shows that the upper housing portion 112A and the bottom housing portion 112B can be separated at their distal ends such that the flap is no longer engaged within the track 174 and the handle 146, still attached to the catheter hub 46, can be separated from the housing 112. Although not shown at this stage, the needle safety component 156 disposed within the recess 152 of the handle 146 isolates the distal end of the needle 116. Next, the handle 146 can be manually removed from the catheter hub 46 (FIG. 14F), and the placement of the catheter 42 and the dressing process can be completed. The inserter 110, including the needle 116 isolated by the needle safety component 156 of the handle 146, can be safely discarded.

[0044] Referring to FIGS. 15A-18, a catheter inserter 210 according to one embodiment will now be described. The inserter 210 includes a housing 212 defined by an upper housing portion 212A and a bottom housing portion 212B that together partially house the catheter 42. A sliding needle hub 214 that supports a distally extending hollow needle 216 is slidably attached to the housing 212. In particular, the needle hub 214 includes a track 214A that slidably engages corresponding rails 218 defined on the upper and bottom housing portions 212A, 212B in a manner further described below. As shown in FIG. 15A, the needle hub 214 is positioned distally with respect to the housing 212 such that the needle 216 extends through the needle channel 224 (FIG. 18) and out of a hole defined at the distal end of the upper housing portion 212A as shown in FIG. 15A.

[0045] As shown in FIG. 15A, the housing 212 of the inserter 210 houses a portion of the catheter 42. As shown in FIGS. 15B and 16, an integrated guidewire / dilator 220 is included and disposed within the lumen of the catheter tube 44. The guidewire / dilator 220 includes a distal guidewire portion 220A and a proximal dilator portion 220B. Configured as such, the guidewire / dilator 220 not only functions as a guidewire when directing the catheter tube 44 into the vasculature accessed through the patient's insertion site, but can also dilate the insertion site prior to insertion of the catheter therethrough. In other embodiments, a guidewire / dilator need not be used. In one embodiment, it is understood that the guidewire / dilator 220 extends proximally through the entire catheter 42 and includes a luer cap connectable to the proximal luer connector of the catheter on its proximal end. Note also that FIG. 15A shows a sterile bag 217 attached to the housing 212 to cover and isolate the proximal portion of the catheter 42. For clarity, the bag 217 is included only in FIG. 15A, but may be included in inserters of various configurations to protect and isolate portions of the catheter.

[0046] As shown in FIGS. 17A-17C, the needle 216 includes a longitudinally extending needle slot 226 that extends from a starting point along the length of the needle to its distal end. FIG. 17B shows that the slot 226 may optionally be wider at its proximal portion relative to its more distal slot portion. Configured as such, the needle slot 226 allows the guidewire / dilator 220 to be inserted into, slide relative to, and removed from the needle 216 during operation of the inserter 210 as described below. Note that the needle slot can extend the full length of the needle in one embodiment.

[0047] FIG. 18 shows a method of introducing a guide wire / dilator 220 into a slot 226 of a needle 216 according to an embodiment, the guide wire / dilator extending distally through a hollow needle 216 disposed along a guide channel 222 defined in an upper housing portion 212A and within a needle channel 224 via the needle slot. (The guide channel 222 is also seen in FIG. 15B.) In this method, the guide wire / dilator 220 is slid distally through the hollow needle 216 such that, as can be seen, it extends beyond the distal needle tip and yet can still be removed from the needle via the slot 226 when the guide wire / dilator and the needle are separated from each other.

[0048] FIG. 18 also shows a support structure 270 for stabilizing the needle 216, including a joint surface 272 defined by portions of the upper housing portion 212A and the bottom housing portion 212B around the hole through which the needle extends. Of course, other support structures for providing stability to the needle can be utilized to assist when inserting the needle into the patient's vasculature. FIG. 19 shows details of a lockout 230 of a needle hub 214 included on the bottom housing portion 212B to prevent further movement of the needle hub after retraction, as described below.

[0049] FIGS. 19-24 show various stages of use of the introducer 210 when inserting a catheter into a patient. In the introducer 210 in the configuration shown in FIG. 19, vascular access is achieved by the needle 216 via user insertion of the needle into the patient at the insertion site.

[0050] Once the distal portion of the needle 116 is disposed within the patient's vasculature, the guide wire / dilator 220 is manually supplied through the hollow needle 216 so as to extend beyond the distal end of the needle and into the vasculature. Such advancement is achieved in this embodiment by moving the housing 212 and the catheter 42 distally together while keeping the needle hub 214 stationary. The guide wire 122 is advanced distally a suitable distance in this embodiment, including advancement until the distal end of the housing 212 reaches the skin insertion site.

[0051] Figures 20A and 20B show that after the guide wire / dilator 220 is distally extended into the vasculature, the needle 216 is retracted from the vasculature by sliding the needle hub 214 proximally along the rail portion 218A disposed on the upper housing portion 212A. As shown in Figures 21A and 21B, the proximal sliding of the needle hub 214 continues until the hub engages the rail portion 218B of the bottom housing portion 212B and slides completely to the proximal end of the housing 212. The needle hub 214 engages a lockout 230 (Figure 20B) to prevent further distal movement of the needle hub or the needle 216. In this position, the needle 216 is fully retracted into the inserter housing 212 such that the distal end of the needle is safely isolated from the user (Figure 21B). Note that in one embodiment, a needle safety component may be added to the inserter to further isolate the tip of the needle. Note that the distal portion of the guide wire / dilator 220 remains in the patient's vasculature and can separate from the needle 216 while retracting through the needle slot 226.

[0052] At this stage, the bottom housing portion 212B (Figure 22) and the upper housing portion 212A (Figure 23) are removed from the catheter 42. Next, the catheter 42 can be inserted through the insertion site and into the patient's vasculature. Note that the guide wire / dilator 220 is still disposed within the catheter tube 44, and the dilator portion assists the distal end of the catheter tube in entering the vasculature by gradually expanding the insertion site and the vasculature entry point.

[0053] As previously described, in one embodiment, the proximal portion of the catheter 42, including the hub 46 and the connected spreading legs, is covered by a sterilization bag attached to the housing 212. The sterilization bag can be removed either after the catheter can be fully inserted into the patient's vasculature or after the housing portions 212A and 212B are removed. In Figure 24, the guide wire / dilator 220 is then removed from the catheter 42, the catheter is bandaged, and it is ready for use. The guide wire / dilator 220 and other parts of the inserter 210 are discarded.

[0054] Figures 25A and 25B show details regarding a needle blunting system for isolating the distal end 316A of a hollow needle 316 according to one embodiment. As shown, the distal end 316A of the needle includes a bevel configured such that its cutting surface is disposed within the inner diameter 318 of the needle 316. Thus, a properly dimensioned guide wire 320 is extended distally beyond the distal end 316A of the needle 316, and the cutting surface of the needle is blocked near it, thus safely isolating the end of the needle from the user. Additionally, blunting the distal end 316A of the needle 316 in this way prevents the end of the needle from damaging the sensitive inner wall of the blood vessel after the tip of the needle has been inserted therein. At this point, the distal end 44A of the catheter tube 44 can then be advanced distally over the needle 316 and the guide wire 320. Figure 26 shows a bevel 316A of a needle end according to another embodiment that includes an additional fillet component 319. Such a blunting system can be utilized with one or more of the inserters described herein.

[0055] Referring now to Figure 27, which illustrates a catheter inserter 410 according to one embodiment. The inserter 410 includes a housing 412 that partially houses a catheter 42. A distally extending hollow needle 416 is disposed with the housing 412 such that the needle extends out of the distal end of the housing 412.

[0056] A guide wire advancement assembly 420 for selectively advancing a guide wire 422 is shown that includes a sliding portion 428 that slides along a track 430 defined in the housing 412. The guide wire 422 is attached to the sliding portion 428 and extends proximally within the housing 412 until it curves to form a guide wire curve portion 422A, heads towards the distal end of the housing, and enters the hollow needle 416 through its proximal end 416A for selective distal advancement beyond the distal end of the needle via user actuation of the sliding portion. Distal advancement of the guide wire 422 outside the distal end of the needle 416 stops when the guide wire curve portion 422A engages the proximal end 416A of the needle.

[0057] Also shown is a catheter advancement assembly 440 for selectively advancing catheter tube 44 over needle 416, including a sliding portion 448 that slides along track 430 and a movable platform 450 disposed within housing 412 and operably connected to sliding portion 448. Movable platform 450 is initially engaged with catheter hub 46 such that distal sliding of sliding portion 448 advances the catheter distally toward the distal housing end.

[0058] Insertion tool 410 further includes a support structure 470 for stabilizing needle 416, including two doors 472 hingedly attached to the distal end of housing 412 via pins. Doors 472 function to stabilize needle 416 while the needle is inserted into the patient. Later, when catheter tube 44 and catheter hub 46 are advanced distally by sliding portion 448, doors 472 are opened and catheter 42 can pass through the doors and be separated from insertion tool 410 by the user. In this embodiment, a wedge feature is included on the bottom surface of sliding portion 428 and is configured to push open doors 472 as sliding portion is slid distally, as described herein. Such a wedge or other suitable feature may also be included in other embodiments described herein.

[0059] After separation from insertion tool 410, catheter 42 then advances and can be left in the patient by the user, as needed. Note that although not shown, a needle safety component may be included to isolate the distal tip of needle 416. In one embodiment, distal sliding of guidewire sliding portion 428 can partially open doors 472 in preparation for catheter advancement.

[0060] FIG. 28 shows an inserter 410 including a support structure 480 according to another embodiment, with two semi-conical doors 482 hingedly connected to the housing 412 (via a living hinge or other suitable connection means) and configured to stabilize the needle 416. The movable platform of the inserter 410 in FIG. 28 is also longer than that in FIG. 27. Thus, it is understood that various different support structures and configurations can be utilized to stabilize the needle at or near its exit point from the inserter housing.

[0061] Referring now to FIGS. 29A and 29B, which illustrate a catheter inserter 510 according to one embodiment. The inserter 510 includes a housing 512 that partially surrounds a catheter 42. A hollow needle 516 extends distally from a needle hub 514 that covers the proximal end of the housing 512 such that the needle extends outside the distal end of the housing 512.

[0062] A guide wire advancement assembly 520 for selectively advancing a guide wire 522 is shown, the guide wire advancement assembly 520 including a sliding portion 528 that slides along a track 530 defined within the housing 512. The guide wire 522 is attached to the sliding portion 528 and extends proximally out of the housing 512 through a pigtail 524 attached to the proximal end of the housing 512 and through an upper hole of two holes 514A defined in the needle hub 514 and within the housing 512. Near the proximal end of the pigtail 524, the guide wire 522 curves to form a U-shaped guide wire bend 522A, extends distally back into the housing 512, and, when the sliding portion 528 is selectively actuated by a user, finally advances distally outside the distal end of the needle and into the hollow needle 516 through a bottom hole of the two holes 514A of the needle hub. Such distal advancement of the guide wire 522 outside the distal end of the needle 416 stops when the guide wire bend 522A abuts against a hole 514A defined in the needle hub 514.

[0063] Also shown is a catheter advancement assembly 540 for selectively advancing catheter tube 44 on needle 516, including a sliding portion 548 that slides along track 530 and a movable platform 550 disposed within housing 512 and operably connected to the sliding portion. Movable platform 550 can be initially engaged with catheter hub 46 to advance the catheter distally toward the distal housing end by distal sliding of sliding portion 548. In this embodiment, ridge 522B is included on guide wire 522 such that when the guide wire (guide wire advancement) sliding portion 528 is advanced distally by user actuation, the ridge advances and engages an inner portion of (catheter advancement) sliding portion 548. This in turn advances sliding portion 548, resulting in distal advancement of catheter 42. Thus, the catheter may be advanced directly via sliding portion 548 or indirectly via sliding portion 528 in one embodiment.

[0064] Insertion tool 510 further includes a support structure 570 for stabilizing needle 516, including a stopper 572 having a stopper hole 574 defined therein through which needle 516 extends. Stopper 572 is attached to sliding portion 528 via track 530 and functions to shield the distal end of housing 512 and thus stabilize needle 516 passing therethrough during insertion of the needle into the patient. Later, guide wire 522 is advanced distally by sliding portion 528 and stopper 572 also advances distally out of housing 512, thus opening the distal end of the housing and allowing catheter 42 to pass therethrough. Catheter 42 may then be separated from insertion tool 510 by the user and advanced to a final position by the user. Note that although not shown, a needle safety component may be included to isolate the distal tip of needle 516. Also note that in one embodiment, after stopper 572 is removed from its initial position in housing 512, catheter tube 44 and needle 516, no longer constrained by stopper hole 574 of the support structure, may be axially repositioned toward the center of the housing. This also applies to the embodiments of FIGS. 30 and 31.

[0065] Next, refer to FIG. 30 which illustrates a catheter introducer 610 according to one embodiment. The introducer 610 includes a housing 612 that partially surrounds a catheter 42. A hollow needle 616 extends distally from a needle hub 614 that covers the proximal end of the housing 612 such that the needle extends out of the distal end of the housing 612. The needle 616 includes a longitudinally extending proximal slot 616A that extends from the proximal end of the needle 616 to a distal end 616B of the slot.

[0066] A guide wire advancement assembly 620 for selectively advancing a guide wire 622 is shown and includes a sliding portion 628 that slides along a track 630 defined within the housing 612. The guide wire 622 is attached to the sliding portion 628 and extends proximally within the housing 612 until it curves to form a U-shaped guide wire bend 622A, travels toward the distal end of the housing, and enters the hollow needle 616 through its proximal slot 616A for selective distal advancement beyond the distal end of the needle via user actuation of the sliding portion. Note that distal advancement of the sliding portion 628 separates the sliding portion from the housing 612 while still being attached to the guide wire 622. Distal advancement of the guide wire 622 outside the distal end of the needle 616 stops when the guide wire bend 622A engages the distal end 616B of the proximal slot of the needle.

[0067] Also shown is a catheter advancement assembly 640 for selectively advancing a catheter tube 44 over the needle 616 that includes a movable platform 650 operably connected to the sliding portion 628 such that actuation of the sliding portion advances both the guide wire 622 and the movable platform 650 distally. The movable platform 650 is not initially engaged with the catheter hub 46 but engages the hub after a certain amount of distal advancement. This in turn advances the catheter 42 distally toward the distal housing end.

[0068] The inserter 610 further includes a support structure 670 for stabilizing the needle 616. The support structure 670 includes a stopper 672, and a stopper hole 674 is defined inside the stopper 672. The needle 616 extends through the stopper hole 674. The stopper 672 is attached to the sliding portion 628 via the track 630 and closes the distal end of the housing 612, and as a result, it functions to stabilize the needle 616 passing therethrough while the needle is inserted into the patient. Later, when the guide wire 622 is advanced distally by the sliding portion 628, the stopper 672 also advances distally and exits the housing 612. As a result, the distal end of the housing opens, and the catheter 42 can pass therethrough. Next, the user can separate the catheter 42 from the inserter 610 and advance it to the final position. Note that in one embodiment, the movable stage 650 may include a needle safety component for isolating the distal end of the needle 616.

[0069] Referring now to FIG. 31, which illustrates a catheter inserter 710 according to one embodiment. The inserter 710 includes a housing 712 that partially surrounds the catheter 42. A hollow needle 716 extends distally from a needle hub 714 that covers the proximal end of the housing 712 such that the needle extends outside the distal end of the housing 712.

[0070] Shown is an advancement assembly 720 for selectively advancing guidewire 722 and catheter 42. The advancement assembly 720 includes a rotatable wheel 730 that is selectively user-actuated via a filament 726 or other suitable component attached to a movable stage 750. The guidewire 722 is attached to the movable stage 750 and extends proximally out through a pigtail 724 that is attached to the proximal end of the housing 712 within the housing 712 and through one of two holes defined in the needle hub 514 (similar to hole 514A of needle hub 514 in FIGS. 29A and 29B). Near the proximal end of the pigtail 724, the guidewire 722 curves to form a U-shaped guidewire bend 722A, extends distally back into the housing 712, and enters the hollow needle 716 through the other of two holes defined in the needle hub 714 for final distal advancement out beyond the distal end of the needle when the wheel 730 is selectively actuated by the user. Such distal advancement of the guidewire 722 out beyond the distal end of the needle stops when the guidewire bend 722A abuts the above-described hole defined in the needle hub 714.

[0071] The advancement assembly 720 selectively advances the catheter tube 44 over the needle 716 and includes the aforementioned movable stage 750 disposed within the housing 712 and operably connected to the wheel 730 via a filament 726 such that rotation of the wheel advances the movable stage 750 distally. The guidewire 722, whose proximal end is attached to the movable stage 750, is also advanced distally through the needle as described above. Note that in one embodiment, due to the non-rigid filament 726 connecting the wheel to the movable stage 750, the wheel 730 ensures that the guidewire 722 can only be advanced distally and not retracted proximally.

[0072] Upon distal advancement of the movable stage 750, a movable stage that is not initially engaged with the catheter hub 46 engages the hub after a certain amount of distal advancement. This in turn advances the catheter 42 distally toward the distal housing end.

[0073] The inserter 710 includes a door 772 hingedly attached to the distal end of the housing 712 and includes a hole 774 to allow passage of the needle 716, and further includes a support structure 770 for stabilizing the needle 716. The door 772 functions to stabilize the needle 716 while the needle is inserted into the patient. Later, when the catheter tube 44 and catheter hub 46 are advanced distally by the wheel 730 and movable platform 750, the door 772 is pushed open by the hub, allowing the catheter 42 to be separated from the inserter 710 by the user. The catheter 42 may then be advanced by the user for final placement into the patient. Note that although not shown, a needle safety component may be included to isolate the distal tip of the needle 716.

[0074] Referring now to FIGS. 32A - 32I, which illustrate a catheter inserter 810 according to one embodiment. The inserter 810 includes a housing 812 that at least partially houses the catheter 42. A hollow needle 816 extends distally from a needle hub 814 contained within the housing 812 such that the needle initially extends outside the distal end of the housing 812. The needle 816 includes a distal slot 816A similar to the aforementioned needle slot 226 (FIGS. 17A - 17C) to allow a guide wire / dilator 822, similar to the guide wire / dilator 220 (FIG. 16), to be removably inserted therein. The catheter 42 is disposed on the guide wire / dilator 822.

[0075] The needle hub 814 further includes a needle retraction system 818 for selectively retracting the needle 816 into the housing 812 to isolate the distal tip of the needle from the user in a safe manner. The retraction system 818 includes a spring 819 or other suitable retraction device operably coupled to the needle 816 to effect retraction of the needle.

[0076] A forward assembly 820 for selectively advancing the guide wire / expander 822 and the catheter 42 is shown. The forward assembly 820 includes a sliding portion 828 that moves within a track 830 defined in the housing 812. The sliding portion 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 the retraction trigger 880 of the needle retraction system 818 as described. The hub 46 of the catheter 42 disposed within the housing 812 has a cap 834 that includes a protrusion 836 for engaging the upper teeth 826 of the ratchet bar 824, which is removably attached thereto.

[0077] The inserter 810 further includes a support structure 870 for stabilizing the needle 816, including a housing bore 872 defined by the distal end of the housing 812. The housing bore 872 is dimensioned to provide stability to the needle 816 at its exit point from the housing.

[0078] Figures 32A - 32I show various stages of use of the inserter 810 when inserting a catheter into a patient. In the inserter 810 configured as shown in Figure 32A, vascular access is achieved by the needle 816 via user insertion of the needle into the patient at the insertion site. Blood flashback can be observed through the distal slot 816A of the needle 816 to confirm proper positioning of the distal end of the needle within the patient's vasculature. As shown in Figure 32B, the sliding portion 828 is slid distally to advance the guide wire / dilator 822, the distal portion of which is pre - disposed within the needle 816 through the distal slot 816A and exits the distal end of the needle and enters the patient's vasculature. As shown, the guide wire / dilator 822 is advanced indirectly by a ratchet bar 824 moved by the sliding portion 828. In particular, the proximal teeth of the upper teeth 826 of the ratchet bar 824 engage the protrusion 836 of the cap 834 that fits with the catheter hub 46. Thus, when the sliding portion 828 and the ratchet bar 824 are moved distally, as shown in Figure 32B, the catheter 42 and the guide wire / dilator 822 disposed therein are also moved distally. Similar ratchet movement occurs in successive steps.

[0079] The sliding of the sliding portion 828 at the stage shown in Figure 32B also engages the retraction trigger 880 of the needle retraction system 818 with the bottom teeth 826A of the ratchet bar 824. This in turn enables the needle 816 and the retraction system 818 to be retracted into the housing 812 such that the spring 819 expands and the distal tip of the needle is isolated from the user within the housing.

[0080] Figure 32C shows that the sliding portion 828 returns to its initial position, which causes the ratchet bar 824 to also return to its initial position. However, since the protrusion 836 of the cap 834 attached to the catheter hub 46 is angled distally, the teeth 826 of the ratchet bar slide past without retracting the catheter 42, and the catheter remains in a fixed position.

[0081] In FIG. 32D, the sliding portion 828 is similarly advanced distally, which engages the cap projection 836 with the proximal upper teeth 826 of the ratchet bar 824, further advancing the guide wire / dilator 822 distally into the vessel. Since it is disposed on the guide wire / dilator 822, the catheter 42 at this or successive stages is also advanced into the vessel, depending on the length of the catheter, the distance to the insertion site, etc. The sliding portion 828 is later retracted to its initial position as shown in FIG. 32E. Note that the retraction of the ratchet can be actuated by the user or automatically by a suitable system included in the introducer 810.

[0082] In FIG. 32F, the sliding portion 828 and the ratchet bar 824 are similarly advanced distally, resulting in further distal advancement of the guide wire / dilator 822 and the housing 812 of the catheter 42 outwards. The sliding portion 828 is later retracted to its initial position as shown in FIG. 32G. In FIG. 32H, the sliding portion 828 and the ratchet bar 824 are finally advanced distally, resulting in substantially complete distal advancement of the guide wire / dilator 822 and the attached catheter 42 from the housing 812 of the introducer 810. At this stage, the hub 46 of the catheter 42 is grasped, the catheter is removed from the introducer 810, and the introducer 810 may later be discarded. Next, the final positioning of the catheter 43 within the vessel can be manually performed by the user. The cap 834 is also removed from the catheter hub 46.

[0083] Figures 33A - 33C show details of a needle safety component for isolating the distal end 16A of the needle 16, which includes the distal notch 18 described above in connection with FIGS. 1A - 10C according to one embodiment. As shown, a safety housing 954 including a hinged door is included to straddle the needle 16. Two needle safety components 956 are disposed opposite each other within the safety housing 954, each also straddling the needle 16. Each needle safety component includes a base 958 defining a hole through which the needle 16 passes and a plurality of arms 960. The arms 960 extend from the base 958 and converge towards each other in a conical fashion such that the end of each arm abuts the surface of the needle. 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 component 956. In particular, each arm 960 compressively engages the outer surface of the needle 16 such that when one of the arms faces the needle notch 18, the arm drops slightly into the notch to lock the needle 16 in place relative to the needle safety component 956. The two needle safety components 956 are disposed within the safety housing 954 to prevent further movement of the needle in either the distal or proximal direction. Thus, the distal end 16A of the needle 16 is safely isolated within the safety housing 954 as seen in FIGS. 33A - 33C. Note that the needle safety components described herein are useful for isolating the needle even when, for example, as seen in FIG. 33C, the guide wire 22 still extends therethrough.

[0084] In other embodiments, as described above, only one needle safety component may be used. Thus, the needle safety components described herein serve as an example of the function of various needle safety components that may be utilized in connection with the present disclosure.

[0085] In one embodiment, it is understood that the introducer may include a sterile sheath or bag disposed on the distal portion of the catheter extending distally from the introducer housing to isolate the catheter. A needle pre-disposed within the catheter and retractable within the introducer housing can extend from the bag to obtain vascular access. The bag can then be compressed toward the housing as the catheter advances into the vascular structure and then discarded once the catheter is fully inserted. In one embodiment, the bag may include a gripping wing or other device to assist in grasping the catheter or needle through the bag during insertion. It is further noted that the introducer described herein may include a cap or other protective device removably attached to the introducer prior to use to maintain the sterility of the needle and catheter.

[0086] Referring now to FIG. 34, which shows an exploded view of a catheter introducer 10 according to one embodiment, including components similar to those already described above. Accordingly, only the selected differences will be described below.

[0087] FIG. 34 shows that in this embodiment, the guide wire 22 is looped back on itself such that it substantially defines a U-shaped configuration. FIGS. 36A and 36B show the manner in which the guide wire 22 is disposed within the housing 12 of the catheter insertion device 10. In particular, these figures show that the proximal end of the guide wire 22 is fixed to a fixed point 982 on a part of the device 10, namely, the upper portion 12A of the housing 12. FIG. 37 shows that the guide wire 22 extends proximally and removably within a guide channel 984 defined on the inner surface of the upper housing portion 12A. FIGS. 36A and 36B show that the intermediate portion of the guide wire 22 is looped back on itself in the vicinity of the proximal end of the device 10. A guide surface 980 (FIG. 35) disposed near the proximal end of the guide wire lever 24 constrains the flexible guide wire 22 into a curved, substantially U-shaped configuration. Next, the intermediate portion of the guide wire 22 that loops back extends toward the distal end of the device 10 along a channel 986 defined on the inner surface of the bottom housing portion 12B of the housing 12 before entering the hollow needle 16, as best seen in FIG. 38. The free distal end of the guide wire 22 is initially present within the needle 16.

[0088] Disposed as described immediately above, the guide wire 22 is positioned for selective advancement by the guide wire advancement assembly 20 such that its free distal end can extend distally from the open distal tip of the needle 16. This selective advancement of the guide wire 22 is achieved in this embodiment via distal movement of a guide wire advancement slider 28 included on the housing 12 of the device. The distal movement of the guide wire advancement slider 28 results in a corresponding distal sliding movement of the guide wire lever 24. The guide surface 980 of the guide wire lever 24 pushes the curved portion of the guide wire 22 distally as the lever advances. Note that the guide wire 22 is sufficiently rigid to be advanced by the guide wire lever 24 without buckling. Also, the guide surface 980 and the guide wire 22 are configured such that when the guide wire advancement slider 28 or other suitable mechanism is slid proximally, the guide wire 22 can be retracted back into the insertion tool housing 12.

[0089] This pushing movement of the slidable guide wire lever 24 distally extends the distal end of the guide wire 22 from the open distal tip of the needle 16. Due to its fixed proximal end at the fixed point 982 and its curved or looped U-shaped configuration, the guide wire 22 is advanced distally at approximately twice the sliding speed of the guide wire advancing slider 28 and at approximately twice the speed of the guide wire advancing speed in the device configurations of FIGS. 1A-9, which results in approximately twice the length of the guide wire extension compared to the length of the movement of the guide wire advancing slider 28. This, further preferably, results in a relatively long length of the guide wire extending into a vein or other patient's vasculature so as to more appropriately guide the catheter 42 into the patient's body. Thus, the guide wire and advancing assembly described herein operates as a type of "reverse pulley" system for the advancement of the distal guide wire. Note that in addition to what is shown and described herein, other loop configurations of the guide wire may be included in the device 10. Also, different ratios of guide wire extension to advancing assembly movement are possible in other embodiments.

[0090] Note that the loop conduit and guide wire advancing handle are merely examples of structures that can appropriately perform the desired functions described herein. In fact, other structures may be utilized to achieve the principles described in connection with this embodiment. Also, although shown and described above as being attached to the housing of the catheter insertion device, the proximal end of the guide wire may be attached to other structural parts within / on the device, such as the needle hub 14 for example. The main length of the guide wire in one embodiment includes a nickel-titanium metal alloy commonly referred to as nitinol, which is sufficiently rigid and can be arranged in a U-shaped configuration without maintaining its position memory when the guide wire is advanced. Note that other suitable guide wire materials may also be utilized.

[0091] Figures 39A and 39B show various details regarding the coupling element 80 of the needle safety component 56 described further above for shielding the distal tip of the needle 16 once catheter insertion is complete. As shown, the coupling element 80 (also referred to herein as a coupling member) includes a front plate 992 that defines a hole 992A and a fork-shaped rear plate 994. A protrusion 996 extends from one of the forks of the rear plate 994. A U-shaped needle passage element 998 is also included and is spaced from the front plate 992, defining a hole 998A that is coaxially aligned with the hole 992A in the front plate.

[0092] A friction element 1000, also referred to herein as a friction member, is also included in this embodiment with the coupling element 80, namely an annular elastomeric element or O-ring 1002, as seen in Figures 40A and 40B. As shown, the O-ring 1002 is configured to wrap around both a portion of the needle 16 and the fork-shaped rear plate 994. The protrusion 996 is utilized to assist in maintaining the O-ring 1002 in a fixed position, as shown in Figures 40A and 40B. By positioning the O-ring 1002 in this manner, a relatively constant biasing force is imparted by the O-ring to the coupling element 80 for use in shielding the distal tip of the needle 16, as further described below. Note that the elastomeric element serves the same function but takes a form other than an O-ring. For example, a rod or a single elastomeric material wrapped around a portion of the coupling element and the needle may also be utilized.

[0093] Figures 40C and 40D show the coupling element 80 disposed within a movable stage 1008 and in turn within the safety housing 54. As shown, the movable stage 1008 defines two restraint surfaces 1010 where a corresponding portion of the front plate 992 of the coupling element is initially placed when the needle 16 initially extends through the movable stage and the coupling element. A retaining ring 1008A through which the needle 16 slidably passes enables the needle to engage the movable stage 1008.

[0094] The coupling element 80 is initially disposed slidably with the needle 16 in the state shown in FIGS. 40A - 40D (showing the coupling element before shielding the distal tip of the needle) so as to allow relative sliding movement between the needle and the coupling element. The passage of the needle 16 through the hole 998A of the needle passage element 998 initially limits the tilting movement of the coupling element 80.

[0095] The needle 16 also passes through the hole 992A of the front plate 992 such that the needle straddles the fork of the fork - type rear plate 994. As already described, the O - ring 1002 is disposed around the needle 16 and the rear plate 994 so as to provide a resistance force when the movable stage 1008 and the coupling element 80 (both housed within the safety housing 54 (FIG. 34)) are slid distally along the length of the needle 16 during use of the device 10. The resistance force provided by the O - ring 1002 during such distal sliding, in turn, imparts a rotational moment (due to the force provided through the contact of the coupling element with the O - ring) to the coupling element 80 to encourage a clockwise movement rotation from the perspective of the view shown in FIG. 40C.

[0096] Such clockwise rotation of the coupling element 80 is blocked by the needle passage feature 998 while the needle 16 extends through the coupling element. However, once the safety housing 54 that houses the movable stage 1008 and the coupling element 80 has slid distally a sufficient distance such that the needle passage element 998 passes beyond and disengages from the distal end of the needle 16, the coupling element is no longer constrained, and the resistance force provided by the O - ring 1002 tilts the coupling element clockwise with respect to the needle from the perspective of the view shown in FIG. 40C. This tilt locks the movement of the coupling element 80 and thus the movable stage 1008 with respect to the needle 16 by the physical coupling between the outer surface of the needle 16 and the outer periphery of the hole 992A of the front plate (thus, this functions as a coupling surface). The distal tip of the needle 16, safely disposed within the locked movable stage 1008, thus protects the user from accidental needle punctures.

[0097] As described above, the O-ring 1002 applies a relatively constant biasing force to tilt the coupling element (after retracting the distal tip of the needle into the movable base as described above) in order to more securely lock the movable base 1008 on the distal tip of the needle 16. This constant biasing force is beneficial, for example, to ensure that the coupling element does not return to an orientation where the needle passage feature 998 can re-engage the needle 16 and unlock the needle safety component 56 after being locked on the distal tip of the needle, when the needle 16 is pushed back and forth relative to the safety housing 54 / movable base 1008. Note that the O-ring 1002 can be utilized with needles and coupling elements that are larger or smaller than those shown and described herein.

[0098] The O-ring 1002 of the above-described embodiments is sufficiently flexible to extend over the foregoing structure while applying the desired 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, etc. In one embodiment, the O-ring material is selected to provide sufficient tear resistance, the ability to impart the desired friction, and chemical compatibility. The size of the O-ring can vary depending on the size and configuration of the coupling element and the needle. In other embodiments, the O-ring can include other shapes, materials, and locations while still providing the intended function.

[0099] FIG. 41A shows that the guide wire lever 24 may include a catheter advancement feature that can advance the catheter 42 distally in addition to advancing the guide wire 22 as described above. In this embodiment, the catheter advancement feature is disposed on the proximal portion 24A of the guide wire lever 24 and is arranged to physically engage the cap 58 of the safety housing 54 when the guide wire lever 24 is moved distally via distal sliding of the sliding portion 28 by the user (FIG. 34). Such engagement is shown in FIG. 41B. Further distal movement of the guide wire lever 24 results, albeit indirectly, in distal advancement of the safety housing 54 and the catheter 42, which are operably attached thereto (FIG. 34). The sliding portion 28 of this embodiment can be slid to advance the catheter 42 distally by a predetermined distance via the advancement tab 1014 of the guide wire lever 24. In one embodiment, the predetermined distance advances the catheter 42 until its distal end advances distally over the distal tip of the needle 16. Further distal advancement of the catheter 42 can be achieved via distal sliding of the handle 48 as needed (FIG. 34). In another embodiment, the sliding portion 28 is configured to advance the catheter the full distal distance required via the advancement tab 1014.

[0100] The position of the advancement tab 1014 in FIG. 41A is such as to provide a stepwise advancement of the guide wire 22 and the catheter 42. In particular, distal advancement of the guide wire lever 24 from the position shown in FIG. 41A results in immediate advancement of the guide wire 22, while the safety housing 54 and the catheter 42 remain in place. Further distal advancement of the guide wire lever 24 to the position shown in FIG. 41B engages and advances distally the advancement tab 1014 with the safety housing 54 and the catheter 42 while continuing to advance the guide wire 22 distally, as described above.

[0101] Thus, in addition to advancing the guidewire 22 distally out through the needle 16, the guidewire lever 24 can also advance the catheter 42 distally along the needle 16 and into the patient's vasculature, as further described above. Note that the particular shape and configuration of the advancement tab 1014 can differ from that shown and described herein, along with the safety housing and / or the way it engages the catheter, and the scale of movement imparted to them.

[0102] Figures 42 and 43 show details of a guidewire 22 configured according to one embodiment. As shown in Figure 42, the guidewire 22 includes an elongate core wire 1102 that includes a small-diameter distal portion 1104. The outer coil 1108 extends proximally around the core wire 1102 from its distal end 1102B. The stiffening sleeve 1110 is disposed around the core wire 1102 proximate and adjacent to the coil 1108 within the small-diameter distal portion 1104. The stiffening sleeve 1110 can be fixed to the core wire 1102 by adhesion, welding, press-fitting, or another method.

[0103] A portion of the guidewire 22 that includes the coil 1108 is designed to be relatively flexible so as to non-invasively enter a patient's vein or other vasculature and guide the catheter 42 into the vein during insertion of the catheter using the inserter described herein. In contrast, a portion of the guidewire 22 that includes the stiffening sleeve 1110 is relatively rigid. As seen in FIG. 43, the stiffening sleeve 1110 is positioned such that it is disposed adjacent to the distal tip 16B of the needle 16 of the inserter when the guidewire 22 is fully extended during use of the inserter. Together with the notched ramp on the back of the needle distal tip 16B, the stiffening sleeve 1110 effectively bluntsthe needle distal tip, thus preventing inadvertent piercing or shearing of the catheter tube 44 by the needle distal tip during insertion of the catheter into the vein. The stiffening sleeve 1110 may be dimensioned to substantially occupy the entire diameter of the lumen of the needle at the distal tip 16B so as to effectively prevent the needle distal tip from having the potential to pierce the catheter tube 44 even when the catheter tube is retracted while disposed over the needle or when the needle is reinserted into the catheter tube. Note that in another embodiment, the core wire itself may be used to blunt the needle distal tip. In one embodiment, the coil 1108 may include platinum, stainless steel, titanium, nitinol, or other materials having suitable tensile strength and formability. In one embodiment, the stiffening sleeve 1110 includes stainless steel, titanium, a high-rigidity thermoplastic material, or other suitable materials, and the core wire 1102 includes nitinol, although other suitable materials may be used for these and other related components.

[0104] FIG. 42 further shows that the core wire 1102 of the guidewire 22 may include a notch 1112 disposed proximally to the distal portion 1104 of the core wire. The notch 1112 functions as a relatively weak point for preferential breaking of the guidewire 22 at the notch in the event the guidewire is subjected to excessive physical force. By breaking at the notch 1112, the severed distal segment of the guidewire is large enough so as not to embolize within the patient's vasculature and can be easily removed manually from the body. The specific location of the notch on the guidewire may vary.

[0105] FIG. 44 shows that in one embodiment, the distal end of the catheter tube 44 of the inserter catheter 42 may include a reinforcing component 1118 disposed substantially at the distal end 44A of the catheter tube. As shown in FIG. 44, the reinforcing component 1118 here includes an annular sleeve that defines the distal end 44A of the catheter tube 44. The reinforcing component 1118, including an effectively rigid material such as aromatic polyurethane, carbothane, isoplast, pebax, nylon, or other suitable medical grade thermoplastic material, metal (including stainless steel, titanium, nitinol, etc.), is positioned and designed to prevent the distal end 44A of the catheter tube 44 from collapsing during fluid aspiration through the lumen 1114 of the catheter tube after the catheter 42 is placed within a patient's vasculature. In one embodiment, the reinforcing component 1118 includes a material that does not soften at body temperature, has a melting temperature similar to that of the material of the catheter tube 44, and is biocompatible. In one embodiment, the reinforcing component 1118 includes a material having a hardness of about 60D to about 75D Shore hardness, although other hardness ratings are possible. In another embodiment, the reinforcing component 1118 may include a radiopaque agent such as bismuth trioxide, barium sulfate, etc. to enhance the radiopacity of the distal end 44A of the catheter tube 44.

[0106] Figures 45A and 45B show details regarding the manufacture of the catheter tube 44 of FIG. 44 according to one embodiment, although other techniques can be utilized. As shown, during manufacture, the formed mandrel 1120 is disposed within the lumen 1114 of the catheter tube 44. The pre-formed annular reinforcement component 1118 is interposed between the mandrel and the catheter tube 44 and is disposed around the tip portion 1122 of the mandrel 1120 such that its distal end 44A is substantially co-terminal. In other embodiments, the reinforcement component 1118 can also be positioned to result in a finished reinforcement component position that terminates proximally to the distal end 44A of the catheter tube 44 that is either co-terminal with it or distal to it, such as to match a desired reinforcement profile or to address processing parameters.

[0107] Next, the tipping die 1124 is placed on the distal end of the catheter tube 44 and a radio frequency (「RF」) tip forming process is performed to form the distal end of the catheter tube with the reinforcement component 1118 contained therein. This is shown in FIG. 44. A plug 1126 of excess material often results from the tip forming process and can be discarded. In addition to this, other processes can be utilized to form the reinforcement structure along with the distal end of the catheter tube.

[0108] For example, other embodiments of the reinforcement structure of the distal end 44A of the catheter tube 44 are possible, such as the reinforcement component 1118 shown in FIGS. 46 and 47A. FIG. 47B shows another embodiment where the reinforcement component 1118 is recessed proximally from the distal end of the catheter tube 44. That is, it illustrates that in one embodiment it is not necessary to place the reinforcement component at the distal end of the catheter tube. Thus, these and other reinforcement designs are accordingly contemplated.

[0109] Figures 48A - 48F show further details of the inserter 10 according to another embodiment. As shown in Figure 48A, the inserter 10 includes upper and bottom housing portions 12A, 12B of a housing 12 that extends from a catheter 42 disposed on a needle 16. Also shown are a finger pad 1218 of a guide wire advancement assembly 20 slidably disposed within a slot 1236 defined in the upper housing portion 12A, and a portion of a handle assembly 1220 of a catheter advancement assembly 40. Further details of this inserter 10 according to this embodiment and its various details are shown below.

[0110] Figures 48A - 48F show that in order to enable selective advancement of a guide wire 22 (initially disposed within the lumen of the needle 16) beyond the distal end 16B of the needle 16, a finger pad 1218 as part of the guide wire advancement assembly 20 can be slid distally along a slot 1236 by a user's finger. As previously described, the proximal end of the guide wire 22 is attached to an inner portion of the upper housing portion 12A such that distal sliding advancement of a single unit finger pad 1218 results in advancement of two units of the distal guide wire. As previously described, this is made possible by looping the guide wire 22 from its attachment point on the upper housing portion 12A and through a guide surface 980 included on a guide wire lever 24 (Figures 53A and 53B) before extending into the lumen of the needle 16. Note that in this embodiment, the guide wire lever 24 and finger pad 1218 of the guide wire advancement assembly 20 are integrally formed with each other, although they can be formed separately in other embodiments. Also note that the guide wire 22 can be attached to other external or internal portions of the inserter 10, including the bottom housing portion 12B, the needle hub 1214, etc.

[0111] Figures 48A - 48F further show that a catheter advancement assembly 40 for selectively advancing catheter 42 in a distal direction out of housing 12 of inserter 10 includes a handle assembly 1220 which, among other components, in turn includes two wings 1280 that are grasped by a user's fingers when the catheter is advanced. As will be discussed in more detail below, wings 1280 advance distally through a gap 1250 defined between an upper housing portion 12A and a lower housing portion 12B.

[0112] The upper and lower housing portions 12A, 12B are fitted together via the engagement of four tabs 1230 (Figs. 48D, 49) of the upper housing portion with four corresponding recesses 1232 located on the lower housing portion. Of course, other fitting mechanisms and methods for joining the upper and lower housing portions together may be utilized.

[0113] The exploded view of inserter 10 in Fig. 49 shows that handle assembly 1220 includes a head portion 1222 and a tail portion 1224 extending from wings 1280. Both the head portion 1222 and the tail portion 1224 are removably attached to catheter hub 46 as will be discussed further below. The internal components of inserter 10 disposed within housing 12 through which each of them is passed by needle 16 include a safety housing 54 in which a valve 52, a movable stage 1008 and a needle safety component 56 are disposed, and a cap 58 for the safety housing. An O - ring 1002 included in the needle safety component 56 is also shown, such as a needle hub 1214 fixed to the proximal end of needle 16 and attached to housing 12 to fix needle 16 in a fixed position within inserter 10. Note that in Fig. 49, in one embodiment, slot 1236 in which a finger pad of guide wire advancement assembly 20 is disposed includes a relatively wide portion through which guide wire lever 24 can be inserted to couple the guide wire advancement assembly to housing 12.

[0114] Figures 50A and 50B show various details regarding a stabilization structure 70 for supporting and stabilizing the needle 16 at its exit point from the housing 12 according to the present embodiment. As shown, proximal portions of the upper and bottom housings 12A, 12B engage with each other to provide the stabilization structure 70 to the needle 16. The bottom housing portion 12B includes two distally disposed arms 1248 separated by a slot 1246 that can separate from each other when the arms are unconstrained. The upper housing portion 12A defines a distal slot 1240 and a U-shaped feature 1242 distal to the slot. Considering the downward curvature of the upper housing portion 12A (see FIG. 48C), the slot 1240 allows the arms 1248 of the bottom housing portion 12B to project upward through the slot to surround and support the needle 16 for stabilization. The U-shaped feature 1242 is disposed around the needle 16 at the distal ends of the bottom housing arms 1248 and functions as a collar to stabilize the needle.

[0115] The arms 1248 of the bottom housing portion 12B are configured to move back and forth in the x-direction by the x - y axes shown in FIGS. 50A and 50B, while remaining substantially rigid in the y-direction. Conversely, the distal portion of the upper housing portion 12A including the slot 1240 and the U-shaped feature 1242 is configured to bend in the y-direction by the x - y axes shown in FIGS. 50A and 50B, while remaining substantially rigid in the x-direction. Thus, when overlapping or engaging with each other as shown in FIGS. 50A and 50B, the components of the aforementioned stabilization structure 70 cooperate to support the needle 16 and prevent its substantial movement when the housing 12 is in the configuration shown in FIGS. 50A and 50B, i.e., before the catheter 42 is removed from the housing 12. This in turn assists the user when accurately puncturing the skin to access the patient's vasculature. It is understood that the stabilization structure may include other components for stabilizing the needle in addition to those explicitly described herein.

[0116] Figures 51-54 show various details regarding the catheter advancement assembly 40 and the guidewire advancement assembly 20 according to this embodiment. As previously discussed, the catheter advancement assembly 40 includes a handle assembly 1220, which in turn includes a head portion 1222 having corresponding wings 1280, and a tail portion 1224 disposed around a portion of the catheter hub 46 and the safety housing 54. As further discussed below, the handle assembly 1220 is utilized when advancing the catheter 42 distally and removing it from the introducer 10.

[0117] Figures 51-54 further show the finger pad 1218 and the guidewire lever 24 of the guidewire advancement assembly 20 of this embodiment. As shown, the guidewire lever 24 extends proximally from the finger pad 1218 and includes the previously discussed guide surface 980 on its proximal end for guiding a loop of the guidewire 22. An actuation block 1258 is also included near the proximal end of the guidewire lever 24 for use when enabling catheter advancement, as further described below. It should be noted that the specific size, shape, and other configurations of the actuation block may differ from those shown and described herein while maintaining the desired function.

[0118] The spring arm 1260 extends downwardly from the guidewire lever 24 and is configured to be slidably maintained between two guide posts 1264 of the needle hub 1214, as best seen in FIGS. 53A and 53B. The spring arm 1260 is utilized to lock further movement of the guidewire advancement assembly 20 when the guidewire 22 extends completely distally from the introducer 10 and the catheter 43 has advanced an incremental amount. In particular, distal sliding of the finger pad 1218 by the user also moves the guidewire lever 24 distally, which in turn advances the guidewire 22 (which loops internally within the needle lumen, beyond the guide surface 980 of the guidewire lever 24 and beyond the distal end 16B of the needle) distally through the lumen of the needle 16, as seen in FIG. 54.

[0119] As shown in FIG. 54, when the finger pad 1218 and the guide wire lever 24 have advanced completely distally, the free end of the spring arm 1260 is positioned directly above the pocket 1266 defined between the guide posts 1264 of the needle hub 1214, as shown in FIG. 53B. Due to the position of the safety housing 54 adjacent and proximal to the needle hub 1214 at this stage (as well as the catheter 42 and the attached safety housing, which are still not advanced distally through the distal advancement of the catheter advancement assembly 40 and are thus in their initial seating positions), the free end of the spring arm 1260 cannot yet seat in the pocket 1266. However, when the catheter 42 advances distally by an incremental distance, the attached safety housing 54 no longer impedes the downward movement of the spring arm 1260, and its free end seats within the pocket 1266 of the needle hub 1214. Further distal movement of the guide wire advancement assembly 20 is blocked by the finger pad 1218 abutting against the distal end of the slot 1236, while proximal movement is blocked by seating the spring arm in the pocket 1266 of the needle hub.

[0120] Note that the finger pad 1218 includes, adjacent to its distal end and on its underside, a protrusion 1254 that engages a recess 1252 defined on the upper housing portion 12A when the finger pad is advanced completely distally. This aids in keeping the finger pad 1218 seated in its distal position and provides a tactile cue that the finger pad has been advanced completely distally.

[0121] Note also that when the catheter advancement assembly 40 returns proximally to its initial position (as shown in FIG. 52), the safety housing 54 abuts against the needle hub 1214 again, pushing the free end of the spring arm 1260 upward and out of the pocket 1266. This in turn enables the guide wire advancement assembly 20 to move proximally and distally again, resulting in corresponding proximal and distal advancement of the guide wire 22 itself. Thus, the lock on the guide wire advancement is reversible in this embodiment.

[0122] In another embodiment, for example, in order to release the spring arm 1260 from the pocket 1266 of the needle hub, such as by pressing a button, it is understood that a push button may be included in the guide wire advancement assembly 20 so that the guide wire can be newly extended or retracted after the lock of the guide wire has occurred initially. Thus, these and other variations are contemplated.

[0123] Figures 55-56C show that, according to this embodiment, as described herein, the inserter 10 further includes a lock on catheter movement prior to distal advancement of the guide wire 22 as described above. Specifically, FIGS. 55 and 56A show their initial positions within the inserter housing 12, i.e., the handle assembly 1220 of the guide wire advancement assembly 20 and the catheter advancement assembly 40 prior to advancement of the distal guide wire and distal advancement of the catheter. In this position, the two spring arms 1272 of the tail portion 1224 are positioned such that the guide posts 1264 on both sides of the needle hub 1214 seat within the respective notches 1274 of the spring arms, as best seen in FIG. 56A. In this position, the movement of the tail portion 1224 is blocked. Considering the attachment of the tail portion 1224 to the hub 46 of the catheter 42, this also blocks the distal advancement of the catheter or any other part of the catheter advancement assembly 40.

[0124] As seen in FIGS. 56A and 56B, the distal advancement of the guide wire lever 24 engages the inclined surface 1276 of each spring arm 1272 with its actuating block 1258. As best seen in FIG. 56B, as the guide wire lever 24 continues to move distally, it spreads the spring arms 1272 against the actuating block 1258, which releases the guide post 1264 from the notch 1274 of the spring arm. The actuating block 1258 affects the guide post 1264 as seen in FIG. 56B when the guide wire 22 has advanced fully distally and the free end of the spring arm 1260 of the guide wire lever 24 is positioned directly above the pocket 1266 of the needle hub 1214, as described above with respect to FIGS. 52 - 54. At this point, the spring arms 1272 of the tail portion 1224 are released from the guide post 1264 of the needle hub 1214, thus enabling distal catheter advancement as shown by the distal movement of the spring arms in FIG. 56C. Also, as described above with respect to FIGS. 52 - 54, this distal catheter advancement correspondingly moves distally the safety housing 54 attached to the catheter 42. The movement of the safety housing fits the free end of the spring arm 1260 of the distally advanced guide wire lever 24 into the pocket 1266 of the needle hub 1214, locking further movement of the guide wire 22 and preventing the safety housing from returning to its initial position adjacent to the needle hub.

[0125] Thus, it can be seen that the configuration of the inserter 10 of this embodiment prevents distal movement of the catheter 42 until full distal extension of the guide wire 22 occurs. Also, further movement of the guide wire 22 is blocked while the catheter 42 is advancing at least gradually distally from its original proximal position. In another embodiment, an increment of distal advancement of the guide wire may enable catheter advancement.

[0126] In yet another embodiment, the lock of the guide wire movement becomes permanent after complete distal advancement. This can be achieved in one embodiment by configuring the spring arm 1260 of the guide wire lever 24 and the pocket 1266 of the needle hub 1214 not to interact with the safety housing 54, so that once the free end of the spring arm 1260 seats within the pocket 1266 of the needle hub, it remains seated permanently. In another embodiment, the lock of the catheter movement is made after complete distal catheter advancement. In yet another embodiment, the guide wire and / or catheter advancement can be achieved via a ratchet mechanism.

[0127] In another embodiment, the ability to advance the catheter is independent of the advancement of the guide wire. In yet another embodiment, the spring arm 1260 of the guide wire lever 24 may be removed so that no lock of the guide wire advancement assembly 20 occurs. In turn, this allows for the locking of the catheter advancement until complete distal advancement of the guide wire occurs. Thus, these and other variations are contemplated.

[0128] Figures 57A and 57B show various details regarding the distal advancement of catheter 42 from inserter 10. As shown, when guide wire advancement assembly 20 advances guide wire 22 distally such that it extends beyond distal end 16B of needle 16, catheter advancement assembly 40 is freely available for advancing catheter 42 distally out of the distal end of inserter housing 12 (as described above with respect to FIGS. 55 - 56C). Catheter 42 is advanced by a user grasping one or both of wings 1280 of head portion 1222 of handle assembly 1220 and moving the wings distally. Note that ridge portion 1282 (FIG. 50B) is included to assist the user when grasping wings 1280. Wings 1280 slide distally within gap 1250 defined between the upper housing portion and the lower housing portion. Assuming that wings 1280 are attached to head portion 1222 which in turn is attached to hub 46 of catheter 42, the distal sliding of the wings advances the catheter distally.

[0129] Figures 57A and 57B show that when catheter 42 advances distally, the distal movement of wings 1280 causes the wings to abut against upper housing portion 12A and push upper housing portion 12A upward, which in turn lifts the distal portion of the upper housing portion including slot 1240 and U - shaped feature 1242 of stable structure 70. Lifting slot 1240 releases arm 1248 of lower housing portion 12B from the slot, thus allowing the arm to spread. Figures 57A and 57B show that two posts 1286 (see also FIG. 60) disposed on head portion 1222 of handle assembly 1220 push against each of arms 1248 when the catheter advances distally, causing the arms to separate. This separation of arms 1248, along with the lifting by wings 1280 of the upper housing portion, enables catheter 42 to pass through the distal end of housing 12.

[0130] Figures 58 and 59 show the removal of the catheter 42 and the catheter advancement assembly 40 from the insertion tool housing 12. By the user grasping and advancing the wing 1280 to continue the distal advancement of the head portion 1222, the catheter 42 removably attached to the catheter hub 46, the handle assembly 1220 (including the head portion 1222 and the tail portion 1224), and the safety housing 54 slide distally along the needle 16 and out of the housing 12. This operation is performed, for example, after the needle 16 and the guide wire 22 cooperate to provide a path into the vasculature to advance the catheter tube 44 into the patient's vasculature.

[0131] Figure 59 shows that as the catheter 42 and the handle assembly 1220 further separate from the housing 12, the safety housing 54 reaches the distal end 16B of the needle 16. At that point, the needle safety component 56 (Figure 49) disposed within the safety housing engages the distal tip of the needle to prevent accidental needle puncture by the user, and the safety housing is removed laterally from the catheter hub 46 and remains with the needle.

[0132] FIG. 60 shows various features of a handle assembly 1220 including a head portion 1222 and a tail portion 1224. After separation of the safety housing 54 and the catheter 42 with the needle 16 from the handle assembly 1220, the head portion 1222 and the tail portion 1224 remain attached to the needle hub 46 and its corresponding relaxation fitting 47 via clip arms 1300 and 1304, respectively. At this point, the head portion 1222 may be removed from the catheter hub 46 / relaxation fitting 47 by the user's hand to release the friction fit of the clip arm 1300. The tail portion 1224 including a loop 1306 disposed around the valve 52 can also be removed by the user pulling and twisting to release the friction fit of the clip arm 1304 and avoid the threads of the catheter hub 46. This operation removes the valve 52 (see FIG. 49) attached to the tail portion 1224. In another embodiment, the loop 1306 of the tail portion is configured such that the valve 52 is exposed after the tail portion 1224 is removed, enabling removal of the valve by the user when desired. Once the head portion 1222 and the tail portion 1224 of the handle assembly 1220 are removed from the catheter 42, the catheter can be bandaged and used as desired.

[0133] The handle assembly 1220 can be configured in other ways in addition to those described above. FIGS. 61 and 62 show an example of the handle assembly 1220 where the head portion and the tail portion are integrated into a single body 1312. As shown in FIG. 62, this allows the safety housing 54 to be removed laterally from the handle assembly 1220, after which the catheter hub 46 can be removed vertically therefrom. FIG. 63 includes a similar configuration of the handle assembly 1220 where the valve 52 includes opposing extensions 1316 which, when gripped (after the safety housing 54 has been removed laterally), allow the handle assembly 1220 to be removed vertically. These operations leave the valve 52 and the extensions 1316 attached to the hub 46 of the catheter 42, at which point the valve may be removed laterally from the hub using the extensions if desired.

[0134] In FIG. 64, the handle assembly 1220 includes a unitary body that defines a living hinge 1320 disposed just distal to the loop 1306, although other positions of the living hinge are possible. Note that the loop 1306 captures the valve 52. In one embodiment, the valve 52 is formed integrally with or attached to the handle assembly body. In another embodiment, the valve 52 is separated from the handle assembly 1220 and is not affected by the removal of the handle assembly 1220. The handle assembly 1220 further includes a clip arm 1304 that is removably attached to the catheter hub 46 to fixedly position the catheter 42. The post 1286 is also included on the handle assembly 1220 as in previous embodiments.

[0135] As shown in FIG. 65, the wing 1280 can be grasped to arcuately pull the distal portion of the handle assembly 1220 proximally, which in turn releases the clip arm 1304 and the post 1286 from the catheter hub 46, allowing the handle assembly and the valve 52 to be laterally pulled from the catheter hub. Thus, these and other handle assembly configurations are contemplated.

[0136] FIGS. 66A-66C show details of an inserter including a catheter advancement configuration according to one embodiment, where the inserter housing 1340 includes a catheter advancement lever 1344 that engages the guide wire advancement button to initially hold the catheter advancement lever in a recessed position below the guide wire advancement button and prevent catheter advancement. When the guide wire advancement button 1348 is moved distally, the catheter advancement lever 1344 moves upward, which unlocks catheter advancement and allows the catheter tube 44 to advance distally, such as by distal movement of the catheter advancement lever. It is understood that one or more of various internal mechanisms may be included in the housing 1340 to facilitate the functions described herein.

[0137] Note that the inserter 10 described immediately above is configured to be grasped by the user's hand and to be utilized when deploying a catheter into a patient without the need for the user to move the hand that is holding the device. In particular, the finger pad 1218 of the guide wire advancement assembly 20 and the wing 1280 of the catheter advancement assembly 40 are positioned distally relative to the location where the user grasps the housing 12 for using the inserter 10, thus eliminating the need for the user to move the hand that is being held during advancement of the finger pad or the wing.

[0138] In one embodiment, the user grasps the inserter housing 12 with one hand and uses the other hand to advance at least one of the finger pad 1218 and the wing 1280 without similarly moving the hand that is grasping the inserter housing. In another embodiment, the user can use the fingers of the hand that is grasping the inserter housing to advance one or both of the finger pad 1218 and the wing 1280.

[0139] Now refer to FIGS. 67A - 67F, which show various details regarding a catheter inserter (the "inserter" or "insertion device") (generally illustrated at 10) according to one embodiment. Note that in the following description, focus is on the placement of a particular type of relatively short length catheter, but it is contemplated that catheters of various types, sizes, and lengths can be inserted via this device. For example, peripheral IV, intermediate or extension dwell catheters, PICC, central venous catheters, etc. In one embodiment, a catheter having a length of about 5.1 cm to about 7.4 cm (about 2.0 inches to about 2.9 inches) can be placed, although many other lengths are possible. In another embodiment, a catheter having a length of about 5.72 cm to about 6.99 cm (about 2.25 inches to about 2.75 inches) can be placed.

[0140] As shown, the inserter 10 includes a housing 12 which in turn includes an upper housing portion 12A that is separably fitted to a bottom housing portion 12B. A needle 16 extends from the housing. A catheter 42 is disposed over the needle 16. Also shown are a finger pad 1218 of a guide wire advancement assembly 20 slidably disposed within a slot 1236 defined in the upper housing portion 12A, and a portion of a handle assembly 1220 of a catheter advancement assembly 40. The finger pad 1218 is also referred to herein as a first user engagement component. Further details of the inserter 10 according to this embodiment and its various details are shown below.

[0141] Figures 67A - 67F show the finger pad 1218, as part of the guide wire advancement assembly 20, being slid distally along the slot 1236 by a user's thumb and / or finger to selectively advance a guide wire 22 (initially disposed within the lumen of the hollow needle 16) beyond the distal end 16B of the needle 16. As described above, the proximal end of the guide wire 22 is attached to an inner portion of the upper housing portion 12A such that a single unit of distal sliding advancement of the finger pad 1218 results in two units of distal guide wire advancement. This is made possible, as described above, by looping the guide wire 22 through a guide surface 980 included on the proximal portion of a guide wire lever 24 from an attachment point on the upper housing portion 12A prior to extending it within the lumen of the needle 16 (Figs. 72A and 72B). Note that in this embodiment, the guide wire lever 24 and the finger pad 1218 of the guide wire advancement assembly 20 are integrally formed with each other, although they may be formed separately in other embodiments. Also note that the guide wire 22 may be attached to other external or internal portions of the inserter 10, including the bottom housing portion 12B, the needle hub 1214, etc.

[0142] Figures 67A - 67F further show a catheter advancement assembly 40 for selectively advancing the catheter 42 distally out of the housing 12 of the introducer 10, including a handle assembly 1220. The handle assembly 1220 itself includes, among other components, a finger pad portion 1290. The finger pad portion 1290 is moved by the user's thumb and / or fingers when attempting to advance the catheter. As will be described in more detail below, the finger pad portion 1290 is advanced distally through a gap 1250 defined between an upper housing portion 12A and a lower housing portion 12B. The finger pad portion 1290 is also referred to herein as a second user engagement component, while the finger pad 1218 of the guide wire advancement assembly 20 described above is also referred to herein as a second user engagement component.

[0143] The upper and lower housing portions 12A, 12B are fitted together by engaging four tabs 1230 (Figs. 67D, 68) of the upper housing portion with four corresponding recesses 1232 disposed on the lower housing portion. Of course, other engagement mechanisms and methods for joining the upper and lower housing portions together may be utilized.

[0144] The exploded view of the inserter 10 of FIG. 68 shows that the handle assembly 1220 includes a head portion 1222 (of which the finger pad portion 1290 is a part) 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 further discussed below. The internal components of the inserter 10 disposed within the housing 12 (through which the needle 16 respectively passes) include a valve 52, a safety housing 54 (in which a movable base and a needle safety component are disposed), and a cap 58 for the safety housing. An O-ring may be included in the needle safety component. A needle hub 1214 (fixed to the proximal end of the needle 16) is attached to the housing 12 to fix the needle 16 at a predetermined position within the inserter 10. In one embodiment in FIG. 68, the slot 1236 in which the finger pad of the guide wire advancement assembly 20 is disposed includes a relatively wide portion (or slot cavity 1236A) through which the guide wire lever 24 can be inserted, and note that the guide wire advancement assembly can be coupled to the housing 12 to lock the movement of the guide wire. This will be described later.

[0145] Figures 69A and 69B show various details regarding a stabilization structure 70 for supporting and stabilizing the needle 16 at its exit point from the housing 12 according to the present embodiment. As shown, the proximal portions of the upper and bottom housings 12A, 12B engage with each other to provide the stabilization structure 70 to the needle 16. The bottom housing portion 12B includes two distally disposed arms 1248 separated by a slot 1246 that can separate from each other when the arms are not constrained. The upper housing portion 12A defines a distal slot 1240 and a fork 1241 adjacent to the slot. If the distal portion of the upper housing portion 12A is downwardly curved (see FIG. 67C), the slot 1240 allows the arms 1248 of the bottom housing portion 12B to project upwardly through the slot to surround and support the needle 16 to stabilize it. Further, the fork 1241 of the upper housing portion 12A abuts against the arms 1248 of the bottom housing portion 12B to prevent the arms from spreading while the stabilization structure is fitted and not spreading. This will be described below. Thereby, the stabilization and support for the needle 16 are obtained as required.

[0146] The arms 1248 of the bottom housing portion 12B are configured to be able to move back and forth in the x - direction by the x - y axes shown in FIGS. 69A and 69B, while remaining substantially rigid in the y - direction. Conversely, the distal portion of the upper housing portion 12A including the slot 1240 and the fork 1241 is configured to bend in the y - direction by the x - y axes shown in FIGS. 69A and 69B, while remaining substantially rigid in the x - direction. Thus, when overlapping or engaging with each other as shown in FIGS. 69A and 69B, the components of the aforementioned stabilization structure 70 cooperate to support the needle 16 and prevent its substantial movement when the housing 12 is in the configuration shown in FIGS. 69A and 69B (i.e., before removing the catheter 42 from the housing 12). This also assists the user when accurately puncturing the skin to access the patient's vasculature. It is understood that the stabilization structure may include other components for stabilizing the needle in addition to those explicitly described herein.

[0147] Figures 70-73 show various details regarding the catheter advancement assembly 40 and the advancement assembly 20 according to the present embodiment. As described above, the catheter advancement assembly 40 includes a handle assembly 1220, which in turn includes a head portion 1222 having a corresponding finger pad portion 1290, and a tail portion 1224 disposed around a portion of the catheter hub 46 and the safety housing 54. As will be further discussed below, the handle assembly 1220 is utilized when advancing the catheter 42 distally and removing it from the introducer 10.

[0148] Figures 70-73 further show the finger pad 1218 and the guide wire lever 24 of the guide wire advancement assembly 20 for the present embodiment. As shown, the guide wire lever 24 extends proximally from the finger pad 1218 and includes the above-discussed guide surface 980 at its proximal end for guiding the loop of the guide wire 22. An actuation block 1258 is also included near the proximal end of the guide wire lever 24 for use when enabling catheter advancement, as will be further described below. Note that the specific size, shape, and other configurations of the actuation block may differ from those shown and described herein while maintaining the desired function.

[0149] The spring arm 1260 extends downwardly from the guide wire lever 24 (from the perspective views shown in Figures 70-73) and is configured to be slidably retained between two guide posts 1264 of the needle hub 1214, as best seen in Figures 72A and 72B. The spring arm 1260 is utilized to lock further movement of the guide wire advancement assembly 20 when the guide wire 22 extends completely distally from the introducer 10 and the catheter 43 has advanced an incremental amount. Specifically, when the user slides the finger pad 1218 distally, the guide wire lever 24 is also moved distally. And then, as seen in Figure 73, the guide wire 22 (which internally loops through the lumen of the needle 16 past the guide surface 980 of the guide wire lever 24) is advanced distally through the lumen of the needle 16 past the distal end 16B of the needle.

[0150] As shown in FIG. 73, when the finger pad 1218 and the guide wire lever 24 are fully advanced distally (the finger pad advances to the distal end point), as shown in FIG. 72B, the free end of the spring arm 1260 is disposed directly above the pocket 1266 defined between the guide posts 1264 of the needle hub 1214. Due to the position of the safety housing 54 adjacent and proximate to the needle hub 1214 at this stage (as further described below, the catheter 42 and the attached safety housing in its initial seating position have not yet been advanced distally via the distal advancement of the catheter advancement assembly 40), the free end of the spring arm 1260 cannot yet seat in the pocket 1266. However, as soon as the catheter 42 is advanced distally by an incremental distance from a point herein referred to as the proximal starting point, the attached safety housing 54 no longer impedes the downward movement of the spring arm 1260, and its free end seats within the pocket 1266 of the needle hub 1214. Further distal movement of the guide wire advancement assembly 20 is prevented by the finger pad 1218 colliding with the distal end of the slot 1236, while proximal movement of the guide wire advancement assembly 20 is prevented by disposing the spring arm within the pocket 1266 of the needle hub.

[0151] Note that in one embodiment, the finger pad 1218 can include a protrusion or enlarged surface 1308 (FIG. 79) on its underside, proximate to its distal end, that engages a slot cavity 1236A (FIG. 68). The slot cavity 1236A is defined as part of the slot 1236 on the upper housing portion 12A when the finger pad is fully advanced distally. This can help to hold the finger pad 1218 seated in its distal position and provide a tactile cue that the finger pad has been fully advanced distally. In another embodiment, engaging the finger pad enlarged surface 1308 with the slot cavity 1236A can be used to prevent further distal and / or proximal movement of the guide wire 22 by preventing movement of the guide wire lever 24.

[0152] Even if the catheter advancement assembly 40 moves proximally and returns to its initial position (as seen in FIG. 71), note that the safety housing 54 abuts the needle hub 1214 again, pushing up the free end of the spring arm 1260 and out of the pocket 1266. This in turn unlocks the guide wire advancement assembly 20, allowing it to move proximally and distally again, resulting in corresponding proximal and distal advancement of the guide wire 22 itself. Thus, the lock on guide wire advancement is reversible in this embodiment.

[0153] In another embodiment, for example, a push button may be included in the guide wire advancement assembly 20 such that after the lock on the guide wire is initially engaged, the guide wire can be newly extended or retracted, for example, via depression of a button to release the spring arm 1260 from the pocket 1266 of the needle hub. Thus, these and other variations are contemplated.

[0154] FIGS. 74-75C show, according to this embodiment, that the inserter 10 described herein further includes a lock on catheter movement prior to distal advancement of the guide wire 22 as described above. Specifically, FIGS. 74 and 75A show their initial positions within the inserter housing 12, i.e., the tail portion 1224 of the handle assembly 1220 of the guide wire advancement assembly 20 and the catheter advancement assembly 40 prior to distal guide wire advancement and catheter distal advancement. In this position, the two spring arms 1272 of the tail portion 1224 are positioned such that the guide posts 1264 on both sides of the needle hub 1214 seat within the respective notches 1274 of the spring arms, as best seen in FIG. 75A. In this position, the tail portion 1224 is prevented from moving. Considering the attachment of the tail portion 1224 to the hub 46 of the catheter 42, this also prevents distal advancement of the catheter or any other part of the catheter advancement assembly 40.

[0155] As seen in FIGS. 75A and 75B, when the guide wire lever 24 moves distally forward, its actuating block 1258 engages the inclined surface 1276 of each spring arm 1272. As best seen in FIG. 75B, as the distal movement of the guide wire lever 24 continues, the actuating block 1258 spreads the spring arms 1272. As a result, the guide post 1264 is released from the spring arm notch 1274. The actuating block 1258 strikes the guide post 1264 when the guide wire 22 has moved completely distally forward such that the free end of the spring arm 1260 of the guide wire lever 24 is positioned directly above the pocket 1266 of the needle hub 1214, as seen in FIG. 75B. This is as previously described in connection with FIGS. 71-73. At this point, the spring arms 1272 of the tail portion 1224 are released from the guide posts 1264 of the needle hub 1214, and as a result, distal catheter advancement becomes possible, for example, by the user moving the handle assembly 1220 (as shown by the distal movement of the spring arms in FIG. 75C). Similarly, as also previously described in connection with FIGS. 71-73, this distal catheter advancement correspondingly moves the safety housing 54 (attached to the catheter 42) distally. The movement of the safety housing fits the free end of the spring arm 1260 of the distally advanced guide wire lever 24 into the pocket 1266 of the needle hub 1214, locking further movement of the guide wire 22 and preventing the safety housing from returning to its initial position adjacent to the needle hub.

[0156] Thus, it can be seen that the configuration of the inserter 10 of the present embodiment prevents distal movement of the catheter 42 until complete distal extension of the guide wire 22 occurs. While preventing further movement of the guide wire 22, the catheter 42 is advanced distally in an amount that gradually increases, at least from its initial proximal position. In another embodiment, increments of distal advancement of the guide wire may enable catheter advancement.

[0157] In yet another embodiment, the lock of the guidewire movement becomes permanent after complete distal advancement. This can be achieved, in one embodiment, by configuring the spring arm 1260 of the guidewire lever 24 and the pocket 1266 of the needle hub 1214 not to interact with the safety housing 54, such that once the free end of the spring arm 1260 seats within the pocket 1266 of the needle hub, it remains seated permanently. In another embodiment, the lock of the catheter movement is made after complete distal catheter advancement. In yet another embodiment, the guidewire and / or catheter advancement can be achieved via a ratchet mechanism.

[0158] In another embodiment, the ability to advance the catheter is independent of the advancement of the guidewire. In yet another embodiment, the spring arm 1260 of the guidewire lever 24 may be removed so that the lock of the guidewire advancement assembly 20 does not occur. In turn, this enables the lock of the catheter advancement until complete distal advancement of the guidewire occurs. Thus, these and other variations are contemplated.

[0159] FIG. 76 shows various details regarding the distal advancement of the catheter 42 from the introducer 10. When the guidewire advancement assembly 20 advances the guidewire 22 distally to extend beyond the distal end 16B of the needle 16, the catheter advancement assembly 40 is freely available to advance the catheter 42 distally out of the distal end of the introducer housing 12 (as previously described in connection with FIGS. 74 - 75C). The user advances the catheter 42 by engaging and moving distally the finger pad portion 1290 of the head portion 1222 of the handle assembly 1220. Note that the ridge portion 1282 (FIGS. 69A, 69B) is included to assist the user in gripping the finger pad portion 1290. The finger pad portion 1290 slides distally within a gap 1250 defined between an upper housing portion and a bottom housing portion. As part of the head portion 1222 (which itself is attached to the hub 46 of the catheter 42), sliding the finger pad portion 1290 distally advances the catheter distally.

[0160] When the catheter 42 is advanced distally, as a part of the head portion 1222 slides through the gap 1250, the distal movement of the finger pad portion 1290 causes the finger pad portion to abut against the upper housing portion 12A and push it upward. As a result, next, the distal portion of the upper housing portion 12A (including the slot 1240 and the fork 1241 of the stable structure 70) is lifted. When the slot 1240 and the fork 1241 are lifted, the arm 1248 of the bottom housing portion 12B is released from the slot, so that they can be spread apart. Two posts 1286 (see also FIG. 77) disposed on the head portion 1222 of the handle assembly 1220 push each arm 1248 when the catheter advances distally, and the arms separate. While separating the arms 1248 in this way and by lifting with the finger pad portion 1290 of the upper housing portion, the catheter 42 can pass through the distal end of the housing 12.

[0161] FIG. 76 shows the state of removing the catheter 42 and the catheter advancement assembly 40 from the insertion tool housing 12. Here, by the user engaging and advancing the finger pad portion 1290, the distal advancement of the head portion 1222 of the handle assembly 1220 is continued, so that the catheter 42, the handle assembly 1220 (including the head portion 1222 and the tail portion 1224), and the safety housing 54 (removably attached to the catheter hub 46) are slid distally along the needle 16 and taken out of the housing 12. By performing such an operation, for example, after the needle 16 and the guide wire 22 cooperate to achieve a percutaneous path into the blood vessel, the catheter tube 44 is advanced into the blood vessel of the patient.

[0162] By further separating the catheter 42 from the handle assembly 1220 from the housing 12, the safety housing 54 is brought to the distal end 16B of the needle 16. At that point, the needle safety component disposed within the safety housing engages the distal tip of the needle, covering the distal tip and preventing accidental needle sticks to the user. The safety housing is removed laterally from the catheter hub 46 and remains with the needle.

[0163] Shown in FIG. 77 are various features of the handle assembly 1220 (including the head portion 1222 and the tail portion 1224). After the above separation of the catheter 42, the safety housing 54, and the needle 16 from the handle assembly 1220, the head portion 1222 and the tail portion 1224 remain attached to the needle hub 46 and its corresponding relaxation fitting 47 via the clip arms 1300 and 1304, respectively.

[0164] At this point, the head portion 1222 may be removed from the catheter hub 46 / relaxation fitting 47 by the user's hand to release the friction fit of the clip arm 1300. The tail portion 1224, including the loop 1306 disposed around the valve 52, can also be removed by the user pulling and twisting to release the friction fit of the clip arm 1304 and avoid the threads of the catheter hub 46. This action removes the valve 52 (see FIG. 68) attached to the tail portion 1224. In another embodiment, the loop 1306 of the tail portion is configured such that the valve 52 is exposed after the tail portion 1224 is removed, allowing removal of the valve by the user when desired. Once the head portion 1222 and the tail portion 1224 of the handle assembly 1220 are removed from the catheter 42, the catheter can be bandaged and used as desired. The handle assembly 1220 can be configured in a different manner than that shown and described above.

[0165] Figures 78A and 78B show various details regarding the handle assembly 1220 (including the head portion 1222 and the tail portion 1224) as part of the catheter advancement assembly 40. As shown, the head portion 1222 includes a finger pad portion 1290, and the finger pad portion 1290 is configured such that the user's thumb and / or fingers can advance the catheter 42 distally out of the introducer 10 as shown in Figure 76. A ridge portion 1292 is included on the finger pad portion 1290 to assist the user in gripping it. A rounded raised surface 1292 is included on the upper surface of the finger pad portion 1290, providing a surface against which the user can apply force to push the head portion 1222 distally.

[0166] The head portion 1222 defines a cavity 1294 within which a part of the distal portion of the upper housing portion 12A of the introducer housing 12 is disposed, such that the head portion can slide over the distal portion of the upper housing portion 12A as seen, for example, in Figure 76. Such engagement enables the head portion to slide distally over the distal portion of the upper housing portion 12A when the user engages the finger pad portion 1290, advancing the catheter 42 distally out of the distal end of the introducer housing 12. As a result of such advancement (separating the catheter 42 from the housing 12), it can be seen that the cavity 1294 of the head portion 1222 separates from the upper housing portion 12A.

[0167] Figures 67E, 70, and 78B note that the finger pad portion 1290 of the handle assembly 1220 further includes a recess 1295 within which the finger pad 1218 of the guide wire lever 24 seats when the user slides the finger pad 1218 distally to advance the guide wire 22 distally. Thus, it can be seen that the finger pad 1218 of the guide wire advancement assembly 20 and the finger pad portion 1290 of the head portion 1222 of the catheter advancement assembly 40 cooperate to achieve advancement of the guide wire 22 and the catheter 42 with one hand.

[0168] Specifically, the finger pad 1218 slides distally over the housing 12 to advance the guide wire 22 until the finger pad 1218 seats within the recess 1295 of the finger pad portion 1290 of the head portion 1222. The user can then move 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 substantial repositioning of the thumb and / or finger. At that point, if desired, continued distal pressure can be applied to slide the finger pad portion 1290 distally and correspondingly advance the catheter 42 distally out of the distal end of the introducer housing 12. As a result, the distal end point of the sliding finger pad 1218 of the guide wire advancement assembly 20 closely corresponds to the position of the proximal starting point of the finger pad portion 1290 of the catheter advancement assembly 40. It is understood that the finger pad 1218, finger pad portion 1290, crest portion 1282, raised surface 1292, etc. can be configured in other ways as well.

[0169] Figures 80 and 81 show details of the catheter inserter 10 according to one embodiment, where the finger pad 1218 of the guide wire advancement assembly 20 is elongate and includes a pair of crest portions to assist engagement with the finger pad by the user's thumb and / or fingers. Further, the handle assembly 1220 of the catheter advancement assembly 40 has a head portion 1222 and a tail portion formed as an integral component as shown. The head portion 1220 includes two wings 1280 as previously described in connection with FIGS. 48A - 49 and is adapted to distally advance the catheter 42 out of the housing 12. The head portion 1220 further includes a cover portion 1310. The cover portion 1310 is arched over the upper housing portion 12A as shown in FIG. 80, extends between the wings 1280 and connects to each wing 1280. So disposed, the cover portion 1310 is disposed over a portion of the finger pad 1218. Crest portions (or profiles 1310) are included on the upper surface of the cover portion 1310 to assist the user in engaging the cover portion with the thumb and / or fingers. Thus, it can be seen that advancing the catheter 42 distally using the catheter advancement assembly 40 is possible by the user manually engaging one or both of the wings 1280 and / or the cover portion 1310 and slidingly moving them.

[0170] FIG. 81 shows the head portion 1220 and the tail portion 1224 of the handle assembly 1220 integrally formed in this embodiment. FIGS. 82A and 82B show, as in the previous embodiment, that the handle assembly 1220 can be removed from the catheter 42 immediately after removal from the catheter inserter 10 (which would occur after the catheter tube 44 has been inserted into the patient's vasculature). This is done by first bending the head portion of the handle assembly upwardly and proximally (FIG. 82B), where the clip arms 1300 and 1304 are released from the tension relief portion 47 and the catheter hub 46, respectively. The handle assembly 1220 can then be pulled proximally with respect to the catheter 42 to release the engagement therebetween.

[0171] Figures 83-85 show various details regarding a continuous blood flush indicator 1330 that allows a user to confirm that blood or other fluid is present within the lumen of the needle 16 of the catheter introducer 10. This ensures that the needle distal tip 16B is properly positioned within a patient's vein or vessel during use of the introducer for placing the catheter 42. In FIG. 83, the flush indicator 1330 includes an elongated channel 1332 in fluid communication with the lumen of the needle 16 of the insertion device 10. The channel 1332 is shaped to define a path 1334 (e.g., a serpentine path) along which blood present within the lumen of the needle 16 can exit the needle and move into the channel after entering the channel.

[0172] More particularly, FIG. 83 shows how the channel 1332 establishes fluid communication with the lumen of the needle 16 via a conduit (or access point 1336A) defined through a loop 1306 in the tail portion 1224 of the handle assembly 1220. The conduit fluidly connects with the needle 16 via a notch defined within the needle (or by other suitable means). In one embodiment, the access point 1336A is defined through the valve body 52 (FIG. 68). The valve body defines a hole that fluidly connects the valve body with the catheter hub lumen. In another embodiment, the access point 1336A is defined at a point proximal to the safety housing 54 but distal to the needle hub 1214. These and other possible locations are contemplated.

[0173] The channel 1332 extends distally from the conduit and, as shown in FIG. 83, the channel is defined by a portion of the handle assembly 1220. Here, the channel 1332 is covered by a portion of the upper housing part 12A. The thermoplastic or other material of the upper housing part 12A covering the channel 1332 is translucent in this embodiment, allowing the user to view the blood present within the channel. In another embodiment, the housing itself can define at least a portion of the channel 1332.

[0174] Figures 83 and 84 show that in one embodiment of the blood flush indicator 1330, the channel 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 the access point 1336B, and the path 1334 is also defined on the finger pad portion. Also in this case, a part of the finger pad portion 1290 that defines the channel 1332 is translucent in this embodiment, allowing the user to see the blood flowing therein.

[0175] In one embodiment of the blood flush indicator 1330, the path 1334 formed by the channel 1332 can be defined at multiple positions. FIG. 85 shows this example, where a part of the path 1334 is included at a position proximal to the finger pad portion 1290 on the upper housing portion 12A (fluid access thereto is provided via the access point 1336C), and another part of the path 1334 is included at a position distal to the finger pad portion on the upper housing portion (fluid access thereto is provided via the access point 1336D). The access points 1336C and 1336D are in fluid communication with a part of the channel 1332 that extends to be in fluid connection with a part of the needle 16 (via an access point, such as the access point 1336A as seen in FIG. 83) or with another fluid conveyance part of the insertion device 10.

[0176] The path 1334 shown in FIGS. 84 and 85 forms an elongated serpentine-shaped path along which blood present within the lumen of the needle 16 can move after exiting the needle. The path 1334 shown in FIG. 84 defines a circuitous pattern that moves along the shape of the finger pad portion 1290, while the path in FIG. 85 defines a back-and-forth pattern along the upper surface of the upper housing portion 12A. However, it is understood that various different path designs and positions on / within the insertion device 10 can be used. In the present embodiment, the path 1334 defined on the upper housing portion 12A is formed by a transparent tubing that is attached to the upper housing portion in the illustrated pattern (e.g., by pressing). In one embodiment, when the handle assembly 1220 of the catheter advancement assembly 40 extends distally and the handle assembly 1220 is removed from the housing 12, the transparent tubing separates from the upper housing portion. In another embodiment, the channel 1332 is formed integrally with the housing 12.

[0177] The user can observe the blood within the path 1334 defined by the channel 1332 to confirm that the distal tip of the needle 16 is positioned within a patient's vein or other desired blood-carrying vessel. Because the path 1334 is relatively very long, the flush indicator 1330 can function as a continuous flush indicator due to the progression as the blood travels within the channel 1332. The blood remains within and travels along the route defined by the path 1334 as long as the needle distal tip 16B is positioned within a blood-carrying vessel (or other fluid-carrying vessel in other embodiments). It is understood that the channel and path can be formed using one of various processes such as molding, machining, etc. Note that the channel 1332 can be included in other structures in addition to those illustrated and described herein. For example, the hub 46 of the catheter 42 or other portions, valve assemblies, other portions of the housing 12, etc.

[0178] Various path designs can be considered. Examples include the trunk-branch pattern, the front-back pattern, the periodic toothed pattern around the components, the zigzag pattern, the converging front-back pattern, the circular pattern, the spiral winding pattern, and so on.

[0179] Embodiments of the present invention can be implemented in other specific forms without departing from the spirit of the present disclosure. The described embodiments are illustrative in all respects and should be construed as non-limiting. Accordingly, the scope of the embodiments is defined by the appended claims rather than the above description. All modifications within the meaning and scope equivalent to the claims are included within these scopes. The invention described in the original claims of the present application is appended below. [1] An insertion device for inserting a catheter into a patient's body, comprising a housing in which at least a part of the catheter is initially disposed, A needle extending distally from the housing, with at least a portion of the catheter pre - disposed on the needle, the needle; A guide wire; A guide wire advancement assembly including a first user engagement component configured for a user's thumb or finger abutment, and selectively advancing the distal end of the guide wire distally out of the distal opening of the needle to prepare for distal advancement of the catheter, the guide wire advancement assembly; A catheter advancement assembly including a second user engagement component configured for a user's thumb or finger abutment, and selectively advancing the catheter distally. The user can start advancing the second user component after advancing the first user engagement component without substantially re - positioning the thumb or finger used for advancing the guide wire and the catheter, the catheter advancement assembly; an insertion device comprising the above. [2] The insertion device according to [1], wherein the first user engagement component is slidable distally to a distal end point adjacent to a proximal starting point of the second user engagement component. [3] The insertion device according to [2], wherein the first user engagement component includes a first finger pad and the second user engagement component includes a second finger pad. [4] The insertion device according to [3], wherein the second finger pad defines a depression configured such that the first finger pad seats when the first finger pad is slid distally to the distal end point and the second finger pad is disposed at the proximal starting point. [5] The insertion device according to [1], wherein the second finger pad includes a curved raised surface configured to assist the user in sliding the second finger pad distally. [6] The insertion device according to [1], wherein the guide wire advancement assembly is configured to prevent advancement of the catheter until distal advancement of the guide wire is performed. [7] The insertion device according to [1], wherein the guide wire advancement assembly includes a spring arm that engages a pocket within the housing and is configured to prevent proximal retraction of the guide wire after complete distal advancement of the guide wire. [8] The spring arm is disposed on the guide wire lever, the guide wire lever is attached to a finger pad slidably disposed on the housing, the pocket is included within a needle hub in the housing, and the proximal end of the needle is attached to the needle hub, the insertion device according to [7]. [9] The catheter advancement assembly includes a safety housing, a needle safety component is disposed within the safety housing, the safety housing is initially disposed in an initial position adjacent to the needle hub, and when the safety housing is displaced distally via the catheter advancement assembly, after complete distal advancement of the guide wire, the free end of the spring arm is capable of seating within the pocket of the needle hub, the insertion device according to [8].

[10] The catheter advancement assembly is configured such that when the safety housing is displaced proximally to the initial position adjacent to the needle hub, the free end of the spring arm is pushed out of the pocket of the needle hub, enabling the guide wire to be advanced and retracted again, the insertion device according to [9].

[11] The guide wire lever includes an actuation block configured to engage a portion of the catheter advancement assembly when the guide wire is advanced completely distally, and by the actuation block engaging the portion of the catheter advancement assembly, it is possible to advance the catheter distally, the insertion device according to [8].

[12] The housing includes a stable structure configured to support the needle extending from the housing, the needle stabilization assembly is configured to separate when the catheter is advanced distally, enabling the catheter to exit the housing, the insertion device according to [1].

[13] The housing includes an upper housing portion and a lower housing portion, the bottom of the stable structure is included in the lower housing portion, the top of the stable structure is included in the upper housing portion, and the stable structure is disposed at the exit point of the needle from the housing, the inserter according to

[12] .

[14] The bottom of the stabilizing structure is configured to be substantially flexible in a first direction and substantially rigid in a second direction, and the top of the stabilizing structure is configured to be substantially flexible in the second direction and substantially rigid in the first direction, the inserter according to

[13] .

[15] The bottom and top of the stabilizing structure are configured to overlap each other to provide support for the needle, the insertion device according to

[14] .

[16] The bottom stabilizing structure includes first and second arms that can be laterally expanded such that when the catheter advancement assembly is advanced distally, the catheter can pass through the first and second arms, the insertion device according to

[15] .

[17] The top of the stabilizing structure is included on the distal portion of the upper housing portion, the top of the stabilizing structure is vertically flexible, includes a slot defined within the distal portion of the upper housing portion, and the first and second arms of the bottom of the stabilizing structure extend partially through the slot before distal advancement of the catheter occurs to provide support for the needle, the insertion device according to

[16] .

[18] The top of the stabilizing structure includes a U-shaped feature disposed adjacent to the slot and partially around the needle, the insertion device according to

[17] .

[19] When the catheter is advanced distally, the catheter advancement assembly is configured to abut against the upper housing portion and retract the first and second arms of the bottom of the stabilizing structure from the slot in the top of the stabilizing structure, and the catheter spreads the first and second arms to allow the catheter to pass through, the insertion device according to

[18] .

[20] The second user engagement component includes a head portion that wraps around a portion of the upper housing portion, and when the head portion slides distally, it causes upward movement of the upper housing portion to allow the catheter to pass distally from the housing, the insertion device according to

[19] .

[21] An insertion device for inserting a catheter into a patient's body, a housing in which at least a portion of the catheter is initially disposed, A needle extending distally from the housing, with at least a portion of the catheter pre - disposed on the needle, the needle and, a guide wire, a guide wire advancement assembly for selectively advancing the distal end of the guide wire distally out of the distal opening of the needle to prepare for distal advancement of the catheter, a catheter advancement assembly for selectively advancing the catheter distally, the catheter advancement assembly including a handle assembly, the handle assembly including first and second wings, a cover portion extending between the first wing and the second wing, the cover portion being positioned such that advancement of the guide wire advancement assembly and the catheter advancement assembly can be performed by a single thumb or finger of the user, the catheter advancement assembly and, comprising an insertion device.

[22] The first and second wings are manually grippable by the user to advance the catheter distally from the housing, the first and second wings including a ridge portion to assist user engagement of the wings by the user, the insertion device according to

[21] .

[23] The cover portion of the handle assembly is arched over the upper portion of the housing, the insertion device according to

[22] .

[24] The cover portion of the handle assembly is arched over the upper portion of the housing and covers a part of the finger pad of the guide wire advancement assembly, the insertion device according to

[23] .

[25] The cover portion includes a contoured surface to assist user engagement of the cover portion with the thumb or finger, the insertion device according to

[21] .

[26] At least one of the guide wire advancement assembly and the handle assembly is configured to prevent advancement of the catheter until distal advancement of the guide wire is performed, the insertion device according to

[21] .

[27] The handle assembly includes a head portion and a tail portion, the head portion and the tail portion are removably attached to the catheter, the tail portion being engagable with the guide wire advancement assembly to selectively enable distal advancement of the catheter, the insertion device according to

[21] .

[28] The insertion device according to

[27] , wherein the head portion and the tail portion of the handle assembly are integrally formed with each other.

[29] The catheter includes a catheter hub, the handle assembly is removably attached to the catheter hub, a valve is removably included within the catheter hub, a safety housing is removably disposed within the valve, the safety housing is configured to be removed laterally, and the handle assembly and the catheter hub are configured to be separated from each other in a vertical direction. The insertion device according to

[28] .

[30] The catheter includes a catheter hub, the handle assembly is removably attached to the catheter hub, and the handle assembly includes a living hinge configured to selectively remove the handle assembly from the catheter hub. The insertion device according to

[28] .

[31] The insertion device according to

[30] , wherein the handle assembly includes a valve removably disposed within the catheter hub.

[32] An insertion device for inserting a catheter into a patient's body, a housing in which at least a portion of the catheter is initially disposed therein, a needle extending distally from the housing, wherein at least a portion of the catheter is pre-disposed on the needle, the needle, a guide wire, a guide wire advancement assembly including a first user engagement component configured for a user's thumb or finger rest, the guide wire advancement assembly for selectively advancing the distal end of the guide wire distally out of the distal opening of the needle in preparation for distal advancement of the catheter, a catheter advancement assembly including a second user engagement component for selectively advancing the catheter in a distal direction, the first user engagement component being slidable distally to a distal end point adjacent to a proximal starting point of the second user engagement component. The catheter advancement assembly. A flash indicator configured to indicate the presence of fluid within the lumen of the needle, the flash indicator including an elongate channel in fluid communication with the needle lumen, the channel defining a path configured for the fluid present within the needle lumen to pass therethrough, the fluid within the path being observable by a user of the insertion device, and a flash indicator. The insertion device includes the flash indicator.

[33] The fluid includes blood, and the blood is present within the needle lumen when the distal end of the needle is disposed within a blood transport vessel of the patient. The insertion device according to

[32] .

[34] The blood travels along the path, while the distal end of the needle is disposed within the blood transport vessel of the patient. The insertion device according to

[33] .

[35] The channel is included in at least one of the housing and the catheter advancement assembly. The insertion device according to

[32] .

[36] The channel is in fluid communication with the needle via an access point defined by a portion of the catheter advancement assembly. The insertion device according to

[35] .

[37] The channel extends from the catheter advancement assembly to a portion of the housing. The insertion device according to

[36] .

[38] The path is included at a plurality of positions of the housing. The insertion device according to

[35] .

[39] A portion of the path is included on a finger pad portion of the catheter advancement assembly and is in communication with a portion of the path included in the housing. The insertion device according to

[35] .

[40] The path defines a serpentine path. The insertion device according to

[32] .

[41] The path includes one of a helical winding, a spiral winding, a back-and-forth, a zigzag, a trunk and branch, and a circular configuration. The insertion device according to

[40] .

[42] The channel is in fluid communication with the proximal end of the needle. The insertion device according to

[32] .

[43] The channel is defined within a translucent portion of the insertion device and is observable by a user. The insertion device according to

[32] .

Claims

Claim 1 An insertion device for inserting a catheter into a patient's body, comprising: a catheter hub for supporting the catheter, a catheter advancement assembly for advancing the catheter distally; a housing having an upper housing portion and a lower housing portion that engage with the catheter advancement assembly and define an opening for the distal end of the catheter to extend distally outwardly, and having a track for passing the catheter advanced by the catheter advancement assembly; a guide wire disposed engageably with the catheter for guiding the catheter; a needle having a lumen in which a portion of the distal end of the guide wire is pre-disposed; a needle hub disposed on the proximal end side of the housing for supporting the needle within the housing; a guide wire advancement assembly comprising a first user engagement component including a guide wire lever configured to move the guide wire distally relative to the needle; characterized in that the guide wire advancement assembly has a pair of movable members provided in the track of the housing for opening and closing the opening of the housing; the housing includes a stable structure configured to support the needle extending from the housing; the stable structure has a bottom included in the bottom housing portion and an upper portion included in the upper housing portion; the bottom of the stable structure is configured to be substantially flexible in a first direction and substantially rigid in a second direction; the upper portion of the stable structure is configured to be substantially flexible in the second direction and substantially rigid in the first direction; the bottom and the upper portion of the stable structure overlap each other and are configured to provide support for the needle; the guide wire lever includes an operating block configured to engage with a part of the catheter advancement assembly when the guide wire is advanced completely distally, and when the operating block engages with the part of the catheter advancement assembly, it becomes possible to advance the catheter distally. When the guide wire advancement assembly distally advances the first user engagement component, the actuating block engages the pair of movable members, and the distal advancement of the guide wire lever laterally pushes and spreads apart the pair of movable members, completely distally advancing the guide wire and enabling the catheter to extend out of the housing through the opening. An insertion device characterized by the above. **Claim 2** The insertion device according to claim 1, wherein the pair of movable members are first and second arms that can move laterally and apart from each other. **Claim 3** The upper part of the stabilizing structure is included on the distal part of the upper housing portion. The upper part of the stabilizing structure is vertically flexible and includes a slot defined within the distal part of the upper housing portion. The first and second arms of the bottom of the stabilizing structure partially extend through the slot before distal advancement of the catheter occurs, providing support for the needle. **Claim 4** The insertion device according to claim 3, wherein the catheter advancement assembly has a second user engagement component including a head portion that wraps around a part of the upper housing portion. **Claim 5** The upper part of the stabilizing structure includes a U-shaped feature disposed adjacent to the slot at the distal ends of the first and second arms and partially disposed around the needle. When the catheter advances distally, the catheter is configured to push the first and second arms apart to allow passage of the catheter and to impact the upper housing portion such that the first and second arms at the bottom of the stabilizing structure retract from the slot at the upper part of the stabilizing structure. The second user engagement component includes a head portion that wraps around a part of the upper housing portion. The distal sliding of the head portion provides an upward movement of the upper housing portion to allow the catheter to pass distally through the housing. **Claim 6** It further has a needle holder included on the distal end of the needle hub. The insertion device according to claim 5, wherein the needle hub is attached to the upper housing portion, and the proximal end of the needle is received within the needle holder. **Claim 7** The insertion device according to claim 6, further comprising a pair of extension portions included on both sides of the needle holder and configured to be slidably received in corresponding slots defined on the side surface of the bottom housing portion.

8. The upper housing portion has an upper housing rail, and the bottom housing portion has a bottom housing rail. The insertion device according to claim 1, wherein the first user engagement component has a sliding arm configured to move along at least one of the upper housing rail and the bottom housing rail.

9. The insertion device according to claim 1, wherein the guide wire lever includes a lever tab engaged with the proximal end of the guide wire and configured to push the guide wire.

10. The insertion device according to claim 1, wherein the needle includes a needle slot extending longitudinally along its length from a starting point to a distal end.

11. The first user engagement component includes a finger pad, and the second user engagement component includes a finger pad portion. The finger pad portion defines a depression configured such that the finger pad seats when the finger pad is slid distally to a distal end point and the finger pad portion is disposed at a proximal starting point, or the finger pad portion includes a curved raised surface configured to assist a user in sliding the finger pad portion distally. The insertion device according to claim 4.

12. The guide wire advancement assembly has a spring arm configured to engage a pocket in the housing to prevent proximal retraction of the guide wire after complete distal advancement of the guide wire. The insertion device according to claim 11.

13. The spring arm is disposed on the guide wire lever, the guide wire lever is attached to a finger pad slidably disposed on the housing, the pocket is included in a needle hub within the housing, and the proximal end of the needle is attached to the needle hub. The insertion device according to claim 12.

14. The insertion device according to claim 1, wherein a loop portion of the guide wire, the catheter hub, and the needle hub are respectively disposed within the housing. **Claim 15**: The first user engagement component includes a first spring arm having a fixed end attached to the guide wire lever and a free end configured to be lockable to a pocket of the needle hub, and an actuating block formed in the vicinity of the proximal end of the guide wire lever for stopping the proximal movement of the needle hub. The second user engagement component includes a handle assembly, and a pair of second spring arms having a fixed end attached to the tail portion of the handle assembly and a free end that engages with the needle hub in the initial position and is expanded by the actuating block in the proximal movement stop position to release the locking of the needle hub. The insertion device according to claim 4. **Claim 16** The needle hub has a guide post that engages with a notch formed at the proximal end of the second spring arm. The insertion device according to claim 15. **Claim 17**: The second user engagement component includes a handle assembly including a cover portion formed by integrally connecting a first wing to a second wing, extending out on the outer surface of the housing, and configured to move over the guide wire lever when advancing from a first handle assembly position to a second handle assembly position, a head portion removably attached to the catheter, and a tail portion removably attached to the catheter and configured to engage with the guide wire advancement assembly. The catheter is provided coaxially with the needle and has a proximal end within the housing and a distal end extending from the opening of the housing at the first handle assembly position. The insertion device according to claim 4. **Claim 18** The first wing and the second wing are manually graspable for distally advancing the catheter from the housing, and each of the first and second wings includes a crest portion. The insertion device according to claim 17. **Claim 19** The proximal end of the guide wire is fixed to the housing, and the intermediate portion of the guide wire includes a U-shaped guide wire bend. The insertion device according to claim 17. **Claim 20** The insertion device according to claim 17, wherein when the guide wire lever is in the first guide wire lever position, the cover portion of the handle assembly covers a part of the guide wire lever of the guide wire advancement assembly.

21. The insertion device according to claim 17, wherein the head portion and the tail portion of the handle assembly are integrally formed with each other.

22. The handle assembly is removably attached to a catheter hub, the catheter hub removably includes a valve, a safety housing is removably disposed within the valve, the safety housing being configured to be removed laterally, the insertion device according to claim 17, wherein the handle assembly and the catheter hub are configured to be separated from each other in a vertical direction.

23. The insertion device according to claim 22, wherein the handle assembly includes a living hinge configured to be selectively removable from the catheter hub.

24. The insertion device according to claim 23, wherein the handle assembly includes a valve removably provided on the catheter hub.

25. The insertion device according to claim 1, wherein the first user engagement component includes a spring arm configured to engage a pocket within the housing to prevent proximal retraction of the guide wire after complete distal advancement of the guide wire.

26. the spring arm is provided on the guide wire lever of the first user engagement component, the pocket is included in the needle hub within the housing, the insertion device according to claim 25, wherein the proximal end of the needle is attached to the needle hub.

Images